ALS

How Do Companies Avert Further Frustration among Neurologists Due to Relyvrio’s (Amylyx) Phase 3 Failure and Donanemab’s (Lilly) FDA delay?

Retrieved on: 
Tuesday, March 12, 2024

ALS strikes adults in the prime of their life, is fatal, and the life expectancy of patients is generally 15 years or less.

Key Points: 
  • ALS strikes adults in the prime of their life, is fatal, and the life expectancy of patients is generally 15 years or less.
  • ALS patients maintain their cognitive functions while their muscle function deteriorates and eventually renders them bed-ridden, unable to swallow, and unable to breathe.
  • In an unusual decision the FDA conditionally approved Relyvrio based on the Phase 2 results as long as Phase 3 trial outcomes confirmed the results.
  • Only 40% of neurologists were initially aware of the FDA announcement regarding donanemab for Alzheimer's Disease (AD) when prompted.

Pan American Energy Announces Completion of the Phase Two Drill Program at the Big Mack Lithium Project

Retrieved on: 
Tuesday, March 12, 2024

CALGARY, Alberta, March 12, 2024 (GLOBE NEWSWIRE) -- Pan American Energy Corp. (CSE: PNRG | OTC: PAANF | FRA: SS60) ("Pan American” or the "Company") is pleased to announce the completion of the Phase Two Drilling program on its Big Mack Lithium Project (the “Property”), located approximately 80 kilometers north of the town of Kenora, ON.

Key Points: 
  • CALGARY, Alberta, March 12, 2024 (GLOBE NEWSWIRE) -- Pan American Energy Corp. (CSE: PNRG | OTC: PAANF | FRA: SS60) ("Pan American” or the "Company") is pleased to announce the completion of the Phase Two Drilling program on its Big Mack Lithium Project (the “Property”), located approximately 80 kilometers north of the town of Kenora, ON.
  • This brings the 2023 Phase One and 2024 Phase Two drilling program total to 8322 meters.
  • Phase Two Drill Program Details:
    Two drill holes totaling 369 meters tested the down dip extension of the Big Mack Pegmatite.
  • Jason Latkowcer, Chief Executive Officer, commented, “We are extremely pleased to have completed the Second Phase of the Big Mack Drilling Program.

AMLX LAWSUIT ALERT: The Gross Law Firm Notifies Amylyx Pharmaceuticals, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline

Retrieved on: 
Tuesday, March 12, 2024

DEADLINE: April 9, 2024 Shareholders should not delay in registering for this class action.

Key Points: 
  • DEADLINE: April 9, 2024 Shareholders should not delay in registering for this class action.
  • WHY GROSS LAW FIRM?
  • The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.

AMYLYX PHARMACEUTICALS 96 HOUR DEADLINE ALERT: Former Louisiana Attorney General and Kahn Swick & Foti, LLC Remind Investors With Losses in Excess of $100,000 of Deadline in Class Action Lawsuit Against Amylyx Pharmaceuticals, Inc. - AMLX

Retrieved on: 
Saturday, April 6, 2024

This action is pending in the United States District Court for the Southern District of New York.

Key Points: 
  • This action is pending in the United States District Court for the Southern District of New York.
  • Amylyx and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
  • The case is Shih v. Amylyx Pharmaceuticals, Inc., et al., No.
  • About Kahn Swick & Foti, LLC
    KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms.

Amylyx Pharmaceuticals Announces Formal Intention to Remove RELYVRIO®/ALBRIOZA™ from the Market; Provides Updates on Access to Therapy, Pipeline, Corporate Restructuring, and Strategy

Retrieved on: 
Thursday, April 4, 2024

Amylyx will continue to evaluate and share learnings from PHOENIX to help inform future ALS research.

Key Points: 
  • Amylyx will continue to evaluate and share learnings from PHOENIX to help inform future ALS research.
  • At this time, Amylyx intends to continue to collect available data on survival at the encouragement of ALS specialists.
  • “Our pipeline is supported by compelling clinical and preclinical science demonstrating the potential of AMX0035 and AMX0114 in neurodegenerative diseases.
  • “We are so thankful and grateful to our Amylyx team for their contributions and steadfast dedication,” said Cohen and Klee.

Prilenia Names Jina Swartz, M.D. Ph.D., as Chief Medical Officer

Retrieved on: 
Wednesday, April 3, 2024

Ph.D., as its first Chief Medical Officer (CMO).

Key Points: 
  • Ph.D., as its first Chief Medical Officer (CMO).
  • In this role, Jina will lead all clinical development and medical affairs activities at Prilenia.
  • Ph.D., Chief Medical Officer at Prilenia (Photo: Business Wire)
    Jina has more than 30 years’ experience in both academic neurology practice and in global drug development at leading pharmaceutical companies and joins Prilenia from Exciva, a neurodegeneration-focused biotech, where she was Chief Medical Officer.
  • Ph.D., Chief Medical Officer of Prilenia.

Asha Therapeutics Announces the Nomination of a Novel Intra-Molecular Glue Development Candidate ASHA-624 as a Disease Modifying Therapeutic for Amyotrophic Lateral Sclerosis

Retrieved on: 
Monday, April 1, 2024

Asha Therapeutics (Asha) ( www.ashatherapeutics.com ), a life sciences company designing de novo disease modifying medicines for neurodegenerative diseases with high unmet medical need, announced today the nomination of a development candidate, ASHA-624 targeting SARM1 as a potential disease modifying therapy for Amyotrophic Lateral Sclerosis (ALS) with additional indications in Chemotherapy-Induced Peripheral Neuropathy (CIPN), Glaucoma, and traumatic brain and spinal cord injuries.

Key Points: 
  • Asha Therapeutics (Asha) ( www.ashatherapeutics.com ), a life sciences company designing de novo disease modifying medicines for neurodegenerative diseases with high unmet medical need, announced today the nomination of a development candidate, ASHA-624 targeting SARM1 as a potential disease modifying therapy for Amyotrophic Lateral Sclerosis (ALS) with additional indications in Chemotherapy-Induced Peripheral Neuropathy (CIPN), Glaucoma, and traumatic brain and spinal cord injuries.
  • Dr. Michael Gold, MD, MS, a member of Asha’s Scientific Advisory Board noted, “SARM-1 is a well-validated therapeutic target that could yield novel therapies for patients suffering from a range of both central and peripheral nervous disorders.
  • ASHA-624 prevents the activation of SARM-1 using a completely novel approach that has the potential to deliver a therapy with robust clinical efficacy and few, if any, off-target side effects.
  • We are committed through our work to the transformation of patient outcomes, and believe ASHA-624 is a significant step forward towards achieving that goal,” commented Dr. Heckmann, PhD.

Peer-Reviewed Scientific Publication Proposes Unifying Single Toxin Theory of Brain Neurodegeneration that Identifies New Drug Targets and Treatments for Alzheimer’s Disease and Other Neurodegenerative Disorders

Retrieved on: 
Tuesday, March 26, 2024

In addition, our single toxin theory of brain neurodegeneration identifies new targets and approaches for the development of disease-modifying treatments,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.

Key Points: 
  • In addition, our single toxin theory of brain neurodegeneration identifies new targets and approaches for the development of disease-modifying treatments,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.
  • The application of biomarkers, in particular p-tau, synaptic markers, and brain volumetrics for the evaluation of disease course and therapeutic efficacy in AD trials.
  • Other neurodegenerative disorders follow the same pattern of protein dysregulation, impaired clearance, and increased aggregation, leading to neurotoxicity and loss of function.
  • In these diseases, a normal essential protein starts accumulating in the brain, misfolding and aggregating into soluble oligomers.

KeifeRx Announces the Appointments of Dan Feehan and Alison Finger to Board of Directors

Retrieved on: 
Wednesday, March 27, 2024

KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announces the appointments of Dan Feehan and Alison Finger to its Board of Directors.

Key Points: 
  • KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announces the appointments of Dan Feehan and Alison Finger to its Board of Directors.
  • KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations – KFRX03, KFRX04, KFRX05, and KFRX06 – with patent life through 2037.
  • Ms. Finger, the Principal at Auburn House Consulting, LLC, serves on the Board of ADMA Biologics, Inc. and is an Advisor at Quantile Health.
  • She previously held Board positions at Decibel Therapeutics, Vascular Biogenics and served as Chief Commercial Officer at Bluebird Bio.

Verge Genomics and Ferrer Announce Agreement to Co-Develop Clinical-Stage ALS Therapy VRG50635

Retrieved on: 
Monday, March 25, 2024

VRG50635 is a potential best-in-class, small molecule inhibitor of PIKfyve, a therapeutic target for ALS discovered in diseased human tissues using CONVERGE®, Verge’s all-in-human, AI-powered platform.

Key Points: 
  • VRG50635 is a potential best-in-class, small molecule inhibitor of PIKfyve, a therapeutic target for ALS discovered in diseased human tissues using CONVERGE®, Verge’s all-in-human, AI-powered platform.
  • Under the terms of the agreement, Ferrer will obtain the exclusive rights to co-develop and commercialize VRG50635 for ALS in multiple regions outside of the United States of America.
  • Verge has retained all rights to development and commercialization for VRG50635 for all uses in the United States and all countries outside the agreement.
  • “We're thrilled to work with Ferrer to progress VRG50635 through clinical development and towards potential commercialization.