It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed and refractory multiple myeloma. A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, Lynozyfic was cleared under the accelerated approval pathway, with continued approval contingent upon a confirmatory trial.
The BioWorld Cancer Index reversed its early year losses, rebounding from a 4.74% decline at the end of the first quarter (Q1) to finish Q2 up 12.78%. The Dow Jones Industrial Average followed a similar pattern, dropping to -4.41% by the end of April before recovering to a 3.64% gain by Q2’s end. Meanwhile, the Nasdaq Biotechnology Index, down 5.37% at the end of May, narrowed its losses to close June down just 1.92%.
Taiwan’s Hanchorbio Inc. is out-licensing its breakthrough checkpoint inhibitor, HCB-101, to Shanghai Henlius Biotech Inc. in a deal worth more than $200 million.
Unnatural Products Inc. notched another collaboration by signing on with Argenx SE in a multitarget research collaboration. Unnatural Products, which is getting up-front, near-term payments and R&D funding, could end up with about $1.5 billion in milestones and options payments plus tiered royalties on net sales.
The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
Experts in mRNA convened at the Global Vaccine Forum (GVF) 2025 to weigh the present and future of vaccine technology, including emerging innovations in self-amplifying mRNA (sa-mRNA) and drug delivery platforms. “Breakthroughs in mRNA and next-generation vaccine platforms are revolutionizing how we prepare for and respond to global health challenges,” Jerome H. Kim, International Vaccine Institute (IVI) director general, told the audience in Seoul, South Korea, June 19.
China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA.
Innovent Biologics Inc. announced a HKD$4.3 billion (US$547 million) placement on the Hong Kong Stock Exchange to advance its R&D projects and to fund its global expansion.
Kymera Therapeutics Inc. found itself juggling partnerships by bringing one on board while going to the development bench in another. Kymera and Gilead Sciences Inc. will collaborate on a molecular glue degrader program that targets cyclin-dependent kinase 2 in solid tumors, including breast cancer.
Abion Inc. signed a potential $1.315 billion deal with an anonymous partner June 22, granting the counterparty exclusive global rights to a preclinical claudin 3-targeting monoclonal antibody, ABN-501, and the potential to license four more protein targeting antibodies.
RSS
