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Dynamic Mind

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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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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Aura Biosciences Reports Second Quarter 2026 Financial Results and Recent Business Highlights

August 11, 2026PDF Version Phase 3 CoMpass trial fully enrolled with 108 patients, exceeding enrollment target; on track for topline data in 2H 2027 Strategic operating plan refined to focus on development of bel-sar in ocular oncology Interim NMIBC data reinforce bel-sar’s potential for durable efficacy and favorable safety profile; NMIBC program being strategically deprioritized…

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Aura Biosciences Announces Appointment of Jeremy Bender, Ph.D., M.B.A., to Board of Directors

BOSTON, July 08, 2026 (GLOBE NEWSWIRE) — Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced the appointment of Jeremy Bender, Ph.D., M.B.A., to its Board of Directors. “I am thrilled to welcome Jeremy to our Board of Directors and excited to be working alongside him again,”…

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Aura Biosciences Reports First Quarter 2026 Financial Results and Business Highlights

May 11, 2026 PDF Version Phase 3 CoMpass trial advancing toward enrollment completion, supporting 2H 2027 topline data Natalie Holles appointed Chief Executive Officer and President and member of the Board of Directors Strengthened balance sheet with oversubscribed $299 million equity financing; cash position expected to fund operations into 2H 2028 BOSTON, May 11, 2026 (GLOBE NEWSWIRE) — Aura Biosciences, Inc. (NASDAQ:…

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