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Advances in Nomlabofusp Development and Strategic Financing Position Company for Future
Positive top-line data from Phase 2 dose exploration study of nomlabofusp, which was generally well-tolerated, with dose-dependent increases in tissue frataxin levels observedInitiated discussions with the Food and Drug Administration (FDA) on the potential use of tissue frataxin levels as a novel surrogate endpoint to support a Biologics License Application (“BLA”) submission for accelerated approval targeted for 2H 2025In January 2024, initiated open label extension (OLE) study with 25 mg dail
Study will inform on long-term safety profile and tissue frataxin levels OLE initiated with 25 mg daily subcutaneous injections of nomlabofusp Frataxin data and safety data from the OLE study are intended to help support a potential Biologics License Application (“BLA”) submission for accelerated approval targeted for H2 2025Initial data expected in Q4 2024 BALA CYNWYD, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology c
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. Details on the presentation can be found below. Date: Wednesday, M
BALA CYNWYD, Pa., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the closing of its previously announced underwritten public offering of 19,736,842 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 2,574,370 additional shares, at the public offering price of $8.74 per share, the closing p
BALA CYNWYD, Pa., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the pricing of its previously announced underwritten public offering of 17,162,472 shares of its common stock at a price to the public of $8.74 per share, the closing price of its common stock on February 13, 2024, for gross proceeds of approximately $150.0 million, before dedu
BALA CYNWYD, Pa., Feb. 13, 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 it has commenced an underwritten public offering of shares of its common stock and, in lieu of shares of common stock to certain investors that so choose, pre-funded warrants to purchase shares of common stock. In addition, Larimar expects to grant the underwriters a 30-da
Nomlabofusp was generally well tolerated following repeated subcutaneous injections in patients in the 25 and 50 mg cohorts with no serious adverse eventsDose dependent increases in frataxin levels were observed in skin and buccal cells Open Label Extension (OLE) study initiated in January 2024 to dose 25 mg daily of nomlabofusp with dosing anticipated to be starting later this quarter; Initial data expected in Q4 2024Initiated discussions with the FDA on use of tissue frataxin levels as a novel
Key Insights Given the large stake in the stock by institutions, Larimar Therapeutics' stock price might be vulnerable...
Completed full enrollment and dosing of the 50 mg cohort in Phase 2 Friedreich's ataxia (FA) dose exploration trial; based on blinded observations during the dosing period, there were no serious adverse events in either the CTI-1601 (nomlabofusp) or placebo groups.Top-line safety, pharmacokinetic, and frataxin data from the Phase 2 trial now expected in Q1 2024, refined from H1 2024Initiation of open label extension (OLE) trial with 25 mg daily dosing of nomlabofusp remains on track for Q1 2024;