CLEVELAND / Jun 01, 2023 / Business Wire / Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine company developing MultiStem® (invimestrocel) cell therapy for critical care indications, announces patient enrollment has begun in the third and final cohort in MATRICS-1, the Phase 2 clinical study evaluating MultiStem® in patients following resuscitation from hemorrhagic trauma. This study is being conducted at The University of Texas Health...Read more
U.S. Clinical Sites Screening Treatment-Experienced Participants with Wet AMD ODYSSEY Topline Results Expected in Q3 2024 ALPHARETTA, Ga., June 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that enrollment has opened in ODYSSEY, its Phase 2b...Read more
Study is Investigating RenovoGem™ as Potential New Option for Pancreatic Cancer Treatment Recent Positive Interim Data Analysis from Study Revealed 60% Survival Benefit and 65% Side Effect Reduction Versus Systemic Chemotherapy LOS ALTOS, Calif. & DALLAS / Jun 01, 2023 / Business Wire / RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies,...Read more
HAT-301 is the Pivotal Efficacy Study to Support Upcoming NDA Filing Top Line Results Planned for Release in July 2023 TARRYTOWN, NY, June 01, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD), and other serious conditions with intractable...Read more
Hyalofast – a single-stage, off-the-shelf, resorbable, hyaluronic acid scaffold for cartilage repair – is marketed in over 35 countries outside the U.S. where it has been clinically demonstrated to be safe and effective Hyalofast has been designated as a breakthrough device by FDA, allowing prioritized interaction and review; Anika to begin filing modular PMA in 2024 with final module filing expected in 2025 Hyalofast...Read more
STAMFORD, Conn., May 30, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that it has achieved full enrollment in its Phase 2 trial evaluating nirogacestat, an investigational gamma secretase inhibitor, as a monotherapy in patients with recurrent ovarian...Read more
Reports significant uptick in enrollment activities Tigris trial enrollment at 61 patients TORONTO, May 30, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an enrollment update on Tigris, the Company’s follow-on study designed to build on knowledge gained from the earlier EUPHRATES...Read more
Highlights: Immuron receives approval from U.S. Army Medical Research and Development Command Recruitment and screening of healthy volunteers for Travelan® Controlled Human Infection Model (CHIM) Clinical Trial is in progress Clinical Trial to examine a dosing regimen for Travelan® more suited to the US military will commence shortly Travelan® is known to protect against the onset of Travelers diarrhea (TD), the most common illness...Read more
256-patient enrollment target met plus 11% over-enrollment; Primary endpoint based on patient reported outcomes from study expected in October 2023 SAN FRANCISCO, CA / ACCESSWIRE / May 25, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that the Company has successfully over-enrolled its global, pivotal, Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer...Read more
PLYMOUTH MEETING, Pa., May 25, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that its Phase 3 registrational INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia (IH) has completed enrollment nine...Read more
Company continues to execute on rapid progression of enrollment toward planned interim analysis expected in the third quarter of 2023 45 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland open and enrolling patients HOUSTON, TX / ACCESSWIRE / May 25, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of...Read more
ASHBURN, Va., May 24, 2023 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, announces that its open label study evaluating QRX003 as a treatment for Netherton Syndrome has reached 50% enrollment. The company’s open label study is investigating the safety and efficacy of QRX003 topical lotion in Netherton...Read more
ATLANTA, May 24, 2023 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announces that it has completed enrollment for the company’s NEW DAY clinical trial, a randomized, controlled, multi-center study designed to generate prospective data for...Read more
IRVINE, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced planned enrollment of the PEERLESS II trial, Inari’s third randomized controlled trial (RCT) in venous thromboembolism (VTE). The trial design was presented at the Society for Cardiovascular Angiography &...Read more
FLORHAM PARK, N.J., May 18, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced the completion of enrollment in the immune checkpoint inhibitor naïve group (ICI naïve) of its VERSATILE-002 Phase 2 trial for the treatment of recurrent or metastatic human papillomavirus...Read more
Over 50% of patients dosed across 20 active clinical sites On Track for Topline Results in late 2023 NEW YORK / May 17, 2023 / Business Wire / Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that the company’s Phase 2b study evaluating MM-120...Read more
Primary Study Completion Anticipated in the Second Quarter of 2024 PASADENA, Calif. / May 16, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has completed enrollment of its global Phase 3 clinical trial (PALISADE) evaluating ARO-APOC3 for the treatment of familial chylomicronemia syndrome. The company anticipates that the primary portion of the study will be complete in the second quarter...Read more
96% of participants who completed the trial opted to receive treatment with PrimeC in a 12-month open label extension Topline results expected Q4 2023 CAMBRIDGE, Mass., May 15, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the completion of enrollment in PARADIGM, a multinational, randomized, double-blind,...Read more
Topline data are expected in second half of 2023. EMBARK will be the first completed randomized study of an IBAT inhibitor for the treatment of biliary atresia. FOSTER CITY, Calif. / May 11, 2023 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed enrollment of its Phase 2b EMBARK study for pediatric patients with biliary atresia, the most common indication for pediatric liver transplant. The...Read more
Study designed to determine if a different dosing protocol for all indications might enhance the risk profile of LB1148 while simultaneously providing efficacy Company expects enrollment to be completed in Q3 2023 Carlsbad, CA, May 11, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today...Read more
MELBOURNE, Australia and SAN FRANCISCO, May 10, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first participant in Australia has been treated in the Company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating...Read more
Primary endpoint based on patient reported outcomes from study expected in October 2023 With the completion of the PIPE financing of unregistered shares and 6-month lock up term, Jaguar has agreed, as described below, not to issue additional equity securities before October 22, 2023 - by which point the Company expects to have released top line data for the OnTarget trial SAN FRANCISCO, CA / ACCESSWIRE / May 9, 2023 / Jaguar Health,...Read more
Phase III Study Designed to Establish the Effect of Ivonescimab in Lung Cancer Patients Whose Tumors Progressed after EGFR-TKI Therapy MENLO PARK, Calif. / May 09, 2023 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the first United States-based patient has been enrolled in the Phase III HARMONi study. HARMONi is a Phase III multiregional, randomized, double-blinded...Read more
Scilex Holding Company, an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced complete enrollment of its SP-103 Phase 2 study to evaluate the safety and efficacy in subjects with acute low back pain. Top-line data from the Phase 2 study is expected in Q3-2023. The Phase 2, randomized, double-blind,...Read more
Top-line data expected in Q3 2023 and has the potential to support an NDA submission for DCCR in Prader Willi Syndrome Enrollment completion satisfies closing condition on December 2022 Securities Purchase Agreement and triggers $10 million capital infusion REDWOOD CITY, Calif., May 03, 2023 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel...Read more
DUBLIN / May 02, 2023 / Business Wire / Horizon Therapeutics plc (Nasdaq: HZNP) today announced the first patient has enrolled in a Phase 2 randomized placebo-controlled trial to evaluate its development-stage medicine daxdilimab, a potentially first-in-class, fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7) that depletes certain dendritic cells, to treat people with active proliferative lupus nephritis...Read more
A total of 652 children, ages 2 to 5, were enrolled in the study Topline data expected in the third quarter Atopic dermatitis (AD) affects approximately 26 million adults and children in the United States WESTLAKE VILLAGE, Calif., May 02, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immune-dermatology,...Read more
ADELAIDE, Australia, April 27, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel allosteric ion channel modulators for serious central nervous system (CNS) disorders with high unmet medical need, today announced that the Company has completed target enrollment of approximately 200 participants in its randomized, double-blind,...Read more
CAMBRIDGE, MA / ACCESSWIRE / April 27, 2023 / Recently, Allarity Therapeutics, Inc. (NASDAQ:ALLR) announced plans to speed up its Phase 2 clinical trial for IXEMPRA®, the clinical-stage pharma company's metastatic breast cancer treatment. Already approved by the Food and Drug Administration (FDA) for patients in the United States, the company is sponsoring this current trial as part of its work to get IXEMPRA® and IXEMPRA-DRP® the...Read more
Topline data anticipated in mid-2024 SIGNAL-AD builds on promising data from the Phase 2 SIGNAL Study in Huntington’s Disease ROCHESTER, N.Y., April 25, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced that it has completed enrollment goal in the...Read more
Topline safety and clinical efficacy data from NEST-IN1 expected in the first quarter of 2024 HIL-214 is the most advanced vaccine candidate for norovirus infection There are currently no approved vaccines for norovirus BOSTON, April 25, 2023 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today announced completion of enrollment...Read more
Three U.S. clinical trial sites actively screening and enrolling patients Top line data of adrulipase in Cystic Fibrosis patients expected in July 2023 BOCA RATON, Fla., April 25, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI)...Read more
Enrollment Completed Several Months Ahead of Schedule, Reflecting Significant Unmet Need and Patient Demand for New Options Topline Results Expected in 2H 2024 NAARDEN, the Netherlands and MIAMI, April 24, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam Pharma” or the “Company”), a clinical-stage company focused on the research and development of transformative oral therapies for major...Read more
Clinical data from safety run-in scheduled to be released in second half of 2023 MELVILLE, N.Y., April 24, 2023 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has completed enrollment for the safety run-in component of its Phase 2 clinical study of BRTX-100 targeting patients suffering from...Read more
Phase 1 Thermography Study Quantitative Data Expected to Complement Patient Reported Outcome Data Collected in the Exploratory Phase 2b RESPOND At-Home Study Topline Data for the Exploratory Phase 2b RESPOND Study Anticipated in 2Q-2023 SAN DIEGO, April 20, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based...Read more
PRINCETON, N.J., April 20, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces that its pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial has enrolled 80 patients, achieving the second...Read more
AUSTIN, Texas, April 19, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the completion of enrollment of the original three patients required in Cohort 8 of the ReSPECT-GBM Phase 1/2a dose escalation clinical trial of rhenium (186Re)...Read more
Phase 2/3 AD Study continues to make steady progress in patient recruitment Company to hold R&D webcast on Thursday, April 20th to review ongoing clinical programs in Alzheimer's disease and Parkinson's disease BERWYN, Pa., April 19, 2023 /PRNewswire/ -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing neurodegenerative diseases, today announced that...Read more
Rehovot, Israel, April 18, 2023 (GLOBE NEWSWIRE) -- G Medical Innovations Holdings Ltd. (Nasdaq: GMVD) (the “Company” or “G Medical"), a global leader in next-generation mobile health (mHealth) and digital health, is excited to report that patient enrollment has grown in its home monitoring services by 194% between January and April of 2023, as compared to the same period last year. The increase is due to growing demand for homecare...Read more
AUSTIN, Texas, April 17, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) has enrolled the first subject in a randomized, open-label, placebo-controlled dose escalation clinical study to evaluate safety and pharmacokinetics of Hutrukin. Hutrukin is being developed as a novel treatment to reduce brain injury following ischemic stroke. There are more than 10 million ischemic strokes each year—the leading cause of death and morbidity...Read more
Top-Line Results Expected in the First Half of 2023 LEXINGTON, Mass. / Apr 13, 2023 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced completion of enrollment in the Phase 3 INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis. “Today, millions of allergic conjunctivitis patients rely on therapies...Read more
MINNEAPOLIS, April 12, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced the first patient enrolled in a Phase II double-blind, randomized study to evaluate CPP-1X-T (Eflornithine tablets) for recent onset type 1 diabetes. The multi-site clinical trial is led by researchers at...Read more
CAMBRIDGE, Mass., April 12, 2023 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that enrollment has been completed in Part A of the Phase 2 DeFianCe study evaluating DKN-01, Leap's anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients...Read more
SAN DIEGO, April 12, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced it has completed enrollment in the first cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. "Completion of enrollment in the first cohort of the Phase 1b MAD...Read more
DURHAM, N.C., April 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced it has completed enrollment of a Phase 3 trial in hemodialysis access. The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for...Read more
GAITHERSBURG, Md., April 11, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company (the Company), today announced that it has completed enrollment in its Phase 2 clinical trial of HepTcell, an immunotherapeutic for the treatment of chronic hepatitis B (CHB). With the achievement of this milestone, data readout is planned for the first quarter of 2024. The multicenter clinical trial, which is...Read more
Enrollment expected to complete in mid-Q2 2023 As of March 24, 2023, as previously announced, the Company's cash position was approximately $15.3 million SAN FRANCISCO, CA / ACCESSWIRE / April 11, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that patient enrollment has surpassed 90% in the Company's pivotal Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult...Read more
Enrollment continues to rapidly progress toward planned interim analysis expected in the third quarter of 2023 HOUSTON, TX / ACCESSWIRE / April 10, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that over 100 patients have been enrolled in...Read more
Top-Line Results from Part 1 of the Trial Expected in the Second Half of 2023 LEXINGTON, Mass. / Apr 06, 2023 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced enrollment of the first patient in the Phase 2 clinical trial of orally administered RASP modulator ADX‑629, an investigational new drug, for the treatment of atopic dermatitis. The multicenter, adaptive, two-part Phase 2 clinical trial will...Read more
Enrollment triggers milestone payment Carlsbad, CA and Shanghai, China, April 05, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, announced today that its development partner Newsoara Biopharma Co. Ltd, has enrolled the first patient in its ongoing Phase 3 clinical trial in...Read more
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 04, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has consulted the China National Medical Products Administration (“NMPA”) and reached an agreement to initiate the registration phase of the ongoing Phase II trial of HMPL-453 for intrahepatic cholangiocarcinoma (“IHCC”) patients with fibroblast growth factor...Read more
MELBOURNE, Australia and SAN FRANCISCO, April 04, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first participant has been dosed in the United Kingdom in the Company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA). “MSA is a rare and...Read more
Largest randomized coronary atherectomy trial ever conducted ST. PAUL, Minn. / Apr 03, 2023 / Business Wire / Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the company completed the enrollment of its 2,000 patient ECLIPSE coronary trial. ECLIPSE is a...Read more
372 IPF Patients Enrolled Topline Data Anticipated Mid-2024 SAN FRANCISCO, April 03, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the completion of patient enrollment for ZEPHYRUS-2, a Phase 3 clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and fatal lung disease. “We are pleased to announce the completion of enrollment for our...Read more
Topline Results anticipated by the end of Q2 2023 CRANFORD, N.J., April 3, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) today announced that the last patient has been enrolled in the Company's Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoids. CITI-002 would be the first prescription product indicated for the treatment of...Read more
Topline Data Remains on Track to be Reported in Q2 of 2024 More than 1,700 Adult Patients Enrolled in Global, Registrational Study of First-in-Class Treatment Candidate BRIDGEWATER, N.J., March 31, 2023 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, announced that adult patient enrollment is complete as of today in...Read more
Top-Line Results Expected in the First Half of 2023 LEXINGTON, Mass. / Mar 30, 2023 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the completion of enrollment in the Phase 2 clinical trial of the orally administered RASP modulator ADX-629, an investigational new drug, for the treatment of chronic cough. The multicenter, randomized, double-blind, placebo-controlled, two-period Phase 2 crossover...Read more
PLYMOUTH MEETING, Pa., March 29, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced an accelerated timeline for completing its Phase 3 INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic...Read more
Marks the first time a Phase 2 trial has studied a cannabinol (CBN) formulation as a treatment option for any disease Data expected to be released in early calendar Q3 2023 Vancouver, British Columbia--(Newsfile Corp. - March 28, 2023) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, today...Read more
U.S. Food & Drug Administration (FDA) approves enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial who have: 1) RP associated with NR2E3 and RHO mutations and 2) LCA associated with CEP290 gene mutations Ocugen has completed enrollment of adult RP patients with NR2E3 and RHO mutations in the Phase 1/2 trial and expanded enrollment in LCA patients with CEP290 mutations MALVERN, Pa., March 27, 2023 (GLOBE NEWSWIRE)...Read more
Significant investigator and patient interest drove strong recruitment, exceeding enrollment goals Topline DAVIO 2 data anticipated in Q4 2023 WATERTOWN, Mass., March 27, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2...Read more
The independent Data Safety Monitoring Board recommended continuation of patient enrollment as planned No safety or futility signals were reported in the first 50 patients This patient population could represent up to 1 million bipolar depression patients in the US and represents a portion of the indication expansion recommended in recent correspondence with the FDA Trial has been upgraded to a Phase 2b/3 study that may be used for a...Read more
MELBOURNE, Australia and SAN FRANCISCO, March 16, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first participant has been dosed in the U.S. in the Company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly...Read more
LEXINGTON, Mass. / Mar 16, 2023 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the completion of enrollment in the Phase 2 clinical trial of ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of retinitis pigmentosa, a group of rare genetic eye diseases characterized by retinal cell death and loss of vision, for which there is no U.S. Food and Drug...Read more
Results from Planned Interim Analysis Expected Fourth Quarter 2023 Approximately 21 Million Adults in U.S. Suffer From a Major Depressive Episode Each Year TNX-601 ER is a Once-Daily Tablet that is Bioequivalent to Three-Times-Daily Tianeptine Sodium Immediate Release (IR) that has been available in Europe, Asia and Latin America for More than Three Decades Tianeptine IR is Associated with Low Incidences of Sexual Dysfunction, Sleep...Read more
IRVINE, Calif., March 14, 2023 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today announced that the company has achieved the target enrollment in the pivotal STRIDE study of mavodelpar (REN001) in primary mitochondrial myopathies (PMM). Topline data from the STRIDE...Read more
SOUTH SAN FRANCISCO, Calif., March 13, 2023 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced that, following a positive independent Data Safety Monitoring Board (DSMB) safety review, enrollment has commenced in a Phase 2a trial of bexotegrast at 320 mg dosed once daily for at least 24...Read more
Interim analysis will be performed when the last of these patients has completed a tumor assessment scan approximately 9 weeks after initiating treatment The open-label Phase 1b/2 KEYNOTE B-84 study is evaluating the use of pepinemab in combination with Merck’s KEYTRUDA (pembrolizumab) in R/M HNSCC ROCHESTER, N.Y., March 09, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a...Read more
Enrollment continuing to progress toward an interim analysis, planned when 30-50% of subjects reach the primary endpoint expected mid-year 2023 HOUSTON, March 9, 2023 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that the first...Read more
MELBOURNE, Australia and SAN FRANCISCO, March 08, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first participant in Italy has been dosed in the Company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating...Read more
MINNEAPOLIS, March 07, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced its first patient enrolled in South Korea for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind placebo-controlled clinical...Read more
CARSON CITY, Nev., March 02, 2023 (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, today announced that its NM101 trial evaluating NE3107 in the treatment of patients with Alzheimer’s Disease, has achieved its revised enrollment target of...Read more
NEW YORK, March 01, 2023 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that the first patient has been enrolled in BeyondSpring’s Phase 2 investigator-initiated trial with lead asset, Plinabulin, in combination with Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab) and Docetaxel...Read more
Phase 2 OraGrowtH210 and Phase 2 PK/PD OraGrowtH212 Trials Are Fully Enrolled Primary Outcome Data for Both OraGrowtH Trials Expected 4Q 2023 AUSTIN, Texas, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, announced today that the last subjects have been enrolled and...Read more
FLORHAM PARK, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that a patient with primary central nervous system lymphoma (PCNSL) enrolled in its Phase 2 CLOVER-1 Trial demonstrated a complete response according to the 2005 Response Criteria...Read more
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that it has completed patient enrollment of Phase II registration trial of amdizalisib in patients with relapsed or refractory follicular lymphoma (“FL”), a subtype of non-Hodgkin’s lymphoma (“NHL”). The last patient was enrolled on February 24, 2023. The clinical trial...Read more
Robust enrollment of up to 5 patients per month continues in ongoing Phase 1b/2a next-generation CAR-T NXC-201 clinical trial in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis Nexcella on track to present 50-patient cohort multiple myeloma data later this year at a premier scientific forum Los Angeles, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”), a biopharmaceutical company...Read more
The study will be partially funded by Break Through Cancer through the Ovarian Minimal Residual Disease Team Lab LAWRENCEVILLE, NJ and CAMBRIDGE, MA, Feb. 27, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, and Break Through Cancer, a public foundation dedicated to empowering outstanding researchers and clinicians to both intercept and find cures for some of the most difficult-to-treat...Read more
RAHWAY, N.J. / Feb 22, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the company has opened enrollment in its new Phase 3 clinical program with investigational once-daily islatravir 0.25 mg in combination with doravirine 100 mg (DOR/ISL) for the treatment of HIV-1 infection. “Our extensive efficacy and safety analyses from the islatravir clinical program over the past...Read more
The multinational Phase III study is evaluating leniolisib tablets in children aged 4 to 11 years with APDS, a rare primary immunodeficiency LEIDEN, Netherlands, Feb. 21, 2023 /CNW/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces that the first patient has been enrolled in its Phase III clinical trial (NCT05438407) evaluating the investigational drug leniolisib, an oral,...Read more
Addition of OnTarget trial sites in Europe, South America and Asia has significantly accelerated enrollment, which is expected to complete in Q2 2023 Adoption of premier digital health technology for data collection facilitates operational efficiency of this global trial SAN FRANCISCO, CA / ACCESSWIRE / February 21, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that patient enrollment has...Read more
ROOT, Switzerland / Feb 15, 2023 / Business Wire / Novocure (NASDAQ: NVCR) today announced that the final patient has been enrolled in the pivotal PANOVA-3 study evaluating the efficacy of Tumor Treating Fields (TTFields) together with nab-paclitaxel and gemcitabine for treatment of patients with locally advanced pancreatic cancer. “There is a severe unmet need for patients with pancreatic cancer,” said Asaf Danziger, Novocure’s Chief...Read more
CAMBRIDGE, Mass. & SALISBURY, England / Feb 14, 2023 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided multiple clinical trial and regulatory updates for its lead compound sebetralstat, as a potential oral on-demand therapy for HAE attacks. Clinical Trial and...Read more
GENEVA, SWITZERLAND / ACCESSWIRE / February 14, 2023 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(ORCQB:RLFTY) ("Relief Therapeutics" or the "Company"), a biopharmaceutical company developing and commercializing novel, patent-protected products in select specialty and rare diseases, announced today the first three patients have been enrolled in a proof-of-concept, investigator-initiated study to evaluate RLF-TD011 as a...Read more
The randomized, double-blind, placebo-controlled study is evaluating SLS-005 in 160 patients over 24 weeks and Seelos anticipates delivering topline data in the second half of 2023. Seelos will also enroll patients in an Expanded Access Program that will be fully funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the Accelerating Access for Critical Therapies for ALS Act (ACT for...Read more
NEWTON, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced full enrollment of its Phase 2a proof of concept trial of ACER-801 (osanetant), a novel, non-hormonal, neurokinin 3 receptor (NK3R) antagonist, being...Read more
CHARLOTTESVILLE, Va. and CARMEL, Ind., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced the completion of enrollment in its Phase 1 INTERCEPT-AD trial of ACU193 in patients with early...Read more
MARLBOROUGH, Mass., Feb. 10, 2023 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced that an independent Data Monitoring Committee (DMC) completed its prespecified review of interim safety data in the Company's Phase 1b clinical trial of PH-762 for the...Read more
NEW YORK, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage neuroscience company developing drugs that treat neurodegenerative disorders by regulating cellular damage response pathways, today announced that enrollment has completed in the randomized, double-blind Phase 2 SEQUEL study (COG0202, NCT04735536) of CT1812 in 16 adults with mild-to-moderate Alzheimer’s disease. The study was designed...Read more
953 Alzheimer’s Patients Are Now Enrolled Across Phase 3 Studies Both Phase 3 Studies Have Passed the Halfway Mark for Enrollment Goal Is to Complete Enrollment for Both Phase 3 Studies by Year-End 2023 AUSTIN, Texas, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced an update on patient enrollment for its on-going Phase 3 clinical studies of simufilam...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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