All articles tagged with #regeneron
The FDA has issued its first nine priority review vouchers to expedite the approval process for certain drugs and therapies, including Regeneron's gene therapy for hearing loss, with the aim of reducing approval times from 10-12 months to 1-2 months, focusing on public health priorities and affordability.
Insmed is considered an attractive investment opportunity but is currently expensive, while Regeneron faces ongoing troubles, raising questions about its future prospects in biotech.
Since filing for bankruptcy, 15% of 23andMe customers have requested their genetic data be deleted amid concerns over data security and sale of customer information to Regeneron, which acquired the company’s assets including DNA data, raising privacy and legal issues.
Twenty-seven states and D.C. sued to prevent the sale of 23andMe's personal genetic data without customer consent amid its bankruptcy and potential sale to Regeneron, emphasizing the importance of informed consent and data privacy.
The sale process of 23andMe has been reopened with new bids after a previous deal with Regeneron was announced. Co-founder Anne Wojcicki, through her nonprofit TTAM Research Institute, has increased her bid to over $305 million, surpassing Regeneron's offer, as the auction heats up with new rules allowing Regeneron to counter with at least $315 million. The sale raises privacy concerns, but both parties have committed to maintaining existing privacy policies.
23andMe, a genetics company in bankruptcy, is seeking to reopen its asset sale process after founder Anne Wojcicki's nonprofit made a $305 million bid, surpassing Regeneron's previous offer. Regeneron is considering a new bid but demands a breakup fee, as the companies negotiate in court. The company's bankruptcy followed a high-profile launch, financial losses, and a data breach, leading to legal and financial challenges.
23andMe is holding a second auction for its DNA data with a bid of $305 million from Anne Wojcicki's group, after a legal dispute with Regeneron over the initial auction win. The auction aims to resolve the sale of the company's genetic data amid its bankruptcy due to financial struggles and legal issues.
The founder of 23andMe, Anne Wojcicki, has announced she has secured backing from a Fortune 500 company to reopen the company's bankruptcy auction, challenging the previous winning bid by Regeneron, amid ongoing legal disputes and potential new bids.
A key Phase 3 trial of Regeneron and Sanofi's COPD drug, itepekimab, failed to meet its primary endpoint, causing a significant drop in their stock prices, although one of the two trials showed a meaningful benefit. The companies are reviewing the data and consulting with regulators to determine next steps.
Regeneron Pharmaceuticals' stock dropped 17% after its late-stage trials for the COPD drug itepekimab only partially met goals, with one study showing some benefit and the other failing to meet primary endpoints, leading to concerns about the drug's future and impacting investor sentiment.
Regeneron Pharmaceuticals' stock dropped 12% after its COPD drug, developed with Sanofi, failed in a Phase 3 trial, with mixed results across two studies, potentially hindering approval efforts.
Nike and Alpine Immune Sciences stocks rise in premarket trading, while CarMax, Robinhood, and Regeneron stocks fall.
Intellia has exited a partnership with Regeneron to develop a factor IX gene editing therapy for hemophilia B, opting out of a deal that was signed in 2020. Despite this, Intellia remains eligible for up to $320 million in future milestones and still holds a 35% stake in a factor XIII insertion program for hemophilia A.
The FDA has approved Regeneron's monoclonal antibody, Veopoz (pozelimab), as the first treatment for Chaple disease, a rare hereditary immune disease affecting fewer than 100 people worldwide. The drug is expected to be available to patients this quarter and can be used to treat both adults and children aged one and older, who may experience severe gastrointestinal issues or blood clots due to the condition.
Regeneron is acquiring Decibel Therapeutics, a biotech company specializing in gene therapies for hearing loss, in a $109 million deal. The two companies have been collaborating since 2017, and Decibel's lead program focuses on a gene therapy for congenital hearing loss caused by mutations in the otoferlin gene.