LOGO
LOGO

Slide Shows

Biotech Stocks Facing FDA Decision In June 2024

Bristol Myers Squibb
Bristol Myers Squibb

Bristol Myers Squibb (BMY) has sought FDA approval of Augtyro for a second indication, and a decision is expected by June 15, 2024.

The proposed indication is for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.

Augtyro received its initial FDA approval in the indication of ROS1-positive locally advanced or metastatic non-small cell lung cancer last November.

Zai Lab holds an exclusive license agreement with Turning Point Therapeutics, a Bristol Myers Squibb company, to develop and commercialize Augtyro in Greater China (Mainland China, Hong Kong, Taiwan, and Macau).

Augtyro brought home sales of $6 million for Bristol Myers Squibb in the first quarter of 2024, which is also its debut quarter on the market.

BMY closed Wednesday’s trading at $40.25, down 0.59%.