Leriglitazone Marketing Authorization Application submitted for treatment of cerebral adrenoleukodystrophy has been validated by European Medicines Agency

Leriglitazone Marketing Authorization Application submitted for treatment of cerebral adrenoleukodystrophy has been validated by European Medicines Agency

Barcelona, Spain and Düsseldorf, Germany – 23 July 2025 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, today announce that the Marketing Authorization Application (MAA) for Minoryx’s lead candidate leriglitazone (NEZGLYAL®) has been submitted to the European Medicines Agency (EMA) for the treatment of paediatric and adult male patients with cerebral adrenoleukodystrophy (cALD). EMA has now validated the MAA file and it is under review by the Committee for Medicinal Products for Human Use (CHMP).

Minoryx receives a EUR 26.9m grant within the framework of the European IPCEI Med4Cure project for the continued development of leriglitazone in lethal orphan CNS diseases

Barcelona, Spain, 17 July 2025 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders today announces that it has secured a EUR 26.9m non-dilutive grant for the development of its LERI4CNS project, which will validate leriglitazone for treating potentially lethal rare diseases affecting the CNS. The grant was given as part of the pan-European project “Important Project of Common European Interest (‘IPCEI') Med4Cure”, of which Minoryx Therapeutics is an Associated Member.

BioAtla Presents Phase 2 Ozuriftamab Vedotin (Oz-V) Clinical Trial Data Demonstrating Compelling Antitumor Activity in HPVAssociated Oropharyngeal Squamous Cell Carcinoma

SAN DIEGO, June 02, 2025 -- BioAtla, Inc. (Nasdaq: BCAB) (the “Company”), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced data in a poster titled, “Phase 2 Trial of Ozuriftamab Vedotin (Oz-V), a Conditionally Binding CAB-ROR2-ADC, in Patients with Heavily Pretreated Squamous Cell Carcinoma of the Head and Neck.” The poster will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting at the McCormick Place Convention Center in Chicago, Illinois.

Aktis Oncology Initiates Phase 1B Clinical Trial of its Nectin-4-Targeting Radiopharmaceutical Product Candidate, AKY-1189, Across Multiple Tumor Types

BOSTONMay 28, 2025 -- Aktis Oncology, Inc., an oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for patient populations not addressed by existing platform technologies, today announced that it has initiated clinical development of AKY-1189 in its Phase 1b clinical trial for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC), triple negative breast cancer (TNBC) and potentially other Nectin-4 expressing tumors.

Glycomine Announces $115 Million Series C Financing to Advance Lead Drug Candidate, GLM101, into a Phase 2b Clinical Trial for PMM2-CDG

SAN CARLOS, Calif.--April 16, 2025--Glycomine, Inc., a biotechnology company focused on developing transformative new therapies for orphan diseases, today announced a $115 million Series C financing to advance its lead candidate, GLM101, into a Phase 2b clinical trial. The financing was led by CTI Life Sciences Fund, funds managed by abrdn Inc., and Advent Life Sciences, alongside continued investment from existing investors, Novo Holdings, Sanofi Ventures, Abingworth, RiverVest Venture Partners, Sanderling Ventures, Chiesi Ventures, Remiges Ventures, and Asahi Kasei Ventures.

Solu Therapeutics Closes $41M Series A Financing and Announces First Patient Dosed in Phase 1 Clinical Trial

BOSTONApril 9, 2025 -- Solu Therapeutics, a biotechnology company pioneering therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, today announced the successful completion of a $41 million Series A financing that included participation from five new investors – Eli Lilly and Company, Biovision Ventures, Pappas Capital, Hengdian Group Capital (HgC), and The Leukemia & Lymphoma Society Therapy Acceleration Program® – as well as continued support from existing Solu investors Longwood Fund, DCVC Bio, Santé Ventures, Astellas Venture Management, and Alexandria Venture Investments. The company also announced initiation of treatment of the first patient in its first-in-human Phase 1 clinical trial evaluating STX-0712 in patients with resistant/refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies.

Minoryx announces dosing of the first patient with leriglitazone in the phase 2a study in Rett syndrome (TREE study)

Barcelona, Spain – 4 March 2025 – Minoryx Therapeutics, a late-stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders, today announces that the first patient in the TREE study has been dosed with leriglitazone. TREE is a phase 2a clinical study assessing the safety and efficacy of lead candidate leriglitazone, a novel, brain-penetrant and selective PPAR gamma agonist, to treat patients with Rett syndrome.

Tune Therapeutics Names John McHutchison as CEO and Chairman of the Board

DURHAM, N.C. & SEATTLE--March 4, 2025--Leading epigenome company Tune Therapeutics is proud to announce that veteran drug-development executive John McHutchison AO, MD will be its new CEO and Chairman of the Board. Dr. McHutchison is an internationally recognized leader of the biopharma industry and accomplished drug developer who brings decades of executive leadership and experience in developing novel therapeutics.

Aura Biosciences Announces Additional Data from Ongoing Phase 1 Trial in Non-Muscle Invasive Bladder Cancer

BOSTON, March 03, 2025 -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced that additional Phase 1 data evaluating bel-sar (AU-011) for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) will be presented at the 40th Annual European Association of Urology (EAU) Congress being held March 21-24, 2025, in Madrid, Spain. Aura will also participate in the EAU Research Forum during the Congress.

CuraSen Therapeutics Announces First Subject Treated with CuraAX (CST-3056) in a Phase 1 Clinical Trial

SAN CARLOS, Calif.--February 20, 2025--CuraSen Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral, rapid onset, small molecule drugs to treat psychiatric and neurodegenerative diseases, announced today that it has treated its first subject with CuraAX, an alpha-1A adrenoceptor agonist, in a Phase 1 clinical trial. The company is developing CuraAX for patients with neurogenic orthostatic hypotension (nOH). Neurogenic orthostatic hypotension is a condition characterized by a significant, sudden drop in blood pressure upon standing, resulting in debilitating dizziness, fainting and cognitive impairment, due to inadequate blood flow to the brain. CuraAX is also expected to benefit cognition in patients with a range of neurologic conditions.