Nuvalent Inc. followed positive data during the European Society for Medical Oncology (ESMO) meeting with an upsized $500 million public offering. The Cambridge, Mass.-based firm is selling 5 million shares of class A common stock at $100 each. At the ESMO gathering in Barcelona, Nuvalent rolled out updated phase I dose-escalation findings from the Arros-1 and Alkove-1 studies, which continue to support potential best-in-class profiles for ROS1-targeting zidesamtinib and ALK inhibitor NVL-655, the firm said.

Capricor and Nippon Shinyaku add Europe to DMD deal

Capricor Therapeutics Inc. has expanded its commercialization and distribution deal with Nippon Shinyaku Co. Ltd. to include the EU and the U.K. for deramiocel, Capricor’s lead asset, in treating Duchenne muscular dystrophy. The allogeneic cardiac-derived cell therapy is wrapping up a phase III study in the rare disease. The original 2022 agreement included the U.S. and a February 2023 extension included Japan. Capricor will also receive an up-front payment of $20 million. The company’s stock (NASDAQ:CAPR) benefited from the deal expansion, with shares trading 15% upward at midday to $5.05 each.

Senate IRA hearing mix of praise, scathing reviews

Two tales of one law were told this morning as the U.S. Senate Finance Committee discussed the successes and failures of the health care provisions included in the Inflation Reduction Act (IRA). Proponents of the IRA’s Medicare price negotiations, inflation rebates and premium subsidies told a rosy story as they looked forward to a sequel to expand the successes they narrated. Opponents gave a scathing review, saying the partisan law wrote a negative plot line for drug innovation and ignored the real problems resulting from patent thickets, pharmacy benefit managers and supply chain issues. The opponents pointed to the 21 drugs and 36 development programs that already have been discontinued because of the IRA. Dismissing those concerns, supporters of the law claimed stock prices are up for biopharma companies, innovation is up and R&D spending is up.

Australia’s HTA consultation wraps up with 50 recommendations

Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate. The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current HTA process that has remained unchanged for 30 years.

ESMO 2024: Cancer vaccines, and maybe nonspecific vaccines, can boost antitumor immunity

One of the current challenges of immunotherapy is the hunt for good targets, and the Claudins – a family of roughly two dozen transmembrane proteins – would appear to have a lot going for them. “Some Claudins distribute in a tissue-specific manner, and malignant transformation causes their exposition,” Cinta Hierro told the audience at the European Society of Medical Oncology (ESMO) 2024 Congress. “Others are rarely expressed in healthy tissue.” At the meeting, researchers presented data from trials targeting both Claudin 18.2 and Claudin-6.

Also in the news

89bio, Abata, Akari, Ascendis, Bioinvent, Boehringer Ingelheim, Bpgbio, Bristol Myers Squibb, Eli Lilly, Entact, Equillium, Evaxion, Gan & Lee, Genentech, Immatics, Immuneonco, Immutep, IMU, Immvira, Instil, Intercept, Ipsen, Iteos, Korro, Kura, Medexus, Mirador, Nautilus, Novo Nordisk, Nura, Nuvalent, Quantum, Quine, Poseida, Regeneron, Sama, Scorpion, Simcere, Somite, Sumitomo, T2 Biosystems, Tonix, Transgene, Vivtex, Zentalis