Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for preventing moderate to severe vasomotor symptoms, also known as hot flashes, associated with menopause. It is administered orally once daily in a 60-mg soft capsule. Lynkuet will join Astellas Inc.’s Veoza (fezolinetant), an NK-3 receptor agonist, which was approved by the EMA in December 2023 and the U.S. FDA in May 2023, also for preventing vasomotor symptoms of menopause.

ACIP mulls COVID-19 shots; efficacy and safety measures in the crosshairs

The second day’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) took up guidelines related to COVID-19 vaccines. ACIP members debated how the vaccine’s efficacy is measured, and whether the risks are downplayed. A vote was slated for later this afternoon, though the voting question has not been made clear.

QL Biopharm’s monthly GLP-1 meets phase II endpoints

Beijing QL Biopharmaceutical Co. Ltd.’s once-monthly GLP-1 receptor agonist, zovaglutide (ZT-002), met its primary and secondary endpoints in a phase II obesity trial, and QL Biopharm will now advance the GLP-1 to a pivotal phase III study. The randomized, double-blind, placebo-controlled phase II multicenter trial enrolled 303 overweight or obese patients who were randomized to receive subcutaneous injections of placebo or zovaglutide at maximum doses of 80 mg or 160 mg administered once monthly, or 80 mg or 160 mg delivered every two weeks, for 24 weeks. Zovaglutide showed better efficacy in all dose groups compared to placebo. The percent change in body weight from baseline was -10.6% in the 80-mg once-monthly group, -13.8% in the 160-mg once-monthly group, -12.5% in the 80-mg every two weeks group, and -14.4% in the 160-mg every two weeks group. The placebo group change was -2.4%.

Trying again: Rare pediatric PRV program heads to House

Renewing hopes of restoring the rare pediatric disease priority review voucher (RPD PRV) program that expired at the end of 2024, the House Energy and Commerce Committee voted 47-0 Sept. 17 to advance the Give Kids a Chance Act of 2025, one of six pieces of legislation cleared to move to the full U.S. House for consideration. While still early days, as the bill still has to clear both the House and Senate, its passage would reinstate the RPD PRV program and keep it active through Sept. 30, 2029.

Genfleet raises $234M with Hong Kong IPO

Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange (HKEX) on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price. The Shanghai-based company had priced the sale of 89.24 million H shares at HK$20.39 per share. Most of the funds raised will support its core programs, with about 38% allocated to GFH-375 and 33% to GFH-925’s development.

US FDA adds five NMEs in August, led by Brinsupri and Modeyso

The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorld for the period, after 2024’s high of 159. Five new molecular entities (NMEs) were approved in August: Brinsupri (brensocatib), Dawnzera (donidalorsen), Hernexeos (zongertinib), Modeyso (dordaviprone) and Wayrilz (rilzabrutinib).

Rewiring SCLC: a neural path to therapy

Two back-to-back papers published in Nature on Sept. 10, 2025, shed new light on the unexpected role of neurons in shaping the evolution of small-cell lung cancer (SCLC). It’s already known that, in gliomas, cerebral cancer cells actively damage axons, contributing to tumor progression through direct neural disruption. Comparable nerve-tumor interactions have been reported in peripheral cancers, where tumor-induced nerve disruption promotes inflammation and an immunosuppressive microenvironment linked to immunotherapy resistance. SCLC, one of the most aggressive and neuroendocrine-driven forms of lung cancer, is now at the center of a surprising twist: Neurons may not only be bystanders but active contributors to tumor evolution.

Also in the news

Almirall, Astrazeneca, Biogen, Carsgen, Contineum, Corestemchemon, Curatis, Deciphera, Eli Lilly, Epitopea, Flagship, Geneos, J&D, Kairos, Leo, , Lipella, MagicRNA, Mink, Minovia, Nanobiotix, Nektar, Neumirna, Novo Nordisk, PDS, QL, Replimune, Vaxart, X4