Morningstar

Pentixapharm Receives FDA "Study May Proceed" Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program

U.S. Investigational New Drug (IND) applications for radiotheranostic pair PentixaFor and PentixaTher became active following completion of the FDA 30-day review period. Proposed phase I/II trial ...
Nasdaq

Vistagen Receives FDA "Study May Proceed" Letter Under its Refisolone IND Application, Enabling Further Phase 2 Clinical Development for the Treatment of Vasomotor Symptoms ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and ...
Business Insider

Calidi Biotherapeutics Receives Positive Pre-IND Feedback from US FDA for CLD-401 Indicating Agreement on its Current Development Strategy as it Advances Towards a First-in ...

SAN DIEGO, June 16, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or “the Company”), a biotechnology company pioneering the development of targeted genetic ...
EurekAlert!

Insilico Medicine receives IND approval from FDA for ISM8969, an AI-empowered potential best-in-class NLRP3 inhibitor

Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) paves the way for ISM8969 clinical study in the United States. The Phase I clinical trial aims to evaluate ...
Seeking Alpha

GH Research: GH001 Shows Robust Data Ahead Of FDA IND Decision

GH Research is advancing GH001, an inhaled mebufotenin therapy for treatment-resistant depression, with a critical FDA IND update imminent. GH001 demonstrated robust Phase 2b efficacy—a 15.5-point ...
Business Wire

Medical-imaging company Imagion Biosystems Lodges IND with FDA for Phase 2 Trial of MagSense® HER2 targeted imaging agent

MELBOURNE, Australia--(BUSINESS WIRE)--Imagion Biosystems, Ltd. (ASX: IBX) announced that the company has lodged an Investigational New Drug (IND) application with the U.S. Food and Drug ...
Morningstar

Pentixapharm Announces IND Submission to FDA for Phase 3 PANDA Study of First-in-Class CXCR4-Targeted Cardiovascular Diagnostic

BERLIN, DE / ACCESS Newswire / May 11, 2026 / Pentixapharm Holding AG (Frankfurt Prime Standard:PTP), a clinical-stage biotech developing novel radiopharmaceuticals today announced the submission of ...
Sarasota Herald-Tribune

TriCelX Files IND with FDA & Concurrently Requests RMAT Designation for XytriX™ in the Treatment of Knee Osteoarthritis

IND Filing and Concurrent RMAT Request Position XytriX™ as a Potential Breakthrough Biotherapeutic for More Than 500 Million People Living with Osteoarthritis Our concurrent request for RMAT ...
USA Today

Aspire Biopharma Announces Successful Pre-IND Meeting with FDA for High-Dose Sublingual Aspirin (OTASA)

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical trial ESTERO, FL / ACCESS Newswire / January 7, 2026 / Aspire Biopharma ...