hotspot -WSS

hotspot

author：comprehensive 2025-09-27 19:21:24 - browse：72734

Scientist pipetting in a biotech lab -- biotech coverage from STAT — A researcher working in the lab at Crinetics Pharmaceuticals in San Diego. Courtesy Crinetics

SAN DIEGO — Crinetics Pharmaceuticals announced on Sunday that its experimental drug for acromegaly, a rare and serious hormonal disorder, succeeded in a late-stage trial, bringing the San Diego biotech a step closer to applying for Food and Drug Administration approval — and entry into a crowded market with blockbuster therapies sold by pharma giants.

In the Phase 3 study, dubbed PATHFNDR-1, nearly 60 patients were randomly assigned to receive a placebo or a daily dose of paltusotine, an oral medicine designed to lower levels of growth hormone, which is produced in excess by people with acromegaly. After 36 weeks of treatment, 25 of the 30 patients given the drug had growth-factor levels that were within the normal range compared to just 1 of 28 participants who took the placebo, a difference that was statistically significant. Researchers also found that the treatment’s side effects were mild overall.

Crinetics plans to file for FDA approval if it gets positive results from a second, ongoing Phase 3 trial of the drug in acromegaly patients. The biotech expects results from that study, known as PATHFNDR-2, by the first quarter of next year.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： The Supreme Court will review a ruling striking down a domestic violence federal gun ban
Next article： The biotech scorecard for Q4: 16 stock

WSS

Readout Newsletter: Bayer, Rapt Therapeutics, Sanofi shortage

FDA sees ‘potential systemic bias’ in Amgen’s KRAS drug trial

Measles policy set amid Florida outbreak alarms vaccine proponents

Medicare Advantage enrollment hits roughly 33.4 million

European officials brace for rough respiratory virus season

CRISPR base editing slashes cholesterol levels in monkeys

hotspot

hotspot

explore

The high cost of giving birth even with insurance

Some top drug companies are starting to take action on climate

Psychedelics group wrestles with new pharma identity

Weight loss drugs aren’t covered by Obamacare. That may change

Medicare proposal to cover medical devices draws a mixed reaction

Congress extends some pandemic preparedness programs

At least 13 dead in Texas as scorching temps continue

Abridge raises $150m as clinical notes automation market heats up

United colonoscopy coverage change 'may cost lives,' doctors say

A new drug could help frostbite victims avoid its ravages

Wikipedia

Secretariat’s lessons for human medicine

Will an HIV vaccine ever be a reality?

Lawsuit highlights wrinkle for disputes over surprise medical bills

Flu, Covid vaccination rates decline, new survey data show

Obamacare plans could cover weight loss drugs

AbbVie CEO Gonzalez to step down after a decade fiercely defending Humira

explore

hotspot

entertainment

focus