最新ニュース UCB (OTC:UCBJF) 株価情報

UCB is a Belgium-based biopharma firm focused on the development of novel therapies for the treatment of central nervous system and immunologic diseases. Historically, revenue was derived from allergy medicine Zyrtec and epilepsy drug Keppra, which have both lost patent protection. The firm's key products are Cimzia (immunology), Vimpat (epilepsy), Neupro (Parkinson's disease and restless leg syndrome), Briviact (epilepsy), Bimzelx (psoriasis), Evenity (osteoporosis), Nayzilam (cluster seizures), and Fintepla (Dravet Syndrome and Lennox-Gastaut Syndrome).

UCB SA

Protagonist Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTGX#NASDAQ">PTGX</a>), in collaboration with Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), released new clinical data from the Phase 3 ICONIC-TOTAL&nbsp;study investigating icotrokinra for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">scalp and genital psoriasis</a>.
Key findings from the high-impact skin sites cohort:
<ul class="wp-block-list">
<li>At week 16, 57% of patients treated with once daily icotrokinra achieved the study&#8217;s primary endpoint with an Investigator&#8217;s Global Assessment (IGA)&nbsp;b&nbsp;score of 0/1 (clear or almost clear skin) and a ≥2-grade improvement from baseline at Week 16 compared to 6% of <a href="https://www.benzinga.com/pressreleases/25/05/ac45315482/protagonist-announces-icotrokinra-phase-3-data-on-difficult-to-treat-scalp-and-genital-psoriasis-" target="_blank" rel="noreferrer noopener">patients receiving placebo</a>.</li>
<li>66% of patients with scalp psoriasis achieved a scalp-specific Investigator&#8217;s Global Assessment (ss-IGA)&nbsp;c&nbsp;score of 0/1 compared to 11% receiving placebo at 16 weeks.</li>
<li>77% of patients with genital psoriasis achieved a static Physician&#8217;s Global Assessment of Genitalia (sPGA-G)&nbsp;d&nbsp;score of 0/1 at 16 weeks, compared to 21% receiving placebo.</li>
<li>In the smaller subset of patients with hand/foot psoriasis, patients showed a numerically higher rate of skin clearance at Week 16, with 42% achieving a hand and/or foot Physician&#8217;s Global Assessment (hf-PGA)&nbsp;e&nbsp;score of 0/1 compared to 26% receiving placebo.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44737545/johnson-johnson-protagonist-partnered-investigational-psoriasis-oral-pill-shows-75-of-adolescents-achieved-completely-clear-skin" rel="noreferrer noopener">Johnson &amp; Johnson, Protagonist Tout Positive Results For Psoriasis Oral Pill Study</a>
In March, the companies announced topline results from ANTHEM-UC Phase 2b study of icotrokinra (JNJ-2113) in adults with moderately to severely active&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44220449/why-is-protagonist-therapeutics-stock-trading-higher-on-monday" rel="noreferrer noopener">ulcerative colitis (UC)</a>.
The study met its primary endpoint of clinical response&nbsp;in all icotrokinra dose groups evaluated.
Additionally, the study demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/ac44217207/protagonist-reports-positive-top-line-results-from-phase-2b-study-of-icotrokinra-showing-potentia" rel="noreferrer noopener">improvement at Week 12</a>.
The company also shared preclinical characterization of PN-881, the first-in-class oral peptide antagonist blocking the three dimeric forms of IL-17 (AA, AF and FF), at the Society for Investigative Dermatology (SID) Annual Meeting.
PN-881 represents Protagonist&#8217;s next generation of oral peptides for psoriasis. Key takeaways:
<ul class="wp-block-list">
<li>Exhibited nanomolar to picomolar in vitro potency comparable to UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) Bimzelx (bimekizumab) and superior (70-fold) to Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Consentyx secukinumab.</li>
<li>Showed metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery.</li>
<li>Demonstrated PD-based target engagement in a mouse IL-17 challenge model after oral dosing.</li>
<li>Demonstrated dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model after oral dosing.</li>
</ul>
Price Action: PTGX stock is up 1.87% at $44.74 at the last check on Friday.
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Protagonist/Johnson & Johnson Partnered Drug Shows Significant Skin Clearance In Pivotal Psoriasis Study

U.S.&nbsp;President Donald Trump, on Tuesday, disclosed plans for a "major tariff" on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
"We're&nbsp;going to be announcing very&nbsp;shortly a major tariff on&nbsp;pharmaceuticals… when they hear that&nbsp;they will leave China, they&nbsp;will leave other places because… most of their product&nbsp;is sold here," Trump expressed at&nbsp;a National Republican <a target="_blank" href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" rel="noreferrer noopener">Congressional Committee&nbsp;dinner</a>.
He also told reporters on board his Air Force One plane that "pharma" tariffs would arrive "at a level that you haven't really seen before," saying these would be announced "in the near future," BBC <a target="_blank" href="https://www.bbc.com/news/articles/cedyylj1v32o" rel="noreferrer noopener">report</a> added.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">Trump Tariff Strategy Creates ‘Self-Inflicted Market Debacle': Analyst</a>
When President Trump announced tariffs last week, he excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" rel="noreferrer noopener">on pharmaceutical imports</a>.&nbsp;
On Wednesday, in a surprise announcement from President Donald Trump, a 90-day pause on tariffs for countries that have not retaliated <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">against U.S. trade measures.</a>
The news ignited a broad risk-on rally, catapulting major indices to multi-month highs and sending volatility plunging.
Trump's latest Truth Social post slammed China for showing "a lack of respect" and declared an immediate 125% tariff hike on Chinese goods.
"At some point, hopefully in the near future, China will realize that the days of ripping off the U.S.A. and other Countries is no longer sustainable or acceptable," he said.
He praised the over 75 countries that, in his words, "have not, at my strong suggestion, retaliated in any way, shape, or form."
As a reward, those countries would benefit from a temporary 10% reciprocal tariff and a 90-day pause on additional duties.
The biopharma industry has historically been shielded from tariffs, including during Trump's first term.
Although Trump didn't provide many details, his remarks have unsettled buyers, especially those who depend on medicines from India. India provides nearly half of all generic drugs used in the U.S., helping cut billions from healthcare costs.
The U.S. is a major market, buying about a third of India's $13 billion in yearly drug exports.
Indian drug companies warn that if tariffs are added, they'd have to raise prices—which could increase healthcare costs in the U.S.
Even though some companies like Cipla and Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) have factories in the U.S., most say it's too expensive to move production for low-profit generic drugs.
BofA Securities analyst says if the Trump administration plans to impose tariffs on the pharmaceutical industry, it would likely do so through a "Section 232 investigation" under the Trade Expansion Act of 1962 to determine whether importing certain goods threatens national security.
The typical timeline for a Section 232 investigation is about a year. If the same timeline applied here, tariffs on drug imports likely wouldn't take effect until late in the year—at the earliest.
It's unclear whether the Section 232 investigation into the drug industry is about to start, but based on recent comments from the administration, it seems possible. However, launching an investigation doesn't guarantee that tariffs will follow.
As the first quarter 2025 earnings season starts soon, analyst Tim Anderson says it will be worth watching whether companies discuss potential tariffs during earnings calls.
That said, any actual earnings impact likely wouldn't show up until sometime after 2025, which could leave investors with more questions than answers.
Wedbush analyst Daniel Ives <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">on Tuesday wrote</a> that "saying we can just make this in the USA" understates how complex the supply chain in Asia really is—and how electronics, chips, semiconductors, hardware, and smartphones have been built for U.S. consumers over the past 30 years."
Shares of major drugmakers such as Gilead Sciences&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Eli Lilly&nbsp;And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Roche&nbsp;Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi&nbsp;SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Novartis&nbsp;AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Argenx&nbsp;SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB&nbsp;SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>), Novo Nordisk&nbsp;A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell on Wednesday, only reverse course later after the 90-day tariff pause.
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Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline

The Association of the British Pharmaceutical Industry (ABPI) is urging ministers to address excessive levies on manufacturers to ensure the sector remains competitive globally.
The life sciences industry, a key pillar of the UK&#8217;s economic strategy, could struggle to attract investment unless payment rates are adjusted.
Last week, the government <a href="https://www.abpi.org.uk/media/news/2025/march/uk-set-to-demand-a-third-of-pharmaceutical-company-revenue-in-second-half-of-2025/" target="_blank" rel="noreferrer noopener">proposed</a> raising the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies&#8217; National Health Service (NHS) sales in the second half of 2025.
The payment rate is the revenue companies must hand back to the government on their sales of branded medicines to the NHS. It is an additional charge to the taxes paid by companies.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44362710/uk-pharma-industry-trade-association-restores-wegovyozempic-maker-novo-nordisks-membership-after-two-years-of-suspension" rel="noreferrer noopener">UK Pharma Industry Trade Association Restores Wegovy/Ozempic Maker Novo Nordisk&#8217;s Membership After 2 Years Of Suspension</a>
UK pharmaceutical leaders from Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), Boehringer Ingelheim, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>), Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) and UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) point to the challenges to investing in the U.K.
The pharmaceutical sector <a target="_blank" href="https://www.abpi.org.uk/media/news/2025/march/medicine-levy-makes-the-uk-un-investable-say-pharma-leaders/" rel="noreferrer noopener">contributes</a> over 17.6 billion pounds ($22.76 billion) directly to the U.K. economy, with an additional 45 billion generated through research and development spillovers.
However, companies argue that growth is being stifled due to escalating mandatory payments. Under the current system, firms must pay between 23.5% and 35.6% of their branded medicine sales revenue to the NHS. This is significantly higher than other European nations, where comparable rates range from 5.7% to 9%, ABPI writes.
The ABPI report highlights that while the UK once led in medicine availability, it has slipped to ninth place in Europe over the past decade. One year after launch, medicine usage in England is only 52% of the average of comparable nations, rising to 62% after five years.
Additionally, the UK has dropped from fourth to tenth in global rankings for phase 3 clinical trials, lagging behind Spain, Germany and Italy.
Investment in UK pharmaceutical research has also declined, with the country&#8217;s share of global R&amp;D investment falling from 7.3% to 5.7% in just three years.
This marks the fastest decline of any European G7 nation. Meanwhile, NHS funding has grown by 33% in real terms over the past decade, but spending on branded medicines has been capped at annual growth rates between 1.1% and 2%, declining by 11% when adjusted for inflation.
The industry and government have long collaborated on agreements to ensure NHS access to medicines.
The latest, the Voluntary Scheme for Branded Medicines, Pricing, Access, and Growth (VPAG), was intended to realign UK payment rates with international standards. While rates for newer medicines briefly dropped to 15.1% in 2024, they surged again in 2025 to 23.5% for newer medicines, with companies still paying 10.6%-35.6% for older products.
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Pharmaceutical Firms Say UK Investment Is 'Unlikely' Unless Payment Levy Is Adressed

On Friday, UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) announced further long-term data from the Phase 3 trials and their open-label extensions, investigating Bimzelx&nbsp;(bimekizumab) in adults with moderate-to-<a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">severe plaque psoriasis (PSO)</a>.
In a subset of 153 patients from the second extension of BE BRIGHT, 67.7% achieved complete skin clearance (PASI100+)&nbsp;at five years.
Among patients with PSO only at baseline, at risk of progression to&nbsp;psoriatic arthritis, 68.7–71.6% <a target="_blank" href="https://www.ucb.com/newsroom/press-releases/article/bimzelxr-bimekizumab-bkzx-five-year-data-at-aad-2025-showed-sustained-skin-clearance-and-long-term-efficacy-in-moderate-to-severe-plaque-psoriasis" rel="noreferrer noopener">achieved</a> complete skin clearance at three years, generally consistent with the overall treated group, who achieved 72%.
In this subgroup over the five years, bimekizumab was generally well tolerated with no unexpected safety findings.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/11/42095739/fda-approves-expanded-use-of-ucbs-psoriasis-drug-for-painful-inflammatory-skin-disease" rel="noreferrer noopener">FDA Approves UCB's Psoriasis Drug For Expanded Use In Painful Inflammatory Skin Disease</a>
Concurrently, UCB released two-year data from the BE HEARD trials for Bimzelx&nbsp;in moderate to severe hidradenitis suppurativa (HS).
In 425 HS patients with ≥1 draining tunnels (DTs) at baseline, 55.7% (195/350) had no DTs at two years of treatment. 41.1% had no DTs at two years.
DTs are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring.
Among patients with one or more DTs at baseline, the proportion who had 1–2, 3–5, or &gt;5 DTs at two years <a target="_blank" href="https://www.ucb.com/newsroom/press-releases/article/bimzelxr-bimekizumab-bkzx-two-year-data-at-aad-showed-potential-to-eliminate-draining-tunnels-in-hidradenitis-suppurativa-hs-and-reduction-in-disease-burden" rel="noreferrer noopener">were</a> 26.6%, 11.1%, and 6.6%, respectively.
At two years of bimekizumab treatment, 63.6% (279/439) of patients reported no or mild skin pain, compared to 10.0% (55/551) at baseline.
Price Action: UCBJY stock is down 0.87% at $102.41 at the last check Friday.
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Europe-Based UCB's Bimzelx Data Reveals Sustained Skin Clearance In Inflammatory Skin Disorders

On Tuesday, UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) and&nbsp;Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP) for <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42054524/dapirolizumab-pegol-phase-3-data-presented-at-the-american-college-of-rheumatology-shows-significa" rel="noreferrer noopener">systemic lupus erythematosus</a>.
The drug candidate demonstrated significant clinical improvement in disease activity in patients with moderate-to-severe systemic lupus erythematosus (SLE).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41000544/biogenucb-partnered-autoimmune-disease-candidate-hits-primary-goal-in-late-stage-study-sets-stage" rel="noreferrer noopener">Biogen/UCB Partnered Autoimmune Disease Candidate Hits Primary Goal In Late-Stage Study, Sets Stage Another Pivotal Trial</a>
The results were shared at the American College of Rheumatology&#8217;s annual meeting. In the 321-subject trial, DZP was administered intravenously every four weeks.
On the primary endpoint measuring improvement of moderate-to-severe disease activity after 48 weeks, study participants receiving DZP plus standard care had a statistically significant 14.6% higher response rate (49.5%) than those receiving SOC alone (34.6%).
On the first secondary endpoint of disease activity response at Week 24, study participants receiving DZP plus SOC had a 7.9% higher response rate (46.6%) than those receiving SOC alone (38.3%). However, the difference did not reach statistical significance.
A greater response was observed across multiple clinical endpoints among participants treated with DZP, including 50% less severe disease flares than participants on standard of care alone.
Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.
In 2024, UCB and Biogen will initiate a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY.
From a stock perspective, William Blair writes that dapirolizumab isn&#8217;t significantly impacting Biogen&#8217;s valuation, as investors remain focused on Leqembi&#8217;s commercial rollout, which is still a work in progress.
The success of Biogen&#8217;s late-stage development programs is crucial for future growth, complementing opportunities from Leqembi, Skyclarys, and potentially zuranolone, especially as its multiple sclerosis business continues to feel pressure from generic competition.
Leqembi remains a growth driver, particularly with potential advancements like subcutaneous administration approval, though its progress has been slower than expected. Despite these challenges, Biogen&#8217;s modest valuation presents an upside, supported by its commercial portfolio and cost-cutting measures. The analyst maintains an <a target="_blank" href="https://www.benzinga.com/quote/biib/analyst-ratings" rel="noreferrer noopener">Outperform rating on the stock.</a>
Price Action: BIIB stock is down 0.72% at $154.31 at last check Wednesday.
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Biogen Gains Momentum With Positive Lupus Drug Results, Analyst Sees Modest Valuation Upside

On Wednesday, the FDA approved UCB SA&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) Bimzelx&nbsp;(bimekizumab-bkzx) for adults with moderate to severe hidradenitis suppurativa (HS).
Bimekizumab-bkzx is the first and only approved medicine <a target="_blank" href="https://www.ucb.com/stories-media/Press-Releases/article/UCB-receives-US-FDA-approval-for-BIMZELXR-bimekizumab-bkzx-as-the-first-IL-17A-and-IL-17F-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa" rel="noreferrer noopener">designed</a> to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40549706/belgium-based-pharma-firm-ucb-to-offload-china-neurology-allergy-business-for-680m-to-asset-manag" rel="noreferrer noopener">Belgium-Based Pharma Firm UCB To Offload China Neurology, Allergy Business For $680M To Asset Management Companies</a>
Hidradenitis suppurativa is a chronic inflammatory skin disease.
The main symptoms are nodules, abscesses, and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin, and buttocks.
Data from two Phase 3 studies, BE HEARD I and BE HEARD II, support the approval.
Results showed that a higher proportion of patients treated with bimekizumab-bkzx vs. placebo achieved a 50% or greater improvement in signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials.
Bimekizumab-bkzx treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16. Clinical responses were sustained to Week 48.
This FDA approval of bimekizumab-bkzx for adults with moderate to severe hidradenitis suppurativa follows its recent approvals for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis.
Bimekizumab-bkzx was first approved in the U.S. in October 2023 for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
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Image via Adobe Stock

FDA Approves UCB's Psoriasis Drug For Expanded Use In Painful Inflammatory Skin Disease

Tuesday, UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>)&nbsp;and&nbsp;Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>)&nbsp;released topline results from the Phase 3 PHOENYCS GO study of dapirolizumab pegol for moderate-to-severe systemic <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g40994898/ucb-and-biogen-announce-positive-topline-results-from-phase-3-study-of-dapirolizumab-pegol-in-syst" rel="noreferrer noopener">lupus erythematosus (SLE)</a>.
SLE is&nbsp;a chronic autoimmune disease that can affect many organs in the body.&nbsp;It occurs when the body&#8217;s immune system attacks healthy tissue, causing inflammation and sometimes permanent tissue damage.
SLE can present itself in several ways, including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, seizures or psychosis.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40514109/biogens-alzheimers-drug-secures-uk-approval-but-an-independent-agency-does-not-recommend-reimburs" rel="noreferrer noopener">Biogen&#8217;s Alzheimer&#8217;s Drug Secures UK Approval, But An Independent Agency Does Not Recommend Reimbursement</a>.
Dapirolizumab pegol, in addition to standard-of-care (SOC) treatment, met the primary endpoint to demonstrate greater improvement of moderate-to-severe disease activity after 48 weeks versus placebo in addition to SOC. The study enrolled 321 patients.
Clinical improvements were observed among key secondary endpoints measuring disease activity and flares.
The safety profile of dapirolizumab pegol was generally consistent with previous studies and with that expected in study participants with systemic lupus erythematosus receiving an immunomodulator.
UCB and Biogen are initiating a second Phase 3 trial of dapirolizumab pegol in 2024, PHOENYCS FLY.
Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.
Detailed results from the PHOENYCS GO study will be presented at an upcoming medical congress.
Price Action: At last check Tuesday, BIIB stock was up 1.66% at $199.06 during the premarket session.
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</ul>

Biogen/UCB Partnered Autoimmune Disease Candidate Hits Primary Goal In Late-Stage Study, Sets Stage Another Pivotal Trial

Truist Securities initiated coverage on Longboard Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LBPH#NASDAQ">LBPH</a>), citing it as a CNS-focused biotech with <a target="_blank" href="https://www.benzinga.com/quote/Lbph" rel="noreferrer noopener">high-value epilepsy assets</a>.
The company plans to advance its lead drug bexicaserin&nbsp;(LP352), into the Phase 3 program later this year.
The FDA has granted Breakthrough Therapy designation for bexicaserin for seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older.
Earlier this year, Longboard reported topline data from the PACIFIC Phase 1b/2a trial evaluating bexicaserin in <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/01/36454681/theres-optimism-around-longboard-pharmaceuticals-anti-seizure-candidate-analyst-boo" rel="noreferrer noopener">participants with DEEs</a>.
Recently, the company revealed interim results from its ongoing 52-week open-label extension of the PACIFIC Study evaluating bexicaserin (LP352) in participants ages 12-65 with DEEs.
Bexicaserin achieved an overall median seizure reduction of 57.7% in countable motor seizures over an approximate 9-<a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b40763452/longboard-pharmaceuticals-announces-positive-interim-analysis-results-from-the-open-label-extensio" rel="noreferrer noopener">month treatment period</a>.
Longboard is also evaluating LP659, which is in development for the potential treatment of rare neuroinflammatory conditions.
Truist writes bexicaserin is competitive to current market leader UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) Fintepla (fenfluramine) in epilepsy.
The analyst initiates with a Buy rating and a <a target="_blank" href="https://www.benzinga.com/quote/LBPH/analyst-ratings" rel="noreferrer noopener">price target of $60</a>.
Fintepla is on track for approximately $1 billion in estimated sales by 2027 per UCB Pharma.
The analyst notes that, unlike fenfluramine, bexicaserin does not bind to the 5HT2B receptor, which is linked to the heart-related side effects seen with Fintepla.
&#8220;Based on bexicaserin&#8217;s superior safety and comparable efficacy to Fintepla, we think bexicaserin could not only displace Fintepla but also further expand the market, which remains under-penetrated at around 5%,&#8221; Truist analyst writes.
Price Action: LBPH stock is up 0.20% at $34.58 at last check Tuesday.
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</ul>

Initiation

LBPH

Longboard Pharmaceuticals Boasts High-Value Epilepsy Assets, Analyst Initiates Coverage

Thursday, Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) announced the submission of a Biologics License Application (BLA) to the FDA seeking the first approval of nipocalimab globally for generalized <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/n40623420/johnson-johnson-seeks-first-approval-of-nipocalimab-to-treat-broadest-population-living-with-antib" rel="noreferrer noopener">myasthenia gravis (gMG)</a>.&nbsp;
gMG is an autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
The update marks the first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce autoantibody levels.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/04/38189788/cartesian-therapeutics-rare-disease-candidate-shows-long-lasting-benefit-over-argen" rel="noreferrer noopener">Cartesian Therapeutics&#8217; Rare Disease Candidate Shows Long Lasting Benefit Over Argenx&#8217;s Vyvgart, Analyst Initiates With Buy</a>.
The application included data from the Phase 3 Vivacity-MG3 study, which showed that outcomes for a broad population of antibody-positive participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC.
In the Phase 3 VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving a statistically significant reduction in MG-ADL score from baseline over weeks 22 to 24 <a target="_blank" href="https://www.benzinga.com/general/biotech/24/02/36938146/new-hope-for-patients-with-chronic-autoimmune-conditions-johnson-johnsons-investigational-drug-me" rel="noreferrer noopener">compared with placebo</a>.&nbsp;
Earlier this year, at the American Academy of Neurology Annual Meeting, Johnson &amp; Johnson&nbsp;presented data&nbsp;on the molecular properties of nipocalimab.
Last year, the FDA approved&nbsp;UCB SA&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>)
Rystiggo (rozanolixizumab-noli) for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/06/33029533/fda-approves-rystiggo-the-only-treatment-for-two-most-common-subtypes-of-generalized-myasthenia-g" rel="noreferrer noopener">kinase (MuSK) antibody positive</a>.
The company says Rystiggo is the only FDA-approved treatment in adults for anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
Johnson &amp; Johnson&#8217;s drug will also compete with Argenx SE&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>) Vyvgart Hytrulo for gMG in adult patients who are anti-acetylcholine&nbsp;<a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/23/06/32942320/argenxs-vyvgart-hytrulo-becomes-first-fda-approved-subcutaneous-option-for-generali" rel="noreferrer noopener">receptor antibody positive</a>.&nbsp;
The drug is available in subcutaneous and intravenous injections.
Price Action: JNJ stock is up 0.36% at $164.51 at the last check on Thursday.
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</ul>
Image By Sundry Photography Via Shutterstock

Johnson & Johnson Seeks FDA Approval For Muscle Weakness Drug And Gears Up Showdown With Argenx and UCB

European&nbsp;biopharmaceutical company UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) announced a $680 million strategic divestment deal in China.
The transaction involves the sale, divestment, and license of UCB&#8217;s mature business (neurology and allergy) in China to CBC Group, an Asia-based healthcare-dedicated asset management group, and Mubadala, an Abu Dhabi-based investment company.
&#8220;In the short term, UCB is exploring the launch of novel medicines in immunology, neurology, and rare diseases in China,&#8221; <a target="_blank" href="https://www.ucb.com/stories-media/Press-Releases/article/UCB-to-Accelerate-Innovation-and-Strategic-Partnerships-Divesting-Mature-Product-Portfolio-in-China" rel="noreferrer noopener">stated</a> Jean-Christophe Tellier, CEO of UCB.
&#8220;The demand for central nervous system products in China has been increasing over the past decade, and by leveraging CBC&#8217;s unique investor-operator approach, we are excited to channel our expertise, resources, and platform synergies to meet these evolving needs and drive value for our stakeholders,&#8221; said Fu Wei, Chief Executive Officer of CBC Group.
The scope of this divestment includes UCB&#8217;s neurology portfolio (Keppra, Vimpat, Neupro) and allergy portfolio (Zyrtec, Xyzal) in Mainland China and UCB&#8217;s Zhuhai manufacturing site.
This transaction will allow UCB to focus its efforts on innovation and partnerships, ensuring that its strategic goals align with the evolving demands of the Chinese market.
Combined net sales for these medicines in China for 2023 were 131 million euros. The transaction is expected to close in the fourth quarter of 2024.
This agreement does not impact UCB&#8217;s financial guidance for 2024. For 2025, a marginal dilution of the adjusted EBITDA margin is anticipated.
The adjusted EBITDA margin for 2025 is expected to remain unchanged at the low end of the range of low to mid-thirties in percent of revenue.
Photo via Shutterstock
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</ul>

Asset Sales

Belgium-Based Pharma Firm UCB To Offload China Neurology, Allergy Business For $680M To Asset Management Companies

Tuesday,&nbsp;Longboard Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lbph#NASDAQ">LBPH</a>) released topline data from the PACIFIC Phase 1b/2a study evaluating bexicaserin (LP352) for seizures associated with a broad range of Developmental&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/24/01/36451590/neurology-focused-longboard-pharmaceuticals-stock-soars-over-200-today-heres-why" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">and Epileptic Encephalopathies (DEEs)</a>.
Cantor Fitzgerald&nbsp;writes that the data are among the best reported for seizure meds, with a median 53% reduction in seizures across subtypes (~33% placebo adjusted).
Even though there were just four patients with Dravet Syndrome in the trial, the median seizure reduction achieved with bexicaserin was a remarkable 72%. This level of reduction is comparable to what&nbsp;UCB SA&#39;s&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ucbjy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">UCBJY</a>) (OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ucbjf#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">UCBJF</a>) Fintepla has demonstrated, a bar Cantor initially believed bexicaserin couldn&#39;t reach.
Cantor says &quot;in light of these excellent results&quot; that the price target for LBPH stock has been raised from $35 to $55,&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/LBPH/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">with an overweight rating</a>.&nbsp;
Cantor notes that the increased price target might still prove highly conservative since it hasn&#39;t yet reflected the broad &quot;DEE&quot; opportunity in the model.&nbsp;
The analyst awaits additional clarity on that path before incorporating.
The analyst lowered the discount rate from 14% to 12% and factored in less dilutive equity raises, given the stock action.
Cantor analyst notes LBPH remains a top pick - with even higher conviction now that the program is substantially derisked. The analyst sees peak bexicaserin sales of over $1 billion and potentially over $2 billion.
Price Action:&nbsp;LBPH shares are up 222.60% at $19.45 on the last check Tuesday.

Price Target

Small Cap

There's Optimism Around Longboard Pharmaceuticals' Anti-Seizure Candidate: Analyst Boosts Price Target

Raymond James&nbsp;initiated coverage on&nbsp;Dianthus Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dnth#NASDAQ">DNTH</a>), a recent reverse merger with the old Magenta Therapeutics.
The analysts initiate with an Outperform rating and a&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/DNTH/analyst-ratings" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">price target of $24</a>.
The lead asset, DNTH103, is an antibody designed to target active C1s, a key component in the classical pathway, and is protected by intellectual property rights until 2043.
This targeting strategy has been de-risked, especially in light of&nbsp;Sanofi SA&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) approval of Enjaymo, an antibody targeting total C1s for Cold Agglutinin Disease (CAD). However, DNTH103&#39;s focus on active C1s offers distinct advantages, such as avoiding the protein sink associated with total C1s.
Dianthus is initiating a Phase 2 gMG study with a target product profile that will potentially offer dosing advantages and safety advantages over prevailing comps. Phase 2 data are expected by 2H25. With clear data precedents in gMG, it will be easy to know if DNTH103 is an active and promising drug for gMG. Based on disease biology and PK/PD data, analysts expect DNTH103 to be at least as efficacious as&nbsp;AstraZeneca Plc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) Soliris/Ultomiris or&nbsp;Ra Pharmaceuticals, a subsidiary of&nbsp;UCB SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) Zilucoplan.
Dianthus is commencing a Phase 2 study for gMG, with a target product profile with the potential for improved dosing and safety advantages compared to current competitors. Anticipated Phase 2 data results are slated for 2H of 2025. Given the well-established data benchmarks within the gMG field, it will be straightforward to determine if DNTH103 demonstrates active and promising qualities for gMG treatment. Based on our understanding of the disease&#39;s biology and pharmacokinetic/pharmacodynamic data, DNTH103 is expected to exhibit efficacy at least on par with&nbsp;AstraZeneca Plc&#39;s&nbsp;(NASDAQ:&nbsp;AZN) Soliris/Ultomiris or Zilucoplan from&nbsp;Ra Pharmaceuticals, a subsidiary of&nbsp;UCB SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>).
Price Action:&nbsp;DNTH shares are up 1.80% at $13.55&nbsp;on the last check Thursday.

Markets

DNTH

Dianthus' Monoclonal Antibody On Promising Pathway To Gaining The Upper Hand - Analyst

Needham&nbsp;initiated coverage on&nbsp;MoonLake Immunotherapeutics&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mltx#NASDAQ">MLTX</a>) with a Buy rating and&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/MLTX/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">a price target of $76</a>.&nbsp;
The analysts&nbsp;Serge Belanger&nbsp;and Rohit Bhasin note the company&#39;s lead product developing sonelokimab (SLK), a dual IL-17A/-17F inhibitor nanobody for chronic dermatological ailments like hidradenitis suppurativa (HS) and psoriasis (PsO), outshining established biologics in terms of efficacy.
The analysts expound that SLK has positioned itself as a potential best-in-class treatment, boasting remarkable efficacy that surpasses that of well-known biologics.&nbsp;
The differentiation comes through its innovative approach of concurrently inhibiting both IL-17A and IL-17F, promising a robust and holistic mode of action.
What further adds to SLK&#39;s allure is its applicability to various indications, offering a collective market opportunity estimated at a substantial $30 billion.&nbsp;
Anticipated growth projections propel this figure even higher, with the market value expected to swell to a noteworthy $40 billion-$50 billion by the mid-2030s.
The analysts emphasize that the upcoming six months hold significant promise for MoonLake Immunotherapeutics. They anticipate a flurry of catalysts and news releases that could drive additional value.&nbsp;
Furthermore, this could amplify the company&#39;s desirability as an acquisition target for major pharmaceutical players deeply invested in these chronic indications,&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/07/33244249/moonlakes-potential-sale-stock-price-up-fivefold-since-public-debut-in-2022" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">armed with a biologics portfolio</a>.
Needham sees&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) bimekizumab and izokibep by&nbsp;Acelyrin Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/slrn#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">SLRN</a>) as the main competitors to SLK.
In late June, SLK demonstrated efficacy results in HS that&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/06/33001374/why-moonlake-immunotherapeutics-stock-is-shooting-higher-today" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">appear superior to those of bimekizumab</a>, and izokibep has yet to demonstrate placebo-controlled efficacy results that rival those of SLK or bimekizumab.
Price Action:&nbsp;MLTX shares are down 0.11% at $56.13 on the last check Thursday.

MLTX

SLRN

Skin Disease Focused MoonLake Immunotherapeutics Poised To Outshine Rivals, Analyst Asserts

The FDA approved&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) Rystiggo (rozanolixizumab-noli) for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/06/n33019645/ucb-announces-u-s-fda-approval-of-rystiggo-rozanolixizumab-noli-for-the-treatment-of-adults-with-g" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">kinase (MuSK) antibody positive</a>.
The company says Rystiggo is the only FDA-approved treatment in adults for anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
The FDA approval is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study. The primary efficacy endpoint was comparing the change from baseline between treatment groups in the MG-ADL total score, a measurement tool that assesses the impact of gMG on the daily functions of 8 signs or symptoms.
A statistically significant difference favoring Rystiggo was observed in the MG-ADL total score change from baseline [-3.4 points in the Rystiggo-treated group at either dose vs. -0.8 points in the placebo-treated group.
Rystiggo will be commercially available in the U.S. during Q3 of 2023.&nbsp;
Last week, the FDA approved&nbsp;Argenx SE&#39;s&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/argx#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">ARGX</a>) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), an injection for subcutaneous (SC) use for gMG in adult patients who are anti-acetylcholine receptor antibody positive. These patients represent approximately&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/analyst-ratings/analyst-color/23/06/32942320/argenxs-vyvgart-hytrulo-becomes-first-fda-approved-subcutaneous-option-for-generali" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">85% of the total gMG population</a>.

FDA Approves Rystiggo: The Only Treatment for Two Most Common Subtypes of Generalized Myasthenia Gravis in Adults

<ul>
<li>Cantor Fitzgerald&nbsp;has initiated coverage on&nbsp;MoonLake Immunotherapeutics&nbsp;AG&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mltx#NASDAQ">MLTX</a>) with an Overweight rating and a&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/MLTX/analyst-ratings" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">price target of $23</a>.&nbsp;</li>
<li>MoonLake&#39;s lead program Sonelokimab or SLK (IL-17A &amp; IL-17F nanobody), is currently in Phase 2 trials in Hidradenitis Suppurativa (HS-severe skin disease) and Psoriatic Arthritis (PsA).&nbsp;</li>
<li>A more than $5 billion opportunity for SLK in HS is the primary driver of the analyst&#39;s bullish view.&nbsp;</li>
<li>Also See:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/analyst-ratings/analyst-color/22/07/28155579/hc-wainwright-starts-coverage-on-this-best-in-class-agent-for-inflammatory-disorder" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">HC Wainwright Starts Coverage On This &#39;Best-In-Class Agent For Inflammatory Disorders</a>.</li>
<li>After recent positive phase 3 trials from competitor IL-17 injectables,&nbsp;Novartis AG&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvs#NYSE">NVS</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/02/tr30717197/patients-with-hidradenitis-suppurativa-experienced-sustained-efficacy-and-symptom-improvement-at-" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Cosentyx</a>&nbsp;and&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/02/n25695387/health-canada-approves-bimzelx-bimekizumab-for-the-treatment-of-adults-with-moderate-to-severe-pla" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Bimekizumab</a>&nbsp;raise the analyst&#39;s confidence that SLK will work in HS and will likely raise the efficacy bar.&nbsp;</li>
<li>Approval of IL-17 injectables over the next few years will significantly expand the HS market, and SLK could be a ~$1.5 billion drug.&nbsp;</li>
<li>SLK is also de-risked in PsA. In September, FDA signed off Phase 2 study of sonelokimab for&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/09/29010373/fda-clears-moonlakes-nanobody-study-for-arthritis-patients" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">active psoriatic arthritis</a>.&nbsp;</li>
<li>This is a good entry point and timing for buying MLTX shares. The valuation is inexpensive relative to other immunology peers and has a strong catalyst path over the next 12 months.</li>
<li>Price Action:&nbsp;MLTX shares are up 4.79% at $17.08 on the last check Tuesday.</li>
</ul>

Cantor On MoonLake Immunotherapeutics - Initiates On Inexpensive Valuation, Strong Catalyst Path

<ul>
<li>The&nbsp;<a class="editor-rtfLink" href="https://www.prnewswire.com/news-releases/fintepla-fenfluramine-oral-solution-now-fda-approved-for-treatment-of-seizures-associated-with-lennox-gastaut-syndrome-lgs-301511407.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA approved</a>&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) drug to treat seizures associated with Lennox-Gastaut Syndrome (LGS), a rare form of childhood epilepsy.</li>
<li>The drug, branded as Fintepla, is approved in the U.S. to treat another form of childhood-onset epilepsy, Davet Syndrome (DS), in patients aged two years and older.</li>
<li>LGS causes cognitive dysfunction and frequent seizures.</li>
<li>Developed by Zogenix, Fintepla is available only through a restricted drug distribution program in the U.S.</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/01/25103213/ucb-to-buy-epilepsy-focused-zogenix-in-1-9b-deal-see-the-highlights" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">UCB to Buy Epilepsy-Focused Zogenix In $1.9B Deal: See The Highlights</a>.</li>
<li>The FDA approval was supported by safety and efficacy data from a Phase 3 clinical trial in 263 patients with LGS.</li>
<li>Fintepla at a dose of 0.7 mg/kg/day significantly reduced monthly drop seizures frequency by a median of 23.7% from baseline compared to 8.7% placebo.&nbsp;</li>
<li>Nearly a fourth of those patients on FINTEPLA 0.7 mg/kg/day experienced a &ge;50% reduction in drop seizure frequency per 28 days; 18% with &ge;50% to &lt;75% reduction and 6% &ge;75% reduction.</li>
<li>Price Action:&nbsp;UCBJY shares are trading at $59.56 during the market session on the last check Monday.</li>
</ul>

UCB's Rare Childhood Epilepsy Drug Scores FDA Approval

Biogen Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/biib#NASDAQ">BIIB</a>) and&nbsp;Xbrane Biopharma AB&nbsp;have&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/02/g25463604/biogen-and-xbrane-announce-commercialization-and-license-agreement-for-proposed-biosimilar-referen" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">entered into a license agreement</a>&nbsp;to develop, manufacture, and commercialize Xcimzane, a preclinical monoclonal antibody, a proposed biosimilar referencing&nbsp;UCB SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjy#OTC">UCBJY</a>) Cimzia (certolizumab pegol)
<ul>
<li>Cimzia&#39;s primary indication is for rheumatoid arthritis in adults and axial spondylarthrosis, psoriasis, and Crohn&#39;s disease.&nbsp;</li>
<li>In 2020 global sales of Cimzia were &euro;1.8 billion. Under the agreement terms, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane.</li>
<li>Biogen will make an upfront payment of $8 million to Xbrane.</li>
<li>Xbrane can receive up to $80 million in potential milestone payments and tiered sales-based royalties.&nbsp;</li>
<li>Xbrane will be responsible for completing the preclinical development of Xcimzane, and Biogen will be responsible for all remaining development activities and costs required to achieve Marketing Authorization in all territories, including clinical development.</li>
<li>Price Action:&nbsp;BIIB shares traded 1.11% lower at $218.85 on Tuesday.</li>
</ul>

Contracts

Biogen-Xbrane Enter License Agreement For Cimzia Referenced Biosimilar, Xcimzane

UCB SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>)&nbsp;<a class="editor-rtfLink" href="https://www.ucb.com/stories-media/Press-Releases/article/Positive-Top-Line-Results-for-BIMZELXRVbimekizumab-in-Second-Phase-3-Psoriatic-Arthritis-Study" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">posted topline results</a>&nbsp;from the Phase 3 BE COMPLETE study evaluating Bimzelx (bimekizumab) for active psoriatic arthritis patients who were inadequate responders or intolerant to anti-tumor necrosis factor-alpha (anti-TNF-&alpha;) therapy.1&nbsp;
<ul>
<li>The study demonstrated that significantly more patients treated with bimekizumab achieved 50% or greater improvement in signs and symptoms of the disease compared with placebo.</li>
<li>Bimekizumab showed significant improvements over placebo at week 16 in physical function, skin clearance, physical health status, and low disease activity.</li>
<li>Based on these results, UCB plans to submit regulatory applications for bimekizumab in psoriatic arthritis in the U.S. and the European Union in Q3 of 2022.</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/01/25103213/ucb-to-buy-epilepsy-focused-zogenix-in-1-9b-deal-see-the-highlights" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">UCB to Buy Epilepsy-Focused Zogenix In $1.9B Deal: See The Highlights</a>.</li>
<li>In the latest study, bimekizumab met the primary and secondary goals in non-radiographic axSpA in Phase 3 Be Mobile 1 study&nbsp;<a class="editor-rtfLink" href="https://www.prnewswire.com/news-releases/positive-top-line-results-for-bimekizumab-in-phase-3-non-radiographic-axial-spondyloarthritis-study-301462807.html" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">disclosed</a>&nbsp;Tuesday.&nbsp;</li>
<li>Bimekizumab led to at least 40% improvement compared to baseline across measurements of disease activity, spinal pain, physical function, and inflammation at week 16.&nbsp;</li>
<li>The results add to the drug&#39;s achievement of primary and secondary goals in&nbsp;<a class="editor-rtfLink" href="https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/positive-top-line-results-bimekizumab-phase-3-ankylosing" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">another phase 3</a>&nbsp;study called Be Mobile 2.&nbsp;</li>
<li>The drug also beat out placebo at other disease activity measurements, partial remission, and nighttime pain.&nbsp;</li>
<li>Price Action:&nbsp;UCBJY shares are up 0.06% at $51.43&nbsp;during the market session on the last check Friday.</li>
</ul>

UCB's Bispecific Marks Phase 3 Win For Second Psoriatic Arthritis Study

Belgian-based&nbsp;UCB SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) has agreed to buy&nbsp;Zogenix Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/zgnx#NASDAQ">ZGNX</a>), a U.S. maker of drugs to treat seizures and rare diseases, for $1.9 billion, expanding its portfolio to treat epilepsy.
<ul>
<li><a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/01/n25101797/ucb-to-acquire-zogenix" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Investors will get $26 in cash</a>&nbsp;for every Zogenix share, plus a potential $2 per share payment if Zogenix&#39;s Fintepla drug gets regulatory approval for Lennox-Gastaut syndrome by the end of 2023.&nbsp;</li>
<li>The initial payment is 66% higher than Tuesday&#39;s closing price of $15.64.</li>
<li>Lennox-Gastaut syndrome is an orphan disease that causes seizures.&nbsp;</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/21/09/23178444/zogenixs-fintepla-shows-long-term-seizure-frequency-reductions-in-childhood-epilepsy" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Zogenix&#39;s Fintepla Shows Long-Term Seizure Frequency Reductions In Childhood Epilepsy</a>.</li>
<li>Fintepla has already received regulatory approval in the U.S. and European Union for seizures caused by Dravet syndrome, a rare form of epilepsy.</li>
<li>UCB said it would finance the deal with cash and a new term loan.&nbsp;</li>
<li>In addition to contributing to UCB&#39;s revenue growth after closing, the Zogenix deal is expected to be accretive to UCB&#39;s earnings from 2023 onwards.</li>
<li>Lazard and Barclays are UCB&#39;s financial advisors, while Bank of America Securities and SVB Leerink advised Zogenix.</li>
<li>Price Action:&nbsp;ZGNX shares surged 59.9% at $25.00 during the premarket session on the last check Wednesday.</li>
</ul>

Long Ideas

ZGNX

UCB to Buy Epilepsy-Focused Zogenix In $1.9B Deal: See The Highlights

<ul>
<li>The&nbsp;<a class="editor-rtfLink" href="https://www.ucb.com/stories-media/Press-Releases/article/UCB-Announces-European-Commission-Approval-of-BIMZELX-bimekizumab-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">European Commission has cleared</a>&nbsp;UCB&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ucbjf#OTC">UCBJF</a>) Bimzelx (bimekizumab) for moderate to severe plaque psoriasis in adults.</li>
<li>UCB&#39;s confidence lies in head-to-head studies that pitted Bimzelx against&nbsp;Novartis AG&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvs#NYSE">NVS</a>) Cosentyx (secukinumab) and found that it was better at achieving complete clearance of skin lesions at both 16 and 48 weeks.</li>
<li>Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections every four weeks to week 16 and every eight weeks after that.</li>
<li>Bimzelx has already been&nbsp;<a class="editor-rtfLink" href="https://www.nice.org.uk/guidance/gid-ta10649/documents/final-appraisal-determination-document" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">pre-approved for NHS reimbursement</a>&nbsp;by NICE. Its costs are likely &quot;similar or lower&quot; than Cosentyx and other biologics used for psoriasis.</li>
<li>Related content:&nbsp;Benzinga&#39;s Full&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/calendars/fda#historical" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA Calendar</a></li>
<li>Price Action:&nbsp;UCBJF shares are up 9.07% at $114.95 during the market session on the last check Wednesday.</li>
</ul>

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