Invivyd Shares Plunge as Pemgarda Emergency Authorization Ends, Company Pursues Full Approval
IVVD•Invivyd shares plunged after the FDA revoked Pemgarda’s emergency use authorization, effective in early 2027, removing temporary market access for the lead therapy. Management now aims to submit a rolling Biologics License Application this year to secure full FDA approval and restore commercial prospects.
1. Emergency Authorization Revoked
The FDA confirmed that Pemgarda’s emergency use authorization will terminate in early 2027 after concluding the therapy no longer meets criteria for expedited access. This decision removes Pemgarda’s temporary pathway to patients while a full approval is pending.
2. Market Reaction and Outlook
On the revocation announcement, Invivyd shares plunged as investors weighed the commercial impact of losing emergency status for its flagship product. The stock move reflects concern over Pemgarda’s sales trajectory without interim FDA backing.
3. Full Approval Strategy
Invivyd management announced plans to submit a rolling Biologics License Application for Pemgarda later this year, leveraging additional Phase III data to support a full approval decision. The company targets a complete FDA review by late 2027 to restore market access.
