Clinical Trials News

Latest clinical-trials news and updates for US-listed public companies.

📣 Get clinical-trials alerts and analysis

ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)

How does this development compare to similar FDA approvals and clinical progress among ONWD's competitors? What is the expected timeline and potential market size for the ARC-IM System if the pivotal study is successful? How will the FDA IDE approval for the Empower BP pivotal study affect ONWD's short-term stock performance?
Symbol: ONWD
4 days ago
Read more globenewswire

Anixa Biosciences Announces Treatment of Second Patient in Fourth Cohort of Ovarian Cancer CAR-T Clinical Trial

Fourth Cohort Receiving 30x Initial Dose with No Dose-Limiting Toxicities Observed to Date SAN JOSE, Calif., Aug. 18, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ...

How does Anixa’s CAR‑T progress compare to competing ovarian cancer immunotherapies, and what market share potential does it create if the trial continues to succeed? What immediate impact could this trial update have on ANIX’s stock price and trading volume, considering market expectations and analyst sentiment? How will the lack of dose‑limiting toxicities and the higher 30x dose in the fourth cohort influence the likelihood and timeline of regulatory approval for Anixa’s ovarian cancer CAR‑T therapy?
Symbol: ANIX
5 days ago
Read more prnewswire

Capricor Therapeutics Announces First Subjects Dosed in Phase 1 Clinical Trial of Novel Exosome-Based Vaccine

SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today a...

Are there any contingent milestones, regulatory pathways, or additional funding requirements tied to the NIH Project NextGen partnership that could impact future cash flow or dilution risk? What is the competitive landscape for exosome‑based vaccines, and does Capricor have a differentiated platform versus peers like Moderna, BioNTech, and other exosome players? How will the Phase 1 data and timeline for StealthX™ affect CAPR's near‑term valuation and trading volume?
Symbol: CAPR
5 days ago
Read more globenewswire

jCyte Inc. Announces First Patients Treated in JC02-88 Trial for Retinitis Pigmentosa

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte, Inc. is pleased to announce the first patients have been enrolled and treated in the JC02-88 study evaluating the safety and efficacy of jCell (famzer...

How does jCell’s mechanism and dosing strategy compare with other gene‑ or cell‑based therapies targeting retinitis pigmentosa in terms of efficacy, safety, and market size? What is the expected timeline for data readout from this trial, and how could that timeline align with upcoming FDA interactions or potential partnership announcements? How might the initiation of the JC02-88 trial and the higher cell dose affect JCyte's short‑term stock volatility and valuation multiples?
Symbol: JCYT
5 days ago
Read more businesswire

Plus Therapeutics Presents Positive ReSPECT-LM Clinical Trial Results of REYOBIQ™ in Leptomeningeal Metastases

REYOBIQ produced a clinical benefit rate of over 75% in 3 clinically relevant outcome measures

How does the 75% clinical benefit rate compare to existing therapies and pipeline competitors, and what impact could this have on market share and partnership opportunities? What are the regulatory pathways and expected timeline for FDA approval of REYOBIQ in leptomeningeal metastases, and how might that influence near‑term price volatility? How will the positive REYOBIQ trial results affect Plus Therapeutics' revenue forecasts and valuation multiples?
Symbol: PLUS
5 days ago
Read more globenewswire

Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer

BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)--Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the tre...

What are the risks and upside scenarios surrounding upcoming clinical trial data or regulatory milestones for I‑DXd that could drive significant price volatility? What is the potential market size and competitive landscape for B7‑H3 directed ADCs in extensive‑stage small cell lung cancer, and how might this influence Daiichi Sankyo's revenue forecasts? How will the Breakthrough Therapy Designation affect Ifinatamab deruxtecan's expected FDA approval timeline and market valuation of Daiichi Sankyo (DSKY)?
Symbol: DSKY
5 days ago
Read more businesswire

IMvigor011 Bladder Cancer Trial Achieves Positive Results, with Signatera™ Strongly Predicting Adjuvant Immunotherapy Benefit

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced positive topline results from the randomized, phase III IMvigor...

How does this development position Natera relative to competitors in the circulating tumor DNA (ctDNA) testing market, and could it affect market share dynamics? What are the potential revenue implications for Natera from expanded Signatera™ usage in bladder cancer and other oncology indications? How will the positive IMvigor011 trial results influence Natera's (NTRA) stock valuation in the short term?
Symbol: NTRA
5 days ago
Read more businesswire