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CHMP Issues Positive Opinion for Label Expansion of BMY's Opdivo
ZACKS· 2025-04-01 20:00
Core Viewpoint - Bristol Myers Squibb (BMY) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the approval of Opdivo (nivolumab) for additional indications in treating non-small cell lung cancer (NSCLC) and for a subcutaneous formulation across multiple solid tumor indications [1][10]. Group 1: Opdivo Approval and Clinical Trials - The CHMP recommended Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy after surgical resection for high-risk resectable NSCLC patients with PD-L1 expression ≥1% [2]. - The positive CHMP opinion was based on the CheckMate-77T trial, which showed significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo [3]. - The CheckMate-77T study also demonstrated improvements in secondary efficacy endpoints, including pathologic complete response and major pathologic response (MPR) [4]. Group 2: Market Performance and Growth - BMY's shares have increased by 21.4% over the past year, contrasting with a 7.1% decline in the industry [9]. - The approval of Opdivo Qvantig for subcutaneous use is expected to enhance the immuno-oncology franchise's impact into the next decade [12]. - BMY's growth portfolio, including drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition [13]. Group 3: Recent Acquisitions and New Approvals - BMY recently acquired 2seventy bio, Inc. for $286 million, with plans to close the acquisition in the second quarter of 2025 [15]. - The approval of Cobenfy for schizophrenia represents a new pharmacological approach, with initial sales of $10 million in 2024 expected to contribute significantly to BMY's revenue [14].
ALERT: Rowley Law PLLC is Investigating Proposed Acquisition of 2seventy bio, Inc.

Prnewswire· 2025-03-11 19:31
Core Viewpoint - Rowley Law PLLC is investigating potential securities law violations related to the proposed acquisition of 2seventy bio, Inc. by Bristol Myers Squibb, which is valued at approximately $286 million [1] Group 1: Acquisition Details - The proposed acquisition will provide stockholders of 2seventy bio with $5.00 for each share they hold [1] - The transaction is expected to close in the second quarter of 2025 [1] Group 2: Legal Investigation - Rowley Law PLLC is representing shareholders in the investigation concerning the acquisition [1] - The firm specializes in class actions and derivative lawsuits in complex corporate litigation [3]
Bristol Myers Squibb Scoops Up Its Blood Cancer Drug Partner 2seventy Bio In $286 Million Deal

Benzinga· 2025-03-11 14:17
Acquisition Details - Bristol Myers Squibb & Co (BMY) has agreed to acquire 2seventy bio, Inc (TSVT) at $5.00 per share, totaling an equity value of approximately $286 million, or $102 million net of estimated cash, representing an 88% premium to TSVT's closing price of $2.66 on March 7, 2025 [1] - The acquisition is expected to close in the second quarter of 2025 [1] Financial Implications - The decision to acquire 2seventy bio is anticipated to conserve over $80 million in near-term expenditures and accelerate the path to breakeven for 2seventy bio in 2025, according to the CEO Chip Baird [3] Recent Developments - In September, the companies discontinued enrollment in the Phase 3 KarMMa-9 study of Abecma for newly diagnosed multiple myeloma patients [2] - The FDA approved Abecma for adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy in April 2024 [4] Market Reaction - Following the acquisition announcement, TSVT stock increased by 76.4% to $4.9, while BMY stock decreased by 1.04% to $62.45 during the premarket session [4]