Shares of Regeneron Pharmaceuticals, Inc. (REGN) have gained 13.5% in the year so far against the industry’s decline of 2.8%.The stock has outperformed the sector during this timeframe but underperformed the S&P 500 Index.REGN Outperforms Industry & SectorImage Source: Zacks Investment ResearchRegeneron’s efforts to diversify its portfolio have impressed its investors, even as lead drug Eylea faces challenges.Regeneron’s EYLEA HD Stabilizes Ophthalmology UnitEylea is an anti-vascular endothelial growth fact ...

Core Viewpoint - Regeneron Pharmaceuticals has faced challenges with its key product Eylea, particularly due to competition and recent regulatory developments, which have impacted its stock price significantly [1] Group 1: Eylea Overview - Eylea is a treatment for wet age-related macular degeneration (AMD), with Regeneron holding U.S. licensing rights and sharing international rights with Bayer [2] - The approval of Vabysmo, a competing drug by Roche, in early 2022 marked the beginning of challenges for Eylea [2] - Regeneron introduced a higher-dose formulation of Eylea, which has helped maintain its market position against Vabysmo [2] Group 2: Financial Performance - In Q2, combined U.S. sales of Eylea and its higher-dose version reached $1.53 billion, a 2% increase year-over-year, with the higher-dose contributing $304 million [3] - Regeneron's total revenue for the same quarter was $3.55 billion, reflecting a 12% increase compared to the previous year, with Eylea sales accounting for 43% of total revenue [3] Group 3: Competitive Landscape - The FDA approved Pavblu, a biosimilar for Eylea's original formulation, and a recent court ruling favored Amgen, allowing them to potentially launch Pavblu [4] - Regeneron is appealing the court's decision, indicating ongoing legal battles regarding Eylea's patent exclusivity [4] Group 4: Future Outlook - The potential loss of patent exclusivity for Eylea could negatively impact Regeneron, but the company has other growth drivers, including the eczema treatment Dupixent, which saw a 27% revenue increase to $3.56 billion in Q2 [5][6] - Dupixent's recent approval for treating chronic obstructive pulmonary disease (COPD) is expected to significantly boost its sales [6] - Regeneron has a robust pipeline with over 50 programs, particularly focusing on oncology, which may help mitigate the impact of Eylea's challenges [6]

  Dupixent approved in the US as the first-ever biologic medicine for patients with COPD         Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype Following recent approvals in the EU and China, the US approval is based on two landmark phase 3 studies that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placeboDupixen ...

Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placebo Dupixent is the leading biologic medicine for all of its FDA ...

Dupixent approved in China as the first-ever biologic medicine for patients with COPD Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark phase 3 studies showing Dupixent significantly reduced exacerbations, improved lung function, and also improved health-related quality of lifeCOPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now a ...

Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now approved in four indications across respiratory and dermatological diseases in China TA ...

TARRYTOWN, N.Y., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2024 financial and operating results on Thursday, October 31, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference call live via webcast on the ’Investors and Media’ page of Regeneron’s website at ht ...

Chief District Judge Thomas Kleeh denied Regeneron Pharmaceuticals, Inc.‘s REGN effort to prevent the sale of Amgen Inc‘s AMGN Eylea biosimilar.Regeneron filed a notice of its appeal to the U.S. Court of Appeals for the Federal Circuit.The appeal is from the Order issued on September 23, 2024, which denied Regeneron’s request for a preliminary injunction, along with any related orders, decisions, rulings, findings, or conclusions connected to that Order.Reuters highlighted that an Amgen spokesperson express ...

Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescentsIf approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group Paris and Tarrytown, NY, September 20, 2024. The European Medicines ...

Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission compared to placebo, consistent with improvements seen in adults and adolescents If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group TARRYTOWN, N.Y. and PARIS, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for ...