After One Year Of Regulatory Hold, Larimar's Ataxia Candidate Sees Some Hope

The FDA has cleared the initiation of Larimar Therapeutics Inc's LRMR 25 mg cohort of Phase 2 trial of CTI-1601 in Friedreich's ataxia patients.
In a written communication to Larimar, the FDA indicated it was lifting its full clinical hold on the CTI-1601 program and imposing a partial hold.
The design of the upcoming Phase 2 trial is identical to the design proposed by Larimar, except for a requirement for the FDA to review data from the 25 mg cohort before escalating the dose in the second cohort.
Larimar expects to begin the Phase 2 trial in Q4 2022, with top-line data expected in 2H 2023.
The CTI-1601 program was placed on a clinical following three mortalities out of 34 animals in a 26-week non-human primate (NHP) toxicology study designed to support extended dosing of patients with CTI-1601.
All 3 of these NHPs were in the study's two highest dose groups, and all NHPs in the two lower dose groups survived until the study's end.
To support CTI-1601 development, Larimar priced an underwritten offering of 22.22 million shares at $3.15 for gross proceeds of $70 million.
Underwriters have an option to purchase up to 3.33 million additional shares.
Price Action: LRMR shares are up 1.27% at $3.19 during the market session on the last check Wednesday.