Russ Cohen

Larimar Therapeutics: A Resilient Rise After FDA Removal of Clinical Hold The Triumph of Larimar Therapeutics Amid FDA Regulatory Shift

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Iryna Drozd

Larimar Therapeutics’ stock, listed under NASDAQ as LRMR, soared by an impressive 24% during after-hours trading on Monday. This surge was triggered by the exhilarating news that the FDA had lifted a partial clinical hold on Larimar’s nomlabofusp clinical program following a meticulous assessment of Phase 2 data pertaining to the drug.

Among the band of illnesses that Larimar has been valiantly combatting is Friedreich’s ataxia (FA). The concoction under scrutiny has been undergoing rigorous testing for the treatment of this ailment. Anticipation is mounting for the unveiling of interim data from an ongoing open-label extension study in the fourth quarter. The company is eyeing the submission of an FDA market application, projected to unfurl in the latter half of 2025.

It’s noteworthy that alongside Larimar, other players in the pharmaceutical arena are also diligently crafting treatments for FA. Notable among these are PTC Therapeutics (PTCT) and Design Therapeutics (DSGN). Back in February, Biogen (BIIB) secured EU approval for its FA drug, Skyclarys, which has already graced the shelves of US markets with its healing potential.

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