Larimar Therapeutics, Inc. LRMR
Larimar Therapeutics, Inc. (Nasdaq: LRMR) is a rare genetic drug developer. Its lead program, nomlabofusp, is in Phase 2 for Friedreich's ataxia. Its next catalyst on record is nomlabofusp: Planned commercial launch if approved (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: nomlabofusp — Planned commercial launch if approved (2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| nomlabofusp (open label study; planned global confirmatory Phase 3) | Friedreich's ataxia | protein/peptide | Phase 2 |
Recent results and decisions
- Jun 29, 2026positive Long-term open-label data: 100% (9/9) reached asymptomatic-carrier skin FXN levels at 1 year; mFARS improved 1.0 point vs 1.6-point worsening in FACOMS reference (n=13, 2.6-point difference); anaphylaxis in 10 of 43 dosed, 9 with prior exposure.
Daily nomlabofusp increased and sustained skin FXN levels at 1 year and 18 months; 100% (9/9) of participants achieved and maintained levels over 50% of mean levels in healthy volunteers (comparable to asymptomatic heterozygous carriers) at 1-year
Filing - Jun 29, 2026submitted First module of the rolling BLA seeking accelerated approval was submitted after a Type B pre-BLA meeting; remaining modules expected 2H 2026.
today announced it has submitted the first module of its rolling Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) for accelerated approval of nomlabofusp; the remaining modules are expected to be submitted in the second half of 2026.
Filing - Feb 24, 2026n/a FDA granted Breakthrough Therapy Designation to nomlabofusp for adults and children with Friedreich's ataxia (a designation, not an approval).
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 Friedreich’s ataxia (FA).
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.