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Phase 3 Trial

All articles tagged with #phase 3 trial

RAS-targeting drug daraxonrasib nearly doubles median survival in pancreatic cancer trial
health17 hours ago

RAS-targeting drug daraxonrasib nearly doubles median survival in pancreatic cancer trial

A phase 3 trial published in the New England Journal of Medicine finds the oral RAS-inhibitor daraxonrasib significantly improves survival for metastatic pancreatic cancer, with a median of 13.2 months versus 6.7 months with chemotherapy; the FDA has granted an early-access program ahead of potential approval later in 2026, marking a potential paradigm shift by directly targeting mutant RAS to halt cancer growth.

via USA Today|
#daraxonrasib#health#pancreatic-cancer
First-in-class KRAS therapy boosts survival in metastatic pancreatic cancer
health6 days ago

First-in-class KRAS therapy boosts survival in metastatic pancreatic cancer

A new oral drug, daraxonrasib, targets the KRAS-driven mechanism in pancreatic cancer by engaging cyclophilin A to shut down KRAS signaling. In a Phase 3 trial of 500 patients with metastatic pancreatic cancer who had prior treatment, daraxonrasib nearly doubled median survival from 6.7 to 13.2 months and reduced the risk of death by about 60% versus standard chemotherapy. The most common side effects were a skin rash, stomatitis, diarrhea, nausea and vomiting, though discontinuation due to adverse effects was lower and quality of life improved. Regulatory review by the FDA and other global authorities is the immediate next step, with expedited review likely; if approved, the drug could reach clinics within months and herald a shift toward targeted, personalized therapy and potential combination approaches to prevent resistance.

via The Conversation|
#daraxonrasib#health#kras
Nightly Pill Could Redefine Sleep Apnea Treatment
health7 days ago

Nightly Pill Could Redefine Sleep Apnea Treatment

A six-month phase 3 study of AD109 (an oral combo of aroxybutynin and atomoxetine) in 646 adults with mild–severe obstructive sleep apnea showed a ~44% drop in the apnea-hypopnea index versus an 18% reduction with placebo, with improved oxygen metrics and about 40% moving to a lower OSA severity category and 18% achieving complete control; AD109 targets neuromuscular pathways to keep throat muscles active, offering an alternative for CPAP-intolerant patients. Safety was mostly mild; 21% discontinued due to side effects. The drug has FDA Fast Track status and an NDA is with the FDA, with potential action in early 2027.

via SciTechDaily|
#ad109#cpap#fda-fast-track
Oral Sleep Apnea Pill AD109 Nears FDA Sign-Off After Phase 3 Win
health15 days ago

Oral Sleep Apnea Pill AD109 Nears FDA Sign-Off After Phase 3 Win

A phase 3 trial of the oral drug AD109 (a combo of aroxybutynin and atomoxetine) reduced the apnea-hypopnea index by about 44% versus 18% with placebo over 26 weeks in 646 patients with mild–severe obstructive sleep apnea, with roughly 42% moving to a lower severity category and about 18% no longer meeting OSA criteria. Side effects were mild (dry mouth, nausea, insomnia). The FDA has fast-tracked AD109, with a decision anticipated in 2027, potentially offering a convenient alternative to CPAP for patients unable or unwilling to use the machine.

via ScienceAlert|
#ad109#cpap-alternative#fda-fast-track
New Pancreatic Cancer Drug Daraxonrasib Delivers Landmark Phase 3 Results
health1 month ago

New Pancreatic Cancer Drug Daraxonrasib Delivers Landmark Phase 3 Results

Revolution Medicines announced that its pancreatic cancer drug daraxonrasib met all primary and secondary endpoints in a Phase 3 trial, nearly doubling median overall survival (13.2 months vs 6.7 months) and reducing the risk of death by about 60% versus chemotherapy, prompting an FDA filing using a Commissioner’s National Priority Voucher; safety was manageable and the company is pursuing second-line use and trials in newly diagnosed patients.

via CNBC|
#daraxonrasib#health#overall-survival
Pfizer pushes ahead with Lyme vaccine despite late-stage trial miss
business2 months ago

Pfizer pushes ahead with Lyme vaccine despite late-stage trial miss

Pfizer intends to seek FDA approval for its Lyme disease vaccine candidate even after a late-stage trial failed to meet statistical goals due to too few Lyme cases; the company says efficacy exceeded 70% in vaccine recipients versus placebo, which they consider strong enough to move forward. Partner Valneva projects up to $1 billion in peak annual sales. The Phase 3 study started with about 18,000 participants but was reduced to roughly 9,400 due to site-quality issues, and Pfizer reports no safety concerns; the vaccine requires three initial doses followed by a booster and targets the outer surface protein A of the bacteria.

via CNBC|
#business#lyme-disease#pfizer
aTyr's Efzofitimod Demonstrates Promise in Largest Sarcoidosis Trial Despite Missed Endpoint
healthcare8 months ago

aTyr's Efzofitimod Demonstrates Promise in Largest Sarcoidosis Trial Despite Missed Endpoint

aTyr Pharma's Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis did not meet its primary endpoint of reducing corticosteroid dose at week 48, but secondary outcomes showed some benefits such as higher rates of steroid withdrawal and improved lung scores. The drug was well-tolerated, and the company plans to consult with the FDA to determine the next steps.

via Stock Titan|
#atyr-pharma#clinical-results#efzofitimod
Compass Psilocybin Achieves Key Phase 3 Success in Depression Treatment
business11 months ago

Compass Psilocybin Achieves Key Phase 3 Success in Depression Treatment

Compass Pathways' Phase 3 trial of its synthetic psilocybin, COMP360, showed a significant separation from placebo in treating treatment-resistant depression, with no new safety concerns, marking a major milestone for psychedelic drug development. The company is now focusing on a larger, multi-dose trial expected to provide clearer efficacy data and aims for FDA submission, while preparing for potential U.S. market launch.

via Psychedelic Alpha|
#business#compass-pathways#phase-3-trial
Summit's Lung Cancer Drugs Show Mixed Results in Global Trials
healthcare1 year ago

Summit's Lung Cancer Drugs Show Mixed Results in Global Trials

Akeso and Summit Therapeutics' drug ivonescimab showed promising results in delaying progression of certain lung cancers in a global phase 3 trial, with significant improvements in progression-free survival, though overall survival benefits are still being evaluated. The drug demonstrated consistent effects across Asian and Western populations, and the companies plan to seek FDA approval, despite some investor disappointment over the overall survival data.

via Fierce Pharma|
#healthcare#ivonescimab#lung-cancer