Moderna Inc.’s shares (NASDAQ:MRNA) sank 19% to a $64.11 low in early trading Sept. 12 as investors learned during the annual R&D Day event of a $1.1 billion reduction to R&D and the U.S. FDA’s reluctance to support an accelerated approval filing for its individualized neoantigen therapy for melanoma.

TFF Pharmaceuticals Inc. has announced promising preclinical data advancing a multivalent universal influenza vaccine manufactured by its Thin Film Freezing (TFF) technology to protect against seasonal and pandemic viruses.

A drive to overcome the limitations of traditional antibodies led Toronto-based scientists Jean-Philippe Julien and Bebhinn Treanor to work toward discovering a multivalent, multispecific platform to develop therapies that can reach difficult targets. As a result, through the support of VC firm Amplitude Ventures, Radiant Biotherapeutics emerged in 2020 armed with what has become its Multabody platform.

Technological breakthroughs are changing the biopharmaceutical landscape and forcing regulators to think on their feet and facilitate (not impede) innovation, experts said at the Global Bio Conference (GBC) 2024. “Regulatory speed and agility are necessary amid emergencies to cater to unmet medical needs,” Choong May Ling, CEO of Singapore’s Health Sciences Authority, told audience members in Seoul, South Korea.

With antimicrobial resistance growing to many first-line antibiotics, a key concern in the U.S. FDA’s approving an oral penem like Iterum Therapeutics International Ltd.’s tablet combining sulopenem etzadroxil and probenecid is that it could become a first-line, go-to drug in treating uncomplicated urinary tract infections and, possibly, more serious infections off-label.

TC Biopharm (Holdings) plc has announced plans to begin proof-of-concept preclinical studies for its lead therapeutic, TCB-008, for the treatment of mpox.

Researchers from Southern Medical University have divulged the discovery and preclinical characterization of novel PDE4 inhibitors for the treatment of hepatic sepsis. Synthesis and optimization of a series of 7-alkoxybenzofurans led to the identification of compound [I] as the lead PDE4 inhibitor, with PDE4B and PDE4D IC50 values of 10.0 and 15.2 nM, respectively.

On news that drove shares up by 36% on Sept. 3, San Carlos, Calif.-based Vaxcyte Inc. priced a $1.3 billion follow-on offering a day later. It is the fourth highest amount raised through a follow-on offering of shares in BioWorld’s records, as well as the second largest financing of all types for 2024, behind New York-based Pfizer Inc.’s $3.1 billion global sale of shares in March.