Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) has validated its Type II Variation Marketing Authorization Applications for Opdivo in combination with Yervoy and chemotherapy as first-line treatments for unresectable advanced esophageal squamous cell carcinoma (ESCC). This validation confirms the completeness of the applications and initiates the EMA's review process. The applications are based on the impressive results from the Phase 3 CheckMate -648 trial, demonstrating significant overall survival benefits for patients treated with these combinations.

Bristol Myers Squibb (BMY) has launched a multimillion-dollar initiative called Tomorrow's Innovators to enhance access and awareness of the biopharma industry among Black talent. Collaborating with several Historically Black Colleges and Universities (HBCUs), this program aims to double executive representation of Black and Hispanic/Latino employees in the U.S. by 2022 and achieve global gender parity at the executive level. Activities include career-focused workshops, a two-way exchange program, and a custom biopharma curriculum to better prepare diverse students for careers in the industry.

Bristol Myers Squibb (NYSE: BMY) has finalized the sale of its manufacturing facility in Couvet, Switzerland, to WuXi STA, a subsidiary of WuXi AppTec. This divestiture is part of the company's strategic evolution of its manufacturing network to better align with its product portfolio. The Couvet site, known for its state-of-the-art commercial-scale production capabilities, will allow BMY to focus on its core operations while maintaining a significant presence in Switzerland.

Bristol Myers Squibb (BMY) has received European Commission approval for Opdivo (nivolumab) as an adjuvant treatment for adults with esophageal or gastroesophageal junction cancer who have residual pathologic disease after neoadjuvant chemoradiotherapy. This approval is based on the Phase 3 CheckMate -577 trial, which showed that Opdivo significantly improved disease-free survival (DFS) to a median of 22.4 months versus 11.0 months for placebo. The drug also has a consistent safety profile, with serious treatment-related adverse events occurring in less than 10% of patients. This approval expands access for patients in the EU, Norway, and Iceland.

Bristol Myers Squibb (NYSE:BMY) reported a strong second quarter of 2021, with total revenues reaching $11.7 billion, a 16% increase year-over-year. Notably, Eliquis sales rose by 29% to $2.8 billion, while Opdivo generated $1.9 billion in revenue, up 16%. The company achieved a GAAP EPS of $0.47, compared to a loss of $0.04 in Q2 2020, and a non-GAAP EPS growth of 18% to $1.93. Research and development expenses increased by 30% to $3.3 billion. Bristol Myers Squibb reaffirmed its full-year guidance, projecting non-GAAP EPS between $7.35 and $7.55.

Bristol Myers Squibb (NYSE: BMY) reported that the Phase 3 CheckMate-651 trial comparing Opdivo (nivolumab) plus Yervoy (ipilimumab) against the EXTREME regimen for squamous cell carcinoma of the head and neck did not meet its primary endpoints. Although a trend favoring overall survival was noted in patients with tumors expressing PD-L1 (CPS ≥ 20), results lacked statistical significance. Safety profiles were consistent with prior studies. The company remains committed to ongoing research and trials for this challenging cancer type.

Bristol Myers Squibb (NYSE: BMY) has received approval from the European Commission for Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of dMMR or MSI-H metastatic colorectal cancer after prior chemotherapy. This marks the first dual immunotherapy for GI tumors in the EU, based on the CheckMate -142 trial which demonstrated a 64.7% objective response rate. The combination has also been FDA-approved since July 2018 and received prior approval in Japan. With this, patients in the EU gain a significant new treatment option.

Bristol Myers Squibb (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo for adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer post-neoadjuvant chemoradiotherapy. This positive opinion follows Phase 3 CheckMate -577 trial results, which showed that Opdivo improved disease-free survival compared to placebo. The European Commission will now review the recommendation.

Bristol Myers Squibb (NYSE: BMY) announced that the CHMP has recommended Conditional Marketing Authorization for Abecma (idecabtagene vicleucel), a CAR T cell therapy for relapsed and refractory multiple myeloma. This recommendation follows positive outcomes from the Phase 2 KarMMa study involving 128 patients. The European Commission will review this recommendation, with a decision expected within 67 days. Abecma targets patients with limited options, marking a potential advancement in their treatment. The therapy has previously been granted access to the EMA's PRIME scheme.