Riluzole

Aquestive Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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tisdag, maj 7, 2024
Angioedema, FDA, Mouth, NDA, Food, Swelling, Skin, Research, Attention deficit hyperactivity disorder, Insurance, Trial of the century, ADHD, Lennox–Gastaut syndrome, Dermatology, Seizure, Prescription, Public expenditure, Riluzole, Vomiting, Patent, Patient, Adrenaline, Common stock, Anaphylaxis, Epilepsy, Diazepam, PD, Therapy, Serdexmethylphenidate/dexmethylphenidate, Type, Pharmaceutical industry

“We continue to successfully execute on our growth strategy as demonstrated by our first quarter results,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “We continue to successfully execute on our growth strategy as demonstrated by our first quarter results,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • Total revenues increased to $12.1 million in the first quarter 2024 from $11.1 million in the first quarter 2023.
  • Research and development expenses increased to $5.9 million in the first quarter 2024 from $3.5 million in the first quarter 2023.
  • Non-GAAP adjusted EBITDA loss was $7.2 million in the first quarter 2024, compared to non-GAAP adjusted EBITDA loss of $3.9 million in the first quarter 2023.

Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Positive

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tisdag, april 9, 2024
Eurostat, Civil service commission, Diagnosis, DSM-IV codes, Brain, Disease, ALS, Paralysis, Nervous system, Patient, Committee, Knowledge, Lactiplantibacillus plantarum, Regulation, Bacteria, EMA, IRIS, Death, Respiratory failure, Woman, Saliva, European, COMP, Spinal cord, Safety, European Commission, MDC, Riluzole, Marketing, Hand, Medicine, Pharmaceutical industry

Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Positive

Key Points: 


Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Positive

AB Science provides a summary of the live webcast held on March 4, 2024 giving an update on AB Science development

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torsdag, mars 7, 2024
Bias, Lung compliance, NON, SCIENCE, Tracheotomy, Acute myeloid leukemia, Mast cell activation syndrome, BTK, Alzheimer's disease, ANCOVA, Azacitidine, Missionary, B cell, Riluzole, CHMP, Guideline, NOD, Sickle cell disease, ALZ, Tablet, MECOM, AML, SCD, Biomarker, DSM-IV codes, Survival, Science, Prostate cancer, Oxygen, EMA, Docetaxel, Health Canada, ISM, FDA, Masitinib, Euronext, Cell, Chromosome abnormality, OS, UPDATE, Multiple sclerosis, COVID-19, Patient, Disease, Itch, RHU, CAFS, Failure, Depression, Pharmaceutical industry

SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT

Key Points: 
  • SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT
    AB Science SA (Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on March 4, 2024, giving an update on AB Science development.
  • Regarding Health Canada, a Notice of Deficiency-Withdrawal (NOD/w) has been issued and AB Science intends to submit a Request for Reconsideration.
  • Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration.
  • AB Science will be free to continue the development of masitinib in SCD based on phase 2 data with biomarkers.

Aquestive Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

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tisdag, mars 5, 2024
PD, Research, FDA, ATM, Food, Growth, Anaphylaxis, Loss, PDUFA, Attention deficit hyperactivity disorder, Emergency, Safety, Therapy, Allergy, Patent, Diazepam, Patient, Serdexmethylphenidate/dexmethylphenidate, Lennox–Gastaut syndrome, Net, ADHD, Adrenaline, Clutch (eggs), Trial of the century, NDA, Riluzole, Seizure, Pharmaceutical industry

Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm.

Key Points: 
  • Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm.
  • Aquestive commenced dosing in December 2023 in the Phase 3 pivotal PK clinical study of Anaphylm.
  • Non-GAAP adjusted EBITDA loss was $2.8 million in the fourth quarter 2023, compared to a $9.6 million loss in the fourth quarter 2022.
  • During the fourth quarter 2023, the Company accessed capital net proceeds of $3.7 million under its "At-the-Market" (ATM) facility.

Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS

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fredag, mars 8, 2024
Health, Neurology, Clinical Trials, General Health, Pharmaceutical, Biotechnology, International, Week, ALS, Wolfram syndrome, PSP, Physician, Edaravone, Palsy, Riluzole, Amylyx Pharmaceuticals, Safety, AMX0035, Webcast, Endoplasmic reticulum, PB, Medication, Trial of the century, Research, Pharmaceutical industry

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S., ALBRIOZA™ in Canada) in people living with amyotrophic lateral sclerosis (ALS).

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S., ALBRIOZA™ in Canada) in people living with amyotrophic lateral sclerosis (ALS).
  • Amylyx intends to share plans for RELYVRIO/ALBRIOZA in ALS, which may include voluntarily withdrawing RELYVRIO/ALBRIOZA from the market.
  • “We are surprised and deeply disappointed by the PHOENIX results following the positive data from the CENTAUR trial.
  • Update on Ongoing AMX0035 Studies:
    The global, randomized, double-blind, placebo-controlled Phase 3 ORION clinical study of AMX0035 in PSP remains ongoing.

Cytokinetics Presents Results From COURAGE-ALS at the 34th International Symposium on ALS/MND

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torsdag, december 7, 2023
Patient, Research and development, HHD, Caregiver, Hope, Weakness, Disease, Incidence, Muscle weakness, SAN, Edaravone, Clinical trial, University, Barrow Neurological Institute, FVC, COVID-19, Death, Data monitoring committee, Infection, Weather, Transport, Riluzole, Vital capacity, General Grievous, Cytokinetics, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the full results of COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), were presented at the 34th International Symposium on ALS/MND by Jeremy Shefner, M.D., Ph.D., Lead Investigator of COURAGE-ALS, Professor of Neurology, Barrow Neurological Institute, University of Arizona College of Medicine Phoenix.

Key Points: 
  • At the second interim analysis the Data Monitoring Committee recommended the discontinuation of the clinical trial due to futility.
  • At the time of the discontinuation of COURAGE-ALS, 486 patients had started treatment with reldesemtiv or placebo and 276 had completed dosing through 24 weeks.
  • Patients treated with reldesemtiv declined 5.3 points per month (SD=5.3) while patients treated with placebo declined 4.8 points per month (SD=4.4).
  • The survey results showed that site personnel viewed remote visits favorably when considering whether to participate as a site in COURAGE-ALS.

Athira Pharma Reports Third Quarter 2023 Financial Results and Pipeline and Business Updates

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torsdag, november 9, 2023
ACT, Walter, Investment, Neuromuscular junction, Patient, Pathology, Conference, Cognition, R, ADAS, Inflammation, AFL, Society, Glial fibrillary acidic protein, Food, Toxicity, HGF, IND, Administration, GFAP, Excitotoxicity, Alzheimer's disease, G&A, Microglia, Communication, Neuroinflammation, Athira Pharma, Research and development, Brain cell, Biomarker, Riluzole, ALS, Frontotemporal dementia, Washington Convention Center, Drug development, AAIC, Enzyme inhibitor, Plasma, Mouse, Doctor of Philosophy, FDA, Neurodegenerative disease, Survival, Central nervous system, GST, Fine chemical, Pharmaceutical industry, Medical imaging, Cryptocurrency, Neuroscience, Athira

BOTHELL, Wash., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the quarter ended September 30, 2023, and provided pipeline and business updates.

Key Points: 
  • BOTHELL, Wash., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the quarter ended September 30, 2023, and provided pipeline and business updates.
  • R&D expenses were $27.2 million for the quarter ended September 30, 2023, compared with $17.0 million for the quarter ended September 30, 2022.
  • G&A expenses were $7.8 million for the quarter ended September 30, 2023, compared with $7.2 million for the quarter ended September 30, 2022.
  • The increase was primarily due to increases in personnel expenses, partially offset by a decrease in business development expenses.

MediciNova Receives a Notice of Allowance for a New Patent Covering the Combination of MN-166 (ibudilast) and Riluzole for the Treatment of Amyotrophic Lateral Sclerosis (ALS) in Canada

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onsdag, oktober 11, 2023
Patent, ALS, Code, MD, Intellectual property, MPH, Disease, Standard Market Design, FDA, Riluzole, Clinical trial, Tokyo Stock Exchange, Canadian Intellectual Property Office, Patient, Pharmaceutical industry, Doctor of Philosophy

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than November 2035.

Key Points: 
  • Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than November 2035.
  • The allowed claims cover a wide range of doses and a range of dosing regimens for both MN-166 (ibudilast) and riluzole.
  • Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "We are very pleased to receive notice that this new patent will be granted.
  • The U.S. FDA granted both orphan-drug designation and fast-track designation to MN-166 for the treatment of ALS, and the European Commission granted Orphan Medicinal Product Designation to MN-166 for the treatment of ALS."

Athira Pharma Presents Preclinical Data Further Supporting the Therapeutic Potential of ATH-1105 in Amyotrophic Lateral Sclerosis (ALS)

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torsdag, oktober 5, 2023
ALS, Asian literature, Neuromuscular junction, Plasma, Excitotoxicity, Brain cell, Poster, Mouse, AFL, HGF, Athira Pharma, Riluzole, Pharmaceutical industry

BOTHELL, Wash., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, presented new preclinical data supporting the potential benefit of ATH-1105 for the treatment of amyotrophic lateral sclerosis (ALS) at the 22nd Annual Northeast ALS Consortium (NEALS) Meeting, taking place October 4-6, 2023, virtually and in-person in Clearwater, Florida. ATH-1105 is an orally administered small molecule therapeutic candidate designed to enhance the neurotrophic hepatocyte growth factor (HGF) system.

Key Points: 
  • ATH-1105 is an orally administered small molecule therapeutic candidate designed to enhance the neurotrophic hepatocyte growth factor (HGF) system.
  • “There is an urgent need for new ALS treatment options, particularly those aimed at stopping or slowing neurodegeneration.
  • We are encouraged by the consistent benefit of ATH-1105 in these animal models, whether given pre- or post-symptom onset or in combination with riluzole.
  • NEALS is a closed meeting, and the presentation will be available on the Scientific Publications & Presentations page of the company’s website at w ww.at hira.com .

AKC Canine Health Foundation Funds Groundbreaking Study to Evaluate Potential Treatment for Degenerative Myelopathy

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torsdag, juni 1, 2023
DSM-IV codes, Tufts University, Ohio State University, Human, University, DM, Principal investigator, University of Missouri, Quality of life, Data collection, Research, North Carolina State University, Canine degenerative myelopathy, Synthetic control method, Dog, Riluzole, Spondylosis, Health, FDA, CHF, ALS, Disease, Pharmaceutical industry

RALEIGH, N.C., June 1, 2023 /PRNewswire/ -- The AKC Canine Health Foundation (CHF), a non-profit organization dedicated to advancing the health of all dogs, announces funding for a groundbreaking study evaluating a potential treatment for canine degenerative myelopathy.

Key Points: 
  • RALEIGH, N.C., June 1, 2023 /PRNewswire/ -- The AKC Canine Health Foundation (CHF), a non-profit organization dedicated to advancing the health of all dogs, announces funding for a groundbreaking study evaluating a potential treatment for canine degenerative myelopathy.
  • Degenerative myelopathy (DM) is a progressive neurologic disease in dogs with characteristics similar to some forms of amyotrophic lateral sclerosis (ALS or Lou Gehrig's Disease) in humans.
  • There is currently no treatment available to slow disease progression in dogs.
  • The DM treatment study is part of CHF's $13.4 million active research portfolio funding studies into all aspects of canine physical and behavioral health.