Replies to post #246360 on Biotech Values

[DewDiligence]

GSK—FDA approves Arexvy RSV vaccine for_adults_60+:

https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine

Today was GSK’s PDUFA date. The PDUFA date for PFE’s competing adult-RSV vaccine is 5/31/23. See #msg-171324277 for related info.

[DewDiligence]

BAVA.CO drops RSV-vaccine program after phase-3 failure:

https://www.globenewswire.com/news-release/2023/07/22/2709174/0/en/Bavarian-Nordic-Provides-Update-on-RSV-Vaccine-Program.html

The final [phase-3] study results showed that the vaccine candidate had a 59% efficacy in preventing at least 2 pre-defined LRTD symptoms meeting one of the efficacy criteria of the study. However, when measuring more severe LRTD based on at least 3 pre-defined symptoms, the vaccine candidate only demonstrated a 42.9% efficacy and missed the co-primary endpoint of the study.

Based on this outcome, Bavarian Nordic will discontinue its RSV program, including its partnership with Nuance Pharma to develop and launch the vaccine for selected Asian markets.