Bristol-Myers Squibb Co Stock Price, News & Analysis

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.

Bristol Myers Squibb (NYSE: BMY) announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference. CEO and Board Chair Christopher Boerner, Ph.D., will partake in a fireside chat on June 11, 2024, starting at 11:20 a.m. ET. Investors and the public can listen via a live webcast accessible through the company's investor relations website. An archived version will be available post-event.

Bristol Myers Squibb's Breyanzi has shown significant clinical benefits for patients with various B-cell malignancies, according to new data presented at the 2024 ASCO Annual Meeting. The three-year follow-up from the Phase 3 TRANSFORM trial demonstrates sustained event-free survival and durable responses in patients with large B-cell lymphoma (LBCL), outperforming standard care.

The study also highlights Breyanzi's consistent efficacy and safety in mantle cell lymphoma (MCL) and follicular lymphoma (FL) across different subgroups, regardless of the number of prior treatments or use of bridging therapy. This underscores Breyanzi's potential for earlier lines of treatment and relapsed or refractory cases. Recently, the FDA granted accelerated approval for Breyanzi in relapsed or refractory FL and MCL, expanding its use across four types of B-cell lymphomas.

These findings emphasize Breyanzi's role as a transformative CAR T cell therapy with a robust clinical profile, offering hope for improved patient outcomes.

Bristol Myers Squibb presented multiple analyses at the 2024 ASCO Annual Meeting showcasing Opdivo and Opdivo-based combinations for non-small cell lung cancer (NSCLC).

Key findings include: improved event-free survival and pathologic complete response in stage III resectable NSCLC patients from the CheckMate -77T study; four-year survival data from CheckMate -816 showing enhanced event-free survival with neoadjuvant Opdivo plus chemotherapy; and five-year data from CheckMate -9LA indicating survival benefits with Opdivo plus Yervoy and chemotherapy in metastatic NSCLC patients.

Additional studies showed promising results for Augtyro and KRAZATI in specific NSCLC patient subsets. No new safety concerns were noted across these studies.

Bristol Myers Squibb announced that KRAZATI (adagrasib) showed a statistically significant improvement in progression-free survival (PFS) for patients with pretreated locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) compared to standard chemotherapy in the Phase 3 KRYSTAL-12 study. Median PFS was 5.5 months for KRAZATI versus 3.8 months for chemotherapy. The overall response rate (ORR) was 32% with KRAZATI compared to 9% for chemotherapy. KRAZATI also demonstrated a higher intracranial response rate in patients with CNS metastases. The safety profile of KRAZATI was consistent with known data, with treatment-related adverse events reported in a high percentage of patients. These results will be presented at the 2024 ASCO Annual Meeting.

Bristol Myers Squibb (NYSE: BMY) has received FDA approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CAR T cell therapy targeting relapsed or refractory mantle cell lymphoma (MCL). This marks the fourth subtype of non-Hodgkin lymphoma for which Breyanzi is approved. In the TRANSCEND NHL 001 trial, Breyanzi demonstrated an 85.3% response rate, with a 67.6% complete response rate in patients who had at least two prior lines of systemic therapy, including a BTK inhibitor. The treatment involves a one-time infusion and has shown a consistent safety profile, making it an option for outpatient management. Despite high rates of response, significant risks such as Cytokine Release Syndrome (CRS) and neurologic toxicities persist. The approval extends Breyanzi's reach in treating B-cell malignancies, offering new hope for patients with options.