Bristol Myers (BMY) Gets FDA Nod for Label Expansion of Augtyro [Yahoo! Finance]
Bristol-Myers Squibb Company (BMY)
Last bristol-myers squibb company earnings: 2/6 07:05 am
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Source: Yahoo! Finance
The regulatory body granted accelerated approval to Augtyro for the treatment of adult and pediatric patients aged 12 years and above with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. The accelerated approval is based on positive results from the phase I/II TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors. The TRIDENT-1 trial included both TKI-naïve (n=40) and TKI-pretreated (n=48) patients with NTRK-positive locally advanced/metastatic solid tumors collectively representing 15 different types of cancer. The latest approval was granted under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of c
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- European Medicines Agency Validates Bristol Myers Squibb's Application for Subcutaneous Nivolumab [Yahoo! Finance]Yahoo! Finance
- European Medicines Agency Validates Bristol Myers Squibb’s Application for Subcutaneous NivolumabBusiness Wire
BMY
Earnings
- 4/25/24 - Miss
BMY
Sec Filings
- 6/18/24 - Form 8-K
- 5/9/24 - Form 8-K
- 5/3/24 - Form 4
- BMY's page on the SEC website