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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.

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Roche&#39;s phase 3 CENTERSTONE study shows Xofluza (baloxavir marboxil) significantly reduces influenza transmission in households, marking a global first for an antiviral.

Roche&#39;s Antiviral Drug Reduces Transmission Of Influenza Viruses, Late-Stage Study Shows

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The FDA has approved Roche&#39;s Ocrevus Zunovo for relapsing and primary progressive multiple sclerosis, offering the first twice-a-year subcutaneous injection option for both forms of the disease.

Back-To-Back FDA Approvals For Roche&#39;s Two Under-The-Skin Injections

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FULC

BofA Securities upgraded Fulcrum Therapeutics ahead of its phase 3 losmapimod results for Facioscapulohumeral muscular dystrophy, boosting the price target from $5 to $10 due to increased confidence in the study&#39;s success.

Fulcrum Therapeutics Upgraded: BofA Debates Pivotal Study Success For Losmapimod In Rare Genetic Muscle Disease

ROCHE HOLDING LTD S/ADR by Roche Holding Ltd

Roche Holding AG

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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</ul>

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>

RHHBF

RHHVF

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.
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>.
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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</ul>

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

&ndash; Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous (IV) Tecentriq &ndash;
&ndash; New subcutaneous (SC) option reduces treatment time to approximately 7 minutes, compared with 30-60 minutes for IV infusion &ndash;

Reported Earlier, Roche's Genentech And Halozyme Receives FDA Approval Of Tecentriq Hybreza, The First Subcutaneous PD-(L)1 Cancer Immunotherapy, Offering Faster Treatment For Multiple Cancer Types

WIIM

Roche shares are trading lower following weight loss data.

Roche Says In CT-996 Phase 1 Trial, 4-Week Weight Loss Was 5.8% In Second-Best-Performing Cohort Vs 1.2% Weight Loss In Placebo Cohort; Placebo-Adjusted Average Weight Loss Of 6.1% From CT-996 Obesity Pill Trial Was From 1 Of 3 Active Cohorts In The Phase I Trial; In CT-996 Phase 1 Trial, 4-Week Weight Loss Was 7.3% In Best-Performing Cohort With 6 Patients Vs 1.2% Weight Loss In Placebo Cohort

BofA Securities has upgraded Fulcrum Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FULC#NASDAQ">FULC</a>) ahead of the company&#8217;s phase 3 losmapimod readout, expected by the end of October for Facioscapulohumeral <a target="_blank" href="https://www.benzinga.com/pressreleases/24/07/g40063519/fulcrum-therapeutics-announces-recent-business-highlights-and-financial-results-for-second-quarter" rel="noreferrer noopener">muscular dystrophy (FSHD)</a>.
FSHD is&nbsp;a rare genetic muscle disease affecting a child&#8217;s facial muscles, shoulders, upper arms, and lower legs. These muscles <a target="_blank" href="https://www.benzinga.com/quote/fulc" rel="noreferrer noopener">weaken and shrink</a> (atrophy).
The analyst notes that although a previous pivotal study failed using the DUX4 expression endpoint, the company conducted a post-hoc analysis and designed a new study with the endpoint &#8220;reachable workspace&#8221; (RWS), which has sparked debate in the investment community.
Two key opinion leaders (KOLs) expressed optimism about the upcoming phase 3 results, citing the functional benefits seen in phase 2 using RWS, which measures upper extremity function. Despite being a newer endpoint, the KOLs believe RWS accurately tracks disease progression.
They view the stabilization of RWS in phase 3 as clinically meaningful and believe replicating the phase 2 results—showing a 10% placebo-adjusted change at 48 weeks—would be a success.
However, the analyst remains uncertain about the study&#8217;s likelihood of success due to the unpredictability of the control arm&#8217;s response.
BofA upgraded the stock from Underperform to Neutral and increased the <a target="_blank" href="https://www.benzinga.com/quote/FULC/analyst-ratings" rel="noreferrer noopener">price target from $5 to $10</a>, as the analyst increased the likelihood of success (LOS) from 35% to 50%
&#8220;We await the ph 3 readout before further de-risking the program and note we continue to view the pociredir story in sickle cell disease (SCD) as a stock overhang,&#8221; the analyst adds.
BofA notes that losmapimod is expected to be the first treatment for FSHD, but it may face future competition from Avidity Biosciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RNA#NASDAQ">RNA</a>) and Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), which are further behind in development.
Price Action: FULC stock is up 1.30% at $8.651 at last check Monday.
Photo via Shutterstock
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HC Wainwright initiated coverage on Enliven Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ELVN#NASDAQ">ELVN</a>) and noted the company as an emerging biotech company developing next-gen precision-oriented small molecules for solid and <a target="_blank" href="https://www.benzinga.com/quote/ELVN" rel="noreferrer noopener">liquid tumor indications</a>.
Enliven&#8217;s pipeline includes:
<ul>
<li>ELVN-001— a tyrosine kinase inhibitor (TKI) targeting mutant BCR::ABL. HC Wainwright highlights that ELVN-001 could meaningfully improve on existing TKI drugs used in chronic myelogenous leukemia, with applicability across multiple lines of therapy.</li>
<li>In April, the company released proof of concept data from the Phase 1 trial of ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or <a href="https://www.benzinga.com/general/biotech/24/04/38208363/enliven-therapeutics-shares-first-look-at-safety-clinical-activity-of-lead-program" target="_blank" rel="noreferrer noopener">intolerant to available TKIs</a>.</li>
<li>ELVN-001 achieved a cumulative major molecular response (MMR) rate of 44% (7/16) by 12 weeks and demonstrated responses in patients with prior exposure to asciminib and who were TKI-resistant.</li>
<li>ELVN-002 is being evaluated in combination with trastuzumab plus chemotherapy or as monotherapy in HER2-driven malignancies within non-small cell lung, colorectal, and metastatic breast cancer, among others.</li>
</ul>
The analyst initiates with a Buy rating and a <a target="_blank" href="https://www.benzinga.com/quote/ELVN/analyst-ratings" rel="noreferrer noopener">price target of $37</a>.
CML is a chronic disease requiring multiple years of continuous treatment. Patients frequently switch therapies due to liabilities of the existing approved drugs, including poor tolerability due to off-target effects and inability to dose to maximal efficacy.
Six approved drugs—Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Gleevec (imatinib), Scemblix (asciminib), and Tasigna (nilotinib), Bristol-Myers Squibb &amp; Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Sprycel (dasatinib), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Bosulif (bosutinib), and Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) Iclusig (ponatinib)—generate over $6 billion in annual sales, with each drug bringing in around $500 million. Some even achieve peak annual sales of up to $2 billion despite competition from generic versions.
HC Wainwright analyst projects that positioning ELVN-001 as a third-line treatment could surpass $500 million in peak annual sales.
ELVN-002 has the potential to address unmet needs in HER2-mutant NSCLC, CRC, and mBC, where current treatments have limitations. It could challenge competitors like Pfizer&#8217;s Tukysa and tap into the growing post-AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Enhertu market, with sales possibly reaching hundreds of millions.
While Enliven focuses on precision oncology, its target market is broader than that of past agents like Bristol-Myers&#8217; Augtyro (repotrectinib) and Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Rozlytrek (entrectinib).
Price Action: ELVN stock is up 7.32% at $23.01 at the last check on Monday.
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</ul>

Movers

ELVN

Enliven Therapeutics' Leukemia Candidate Could Challenge Pfizer, AstraZeneca In Broader Target Market: Analyst

<ul>
<li>The Roche Digital Pathology Open Environment brings together a wide array of innovative AI-based pathology tools to help clinicians improve patient care and expand personalised healthcare.</li>
<li>Roche is now integrating more than 20 artificial intelligence (AI) algorithms from eight new collaborators into its digital pathology open environment.</li>
<li>AI technology helps enhance pathology with high value insights, which can benefit cancer patients through precision medicine leading to targeted treatment.</li>
</ul>

Roche Expands AI-Driven Cancer Diagnostics With Integration Of Over 20 Algorithms In Digital Pathology With New Collaborations

Latest data from Poseida's lead investigational allogeneic CAR-T program, which is based on the Company's unique stem cell memory T cell (TSCM) platform
Company to host conference call on Saturday, September 28, 2024, at 1 PM ET / 10 AM PT to review the P-BCMA-ALLO1 Phase 1 IMS oral presentation data
Poseida initiates P-BCMA-ALLO1 Phase 1b clinical trial in patients with multiple myeloma, generating $20 million payment from Roche
SAN DIEGO, Sept. 5, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTX#NASDAQ">PSTX</a>), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, announced today that new clinical data from an ongoing Phase 1 study of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma will be presented in an oral session at the 21st International Myeloma Society (IMS) Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024. The Company is developing P-BCMA-ALLO1, an investigational off-the-shelf allogeneic CAR-T cell therapy enriched for stem cell memory T cells (TSCM), in partnership with Roche for the treatment of relapsed/refractory multiple myeloma.

Contracts

PSTX

Poseida Therapeutics To Present New Clinical Data From Phase 1 Study Of Allogeneic CAR-T P-BCMA-ALLO1 In Patients With Relapsed/Refractory Multiple Myeloma At 21st International Myeloma Society Annual Meeting; Initiation Of P-BCMA-ALLO1 Phase 1b Clinical Trial In Patients With Multiple Myeloma, Generated $20M Payment From Roche

BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) and Moderna Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) are making strides in personalized cancer vaccines, leveraging the mRNA technology instrumental during the COVID-19 pandemic.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40514864/fda-approves-updated-covid-vaccines-from-pfizer-and-moderna-but-leaves-out-novavaxs-shot" rel="noreferrer noopener">FDA Approves Updated COVID Vaccines From Pfizer And Moderna, But Leaves Out Novavax&#8217;s Shot</a>.
These companies, whose stocks plummeted by about 80% since their 2021 pandemic peaks, are now focusing on cancer treatments to revive their fortunes.
<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="750" height="650" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/08/29092654/newplot-2-2.png" alt="" class="wp-image-520824" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/08/29092654/newplot-2-2.png 750w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/08/29092654/newplot-2-2-300x260.png 300w" sizes="(max-width: 750px) 100vw, 750px" /></figure>
<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="750" height="650" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/08/29092708/newplot-3-1.png" alt="" class="wp-image-520827" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/08/29092708/newplot-3-1.png 750w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/08/29092708/newplot-3-1-300x260.png 300w" sizes="(max-width: 750px) 100vw, 750px" /></figure>
The personalized approach, though promising, faces skepticism due to the high cost and difficulty of scaling production.
Miranda Payne, a melanoma specialist leading a Moderna trial at Oxford&#8217;s Churchill Hospital, expressed excitement about the potential but noted the challenges in making these vaccines widely available.
The Financial Times <a target="_blank" href="https://www.ft.com/content/efff95f4-e7c4-4a3c-bccd-f449fecac27e" rel="noreferrer noopener">notes</a> the high cost of sequencing each patient&#8217;s tumor and producing bespoke vaccines raises concerns about the feasibility of widespread application.
Moderna&#8217;s melanoma vaccine, developed in partnership with Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), is in advanced trials, while BioNTech&#8217;s product, co-developed with Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) subsidiary Genentech, is being <a target="_blank" href="https://www.benzinga.com/general/biotech/22/06/27560328/early-data-shows-biontechs-personalized-therapy-safe-in-pancreatic-cancer-patients" rel="noreferrer noopener">tested in an NHS trial</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39138772/moderna-merck-reveal-three-year-data-for-individualized-cancer-therapy-in-high-risk-melanoma-pati" rel="noreferrer noopener">Moderna, Merck Reveal Three Year Data For Individualized Cancer Therapy In High-Risk Melanoma Patients</a>.
Despite the optimism, experts caution that while the individual approach is exciting, the high costs and challenges of production make it uncertain whether these personalized vaccines will be scalable or affordable.
Uğur Şahin, CEO of BioNTech, emphasized the importance of innovation in personalizing mRNA vaccines, predicting that these treatments could be as impactful as existing immunotherapies by 2030.
Moderna is likely to bring its cancer vaccine to market first, focusing on lung and skin cancers. The company is also investing in new manufacturing facilities to improve production efficiency. BioNTech is taking a dual approach, developing personalized and off-the-shelf vaccines to address different cancer types.
As BioNTech and Moderna push forward, the cancer treatment landscape could be transformed, but the journey is fraught with obstacles.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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Media

BNTX

MRNA

Moderna And BioNTech Bet On Personalized Cancer Vaccines To Revive Fortunes After Dwindling COVID-19 Vaccine Sales

Labcorp Holdings Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LH#NYSE">LH</a>) is reportedly collaborating with U.S. health regulators to determine whether it should scale up its mpox testing capabilities, following global concerns over a newly detected <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40554882/tonix-pharma-collaborates-with-worlds-largest-vaccine-manufacturer-for-mpox-vaccine" rel="noreferrer noopener">virus strain outside Africa</a>.
According to Marcia Eisenberg, the company's chief scientific officer, Labcorp currently processes around 500 mpox tests monthly but can ramp up to 25,000 if necessary, Reuters noted, citing an emailed statement.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40418733/mpox-vaccine-maker-bavarian-nordic-targets-broader-access-with-european-submission-for-imvanex-ad" rel="noreferrer noopener">Mpox Vaccine Maker Bavarian Nordic Targets Broader Access With European Submission For Imvanex Adolescent Use During WHO Emergency</a>.
The company recently received U.S. clearance for a home collection kit that doctors can order for patients aged 18 and older who are suspected of having mpox.
The clade Ib variant, previously found in the Democratic Republic of Congo and surrounding regions, has been detected in countries like Sweden and Thailand.
Labcorp, which produces a PCR test to detect mpox, is among several companies working on enhancing mpox testing infrastructure. Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) stated it is also monitoring global demand and exploring ways to leverage existing HIV testing infrastructure for mpox and other diseases in collaboration with African regulators.
Roche emphasized that its production capacities are designed to adapt to fluctuating global needs.
Other major diagnostics companies are also involved. Quest Diagnostics Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DGX#NYSE">DGX</a>) offers mpox testing services, while Abbott Laboratories (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABT#NYSE">ABT</a>) has developed the Alinity m test kit, which is authorized for emergency use in the U.S. as part of the ongoing response to the mpox outbreak.
Reuters also noted that Germany would donate 100,000 mpox vaccine doses from its military reserves to support efforts in containing the outbreak in Africa, a government spokesperson announced on Monday.
The government also plans to provide the World Health Organization with flexible funding to fight the virus and will back African partners through the GAVI vaccination alliance.
Germany currently holds around 117,000 doses of the Bavarian Nordic A/S (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BVNRY#OTC">BVNRY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BVNKF#OTC">BVNKF</a>)&nbsp;Jynneos vaccine, initially acquired for <a target="_blank" href="https://www.benzinga.com/news/24/08/40384390/mpox-declared-a-global-public-health-emergency-by-who-amid-rapid-international-spread" rel="noreferrer noopener">military stockpiling in 2022</a>.
Price Action: LH stock is up 0.29% at $231.56 at last check Monday.
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</ul>
Photo by NIAID via <a href="https://www.flickr.com/photos/niaid/52508743460/">Flickr</a>

BVNKF

BVNRY

Laboratory Corporation Of America Holdings

Diagnostic Giants Labcorp, Roche To Ramp Up Testing Capacity Amid Global Concerns Over New Mpox Strain

Roche Holding AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) reportedly turned down a potential blockbuster weight-loss pill in 2018, allowing Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) to acquire the drug, now known as orforglipron, <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">for just $50 million</a>.
Despite its initial valuation in the tens of millions, the drug is projected to generate up to $14 billion annually by 2032, highlighting the weight-loss market&#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">massive growth potential</a>.
The missed opportunity came as Roche opted not to exercise its &#8220;right of first refusal&#8221; on the drug, initially developed by Chugai Pharmaceutical, with which Roche has had a long-standing partnership.
At the time, the Financial Times <a target="_blank" href="https://www.ft.com/content/78057a2c-60b8-410f-8731-b7c787991a57" rel="noreferrer noopener">reported</a> that the drug—then called Owl-833—was in early phase-one trials.
Roche&#8217;s decision to pass on the acquisition reflects a cautious approach influenced by past setbacks in the anti-obesity and diabetes market.
Roche&#8217;s reluctance to enter the weight-loss race stemmed from its experience with earlier failures, such as Orlistat and taspoglutide, which caused side effects or failed trials.
Despite these challenges, Roche re-entered the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39812408/roche-highlights-encouraging-data-from-newly-acquired-second-weight-loss-drug-candidate-in-early-" rel="noreferrer noopener">obesity market in 2023</a> by acquiring Carmot Therapeutics, aiming to rival established players like Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) and Eli Lilly.
Roche&#8217;s new weight-loss pill, although promising, is not expected to launch before 2028, leaving it behind competitors like Eli Lilly, whose orforglipron could be the only available small molecule GLP-1 drug for at least two years after its anticipated 2026 launch.
Eli Lilly&#8217;s bet on orforglipron exemplifies the advantage of companies with deep expertise in insulin-based diabetes treatments, giving them a head start in understanding metabolism and weight loss.
The Financial Times report added that the drug is expected to be a game-changer, potentially dominating the market as it is easier to manufacture and distribute than Novo Nordisk&#8217;s oral semaglutide, which faces production challenges.
Analysts estimate that Roche&#8217;s weight-loss products will only generate around $4 billion in sales by 2032, a far cry from what Eli Lilly could achieve.
As the competition heats up, Roche&#8217;s late entry into the market underlines the high stakes and rapid evolution of the weight-loss industry.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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Roche Misses Out On Weight-Loss Blockbuster Drug, Now Playing Catch-Up In Booming Market

On Thursday, Tempest Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TPST#NASDAQ">TPST</a>) announced feedback from its end-of-Phase 2 meeting with the FDA for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/g40392046/tempest-announces-successful-end-of-phase-2-meeting-with-fda-for-amezalpat-tpst-1120-to-treat-firs" rel="noreferrer noopener">hepatocellular carcinoma (HCC)</a>.
Roche Holding AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Genentech sells bevacizumab as Avastin and atezolizumab as Tecentriq.
&#8220;Tempest and the FDA are in broad agreement on all major aspects of the proposed pivotal Phase 3 clinical trial for amezalpat in patients with hepatocellular carcinoma in the first-line setting. This planned Phase 3 study closely mirrors the randomized Phase 2 study, and the strongly favorable hazard ratio for overall survival observed at topline analysis of Phase 2, confirmed at the latest survival follow-up, gives us confidence in the potential success of Phase 3,&#8221; said Sam Whiting, chief medical officer and head of R&amp;D.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39412888/whats-going-on-with-cancer-focused-tempest-therapeutics-stock-on-thursday" rel="noreferrer noopener">What&#8217;s Going On With Cancer-Focused Tempest Therapeutics Stock On Thursday</a>?
Key outcomes of the FDA meeting include:
<ul>
<li>Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints.</li>
<li>Agreement on the appropriateness of the current amezalpat dose and the Phase 3 study schedule.</li>
<li>Agreement on the Phase 3 statistical plan, including a pre-specified early efficacy analysis that the company currently estimates, could shorten the time to primary analysis by up to 8 months.</li>
</ul>
The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab vs. atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC treated in the first line setting.
The company is preparing for the Phase 3 study start in the first quarter of 2025.
Price Action: TPST stock is up 34.90% at $1.61 at the last check on Thursday.
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</ul>
Don&#8217;t miss the opportunity to dominate in a volatile market at the&nbsp;<a target="_blank" href="https://www.benzinga.com/events/small-cap/global-small-cap-conference-2024/" rel="noreferrer noopener">Benzinga SmallCAP Conference</a> on Oct. 9-10 at the Chicago Marriott Downtown Magnificent Mile. Get exclusive access to CEO presentations, 1:1 meetings with investors, and valuable insights from top financial experts. Whether you&#8217;re a trader, entrepreneur, or investor, this event offers unparalleled opportunities to grow your portfolio and network with industry leaders. Secure your spot and get your tickets today!

Small Cap

Tempest Therapeutics, Inc. - Common Stock

TPST

Why Is Small-Cap Tempest Therapeutics Stock Trading Higher On Thursday?

Syros Pharmaceuticals&nbsp;Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SYRS#NASDAQ">SYRS</a>) stock is trading lower on Tuesday after the company issued an update on the <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/b40324082/syros-provides-update-on-select-aml-1-phase-2-clinical-trial" rel="noreferrer noopener">SELECT-AML-1 Phase 2 trial</a>.
The company announced that it will discontinue enrollment in the SELECT-AML-1 Phase 2 trial evaluating the triplet regimen of tamibarotene in combination with venetoclax and azacitidine compared to the doublet regimen of venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and&nbsp;RARA gene overexpression.
AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) and Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) sell venetoclax as Venclexta. Bristol
Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) markets azacitidine as Vidaza. This decision is based on the results of a prespecified interim analysis of the trial.
Data from 51 patients enrolled in SELECT-AML-1 were reviewed on August 9. This review included a prespecified non-binding futility analysis conducted on the first 40 randomized patients after the fortieth randomized patient received approximately three months of study drug or discontinued treatment.
A similar complete response (CR)/complete response with incomplete hematologic recovery (CRi) rate was observed in the triplet arm (n=20; 65%) and the doublet arm (n=20; 70%).
As a result, the probability of the SELECT-AML-1 study&#8217;s success in demonstrating superiority in the final analysis of 80 randomized patients was considered low.
There were no new safety signals associated with the use of tamibarotene in combination with venetoclax and azacitidine.
Patients currently enrolled in SELECT-AML-1 will have the opportunity to remain on the study at the discretion of study investigators.
Syros plans to present data from SELECT-AML-1 at the Society of Hematologic Oncology Annual Meeting in September.
&#8220;We are disappointed by this unexpected outcome&#8230;&#8221; said David Roth, Chief Medical Officer of Syros.
&#8220;In our prior Phase 2 clinical trial, the doublet combination of tamibarotene and azacitidine <a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36117732/why-is-blood-cancer-focused-syros-pharmaceuticals-stock-soaring-today" rel="noreferrer noopener">delivered a 61% CR/CRi rate</a> in newly diagnosed AML patients with&nbsp;RARA&nbsp;overexpression,&#8221; Roth added.
Syros continues to evaluate tamibarotene in combination with azacitidine in the SELECT-MDS-1 Phase 3 trial in newly diagnosed higher-risk myelodysplastic syndrome patients with&nbsp;RARA&nbsp;gene overexpression.
The SELECT-MDS-1 trial passed a prespecified futility analysis in the first quarter of 2024. Pivotal CR data are expected by the middle of the fourth quarter of 2024.
Price Action: At last check on Tuesday, SYRS stock was down 60.50% to $1.98.
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</ul>

ABBV

SYRS

Cancer-Focused Syros Pharmaceuticals Stops Mid-Stage Leukemia Combo Therapy Study, Cites Disappointing Unexpected Outcome

On Thursday, Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) announced discontinuing the Phase 3 KeyVibe-008 trial based on an independent Data Monitoring <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/b40246517/merck-provides-update-on-phase-3-keyvibe-008-trial-evaluating-an-investigational-fixed-dose-combin" rel="noreferrer noopener">Committee (DMC) recommendation</a>.
The trial is evaluating the investigational fixed-dose combination (coformulation) of vibostolimab and Keytruda (pembrolizumab), in combination with chemotherapy, compared to Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Tecentriq (atezolizumab) in combination with chemotherapy, for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39526817/fda-declines-to-approve-merck-daiichi-sankyo-partnered-lung-cancer-drug" rel="noreferrer noopener">FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug</a>.
At a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria.
Additionally, when compared to patients in the control arm, patients in the vibostolimab and pembrolizumab fixed-dose combination arm experienced a higher rate of adverse events (AEs) and immune-related AEs.
A comprehensive analysis of this study is ongoing.
Merck is notifying study investigators of the decision and that patients should stop ongoing treatment with the fixed-dose combination of vibostolimab and pembrolizumab and be offered the option to be treated with atezolizumab.
Merck and Daiichi Sankyo&nbsp;recently announced&nbsp;that the first patient has been dosed in the IDeate-Lung02 Phase 3 trial of investigational ifinatamab deruxtecan (I-DXd) in patients with relapsed SCLC versus treatment of physician&#8217;s <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/b40097404/ideate-lung02-phase-3-trial-of-ifinatamab-deruxtecan-initiated-in-patients-with-relapsed-small-cel" rel="noreferrer noopener">choice of chemotherapy</a>.
Merck and Daiichi Sankyo also&nbsp;expanded their existing global co-development and co-commercialization agreement&nbsp;for three investigational DXd antibody-drug conjugates to include Merck&#8217;s MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager that is currently being evaluated in a Phase 1/2 clinical trial.
The companies are planning to <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/b40182859/daiichi-sankyo-and-merck-enter-into-global-development-and-commercialization-agreement-for-mk-6070" rel="noreferrer noopener">evaluate MK-6070</a> in combination with I-DXd in certain patients with SCLC, and other potential combinations. Merck obtained MK-6070 through its&nbsp;acquisition&nbsp;of Harpoon Therapeutics.
Price Action: MRK stock is up 0.82% at $113.09 at last check Thursday.
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</ul>
Image created using artificial intelligence via Midjourney.

Merck Stops Lung Cancer Study For Keytruda Combo Due To Ineffective Results, Side Effects

Roche Holding AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) is reportedly contemplating the divestiture of Flatiron Health, a cancer data specialist Roche acquired in 2018 for $1.9 billion.
The move underscores the complexities and potential pitfalls that large pharmaceutical companies encounter when investing in early-stage health technology firms.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39645630/roches-new-immunotherapy-fails-to-show-benefit-over-mercks-blockbuster-keytruda-in-lung-cancer-pa" rel="noreferrer noopener">Roche&#8217;s New Immunotherapy Fails To Show Benefit Over Merck&#8217;s Blockbuster Keytruda In Lung Cancer Patients</a>.
Flatiron Health was founded by two former executives from Alphabet Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOG#NASDAQ">GOOG</a>) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOGL#NASDAQ">GOOGL</a>) Google.
The company manages electronic patient records for numerous U.S. cancer clinics, boasting one of the most extensive repositories of cancer data.
The start-up mines this data and sells it to pharmaceutical companies to aid in research and development.
Roche&#8217;s acquisition of Flatiron has not been without its challenges. Despite operating as a separate legal entity, Flatiron&#8217;s association with Roche has deterred some rival drugmakers from engaging with the start-up, impacting its sales.
Flatiron generates approximately two-thirds of its revenue from selling data to pharmaceutical companies, a business model similar to that of Warburg Pincus-backed Modernizing Medicine, which has seen profitable returns for private equity investors.
The departure of key Roche executives who initially supported the Flatiron acquisition has left the company with fewer advocates within Roche.
The Financial Times report <a target="_blank" href="https://www.ft.com/content/3f87d26c-c98d-42f4-b460-5011e255aa95" rel="noreferrer noopener">adds</a> that Roche is collaborating with Citigroup Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/C#NYSE">C</a>) to explore strategic options for Flatiron, including a potential divestiture or partial sale to a partner who can assist in managing the business.
Despite its financial struggles, Flatiron&#8217;s data has significantly contributed to Roche&#8217;s cancer drug development, currently with about 60 oncology drugs in clinical trials.
The strategic review may not result in Flatiron changing hands, the FT report added.
Last month, Roche 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/24/07/39812408/roche-highlights-encouraging-data-from-newly-acquired-second-weight-loss-drug-candidate-in-early-" 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.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Rumors

GOOG

GOOGL

Roche Considers Selling Cancer Data Specialist Flatiron Health Business, Highlights Challenges With Start-Up Acquisitions

In a&nbsp;regulatory filing&nbsp;Friday, Agenus Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) revealed Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) terminated a license, development, and commercialization agreement forged in 2021.
The company said that as part of a broader strategic realignment of their development pipeline, which involves other licensed products, Bristol Myers Squibb is <a target="_blank" href="https://www.sec.gov/ix?doc=/Archives/edgar/data/1098972/000095017024089932/agen-20240730.htm" rel="noreferrer noopener">returning</a> AGEN1777, a TIGIT bispecific antibody, to Agenus and voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.
Related: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/07/39864146/agenus-faces-regulatory-and-financial-challenges-analyst-downgrades-stock-pending-t" rel="noreferrer noopener">Agenus Faces Regulatory and Financial Challenges: Analyst Downgrades Stock Pending Trial Clarity</a>.
Most recently, Roche Holdings AG's (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) TIGIT drug, tiragolumab,&nbsp;failed in Phase 3 SKYSCRAPER-02 study in extensive-stage small-cell lung cancer (ES-SCLC) and did not meet its co-primary endpoint of <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39645630/roches-new-immunotherapy-fails-to-show-benefit-over-mercks-blockbuster-keytruda-in-lung-cancer-pa" rel="noreferrer noopener">progression-free survival</a>.
In August last year, Roche was made aware of the inadvertent disclosure of the second interim analysis of the Phase 3 SKYSCRAPER-01 study, evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for PD-L1-high locally advanced or metastatic&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/08/34010167/who-are-other-players-gaining-from-roches-accidental-lung-cancer-data-update" rel="noreferrer noopener">non-small cell lung cancer</a>.
In May, Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) discontinued the vibostolimab, its TIGIT drug, and pembrolizumab coformulation arm of the&nbsp;Phase 3 <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38793420/merck-halts-skin-cancer-drug-trial-on-high-discontinuation-rate-a-setback-in-high-risk-melanoma-t" rel="noreferrer noopener">KeyVibe-010 trial</a>.&nbsp;
Results from Merck's Phase 2 KeyVibe-002 trial of vibostolimab/pembrolizumab combo, with or without docetaxel for metastatic non-small cell lung cancer with progressive disease after treatment with immunotherapy and&nbsp;platinum-doublet chemotherapy, did not show an improvement in median PFS <a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36132441/double-flops-for-mercks-lung-cancer-studies" rel="noreferrer noopener">compared to docetaxel alone</a>.
Bristol Myers acquired AGEN1777 in 2021 by paying Agenus $200 million in cash.
Price Action: AGEN stock is down 7.10% at $5.23 at last check Monday.
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</ul>
Don't miss the opportunity to dominate in a volatile market at the <a target="_blank" href="https://www.benzinga.com/events/small-cap/global-small-cap-conference-2024/" rel="noreferrer noopener">Benzinga SmallCAP Conference</a> on Oct. 9-10 at the Chicago Marriott Downtown Magnificent Mile. Get exclusive access to CEO presentations, 1:1 meetings with investors, and valuable insights from top financial experts. Whether you're a trader, entrepreneur, or investor, this event offers unparalleled opportunities to grow your portfolio and network with industry leaders. Secure your spot and get your tickets today!

AGEN

Bristol Myers Squibb Terminates Cancer Drug Development Program With Agenus

Regeneron Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>) reported earnings per share of $11.56, which beat the Zacks Consensus Estimate of $10.57. The company recorded an EPS of $10.24 in the year-ago period.
The upside in the bottom line can be attributed to higher revenues.
Total revenues increased 12% year over year to $3.54 billion, fueled by higher Dupixent, Eylea HD and Libtayo sales. Revenues also beat the Zacks Consensus Estimate of $3.38 billion.&nbsp;
Shares are trading up in response to the better-than-expected results.
Regeneron&#39;s shares have risen 22.8% year to date against the industry&#39;s decline of 0.6%.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/8d/73084.jpg?v=2091733934" /> 
Image Source: Zacks Investment Research
<h3>Quarterly Highlights</h3>
Eylea&#39;s sales in the United States declined 18% year over year to $1.2 billion, primarily due to increased competition resulting in lower volumes and a reduced net selling price.
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>). Regeneron records net product sales of Eylea in the United States and Bayer does the same outside the country. Regeneron records its share of profits/losses in connection with the sales of Eylea outside the United States.
In August 2023, the FDA approved Eylea HD (higher dose of Eylea) for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.
Eylea HD generated revenues of $304 million in the United States, driven by the addition of new patients and the transition of patients from other anti-VEGF products, including Eylea.
Total Eylea and Eylea HD sales in the United States were $1.53 billion, up 2% year over year. The figure also beat the Zacks Consensus Estimate of $1.52 billion.
Total revenues include collaboration revenues of $1.52 billion from Sanofi (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) and Bayer. The figure increased 15.7% from that recorded in the year-ago quarter. Total collaboration revenues beat the Zacks Consensus Estimate of $1.43 billion.
Sanofi&#39;s collaboration revenues increased 21% to $1.1 billion, driven by profits associated with higher Dupixent sales. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with the global sales of both drugs. Dupixent&#39;s sales increased 27% year over year to $3.5 billion.
Bayer&#39;s collaboration revenues totaled $375 million, down 1% year over year.
Regeneron records net product sales of Praluent in the United States and Sanofi does the same outside the country. SNY pays REGN a royalty on such sales. Regeneron records global net product sales of Libtayo and pays Sanofi a royalty on such sales.
Total Libtayo sales came in at $297.4 million, up 42% year over year. The figure beat the Zacks Consensus Estimate of $285 million.
Praluent&#39;s net sales in the United States were $56.1 million. Kevzara recorded global sales of $109.7 million, up 10% from the year-ago quarter&#39;s level.
Adjusted R&amp;D expenses jumped 10% year over year to $1.1 billion due to the advancement of the company&#39;s late-stage oncology programs, and higher headcount and headcount-related costs. Adjusted SG&amp;A expenses increased 19% to $667 million due to higher commercialization-related expenses to support the launch of Eylea HD and higher headcount and headcount-related costs.
<h3>Pipeline and Regulatory Update</h3>
In June 2024, the European Commission approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
However, in May 2024, the FDA extended the target action date of its priority review of the supplemental biologics license application (sBLA) for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD by three months. The revised target action date is Sep 27, 2024.
The FDA accepted (for priority review) the sBLA for Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), with a target action date of Sep 15, 2024.
The European Medicines Agency&#39;s, Committee for Medicinal Products for Human Use adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
Regeneron initiated a phase II study on fianlimab, an antibody to LAG-3, in combination with Libtayo, for the treatment of perioperative non-small cell lung cancer. A phase II/III study evaluating fianlimab, in combination with Libtayo, for treating perioperative melanoma was also initiated.
A phase II study was initiated for trevogrumab, an antibody to myostatin (GDF8), in combination with semaglutide with and without garetosmab, for the treatment of obesity.
<h3>Our Take</h3>
Regeneron&#39;s performance in the second quarter was impressive with both the top and bottom lines surpassing their respective estimates.
<div class="chart_embed">
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
<img alt="Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise" src="https://staticx-tuner.zacks.com/images/charts/df/1722516299.png" style="height:265px; width:596px" title="" />
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
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While Eylea sales have been under pressure due to competition from Roche&#39;s (OTC: <a class="ticker" href="https://www.benzinga.com/stock/rhhby#OTC">RHHBY</a>) Vabysmo, the uptake of the higher dose of the drug is encouraging as Eylea patients transition to the higher dose.
Regeneron&#39;s efforts to broaden its oncology portfolio and foray into the lucrative obesity space are also encouraging.
The uptake of Vabysmo has been outstanding. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. Roche recorded CHF 1.8 billion of Vabysmo sales in the first half of 2024 on strong demand in all regions.
<h3>Zacks Rank</h3>
Regeneron currently carries a Zacks Rank #3 (Hold).
<a href="https://www.zacks.com/stock/news/2314372/regeneron-regn-tops-on-q2-earnings-eylea-hd-dupixent-fuel-sales?cid=CS-BENZ-FT-analyst_blog|earnings_article-2314372">To read this article on Zacks.com click here.</a>

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Regeneron Tops on Q2 Earnings, Eylea HD, Dupixent Fuel Sales

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