Cancer drugmaker CEO resigns after FDA setback

Maria Fardis has submitted her resignation as president, CEO and director of the immune-oncology company Iovance Biotherapeutics, reports the San Francisco Business Times.

Iovance disclosed her resignation May 19 in a three-sentence filing with the Securities and Exchange Commission, but did not reveal when Ms. Fardis would leave her role. 

Her resignation comes after the company had a regulatory setback for its drug candidate lifileucel, designed to treat metastatic melanoma. The FDA asked the company May 18 for more information about the drug's manufacturing process, a request that will delay Iovance's filing for regulatory approval until the first half of 2022. 

After disclosing the regulatory hurdle May 19, the company lost nearly 40 percent of its value compared to the previous day's close, according to San Francisco Business Times.

The company's general counsel Frederick Vogt will serve as interim president and CEO while Iovance looks for Ms. Fardis' successor.

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