Tag: trial

Rincell-1 addresses a multi $Bn global market opportunity  where no disease modifying treatments currently exist

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).

Combined Company Expected to be Listed on NASDAQ Global Market

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.

NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) --

Class Action Attorney Juan Monteverde with Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report. The firm is headquartered at the Empire State Building in New York City and is investigating Guaranty Bancshares, Inc. (NYSE: GNTY) related to its sale to Glacier Bancorp, Inc. Upon completion of the proposed transaction, existing Guaranty shareholders will receive 1.0000 share of Glacier common stock for each share of Guaranty (subject to certain adjustments). Is it a fair deal?

TORONTO, ONTARIO, June 30, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI; TSX: CSCI) (“COSCIENS” or the “Company”), a life sciences company developing and commercializing a diversified portfolio of cosmeceutical, nutraceutical and pharmaceutical products, today announced the voting results on the items of business considered at the virtual annual general and special meeting of shareholders of the Company (the “AGSM”) held today.

NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Class Action Attorney Juan Monteverde with Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report. The firm is headquartered at the Empire State Building in New York City and is investigating Turnstone Biologics Corp. (NASDAQ: TSBX) related to its sale to XOMA Royalty Corporation in which existing Turnstone shareholders will receive $0.34 in cash per share and one non-transferable contingent value right. Is it a fair deal?

PWR delivers science-driven cellular energy and recovery support as part of Jupiter’s expanding longevity supplement portfolio