Positive Outlook on KalVista Pharmaceuticals’ Sebetralstat Approval Despite FDA Decision Delay

Leerink Partners analyst Joseph Schwartz has reiterated their bullish stance on KALV stock, giving a Buy rating yesterday.

Joseph Schwartz’s rating is based on the belief that the delay in the FDA’s decision regarding KalVista Pharmaceuticals’ drug, sebetralstat, is due to the agency’s heavy workload and not due to any issues with the drug itself. The FDA has not requested additional data or raised concerns about the drug’s safety or efficacy, which supports the expectation of eventual approval. Schwartz notes that KalVista has been responsive to all information requests and that the review process has been progressing without issues.
Despite the delay, Schwartz maintains a positive outlook on sebetralstat’s approval and suggests that the current situation presents a buying opportunity. The confidence in the drug’s approval is reinforced by the management’s communication, which has provided reassurance about the situation. The delay is seen as a temporary setback rather than a fundamental problem with the drug’s approval process.

In another report released yesterday, TD Cowen also maintained a Buy rating on the stock with a $30.00 price target.

KALV’s price has also changed dramatically for the past six months – from $8.690 to $12.960, which is a 49.14% increase.