PEMGARDA’s emergency status will end on June 29, 2027, unless the company secures full FDA approval in the meantime.
- Invivyd said it is already in active talks with the FDA about next steps.
- PEMGARDA received its emergency authorization in March 2024.
- In 2025, PEMGARDA generated $53.4 million in net product revenue for Invivyd.
Shares of Invivyd (IVVD) fell 6% on Monday after the company announced that it has received notice from the U.S. Food and Drug Administration (FDA) of the impending expiry of the emergency use authorization for its PEMGARDA preventive treatment
PEMGARDA’s emergency status will end on June 29, 2027, unless the company secures full FDA approval in the meantime.
Invivyd said it is already in active talks with the FDA about next steps and plans to pursue every available path to keep the treatment available for vulnerable patients.
PEMGARDA EUA And Demand
PEMGARDA received its emergency authorization in March 2024 for use as a preventive option in adults and adolescents with moderate-to-severe immune compromise who are unlikely to respond adequately to COVID vaccines.
In 2025, PEMGARDA generated $53.4 million in net product revenue for Invivyd — more than double the $25.4 million recorded in its first partial year of sales in 2024.
IVVD Responds
Invivyd board Chairman Marc Elia said the end of emergency status for COVID products is long overdue but stressed that PEMGARDA has compiled enough clinical and real-world data to support full approval.
“The EUA designation is not a product approval,” Elia noted. “We believe PEMGARDA has sufficient clinical and post-authorization data to support Biologics License Application submission and approval.”He added that the uncertainty created by the transition has been frustrating for the immunocompromised patients who rely on the treatment as a non-vaccine option.
How Did IVVD Retail Traders React?
On Stocktwits, retail sentiment around IVVD stock stayed within the ‘bearish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.
According to data from Koyfin, all three analysts covering IVVD rate it a ‘Buy.’ The 12-month average price target on the stock is $10, representing a potential upside of over 1000% from the stock’s last closing price.
IVVD stock has lost about 67% year-to-date.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<
