2seventy bio, Inc. - TSVT STOCK NEWS

The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for Bristol Myers Squibb (NYSE:BMY) and 2seventy bio's Abecma (idecabtagene vicleucel), with a target action date set for December 16, 2023. This application is based on promising interim results from the Phase 3 KarMMa-3 study, which demonstrated a significant reduction in disease progression or death for patients with relapsed and refractory multiple myeloma compared to standard treatments. Additionally, the European Medicines Agency validated a Type II variation application for Abecma, and Japan's Ministry of Health accepted the supplemental New Drug Application. These developments highlight the commitment to enhance treatment options for multiple myeloma patients.

2seventy bio, Inc. (TSVT) reported its financial results for Q4 2022, with U.S. revenue from Abecma reaching $94M for the quarter and $297M for the full year. The company forecasts U.S. revenue of $470-$570M in 2023, supported by positive Phase 3 KarMMa-3 study results. As of December 31, 2022, 2seventy bio held $267.7M in cash and equivalents, with a projected net cash spend of $180-$220M for 2023. Following a $117M equity offering in early 2023, the company expects a cash runway into 2026, allowing further advancement of its pipeline, including potential FDA submissions and collaborations with Regeneron.

2seventy bio, Inc. (NASDAQ: TSVT) has announced the immediate appointment of Dr. Wei Lin to its Board of Directors. Dr. Lin brings extensive experience in clinical development, particularly in cancer immunotherapy, which is essential for the company during its growth phase. His previous roles include Chief Medical Officer at Erasca and Head of Development at Nektar Therapeutics. Dr. Lin’s expertise is expected to enhance 2seventy's strategies in developing novel treatments, aligning with the company's mission to innovate therapies for cancer patients.

2seventy bio, Inc. (NASDAQ: TSVT) will present at the 43rd Annual TD Cowen Health Care Conference on March 7, 2023, at 10:30 AM ET in Boston, MA. The management team will discuss the company's innovative approaches to immuno-oncology and cellular therapies aimed at treating various cancer types. A live webcast of the presentation will be available on the company's website, with a replay accessible for 30 days afterward. 2seventy bio is focused on developing groundbreaking therapies to disrupt the cancer treatment landscape through rapid and genuine innovation.

Marengo Therapeutics, Inc. announced the appointment of Kevin Chin, M.D., M.S., as the new Chief Medical Officer on March 1, 2023. Dr. Chin brings extensive experience in oncology clinical development, particularly in T cell-directed immunotherapies. He will oversee the company's clinical portfolio, including the START-001 Phase 1/2 clinical trial for STAR0602, an innovative immunotherapy targeting T cell receptors to enhance cancer treatment. Marengo's CEO, Zhen Su, emphasized the significance of Dr. Chin’s expertise as the company advances its promising pipeline and capitalizes on the STAR platform's development opportunities.

2seventy bio (NASDAQ: TSVT) announced the pricing of a public offering of 10,869,566 shares at $11.50 per share, aimed to raise approximately $125 million before expenses. This offering, scheduled to close around March 3, 2023, includes an option for underwriters to purchase an additional 1,630,434 shares. The company focuses on cell and gene therapies for cancer, striving to expedite treatment solutions. All shares are being offered by 2seventy bio, with Goldman Sachs, Cowen, and SVB Securities as joint book-running managers.

2seventy bio, Inc. (NASDAQ: TSVT) has announced an underwritten public offering of $100 million in common stock, with a potential additional $15 million from underwriters. The offering is contingent on market conditions and is managed by Goldman Sachs, Cowen, and SVB Securities. This move is part of the company's ongoing efforts in cell and gene therapy for cancer treatments. The shares are being offered under a registration statement with the SEC that is effective since November 2022. The company aims to utilize the proceeds to further their mission in developing innovative cancer therapies.

Bristol Myers Squibb (NYSE: BMY) and 2seventy bio (NASDAQ: TSVT) announced positive results from the pivotal Phase 3 KarMMa-3 study of Abecma (idecabtagene vicleucel) for patients with relapsed and refractory multiple myeloma. Abecma showed a significant improvement in median progression-free survival (PFS) of 13.3 months versus 4.4 months for standard regimens. The study demonstrated a 51% reduction in risk of disease progression or death. Overall response rates were also significantly higher for Abecma at 71%, with 39% achieving a complete response. Safety results were consistent with prior data, with no new safety signals reported.

2seventy bio, Inc. (Nasdaq: TSVT) announced participation in two upcoming investor conferences. The first event is the Guggenheim Oncology Conference on February 9 at 9:00 am ET, held at the St. Regis New York. The second is the SVB Securities Global Biopharma Conference on February 15 at 10:00 am ET, conducted virtually. Both events will feature a fireside chat with management. Investors can access a live webcast and find a replay on the company's website, which will be available for 30 days post-event. 2seventy bio focuses on developing innovative immuno-oncology cell therapies to disrupt cancer treatment.