Larimar Therapeutics Aktie

Larimar Therapeutics filed the first module of a Biologics License Application to the FDA for Nomlabofusp on June 29 and plans to submit remaining modules in the second half of 2026. The company reported positive results from an open-label study in adults with Friedreich's ataxia and says the FDA confirmed existing data based on skin frataxin is sufficient as a surrogate endpoint. CEO Carole Ben-Maimon called the data an important development; Baird cut its target price from $7 to $5 but maintained an Outperform rating, citing clinical benefit alongside safety concerns. » Więcej na finance.yahoo.com

Shares of Larimar Therapeutics rose about 15.5% on Thursday after a significant insider purchase. According to Form 4, board member Thomas Edward Hamilton acquired a total of 50,000 common shares at a weighted average price of $3.3378 (transaction prices $3.33–$3.35). After the purchase, Hamilton directly holds 714,798 shares and indirectly holds 159,433 shares through Post Edison, LLC; the purchase amounted to about $166,890. » Więcej na de.investing.com

Shares of Larimar Therapeutics fell 17% after the company released data from an open-label study and submitted the first module of a rolling BLA to the FDA for Nomlabofusp. The study showed increased and sustained frataxin levels in the skin for most participants and trend-level improvements in clinical measures, while 10 of 43 patients experienced anaphylaxis. Additional BLA modules are expected in the second half of 2026; a global Phase 3 study is planned to start in Q3 2026 with a target market entry in mid-2027 if approved. » Więcej na de.investing.com