The FDA rejected BeyondSpring's drug for chemotherapy-induced neutropenia (CIN) in late-November, and now the biotech is letting go 35% of its U.S. staff.
The New York biotech slashed its workforce Tuesday in an effort to trim costs as the uphill battle with the FDA rolls on.
The agency rejected the biotech's lead drug, plinabulin, Nov. 30 for CIN, saying one registrational study was not enough to pass muster in showing the drug's benefit. CIN is the main side effect that prevents increased dosing in patients undergoing chemotherapy.
BeyondSpring is still attempting to move the needle forward in that indication, saying it will look at ways to bring plinabulin onto the market in the U.S. The drug is also under review in China, where Dalian Wanchunbulin Pharmaceuticals owns the rights. BeyondSpring holds a 57.97% interest in Wanchunbulin.
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If the biotech is unable to get plinabulin approved in CIN, it at least hopes to get a regulatory nod for the therapy in non-small cell lung cancer, or NSCLC, in the U.S. and China. The company wooed investors with phase 3 data in that indication in August showing plinabulin plus chemotherapy docetaxel improved overall survival in second- and third-line patients over chemotherapy alone.
Lan Huang, Ph.D., CEO, co-founder and chairwoman, characterized the layoffs as "a necessary step forward" in a statement.
Severance-related charges will cost the company about $1 million, mostly paid in the first quarter of this year, BeyondSpring said in a U.S. Securities and Exchange Commission (SEC) filing.
The company also proposed amendments to employment agreements with executives "to further retain the senior leadership necessary to grow the company's business." This seems like an effort to save the company's CEO, chief medical, regulatory and financial officers. Other members of the C-suite, including operating, commercial and scientific officers, were not mentioned in the SEC filing.
Also departing the company is board member Ravi Majeti, who resigned Dec. 22. The Stanford chief of hematology joined in August 2020 after the biotech he previously co-founded, Forty Seven, was acquired by Gilead Sciences for $4.9 billion in March 2020.