EndoCyclic Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for ENDO-205, a First-in-Class Non-Hormonal Precision Peptide Therapeutic for ...

Unlike existing therapies that primarily suppress symptoms through hormonal modulation, ENDO-205 is the first candidate in development designed to eliminate endometriosis lesions and address ...

Ultragenyx Announces FDA Clearance of Investigational New Drug (IND) Application for UX016, a Sialic Acid Prodrug for the Treatment of GNE Myopathy

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for UX016, an investigational ...
News-Medical.Net

FDA clears investigational new drug application to test sCAR-T therapy for autoimmune conditions

Calibr-Skaggs Institute for Innovative Medicines, the drug discovery division of Scripps Research, announced today that the ...

Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis

The IND submission includes data from nonclinical pharmacology and toxicology studies, along with manufacturing and quality information, to support initiation of the planned Phase 2 clinical trial.
Seeking Alpha

Traws Pharma Files Tivoxavir Marboxil Investigational New Drug (IND) Application for Influenza Therapy, and Provides Updated Results from the Ongoing Clinical Study of ...

NEWTOWN, Pa., Jan. 13, 2026 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (TRAW) (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage ...
The Caledonian-Record

Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and ...

Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of ...
Morningstar

Belief BioMed Congratulates Partner AskBio on IND Acceptance by FDA for Investigational Gene Therapy for Late-Onset Pompe Disease

SHANGHAI, Jan. 14, 2026 /PRNewswire/ -- AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, recently announced that the United States Food ...
Seeking Alpha

Quality Longevity Company Enlivex Receives Investigational New Drug (IND) Clearance from the FDA for Phase 2b Trial of Allocetra in Age-Related Primary Moderate-to-Severe Knee ...

Enlivex’s first regulatory approval for a late-stage global Phase 2b study in Age-Related Primary Moderate-to-Severe Knee Osteoarthritis following the implementation of its dual-engine value creation ...
Healio

FDA clears investigational new drug application for NOV05

Please provide your email address to receive an email when new articles are posted on . NOV05 will be evaluated in patients with noninfectious anterior uveitis. Novaliq plans to initiate a phase 2 ...
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Ultragenyx Pharmaceutical announces FDA acceptance of UX016 IND

Ultragenyx Pharmaceutical RARE announced that the FDA has accepted its investigational new drug (IND) application for UX016, ...
Morningstar

TuHURA Files Investigational New Drug Application for TBS-2025 in the Treatment of Blood-Related Cancers

TAMPA, Fla., Feb. 17, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to ...
MarketWatch

Belief BioMed Congratulates Partner AskBio on IND Acceptance by FDA for Investigational Gene Therapy for Late-Onset Pompe Disease

The MarketWatch News Department was not involved in the creation of this content. SHANGHAI, Jan. 14, 2026 /PRNewswire/ -- AskBio Inc. (AskBio), a gene therapy company wholly owned and independently ...