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Investing.com - Kalvista Pharmaceuticals Inc (NASDAQ:KALV) shares experienced volatility following a report about potential intervention in the drug approval process by a top FDA official.
Endpoints News reported that FDA Commissioner Dr. Marty Makary requested drug reviewers issue a Complete Response Letter (CRL) for sebetralstat in hereditary angioedema (HAE), according to Stifel. The Department of Health and Human Services (HHS) has denied these claims, and no specific reason was cited for the alleged intervention.
The report comes after Kalvista’s June 17 PDUFA date passed without a decision, with the company announcing a delay of up to four weeks due to "resource constraints" at the FDA. Prior to this news, Kalvista management had indicated they were in detailed labeling discussions with the agency.
Stifel analyst Paul Matteis, who maintains a Buy rating and $39.00 price target on Kalvista, described the reported intervention as "surprising and unusual" for a commissioner to become involved in reviewing a drug, "especially one with fairly clear clinical data that aren’t all that high profile."
The sebetralstat application is for an oral treatment for hereditary angioedema, a rare genetic condition causing painful and potentially dangerous swelling episodes.
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