Bristol-Myers Squibb stock drops 3% premarket after FDA delays approval deadline for cancer drug [MarketWatch]
Bristol-Myers Squibb Company (BMY)
Last bristol-myers squibb company earnings: 2/6 07:05 am
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Source: MarketWatch
Bristol-Myers Squibb stock drops 3% premarket after FDA delays approval deadline for cancer drug Bristol-Myers Squibb Co. BMY, -5.43% shares dropped nearly 3% in Monday premarket trade after the company said that, because of new information from a cancer clinical trial, the U.S. Food and Drug Administration is extending the review period for the company's new drug application by three months. The FDA now aims for an approval decision of May 20, 2019. The trial, called CheckMate-227, is an ongoing phase 3 study testing Bristol-Myers' drug Opdivo plus a low dose of another Bristol-Myers drug, Yervoy, against chemotherapy in metastatic first-line non-small cell lung cancer. The new information that Bristol-Myers submitted to the FDA pertains to overall survival for patients whose tumors have a relatively low level of mutations, or a "tumor mutational burden" (TMB) of less than 10 mutations/megabase. TMB is thought to have promise in cancer treatment, as a way of matching patients with
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BMY
Earnings
- 4/25/24 - Miss
BMY
Sec Filings
- 5/9/24 - Form 8-K
- 5/3/24 - Form 4
- 4/25/24 - Form 10-Q
- BMY's page on the SEC website