Larimar Therapeutics Announces FDA Breakthrough Therapy Designation for Nomlabofusp in FA and Reiterates Planned BLA Submission in June 2026
Larimar Therapeutics, Inc. (LRMR)
Company Research
Source: GlobeNewswire
Nomlabofusp program granted Breakthrough Therapy Designation for the treatment of adults and children with FA based on FDA’s review of available clinical data from open label studyFDA written communications after recent START meeting continue to align with use of skin FXN to support BLA submission seeking accelerated approvalTopline open label study data to support BLA submission expected in Q2 2026 Planned BLA submission seeking accelerated approval on track for June 2026; U.S. launch targeted for first-half 2027, if approved BALA CYNWYD, Pa., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to nomlabofusp, a frataxin (FXN) protein replacement therapy with disease modifying potential, for the treatment of adults and children with Friedre
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News
- Larimar Therapeutics to Participate in Upcoming Investor Conferences in MarchGlobeNewswire
- Larimar Therapeutics price target raised to $12 from $11 at Wedbush [Yahoo! Finance]Yahoo! Finance
- Larimar Therapeutics (LRMR) had its price target raised by Wedbush from $11.00 to $12.00. They now have an "outperform" rating on the stock.MarketBeat
- Larimar Therapeutics (LRMR) Is Up 78.8% After Breakthrough Nod And $100M Raise Has The Bull Case Changed? [Yahoo! Finance]Yahoo! Finance
- Larimar Therapeutics Announces Pricing of Upsized $100 Million Underwritten Public OfferingGlobeNewswire
LRMR
Earnings
- 11/5/25 - Miss
LRMR
Sec Filings
- 3/2/26 - Form SCHEDULE
- 3/2/26 - Form 4
- 3/2/26 - Form 4
- LRMR's page on the SEC website