2seventy bio, Inc. - Common Stock (TSVT)

2seventy bio, Inc. (Nasdaq: TSVT), today reported financial results and recent highlights for the third quarter ended September 30, 2024.

2seventy bio, Inc. (Nasdaq: TSVT) will announce its third quarter 2024 financial results on Tuesday, November 12, 2024. A conference call and webcast will be held at 8:00 a.m. ET.

Attorney Advertising--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of 2seventy bio, Inc. (“2seventy bio” or “the Company”) (NASDAQTSVT). Investors who purchased 2seventy bio securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/TSVT.

Attorney Advertising--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of 2seventy bio, Inc. (“2seventy bio” or “the Company”) (NASDAQTSVT). Investors who purchased 2seventy bio securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/TSVT.

2seventy bio, Inc. (Nasdaq: TSVT) today announced that the Company, in partnership with study sponsor Bristol Myers Squibb (BMS), will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study evaluating Abecma® (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant.

2seventy bio, Inc. (Nasdaq: TSVT), announced today that members of the management team will participate in a fireside chat at the upcoming Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024 at 12:20 p.m. ET in New York.

2seventy bio, Inc. (Nasdaq: TSVT), today reported financial results and recent highlights for the second quarter ended June 30, 2024.

2seventy bio, Inc. (Nasdaq: TSVT) will announce its second quarter 2024 financial results on Wednesday, August 7, 2024. A conference call and webcast will be held at 8:00 a.m. ET.

2seventy bio, Inc. (Nasdaq: TSVT), announced today the completion of an asset purchase agreement (“APA”) by Novo Nordisk. Under the terms of the APA, Novo Nordisk has acquired the Hemophilia A program and rights to 2seventy’s in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune cells for the treatment of autoimmune disease. The 2seventy bio team currently involved in the program will join Novo Nordisk and continue to advance the technology.

2seventy bio, Inc. (Nasdaq: TSVT) announced today that members of the management team will present at the following upcoming investor conferences:

2seventy bio, Inc. (Nasdaq: TSVT), today reported financial results and recent highlights for the first quarter ended March 31, 2024.

2seventy bio, Inc. (Nasdaq: TSVT) will announce its first quarter 2024 financial results on Wednesday, May 8, 2024. A conference call and webcast will be held at 8:00 a.m. ET.

2seventy bio, Inc. (Nasdaq: TSVT), announced today the completion of the asset purchase agreement (“APA”) by Regeneron Pharmaceuticals, Inc. Under the terms of the APA, Regeneron has acquired all oncology and autoimmune research and development programs and has hired approximately 160 employees from 2seventy bio as part of their newly launched cell medicines business. Going forward, 2seventy bio will focus exclusively on the commercialization and development of Abecma (idecabtagene vicleucel), its BCMA-targeted CAR T cell therapy for multiple myeloma, in collaboration with their partner Bristol Myers Squibb (BMS).

Bristol Myers Squibb (NYSEBMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial. This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome, Neurologic Toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome, Prolonged Cytopenia, and Secondary Hematological Malignancies.

2seventy bio, Inc. (Nasdaq: TSVT), announced today that Eli Casdin, Chief Investment Officer, and Founder of Casdin Capital, and Charles Newton, Chief Financial Officer, Lyell Immunopharma, have been appointed as new independent members of the Company’s Board of Directors (the “Board”), effective immediately. Casdin Capital owns approximately 2.3% of 2seventy bio’s outstanding shares as of 03/20/24.

Bristol Myers Squibb (NYSEBMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival. The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application (sBLA) for Abecma for this patient population. The FDA has not yet assigned a new target action date for review of the sBLA.

2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, today reported financial results and recent highlights for the fourth quarter and full year ended December 31, 2023.

2seventy bio, Inc. (Nasdaq: TSVT) will announce its fourth quarter and full year 2023 financial results on Tuesday, March 5, 2024. A conference call and webcast will be held at 8:00 a.m. ET.

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2seventy bio, Inc. (Nasdaq: TSVT), announced today that members of the management team will present at the following upcoming investor conferences:

Bristol Myers Squibb (NYSEBMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that a notice was published in the Federal Register that the U.S. Food and Drug Administration (FDA) will convene a virtual meeting of the Oncologic Drugs Advisory Committee (ODAC) on March 15, 2024, to review data supporting the supplemental Biologics License Application (sBLA) for Abecma® (idecabtagene vicleucel) for triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study. The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival (OS) from the study.

2seventy bio, Inc. (Nasdaq: TSVT), announced today that it is transforming the Company to focus exclusively on the commercialization and development of Abecma (idecabtagene vicleucel), its BCMA-targeted CAR T therapy for multiple myeloma. The actions announced today follow an extensive evaluation of the Company’s business and strategic alternatives by its Board of Directors. As a result of this strategic re-alignment, the Company expects annual savings of approximately $150 million in 2024 and approximately $200 million in 2025, inclusive of one-time restructuring costs of approximately $8 million. The Company expects to have extended cash runway beyond 2027.

Bristol Myers Squibb (NYSEBMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced results from the preplanned final progression-free survival (PFS) analysis of KarMMa-3, the pivotal Phase 3, open-label, global, randomized controlled study evaluating Abecma (idecabtagene vicleucel) compared with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (triple-class exposed), who were refractory to their last regimen. At a median follow-up of 30.9 months (range: 12.7-47.8), representing the longest follow-up for a randomized Phase 3 CAR T cell therapy trial in this patient population, significantly improved PFS was maintained with Abecma compared to standard regimens (95% CI: 13.8 months vs. 4.4 months), with a 51% reduction in the risk of disease progression or death (HR: 0.49; 95% CI: 0.38-0.63). These data are being presented today in an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition (Oral Presentation #1028).

2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, announced today that the Company will host a conference call on Tuesday, December 12, 2023, at 8:00am ET. The event will highlight data presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place from December 9-12, 2023, in San Diego.

2seventy bio, Inc. (NASDAQTSVT), (“2seventy” or “the Company”), a leading immuno-oncology cell therapy company, today issued the following statement reiterating its commitment to maximizing shareholder value: