Sage Therapeutics Stock Plummets 50% After FDA Rejects Key Drug Application
VYNE Therapeutics (NASDAQ:VYNE) saw its stock value collapse by 70% on Wednesday following the announcement that its Phase 2b trial for repibresib gel, a treatment for nonsegmental vitiligo, did not meet its primary and key secondary endpoints
The biopharmaceutical company announced it had received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for the MDD indication. A CRL indicates that the agency has completed its review but cannot approve the application in its present form.
However, in a mixed decision, the FDA did approve zuranolone, to be marketed as Zurzuvae, for the treatment of postpartum depression (PPD), making it the first and only oral medication specifically for that condition.
The FDA’s rejection for the much larger MDD market was reportedly due to a lack of substantial evidence of effectiveness, stating that an additional study or studies would be required to support an approval. This was a significant blow to the company and its partner, Biogen (NASDAQ:BIIB).
“We are highly disappointed for patients, particularly in a time of dire need for new, rapidly acting options to treat MDD,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “Looking ahead, we are proud to have delivered the first-ever oral treatment specifically for PPD and we are excited to have the opportunity to launch Zurzuvae for women with PPD.”
Following the decision, Sage and Biogen announced they are reviewing the FDA’s feedback and will evaluate the next steps for zuranolone in the treatment of MDD. The companies will proceed with the commercial launch of Zurzuvae for PPD, which is anticipated to be available in the fourth quarter of 2023.
Zuranolone is a 14-day, once-daily oral drug. The rejection for MDD undermines the drug’s blockbuster potential, as the patient population for MDD is substantially larger than that for PPD.
Sage Therapeutics reported it had approximately $1.0 billion in cash, cash equivalents, and marketable securities as of June 30, 2023.
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