Benzinga -
- Needham initiates coverage on Cytokinetics Inc (NASDAQ: 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.
| Dec 2021 | Oppenheimer | Initiates Coverage On | Outperform | |
| Dec 2021 | HC Wainwright & Co. | Maintains | Buy | |
| Dec 2021 | JP Morgan | Initiates Coverage On | Overweight |
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