This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson’s disease RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated approval and Priority Review LONDON and NEW YORK, May 09, 2025 (GLOBE...Read more
BETHESDA, Md., April 30, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced an oral poster presentation at the International Association of Parkinsonism and Related Disorders (IAPRD) 30th World Congress on Parkinson's Disease and Related...Read more
Study supported by the Michael J. Fox Foundation through a grant awarded to ZyVersa and leading inflammasome experts at University of Miami Miller School of Medicine who conducted the study. Parkinson’s Disease (PD) affects over 10 million people globally and is driven by inflammation leading to progressive neurodegeneration resulting in impaired mobility, cognitive decline, and other neurological symptoms. Abnormal alpha-synuclein...Read more
SUNRISE-PD evaluating the Company’s anti-inflammatory, insulin-sensitizing candidate bezisterim in patients with Parkinson’s disease who have not been treated with carbidopa/levodopa SUNRISE-PD is one of very few clinical trials for a Parkinson’s disease treatment to incorporate a decentralized approach option to allow for remote participation Patient enrollment has commenced, with recruitment being supported by The Michael J. Fox...Read more
CREXONT added to 3 large national formularies: Veterans Administration, UnitedHealthcare and CVS Health Increases insurance coverage to over 50% of covered lives CREXONT was approved by the U.S. FDA to treat Parkinson’s disease in 2024 BRIDGEWATER, N.J. / Apr 03, 2025 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that three large...Read more
BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development...Read more
Parkinson's Patients Have Improved Motor and Non-Motor Function After Treatment with Theralase(R) Cool Laser Therapy Toronto, Ontario--(Newsfile Corp. - March 10, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations,...Read more
New closed-loop system self-adjusts DBS therapy to individual brain activity in real time; the largest commercial launch of brain-computer interface technology ever GALWAY, Ireland, Feb. 24, 2025 /PRNewswire/ -- For the one million people diagnosed with Parkinson's disease in the United States1, Medtronic plc (NYSE:MDT), a global leader in healthcare technology, proudly announces U.S. Food and Drug Administration...Read more
Vancouver, British Columbia--(Newsfile Corp. - February 6, 2025) - PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (the "Company" or "PreveCeutical"), announces a program aiming to deliver Dopamine and/or its precursor L-Dopa directly to the brain using their Nose to Brain (N2B) Sol-Gel platform delivery technology. PreveCeutical's program is aiming to deliver Dopamine and/or its precursor L-Dopa directly to the brain...Read more
ONAPGO is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease ONAPGO is a wearable subcutaneous infusion device that provides continuous treatment during the waking day for more consistent control of OFF time ONAPGO will be available in the U.S. in second quarter 2025 ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus...Read more
Jupiter, Florida, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter” or the “Company”), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based platform, today announced it has entered into an agreement with Catalent Pharma Solutions, LLC ("Catalent") for the production of JOTROL™ softgel capsules to support Jupiter’s upcoming Phase 2a clinical trial in Parkinson’s...Read more
‘Chronos-PD’ is looking for biological signals that could indicate increased chance of developing Parkinson’s disease (PD) years before symptoms appear, leading to new diagnostic tools and disease-modifying therapies Part of broad Grifols program to find disease-revealing clues in more than 100 million proprietary plasma samples connected to real-world data on thousands of disease states in many therapeutic areas Cutting-edge use of...Read more
The Company has received approval to begin enrollment of the Phase 1b clinical trial in Australia Phase 1b clinical trial will assess safety and tolerability along with biomarkers during three months of dosing with GT-02287 in people diagnosed with Parkinson’s disease Phase 1b clinical trial follows successful Phase 1 study in which GT-02287 was safe and well tolerated while demonstrating GCase target engagement BETHESDA, Md.,...Read more
PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints Prasinezumab continues to be well tolerated and no new safety signals were observed Genentech is further evaluating the data and will work together with health authorities to determine next steps SOUTH SAN FRANCISCO, Calif. / Dec 19, 2024 / Business Wire / Genentech, a member of the Roche...Read more
Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-2 flexible-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 261 Trial also met its key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score at week 261 Positive results across all three Phase 3 TEMPO...Read more
Active immunotherapy with ACI-7104.056 induces high anti-a-synuclein antibody levels on average 16-fold higher than placebo after 3 immunizations 100% of patients receiving ACI-7104.056 responded against the target antigen ACI-7104.056 is well tolerated with no clinically relevant safety issues reported to date Lausanne, Switzerland, November 14, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company...Read more
CARSON CITY, Nev., Nov. 04, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, is pleased to announce that the upcoming PD-202 A Double-Blind, Randomized, Placebo-controlled, Study of Bezisterim in Subjects with Early Parkinson’s Disease is now fully...Read more
VYALEV™ is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease Adults treated with VYALEV reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa1 VYALEV allows for personalized dosing based on individual needs, morning, day and night NORTH CHICAGO, Ill.,...Read more
The primary study objective of safety and tolerability was met Significant and clinically meaningful improvements from baseline demonstrated for key efficacy endpoints at 26 weeks Significant improvement of 18 points in Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 in the high dose group at 26 weeks Significant improvement in the Parkinson’s Disease Questionnaire (PDQ-39) score, a key quality of life measure, for both the...Read more
Tavapadon met the primary endpoint in the pivotal Phase 3, TEMPO-1 fixed-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 26 Trial also met key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score Results from the Phase 3 TEMPO-2 trial, studying tavapadon as a...Read more
CREXONT now available in U.S. pharmacies nationwide Comprehensive access and affordability services to be made available to Parkinson’s patients and healthcare providers Amneal to hold CREXONT launch symposium and scientific presentations at the International Congress of Parkinson’s Disease and Movement Disorders on Sept. 27 – Oct. 1, 2024 BRIDGEWATER, N.J. / Sep 23, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX)...Read more
A key aspect of Parkinson’s disease (PD) pathophysiology is decreased systemic regulatory T cell (Treg) function with associated neuroinflammation in the nigrostriatal pathway of the brain, including the presence of reactive astrocytes and microglia that have an initiating and progressing role in PD; Subcutaneous injection of COYA 302, an anti-inflammatory, Treg-enhancing combination biologic (comprising low dose interleukin-2 and CTLA-4...Read more
SAN DIEGO, Sept. 06, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced that the first patient has been dosed in a Phase 2a trial of VTX3232 in patients with early Parkinson’s disease. “We are excited to initiate this trial...Read more
Results Include Safety, Tolerability, Pharmacokinetics, and Target Engagement GT-02287, in Development for GBA1 Parkinson’s Disease, on Track to Initiate Phase 1b Trial in Patients in Q4 2024 BETHESDA, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule...Read more
SUNRISE-PD to evaluate the effect of bezisterim (NE3107) on motor and non-motor symptoms in ~60 patients with Parkinson’s disease who are naïve to carbidopa/levodopa Company engaged in trial start-up activities and plans to initiate patient screening Q4 2024 CARSON CITY, Nev., Aug. 08, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for...Read more
Delivers more “Good On” time with less frequent dosing compared to Immediate Release CD/LD Underscores Amneal’s leadership in Parkinson’s disease and commitment to one million people currently living with Parkinson’s disease in the U.S. CREXONT commercial launch planned in September 2024 BRIDGEWATER, N.J. / Aug 07, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the...Read more
ZURICH, SWITZERLAND / ACCESSWIRE / June 27, 2024 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP) (NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company dedicated to pioneering therapies for rare and complex central nervous system disorders, today announced preclinical results from multiple in vitro studies targeting alpha-synuclein (α-synuclein), specifically the A53T mutation, that demonstrate the compounds'...Read more
SOLANA BEACH, Calif., June 20, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today congratulates its partner Aspen Neuroscience, Inc. on use of the ClearPoint Neuro Navigation System to transplant dopaminergic neuron precursor cells (DANPCs) for all enrolled patients with Parkinson’s Disease (PD)...Read more
UB-312 is the first Parkinson's candidate to reduce pathology as measured by a seed amplification assay, and suggest clinical improvement on motor experiences of daily living. Data demonstrates target engagement and immunogenicity of the active immunotherapy UB-312 targeting pathological alpha-synuclein. CAPE CANAVERAL, Fla., June 20, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (OTC: VAXX), a U.S. company pioneering the development of...Read more
BOSTON and ATLANTA, June 17, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the company has completed enrollment in the Phase 2 ‘201’ trial evaluating the...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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