The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is deliberating the merits of Moderna Inc.’s mRNA influenza vaccine, mRNA-1010, which the company wants to brand Mflusiva. VRBPAC will vote on whether the benefits of the vaccine outweigh the risks in people ages 50 to 64 and, separately, whether the same is true in those 65 and older. In February, a week after Moderna was smacked with a refusal-to-file letter from the FDA, the strife-torn agency changed its mind on the company’s submission, agreeing to review the BLA and setting a PDUFA date of Aug. 5.
F2G preps NDA for first new antifungal in 20 years on solid phase III
Three years on from the rebuff of a U.S. FDA complete response letter, F2G Ltd. now has the data needed to resubmit the NDA for the first novel antifungal drug in more than two decades. Along with partner Shionogi & Co. Ltd., F2G has released positive phase III results for orally administered olorofim, showing noninferiority against I.V.-administered Ambisome (amphotericin B, Gilead Sciences Inc.) in patients with refractory aspergillosis infections, or who were unsuitable for mainstay azole therapy. The primary endpoint of noninferiority was reached with all-cause mortality at day 42 of 23.8% for olorofim and 24.3% for Ambisome.
GSK-Spero’s oral antibiotic Utebzi for cUTI wins US FDA nod
Four years after the U.S. FDA issued a complete response letter (CRL) for Spero Therapeutics Inc.’s oral carbapenem antibiotic, tebipenem pivoxil hydrobromide, to treat complicated urinary tract infections (cUTI), including pyelonephritis, the agency approved the drug based on phase III data showing noninferiority to intravenous imipenem-cilastatin. Branded Utebzi, it will be available by the end of 2026. Under a $600 million license deal signed in September 2022, a few months following the CRL, GSK plc gained global rights to the product, with the exception of Japan and certain Asian countries covered by the original developer, Meiji Seika Pharma Co. Ltd. Spero licensed rights from Meiji in 2017.
J-Pharma drives first cancer LAT1 to phase III study with FDA nod
J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. Advancement of the potential intravenous cancer therapy follows the biotech’s ¥3.28 billion (US$20.4 million) raise on the pre-revenue growth market of the Tokyo Stock Exchange in March, becoming the second Japanese biotech to IPO this year after Innovacell Inc.
Family genomics reveals shared roots of mental illness
Schizophrenia, bipolar disorder, major depression and autism spectrum disorder are serious mental illnesses (SMIs) that affect a significant proportion of the worldwide population. Large genome-wide association studies have pointed to overlapping genetics including both common and rare variants as cause of these SMIs. A recent study published on June 16, 2026, in Genomic Psychiatry has shed some light regarding the etiology of SMIs by analyzing 173 multiplex families from a genetically speaking strategic place, the Portuguese islands: the Azores and Madeira, where their genetic imprint was once mixed and rarely mixed again.
Biopharma IPOs stay strong as Kardigan prices upsized $400M offering
Cardiovascular-focused Kardigan Inc. is the latest biopharma firm to take advantage of the wide open IPO window, pricing an upsized offering of 25 million shares at $16 per share, the high end of its proposed range, to rake in gross proceeds of about $400 million. Another $60 million could come if underwriters exercise their full overallotment option for an additional 3.75 million shares. Those funds, which add to the $554 million in cash, short-term investments and working capital on Kardigan’s balance sheet as of March 31, 2026, will go toward clinical development of its three lead programs, with lead candidate danicamtiv in a phase IIb/III study in genetic dilated cardiomyopathy.
Boston Sci-Mirus pact lifts med-tech dealmaking to record $4.5B in May
Med-tech deal value totaled $5.17 billion through the first five months of 2026, surpassing all previous years. The gain was almost entirely driven by May, the highest month in BioWorld’s records due to the potential $4.5 billion deal between Boston Scientific Corp. and Mirus LLC, which also grants Boston Sci an exclusive option to acquire the Siegel balloon-expandable transcatheter aortic valve replacement (TAVR) system.
Holiday notice
BioWorld's offices will be closed in observance of Juneteenth in the U.S. No issue will be published Friday, June 19.