U.S. FDA declines to approve Merck's cough drug [Reuters]
BELLUS Health Inc. - Common Shares (BLU)
Last bellus health inc. - common shares earnings: 11/14 07:00 am
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Source: Reuters
The FDA's decision was not related to the drug's safety, Merck added. The drugmaker said it would meet with the agency to discuss the next steps, without disclosing further details about the timeline. Shares of the company were down about 2.3% at $78.10. The agency's decision could push back the approval of the oral drug gefapixant by several months, potentially helping Canada's Bellus Health Inc (BLU.TO) play catch up with its rival treatment candidate, BLU-5937. "This setback could delay the launch for gefapixant potentially by six months to one year if no additional clinical trials are needed, and longer if another study is requested," Justin Zelin, analyst at BTIG, wrote in a note. Meanwhile, Bellus in December reported positive results for BLU-5937 in a mid-stage study and the company had said it would start a late-stage trial in the second half of this year. Gefapixant and BLU-5937 target patients who have refractory chronic cough (RCC) which persists after the treatm
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