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Larimar Therapeutics (NASDAQ:LRMR) Azioni, Catena delle Opzioni

LARIMAR THERAPEUTICS INC

Larimar Therapeutics

Larimar Therapeutics Inc is a clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell-penetrating peptide (CPP) technology platform. Its lead product candidate, CTI-1601, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN) an essential protein, to the mitochondria of patients with Friedreich's ataxia.

Larimar Therapeutics, Inc. - Common Stock

Larimar Therapeutics Inc

News

ORKA

Oruka Therapeutics Receives FDA Clearance For Its IND Application For Phase 2a Trial Of ORKA-001 In Psoriasis

Management

BENF

Beneficient Appoints Thomas O. Hicks As Chairman And James G. Silk As Interim Chief Executive Officer Amid Leadership Restructure

Barclays analyst Seth Sigman downgrades Target (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TGT#NYSE">TGT</a>) from Equal-Weight to Underweight and announces $91 price target.

Downgrades

Price Target

Analyst Ratings

Barclays Downgrades Target to Underweight, Announces $91 Price Target

MRT-8102 Phase 1 study includes single and multiple ascending dose cohorts in healthy volunteers and is designed to evaluate safety, pharmacokinetics, NEK7 protein degradation, and other key downstream pharmacodynamic markers; initial results anticipated in H1 2026
Additional Phase 1 cohort designed to evaluate potential early proof of concept in subjects with increased cardiovascular disease (CVD) risk and elevated CRP
BOSTON, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=CJwRfRoEvPDpJiw8f6NmM1lK_UqJ_QSHPwfgoWyzW52PYNSf53f4oKF_KwbQVlXChmIjYAoiClEPWXYilXXnbrVTZQ4Jvwm0BtjiSN5GaaIC11fXsUTv-ZeuQ9vMV1dQ">Monte Rosa Therapeutics, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GLUE#NASDAQ">GLUE</a>), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that the first subjects have been dosed in a Phase 1 study evaluating MRT-8102, a NEK7-directed MGD being developed for the treatment of inflammatory conditions driven by the NLRP3 inflammasome, IL-1β, and IL-6. Initial results from the Phase 1 study are expected in H1 2026.
The MRT-8102 Phase 1 study is a randomized, double-blind, placebo-controlled trial in healthy volunteers that includes both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The study is designed to evaluate safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), including NEK7 degradation and ex vivo responses to inflammasome stimulation. Part 3 of the Phase 1 study is a randomized, placebo-controlled trial that will enroll subjects with increased CVD risk due to obesity and elevated CRP, designed to evaluate safety and tolerability, change in CRP levels, pharmacokinetics, and changes in other inflammatory markers.

GLUE

Monte Rosa Announces First Subjects Dosed In Phase 1 Study Evaluating MRT-8102, NEK7-Directed MGD Being Developed For Treatment Of Inflammatory Conditions Driven By NLRP3 Inflammasome, IL-1β, And IL-6; Initial Results From Phase 1 Study Expected In H1 2026

BTAI

BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package To FDA To Support Potential Label Expansion For IGALMI For Outpatient Use For Acute Treatment Of Agitation Associated With Bipolar Disorders Or Schizophrenia

Mobilicom Secures $1.4M In Orders From Tier-1 U.S. Drone Manufacturer Integrating SkyHopper PRO Into DoD-Focused Platforms

<ul>
<li>Results indicate that patients who switched to donidalorsen from prior prophylactic treatments showed a 62% further reduction in mean monthly HAE attack rate from baseline, and 84% of patients surveyed reported preference for donidalorsen.</li>
<li>Patients switched to donidalorsen without increased breakthrough attacks and experienced further reductions in mean attack rate from baseline.</li>
<li>Donidalorsen is currently under review with the U.S. FDA as a potential first-in-class prophylactic treatment for HAE; PDUFA date August 21</li>
</ul>

Biotech

Health Care

General

IONS

Ionis Pharmaceuticals Says Results From Phase 3 OASISplus Prospective Switch Study Of Donidalorsen In Patients With Hereditary Angioedema Were Published In The Journal Of Allergy And Clinical Immunology In Practice

HBT Finl (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HBT#NASDAQ">HBT</a>) reported quarterly earnings of $0.63 per share which beat the analyst consensus estimate of $0.60 by 5.18 percent. This is a 10.53 percent increase over earnings of $0.57 per share from the same period last year. The company reported quarterly sales of $58.80 million which missed the analyst consensus estimate of $59.40 million by 1.01 percent. This is a 3.81 percent increase over sales of $56.64 million the same period last year.

Earnings

Earnings Beats

Earnings Misses

HBT Finl Q2 Adj. EPS $0.63 Beats $0.60 Estimate, Sales $58.80M Miss $59.40M Estimate

NIVF

NewGen's ewGenDigital Limited Subsidiary Signs MoU With BNW Real Estate Development To Negotiate And Execute JV Agreement To Form Special Purpose Vehicle To Develop NewGenDigital's Plot Of Land In Ras Al Khaimah's Beach District

Helius Medical Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSDT#NASDAQ">HSDT</a>), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced positive outcome from the PoNS (Portable Neuromodulation Stimulator) Stroke Registrational Program (SRP) supporting a planned FDA submission seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under the current Breakthrough Device Designation.
The key primary outcomes from the SRP indicate that:
<ul>
<li>A double-blind randomized clinical trial met the primary endpoint of demonstrating statistically significant greater improvements in gait and/or balance deficit due to stroke with active PoNS therapy with and without including additional data from an open label study using statistical methods to balance baseline characteristics.</li>
<li>The studies also confirmed a minimal incidence of adverse events and good treatment tolerability.</li>
</ul>
Helius started the SRP in March 2024 after a positive interaction with the FDA on the data development program, study design, and endpoints. The SRP includes two pivotal Sponsor-initiated clinical studies: a double-blind, randomized controlled trial and a single-arm trial, which began in April 2024. The SRP is also supported by a pilot investigator-initiated, double-blind randomized controlled trial by Dr. Steve Kautz and Dr. Mark Bowden of MUSC (SC) and Brook Rehabilitation (FL) respectively, which began late in the fall of 2023. All three clinical trials enrolled patients from the same patient population and shared the same study structure/endpoints aimed at establishing the efficacy and safety of PoNS in people with gait deficit due to chronic stroke.
A total of 159&nbsp;patients were enrolled across the three studies, with&nbsp;130&nbsp;patients completing both the 12-week study treatment phase and the 12-week post treatment follow-up period,&nbsp;at 10 clinical sites including centers of excellence for stroke rehabilitation across the US and Canada. Study participants received the (active or sham) study treatment in combination with physical therapy according to the current guidelines for functional rehabilitation of people with chronic stroke.
The primary endpoints for all three studies included improvement of gait and/or balance deficit after 12 weeks of study treatment with two key multiplicity-controlled secondary endpoints assessing risk of falling and 12-week durability of effect. The double-blind randomized clinical trial met the primary endpoint of demonstrating statistically significant greater improvements in gait and/or balance deficit due to stroke with active PoNS Therapy with and without including additional data from an open label study using statistical methods to balance baseline characteristics. The studies also demonstrated minimal incidence of adverse events and confirmed good treatment tolerability.
The PoNS has not yet been approved in the United States for use in stroke rehabilitation and remains investigational for this use. Helius is planning to file a submission to the FDA for an indication in stroke during the third quarter of 2025 under its current FDA breakthrough designation for stroke.

HSDT

Helius Medical Reports Outcome From PoNS SRP Supporting Planned FDA Submission Seeking Indication For Gait And Balance Deficit In Patients With Chronic Symptoms Of Stroke Under Current Breakthrough Device Designation

WBUY

WEBUY GLOBAL Unveils AI Travel Assistant Wearable Powered By DeepSeek V3 Model And Espressif's ESP32-C To Redefine The Global Travel Experience

AUTL

Autolus Therapeutics' AUCATZYL Granted European Marketing Authorization For Relapsed For Refractory B-Cell Precursor Acute Lymphoblastic Leukemia In Adult Patients

<ul>
<li>Transcriptional analysis of white blood cells before and after foralumab therapy revealed profound immune modulatory effects. Significant changes were observed in CD4 cells, CD8 cells, and monocytes, underscoring the broad impact of nasal foralumab on immune cell profiles. These results are consistent with improvement in microglia PET scans conducted at the time of immune analysis which demonstrated a marked reduction in inflammation following nasal foralumab (<a href="https://www.globenewswire.com/Tracker?data=PDv1494qWzmTsvP92DUFgOlwhP2E3HvXnQAAv45SfLXHUIV88d9ZCXlqd29uJgWMFsXTdx2JO9Io4EcScwN_PO-SUtS6wKo5yxLx8QFWm48rnFsHVfTBz7x3E82ZEcHZy9CD4srvRkcuu4_1buCOuJSm4M70kea2j8wZtS7NUzODAYQNZ4gnsQvIuM7pxV30nmMK4Vo-ZbG0BbeQtZX2nA==">Clin Nuclear Med</a>) showing a link between immune effects and resolution of brain inflammation.</li>
<li>In an unexpected discovery, the analysis revealed an increase in phagocytosis markers in classical monocytes, suggesting that nasal foralumab may enhance their ability to clear amyloid plaques. This unexpected effect may open new avenues for treating Alzheimer's Disease by targeting both inflammation and amyloid accumulation</li>
</ul>

TLSA

Tiziana Life Sciences Announced Immunologic Findings From The Treatment Of A Moderate Alzheimer's Disease Patient With Intranasal Foralumab

CGEN

Compugen Doses First Patient In COM701 Global Platform Trial For Platinum Sensitive Ovarian Cancer; Interim Analysis Planned For 2H 2026

Guidance

Roper Technologies Raises FY2025 Adj EPS Guidance from $19.80-$20.05 to $19.90-$20.05 vs $19.94 Est; Lowers FY2025 Sales Guidance from $7.88B to $7.13B vs $7.86B Est

Applications supported by positive results from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials, in which significantly more patients treated with Sotyktu achieved ACR20 response compared with placebo at Week 16
U.S. Food and Drug Administration assigned a target action date of March 6, 2026
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.bms.com%2F&amp;esheet=54292059&amp;newsitemid=20250717182422&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=ef159a533b38560d13828afd7ec80b1e">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026. This latest regulatory milestone is in addition to the sNDA acceptances by China's Center for Drug Evaluation of National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare for Sotyktu for the treatment of adults with active psoriatic arthritis. The European Medicines Agency has also validated Bristol Myers Squibb's Type II variation application to expand the indication for Sotyktu to include this disease.
Sotyktu received approval from the FDA in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then, Sotyktu has earned approvals for this indication from multiple global health authorities and demonstrated durable efficacy and a consistent safety profile over more than 20,000 patient-years of experience.
Sotyktu, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, has the potential to be the first TYK2 inhibitor for the treatment of psoriatic arthritis.
The regulatory applications are based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of Sotyktu in adults with active psoriatic arthritis. Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo. Additional data from POETYK PsA-2 reported outcomes through 52 weeks of treatment and demonstrated that clinical response improved and was maintained from Weeks 16 to 52.
The overall safety profile of Sotyktu through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with that established in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials; no new safety signals were observed. Initial results from the POETYK PsA-2 trial were presented at the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fnews.bms.com%2Fnews%2Fcorporate-financial%2F2025%2FBristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Phase-3-POETYK-PsA-2-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis%2Fdefault.aspx&amp;esheet=54292059&amp;newsitemid=20250717182422&amp;lan=en-US&amp;anchor=2025+American+Academy+of+Dermatology+%28AAD%29+Annual+Meeting&amp;index=3&amp;md5=d2f570b650c63e3e139b7bfea0a983bd">2025 American Academy of Dermatology (AAD) Annual Meeting</a> in March 2025. Data from both POETYK PsA-1 and POETYK PsA-2 were presented at the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fnews.bms.com%2Fnews%2Fdetails%2F2025%2FBristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Pivotal-Phase-3-POETYK-PsA-1-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis%2Fdefault.aspx&amp;esheet=54292059&amp;newsitemid=20250717182422&amp;lan=en-US&amp;anchor=European+Alliance+of+Associations+for+Rheumatology+%28EULAR%29&amp;index=4&amp;md5=b09f92109f26a6956d7d4f0316573f67">European Alliance of Associations for Rheumatology (EULAR)</a> Congress in June 2025; additional results will be presented at future scientific meetings.

FDA Accepts Bristol Myers Squibb's sNDA For Sotyktu For Treatment Of Adults With Active Psoriatic Arthritis For Review

Verizon Communications (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VZ#NYSE">VZ</a>) narrows FY2025 Adj EPS guidance from $4.59-$4.73 to $4.64-$4.73 vs $4.68 analyst estimate..

Verizon Communications Narrows FY2025 Adj EPS Guidance from $4.59-$4.73 to $4.64-$4.73 vs $4.68 Est

WIIM

Verizon shares are trading higher after the company reported better-than-expected Q2 financial results and raised guidance.

Roper Technologies Sees Q3 Adj EPS $5.08-$5.12 vs $5.08 Est

AECOM (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ACM#NYSE">ACM</a>), the trusted global infrastructure leader, today announced it has been awarded three architect-engineer indefinite delivery, indefinite quantity (IDIQ) contracts by the U.S. Army Corps of Engineers (USACE) Honolulu District. Under these contracts, AECOM will provide architectural design, civil design, and environmental planning services across the Pacific region in support of the U.S. Army's mission readiness and infrastructure modernization. The three multi-award IDIQ contracts have a combined contract ceiling of more than $400 million.
AECOM will support USACE in advancing critical infrastructure projects aimed at increasing capacity, modernizing existing facilities, and supporting long-term mission readiness across the Pacific area of responsibility. AECOM's scope includes providing environmental planning services, delivering sustainable architectural and civil design solutions, and providing strategic planning expertise tailored to the unique challenges of the Pacific region.
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AECOM Bags Three Architect-Engineer Indefinite Delivery, Indefinite Quantity Contracts From USACE Honolulu District; IDIQ Contracts Have Combined Contract Ceiling Over $400M

Press Releases

Larimar Therapeutics Reports Third Quarter 2024 Operating and Financial Results

Larimar Therapeutics Presents Additional Data from Phase 1 Studies and Phase 2 Dose Exploration Study Supporting the Nomlabofusp Clinical Program at ICAR 2024

Larimar Therapeutics Announces Positive Initial Data from Ongoing Long-term Open Label Extension Study & Progress Across Nomlabofusp Program for Friedreich's Ataxia

Larimar Therapeutics Announces Dosing of Adolescents in Nomlabofusp Pediatric Pharmacokinetic Run-In Study for Patients with Friedreich's Ataxia

Larimar Therapeutics to Present at the Leerink Partners Global Healthcare Conference

Larimar Therapeutics Provides Nomlabofusp Development Update and Reports Fourth Quarter and Full Year 2024 Financial Results

Larimar Therapeutics Reports First Quarter 2025 Financial Results

Larimar Therapeutics Announces Regulatory Update Call on the Nomlabofusp Program for the Treatment of Friedreich's Ataxia

Larimar Therapeutics Announces FDA Recommendations on Safety Database, and Other Details of Nomlabofusp BLA Submission for Friedreich's Ataxia Program

Larimar Therapeutics Publishes Nonclinical Data Supporting the Therapeutic Potential of Nomlabofusp in Patients with Friedreich's Ataxia

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Larimar Therapeutics

Larimar Therapeutics (LRMR) Opzioni

Larimar Therapeutics (NASDAQ:LRMR) Azioni, Catena delle Opzioni

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