Amyotrophic Lateral Sclerosis Pipeline, Clinical Trials Assessment, NDA Approvals 2023 (Updated) | Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, and others

DelveInsight's, "Amyotrophic Lateral Sclerosis Pipeline Insight 2023" report provides comprehensive insights about 90+ companies and 100+ pipeline drugs in the Amyotrophic Lateral Sclerosis pipeline landscape. It covers the Amyotrophic Lateral Sclerosis pipeline drug profiles, including Amyotrophic Lateral Sclerosis clinical trials and nonclinical stage products. It also covers the Amyotrophic Lateral Sclerosis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Latest Developmental Activities in the Amyotrophic Lateral Sclerosis Treatment Landscape
• In February 2023, NeuroSense Therapeutics Ltd. and QuantalX Neuroscience Ltd; the developer of Delphi-MD, a clinically objective neurodiagnostic medical device, announced a collaboration to improve early diagnosis and treatment of neurodegenerative diseases.In addition, the companies agreed that QuantalX's Delphi-MD would be used for early diagnosis and ongoing monitoring of trial participants in NeuroSense's planned future pivotal Phase III efficacy trial of PrimeC in people living with amyotrophic lateral sclerosis (ALS), pending the successful conclusion of its ALS Phase IIb trial.
• In February 2023, Amylyx Pharmaceuticals, Inc. announced the completion of enrollment in PHOENIX, a global, 48-week, randomized, placebo-controlled Phase III clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis (ALS). Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS.
• In February 2023, UMass Chan Medical School signed a three-year sponsored research agreement with NeuShen Therapeutics Inc. to investigate a gene therapy treatment for amyotrophic lateral sclerosis, a rare neurological disease. Based in Shanghai and Boston, NeuShen is focused on developing innovative treatments for central nervous system disorders using adeno-associated virus-based gene therapy and small molecule delivery.
• In January 2023, Inflamed Pharma, part of the incubator and accelerator company Xlife Sciences, partnered with researchers at the University Medical Center Gottingen in Germany to develop its investigational therapy ProcCluster for the treatment of amyotrophic lateral sclerosis (ALS).The collaboration, led by Jan C. Koch, MD, a principal investigator at the university's Department of Neurology, will be focused particularly on investigating ProcCluster in cellular models of ALS.
• In January 2023, Amylyx Pharmaceuticals and Neopharm signed a license and distribution agreement to commercialize AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) to treat amyotrophic lateral sclerosis (ALS).Neopharm will commercialize the oral, fixed-dose medication in Israel, West Bank, Gaza, and the Palestinian Authority, subject to regulatory review and clearance.According to the agreement, Amylyx will grant exclusive rights to Neopharm for commercializing the therapy in the covered territory.
• In January 2023, uniQure N.V. and Apic Bio announced that they have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS. Under the agreement, uniQure acquires global rights for the development and commercialization of APB-102, adding to its pipeline of gene therapies to treat neurological disorders.

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Key Takeaways from the Amyotrophic Lateral Sclerosis Pipeline Report
• DelveInsight's Amyotrophic Lateral Sclerosis pipeline report depicts a robust space with 90+ active players working to develop 100+ pipeline therapies for Amyotrophic Lateral Sclerosis treatment.
• The Amyotrophic Lateral Sclerosis Companies include Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc., Woolsey Pharmaceuticals,, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others
• Promising Amyotrophic Lateral Sclerosis Pipeline Therapies include BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others.
• The Amyotrophic Lateral Sclerosis companies and academics are working to assess challenges and seek opportunities that could influence Amyotrophic Lateral Sclerosis R&D. The Amyotrophic Lateral Sclerosis therapies under development are focused on novel approaches to treat/improve Amyotrophic Lateral Sclerosis.

Find out more details about Amyotrophic Lateral Sclerosis Pipeline Drugs and Therapies of the report @ https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Amyotrophic Lateral Sclerosis Emerging Drugs Profile

• Tofersen: Biogen
Tofersen is an antisense drug being evaluated for the potential treatment of SOD1-ALS. Tofersen binds to SOD1 mRNA, allowing for its degradation by RNase-H in an effort to reduce synthesis of SOD1 protein production. Tofersen is also being studied in the Phase 3 ATLAS study, which is designed to evaluate the ability of tofersen to delay clinical onset when initiated in presymptomatic individuals with a SOD1 genetic mutation and biomarker evidence of disease activity. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc. under a collaborative development and license agreement. Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for tofersen, an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The application has been granted priority review and given a Prescription Drug User Fee Act action date of January 25, 2023.

• RNS60: Revalesio Corporation
RNS60 is being developed to provide disease modifying and potentially restorative treatments for neurological diseases. It activates intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protects neurons and oligodendrocytes and modulates the activity of immune cells to restore homeostasis. RNS60 has been granted Orphan Drug and Fast Track designations for ALS from the U.S. Food and Drug Administration.

• ANX005: Annexon
ANX005 is an antibody-based medication designed to bind and block the activity of C1q, which is expected to keep synapses healthy and slow or halt neurodegeneration. The antibody is being developed for a number neurodegenerative diseases, such as ALS, Guillain-Barré syndrome (GBS), Huntington's disease (HD), and cold agglutinin disease (CAD). Clinical trials are ongoing in all these indications. The ongoing ALS trial is investigating ANX005 in patients whose first symptoms of weakness began in the past three years. Participants will receive two induction doses about 5-6 days apart, followed by every-two-week injections up to week 22. All then will be followed for another 14 weeks. Preliminary data showed that ANX005 treatment resulted in a reduction in neurofilament light chain (NfL) levels, a marker of nerve cell damage, during the initial 12 weeks of treatment. But levels rose to their initial value when patients stopped receiving treatment.

Amyotrophic Lateral Sclerosis Pipeline Therapeutics Assessment
There are approx. 90+ key companies are developing therapies for Amyotrophic Lateral Sclerosis. The companies which have their Amyotrophic Lateral Sclerosis drug candidates in the most advanced stage, i.e. Preregistration include Biogen.

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Scope of the Amyotrophic Lateral Sclerosis Pipeline Report
• Coverage- Global
• Amyotrophic Lateral Sclerosis Companies- Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc., Woolsey Pharmaceuticals,, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others.
• Amyotrophic Lateral Sclerosis Pipeline Therapies- BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others.
• Amyotrophic Lateral Sclerosis Pipeline Segmentation: Product Type, Molecule Type, Route of Administration

Find out more about the list of FDA-approved drugs for Amyotrophic Lateral Sclerosis @ Amyotrophic Lateral Sclerosis Treatment Landscape- https://www.delveinsight.com/sample-request/amyotrophic-lateral-sclerosis-als-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Content
1. Introduction
2. Executive Summary
3. Amyotrophic Lateral Sclerosis: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Amyotrophic Lateral Sclerosis- DelveInsight's Analytical Perspective
7. Late Stage Products (Preregistration)
8. Tofersen: Biogen
9. Late Stage Products (Phase III)
10. Drug Name: Company Name
11. Drug profiles in the detailed report…..
12. Mid Stage Products (Phase II)
13. RNS60: Revalesio Corporation
14. Drug profiles in the detailed report…..
15. Early Stage Products (Phase I)
16. Drug Name: Company Name
17. Drug profiles in the detailed report…..
18. Preclinical and Discovery Stage Products
19. Drug Name: Company Name
20. Drug profiles in the detailed report…..
21. Inactive Products
22. Amyotrophic Lateral Sclerosis- Unmet Needs
23. Amyotrophic Lateral Sclerosis- Market Drivers and Barriers
24. Appendix

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