FDA granted accelerated approval for Lynozyfic, and J.P. Morgan reiterated a Buy rating for the company.

The entities involved

• FDA →
  • Sanofi, Regeneron, and Bayer are involved in new market developments, including FDA submissions regarding eczema and eye care treatments.17:04
  • FDA approval is the goal for product candidates from Daré Bioscience, Inc.14:49
• Regeneron Pharmaceuticals →

  American pharmaceutical company

  • Sanofi and Regeneron Pharmaceuticals announced a profit split for Dupixent and expanded their antibody alliance.17:04
  • Parabilis Medicines debuted on Nasdaq, achieving IPO haul surpassing Moderna's, while its product received FDA fast-track designation. Regeneron also acquired shares.Sat 13:46
• J.P. Morgan & Co. →

  U.S. investment bank

  Nothing else this week.

• FDA →
  • FDA conducted a raid in Beed on October 30, 2026.14:46
  • BioTech generated encouraging early data for MASH and POTS, and expects an FDA decision regarding cemdisiran next month.14:33

Related events

• FDA communicated eligibility for accelerated approval for ProKidney Corp., which plans to present study results at ASN.Jun 8
• Eli Lilly and Company plans to submit a drug candidate to the FDA for review and approval.Aug 5
• Clene Inc. submitted an NDA to the FDA seeking accelerated approval while trading on the Nasdaq exchange.Oct 20
• FDA granted Fast Track designation while PTC Therapeutics and Eli Lilly acquired assets from Sangamo Therapeutics.Oct 13
• FDA approval expands patient access to therapies for ACCORD.Jul 10