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

Approval is based on NEXUS data and follows positive CHMP opinion in July; first European launch is expected by end of 2026 Barcelona, Spain and Düsseldorf, Germany – 25 September, 2026 – Neuraxpharm Group and Minoryx Therapeutics, today announce that the European Commission (EC) has granted marketing authorisation under exceptional circumstances for NEZGLYAL® (leriglitazone), an…

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

Designation is based on clinical evidence from Phase 2a, including improvements in ataxia and other clinical measures after 24 weeks of GLM101 treatment Topline data from the randomized, placebo-controlled portion of the global Phase 2b POLAR study expected in the fourth quarter of 2026 SAN CARLOS, Calif., September 23, 2026 – Glycomine, Inc. announced today…

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

Top-line results expected in early 2028; trial to support future label expansion in the EU and to enable NDA filing in the US. 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)…

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NEZGLYAL® (leriglitazone) receives a positive CHMP opinion for the treatment of cerebral

2026-07-24 Recommendation based on NEXUS data; Minoryx and Neuraxpharm expect European Commission approval by the end of this quarter Barcelona, Spain and Düsseldorf, Germany – 24 July, 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…

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Aura Biosciences to Participate in Upcoming Investor Conference

September 2, 2026PDF Version BOSTON, Sept. 02, 2026 (GLOBE NEWSWIRE) — Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a potentially transformative first-in-class therapy for patients with ocular cancers, today announced that Natalie Holles, CEO and President, will participate in the following upcoming investor conference: Morgan Stanley 24th Annual Global Healthcare Conference on Wednesday, September 16, 2026.Fireside Chat at 2:35…

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Aura Biosciences Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Aura Biosciences Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)September 1, 2026PDF Version BOSTON, Sept. 01, 2026 (GLOBE NEWSWIRE) — Aura Biosciences, Inc. (NASDAQ: AURA) (“Aura” or the “Company”), a clinical-stage biotechnology company developing a potentially transformative first-in-class therapy for patients with ocular cancers, today announced that inducement equity awards (collectively, “Inducement Awards”) were granted to Erica Kratz, Ph.D., Aura’s…

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