Latest Clene Nanomedicine News & Updates

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Clene Nanomedicine (Clene)

Clinical-stage biopharmaceutical company developing nanotherapeutics for neurodegenerative diseases

clene.com
Headquarters
SALT LAKE CITY, United States
Founded year
2013
Company type
Public company
Number of employees
70–200

Last updated

Latest news about Clene Nanomedicine (Clene)

In short: Clene advanced its ALS program toward an NDA filing for CNM-Au8 after receiving positive FDA feedback on accelerated approval pathways.

Company announcements

  • Clene

    Clene announces $7 million stock offering

    Offers 1,000,000 shares at $7.00 each to one investor. Proceeds fund NDA filing for CNM-Au8, expanded access, manufacturing, and R&D. Closes May 6, 2026.

  • Clene

    Clene plans NDA filing for CNM-Au8 in ALS

    FDA confirms NfL biomarker data supports accelerated approval pathway. Submission expected in Q3 2026.

  • Clene

    Clene reports full year 2025 financial results

    Announces FDA Type C meeting, oversubscribed $28M offering, and CNM-Au8 ALS progress. Cash runway extends to Q3 2026.

  • Clene

    Clene issues stockholder letter highlighting CNM-Au8 2026 catalysts

    Outlines sufficient capital into Q4 2026, upcoming FDA Type C meeting, NDA submission in Q2 2026, and potential PDUFA in H2 2026.

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