Tag: approval

CELEBRATION, Fla., July 28, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare diseases, announced the company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the evaluation of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC). NPC is an ultra-rare, neurological disease caused by genetic mutations that result in lipid accumulation in cells, leading to visceral, neurological, and psychiatric symptoms. Arimoclomol is the only treatment shown to directly target the underlying pathology of NPC by increasing gene expression for improved lipid clearance. Arimoclomol for the treatment of NPC has been designated as an Orphan Medicinal Product by the EMA. Arimoclomol is marketed in the U.S. under the brand name MIPLYFFA®.

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SHANGHAI, China, July 26, 2025 (GLOBE NEWSWIRE) -- Pony AI Inc. (“Pony.ai” or the “Company”) (Nasdaq: PONY), a global leader in achieving large-scale commercialization of autonomous mobility, today announced that it has received a permit to provide fully driverless commercial Robotaxi services of Shanghai’s Pudong New Area, issued at the World Artificial Intelligence Conference (“WAIC”) 2025. This achievement demonstrates not only increasing regulatory trust and recognition in the Company’s technology and safety standards, but also represents another major milestone in advancing Robotaxi commercialization in a top-tier urban market in China.

Atlanta, GA., July 25, 2025 (GLOBE NEWSWIRE) -- Regional Health Properties, Inc. (“Regional”) (OTCBQ: RHEP) (OTCQB: RHEPA) (OTCQB: RHEPB), a self-managed healthcare real estate investment company that invests primarily in real estate purposed for senior living and long-term care, announced today that leading independent proxy advisory firm Institutional Shareholder Services Inc. (“ISS”) recommended that Regional shareholders vote “FOR”: (1) the approval of the Amended and Restated Agreement and Plan of Merger, dated April 14, 2025 (as amended, the “Merger Agreement”), by and between Regional and SunLink Health Systems, Inc. (the “Merger Proposal”), (2) the approval of the issuance of shares of Regional common stock and Regional Series D 8% Cumulative Convertible Redeemable Participating Preferred Shares (the “Regional Series D preferred stock”) in connection with the merger (the “Share Issuance Proposal”), and (3) the approval to adjourn the Regional special meeting to solicit additional proxies in favor of the Merger Proposal or the Share Issuance Proposal if there are insufficient votes at the time of such adjournment to approve the Merger Proposal or the Share Issuance Proposal.

SAN DIEGO, July 25, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, announced today that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-12 (the “Reverse Stock Split”). The Company’s common stock is expected to commence trading on a split-adjusted basis when the NYSE American market opens on August 5, 2025 under the existing symbol of “CLDI.” The new CUSIP number for the Company’s common stock following the Reverse Stock Split will be 320703 408.