MedPage Today on MSN

Investigational Oral Drug Shows Promise in Genetic Bleeding Disorder

Treatment with the investigational oral, allosteric, selective AKT inhibitor engasertib appeared to be safe in patients with ...
Morningstar

Coya Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

FDA acceptance enables initiation of a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS HOUSTON, Aug. 25, 2025 ...
Morningstar

Centessa Pharmaceuticals Announces Clearance of Investigational New Drug Application (IND) for ORX142, a Novel Orexin Receptor 2 (OX2R) Agonist; Clinical Data in Acutely Sleep ...

BOSTON and LONDON, June 16, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration ...
WKRN-TV

YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial ...

SHANGHAI, June 5, 2025 /PRNewswire/ -- YolTech Therapeutics, a clinical-stage biotechnology company developing in vivo genome editing therapies, today announced that the U.S. Food and Drug ...
Seeking Alpha

Synaptogenix and Cleveland Clinic to Submit Investigational New Drug (IND) Application to FDA for Clinical Trial of Bryostatin-1 in Multiple Sclerosis

Study will evaluate drug's potential neuro-restorative mechanism(s) of action for improving synaptic health and cognitive function in MS patients NEW YORK, July 19, 2023 /PRNewswire/ -- Synaptogenix, ...
Seeking Alpha

INmune Bio, Inc. Announces Submission of Investigational New Drug (IND) Application for INKmune™ to the U.S. Food and Drug Administration for Treatment of Metastatic ...

BOCA RATON, Fla., April 03, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s ...
Nasdaq

Ocugen, Inc. Announces U.S. FDA Clearance of Investigational New Drug Amendment to Initiate Phase 2/3 Pivotal Confirmatory Clinical Trial of OCU410ST—Modifier Gene Therapy ...

MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that ...
Business Insider

Hinge Bio Announces FDA Clearance of Investigational New Drug Application for HB2198, a Novel B cell-Depleting Agent, for Patients with Systemic Lupus Erythematosus and Lupus ...

BURLINGAME, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Hinge Bio, Inc., a privately-held biotechnology company engaged in the discovery and development of innovative multi-specific medicines, announced ...
The Manila Times

Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD

Silo Pharma, Inc. (Nasdaq: SILO) ('Silo” or 'the Company), a diversified developmental-stage biopharmaceutical and ...
Nasdaq

Perre Fabre Pharmaceuticals, Inc. Announces Transfer of Investigational New Drug Application for Tabelecleucel from Atara Biotherapeutics, Inc.

Enrollment is ongoing for pivotal, Phase 3 ALLELE Study (NCT03394365) investigating tabelecleucel in patients with EBV+PTLD in Solid Organ Transplant and Allogeneic Hematopoietic Cell Transplant after ...