- Needham initiates coverage on Cytokinetics Inc CYTK with a Buy rating and a price target of $60.
- Tuesday, FDA's Cardiovascular and Renal Drugs Advisory Committee voted 8-3 against the approval of Cytokinetics' omecamtiv mecarbil.
- The analyst writes that these concerns were previously known but appear to be more severe than expected.
- Post-AdCom, the odds of omecamtiv FDA approval have fallen from 60-65% to below 50%. The analyst also expects that, if approved, omecamtiv is likely to carry labeling restrictions to restrict wide usage and minimize safety concerns.
- Like other investors, Needham does not consider omecamtiv as a critical asset for the company, given that aficamten, which has the potential to address a much larger market opportunity, is in phase 3 trials and expected to report top-line in 2H23.
- Several investors may view the AdCom outcome and a potential non-approval of omecamtiv as a blessing in disguise, forcing Cytokinetics to focus its efforts and investments solely on aficamten.
- Price Action: CYTK shares are up 12.10% at $40.35 on the last check Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
date | ticker | name | Price Target | Upside/Downside | Recommendation | Firm |
---|
Posted In: Analyst ColorBiotechNewsHealth CareInitiationFDAAnalyst RatingsMoversTrading IdeasGeneralBriefswhy it's moving
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in