Core Insights - Larimar Therapeutics reported positive long-term data from its open label study of nomlabofusp, indicating potential to alter the disease course of Friedreich's ataxia (FA) [2][3][4] - The company plans to submit a Biologics License Application (BLA) seeking accelerated approval in the second quarter of 2026 [2][4][10] Clinical Development - In the open label study, 100% of participants achieved skin frataxin (FXN) levels over 50% of median levels in healthy volunteers after 6 months [3][4] - A median improvement of 2.25 in the modified Friedreich Ataxia Rating Scale (mFARS) score was observed after 1 year, compared to a worsening of 1.00 in the FACOMS reference population [3][4] - The company is implementing a modified starting dose regimen to mitigate the risk of anaphylactic reactions, which will also be incorporated into the Phase 3 protocol [4][10] Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $175.4 million, with a projected cash runway into the fourth quarter of 2026 [5][10] - The net loss for the third quarter of 2025 was $47.7 million, or $0.61 per share, compared to a net loss of $15.5 million, or $0.24 per share, for the same period in 2024 [6][19] - Research and development expenses for the third quarter of 2025 were $44.9 million, significantly higher than $13.9 million for the same period in 2024, primarily due to increased manufacturing costs for nomlabofusp [7][11] Future Plans - Larimar plans to provide an update on the nomlabofusp development program, including regulatory discussions and the open label study status, in the first quarter of 2026 [10][11] - The company is focused on advancing its global Phase 3 study and preparing for patient enrollment [10][11]

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Larimar Therapeutics, Inc. due to allegations of materially misleading business information issued by the company [1]. Summary by Relevant Sections - **Company Investigation**: The investigation focuses on Larimar Therapeutics, Inc. (NASDAQ: LRMR) and the potential impact of misleading information on its shareholders [1]. - **Shareholder Rights**: Shareholders who purchased Larimar Therapeutics securities may be entitled to compensation without incurring out-of-pocket fees or costs [1].

Core Viewpoint - DJS Law Group is investigating Larimar Therapeutics, Inc. for potential violations of securities laws related to misleading statements and undisclosed information regarding a clinical study [1][2]. Investigation Details - The investigation centers on Larimar's September 29, 2025 announcement of an open-label study involving daily subcutaneous injections of Nomlabofusp for Friedreich's Ataxia, which was presented as having positive results despite severe allergic reactions experienced by multiple participants [2]. - Following the release of this information, Larimar's shares experienced a significant decline of 33.66% [2]. Legal Representation - DJS Law Group specializes in securities class actions and corporate governance litigation, representing large hedge funds and alternative asset managers [4].

Core Viewpoint - Larimar Therapeutics, Inc. is currently under investigation for potential securities fraud violations, which may impact its market reputation and investor confidence [1] Group 1 - The investigation is being conducted by the DJS Law Group, indicating potential legal implications for the company [1] - The announcement suggests that investors may have rights to discuss their concerns regarding the situation [1]

Core Viewpoint - The Schall Law Firm is investigating potential securities law violations by Larimar Therapeutics, Inc. following the announcement of adverse reactions in a clinical study, which led to a significant drop in the company's stock price [1][2]. Summary by Sections Investigation Details - The investigation centers on whether Larimar Therapeutics made false or misleading statements or failed to disclose critical information to investors [2]. - On September 29, 2025, Larimar reported data from an ongoing study of Nomlabofusp for Friedreich's Ataxia, claiming positive results while also revealing that seven participants experienced severe allergic reactions or anaphylaxis [2]. Market Reaction - Following the announcement of the study results and the adverse reactions, Larimar's shares fell by over 33.6% on the same day [2].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Larimar Therapeutics, Inc. following a significant stock price drop after the release of clinical trial data [1] Group 1: Company Overview - Larimar Therapeutics, Inc. is publicly traded on NASDAQ under the ticker LRMR [1] - The company is currently conducting a long-term open-label study on Nomlabofusp for treating Friedreich's Ataxia [1] Group 2: Recent Developments - On September 29, 2025, Larimar announced "positive" data from its ongoing study, but also reported seven cases of anaphylaxis among participants [1] - Following the announcement, Larimar's stock price decreased by $1.72, representing a 33.66% decline, closing at $3.38 per share [1]

Group 1 - U.S. stock futures are higher, with Dow futures gaining approximately 100 points [1] - Quantum Computing Inc. raised $750 million from institutional investors in a market-priced private placement, leading to a sharp decline in its shares by 11.7% to $21.70 in pre-market trading [1] Group 2 - Rich Sparkle Holdings Ltd experienced a significant drop of 15% to $22.10 in pre-market trading after a 10% decline on Friday [3] - Nordic American Tankers Ltd fell 7.8% to $3.07 in pre-market trading [3] - Smurfit WestRock PLC shares decreased by 5.8% to $39.54 in pre-market trading [3] - Mesoblast Ltd shares declined 5.2% to $17.45 in pre-market trading, despite an 8% gain on Friday following the announcement of Ryoncil receiving a J-Code from Medicare & Medicaid Services [3] - Invesco Mortgage Capital Inc saw a decline of 4.4% to $7.42 in pre-market trading [3] - Inventiva ADR shares fell 4.2% to $6.26 in pre-market trading after the appointment of Andrew Obenshain as CEO [3] - International Paper Co dropped 4.2% to $45.21 in pre-market trading ahead of its third-quarter earnings release on October 30 [3] - Lufax Holding Ltd – ADR fell 3.7% to $3.85 in pre-market trading after an 8% decline on Friday [3] - Larimar Therapeutics Inc shares decreased by 3.3% to $4.71 in pre-market trading after a 14% jump on Friday [3]

Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 100 points [1] Quantum Computing Inc. - Quantum Computing Inc. (NASDAQ:QUBT) raised $750 million from institutional investors through a market-priced private placement led by top shareholders [1] - Shares of Quantum Computing fell sharply by 11.7% to $21.70 in pre-market trading [1] Other Stocks in Pre-Market Trading - Rich Sparkle Holdings Ltd (NASDAQ:ANPA) dropped 15% to $22.10 after a 10% decline on Friday [3] - Nordic American Tankers Ltd (NYSE:NAT) decreased by 7.8% to $3.07 [3] - Smurfit WestRock PLC (NYSE:SW) fell 5.8% to $39.54 [3] - Mesoblast Ltd (NASDAQ:MESO) declined 5.2% to $17.45, despite an 8% gain on Friday following the announcement of Ryoncil receiving a J-Code from Medicare & Medicaid Services [3] - Invesco Mortgage Capital Inc (NYSE:IVR) decreased by 4.4% to $7.42 [3] - Inventiva ADR (NASDAQ:IVA) fell 4.2% to $6.26 after appointing Andrew Obenshain as CEO [3] - International Paper Co (NYSE:IP) dropped 4.2% to $45.21 ahead of its third-quarter earnings release on October 30 [3] - Lufax Holding Ltd – ADR (NYSE:LU) fell 3.7% to $3.85 after an 8% decline on Friday [3] - Larimar Therapeutics Inc (NASDAQ:LRMR) decreased by 3.3% to $4.71 after a 14% jump on Friday [3]

Core Points - The conference call is hosted by Larimar Therapeutics, with a focus on their business and clinical developments [1][2] - A slide deck and a news release are available on the company's website for further information [2] - The call includes forward-looking statements regarding the company's future business expectations, plans for nomlabofusp (formerly CTI-1601), and clinical trials [3] Company Developments - Larimar Therapeutics is discussing the development and commercialization of nomlabofusp, highlighting its significance in their business strategy [3] - The company is expected to provide insights into their planned clinical trials and overall business strategies during the call [3] Financial Position - The conference call will address the company's financial position and results of operations, indicating a focus on capital use and future financial expectations [3]

Group 1 - The conference call is hosted by Larimar Therapeutics, with a slide deck available for participants [2] - The call includes forward-looking statements regarding the company's business expectations, plans for nomlabofusp development, and clinical trials [3] - The company emphasizes that the forward-looking statements are based on current beliefs and assumptions, which involve risks and uncertainties [4]