BALA CYNWYD, Pa., Feb. 25, 2026 (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 upsized underwritten public offering of 20,000,000 shares of its common stock at a price to the public of $5.00 per share. The aggregate gross proceeds to Larimar from this offering are expected to be $100 million, before deducting underwriting discounts and commissions ...

BALA CYNWYD, Pa., Feb. 25, 2026 (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 $75 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock. In addition, Larimar expects to grant the underwriters a 30-day o ...

Larimar Therapeutics Inc (NASDAQ:LRMR) shares are jumping on Wednesday after multiple analysts reiterated their bullish outlook.Larimar Therapeutics stock is at critical resistance. What’s behind LRMR new highs?Citigroup's Samantha Semenkow kept her Buy rating and raised her price target from $12 to $14, and Wedbush's Laura Chico reaffirmed her Outperform rating with an $11 target.FDA Grants Breakthrough Designation To Larimar’s NomlabofuspLarimar Stock Soars Year-Over-YearOver the past year, Larimar has se ...

The designation covers adults and children with the rare disease and was based on data from an ongoing open-label study. Here’s what investors need to know.Larimar Therapeutics shares are climbing with conviction. What’s driving LRMR stock higher?FDA Grants Breakthrough Therapy StatusBreakthrough Therapy status is designed to speed development of drugs that may improve outcomes over current therapies for serious conditions. Larimar reported that FDA communications following a recent START program meeting su ...

Larimar Therapeutics, Inc. (LRMR) shares soared 34.34 percent to $3.77, up $0.96 on Tuesday, after the company announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to nomlabofusp for the treatment of Friedreich's ataxia. The stock is currently trading at $3.9200, compared with a previous close of $2.8100. It opened at $3.5900 and has traded between $3.5500 and $4.0000 during the session. Trading volume has surged to 43.95 million shares, far exceeding its average vo ...

Nomlabofusp program granted Breakthrough Therapy Designation for the treatment of adults and children with FA based on FDA’s review of available clinical data from open label studyFDA written communications after recent START meeting continue to align with use of skin FXN to support BLA submission seeking accelerated approvalTopline open label study data to support BLA submission expected in Q2 2026 Planned BLA submission seeking accelerated approval on track for June 2026; U.S. launch targeted for first-ha ...

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Company Overview - Larimar Therapeutics is focused on developing treatments for Friedreich's ataxia, a rare neurodegenerative disease affecting approximately 5,000 patients in the United States and around 20,000 globally [4][5] - The disease primarily affects pediatric patients, with about 70% of diagnoses occurring before the age of 14, leading to progressive deterioration and early mortality [4] Disease Mechanism - Friedreich's ataxia is caused by a deficiency in frataxin, a protein crucial for mitochondrial function [5] - Patients typically have only 20% to 40% of normal frataxin levels, with severely affected individuals having as low as 5% to 10% [5] - Heterozygous carriers, such as the parents of affected children, do not exhibit symptoms of the disease [5]

Summary of Larimar Therapeutics FY Conference Call Company Overview - **Company**: Larimar Therapeutics (NasdaqGM:LRMR) - **Focus**: Development of therapies for Friedreich's ataxia (FA), a rare neurodegenerative disease Industry Context - **Disease**: Friedreich's ataxia is characterized by a deficiency in frataxin, affecting approximately 5,000 patients in the U.S. and 20,000 globally. The disease typically manifests in childhood, leading to severe disability and early mortality [5][6][7]. Core Points and Arguments - **Unmet Medical Need**: Current therapies do not address the root cause of frataxin deficiency. Larimar aims to be the first disease-modifying therapy for FA [8][11]. - **Mechanism of Action**: The therapy, nomlabofusp, is designed to deliver frataxin to mitochondria, potentially restoring normal levels and halting disease progression [9][10][30]. - **Clinical Data**: - Patients with lower frataxin levels experience earlier onset and faster progression of the disease. Increasing frataxin levels to 22% can delay onset by four years and slow progression [12][13]. - Larimar has completed four studies and is currently conducting an open-label study to collect data on frataxin levels and clinical outcomes [14][28]. - The company reported an improvement of 2.25 points in the mFARS score in their patient population, compared to a worsening of 1 point in a reference population [28][29]. Regulatory Status - **Accelerated Approval**: Larimar plans to submit a Biologics License Application (BLA) in Q2 2026, targeting an early 2027 launch. The application will utilize frataxin levels as a novel surrogate endpoint [14][35]. - **Designations**: The company holds orphan drug designation, rare pediatric disease designation, and Fast Track status in the U.S., along with PRIME designation in Europe [14]. Safety and Tolerability - **Adverse Events**: The most common adverse events reported are mild to moderate injection site reactions. Anaphylaxis has occurred in seven patients, all of whom responded well to treatment [21][22][30]. - **Long-term Tolerability**: The drug has been generally well tolerated, with no patients dropping out due to injection site reactions. Education and pre-treatment with antihistamines are being implemented to mitigate risks [24][25][31]. Future Plans - **Phase 3 Trials**: Larimar is initiating a confirmatory phase 3 trial targeting ambulatory patients aged 2 to 40, with a focus on younger patients who progress more quickly [32][41]. - **Regulatory Engagement**: Ongoing discussions with the FDA are aimed at ensuring smooth regulatory submissions and trial initiation [36][41]. Additional Insights - **Patient Impact**: The disease significantly affects patients' daily lives, leading to loss of mobility and communication abilities. Larimar emphasizes the importance of addressing these challenges through their therapy [37][38][39]. - **Market Research**: Clinicians recognize the need for therapies targeting the root cause of FA, indicating a supportive environment for Larimar's approach [11][12]. This summary encapsulates the key points from the conference call, highlighting Larimar Therapeutics' commitment to addressing the unmet needs in the treatment of Friedreich's ataxia through innovative therapeutic approaches and regulatory strategies.

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