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Altay Therapeutics Closes $37 Million Series A Financing to Advance First Oral DUX4 Inhibitor for FSHD into the Clinic

Altay Therapeutics Closes $37 Million Series A Financing to Advance First Oral DUX4 Inhibitor for FSHD into the Clinic

SAN CARLOS, Calif.-- October 14, 2026 -- Altay Therapeutics, Inc., a biotechnology company developing novel small molecule inhibitors of transcription factors, today announced the completion of a $37 million Series A financing. The round was co-led by Sound Bioventures and HealthCap, with participation from new investors including Fountain Healthcare Partners, Biogen New Ventures, Pappas Capital, and Global BioAccess Fund. Proceeds from the financing will be used to accelerate the development of Altay’s lead therapeutic candidate, DX5057, through Phase 1 and Phase 2 proof-of-concept clinical trials for patients with FSHD (facioscapulohumeral muscular dystrophy).

0-Homepage Feature / 0-Megaphone / Altay Therapeutics - 10/14/2026

Solu Therapeutics Initiates Dosing in Acute Myeloid Leukemia Cohort of the Ongoing Phase 1 Study of STX-0712

BOSTON, Oct. 08, 2026 -- Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, today announced that it has initiated dosing in an acute myeloid leukemia (AML) cohort of the ongoing Phase 1 study of STX-0712, the Company’s investigational therapeutic designed to deplete disease-driving CCR2-positive malignant monocytes and CCR2-positive bone marrow progenitors. The cohort will enroll patients with relapsed/refractory monocytic or monocytic-predominant AML.

Solu Therapeutics - 10/08/2026

Aktis Oncology Initiates Second Phase 1b Clinical Trial for AKY-2519, a Miniprotein Radioconjugate Targeting B7-H3

BOSTON, Oct. 01, 2026 -- Aktis Oncology, Inc. (NASDAQ:AKTS) (“Aktis” or the “Company”), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, today announced the initiation of the Phase 1b BActinium-2 trial of AKY-25191 in patients with NSCLC and other B7-H3 expressing solid tumor types. The BActinium-2 trial is part of Aktis’ clinical development strategy to develop AKY-2519 broadly in several B7-H3 expressing tumors. In May 2026, Aktis initiated the Phase 1b BActinium-1 trial of AKY-2519 in mCRPC patients, with preliminary data expected in 2027.

Aktis Oncology - 10/01/2026

Breye Therapeutics raises €67.5 million in over-subscribed Series A financing

COPENHAGEN, Denmark, Sept. 29, 2026 -- Breye Therapeutics ApS (Breye), a clinical-stage biopharmaceutical company developing oral therapeutics for the early treatment of retinal diseases, today announced the successful close of an over-subscribed €67.5 million Series A financing round. The round was co-led by new investor Mission BioCapital and existing investor Novo Holdings, with participation from existing investor Sound Bioventures and additional new investors including the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital. The proceeds of the financing will be used to advance Breye’s lead asset danegaptide into a randomized Phase 2 clinical trial in patients with NPDR. The study, which will aim to demonstrate clinical proof-of-concept, is due to start in 2027.

Breye Therapeutics - 09/29/2026

European Commission grants marketing authorisation for NEZGLYAL® (leriglitazone), the first pharmacological treatment approved for cerebral Adrenoleukodystrophy (cALD), a rare neurodegenerative disease

BARCELONA, Spain and DÜSSELDORF, Germany, Sept. 25, 2026 -- Neuraxpharm Group and Minoryx Therapeutics today announce that the European Commission (EC) has granted marketing authorisation under exceptional circumstances for NEZGLYAL® (leriglitazone), an orally bioavailable, brain penetrating, selective PPAR gamma agonist, as a treatment for male cALD patients, aged 2-12 years with Gadolinium (Gd)-negative brain lesions. The therapy is the first approved pharmacological treatment for cALD in the European Union (EU). The approval is based on results from the Phase 2/3 NEXUS 1 study and additional real-world evidence from compassionate use programmes. The first European launch is expected in Germany by the end of the year, with additional launches in Europe anticipated pending completion of national reimbursement negotiations.

Minoryx - 09/25/2026

FDA Grants Breakthrough Therapy Designation to Glycomine’s GLM101 for the Treatment of PMM2-CDG

SAN CARLOS, Calif.--September 23, 2026--Glycomine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to GLM101 for the treatment of phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG), a serious, multisystem disorder with no approved treatments. GLM101 is an investigational liposomal mannose-1-phosphate substrate replacement therapy designed to address the underlying deficiency in mannose-1-phosphate and resulting disruption of glycosylation in PMM2-CDG. The designation is based on clinical evidence from Glycomine’s open-label Phase 2a study, including improvements in ataxia and other clinical measures after 24 weeks of GLM101 treatment.

Glycomine - 09/23/2026

Minoryx and Neuraxpharm complete enrolment in leriglitazone pivotal Phase 3 trial (CALYX) in adult patients with cerebral Adrenoleukodystrophy (cALD)

Mataró, Barcelona, Spain, and Düsseldorf, Germany, 09 September 2026 - Minoryx Therapeutics and Neuraxpharm Group (Neuraxpharm), announce that the last patient has been enrolled in the global Phase 3 clinical trial (CALYX) evaluating leriglitazone (NEZGLYAL®) in adult male patients with cerebral Adrenoleukodystrophy (cALD), an orphan neurodegenerative disease with no pharmacological therapeutic options. In Europe, leriglitazone has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of boys aged 2-12 with cALD and non-gadolinium enhancing lesions. Approval under exceptional circumstances from the European Commission (EC) is expected later this month and Neuraxpharm, a leading CNS specialist company and Minoryx’s strategic partner in Europe, is preparing for the commercial launch.

Minoryx - 09/09/2026

NEZGLYAL® (leriglitazone) receives a positive CHMP opinion for the treatment of cerebral Adrenoleukodystrophy (cALD), a rare neurodegenerative disease

BARCELONA, Spain and DÜSSELDORF, Germany, July 24, 2026 -- Minoryx Therapeutics and Neuraxpharm Group, announce that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation approval under exceptional circumstances for NEZGLYAL® (leriglitazone) as a treatment for male cALD patients, aged 2-12 years with Gadolinium (Gd) negative brain lesions. European Commission approval is expected by the end of September 2026.

Minoryx - 07/26/2026

Aura Biosciences Announces Enrollment Completion in Phase 3 CoMpass Trial of Bel-sar in Early Choroidal Melanoma

BOSTON, June 01, 2026 -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced it has completed enrollment of 108 patients in the Phase 3 trial evaluating belzupacap sarotalocan (bel-sar) as a frontline treatment for patients with early choroidal melanoma. Topline data for the 15-month primary endpoint are anticipated in the second half of 2027.

Aura - 06/02/2026

Aktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors

BOSTON, May 21, 2026 -- Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, today reported first-in-human clinical imaging and dosimetry data for AKY-2519, a miniprotein radioconjugate targeting B7-H3 expressing tumors. The data from two separate assessments of AKY-2519 – a clinical imaging and dosimetry assessment in patients with mCRPC and a clinical imaging assessment in patients with various solid tumor types – demonstrated robust tumor uptake and limited normal tissue exposure. These findings, which supported the advancement of a broad clinical development program for AKY-2519, will be presented in two poster presentations at the upcoming 2026 ASCO Annual Meeting, being held May 29 – June 2, 2026, in Chicago.

Aktis Oncology - 05/21/2026
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