最新ニュース Roche Holding (OTC:RHHBY) 株価情報

Roche Holding

ROCHE HLDG LTD SPONS

Roche is a Swiss biopharmaceutical and diagnostic company. The firm's bestselling pharmaceutical products include a variety of oncology therapies from acquired partner Genentech, and its diagnostics group was bolstered by the acquisition of Ventana in 2008. Oncology products account for 50% of pharmaceutical sales, and centralized and point-of-care diagnostics for more than half of diagnostic-related sales.

ROCHE HOLDING LTD S/ADR by Roche Holding Ltd

Roche Holding AG

<ul>
<li>The PATHWAY HER2 (4B5) test helps to identify patients with previously-treated,&nbsp;unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.</li>
<li>There are currently very few options for&nbsp;BTC patients as most cases are at an advanced stage at the time of diagnosis.</li>
<li>This approval represents a new indication for&nbsp;Roche's existing PATHWAY HER2 (4B5) test and expands its clinical utility by broadening the scope of patients who are eligible for HER2-targeted therapies.</li>
</ul>

News

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Roche Wins FDA Approval For The First Diagnostic To Identify Biliary Tract Cancer Patients For HER2-Targeted Therapy With ZIIHERA

<ul>
<li>The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers.</li>
<li>The test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE. &nbsp;</li>
<li>This certification follows the unprecedented decision by regulators to grant an early exemption approval for the test in Germany and Austria earlier this year.</li>
</ul>

Roche Secures CE Mark For VENTANA FOLR1 RxDx Assay, The First IHC Diagnostic For Identifying Epithelial Ovarian Cancer Patients Eligible For ELAHERE

The biopharmaceutical sector showed signs of recovery in the third quarter of 2024, fueled by increased investor optimism following the U.S. Federal Reserve&#8217;s interest rate cuts in September. 
According to GlobalData, the top 20 global biopharmaceutical companies <a href="https://www.globaldata.com/media/business-fundamentals/top-20-global-biopharmaceutical-companies-witness-2-growth-in-market-capitalization-in-q3-2024-reveals-globaldata/#:~:text=As%20a%20result%2C%20the%20top,data%20analytics%20and%20research%20company.">saw</a> a 2% rise in their combined market capitalization, reaching $4.3 trillion by the end of September, up from $4.2 trillion in June. 
This rebound highlights the industry&#8217;s potential for growth despite challenges earlier in the year.
Bristol-Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) led the market with the largest increase in capitalization, which surged by 24.6% to $105 billion. This was largely driven by advancements in its pipeline, notably the FDA&#8217;s approval of its antipsychotic drug, Cobenfy, for treating <a href="https://www.benzinga.com/general/biotech/24/09/41064867/schizophrenia-treatment-revolution-fda-approves-bristol-myers-squibb-cobenfy-as-new-class-of-trea">schizophrenia in September 2024</a>. 
Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>) also <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/11/41819570/hiv-drugmaker-gilead-reports-strongest-quarterly-performance-of-2024-analysts-boost">posted impressive growth</a>, rising 22.1% in market value, thanks to the accelerated FDA approval of Livdelzi, a treatment for <a href="https://www.benzinga.com/general/biotech/24/08/40394698/fda-approves-gileads-seladelpar-for-inflammatory-liver-disease-acquired-via-4b-cymabay-deal">primary biliary cholangitis</a>, as well as the approval of its antibody-drug conjugate, Trodelvy, for HR-/HER2- breast cancer in Japan.
Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) experienced a 19.2% jump in market capitalization, largely fueled by its <a href="https://www.benzinga.com/general/biotech/24/10/41541274/sanofi-earns-5b-q3-core-profit-on-strong-dupixent-and-vaccine-sales-raises-2024-forecast">flagship drug Dupixent</a>. The drug&#8217;s strong performance in the treatment of conditions such as asthma and atopic dermatitis, coupled with its recent EMA and FDA approvals for chronic obstructive pulmonary disease (COPD), further <a href="https://www.benzinga.com/general/biotech/24/09/41069388/fda-approves-regeneronsanofis-blockbuster-dupixent-for-smokers-lung-disease">boosted Sanofi&#8217;s standing</a>. 
Similarly, AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) saw a 15.2% increase in its market cap, driven by the continued success of its immunology drugs—Humira, Skyrizi, and Rinvoq—which together generated nearly $7 billion <a href="https://www.benzinga.com/general/biotech/24/07/39960414/abbvies-q2-earnings-beat-estimates-raises-annual-profit-on-strong-sales-from-newer-immunology-and">in Q2 2024 sales</a>.
Alnylam Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALNY#NASDAQ">ALNY</a>) joined the top 20 biopharmaceutical companies with a 14.9% rise in its market value, following its RNAi drug vutrisiran's positive results in treating ATTR <a href="https://www.benzinga.com/general/biotech/24/08/40652720/alnylam-pharmaceuticals-stock-falls-after-detailed-vutrisiran-data-for-a-condition-with-stiff-hea">amyloidosis with cardiomyopathy</a>. 
Roche Holdings AG's (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) market capitalization grew by 13.8%, spurred by the FDA&#8217;s approval of two key products, Ocrevus Zunovo for multiple sclerosis and Tecentriq Hybreza for oncology indications, the latter being the only approved subcutaneous <a href="https://www.benzinga.com/general/biotech/24/08/40652720/alnylam-pharmaceuticals-stock-falls-after-detailed-vutrisiran-data-for-a-condition-with-stiff-hea">PD-L1 inhibitor available</a>.
On the downside, Wegovy maker Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) saw an 18.2% drop in its market cap after the FDA rejected its BLA filing for the once-<a href="https://www.benzinga.com/general/biotech/24/07/39732571/fda-rejects-novo-nordisks-weekly-insulin-requests-information-related-to-manufacturing-process-ty">weekly insulin icodec</a>.
Similarly, Eli Lilly &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) reported a slight decline of 2.1%, though both companies retained their leadership in diabetes and <a href="https://www.benzinga.com/general/biotech/24/10/41622207/eli-lilly-q3-earnings-mounjaro-sales-more-than-double-takes-2-98-billion-hit-to-profit-cuts-annua">weight loss drugs</a>. 
Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) also faced a 8.2% fall in market value, largely due to disappointing sales of its HPV vaccine, <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/11/41693101/mercks-gardasil-shot-challenges-to-continue-analysts-optimistic-for-newly-approved-">Gardasil, in China</a>.
&nbsp;"The biopharmaceutical industry is poised for a recovery, fueled by multiple FDA approvals leading to a rebound in companies that have seen declines in market capitalization in previous quarters, such as Gilead Sciences and Bristol-Myers Squibb,&#8221; says GlobalData analyst.
Read Next:
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<li><a href="https://www.benzinga.com/general/biotech/24/11/41853302/adc-therapeutics-faces-competitive-oncology-market-but-analyst-sees-100-upside-heres-why">ADC Therapeutics Faces Competitive Oncology Market But Analyst Sees 100% Upside &#8211; Here&#8217;s Why</a></li>
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Bristol-Myers Squibb Leads Biopharma Recovery With Almost 25% Growth In Market Cap, But Novo Nordisk And Lilly Suffer Market Setbacks

<a href="https://www.statnews.com/2024/10/30/novo-nordisk-ozempic-wegovy-fda-available-or-in-shortage/">https://www.statnews.com/2024/10/30/novo-nordisk-ozempic-wegovy-fda-available-or-in-shortage/</a>
All doses of Novo Nordisk&#39;s blockbuster diabetes and obesity treatments are <a href="https://dps.fda.gov/drugshortages/activeingredient/semaglutide-injection">listed as available</a> on the Food and Drug Administration&#39;s drug shortage list as of Wednesday, raising the possibility that the medications could soon be taken off the list entirely, a development that could affect compounding pharmacies and patients relying on compounded drugs.
Semaglutide, the scientific name for Novo&#39;s GLP-1 diabetes drug Ozempic and obesity drug Wegovy, has been on the shortage list for over two years, with different doses being listed in shortage at various times. With all doses now listed as available, the FDA may soon pull it off the list, depending on its conversations with Novo about whether the company can sufficiently meet demand going forward.
Over the past two years, patients seeking treatment have been turning to compounding pharmacies, which make cheaper copies of branded treatments and are legally allowed to do so only when the branded treatments are listed on the FDA&#39;s shortage list.&nbsp;

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AMGN

DRIO

Hims & Hers Health, Inc. Class A Common Stock

HIMS

TERN

VANI

VKTX

Reported Earlier, 'Novo Nordisk's Ozempic and Wegovy, long in shortage, are now listed as available by FDA; It remains unclear how the update could affect patients as well as compounders' - STAT News

Shares of Alphabet Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOGL#NASDAQ">GOOGL</a>) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOG#NASDAQ">GOOG</a>) rose sharply in today's pre-market trading after the company reported better-than-expected<a href="https://www.benzinga.com/news/earnings/24/10/41611263/alphabet-q3-earnings-highlights-revenue-beat-eps-beat-google-cloud-up-35-momentum-across-the-compan"> third-quarter financial results</a>.
The company reported third-quarter revenue of $88.27 billion, up 15% year-over-year. The total beat a Street consensus estimate of $86.31 billion
Alphabet shares jumped 6% to $179.77 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Haoxi Health Technology Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HAO#NASDAQ">HAO</a>) gained 82.8% to $0.3382 in pre-market trading. Haoxi Health Technology recently posted FY earnings of 4 cents per share.</li>
<li>Starbox Group Holdings Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/STBX#NASDAQ">STBX</a>) rose 80.2% to $0.2433 in pre-market trading.</li>
<li>Digital Brands Group, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBGI#NASDAQ">DBGI</a>) shares surged 50.5% to $0.1540 in pre-market trading. Digital Brands Group shares fell around 34% on Tuesday after the company announced the pricing of $3 million public offering of 30 million common stock and pre-funded warrants at $0.10 per share.</li>
<li>Ensysce Biosciences, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ENSC#NASDAQ">ENSC</a>) gained 30.8% to $0.5430 in pre-market trading after jumping around 25% on Tuesday.</li>
<li>NerdWallet, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NRDS#NASDAQ">NRDS</a>) shares rose 28.7% to $14.57 in pre-market trading after the company reported better-than-expected fourth-quarter revenue results.</li>
<li>LogicMark, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGMK#NASDAQ">LGMK</a>) climbed 26.4% to $0.1464 in pre-market trading.</li>
<li>Reddit, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDDT#NYSE">RDDT</a>) gained 24% to $101.36 in pre-market trading after the company reported better-than-expected third-quarter financial results and issued fourth-quarter revenue guidance above estimates.</li>
<li>Polyrizon Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PLRZ#NASDAQ">PLRZ</a>) shares gained 20.7% to $1.87 in pre-market trading after dipping 65% on Tuesday. The company priced its IPO at $4.38 per unit.</li>
<li>Snap Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SNAP#NYSE">SNAP</a>) shares rose 11.2% to $12.11 in pre-market trading following better-than-expected third-quarter financial results.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>O-I Glass, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/OI#NYSE">OI</a>) shares dipped 18.4% to $10.15 in pre-market trading after the company reported worse-than-expected third-quarter financial results and issued FY24 adjusted EPS guidance below estimates.</li>
<li>Spero Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRO#NASDAQ">SPRO</a>) shares fell 18.3% to $1.07 in pre-market trading after the company announced its Phase 2a proof-of-concept study of SPR720 did not meet its primary endpoint.</li>
<li>Qorvo, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QRVO#NASDAQ">QRVO</a>) shares fell 18% to $82.40 in pre-market trading after the company reported issued weak guidance for the third quarter.</li>
<li>GlycoMimetics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GLYC#NASDAQ">GLYC</a>) fell 14.5% to $0.4189 in today's pre-market trading. GlycoMimetics shares jumped 191% on Tuesday after the company announced it will merge with Crescent Biopharma and secured $200 in funding to advance its oncology pipeline.</li>
<li>Thryv Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRY#NASDAQ">THRY</a>) fell 13.7% to $15.80 in pre-market trading after the company priced its upsized $80 million public offering of 5,715,000 common shares at $14/share.</li>
<li>Tempest Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TPST#NASDAQ">TPST</a>) fell 12.3% to $0.9645 in pre-market trading. The company recently entered into an agreement with Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a Phase 3 trial for the first-line treatment of liver cancer.</li>
<li>Ambow Education Holding Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AMBO#NYSE">AMBO</a>) shares declined 12.3% to $1.50 in pre-market trading.</li>
<li>Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SHPH#NASDAQ">SHPH</a>) declined 12.2% to $1.58 in pre-market trading as the company priced its $4.5 million public offering of 2,950,820 at-the-market under Nasdaq rules.</li>
<li>Advanced Micro Devices, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMD#NASDAQ">AMD</a>) shares fell 8.6% to $152.00 after the company reported third-quarter financial results.</li>
<li>Trump Media &amp; Technology Group Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DJT#NASDAQ">DJT</a>) fell 8.4% to $47.17 in pre-market trading after gaining around 9% on Tuesday.</li>
</ul>
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Pre-Market Outlook

Markets

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DBGI

ENSC

GLYC

GOOG

GOOGL

LGMK

NRDS

PLRZ

QRVO

RDDT

SHPH

SNAP

SPRO

STBX

THRY

Tempest Therapeutics, Inc. - Common Stock

TPST

Why Alphabet Shares Are Trading Higher By Around 6%; Here Are 20 Stocks Moving Premarket

On Wednesday, Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)&nbsp;released its&nbsp;third-quarter sales report. Sales increased 9% year over year to 15.14 billion Swiss francs (~$17.5 billion).
The company&#8217;s pharmaceuticals division reported sales of 11.62 billion Swiss francs.
Roche&#8217;s top-performing asset was the multiple sclerosis drug Ocrevus; sales increased 11% to 1.69 billion Swiss francs.
Sales of Vabysmo, an age-related macular degeneration (AMD) treatment, <a target="_blank" href="https://assets.roche.com/f/176343/x/ad8d248346/appendix-tables-q3-2024.pdf" rel="noreferrer noopener">surged</a> 59% year over year to 1.02 billion Swiss francs.
Roche <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2024-10-23" rel="noreferrer noopener">reiterated</a> its business outlook, with the growth of around mid-single digits in group sales and the high-single-digit range for core earnings-per-share.
The European drugmaker <a target="_blank" href="https://assets.roche.com/f/176343/x/03b85564df/irp231024-a.pdf" rel="noreferrer noopener">axed</a> a mid-stage chronic cough program, RG6341.
Roche also axed a Phase 3 trial for divarasib in the second-line treatment of non-small cell lung cancer (NSCLC) and started a separate Phase 3 trial in NSCLC.
The company also removed Phase 2 trials for RG6416 (bepranemab) for Alzheimer&#8217;s, RG6139 tobemstomig monotherapy + combos for solid tumors, and RG7854/ RG6346/ RG6084 ruzotolimod/xalnesiran/PDL1 LNA for HBV infection.
Reuters noted that Roche is urging regulatory authorities to block Novo Holdings&#8217; proposed $16.5 billion acquisition of CDMO giant Catalent Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CTLT#NYSE">CTLT</a>), arguing that the deal would have wide-ranging negative effects on the industry.
Novo Holdings is the controlling shareholder of&nbsp;Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>).
Last week, a coalition of unions, consumer groups, and public interest organizations wrote a letter to Lina Khan, Chair of the Federal Trade Commission (FTC), voicing strong opposition to the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41409503/after-us-senator-unions-urge-federal-trade-commission-to-block-novos-16-5b-acquisition-of-catalen" rel="noreferrer noopener">acquisition of Catalent</a>.
In the lawsuit, the coalition <a target="_blank" href="https://fingfx.thomsonreuters.com/gfx/legaldocs/byvrmlxkzpe/Consumer%20and%20Union%20Letter%20on%20Novo%20Catalent-10.17.24.pdf" rel="noreferrer noopener">contended</a> that although Novo and Eli Lilly are currently the only two competitors in the GLP-1 market, several other pharmaceutical and biotech companies—such as Viking Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VKTX#NASDAQ">VKTX</a>), Structure Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GPCR#NASDAQ">GPCR</a>), Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), Sun Pharma, Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Roche, and AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>)—have GLP-1 therapies in development.
These companies will require a CDMO partner to support the launch of their products in the coming years. Catalent is currently the only CDMO with significant experience collaborating with GLP-1 manufacturers.
Roche told Reuters that it is not directly impacted.
Reuters, citing Roche&#8217;s CEO Thomas Schinecker during a media call, highlights that limiting competition in this field would not be wise.
It adds that regulators could be making a mistake from an industry perspective. Schinecker elaborated in an analyst call that if companies start acquiring contract manufacturing organizations, market competition could decline.
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<li><a href="https://www.benzinga.com/news/24/10/41494373/whats-going-on-with-nvidia-stock-on-wednesday" target="_blank" rel="noreferrer noopener">What&#8217;s Going On With Nvidia Stock On Wednesday?</a></li>
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CTLT

GPCR

Roche's Q3 Sales Surge Led By Ocrevus, Vabysmo, Urges Regulators To Block Novo Holdings' $16.5B Catalent Acquisition

Jazz Pharmaceuticals plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JAZZ#NASDAQ">JAZZ</a>) revealed topline results from the Phase 3 clinical trial evaluating Zepzelca&nbsp;(lurbinectedin) in combination with the PD-L1 inhibitor Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) atezolizumab (Tecentriq) compared to atezolizumab alone when administered as a maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/n41328182/jazz-pharmaceuticals-announces-statistically-significant-overall-survival-and-progression-free-sur" rel="noreferrer noopener">etoposide and atezolizumab</a>.
The combination of&nbsp;Zepzelca and atezolizumab showed a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40608567/jazz-and-hikma-accused-of-delaying-sleep-disorder-generic-drug-to-maintain-high-prices" rel="noreferrer noopener">Jazz And Hikma Accused Of Delaying Sleep Disorder Generic Drug To Maintain High Prices</a>.
&#8220;The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the&nbsp;Zepzelca&nbsp;and&nbsp;atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting,&#8221; said&nbsp;Rob Iannone, executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals.
Iannone added, &#8220;These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease.&#8221;
The company plans to submit a supplement marketing application in the U.S. in the first half of 2025 to support this combination in the first-line maintenance setting.
The combination was generally well-tolerated. The preliminary safety data in the ongoing trial were consistent with the known safety profiles of&nbsp;Zepzelca&nbsp;and atezolizumab, with no new safety signals observed in the combination arm.&nbsp;
Price Action: JAZZ stock is up 4.44% at $115.97 at last check Tuesday.
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Equities

JAZZ

Jazz Pharmaceuticals' Zepzelca/Tecentriq Combo Regimen Can Potentially Delay Disease Progression, Extend Survival In Aggressive Form Of Lung Cancer

&ndash; Positive data confirm Evrysdi efficacy and safety in children first treated pre-symptomatically before 6 weeks of age, with most achieving motor milestones similar to children without SMA &ndash;
&ndash; All children were able to swallow and feed orally, with none requiring permanent ventilation &ndash;
&ndash; Evrysdi is the only non-invasive SMA therapy and is approved in over 100 countries, with more than 16,000 people with SMA treated globally &ndash;

Genentech's Evrysdi Two-Year Data Shows Promising Results In Spinal Muscular Atrophy, Most Children Treated Early Reach Key Mobility Milestones

Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) and Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) have dominated the obesity drug market with their leading therapies, Wegovy and Zepbound, but the next generation of treatments could shift this dynamic.
These new drugs, expected to hit the market by 2029, aim to surpass current efficacy levels while offering more convenient dosing options, such as oral and monthly injections. This shift, driven by innovation and competition, could change the market landscape despite Novo and Lilly&#8217;s current hold on the sector.
According to a <a target="_blank" href="https://assets.contentstack.io/v3/assets/blt4eb669caa7dc65b2/blt79266ca5d3a390c1/Obesity_Drug_Market_Report.pdf" rel="noreferrer noopener">report</a> by Morningstar, the global GLP-1 market is poised to reach $200 billion by 2031, with obesity treatment expected to account for 68% of sales.
While Novo Nordisk and Eli Lilly are projected to retain two-thirds of this market, driven by first-mover advantage and robust pipelines, new competitors could claim significant market share.
Public and private biopharma firms are increasingly focusing on cardiometabolic drug development, with 16 new obesity drugs potentially launching by 2029 the report added.
This pipeline includes candidates from major players such as <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40422774/roche-misses-out-on-weight-loss-blockbuster-drug-now-playing-catch-up-in-booming-market" rel="noreferrer noopener">Roche Holdings AG</a> (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), and private companies like Boehringer Ingelheim.
Roche released topline results from the ongoing multi-part Phase 1 trial for CT-996, showing data better compared <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39817857/obesity-drugs-focused-stocks-tumble-on-wednesday-whats-going-on-with-eli-lilly-novo-nordisk-vikin" rel="noreferrer noopener">to existing competitors</a>. Despite Novo Nordisk and Eli Lilly&#8217;s strong market positions, some analysts view their stocks as overvalued.
Achieving the market penetration needed to justify their current valuations would require near-unprecedented success, including capturing 75% of the U.S. obesity market and 95% of the global market by 2031.
Additionally, maintaining stable pricing seems unlikely, with increased competition and innovation expected to put downward pressure on drug prices.
Supply chain issues pose further challenges. Both companies face difficulties in manufacturing peptide-based drugs at scale, such as Wegovy and Zepbound.
While oral peptide drugs like high-dose Novo Nordisk&#8217;s Rybelsus and Viking Therapeutics Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VKTX#NASDAQ">VKTX</a>) <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37937068/viking-therapeutics-investigational-oral-obesity-drug-shows-reduced-weight-in-small-study" rel="noreferrer noopener">VK2735 offer alternatives</a>, they may be even harder to supply due to the higher doses required for efficacy.
Small molecule drugs, like Lilly&#8217;s orforglipron and Pfizer&#8217;s<a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/07/39753273/with-oral-anti-obesity-candidate-development-pfizer-seeks-relevant-and-competitive-" rel="noreferrer noopener"> danuglipron</a>, offer the best potential for scalable production, promising more streamlined manufacturing processes.
New entrants to the obesity drug market are pushing the envelope, with drug candidates from companies like Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), Altimmune Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALT#NASDAQ">ALT</a>), and Zealand Pharma (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ZLDPF#OTC">ZLDPF</a>) on the horizon.
In a phase 1 study, Amgen&#8217;s AMG 133 showed an acceptable safety and tolerability profile and pronounced <a target="_blank" href="https://www.benzinga.com/general/biotech/24/02/36934096/weight-loss-drugs-new-entrant-amgen-to-compete-with-novo-nordisk-eli-lilly-as-investigational-wei" rel="noreferrer noopener">dose-dependent weight loss</a>.&nbsp;
Altimmune said the body composition study of pemvidutide showed preservation of lean mass, with 25.5% of weight loss derived from lean mass and 74.5% <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37958653/why-is-obesity-drug-developer-altimmune-stock-trading-lower-on-wednesday" rel="noreferrer noopener">from adipose tissue</a>.
These next-generation drugs could challenge the dominance of Novo and Lilly, especially if they offer better efficacy or fewer side effects.
However, Wegovy and Zepbound&#8217;s entrenched positions and ongoing innovation may keep Novo and Lilly at the forefront for the foreseeable future.
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</ul>
Photo by Tobias Arhelger via Shutterstock

Analyst Color

Analyst Ratings

ZLDPF

Novo Nordisk, Eli Lilly Could Face Downward Pressure Despite Market Dominance From Potentially 16 New Obesity Drugs: See The Names

Tempest Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TPST#NASDAQ">TPST</a>) stock is trading higher on Thursday, with a strong session volume of over 23 million as per data from <a href="https://www.benzinga.com/pro/feature/newsfeed" target="_blank" rel="noreferrer noopener">Benzinga Pro</a>.
The company entered into an agreement with Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a Phase 3 trial for the first-line <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/g41268391/tempest-announces-agreement-with-roche-to-support-advancement-of-amezalpat-combination-therapy-int" rel="noreferrer noopener">treatment of liver cancer</a>.
Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study.
This agreement builds on a clinical collaboration between the companies under which amezalpat was combined with atezolizumab and bevacizumab in first-line HCC patients and compared to atezolizumab and bevacizumab alone in a randomized Phase 1b/2 study.
Tempest retains all development and commercial rights to amezalpat.
&#8220;Based on the positive Phase 2 data, I believe this combination therapy holds the potential to significantly improve first-line liver cancer treatment, and we look forward to amezalpat moving into this pivotal Phase 3 study,&#8221; said Stephen Brady, president and CEO of Tempest.
In June, Tempest reported updated survival data from the ongoing global randomized Phase 1b/2 study, demonstrating a six-month improvement in median overall survival (OS) for patients receiving the combination therapy compared to the control arm of atezolizumab and bevacizumab alone.
The survival benefit observed in the amezalpat arm was also maintained in key subpopulations.
These June data build upon previously released data from the primary analysis showing that the amezalpat combination therapy provided clinical benefit regardless of PD-L1 status and in patients with both immune excluded and immune desert tumors.
Patients with a mutation in the beta-catenin gene had an increased objective response rate, and a longer median OS was observed in the updated data set. Both were supported by amezalpat&#8217;s purported mechanism of action.
The company is preparing for the Phase 3 study to start in the first quarter of 2025.
Price Action: TPST stock is up 23% at $1.66 during the premarket session at last check Thursday.
Photo via Shutterstock
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</ul>

Contracts

Why Is Cancer Focused Tempest Therapeutics Stock Trading Higher On Thursday?

Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study. This agreement builds on a clinical collaboration between the companies pursuant to which amezalpat was combined with atezolizumab and bevacizumab in first-line HCC patients and compared to atezolizumab and bevacizumab alone in a randomized Phase 1b/2 study. Tempest retains all development and commercial rights to amezalpat.

Tempest Therapeutics Enters Agreement With Roche To Advance Evaluation Of Amezalpat Combination Therapy

Bio-Path Holdings, Inc., (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BPTH#NASDAQ">BPTH</a>) stock is trading higher on Tuesday with a strong session volume of 25.89 million compared to an average of 328.97K as per data from Benzinga Pro.
The company initiated a therapeutic program to develop BP1001-A for treating obesity and <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/g41224384/bio-path-holdings-initiates-development-of-therapeutic-program-for-treatment-of-obesity" rel="noreferrer noopener">related metabolic diseases</a>. This program marks the first application of DNAbilize technology to develop a non-cancer application.
The company expects to begin preclinical studies to confirm these assumptions in the fourth quarter of 2024.&nbsp;These studies are expected to provide crucial insights into the mechanism and efficacy of BP1001-A in enhancing insulin sensitivity and reveal its therapeutic potential for obesity and Type 2 diabetes.&nbsp;
The company also reported completion of enrollment in the third dosing cohort of its ongoing Phase 1/1b clinical trial evaluating BP1002 for refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclax-resistant patients.
AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) and Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Genentech have partnered for Venclexta (venetoclax).
In August, Bio-Path provided an update from its ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reported continued patient progress from its ongoing Phase 2 triple combination study of prexigebersen&nbsp;in <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40495366/what-happened-with-bio-path-stock-today" rel="noreferrer noopener">Acute Myeloid Leukemia</a>.
The cohort enrolled more quickly than projected, within six weeks, which underscores the ongoing need for new treatment options for these relapsed/refractory patients.
Bio-Path says that by targeting the key protein involved in the venetoclax treatment at the mRNA level, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment.
Price Action: At last check Tuesday, BPTH stock was up 51.50% at $1.30 during the premarket session.
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</ul>

BPTH

SAVA

Nano-Cap Bio-Path Takes Plunge In Weight Loss Race, Initiates Obesity Program With Drug Candidate Under Development For Blood Cancer

Scholar Rock&nbsp;Holding (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRRK#NASDAQ">SRRK</a>) stock is trading higher on Monday after the company released topline results from the Phase 3 SAPPHIRE trial of apitegromab in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/b41203511/scholar-rock-reports-apitegromab-meets-primary-endpoint-in-phase-3-sapphire-study-in-patients-with" rel="noreferrer noopener">spinal muscular atrophy</a>.
The study achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement for apitegromab versus placebo in motor function in SMA patients on chronic dosing of standard-of-care therapies.
Standard therapies include Biogen Inc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) Spinraza (nusinersen) and Roche Holdings AG&#8216;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Evrysdi (risdiplam).
In the main efficacy population (ages 2-12), the mean difference in change from baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) was 1.8 points (p=0.0192) for all patients receiving apitegromab 10 mg/kg and 20 mg/kg (n=106) compared to placebo (n=50).
Patients receiving 20 mg/kg of apitegromab (n=53) showed a 1.4-point mean difference compared to placebo (p=0.1149).
The prespecified analysis of the 10 mg/kg dose showed that patients receiving 10 mg/kg of apitegromab (n=53) improved by 2.2 points (nominal p=0.0121) compared to placebo.
Motor function outcomes were meaningful and consistent across the main efficacy population, and the exploratory population ages 13-21 favored apitegromab (n=22) compared to placebo (n=10).
Thirty percent of patients receiving apitegromab had a >3-point improvement in HFMSE compared to 12.5% of patients on placebo.
Patients receiving apitegromab demonstrated early motor function improvement compared to placebo from the first measured time point at 8 weeks, benefit expanded at 52 weeks as measured by HFMSE.
Treatment with apitegromab was well-tolerated across all age groups.
The company plans to submit an FDA and European marketing applications in the first quarter of 2025.
Price Action: SRRK stock is up 320.2% to $31.43 at last check Monday.
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</ul>
Photo: Shutterstock

BIIB

SRRK

Scholar Rock's Muscle Wasting Drug Excels In Pivotal Trial, Plans FDA Submission Next Year

The United States may have reached a turning point in its <a href="https://www.benzinga.com/general/biotech/24/10/41137681/eli-lilly-nears-first-trillion-pharma-title-but-investors-caution-amid-sky-high-valuation?itm_source=parsely-api">decades-long battle against obesity</a>. Recent data suggests that 2020 could mark the year when obesity rates in America not only peaked but began to decline, echoing the historic moment in 1963 when cigarette sales in the U.S. hit their apex before falling.
What Happened:&nbsp;Renowned economist Justin Wolfers highlighted this significant shift on social media platform X, stating, &#8220;From the Department of Things Really Are Getting Better: The U.S. obesity rate may have peaked, and for the first time in a long time, it fell last year.&#8221; Wolfers attributes this change to new weight loss drugs, adding, &#8220;Chalk up another one to progress.&#8221;
John Burn-Murdoch, <a href="https://www.ft.com/content/21bd0b9c-a3c4-4c7c-bc6e-7bb6c3556a56">writing</a> an opinion piece for the Financial Times, suggests that one in eight U.S. adults have used these drugs, with 6% currently taking them.
The potential catalyst for this unprecedented decline? A new generation of diabetes and weight loss drugs, including Ozempic and Wegovy. These medications, which have shown remarkable results in clinical trials, are now being used by a significant portion of the U.S. population. 
As the U.S. leads this potential obesity decline, other countries are likely to follow suit. In Denmark, home to Novo Nordisk (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), the creator of Ozempic and Wegovy, 3% of adults were using these drugs by the end of 2023, coinciding with a slowdown in obesity rate increases.
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">From the Department of Things Really Are Getting Better: The U.S. obesity rate may have peaked, and for the first time in a long time, it fell last year. And yes, it&#39;s the new weight loss drugs, which really work. Chalk up another one to progress.<a href="https://t.co/jFxoPNYsIW">https://t.co/jFxoPNYsIW</a> <a href="https://t.co/icLjvfR57u">pic.twitter.com/icLjvfR57u</a>
&mdash; Justin Wolfers (@JustinWolfers) <a href="https://twitter.com/JustinWolfers/status/1842554331767431512?ref_src=twsrc%5Etfw">October 5, 2024</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
See Also: <a href="https://www.benzinga.com/general/biotech/24/10/41137681/eli-lilly-nears-first-trillion-pharma-title-but-investors-caution-amid-sky-high-valuation?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Eli Lilly Nears First Trillion Dollar Pharma Title, But Investors Caution Amid Sky-High Valuation</a>
Why It Matters: The decline in obesity rates is significant in the context of recent developments in the pharmaceutical industry. Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) has <a href="https://www.benzinga.com/general/biotech/24/09/41097630/roche-fast-tracks-obesity-drug-development-eyes-over-3b-sales-potential">fast-tracked its obesity drug development</a>, aiming for over $3 billion in sales potential. This move underscores the growing market for effective weight loss treatments.
Additionally, Eli Lilly and Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) is exploring broader <a href="https://www.benzinga.com/general/biotech/24/10/41118751/eli-lilly-eyes-new-trials-for-weight-loss-drugs-in-non-obese-patients">applications for its weight-loss drugs</a>, Mounjaro and Zepbound, targeting individuals with a lower BMI. 
Despite the promising results, a <a href="https://www.benzinga.com/general/biotech/24/10/41168351/popular-weight-loss-drugs-like-ozempic-show-gap-between-clinical-trial-promises-and-real-world-us">recent study</a> reveals a gap between clinical trial promises and real-world outcomes for drugs like Ozempic and Wegovy. 
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</ul>
Image Via Shutterstock 
This story was generated using <a href="https://www.benzinga.com/author/benzinga-neuro">Benzinga Neuro</a> and edited by <a href="https://www.benzinga.com/topic/Kaustubh-Bagalkote" target="_blank" rel="noreferrer noopener">Kaustubh Bagalkote</a>

Global

Economist Justin Wolfers Points To Obesity Rate Decline As Ozempic And Wegovy Spur Historic Shift In Fight Against Obesity — Has US Reached A Turning Point?

At its Pharma Day, Swiss pharmaceutical giant Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) outlined five priority therapeutic areas: neurology, oncology and hematology, immunology, ophthalmology, and cardiovascular, renal, and metabolism diseases.
The company shared an &#8216;initial set of assets designated for acceleration based on exceptional potential.&#8217;
To maximize potential, the company plans to expedite enrollment with additional clinical trial sites, reallocate resources, and expand into additional indications.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40422774/roche-misses-out-on-weight-loss-blockbuster-drug-now-playing-catch-up-in-booming-market" rel="noreferrer noopener">Roche Misses Out On Weight-Loss Blockbuster Drug, Now Playing Catch-Up In Booming Market</a>.
The <a target="_blank" href="https://assets.roche.com/f/176343/x/f513f69de2/pharma_day_20240930_final_online_v02.pdf" rel="noreferrer noopener">selected</a> fast-tracked programs include:
<ul>
<li>CT-388 (RG6640) for obesity entered the Phase 2 stage of development in patients with or without type 2 diabetes and comorbidities.</li>
<li>Roche expects a commercial launch for CT-388 beyond 2028.</li>
<li>Trontinemab is currently in Phase 2 for Alzheimer&#8217;s. Potential launch in 2025-2028.</li>
<li>Anti-TL1A Inflammatory Bowel Disease candidate in Phase 3 stage of development.</li>
</ul>
Roche&#8217;s push into the obesity space follows the success of competitors like Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) and Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), which have seen significant demand for weight-loss drugs like Wegovy and Zepbound.
Additionally, Roche highlighted the financial potential of its obesity drug candidates, projecting that <a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36064233/roche-joins-bandwagon-to-challenge-novo-nordisk-eli-lilly-for-weight-loss-drugs" rel="noreferrer noopener">early-stage assets acquired</a> from Carmot Therapeutics (CT-388/CT-996/CT-868) could generate over 3 billion Swiss francs ($3.55 billion) in annual sales.
In July, Roche&nbsp;announced topline results from two arms of an ongoing multi-part Phase 1 clinical trial for CT-996 for&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39817857/obesity-drugs-focused-stocks-tumble-on-wednesday-whats-going-on-with-eli-lilly-novo-nordisk-vikin" rel="noreferrer noopener">type 2 diabetes and obesity</a>.
The data showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks.
In line with its broader strategy, Roche plans to cut drug development costs by 20% and reduce the time it takes for drugs to move from discovery to the end of Phase 3 trials by 40%, aiming to launch 20 transformative medicines by 2030.
The company is targeting three times as many patients during the 2020-2029 period.
Monday, Roche <a target="_blank" href="https://www.prnewswire.com/news-releases/regor-enters-into-a-definitive-purchase-agreement-for-genentech-to-acquire-regors-portfolio-of-next-generation-cdk-inhibitors-for-the-treatment-of-breast-cancer-302262174.html" rel="noreferrer noopener">agreed</a> to acquire a portfolio of next-generation CDK inhibitors for breast cancer from Regor Pharmaceuticals.
Regor will receive an upfront cash payment of&nbsp;$850 million&nbsp;and is eligible for additional milestone cash payments.
Roche&#8217;s Genentech will be responsible for clinical development, manufacturing, and commercialization worldwide.
Regor will continue to manage the two ongoing Phase 1 trials to their completion.
The deal is expected to close in the fourth quarter of 2024.
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Photo via Shutterstock

Roche Fast-Tracks Obesity Drug Development, Eyes Over $3B Sales Potential

Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>), announced today positive topline results from the Phase III REGENCY study of Gazyva&#xAE; (obinutuzumab) in people with active lupus nephritis. In the study, a higher proportion of people treated with Gazyva plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) at 76 weeks compared to those treated with standard therapy alone. Safety was in line with the well-characterized profile of Gazyva. No new safety signals were identified.
"Gazyva achieved a robust complete renal response rate in lupus nephritis, which is associated with long-term preservation of kidney function and delay or prevention of end-stage kidney disease," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Since dialysis or transplants are often required for patients with advanced kidney disease, these findings could represent an important step forward for people living with this devastating disease."
"I am very excited about today's announcement that the Phase III REGENCY study has met its primary endpoint," said Dr. Brad H. Rovin, Director of Nephrology and Medical Director of the Center for Clinical Research Management at The Ohio State University Wexner Medical Center, and investigator for the REGENCY study. "The results of REGENCY are compelling. Obinutuzumab could offer the lupus community an effective new treatment option for controlling this difficult disease that can be associated with high morbidity for individuals living with lupus."
Two key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva – the endpoint proportion of patients achieving CRR with a successful reduction of corticosteroid use, and an improvement in proteinuric response (both at 76 weeks). These endpoints are important indicators for achieving better disease control in lupus nephritis. Other secondary endpoints were not statistically significant, but numerically greater responses were observed for Gazyva in several endpoints.&#x2A;
Data are being shared with health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, with the goal of making this potential new treatment option for lupus nephritis available as soon as possible. Data are also being submitted for publication in a medical journal and presentation at a future medical congress.
Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease that affects approximately 1.7 million people worldwide, predominantly women and mostly women of color and childbearing age. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys. Despite current treatment options, up to a third of people will develop end-stage kidney disease within 10 years, where dialysis or transplant are the only available options and the risk of mortality is high. Data suggest that Gazyva depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.
Gazyva was granted Breakthrough Therapy Designation by the FDA in 2019, based on data from the Phase II NOBILITY study. Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of medicines intended to treat serious or life-threatening conditions where preliminary clinical evidence has indicated they may demonstrate substantial improvement over existing therapies.
In addition to REGENCY, Gazyva is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis. Our pipeline also includes RG6299 (ASO factor B), an antisense oligonucleotide therapy being investigated in people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio&#xAE; (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody being investigated in SLE, PiaSky&#xAE; (crovalimab), a novel recycling monoclonal antibody being investigated in atypical hemolytic uremic syndrome and RG6382, a CD19xCD3 T-cell engaging bispecific antibody being investigated in SLE.

Roche Group Member Genentech's Gazyva Shows Results In Lupus Nephritis Study, Could Delay Kidney Disease

On Thursday, Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) released positive topline results of the phase 3 CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral that showed a reduction in the transmission of influenza viruses.
The <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2024-09-19" rel="noreferrer noopener">study</a> met its primary endpoint, demonstrating that a single oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40881407/back-to-back-fda-approvals-for-roches-two-under-the-skin-injections" rel="noreferrer noopener">Back-To-Back FDA Approvals For Roche&#8217;s Two Under-The-Skin Injections</a>.
Xofluza was well tolerated, and no new safety signals were identified.
CENTERSTONE is the first global phase 3 study to show a transmission reduction benefit with an antiviral used to treat a respiratory viral illness.
This new data may add to the benefits of Xofluza, which is currently approved for treating symptoms and preventing infection following virus exposure.
"Building on Xofluza's established efficacy in treating and preventing influenza after exposure, this new evidence of transmission reduction represents an important advance that could help improve health outcomes at an individual and community level," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "We look forward to discussing these data with regulatory authorities and public health organizations for influenza pandemic preparedness to bring these benefits to patients."
Influenza is one of the most common yet serious infectious diseases. Every year, seasonal influenza infects an estimated one billion people and causes millions of hospitalizations and up to 650,000 deaths globally.
Federal funds from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority have partially supported the CENTERSTONE study.
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Roche's Antiviral Drug Reduces Transmission Of Influenza Viruses, Late-Stage Study Shows

<ul>
<li>&ndash; Data from the CENTERSTONE study shows single-dose Xofluza reduces transmission of influenza from an infected person to household members &ndash;</li>
<li>&ndash; This is the first time that any antiviral used in the treatment of a respiratory&nbsp;viral illness has demonstrated a transmission reduction benefit in a global Phase III study &ndash;</li>
<li>&ndash;&nbsp;Reducing the spread of infection in the household could help limit transmission within communities and societies, easing the burden of both seasonal and pandemic influenza on healthcare systems &ndash;</li>
</ul>

Roche's Genentech Phase III CENTERSTONE Study Of Xofluza Demonstrates Reduction In Influenza Viruses Transmission

Monday, the FDA approved Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Ocrevus Zunovo (ocrelizumab &amp; hyaluronidase-ocsq) for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Ocrevus Zunovo is the <a target="_blank" href="https://www.roche.com/investors/updates/inv-update-2024-09-16" rel="noreferrer noopener">first</a> and only twice-a-year healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both forms of multiple sclerosis.
The FDA approval is based on data from the Phase 3 OCARINA 2 trial, which showed no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously and a safety and efficacy profile consistent with the IV formulation in people with RMS and PPMS.
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In the Phase 2 OCARINA 2 trial, the safety profile of Ocrevus Zunovo was consistent with the well-established safety profile of Ocrevus IV, except for injection reactions.
Just on Friday, the FDA also <a target="_blank" href="https://www.roche.com/investors/updates/inv-update-2024-09-13" rel="noreferrer noopener">approved</a> Roche&#8217;s Tecentriq Hybreza&nbsp;(atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the U.S.
Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab).
It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin, and soft tissue cancer.
The FDA approval is based on Phase 1B/3 IMscin001 study data, which showed comparable levels of Tecentriq in the blood when administered subcutaneously and a safety and efficacy profile consistent with the IV formulation.
The Phase 2 IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab.
The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in 50 countries (outside the U.S., marketed as Tecentriq SC).
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Back-To-Back FDA Approvals For Roche's Two Under-The-Skin Injections

&ndash; Ocrevus Zunovo&trade; has the potential to expand treatment options to centers without IV infrastructure or with IV constraints, like at a doctor&#39;s office &ndash;
&ndash; This approval is backed by a decade of proven safety and efficacy data of Ocrevus&reg; IV, with over 350,000 people treated globally &ndash;
&ndash; Ocrevus Zunovo&trade; offers people with multiple sclerosis (MS) more options to access treatment based on their individual needs &ndash;
Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>), announced today that the United States Food and Drug Administration (U.S. FDA) has approved Ocrevus Zunovo&trade; (ocrelizumab &amp; hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.

HALO

Roche Group's Genentech Announces FDA Approves Ocrevus Zunovo As The First And Only Twice-A-Year 10-Minute Subcutaneous Injection For People With Relapsing And Progressive Multiple Sclerosis

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Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY

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Roche receives CE Mark for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE

Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA

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