Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb (NYSE: BMY) announced the U.S. FDA's accelerated approval of KRAZATI® (adagrasib) in combination with cetuximab for adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).

The approval is based on positive results from the Phase 1/2 KRYSTAL-1 study, which showed an objective response rate (ORR) of 34% in patients with heavily pretreated CRC. The median duration of response (DOR) was 5.8 months. This combination therapy provides a new treatment option for CRC patients who have not responded well to prior therapies.

KRAZATI is the first KRAS G12C inhibitor approved beyond non-small cell lung cancer, marking a significant milestone for BMS and reinforcing the potential of KRAZATI across various tumor types.

However, it comes with warnings and precautions including gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, and interstitial lung disease. The most common adverse reactions include rash, nausea, diarrhea, fatigue, and musculoskeletal pain.

Bristol Myers Squibb (BMY) announced that the European Medicines Agency (EMA) has validated its application for a new subcutaneous formulation of Opdivo® (nivolumab) for multiple solid tumor indications. This validation is based on the Phase 3 CheckMate -67T trial, which showed that subcutaneous nivolumab is noninferior in terms of pharmacokinetics and efficacy compared to the intravenous formulation. The new subcutaneous formulation aims to significantly reduce administration time to 3-5 minutes per injection, compared to longer IV infusions. The validation marks the start of EMA's centralized review process. If approved, the subcutaneous formulation could provide more convenience for patients, allowing them to receive the same quality of care in less time. The Phase 3 trial involved 495 patients with advanced or metastatic clear cell renal cell carcinoma, showing similar safety profiles between subcutaneous and IV formulations. Bristol Myers Squibb is committed to improving patient experiences and advancing innovative treatment formulations.

Bristol Myers Squibb (NYSE: BMY) will release its second quarter 2024 financial results on July 26, 2024. The company's executives will provide an overview of the financial outcomes and answer questions from investors and analysts during a conference call scheduled for 8:00 a.m. ET on the same day.

The live conference call can be accessed through a webcast available on the company’s investor relations website. For those who cannot register for the webcast, dial-in options are available for both U.S. and international participants. Conference materials will be provided on the investor relations website before the call begins. A replay of the webcast and the conference call will be accessible post-event.

Bristol Myers Squibb (NYSE: BMY) has announced the election of Michael R. McMullen to its Board of Directors, effective July 1, 2024. McMullen will also join the Audit Committee. Previously, McMullen was the CEO of Agilent Technologies, where he significantly increased the company's market capitalization and profitability. His extensive experience in global operations and delivering shareholder returns is expected to enhance Bristol Myers Squibb's long-term growth and pipeline progress.

McMullen has over 20 years of executive experience and has held various leadership roles at Agilent, including COO and President of the Chemical Analysis Group. He will continue to serve as a senior advisor to Agilent until October 31, 2024. The appointment increases Bristol Myers Squibb's Board size to 11, and McMullen will receive compensation as per the company’s director compensation program.

Bristol Myers Squibb (NYSE: BMY) has declared a quarterly dividend of $0.60 per share on its $0.10 par value common stock, payable on August 1, 2024, to stockholders of record as of July 5, 2024.

The company also announced a quarterly dividend of $0.50 per share on its $2.00 convertible preferred stock, payable on September 3, 2024, to stockholders of record as of August 6, 2024.

Bristol Myers Squibb (NYSE: BMY) announced that the FDA has granted accelerated approval for Augtyro™ (repotrectinib), a new tyrosine kinase inhibitor (TKI), for treating NTRK-positive solid tumors in patients aged 12 and older. This approval is based on Phase 1/2 TRIDENT-1 trial results, showing significant response rates in both TKI-naïve and TKI-pretreated patients.

Among TKI-naïve patients, 58% had a confirmed objective response with a median follow-up of 17.8 months. In TKI-pretreated patients, the overall response rate was 50%. Intracranial responses were also noted in patients with CNS metastases. Augtyro showed manageable safety profiles, though notable adverse events included dizziness, hepatotoxicity, and pneumonitis.

Continued approval may depend on further confirmatory trials. This is the second indication for Augtyro in the U.S., following its approval for ROS1-positive NSCLC in November 2023. The recommended dosage is 160 mg daily for the first 14 days, then twice daily until disease progression or unacceptable toxicity.

Envisagenics, a biotechnology company specializing in RNA splicing therapeutics, has completed a Series B funding round. The round included existing investors Third Kind Venture Capital, Empire State Development, and Red Cell Partners, along with new strategic investor Bristol Myers Squibb (NYSE: BMY).

The funds will be used to advance Envisagenics' pipeline of preclinical oncology assets using its AI drug discovery platform, SpliceCore®. This platform integrates machine learning and high-performance computing to identify novel splicing isoforms.

Envisagenics has collaborations with Biogen, the Lung Cancer Initiative at Johnson & Johnson, and Bristol Myers Squibb. CEO Maria Luisa Pineda stated that the funding will aid in developing immunotherapies and disease-modifying ASOs for neurodegenerative diseases. The goal is to advance their first asset into clinical trials.

I-Mab (NASDAQ: IMAB), a global biotech company, has announced a clinical trial collaboration with Bristol Myers Squibb (NYSE: BMY). The focus is on evaluating the combination of givastomig, a Claudin 18.2 x 4-1BB bispecific antibody, with nivolumab and chemotherapy for treating advanced gastric and esophageal cancers. The collaboration leverages promising safety and efficacy data from givastomig's monotherapy study, presented at the European Society of Medical Oncology Congress 2023. The multi-national Phase 1 study will be conducted by I-Mab, with Bristol Myers Squibb supplying nivolumab. The aim is to explore the potential of this combination as a first-line treatment for Claudin 18.2-positive cancers.

Bristol Myers Squibb announced the first presentation of Phase 3 CheckMate -9DW trial results showing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improves overall survival (OS) and objective response rate (ORR) in patients with advanced hepatocellular carcinoma (HCC) compared to lenvatinib or sorafenib.

Median OS for Opdivo plus Yervoy was 23.7 months versus 20.6 months for lenvatinib or sorafenib. The ORR for Opdivo plus Yervoy was 36%, more than double the 13% for lenvatinib or sorafenib, with a median duration of response of 30 months versus 12.9 months.

The ASCO Annual Meeting will feature these results, highlighting a reduced risk of symptom deterioration and a manageable safety profile.