Longeveron® Announces Positive Type C Meeting with U.S. FDA Regarding Pathway to BLA for Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS)
Longeveron Inc. - Class A Common stock (LGVN)
Company Research
Source: GlobeNewswire
On-going Phase 2b clinical trial (ELPIS II) deemed pivotal and, if positive, acceptable for Biological License Application (BLA) submission for potential full traditional approvalAlignment with FDA on ELPIS II primary and secondary endpointsAlignment with FDA on CMC and Potency Assay plan and requirements MIAMI, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced the positive Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of Lomecel-B™, a proprietary, scalable, allogeneic, investigational cellular therapy currently being evaluated in a Phase 2b clinical trial (ELPIS II) for hypoplastic left heart syndrome (HLHS). The Company and the FDA reached foundational alignment on the primary endpoint and secondary endpoints for ELPIS II. The FDA confirm
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News
- We're Keeping An Eye On Longeveron's (NASDAQ:LGVN) Cash Burn Rate [Yahoo! Finance]Yahoo! Finance
- Longeveron® Announces Third Quarter 2024 Financial Results and Provides Business UpdateGlobeNewswire
- Longeveron® Appoints Devin Blass as Chief Technology Officer and SVP of Chemistry, Manufacturing and Controls (CMC)GlobeNewswire
- Longeveron® to Report Third Quarter 2024 Financial Results and Host Conference Call on November 12, 2024GlobeNewswire
- Longeveron Inc. (NASDAQ: LGVN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $10.00 price target on the stock.MarketBeat
LGVN
Earnings
- 11/12/24 - Beat
LGVN
Sec Filings
- 11/14/24 - Form SC
- 11/12/24 - Form 8-K
- 11/12/24 - Form 10-Q
- LGVN's page on the SEC website