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INCHEON, South Korea and CAMBRIDGE, Mass. - Samsung (KS:005930) Bioepis Co., Ltd. and Biogen Inc. (NASDAQ:BIIB) announced a significant regulatory milestone as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) endorsed OPUVIZ™ for marketing authorization. This biosimilar references Eylea (aflibercept), known as SB15, and is recommended for treating several retinal conditions.
The CHMP's positive opinion is a step towards making OPUVIZ available to adult patients with neovascular (wet) age-related macular degeneration (AMD (NASDAQ:AMD)), macular edema due to retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularisation (myopic CNV). If the European Commission (EC) follows the CHMP's recommendation, OPUVIZ would be the second ophthalmology biosimilar approved in Europe.
The decision was informed by comprehensive evidence, including analytical, non-clinical, and clinical data. A key Phase 3 study demonstrated SB15's equivalent efficacy to the reference drug, Eylea, with comparable safety and immunogenicity profiles. The study's primary endpoint of change in best corrected visual acuity (BCVA) at week 8 was achieved, with further analysis up to 56 weeks supporting the biosimilar's comparability.
Samsung Bioepis and Biogen, under a commercialization agreement since November 2019, have been working to bring two ophthalmology biosimilar candidates, BYOOVIZ and OPUVIZ, to various markets including the U.S., Canada, Europe, Japan, and Australia. OPUVIZ's potential approval could expand Biogen's existing biosimilar portfolio, which includes BYOOVIZ, BENEPALI, IMRALDI, and FLIXABI.
The companies emphasize the potential healthcare savings and broader access to treatment that biosimilars like OPUVIZ could offer for complex ophthalmic diseases. This development is part of Samsung Bioepis's broader efforts to enhance patient access to biologic therapies through their commitment to product development and quality.
This news is based on a press release statement and the final decision on marketing authorization for OPUVIZ in the EU rests with the European Commission.
In other recent news, Biogen Inc. has reported a series of significant developments. The company announced strong second-quarter results, with a total revenue of $2.5 billion, marking a 5% growth in core pharmaceutical revenue. In response, RBC Capital Markets raised its price target for Biogen, while Mizuho Securities lowered its target due to more conservative sales projections for Biogen's product acoramidis. Both firms, however, maintained an Outperform rating.
Biogen has also expanded its Board of Directors with the appointment of two new members, Lloyd B. Minor, M.D., and Sir Menelas (Mene) Pangalos, Ph.D. Their addition is expected to strengthen Biogen's expertise in the field of life sciences and biopharmaceutical research and development. Biogen also reported positive results from its Phase 2/3 DEVOTE study, evaluating a higher dose regimen of nusinersen for treating spinal muscular atrophy.
Furthermore, the company received approval for its Alzheimer's drug Leqembi in Britain, an unexpected development following a previous negative opinion from the Committee for Medicinal Products for Human Use. The approval, however, is specific to patients with a negative ApoE4 homozygote genotype. These recent developments highlight Biogen's ongoing efforts to innovate and expand its product offerings in the biotechnology sector.
InvestingPro Insights
As the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) endorses OPUVIZ™ for marketing authorization, Biogen Inc. (NASDAQ:BIIB) stands to strengthen its position in the biotechnology industry. With a market capitalization of $29.34 billion and a reputation as a prominent player in the sector, Biogen's financial health appears robust. The company's liquid assets surpass short-term obligations, which is indicative of financial stability and may provide confidence in its ability to invest in future growth and development projects such as OPUVIZ.
InvestingPro data highlights a Price/Earnings (P/E) ratio of 25.34, which adjusts to 16.77 based on the last twelve months as of Q2 2024, reflecting investor sentiment on Biogen's earnings potential. Moreover, the company's Gross Profit Margin stands at an impressive 76.45% for the same period, showcasing its ability to maintain profitability despite market fluctuations. Biogen's stock price has been trading near its 52-week low, potentially presenting an attractive entry point for investors.
According to InvestingPro Tips, analysts predict Biogen will maintain profitability this year, a testament to its enduring business model and innovative pipeline. Notably, Biogen does not pay a dividend, which suggests that it reinvests earnings back into the company to fuel growth and product development. For those interested in a deeper dive into Biogen's performance and potential, InvestingPro provides additional tips, including insights on how the stock generally trades with low price volatility and often moves in the opposite direction of the market.
To explore further, visit https://www.investing.com/pro/BIIB for more InvestingPro Tips, where you can find a total of 8 tips that shed light on Biogen's market behavior and financial health.
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