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
Rostock International Parkinson's Disease (ROPAD) Study demonstrates a significant link between the RAB32 gene variant and Parkinson's disease, further supporting recent findings Data from over subcohort of 3,350 patients shows that the RAB32 mutation is over 100 times more prevalent in Parkinson's patients than in the general population CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Centogene...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
The LRRK2 variant is strongly associated with symptoms of Parkinson’s disease (PD) that are different from non-variant carriers with the disease The study revealed novel findings of genetic “hotspots” in people from Mexico, Cuba, Puerto Rico, and Brazil, where the founder variant has sprung up in other communities 23andMe has the largest LRRK2 G2019S research cohort, and launched the Parkinson’s Impact Project (PIP) in 2018 to better...Read more
Full Dataset from Phase 2a trial in Parkinson’s Disease suggest patients treated with bezisterim experienced significant improvements in both non-motor symptoms and motor control while placebo-treated patients worsened Improvements in non-motor symptoms correlated with improvements in motor symptoms for Parkinson’s Disease patients CARSON CITY, Nev., May 22, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the...Read more
MALVERN, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced successful completion of data cleaning for its Phase III study of buntanetap in patients with early Parkinson’s disease (PD). Topline efficacy data is expected in June. The Phase III study was completed in 4Q 2023 with...Read more
NKGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNK01 Clinical Trial in patients with Parkinson’s disease. The Company expects to initiate a Phase 1 clinical trial in PD in 2H 2024. SANTA ANA, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of...Read more
In vitro studies with SNK01 have shown a direct ability to phagocytose and digest amyloid and alpha-synuclein proteins while also secreting immunoregulatory cytokines and identifying and eliminating autoreactive T cells that contribute to neuroinflammation. SNK01 autologous NK cell therapy demonstrated a positive effect on improving cerebral spinal fluid (“CSF”) and plasma levels of Tau, amyloid, and alpha-synuclein proteins in...Read more
“Bezisterim” has been approved as the non-proprietary name for NE3107 Data shows how bezisterim may be restoring homeostasis via specific genes associated with dementia, metabolism, and inflammation CARSON CITY, Nev., April 25, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (Nasdaq: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including neurological...Read more
Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-3 adjunctive trial, demonstrating a statistically significant increase in total “on” time without troublesome dyskinesia compared with placebo over 27 weeks Results demonstrate tavapadon’s potential to provide the right balance of motor control, safety and tolerability for people living with Parkinson’s disease Additional data from the trial will be presented at a future...Read more
In the Phase 2 PRECEDENT Study, dalzanemdor (SAGE-718) did not show statistically significant differences versus placebo on the primary endpoint in patients with mild cognitive impairment in Parkinson’s disease Dalzanemdor (SAGE-718) was generally well-tolerated and there were no new safety signals observed Topline data readouts from the Phase 2 studies in Huntington’s disease and Alzheimer’s disease are expected later this...Read more
ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830. SPN-830 is an investigational apomorphine infusion device for the continuous treatment of motor fluctuations (“off” episodes) in Parkinson’s disease (PD)...Read more
JERUSALEM and BURLINGTON, Mass., April 04, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced results published in a review article exploring the potential efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS™) as a novel therapeutic approach for Parkinson's Disease (PD). The...Read more
BETHESDA, Md., March 15, 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 therapies, today announced participation in the upcoming Public Ventures Discovery Day on March 19, 2024 at Old Parkland in Dallas, TX. Public Ventures Discovery DayDate: Tuesday, March 19,...Read more
Novel machine learning (ML) approach identifies genetic drivers within specific Parkinson's disease (PD) patient subpopulations and uncovers pivotal disease pathways, enhancing understanding of disease and treatment strategies Data presented at the International Conference on Alzheimer's and Parkinson's Diseases and...Read more
LISBON, Portugal, March 07, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ: VAXX), a U.S. company pioneering the development of a new class of medicines, announced positive clinical data from its UB-312 program in Parkinson’s disease (PD) presented by Jean-Cosme Dodart, PhD, SVP of Research at Vaxxinity in an oral session at the AD/PD™ 2024 International Conference on Alzheimer’s and Parkinson’s Disease, held virtually and in Lisbon,...Read more
New data advances understanding of new approaches to treating Alzheimer’s disease Research on disease progression could help inform future clinical trials CAMBRIDGE, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced it will present new data from its Alzheimer’s disease (AD) portfolio at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2024), taking place March 5-9 in...Read more
BETHESDA, Md., Feb. 27, 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 therapies, announces the initiation of the Multiple Ascending Dose (MAD) part of the Phase 1 clinical trial of GT-02287, Gain’s lead drug candidate for the treatment of GBA1 Parkinson’s...Read more
Positive Efficacy Data for ATH434 in a Primate Model of Parkinson’s Disease to be Presented at International Conference Baseline Biomarker Data to be Presented from Ongoing ATH434-201 Phase 2 Clinical Trial MELBOURNE, Australia and SAN FRANCISCO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments...Read more
ARV-102 is a novel oral PROTAC® protein degrader designed to cross the blood-brain barrier and target leucine-rich repeat kinase 2 (LRRK2) The Phase 1 trial of ARV-102 will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers NEW HAVEN, Conn., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on...Read more
BETHESDA, Md., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc., (Nasdaq: GANX), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced it is holding a 2024 Research & Development update on recent in vivo data for GT-02287 along with valuable insights from Key Opinion Leaders. Event Details “Beyond Symptomatic Treatment of...Read more
VYALEV is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of advanced Parkinson's disease (aPD) in Canada. Advanced Parkinson's disease patients now have a non-surgical treatment option that addresses an unmet need within this community. In clinical trials, patients taking VYALEV achieved the primary endpoint of a reduction in motor fluctuations and morning akinesia, as well as improvements...Read more
BOSTON and ATLANTA, Feb. 07, 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 preliminary outcomes of the Company’s discussion with the U.S. Food and Drug...Read more
BETHESDA, Md., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc., (Nasdaq: GANX), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, announces preclinical data demonstrating that its clinical-stage GCase regulator GT-02287 provided neuroprotection and restored motor function in Parkinson’s disease models following delayed administration. The...Read more
MONTREAL, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has entered into an exclusive license agreement with Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal"), granting Knight the exclusive rights to seek regulatory approval and commercialize IPX203 in Canada and Latin America. IPX203 is a novel, oral formulation of...Read more
CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, and The Michael J. Fox Foundation for Parkinson’s Research (MJFF), a non-profit organization dedicated to finding a cure for Parkinson’s disease (PD), today announced a research project to accelerate research on genetic risk...Read more
All three conditions share common hallmark of complex inflammatory pathways underlying disease pathophysiology that involve dysfunctional regulatory T cell (Treg) biology which may limit efficacy of monotherapy approaches; COYA 302 is a proprietary biologic combination immunotherapy that targets multiple pathways which may successfully overcome the complex immune environment driving these diseases; Cash runway guidance remains into...Read more
PRODUODOPA® (foslevodopa/foscarbidopa) is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of advanced Parkinson's disease PRODUODOPA demonstrated sustained improvements in "Off" time (when symptoms return between medication doses), "On" time (when symptoms are controlled) without dyskinesia (involuntary movement), and morning akinesia ("Off" time upon waking) NORTH CHICAGO, Ill., Jan. 9,...Read more
AB-1005 (AAV2-GDNF), an investigational gene therapy for the treatment of Parkinson’s disease, was well tolerated with no attributed serious adverse events in all 11 patients at 18 months 18-month assessment of all patients demonstrated feasibility of administration of AB-1005 to the putamen via one-time bilateral convection-enhanced delivery AskBio plans to present 18-month study data, including secondary...Read more
ABATE Phase 1b/2 AD trial of ACI-24.060 completed enrollment of cohorts 1 and 2 and is expected to complete cohort 3 in January; 6-month and 12-month amyloid PET data expected in H1 & H2 2024, respectively ReTain Phase 2b clinical trial of ACI-35.030 in preclinical AD being launched now by partner VacSYn Phase 2 PD trial of ACI-7104.056 completed enrollment of cohort 1 and commenced cohort 2; safety and immunogenicity update...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...
CLICK TO LEARN MORE