Biotech Values

[DewDiligence]

CYTK receives CRL for omecamtiv mecarbil in HF:

https://www.globenewswire.com/news-release/2023/02/28/2617757/35409/en/Cytokinetics-Receives-Complete-Response-Letter-From-FDA-for-New-Drug-Application-for-Omecamtiv-Mecarbil.html

FDA wants another clinical trial to establish evidence of efficacy. The CRL is not surprising in light of the 8-3 rejection by the FDA advisory panel in Dec 2022 (#msg-170687104).