Larimar Therapeutics Inc Dossier
Outlook & Key Dates
Estimates, guidance, catalysts, and upcoming events
Analyst Estimates Learn more →
5-Yr Fwd EPS Growth
36.2%projected annual EPS growth
Analyst Coverage
10analysts covering
FY EPS (est.)
-$1.61next fiscal year
Reporting Calendar
| Event | Expected Date |
|---|---|
| Submission of Final BLA Modules (including CMC) | 31 Dec 2026 |
| Potential U.S. Approval and Commercial Launch of Nomlabofusp | 30 Jun 2027 |
Monitoring Framework
Key Performance Indicators
Skin Frataxin (FXN) Levels Quarterly100.0Target: Maintain skin FXN levels above 50% of the median level observed in healthy volunteers (comparable to asymptomatic carriers) in 100% of evaluated participants at Day 180
Cash, Cash Equivalents, and Marketable Securities Quarterly200.4MTarget: Maintain sufficient capital to fund operations into the projected runway of Q2 2027
Modified Friedreich's Ataxia Rating Scale (mFARS) Score Change Annually-2.2Target: Demonstrate sustained clinical improvement or stabilization (negative score change) compared to the +1.0 point worsening observed in the FACOMS natural history reference population
Watch Items
- Anaphylaxis and Severe Allergic ReactionsTrigger: Any new incidence of drug-related anaphylaxis or severe hypersensitivity in the open-label study or the upcoming Phase 3 trialAction: Evaluate the effectiveness of the modified starting dose regimen and antihistamine premedication protocol; coordinate with the FDA under the START pilot program to ensure safety database adequacy.
- FDA Rolling BLA Submission ProgressTrigger: Delay in the initiation of the rolling BLA submission beyond June 2026 or delays in submitting final CMC modules in 2H 2026Action: Assess CMC readiness and regulatory alignment; engage in frequent communications with FDA staff via the START pilot program to resolve outstanding data package queries.
- Global Confirmatory Phase 3 Study DosingTrigger: Failure to initiate dosing of the first patient in the global confirmatory Phase 3 study by mid-2026Action: Accelerate site qualification and screening activities across the U.S., E.U., U.K., Canada, and Australia.
Research as of 20 Jun 2026