Shares of San Diego-based Cidara Therapeutics Inc. (NASDAQ:CDTX) were trading at $40.41, up $19.39, or 92%, on positive top-line 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. The study met its primary endpoint, turning up a statistically significant prevention efficacy (PE) for each of three dose groups in people given a single shot at the beginning of the flu season. They were evaluated for laboratory and clinically confirmed influenza over 24 weeks. The study also met all secondary endpoints, including efficacy at 37.8- and 37.2-degree Celsius temperature thresholds, as well as maintenance of PE up to 28 weeks with statistical significance. The neuraminidase inhibitor proved well-tolerated at all doses with no unexpected dose-limiting treatment-emergent adverse events, Cidara said.

Under new management, ACIP in the spotlight

This week’s 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. Citing the little time the eight new members have to review the materials for the meeting, the CDC has abbreviated the agenda. But despite the lack of prep time, it has added a discussion on the scheduling of measles/mumps/rubella vaccines in young children, as well as a vote on the use of thimerosal in influenza vaccines. Meanwhile, the gutting of the ACIP has led to a growing congressional chorus calling for investigations into Kennedy’s actions.

Compass Pathways succeeds in phase III depression study; stock slides

Hitting the primary endpoint on Compass Pathways plc’s pivotal phase III Comp005 study of synthetic psilocybin only produced a shrug from investors. The first of two phase III studies of a single dose of the oral treatment COMP-360 prompted a statistically significant and clinically meaningful drop in treatment-resistant depression symptom severity compared to placebo. However, the company’s stock (NASDAQ:CMPS) had lost nearly half its value at midday, as shares were down 46% to $2.49 each. Results for the second pivotal phase III study in depression are expected sometime in the second half of 2026.

Novavax jumps 15% on COVID shot nod, among 14 FDA approvals in May

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. Three new molecular entities were approved in May, matching the totals seen in April and January, and exceeding the two approvals recorded in both February and March. Concerns about how the new federal administration might impact vaccine prospects eased somewhat with the U.S. FDA’s approval of Novavax Inc.‘s COVID-19 vaccine, Nuvaxovid. The approval triggered a $175 million milestone payment from Novavax’s partner, Sanofi SA. Shares of Novavax (NASDAQ:NVAX) rose 15% on the news, closing at $7.74 on May 19.

Otsuka licenses Harbour’s bispecific T-cell engager for $670M

Harbour Biomed is out-licensing its B-cell maturation antigen (BCMA) and CD3 bispecific T-cell engager HBM-7020 for autoimmune diseases to Otsuka Pharmaceutical Co. Ltd. in a deal worth up to $670 million. Under terms of the deal, Otsuka gains an exclusive license to develop, manufacture, and commercialize HBM-7020 globally, excluding mainland China, Hong Kong, Macau and Taiwan. In exchange, Harbour Biomed will receive $47 million in up-front and near-term payments and is eligible for additional development and commercial milestone payments up to $623 million, as well as sales-based royalties. The collaboration establishes a foundation for potential future partnerships between the two companies in the T-cell engager area.

Transthera raises $25M with Hong Kong IPO; stock up 78% on debut

Transthera Sciences Inc. debuted on the Hong Kong stock exchange (HKEX) 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. On its second attempt at a Hong Kong IPO, Nanjing, China-based Transthera floated about 15.28 million H shares priced at HK$13.15 per share. Shares of the cancer-focused biotech (HKEX:2617) began trading June 23, reaching as high as HK$24 in intraday trading before closing at HK$23.50 each – 78.7% higher than its listing price.

At EAN 2025, DEI Hub launches to improve care for all

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. The DEI Hub was borne out of a predecessor organization that focused more generally on gender issues, and much of its focus is currently focused on gender. Moro said that the EAN is planning to reach out to other scientific societies and encourage them to join, and visitors to the hub are encouraged to upload content as well.

Also in the news

Abtherx, Alzinova, Annexon, Aptose, Bausch+Lomb, Bayer, Bio-Thera, Biovaxys, Capricor, Cel-Sci, Cycle, Eisai, Eli Lilly, Excellthera, Gilead, GPCR, Grifols, GSK, Hanmi, Incyte, Indivior, Ipsen, Johnson & Johnson, Jyong, Madrigal, Merck, Moleculin, Neurocrine, Orion, Paradigm, Pioneer, Prothena, Quince. Regeneron, Relief, Sanofi, Springworks, Tharimmune, Tulavi, Zealand