FDA Provides Roadmap for Accelerated Approval Pathway Through Submission of Additional CNM-Au8® Biomarker Data in ALS
Clene Inc. (CLNN)
Company Research
Source: GlobeNewswire
FDA recommends that Clene leverage additional Neurofilament Light (NfL) data from its three Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial to support earlier presented findingsFDA recommends a follow-up meeting to discuss in more detail the analyses needed to support the accelerated approval pathway Additional NfL biomarker collection and analyses are underway and planned to be completed during the second quarter of 2025Clene is proceeding with its New Drug Application (NDA) for ALS with a planned submission in mid-2025 following incorporation of the EAP NfL biomarker analysesClene plans to commence the confirmatory Phase 3 trial (RESTORE-ALS) evaluating the survival benefit of CNM-Au8 with initial participant enrollment prior to the NDA submission SALT LAKE CITY, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical compa
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News
- Clene Inc. (NASDAQ: CLNN) had its "buy" rating re-affirmed by analysts at D. Boral Capital. They now have a $23.00 price target on the stock.MarketBeat
- Clene Improves Cash Position and Runway by Securing New Debt Facility to Pay Off Existing Senior Loan [Yahoo! Finance]Yahoo! Finance
- Clene Improves Cash Position and Runway by Securing New Debt Facility to Pay Off Existing Senior LoanGlobeNewswire
- IBN Coverage: Clene (NASDAQ: CLNN) Advances CNM-Au8 in ALS With FDA Guidance on Accelerated Approval Pathway [Yahoo! Finance]Yahoo! Finance
- Clene Inc. (NASDAQ: CLNN) had its "buy" rating re-affirmed by analysts at D. Boral Capital. They now have a $23.00 price target on the stock.MarketBeat
CLNN
Earnings
- 11/13/24 - Beat
CLNN
Sec Filings
- 12/20/24 - Form 8-K
- 12/10/24 - Form 424B5
- 12/10/24 - Form 8-K
- CLNN's page on the SEC website