Vaxcyte Inc (PCVX)

[DewDiligence]

PCVX lays_out_timelines_for VAX-24/VAX-31 programs:

https://www.globenewswire.com/news-release/2024/01/04/2804307/0/en/Vaxcyte-Provides-Clinical-and-Regulatory-Progress-Update-on-Potential-Best-in-Class-Pneumococcal-Conjugate-Vaccine-PCV-Franchise.html

Timeline info:

• In the adult VAX-24 program, the main phase-3 trial, which will seek to show non-inferiority to PFE’s Prevnar-20 on immunogenicity, is expected to start in 2H24. Other (shorter) phase-3 trials in the adult VAX-24 program will start in 2025 and 2026, so it appears that the soonest PCVX could file a BLA is 2027 and the soonest VAX-24 could receive FDA approval for adults is 2028.

• The VAX-24 program for infants is in phase-2; topline data is expected at the end of 2025.

• The VAX-31 program, which is for adults, is in phase-1/2; topline data is expected in 3Q24.

This PR also says that PCVX received “encouraging feedback” from the FDA on the CMC requirements for VAX-24, whatever that means.

I consider PCVX, which has an enterprise value of about $5B, to be somewhat overvalued.