最新ニュース GSK (NYSE:GSK) 株価情報

In the pharmaceutical industry, GSK ranks as one of the largest firms by total sales. The company wields its might across several therapeutic classes, including respiratory, cancer, antiviral, and vaccines. GSK uses joint ventures to gain additional scale in certain markets like HIV.

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President Joe Biden prioritized <a href="https://www.benzinga.com/markets/cannabis/25/01/43054504/biden-commutes-sentences-of-nearly-2500-convicted-of-non-violent-drug-offenses-no-mention-of-cannabis-prisoners">freeing non-violent drug offenders</a> during his final few days in the White House, but TikTok? That's President-elect Donald Trump's problem now. 
According to the <a href="https://apnews.com/article/tiktok-ban-trump-executive-order-1e95d9836bf6f8c0c245ed1c3234d968">Associated Press</a>, Biden has no intention of enforcing the ban, which takes effect on his last full day in office, Jan. 19, and one day <a href="https://www.benzinga.com/news/25/01/42995328/trump-inauguration-from-elon-musk-jeff-bezos-to-barack-obama-george-bush-and-bill-clinton-who-all-will-attend">before Trump&#8217;s inauguration</a>.
With a deadline looming, the app's fate lands in the hands of the so-called People's Bid for TikTok—backed by none other than Kevin O'Leary of &#8220;Shark Tank&#8221; and billionaire Frank McCourt. Apparently, TikTok's U.S. assets are still up for grabs, but no word yet on the price tag or whether a deal can realistically get done <a href="https://www.benzinga.com/general/social-media/25/01/43060894/supreme-court-upholds-tiktok-ban-ahead-of-trumps-inauguration">in a few days</a>.
<h2 class="wp-block-heading">Bankruptcy Block</h2>
Joann Inc. is stitching together a bankruptcy plan for the second time within 12 months. The Ohio-based fabric and crafts retailer is seeking a buyer for its portfolio of some 800 stores. 
Gordon Brothers Retail Partners emerged as the &#8220;stalking horse&#8221; bidder, but Joann remains hopeful for better offers—perhaps from someone who knows how to thread the needle.
Previously, the 82-year-old retailer was under the stewardship of private equity firm Leonard Green &amp; Partners, which acquired it via a $1.6 billion leveraged buyout in 2011. The firm buried the company under a pile of debt (<a href="https://wolfstreet.com/2024/03/18/brick-and-mortar-meltdown-fells-another-retailer-joann-inc-files-for-bankruptcy-3-years-after-ipo/">reportedly</a> $921 million in long-term debt as of Oct. 31, 2020) and <a href="https://www.benzinga.com/news/21/03/20048728/ipo-preview-roblox-coupang-joann-lead-busy-week-of-offerings">sent it public in 2021</a>. 
Joann went private again in <a href="https://apnews.com/article/joann-bankruptcy-chapter-11-filing-75093d4032907c59a45e472dd4e23229">March</a> 2024 while under Chapter 11 bankruptcy protection. The company managed to reduce its $1 billion total debt by about $500 million at the time.
Despite efforts to save itself last year, Joann is joining the growing quilt of recent retail casualties: Party City, Big Lots, LL Flooring, The Body Shop and The Container Store <a href="https://www.benzinga.com/news/legal/24/12/42710619/deal-dispatch-party-city-wraps-big-lots-goes-bust-container-store-continues">to name a few</a>.
Kirkland &amp; Ellis is handling legal matters, while Centerview Partners LLC offers financial advice. Alvarez &amp; Marsal North America, LLC is overseeing the restructuring process.
<h2 class="wp-block-heading">New On The Block</h2>
<ul>
<li>Investment firm KKR &amp; Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KKR#NYSE">KKR</a>) hired Goldman Sachs (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GS#NYSE">GS</a>) to run an auction for its minority stake in Philippine fintech company Maya, Reuters reported. </li>
<li>New York-headquartered KKR owns more than 20% of Maya and the potential sale, if it goes through, could value Maya at more than $2 billion, one of the sources said.</li>
<li>DuPont de Nemours, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DD#NYSE">DD</a>) is looking to <a href="https://www.benzinga.com/news/large-cap/25/01/43028181/chemical-company-dupont-electronics-business-separation-retains-water-business">jettison its electronics business</a>. The Wilmington, Delaware-based company expects the transaction to be completed by Nov. 1. DuPont also decided to retain its water business after evaluating strategic alternatives.</li>
<li>Ingevity Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NGVT#NYSE">NGVT</a>) is shopping its Performance Chemicals Industrial Specialties segment, which includes divesting parts of its North Charleston, South Carolina site. The company hopes to improve earnings cash flow and conclude the review process by year-end. Whether a transaction comes about <a href="https://www.benzinga.com/news/25/01/43027745/ingevity-explores-strategic-options-for-performance-chemicals-segment-to-strengthen-portfolio-projects-fy24-revenue-at-1-40-billion">remains to be seen</a>. </li>
<li>S&amp;W Seed Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SANW#NASDAQ">SANW</a>) is up for sale. It&#8217;s also considering a merger or recapitalization as part of a larger strategic review. The Longmont, Colorado-based company has already sold its Australia subsidiary. &#8220;We continue to support all initiatives that optimize shareholder value and will consider the full range of potential strategic alternatives to ensure S&amp;W Seed is best positioned for future success,&#8221; chairman Alan Willits said.</li>
</ul>
See Also: <a href="https://www.benzinga.com/25/01/43046722/starship-explodes-during-flight-test-elon-musk-says-success-is-uncertain-but-entertainment-is-guaranteed">Starship Explodes During Flight Test, Elon Musk Says: &#8216;Success Is Uncertain, But Entertainment Is Guaranteed!&#8217;</a>
<h2 class="wp-block-heading">Updates From The Block</h2>
<ul>
<li>Lourenco Goncalves raised eyebrows during a Monday press conference. According to <a href="https://www.bloomberg.com/news/articles/2025-01-14/cliffs-ceo-rips-evil-japan-and-doubles-down-on-america-first">Bloomberg</a>, the CEO of Cleveland-Cliffs Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CLF#NYSE">CLF</a>) called Japan, a U.S. ally, &#8220;evil&#8221; and accused it of teaching China harmful practices like dumping and overproduction. His comments came as Cleveland-Cliffs eyes a new bid for U.S. Steel (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/X#NYSE">X</a>), following Biden&#8217;s decision to block Nippon Steel&#8216;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/NPSCY#OTC">NPSCY</a>) <a href="https://www.benzinga.com/trading-ideas/movers/25/01/42787508/biden-blocks-14-9b-us-steel-takeover-shares-plunge">$14 billion acquisition attempt</a>. While positioning his company as a potential buyer, Goncalves&#8217; rhetoric escalated tensions within the steel industry. Nippon is now looking to Trump to <a href="https://www.benzinga.com/news/25/01/42994950/nippon-steel-eyes-trump-administration-to-revive-15b-us-steel-deal-blocked-by-biden-well-do-whatever-it-takes">help close the deal</a>. </li>
<li>T-Mobile (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TMUS#NASDAQ">TMUS</a>) will buy Vistar Media for $600 million. The telecom company expects the deal to strengthen its advertising business, Reuters reported. </li>
</ul>
Deals in the biotech and pharmaceutical sectors piled up this week. Here&#8217;s a sample of Benzinga&#8217;s coverage:
<ul>
<li>Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) submitted an unsolicited bid to acquire all of the outstanding shares of Sage Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAGE#NASDAQ">SAGE</a>) that it does not already own <a href="https://www.benzinga.com/25/01/42957657/biogens-push-for-sage-therapeutics-could-strengthen-its-neurology-strategy-analysts-say">for $7.22 per share</a>. Goldman Sachs analyst Salveen Richter believes the proposal makes strategic sense, considering the financial success of the Zurzuvae launch for postpartum depression (PPD).</li>
<li>GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) <a href="https://www.benzinga.com/25/01/42950025/gsk-to-buy-us-based-stomach-cancer-drug-developer-for-over-1-billion">agreed to acquire</a> IDRx, Inc., a biopharmaceutical company focused on precision therapeutics for gastrointestinal stromal tumors (GIST), for $1 billion. The deal may require an additional $150 million from GSK after certain regulatory approval milestones. </li>
<li>Eli Lilly (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) scooped up Scorpion Therapeutics&#8217; early-stage <a href="https://www.benzinga.com/25/01/42949261/eli-lilly-scoops-up-scorpion-therapeutics-early-stage-cancer-program-for-25-billion">cancer program for $2.5 billion</a>. </li>
<li>Like Bristol-Myers Squibb (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) and AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) is seeking to bolster its neuropsychiatric portfolio<a href="https://www.benzinga.com/general/biotech/25/01/42948170/like-bristol-myers-squibb-and-abbvie-johnson-johnson-seeks-to-bolster-neuropsychiatric-portfolio-with-15-billion-deal"> with a $15 billion deal</a></li>
<li>Crown Laboratories (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CCK#NYSE">CCK</a>) offered to acquire all outstanding common shares of Revance Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RVNC#NASDAQ">RVNC</a>) at $3.10 per share.</li>
<li>Salarius Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLRX#NASDAQ">SLRX</a>) agreed to a deal with Decoy Therapeutics, a preclinical biotech focused on peptide conjugate therapeutics. The merged entity will target unmet needs in respiratory diseases and GI oncology.</li>
<li>Lantheus Holdings Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LNTH#NASDAQ">LNTH</a>) strengthens its radiopharmaceutical position with<a href="https://www.benzinga.com/m-a/25/01/42937565/lantheus-strengthens-radiopharmaceutical-leadership-with-350m-acquisition-of-life-molecular-imaging"> $350 million acquisition of Life Molecular Imaging</a>.</li>
</ul>
For last week&#8217;s edition of Deal Dispatch, <a href="https://www.benzinga.com/ma/25/01/42921113/deal-dispatch-td-bank-charles-schwab-eyenovia-smart-share-hit-auction-block">click here</a>.
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Deal Dispatch: Biden Punts TikTok Ban To Trump, Plus Another Legacy Retailer Goes Bankrupt

On Friday, the U.S. Department of Health and Human Services (HHS) unveiled the selection of 15 additional drugs covered under Medicare Part D for price negotiations, building on efforts to reduce <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534249/novo-nordisks-ozempic-might-be-among-2027-medicare-price-negotiation-targets" rel="noreferrer noopener">prescription drug costs</a>.
These negotiations, mandated by the Inflation Reduction Act, will take place in 2025, with the new prices slated to take effect in 2027.
The selected drugs, used to treat conditions like cancer, diabetes, and asthma, represented approximately $41 billion in Medicare Part D costs between November 2023 and October 2024, accounting for 14% of the program's total expenses.
Under the finalized <a target="_blank" href="https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower" rel="noreferrer noopener">guidance</a> for the second negotiation cycle, drug manufacturers have until February 28, 2025, to decide on their participation.
The selected drug list for the second cycle of negotiations is:&nbsp;
<ul>
<li>Novo Nordisk's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) diabetes and weight loss drugs, Ozempic, Rybelsus, and Wegovy.</li>
<li>Pfizer Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Ibrance for breast cancer and Xtandi for prostate cancer.</li>
<li>GSK Plc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Asthma and Chronic obstructive pulmonary disease treatment Trelegy Ellipta and Breo Ellipta.</li>
<li>Teva Pharmaceutical Industries Ltd.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) Huntington's disease and Tardive dyskinesia drug Austedo, Austedo XR.</li>
<li>Abbvie Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) irritable bowel syndrome treatment Linzess and depression drug Vraylar.</li>
<li>Bristol-Myers Squibb Co's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Pomalyst for a type of blood cancer.</li>
<li>Boehringer Ingelheim's lung disease drug Ofev and diabetes med Tradjenta.</li>
<li>AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) cancer drug Calquence</li>
<li>Salix Pharmaceuticals' irritable bowel syndrome drug Xifaxan</li>
<li>Merck &amp; Co Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) diabetes drug Janumet; Janumet XR.</li>
<li>Amgen Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) psoriasis drug Otezla</li>
</ul>
CMS will evaluate factors such as the drug's clinical benefit, its role in addressing unmet medical needs, and its impact on specific populations, alongside considerations for research, production, and distribution costs.
The first negotiation cycle in 2023 resulted in agreements for price reductions on 10 drugs, with discounts ranging from 38% to 79% off list prices.
The new prices, effective January 2026, are expected to save $6 billion in prescription drug costs annually and reduce out-of-pocket expenses for Medicare beneficiaries by an <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41166018/medicare-drug-price-negotiation-program-gets-final-guidance-for-second-cycle-1-5b-savings-expecte" rel="noreferrer noopener">estimated $1.5 billion</a>.
Looking ahead, CMS plans to expand the program, selecting up to 15 additional drugs for the third cycle and 20 more in subsequent cycles. The Inflation Reduction Act also introduces an out-of-pocket cap of $2,000 for Medicare Part D enrollees starting in 2025. Approximately 11 million beneficiaries are expected to benefit from the cap, saving a projected $7.2 billion annually.
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Popular Ozempic, Wegovy Selected For Next Round Of Medicare Drug Price Negotiations

<a href="https://www.cnbc.com/2025/01/17/medicare-drug-price-negotiations-list-includes-ozempic.html" title="https://www.cnbc.com/2025/01/17/medicare-drug-price-negotiations-list-includes-ozempic.html">https://www.cnbc.com/2025/01/17/medicare-drug-price-negotiations-list-includes-ozempic.html</a>

'Ozempic Is In The Next Round Of Medicare Drug Price Negotiations. See The Full List Of 15 Medications' - CNBC

The CDC issued a health advisory Thursday recommending that hospitalized patients who have tested positive for influenza be tested for the bird flu <a href="https://www.benzinga.com/general/biotech/25/01/42854890/us-records-first-human-bird-flu-death-high-levels-of-respiratory-illnesses-vaccine-stocks-rally">virus within 24 hours.&nbsp;</a>
What To Know: There have been 67 confirmed human cases of bird flu in the U.S. since 2024 and the CDC<a href="https://www.cdc.gov/bird-flu/situation-summary/index.html"> says it is</a> "watching the situation carefully and working with states to monitor people with animal exposures."
The CDC's latest H5N1<a href="https://www.cdc.gov/han/2025/han00520.html"> bird flu advisory</a> comes as new cases continue to be revealed. On Wednesday, the CDC confirmed a bird flu infection in a child in the San Francisco area who was not hospitalized and has since recovered. The CDC said it is still investigating how the child was exposed to the virus. 
Read Next: <a href="https://www.benzinga.com/general/health-care/25/01/43041254/unitedhealth-ceo-highlights-hospitals-doctors-pharmas-role-in-soaring-health-care-costs">UnitedHealth CEO Highlights Hospitals, Doctors, Pharma&#8217;s Role In Soaring Health Care Costs</a>&nbsp;
According to a Washington Post<a href="https://www.washingtonpost.com/health/2025/01/16/bird-flu-testing-patients-in-hospital/"> report</a>, Nirav Shah, CDC's principal deputy director, said the latest recommendation is meant to accelerate testing rather than increase the number of tests being performed.&nbsp;
Shah said it was prompted by cases in which infected patients were later confirmed to have bird flu, including after being discharged.
Earlier this month, the Louisiana Department of Health reported the first human death in the U.S. related to the H5N1 bird flu virus.
Vaccine Makers: Shares of vaccine-related stocks are on watch as previous bird flu developments have caused shares to spike.&nbsp;
Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) received a $176 million government contract in July to advance development of its bird flu vaccine, leveraging the same mRNA technology used in the company's COVID-19 vaccine.  
Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) has a bird flu vaccine in clinical trials<a href="https://www.benzinga.com/general/biotech/24/11/41878334/fda-gives-green-signal-to-novavaxs-covid-19-influenza-combo-vaccine-late-stage-trial"> in addition</a> to a COVID-19-influenza combination vaccine in late-stage clinical trials. 
CureVac N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) stock is also on watch as the company has started a phase I/II study on its bird flu vaccine developed in collaboration with GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>).  
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Bird Flu Raising Red Flags Among Health Officials, CDC Urges Faster Testing

<a href="https://www.washingtonpost.com/health/2025/01/16/bird-flu-testing-patients-in-hospital/">https://www.washingtonpost.com/health/2025/01/16/bird-flu-testing-patients-in-hospital/</a>
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The Centers for Disease Control and Prevention says hospitals treating people for the flu should test them for avian influenza within 24 hours.

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'As Bird Flu Affects More People And Animals, CDC Urges Faster Testing' - Washington Post

GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) expects strong momentum in the specialty business segment to continue with <a href="https://www.benzinga.com/general/health-care">growth from existing assets</a>.
At the JPMorgan Healthcare Conference, the European healthcare giant noted there will be significant launch opportunities in respiratory and oncology.
GSK <a href="https://www.gsk.com/media/11750/gsk-2025-jpm-conf-presentation-14-january-2025.pdf" target="_blank" rel="noreferrer noopener">adds</a> that the strength of these will overcome short-term vaccine challenges from external pressures in the US and China. The Brentford, U.K.-based company remains confident that Arexvy, Shingrix, and all vaccine pipelines will contribute meaningfully in the medium and longer term.
GSK has planned five new product approvals in 2025 and the forefront of these is Blenrep, an off-the-shelf ADC1 for multiple myeloma.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/01/42873977/safety-labels-updated-for-pfizer-and-gsks-rsv-vaccines-fda-adds-warning-for-rare-neurological-disorder" rel="noreferrer noopener">Pfizer And GSK&#8217;s RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder</a>
<ul>
<li>In December, data from the&nbsp;<a href="https://www.benzinga.com/pressreleases/24/12/b42397184/belantamab-mafodotin-shows-significant-overall-survival-benefit-reducing-the-risk-of-death-by-42-i" target="_blank" rel="noreferrer noopener">DREAMM-7 trial</a> of Blenrep showed a statistically significant 42% reduction in the risk of death among patients receiving the Blenrep combination (n=243) versus the <a href="https://www.benzinga.com/general/biotech/24/12/42420807/gsks-blood-cancer-drug-shows-improved-survival-compared-to-johnson-johnsons-darzalex" target="_blank" rel="noreferrer noopener">Darzalex arm (n=251) (HR 0.58)</a>.</li>
<li>The company expects peak-year sales of over $3.68 billion (over 3 billion pounds).</li>
<li>GSK added that Blenrep is most commercially impactful as the company is trying to reposition with a change in dosing. GSK said it would be cautious regarding its initial uptake as bringing back a discontinued product is a difficult journey. Launch and investment <a href="https://www.benzinga.com/general/biotech/24/11/41986367/gsk-raises-prospects-for-withdrawn-blood-cancer-drug-blenrep-to-return-to-us-market-heres-why" target="_blank" rel="noreferrer noopener">will be cautioned</a>.</li>
</ul>
Next in line is depemokimab, a long-acting IL-56 for eosinophilic-led diseases. Data showed a 72% reduction in exacerbations requiring hospitalizations. The company forecasts peak year sales of around 4 billion pounds. GSK <a target="_blank" href="https://jpmorgan.metameetings.net/events/healthcare25/sessions/58196-gsk/webcast?gpu_only=true&amp;kiosk=true" rel="noreferrer noopener">said</a> depemokimab would be exciting in terms of transition from Nucala.
GSK says another product, gepotidacin, is the first in a new class of oral antibiotics for uUTI in over twenty years.
When asked about the change in administration in the U.S., GSK CEO Emma Walmsley said, "Let's wait and see.&#8221;
&#8220;There is categorically no better return on healthcare budgets and no better intervention in public health—and stopping disease before it starts—than keeping people out of the hospital&#8230;We need to run toward these conversations with transparency and trust,&#8221; Walmsley added.
Walmsley noted that GSK invested another $800 million in a Pennsylvania manufacturing for medicines and vaccines. 
&#8220;We've got 15,000 people here,&#8221; Walmsley said. &#8220;The majority of our business development business is still here in some the most exciting cities for innovation. So we're all in on the U.S."
Just before the conference, GSK agreed to acquire&nbsp;IDRx, Inc., a biopharmaceutical company focused on precision therapeutics for&nbsp;gastrointestinal stromal tumors (GIST), <a target="_blank" href="https://www.benzinga.com/25/01/42950025/gsk-to-buy-us-based-stomach-cancer-drug-developer-for-over-1-billion" rel="noreferrer noopener">for $1 billion</a>.
Price Action: GSK stock is up 1.54% at $32.58 at last check Wednesday.
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GSK Highlights New Approvals, Vaccine Momentum At JPMorgan Healthcare Conference

GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) agreed to acquire IDRx, Inc., a biopharmaceutical company focused on precision therapeutics for <a href="https://www.benzinga.com/pressreleases/25/01/b42937762/gsk-enters-agreement-to-acquire-idrx-inc" target="_blank" rel="noreferrer noopener">gastrointestinal stromal tumors (GIST)</a>, for $1 billion.
Under the agreement, GSK could pay an additional $150 million based on regulatory approval milestones.
The acquisition includes the lead molecule IDRX-42. It&#8217;s a highly selective KIT TKI being developed as a first and second-line therapy for the treatment of GIST.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/01/42873977/safety-labels-updated-for-pfizer-and-gsks-rsv-vaccines-fda-adds-warning-for-rare-neurological-disorder" rel="noreferrer noopener">Pfizer And GSK&#8217;s RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder</a>
GIST typically presents in the GI tract, with 80% of cases driven by mutations in the KIT gene that lead to tumor cells&#8217; growth, proliferation, and survival (primary or activating mutations).
90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations) that typically lead to relapse with limited therapeutic options.
Currently, there are no approved TKIs that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT.
IDRX-42 has demonstrated activity against all key primary and secondary KIT mutations, designed to improve outcomes for patients with GIST.
Updated clinical data from StrateGIST 1, an ongoing phase 1/1b trial of IDRX-42 in patients with advanced GIST, were presented in an oral presentation at the Connective Tissue Oncology Society 2024 Annual Meeting.
Across patients with second-line or greater GIST, and amongst all KIT mutation subsets, the objective response rate (ORR) in the total efficacy evaluable population was 29% (n=87), including one complete response (CR) and 24 partial responses (PRs).
Among patients with one prior line of therapy, the ORR was 53% (n=15), including one CR and 7 PRs.
Across all patients, two of the PRs were awaiting confirmation at the time of the data cut, both of which were subsequently confirmed. The emerging durability data from StrateGIST 1 was also favorable. IDRX-42 was generally well-tolerated, and treatment-related adverse events (TRAEs) were mainly low-grade at the recommended phase Ib dose.
The transaction supports GSK&#8217;s ambitions for growth through 2031 and beyond.
GSK will also be responsible for success-based milestone payments and tiered royalties for IDRX-42 owed to Merck KGaA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/MKGAF#OTC">MKGAF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/MKKGY#OTC">MKKGY</a>) in Darmstadt, Germany.
Price Action: GSK stock is down 1.33% at $32.65 during the premarket session on the last check Monday.
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Image: Shutterstock

MKGAF

MKKGY

GSK To Buy US-Based Stomach Cancer Drug Developer For Over $1 Billion

Illumina, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ILMN#NASDAQ">ILMN</a>), a global leader in DNA sequencing and array-based technologies, today announced a pilot proteomics program to analyze 50,000 UK Biobank samples in collaboration with deCODE Genetics, Standard BioTools, Tecan, GSK, Johnson &amp; Johnson, and Novartis. The pilot program is based on Illumina's upcoming proteomics assay, Illumina Protein Prep&#x2122;, powered by SOMAmer&#xAE; technology, a next-generation sequencing (NGS) based solution that will help scale access to proteomic insights.

ILMN

Illumina Launches Proteomics Pilot with 50,000 UK Biobank Samples, Partners with GSK, J&J, and Novartis

GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and IDRx, Inc. (IDRx) today announced that they have entered into an agreement under which GSK will acquire IDRx, a Boston-based, clinical-stage biopharmaceutical company dedicated to developing precision therapeutics for the treatment of GIST. Under the agreement, GSK will pay $1 billion upfront, with potential for an additional $150 million success-based regulatory approval milestone payment. The acquisition includes lead molecule, IDRX-42, a highly selective KIT TKI being developed as a first- and second-line therapy for the treatment of GIST.

GSK To Acquire Biopharma Firm IDRx for $1B And Earnout Of Up To $150M, Targets Precision Therapy for GIST Treatment

CureVac BV (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) shares have been volatile over the past week, gaining some 25% to $4.23, amid increased trading volume following the U.S.&#8217;s first human death from H5N1 bird flu.
What To Know: While the CDC maintains that the public risk remains low, the outbreak has already devastated poultry farms across 16 states. The news has driven interest in vaccine developers, including CureVac, which is <a href="https://www.benzinga.com/general/biotech/25/01/42882233/bird-flu-sparks-vaccine-stock-surge-etfs-to-watch-as-h5n1-outbreak-intensifies">collaborating</a> with GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) to test updated mRNA-based bird flu vaccine candidates.
With <a href="https://www.benzinga.com/general/biotech/25/01/42882233/bird-flu-sparks-vaccine-stock-surge-etfs-to-watch-as-h5n1-outbreak-intensifies">$72 million</a> recently allocated by the U.S. government for bird flu vaccine production and competitors like Moderna securing substantial funding, investors speculate that CureVac could gain from similar opportunities. The company's mRNA technology could provide a next-generation solution, though its current vaccines target earlier strains. 
CureVac's relatively smaller market cap could also make it more sensitive to speculative activity, and any developments in bird flu preparedness could impact its share price significantly.
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<h2 class="wp-block-heading">How To Buy CVAC Stock</h2>
By now you're likely curious about how to participate in the market for CureVac &#8211; be it to purchase shares, or even attempt to bet against the company.
Buying shares is typically done through a brokerage account. You can find a list of <a href="https://www.benzinga.com/money/best-stock-trading-platforms">possible trading platforms here.</a> Many will allow you to buy ‘fractional shares,' which allows you to own portions of stock without buying an entire share. For example, some stock, like Berkshire Hathaway, can cost thousands of dollars to own just one share. However, if you only want to invest a fraction of that, brokerages will allow you to do so.
If you're looking to bet against a company, the process is more complex. You'll need access to an options trading platform, or a broker who will allow you to ‘go short' a share of stock by lending you the shares to sell. The process of shorting a <a href="https://www.benzinga.com/money/how-to-short-a-stock">stock can be found at this resource.</a> Otherwise, if your broker allows you to trade options, you can either buy a put option, or sell a call option at a strike price above where shares are currently trading &#8211; either way it allows you to profit off of the share price decline.
According to data from&nbsp;<a href="https://benzinga.grsm.io/register174">Benzinga Pro</a>, CVAC has a 52-week high of $5.28 and a 52-week low of $2.22.
Image courtesy of CureVac

Why CureVac (CVAC) Shares Are Volatile

The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for pharmacists, physicians and other healthcare professionals who administer vaccinations. The current presentation of the vaccine consists of a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two.&nbsp;1

The FDA Has Accepted For Review GSK's Regulatory Application Of A Prefilled Syringe Presentation Of Shingrix For The Prevention Of Shingles (Herpes Zoster), An FDA Decision Is Expected By 20 June 2025

The U.S. reported its <a href="https://www.benzinga.com/general/biotech/25/01/42854890/us-records-first-human-bird-flu-death-high-levels-of-respiratory-illnesses-vaccine-stocks-rally">first human death</a> from the H5 bird flu strain this week, causing a spike in vaccine developer stocks Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>), Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>), CureVac (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) and Pfizer (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>).
Vaccine production efforts are ramping up as health officials monitor the outbreak closely. In<a href="https://www.cdc.gov/bird-flu/situation-summary/index.html" target="_blank" rel="noreferrer noopener"> an update </a>on Monday, CDC said there have been 66 confirmed cases in the U.S. in the 2024 outbreak. 
CDC said the public risk remains low. Bird flu has severely impacted poultry farms and cattle herds across 16 states, marking the worst outbreak of its kind.
See Also: <a href="https://www.benzinga.com/news/25/01/42851023/why-novavax-nvax-stock-is-rising">Why Novavax (NVAX) Stock Is Rising</a>
<h3 class="wp-block-heading">Vaccine Providers in the Limelight</h3>
In the U.S., vaccines against H5N1 are already stockpiled. Approved shots include those from Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), CSL Seqirus, and ID Biomedical Corporation of Quebec, a subsidiary of GlaxoSmithKline (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), which collectively secured $72 million in funding from the U.S. health department in October to boost the production of bird flu vaccines. These traditional vaccines, developed years ago, target older H5N1 strains but are expected to offer some protection.
Moderna, backed by $176 million from the U.S. government's BARDA, is working on an updated mRNA H5N1 vaccine. Other players, including Pfizer and GSK (in collaboration with CureVac), are testing similar candidates.
<h3 class="wp-block-heading">ETFs in Focus</h3>
For investors who want to play the trend but are wary of choosing individual biotech stocks, here are three ETFs that offer diversified exposure to the biotech companies leading the vaccine efforts. With a mix of traditional and mRNA vaccine developers in focus, these funds could benefit as the world prepares for a potential bird flu pandemic.
iShares Genomics Immunology and Healthcare ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IDNA#NYSE">IDNA</a>) tracks the NYSE FactSet Global Genomics and Immuno Biopharma Index, and has already gained 2.5% so far this year. The fund has an expense ratio of 0.47%, and $129.97 million in assets under management (AUM). The fund has currently invested 4.48% of its assets in Moderna. Sanofi, GSK and Novavax are also part of its portfolio of 51 equity holdings.
First Trust Nasdaq Pharmaceuticals ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FTXH#NASDAQ">FTXH</a>) derives its investment strategy from the Nasdaq US Benchmark Index, and has an expense ratio of 0.60%. Pfizer is one of its top holdings, with 7.28% of assets allocated to it.
SPDR S&amp;P Biotech ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XBI#NYSE">XBI</a>) mirrors the S&amp;P&nbsp;Biotechnology Select Industry&nbsp;Index, and charges a 0.35% expense ratio. Out of its present AUM of $6.37 billion, Moderna holds 2.58%. Almost 100% of its holdings are exposed to the biotechnology sector, with only about 0.04% invested in the pharmaceutical sector.
<h3 class="wp-block-heading">The Bird Flu Menace </h3>
The bird flu scare in humans ratcheted higher in late 2024 when a 13-year-old girl in Canada fell critically ill with H5N1 and required a ventilator. Around the same time, the U.S. reported its first severe case in an elderly patient in Louisiana.
Health experts warn that vigilance is key to preventing mutations that could trigger a pandemic. While the technology to develop vaccines quickly is available, governments may need to fund large-scale clinical trials in advance to ensure rapid distribution in case of a health emergency.
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Photo: Shutterstock.

Sector ETFs

ETFs

FTXH

IDNA

Bird Flu Sparks Vaccine Stock Surge: ETFs To Watch As H5N1 Outbreak Intensifies

<a href="https://www.ft.com/content/fe25ff13-aa55-4090-aae5-8c9f96239fd8" title="https://www.ft.com/content/fe25ff13-aa55-4090-aae5-8c9f96239fd8">https://www.ft.com/content/fe25ff13-aa55-4090-aae5-8c9f96239fd8</a>

'GSK nears $1B deal for biotech developing drug for rare tumour' - Financial Times

The U.S. Food and Drug Administration (FDA) has mandated updates to the safety labeling for Pfizer Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Abrysvo and GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Arexvy respiratory syncytial virus (RSV) vaccines.
New warnings in the prescribing information highlight a potential increased risk of Guillain-Barré syndrome (GBS), a rare neurological disorder, within 42 days of vaccination based on findings from a postmarketing observational study.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42600472/your-healthcare-costs-are-soaring-us-spending-reached-5-trillion-in-2023-with-major-increase-in-obesity-and-diabetes-drugs-hospital-services" rel="noreferrer noopener">Your Healthcare Costs are Soaring! US Spending Reached $5 Trillion In 2023 with Major Increase in Obesity and Diabetes Drugs, Hospital Services</a>
GBS, a condition in which the immune system attacks nerve cells, can lead to muscle weakness and, in severe cases, paralysis.
According to the FDA, while the evidence suggests an elevated risk, it is insufficient to confirm a definitive causal link between the vaccines and the disorder.
This determination is <a target="_blank" href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and" rel="noreferrer noopener">based</a> on data from clinical trials, adverse event reports, and an observational study conducted among Medicare beneficiaries aged 65 and older.
The study, conducted between May 2023 and July 2024, utilized Medicare claims to identify cases of hospitalized GBS in individuals vaccinated with Abrysvo or Arexvy.
Using a self-controlled case series analysis, researchers compared risk windows of 1-42 days post-vaccination with control windows of 43-90 days. The findings estimate nine excess GBS cases per million doses of Abrysvo and seven per million doses of Arexvy administered to individuals aged 65 and older.
These risks reflect excess cases compared to background rates of GBS in the studied population. However, variations in background risks and analytical methods make direct comparisons to other studies challenging. The FDA emphasized that while increased risks were observed, further investigation is needed to fully understand the connection between the vaccines and GBS.
U.S. sales of RSV vaccines&nbsp;have declined after regulators narrowed the age group eligible for the shots and determined they would be a one-time vaccination for now.
For Pfizer and GSK, RSV vaccines are critical as they seek to build new revenue streams before facing generic competition for their <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41278571/gsk-pfizer-face-declining-respiratory-syncytial-virus-vaccine-sales-due-to-narrow-age-recommendat" rel="noreferrer noopener">top-selling drugs</a>.
Price Action: GSK stock is down 1.55% at $33.56, and PFE stock is down 0.18% at $27.08 during the premarket session at last check Wednesday.
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Photo via Shutterstock

Pfizer And GSK's RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder

The Louisiana Department of Health on Monday reported the first human death in the U.S. related to the H5N1 bird flu virus. The CDC is also reporting high levels of acute <a href="https://www.benzinga.com/news/25/01/42851023/why-novavax-nvax-stock-is-rising">respiratory illnesses nationwide</a>.&nbsp;
The Details: The Louisiana Department of Health said <a href="https://ldh.la.gov/news/H5N1-death">the patient</a>, who was over the age of 65 and had underlying health conditions, had been hospitalized since December after contracting the virus following &nbsp;exposure to a backyard flock and wild birds.&nbsp;
The CDC released<a href="https://www.cdc.gov/bird-flu/situation-summary/index.html"> an update </a>on the bird flu situation on Monday that said there have been 66 confirmed cases in the U.S. in the 2024 outbreak. The agency is monitoring for H5 bird flu activity in people and said the public health risk remains low at this time.&nbsp;
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Additionally, other acute respiratory illnesses including COVID-19, influenza and RSV are at high levels and are increasing nationwide, according to the CDC's respiratory illness <a href="https://www.cdc.gov/respiratory-viruses/data/index.html">data channel</a>.&nbsp;
Vaccine Makers: Shares of vaccine-related stocks are trading higher following the latest bird flu developments, as well as the rise in acute respiratory illnesses.&nbsp;
Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) manufactures an FDA-approved COVID-19 vaccine and its pipeline includes<a href="https://www.benzinga.com/25/01/42825231/why-moderna-mrna-stock-is-trading-higher"> combination vaccines</a> targeting COVID-19, RSV and flu. Moderna received a $176 million government contract in July to advance development of its bird flu vaccine, leveraging the same mRNA technology used in the company&#8217;s COVID-19 vaccine.  
Shares of Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) are also climbing. Novavax has a bird flu vaccine in clinical trials<a href="https://www.benzinga.com/general/biotech/24/11/41878334/fda-gives-green-signal-to-novavaxs-covid-19-influenza-combo-vaccine-late-stage-trial"> in addition</a> to a COVID-19-influenza combination vaccine in late-stage clinical trials. 
CureVac N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) shares rose 22% on Monday and are climbing again Tuesday. The company has started a phase I/II study on its bird flu vaccine developed in collaboration with GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>). CureVac also has an agreement with GSK to develop second-generation influenza and COVID-19 vaccines. 
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Movers

US Records First Human Bird Flu Death, High Levels Of Respiratory Illnesses: Vaccine Stocks Rally

<a href="https://ldh.la.gov/news/H5N1-death#:~:text=The%20Louisiana%20Department%20of%20Health,to%20have%20underlying%20medical%20conditions.">https://ldh.la.gov/news/H5N1-death#:~:text=The%20Louisiana%20Department%20of%20Health,to%20have%20underlying%20medical%20conditions.</a>
&nbsp;
<h3>Current general public health risk remains low</h3>
January 06, 2025
The Louisiana Department of Health reports the patient who had been hospitalized with the first human case of highly pathogenic avian influenza (HPAI), or H5N1, in Louisiana and the U.S. has died. The patient was over the age of 65 and was reported to have underlying medical conditions. The patient contracted H5N1 after exposure to a combination of a non-commercial backyard flock and wild birds.&nbsp;
LDH&#39;s extensive public health investigation has identified no additional H5N1 cases nor evidence of person-to-person transmission. This patient remains the only human case of H5N1 in Louisiana.&nbsp;
The Department expresses its deepest condolences to the patient&#39;s family and friends as they mourn the loss of their loved one. Due to patient confidentiality and respect for the family, this will be the final update about the patient.&nbsp;
While the current public health risk for the general public remains low, people who work with birds, poultry or cows, or have recreational exposure to them, are at higher risk.&nbsp;
The best way to protect yourself and your family from H5N1 is to avoid sources of exposure. That means avoiding direct contact with wild birds and other animals infected with or suspected to be infected with bird flu viruses.&nbsp;
Protecting yourself and others from H5N1 infection
<ul>
<li>Do not touch sick or dead animals or their droppings and do not bring sick wild animals into your home.</li>
<li>Keep your pets away from sick or dead animals and their feces.</li>
<li>Do not eat uncooked or undercooked food. Cook poultry, eggs and other animal products to the proper temperature and prevent cross-contamination between raw and cooked food.</li>
<li>Avoid uncooked food products such as unpasteurized raw milk or cheeses from animals that have a suspected or confirmed infection.</li>
<li>If you work on poultry or dairy farms, talk to your provider about getting your seasonal flu vaccination. It will not prevent infection with avian influenza viruses, but it can reduce the risk of coinfection with avian and flu viruses.</li>
<li>Report dead or sick birds or animals to the USDA toll-free at 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab at 318-927-3441.</li>
</ul>
If you have been exposed to sick or dead birds or other animals or work on a farm where avian influenza has been detected, watch for respiratory symptoms or conjunctivitis. If you develop symptoms within 10 days after exposure to sick or dead animals, tell your healthcare provider that you have been in contact with sick animals and are concerned about avian influenza. This will help them give you appropriate advice on testing and treatment. Stay home and away from others while you have symptoms.

NNVC

'LDH Reports First U.S. H5N1-Related Human Death' - Louisiana Department Of Health

On Friday, the China National Medical Products Administration approved&nbsp;GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Nucala&nbsp;(mepolizumab) as an add-on therapy with intranasal corticosteroids for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
The FDA <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/gsk-announces-fda-approval-for-nucala-mepolizumab-for-use-in-adults-with-chronic-rhinosinusitis-with-nasal-polyps/" rel="noreferrer noopener">approved</a> Nucala for the same indication in July 2021. This is the third indication for mepolizumab in China for an IL-5 mediated condition.
It is <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/gsk-s-nucala-mepolizumab-approved-in-china-for-treatment-of-adults-with-chronic-rhinosinusitis-with-nasal-polyps/" rel="noreferrer noopener">estimated</a> that about 107 million people in China suffer from chronic sinusitis, about 1/3 of whom have chronic sinusitis with nasal polyps.
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People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance, and nasal discharge.
CRSwNP is caused by chronic inflammation of the nasal lining, which can cause soft tissue growth, known as nasal polyps, to develop in the sinuses and nasal cavity.
Mepolizumab is already approved in China as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe eosinophilic asthma as well as for adults with eosinophilic granulomatosis with polyangiitis.&nbsp;
In September, GSK released the headline results of the MATINEE Phase 3 trial evaluating&nbsp;Nucala&nbsp;for chronic obstructive&nbsp;pulmonary <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40746735/gsks-asthma-drug-meets-main-goal-in-phase-3-study-in-patients-with-smokers-lungs-prepares-competi" rel="noreferrer noopener">disease or smoker's lungs</a>.
The trial met its primary endpoint with adding&nbsp;Nucala&nbsp;to inhaled maintenance therapy, and study results showed a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks.
In December, the FDA <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/us-fda-accepts-gsk-s-submission-for-the-use-of-nucala-mepolizumab-in-copd/" rel="noreferrer noopener">accepted</a> data from the MATINEE study for review to support the regulatory review process for Nucala, an add-on maintenance treatment for chronic obstructive pulmonary disease with an eosinophilic phenotype. The Prescription Drug User Fee Act date is 7 May 2025.
Price Action: GSK stock closed at $33.95&nbsp;on Thursday.
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Photo by HJBC via Shutterstock

GSK's Sinus Disease Drug Secures Approval In China

The China National Medical Products Administration Has Approved GSK's Nucala (Mepolizumab) As An Add-On Therapy With Intranasal Corticosteroids For Chronic Rhinosinusitis With Nasal Polyps

Pfizer hosted a discussion with sell-side analysts to provide an update on one of the vaccine pipeline items &#8211; a second-generation Clostridioides difficile (C. diff) vaccine effort in Phase 2.
Goldman Sachs analyst Chris Shibutani maintained a Buy rating on Pfizer, Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) with a <a target="_blank" href="https://www.benzinga.com/quote/PFE/analyst-ratings" rel="noreferrer noopener">price target of $33</a>.
Shibutani recalled that Pfizer had reported negative results from a Phase 3 study for a first-generation asset in March 2022, where the primary endpoint was unmet.
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Still, results did include signals from secondary endpoints that suggested reduced disease severity.
Pfizer has since been exploring updated formulations (reducing the 3-dose regimen to 2 doses), including a version in Phase 2. Immunogenicity data are anticipated in 2025, with potential for advancement into Phase 3 by the end of 2025.
For a potential Phase 3 study, Shibutani noted the objective would be to discern the potential to reduce the severity of a C. diff infection (CDI) instead of aiming to reduce the risk and prevention of disease.
Pfizer estimates ~500k infections annually in the U.S., and no vaccine options currently available. Acknowledging that there is an unmet need The analyst acknowledged that there is an unmet need and said the data thus far suggests a potential basis for a path forward for the program in the context of comments from R&amp;D leadership during the discussion Shibutani hosted with investors.
The emphasis on the forward will be on programs with the most significant potential for economic returns. The analyst expects that investor enthusiasm will likely remain relatively subdued, especially in the context of uncertainties deriving from health policy dynamics relating to vaccines, that are an overhang to sentiment.
Shibutani does not currently include revenue estimates for a C. diff vaccine in his model and looks to monitor data updates and decisions regarding plans for this program to guide his forecasts in the future.
Separately, the analyst flagged Pfizer management&#8217;s mention of the fourth generation 25-valent pneumococcal vaccine (PCV), which management affirms continues to progress in Phase 2.
Shibutani recalled that Pfizer had previously commented that the immunogenicity data from Phase 1 were encouraging, as highlighted by the improved immunogenicity observed for serotype 3.
Pfizer is currently in a Phase 2 proof-of-concept study for its second-generation Clostridioides difficile (C. diff) vaccine, PF-07831694. This vaccine targets C. diff toxins A and B, which cause Clostridioides difficile infection (CDI).&nbsp;&nbsp;
Their goal for the second generation is to build off the 1st generation&#8217;s efficacy and duration by developing a more potent, more durable formulation, allowing for a 2-dose regiment (instead of 3-dose), resulting in higher and faster series completion.
After evaluating adjuvants in formulation for their next-generation candidates, Pfizer noted they can increase the strength or magnitude of the immune response, potentially resulting in lower doses.
Pfizer advanced 1 of the three updated 2nd-generation candidates to Phase 2 based on Phase 1/2 safety and immunogenicity data.
The Phase 2 trial endpoints will evaluate the immunogenicity and safety of the 2-dose regimen. Trial data is expected in 2025, with a potential Phase 3 start in late 2025, pending positive results.
Pfizer in Phase 2 is the furthest along of the C. diff vaccine assets. Idorsia Pharmaceuticals initiated Phase 1 for their competing C. diff asset in July. Vaxxilon and Matrivax Research &amp; Development Corporation both have preclinical assets. GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) CDI vaccine completed a Phase 1 trial in 2022 but is no longer listed as a pipeline asset.&nbsp;&nbsp;
Pfizer&nbsp;stock has dropped over 11.5% year-to-date. Investors can gain exposure to the stock through SPDR S&amp;P 500 (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) and Vanguard S&amp;P 500 ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VOO#NYSE">VOO</a>).
Price Action: PFE stock is up 0.82% at $26.58 at the last check on Monday.
Also Read:
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