Tag: clinical studies

GlucoModicum Reports Positive Clinical Results with its Needle-Free CGM and Advances Toward Market Launch

WINSTON-SALEM, N.C., July 01, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced the completion of the domestication process to change the jurisdiction of incorporation of the Company from the Cayman Islands to Delaware. The domestication was approved by shareholders of the Company at its Annual General Meeting held on May 29, 2025. Effective as of July 1, 2025, each (i) Class A ordinary share automatically converted into one share of Class A common stock of ProKidney Corp., a Delaware corporation and (ii) each Class B ordinary share automatically converted into one share of Class B common stock of ProKidney. ProKidney common stock will begin trading on July 2, 2025, and the Company's trading symbol on the Nasdaq Stock Market will remain unchanged as "PROK." The Company’s CUSIP number relating to its Class A common stock changed to 74291D 104. The Company does not anticipate any impact to day-to-day business operations as a result of the domestication.

EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announced the submission of two major regulatory applications for its ARC-EX System. The Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand its indication for home use. In parallel, ONWARD has filed an application with the notified body for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) to enable commercialization of the ARC-EX System in the EU. Completed in June, these submissions represent significant milestones as the Company advances its mission to bring breakthrough therapies to people with SCI around the world.

LAUSANNE, Switzerland and COPENHAGEN, Denmark, July 01, 2025 (GLOBE NEWSWIRE) -- ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women’s health, today announced that the first participant has been included in the company’s Phase 2 clinical trial of its lead candidate RPN-001 (leflutrozole), an orally administered aromatase inhibitor in development for the treatment of male infertility (https://clinicaltrials.gov/study/NCT06993155?term=Leflutrozole&rank=1).

NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor^® (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation.

CAMBRIDGE, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the initiation of dosing in the global clinical study, PROMINENT. The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to tacrolimus in adults diagnosed with primary membranous nephropathy (PMN). PROMINENT is designed to enroll approximately 180 adults with PMN and expected to readout in 2029. PMN is a severe antibody-mediated disease of the kidney that is a leading cause of nephrotic syndrome and carries a significant risk of kidney failure.

SAN DIEGO, June 30, 2025 (GLOBE NEWSWIRE) -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) securities between June 22, 2023 and June 24, 2025, both dates inclusive (the “Class Period”), have until August 25, 2025 to seek appointment as lead plaintiff of the Sarepta class action lawsuit. Captioned Dolgicer v. Sarepta Therapeutics, Inc., No. 25-cv-05317 (S.D.N.Y.), the Sarepta class action lawsuit charges Sarepta and certain of Sarepta’s top executives with violations of the Securities Exchange Act of 1934.

NEW YORK, June 27, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of all persons or entities who purchased or otherwise acquired Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT) securities between June 22, 2023 and June 24, 2025, both dates inclusive (the “Class Period”).

Boca Raton, Florida, June 27, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company, today announced that it has entered into securities purchase agreements with two healthcare focused institutional investors for the purchase and sale of 3,000,000 shares of its common stock in a registered direct offering (the "Offering") at a purchase price of $6.30 per share, priced at-the-market under Nasdaq rules.