MPR

FDA Grants Budoprutug Fast Track Status for Primary Membranous Nephropathy

Budoprutug is an investigational, humanized monoclonal antibody designed to selectively target and bind to CD19 antigen on B cells.
Nasdaq

Supernus Announces Promising Data from Open-Label Phase 2a Study of SPN-820 in Adults with Major Depressive Disorder

“These Phase 2a data underscore our belief that SPN-820 has the potential as a novel treatment option for patients with depression, with the opportunity to decrease symptoms quickly and without ...

Greenwich LifeSciences: 'Buy' On Recent Open-Label Data And Patent Claim

Greenwich LifeSciences (GLSI) stock is a "Buy" as phase 3 FLAMINGO-01 advances in HER2-positive breast cancer with two major ...
Business Wire

Stoke Therapeutics Presents New Open-Label Extension (OLE) Study Data That Further Support the Potential for Zorevunersen as a Disease-Modifying Medicine for the Treatment of ...

– Substantial and durable reductions in convulsive seizure frequency observed in patients treated with 2 or 3 doses of 70mg followed by 45mg maintenance dosing on top of the best available ...
ascopubs.org

STELLAR: Phase III, Randomized, Open-Label Study of Eflornithine Plus Lomustine Versus Lomustine Alone in Patients With Recurrent Grade 3 Astrocytoma

TBCRC 048 (Olaparib Expanded) Expansion Cohorts: Phase II Study of Olaparib Monotherapy for Patients With Metastatic Breast Cancer With Germline Mutations in PALB2 or Somatic Mutations in BRCA1 or ...
BioSpace

FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls

While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external ...
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, ...
Nasdaq

Larimar Therapeutics Announces Positive Data from Ongoing Long-term Open Label Study and Updates to Nomlabofusp Program for Friedreich’s Ataxia

BALA CYNWYD, Pa., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare ...
Business Wire

Open Label Outpatient Switch Study Demonstrates Symptom Stability During Transition from Oral Atypical Antipsychotics to Cobenfy™ (xanomeline and trospium chloride)

Open Label Outpatient Switch Study Demonstrates Symptom Stability During Transition from Oral Atypical Antipsychotics to Cobenfy.
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 ...