Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb (NYSE: BMY) announced that the FDA has accepted its supplemental Biologics License Application for Opdivo (nivolumab) aimed at treating high-risk muscle-invasive urothelial carcinoma post-surgery. The application received Priority Review status, with a PDUFA goal date of September 3, 2021. This follows positive results from the CheckMate -274 trial demonstrating significant disease-free survival improvements. Opdivo is recognized for its potential to provide a critical adjuvant immunotherapy option for patients facing high recurrence risk.

Bristol Myers Squibb (NYSE:BMY) reported Q1 2021 revenues of $11.1 billion, up 3% year-over-year, with an 8% increase excluding COVID-19 buying patterns. Net earnings were $2.0 billion or $0.89 per share, compared to a loss of $775 million in Q1 2020. The company raised its GAAP EPS guidance to $3.18-$3.38 and affirmed non-GAAP EPS guidance of $7.35-$7.55. Key product highlights include growth in Eliquis and Yervoy, while Opdivo saw a 3% decline. Regulatory progress was noted for several drugs, enhancing future growth opportunities.

Bristol Myers Squibb (NYSE: BMY) will participate in the 7th Annual Virtual Truist Life Sciences Summit on May 5, 2021. Senior executives Adam Lenkowsky and Winselow Tucker will discuss the company's oncology and hematology sectors during a live webcast at 8 a.m. ET. Interested investors and the public can access the session through the company’s investor website. An archived version will be available later that day.

Bristol Myers Squibb (NYSE:BMY) announced positive results from two pivotal Phase 3 trials of deucravacitinib, an oral TYK2 inhibitor for moderate to severe plaque psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials showed that deucravacitinib met both co-primary endpoints, with significantly higher PASI 75 responses at Week 16 (58.7% and 53.6%) compared to placebo (12.7% and 9.4%) and superior to Otezla. Safety profile was favorable, with low rates of serious adverse events. Aiming for regulatory discussions, Bristol Myers Squibb views deucravacitinib as a potential new standard of care.

Bristol Myers Squibb has received a positive recommendation from the CHMP of the EMA for Onureg (azacitidine) as maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission. This therapy is targeted at those not eligible for stem cell transplantation. The recommendation follows promising results from the QUAZAR^® AML-001 Phase 3 study, showing a median overall survival of 24.7 months for Onureg users compared to 14.8 months for placebo. The European Commission will review this recommendation within 67 days.

Bristol Myers Squibb (NYSE: BMY) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for the use of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment of unresectable malignant pleural mesothelioma (MPM). This marks a significant advancement, as it has been over 15 years since new treatments have been approved for MPM. The European Commission will now review this recommendation, which is based on the encouraging results of the CheckMate -743 trial, showcasing superior overall survival compared to chemotherapy.

Bristol Myers Squibb announced FDA approval for Opdivo (nivolumab) in combination with chemotherapy for treating patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression. This approval stems from the Phase 3 CheckMate -649 trial, where Opdivo plus chemotherapy improved overall survival (OS) and reduced the risk of disease progression. Notably, one-year survival rates reached 55% with Opdivo compared to 48% for chemotherapy alone. The approval was expedited through the FDA's Real-Time Oncology Review program.

Bristol Myers Squibb (NYSE: BMY) has received approval from the European Commission for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) as a first-line treatment for adults with advanced renal cell carcinoma (RCC). This decision follows the successful Phase 3 CheckMate -9ER trial, highlighting superior efficacy in key endpoints such as progression-free survival and overall survival compared to sunitinib. The combination treatment demonstrated manageable safety with low treatment-related discontinuations, broadening options for RCC patients in Europe.

Bristol Myers Squibb (NYSE: BMY) reported significant results from the CheckMate -816 study, demonstrating that neoadjuvant treatment with Opdivo (nivolumab) plus chemotherapy resulted in a pathologic complete response (pCR) of 24% compared to 2.2% for chemotherapy alone (p<0.0001). This trial is the first Phase 3 study showing improved pCR in resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). Additionally, Opdivo plus chemotherapy was well tolerated, with no new safety signals detected. The findings suggest potential benefits for long-term survival in NSCLC patients.