Larimar TherapeuticsNASDAQ: LRMR

BALA CYNWYD, Pa., May 30, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the United States Food and Drug Administration (FDA) has selected nomlabofusp to participate in the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. Nomlabofusp is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria. START selection was based on demonstrated development program readiness, including the potential of nomlabofusp to address the serious and unmet medical needs in a rare neurodegenerative condition, alignment of chemistry, manufacturing, and controls (CMC) development timelines with clinical development plans, and a proposed communications plan where enhanced communication could accelerate pivotal study initiation and path to potential Biologics License Application (BLA) submission.

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The FDA removes the partial clinical hold on Larimar's (LRMR) nomlabofusp clinical program for the treatment of patients with Friedreich's Ataxia.

BALA CYNWYD, Pa., March 06, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that members of the company's management team will present and participate in 1x1 investor meetings at the Leerink Partners Global Biopharma Conference, taking place in Miami Beach, FL from March 11 – 13, 2024.

Clearance given by FDA to initiate higher 50 mg dosing of CTI-1601 for patients with Friedreich's Ataxia for phase 2 study; results from this cohort expected 1st half of 2024. Clearance given to initiate open-label extension study of CTI-1601 for Friedreich's Ataxia; study initiation Q1 of 2024 and then interim results Q4 of 2024. Prior phase 1 study, using CTI-1601 for the treatment of patients with Friedreich's Ataxia, showed that the drug was able to increase frataxin levels in a dose-dependent manner.

Larimar (LRMR) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).

SIGA, RYI, LRMR, VRTV and PLL have been added to the Zacks Rank #1 (Strong Buy) List on April 19, 2023.