Cidara Therapeutics Inc. will meet with the FDA to discuss strongly favorable phase IIb results from its randomized, double-blind, placebo-controlled phase IIb Navigate trial testing CD-388 for the prevention of seasonal influenza in healthy, unvaccinated adults aged 18-64. Meanwhile, shares of the San Diego-based firm (NASDAQ:CDTX) closed June 23 at $44.95, up $23.93, or 113.8%, as Wall Street learned that the study met its primary endpoint, turning up a statistically significant prevention efficacy for each of three dose groups in people given a single shot at the beginning of the flu season. Read More
The June 25-26 meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) will be anything but business as usual. In wiping the slate clean just two weeks before the panel was to meet, Health and Human Services Secretary Robert Kennedy made sure of that. Read More
Hitting the primary endpoint on Compass Pathways plc’s Comp005 study of synthetic psilocybin, which the company billed as the first classic psychedelic to report phase III efficacy data, produced only a shrug from investors. Read More
The U.S. FDA approved 14 drugs in May, a decline from 20 in April and 22 in March. That brings the year-to-date total for 2025 to 84 approvals, the second highest on record for this period, just behind the 89 approvals recorded in the first five months of 2024. Read More
Harbour Biomed is out-licensing its B-cell maturation antigen and CD3 bispecific T-cell engager HBM-7020 for autoimmune diseases to Otsuka Pharmaceutical Co. Ltd. in a deal worth up to $670 million. Read More
Transthera Sciences Inc. debuted on the Hong Kong stock exchange June 23 with a HK$200.95 million (US$25.6 million) IPO, becoming the latest in a string of mainland Chinese biopharmaceutical firms to turn to the Hong Kong market for capital. Read More
In recognition of the fact that diversity, equity and inclusion (DEI) are necessary prerequisites for precision medicine, the European Academy of Neurology (EAN) announced the launch of a DEI Hub at its 11th Congress, which is being held in Helsinki through June 24. “We know now that when we talk about personalized medicine, we have to understand that talking about stroke, for example, in a woman is different than talking about stroke in a man,” EAN president Elena Moro told the audience at the opening session of the conference. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abtherx, GPCR, Indivior, Neurocrine, Prothena. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Bio-Thera, Cel-Sci, Cycle, Eisai, Eli Lilly, Excellthera, Exelixis, Gilead, GSK, Incyte, Ipsen, Johnson & Johnson, Madrigal, Merck, Orion, Regeneron, Relief, Sanofi, Springworks. Read More
