Invivyd Announces Phase 3 Exploratory Clinical Efficacy Data Regarding Pemgarda, Prel. Q3 Results

(RTTNews) - Invivyd, Inc. (IVVD), Tuesday announced positive exploratory clinical efficacy data from the ongoing CANOPY Phase 3 clinical trial of Pemivibart, a half-life extended investigational monoclonal antibody, for the pre-exposure prophylaxis of COVID-19.

During the follow-up months 7-12 in CANOPY Cohort B, the Pemivibart arm showed a relative risk reduction of 64 percent compared to the placebo group.

Continued protection over this follow-up period, absent continued dosing, was a pre-specified exploratory endpoint and, added to initial 180-day clinical efficacy observations, generated an overall 12-month protection rate of 76 percent following two doses of Pemivibart, the biotech company added.

Notably, the safety profile of Pemivibart over the 12-month study period recorded no new trends or safety signals.

The company estimates Pemgarda net product revenue of $9.3 million for the third quarter. Invivyd withdrew its previous guidance of $150-200 million in Pemgarda net product revenue for fiscal year 2024 due to the recent growth headwind from U.S. FDA's late-Q3 2024 warning on potential for substantially reduced activity of Pemivibart through the Pemgarda Fact Sheet.

Currently, Invivyd's stock is trading at $0.89, down 14.42 percent on the Nasdaq.