Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Wom…

The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip ...
Nasdaq

Annovis Announces Open-Label Extension Study for Parkinson's Disease Patients

MALVERN, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for ...

Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Elsunersen for the Treatment of Seizures Associated with SCN2A Developmental and Epileptic ...

The Breakthrough Therapy Designation (BTD) was granted based on the positive results from the EMBRAVE Part A trial of elsunersen Elsunersen ...
Business Wire

Emalex Biosciences Releases Results of 12-Month Open-Label Extension Study for Tourette Syndrome Candidate

CHICAGO--(BUSINESS WIRE)--An open-label extension study of 121 pediatric patients with Tourette syndrome evaluated the safety profile of the investigational drug ecopipam for up to 12-months of ...
Medscape

CIDP Benefits Persist in Efgartigimod Open-Label Extension

MONTREAL — An open-label extension study of subcutaneous efgartigimod PH20 to treat chronic inflammatory demyelinating polyneuropathy (CIDP) showed durability of functional improvements to week 24, ...
The American Journal of Managed Care

Acoramidis Sustains Benefits in Patients With ATTR-CM in Open-Label Extension Study

Acoramidis showed a 42% reduction in all-cause mortality and cardiovascular hospitalizations at 30 months compared to placebo in the ATTRibute-CM trial. Continuous acoramidis use resulted in a 48.2% ...
Business Wire

Harrow Announces 52-Week Data from VEVYE® ESSENCE-2 Open-Label Extension Study

NASHVILLE, Tenn.--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, is pleased to announce results from its ESSENCE‑2 open-label extension (OLE) clinical ...
Nasdaq

NLS Pharmaceutics Announces Open Label Extension Study Six-Month Data for Quilience(R) (Mazindol ER) in the Treatment of Narcolepsy Type 1 and Type 2

ZURICH, SWITZERLAND / ACCESSWIRE / March 27, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and ...
Seeking Alpha

Atai Beckley N.V. (ATAI) Discusses BPL-003 Phase IIb Open-Label Extension Study Results in Treatment Resistant Depression Transcript

Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Atai Beckley BPL-003 phase IIb open-label extension ...