Shares of ImmunityBio Inc. IBRX plummeted 53.7% toward a record one-day selloff in premarket trading Thursday, after the immunotherapy company disclosed it received a “complete response letter” from the U.S. Food and Drug Administration, but puts the company’s Biologics License Application (BLA) for its bladder cancer treatment Anktiva (N-803) on hold. The FDA determined that it can’t approve the BLA in its present form as a pre-license inspection of the company’s third-party contract manufacturer found deficiencies. “The company plans to request a meeting with the FDA as soon as possible to address the subject matter of the letter and a response timeline, and plans to diligently address and resolve the issues identified and seek approval as expeditiously as possible,” ImmunityBio said in a statement. Separately, ImmunityBio’s Executive Chairman Patrick Soon-Shiong agreed to provide $30 million in non-convertible debt financing, and the company said it was exploring partnering with a large biopharmaceutical company for commercialization of N-803. The stock’s current record selloff on a closing basis is 27.9% on Jan. 14, 2020. The selloff comes after the stock has nearly tripled in the past couple weeks, after the company announced the opening of a clinical trial to study its Tri-Ad5 cancer vaccines plus N-803 to prevent cancer in people with Lynch syndrome. The stock has rallied 22.7% year to date through Wednesday, while the iShares Biotechnology exchange-traded fund IBB has slipped 0.2% and the S&P 500 SPX has gained 7.8%.
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