A Brighter Future for Mental Health Vancouver, British Columbia – May 19, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharmaceutical company dedicated to developing novel and effective mental health treatments, is pleased to announce the enrolment of the 80th participant in its landmark Phase 2B clinical trial evaluating MB22001 for Major Depressive Disorder (MDD)....Read more
Topline data expected by year end Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects ATLANTA, May 19, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease...Read more
Despite growing recognition of long COVID as a serious condition, diagnosed patients have no approved treatment options, with many suffering from debilitating fatigue and brain fog Evidence suggests sustained inflammation plays a central role in the pathogenesis of long COVID, particularly in the associated cognitive dysfunction and other neurological symptoms1 Bezisterim targets key underlying mechanisms of neuroinflammation, and has...Read more
Indication Has Been Granted FDA Breakthrough Device Designation for Potential PMA Filing DENVER, May 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that it has successfully reached the halfway point in the NEUTRALIZE-AKI pivotal clinical...Read more
GAITHERSBURG, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that it has nearly achieved 50% enrollment in the initial randomized portion of its Phase 2 clinical trial of Ropidoxuridine for...Read more
Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled Company on track to report interim biomarker data from the first 12 patients imminently Completion of patient enrollment and topline results expected Q3 2025 LA JOLLA, CA, May 07, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of...Read more
Initial clinical data expected in the second half of 2025 from this first-of-its-kind trial to administer a targeted radiotherapy conditioning agent with a commercial CAR-T therapy Iomab-ACT supported by results of NIH funded trial with MSK showing effective lymphodepletion of targeted immune cells resulting in negligible rates of CAR-T toxicities ICANS and CRS and CAR T-cell persistence with a novel CD19 CAR-T therapy Iomab-ACT has...Read more
CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction (HFrEF) and Elevated Markers of Cardiac Stress Dr. Amish Raval, Professor of Medicine at the University of Wisconsin School of Medicine and Public Health, to serve as Site Principal Investigator and Co-National Principal Investigator SUNNYVALE, Calif., May 06, 2025 (GLOBE NEWSWIRE) --...Read more
Topline results expected H2 2025 REDWOOD CITY, Calif. / May 05, 2025 / Business Wire / Exicure, Inc. (Nasdaq: XCUR), a clinical-stage biotechnology company developing therapeutics for hematologic diseases, today announced it has completed patient enrollment in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients...Read more
MaGic trial exceeded enrollment target of 60 patients Top-line results anticipated this September will be the first of three DNTH103 catalysts by YE'26 Building a neuromuscular franchise with DNTH103 in gMG, CIDP and MMN with a potential best-in-class, potent classical pathway inhibitor intended as a self-administered autoinjector dosed once every two weeks NEW YORK and WALTHAM, Mass., May 05, 2025 (GLOBE NEWSWIRE) --...Read more
SUNNYVALE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company’s lead autologous cell therapy program for the treatment of heart failure at...Read more
Study ANAVEX3-71-SZ-001 successfully completes enrollment with a total of 71 participants Both Part A (16 participants) and Part B (55 participants) of the placebo-controlled Phase 2 study fully enrolled Top line data expected in the second half of 2025 NEW YORK, May 01, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing...Read more
Topline data expected in mid-2025 SOUTH SAN FRANCISCO, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it completed enrollment of its Phase 1 clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. “Completing enrollment in this trial bring us one step closer in our development of a norovirus vaccine,...Read more
The Phase 3 ABTECT trials (Studies 105 and 106) evaluating obefazimod in patients with moderately to severely active ulcerative colitis successfully enrolled 1,275 participants, exceeding the target enrollment of 1,224 by 4%. Top-line results from the 8-week induction trials anticipated in Q3 2025, with 44-week maintenance data on track for Q2 2026 and, if successful, NDA submission planned for H2 2026. Blinded baseline...Read more
Johns Hopkins Medicine’s Valerie Lee, MD joins Michael J. Pishvaian, MD in an Appointed Key Role for TIGeR-PaC Trial By becoming an additional clinical site for TIGeR-PaC, Johns Hopkins Medicine joins several esteemed cancer centers to support RenovoRx’s initiative to complete patient enrollment for the trial during 2025 MOUNTAIN VIEW, Calif. / Apr 29, 2025 / Business Wire / RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT),...Read more
MIAMI, April 29, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven cancer indications, today announced the Company has completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg...Read more
Over 75 patients enrolled in BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor in metastatic breast cancer (MBC) 54 clinical sites across 15 states currently enrolling patients including Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and...Read more
HONG KONG and FLORHAM PARK, N.J., April 22, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed enrollment of the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification. This clinical trial is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and...Read more
Nes-Ziona, Israel, April 21, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and...Read more
76-week trial is evaluating the safety and efficacy of a progranulin-elevating candidate in slowing disease progression Enrollment completed ahead of schedule SOUTH SAN FRANCISCO, Calif., April 17, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today announced the completion of...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
Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern University in Chicago. Based on a successful end-of-Phase II meeting with the US FDA and subject to MAVERIC outcomes, Cardiol believes the results from MAVERIC will support a New Drug Application. Data from Cardiol's Phase II MAvERIC-Pilot study presented at the American Heart...Read more
157 patients enrolled Topline results expected to be released in August 2025 Company to host Corporate Update Call on May 15, 2025 TORONTO, April 16, 2025 (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 announced the completion of full enrollment in the Company’s Tigris trial, a Phase 3 follow-on...Read more
Initial results from randomized Phase 2 CRDF-004 trial in RAS-mut mCRC were released in December 2024 Additional clinical data from CRDF-004 trial expected in 1H 2025 SAN DIEGO, April 15, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced completion of patient enrollment in...Read more
CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction and Elevated Markers of Cardiac Stress Dr. Arshed Quyyumi, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director of the Emory Clinical Cardiovascular Research Institute to Serve as Principal Investigator SUNNYVALE, Calif.,...Read more
DIAMOND is the first and only pivotal trial program ever conducted with a topical treatment for diabetic macular edema (DME) Over 800 patients randomized in DIAMOND-1 or DIAMOND-2 Phase 3 trials at an industry-leading record speed across 119 sites worldwide primarily in the US; topline data readout expected in Q2 2026 with NDA submission to follow Company to provide an update on the DIAMOND program and its innovative late-stage...Read more
LA JOLLA, Calif., April 08, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced enrollment of the first patient in the NIH-funded Expanded Access Program (EAP) trial to evaluate MN-166 (ibudilast) in patients with Amyotrophic Lateral Sclerosis (ALS). This significant milestone marks...Read more
PITTSBURGH, April 08, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing innovative therapies for unmet medical needs, today announced the completion of enrollment in its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal tacrolimus oral rinse for the treatment of oral lichen planus (OLP). The Phase 2a trial...Read more
On track to announce primary endpoint result from ORIGIN 3 trial this quarter (2Q 2025) U.S. FDA BLA submission for accelerated approval planned for 2H 2025 BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it...Read more
NEW YORK and MELBOURNE, Australia, April 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing new oral combination medicines, today announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose...Read more
HOUSTON, TX, April 02, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that it has successfully enrolled the first patients in its clinical trial at the University of California, San Diego (UCSD), in collaboration with the VA San Diego Healthcare System (San Diego VA). The company began treatment...Read more
MIAMI, FLORIDA / ACCESS Newswire / April 1, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing breakthrough therapeutics for neurologic and neuropsychiatric disorders, today announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain. The Phase 1 trial is being conducted at the...Read more
Del-brax FORTITUDE biomarker cohort designed for potential accelerated approval; plan to share regulatory update in Q2 2025 Regulatory alignment on global Phase 3 del-brax trial design and study initiation anticipated in Q2 2025 Plan to present topline data from FORTITUDE dose escalation cohorts in Q2 2025 On track to be first globally approved drug for FSHD SAN DIEGO, March 31, 2025 /PRNewswire/ -- Avidity Biosciences, Inc....Read more
Company expects safety data readout in 2025 as Randomized Arm continues enrollment at key medical centers LOS ANGELES / Mar 31, 2025 / Business Wire / Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company (the “Company’”), announces the completion of the safety lead-in of its Phase 2 clinical trial of ENV105 for the treatment of metastatic, castration-resistant prostate cancer. The trial, titled, “Phase...Read more
2,000+ Average-Risk Patient Study Seeks to Confirm Mainz Biomed’s Industry-Leading Results in the Detection of Advanced Precancerous Lesions (APL) in Independent Samples Study is on Track to Report Top-Line Results in Fourth Quarter 2025 BERKELEY, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of...Read more
NEWTON, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced the completion of enrollment in its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer’s disease. Acumen completed...Read more
13-Week Study Evaluating the Safety and Efficacy of Oral VK2735 Dosed Once Daily Results Expected in 2H25 SAN DIEGO, March 26, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of subject enrollment in its Phase 2 clinical trial of the oral tablet...Read more
Highlights: Screening closed for all sites and final participants being scheduled for dosing On track for top-line 6-week primary endpoint results in late Q2 LONDON & NEW YORK / Mar 26, 2025 / Business Wire / Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced the completion of recruitment in the COMP005 phase 3 trial for treatment...Read more
Initial target enrollment surpassed in fewer than seven months; trial expanded due to high demand First data presentation expected before year-end; sNDA submission by mid-2026 CAMBRIDGE, Mass. & SALISBURY, England / Mar 25, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the completion of enrollment in the open-label KONFIDENT-KID clinical trial of sebetralstat, an investigational, novel, oral...Read more
Phase 3 Data Needed for BLA Submission Expected in the Fourth Quarter 2026 SEATTLE / Mar 21, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today reported that clinical trial site activation for enrollment is underway for the company’s Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart (OMS906) is Omeros’ investigational inhibitor of MASP-3, the key and most proximal activator of...Read more
First US Phase 3 study of Photodynamic Therapy (PDT) to include neck, trunk and extremities Protocol involves one or two PDT treatments using 1-3 tubes of Ameluz® or vehicle gel over a surface area of up to 240 cm2 Treatment phase expected to be complete by Q3 2025 WOBURN, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the...Read more
LONDON, March 18, 2025 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses and diagnosis of viral diseases, announced today that it has started enrolling patients into its United Kingdom based, multi-center clinical study (NCT06731179). Conducted in collaboration with the United Kingdom's National Health Service,...Read more
First patient enrolled in ECLIPSE 1 Phase 3 clinical trial evaluating combination of tobevibart and elebsiran for chronic suppressive treatment ECLIPSE program designed to enable regulatory submissions and support reimbursement and access Rapid study start indicative of significant unmet need for chronic hepatitis delta treatment SAN FRANCISCO / Mar 13, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the...Read more
Miniature, twice-yearly GLP-1 (exenatide) implant under development for chronic weight management NPM-115 has demonstrated comparable preclinical weight loss to injections of semaglutide, the active ingredient in Ozempic®/Wegovy® Rapid full study enrollment with all 24 subjects initiating the 8-week run-in period within four weeks; top-line study results expected in mid-2025 ALAMEDA, Calif. / Mar 13, 2025 / Business Wire / Vivani...Read more
DOVER, Del., March 12, 2025 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (“Portage” or the “Company”) (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of innovative therapeutics, today announced the resumption of patient enrollment in the fourth and final cohort of the dose escalation stage for PORT-6, a highly selective A2A antagonist, within its ADPORT-601 Phase 1b clinical trial. Portage had previously...Read more
Published study shows Nu.Q® Lung Cancer Test differentiated malignant and benign nodules found by Low Dose CT screening. The study is expected to be completed by the end of 2025 HENDERSON, Nev., March 11, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, announces first patient enrollment in a clinical study evaluating the company's proprietary Nu.Q® Cancer...Read more
PETACH TIKVA, Israel, March 11, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery. This milestone follows recommendation by the...Read more
Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and all key secondary endpoints with high statistical significance PALO ALTO, Calif., March 10, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with...Read more
HEROES is Natera’s first clinical trial using Signatera™ to guide de-escalation of therapy in patients with metastatic HER2+ breast cancer Approximately 170 patients are expected to enroll in up to 35 sites in France AUSTIN, Texas / Mar 10, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the enrollment of the first patients in the HEROES clinical trial. HEROES...Read more
EMERYVILLE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating...Read more
CARLSBAD, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced the completion of patient enrollment in its REFINE study of its ZIP™ Interspinous Fixation device for patients suffering from back pain due to symptomatic degenerative disc disease . This...Read more
PRINCETON, N.J., March 07, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment. “We are thrilled to share that the first trial site has been initiated and...Read more
Enrollment completed ahead of schedule in the first dose expansion cohort Momentum continues with first patient dosed in the second expansion cohort Topline results from the 40-patient dose expansion study expected in 1H 2026 Phase 1b dose escalation data expected to be presented in 2H 2025 ROCKVILLE, Md., March 07, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on...Read more
Data to support potential sNDA submission for label expansion of IGALMI® in the home setting Topline data expected in second half of 2025 NEW HAVEN, Conn., March 07, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced it has reached 33% enrollment in its 200-patient SERENITY At-Home...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 06, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma (“IHCC”) patients with fibroblast growth factor receptor (“FGFR”)2 fusion/rearrangement. The study is a single-arm, multi-center, open-label, Phase II...Read more
Marlborough, Massachusetts--(Newsfile Corp. - March 5, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio announced today that it has fulfilled the required enrollment for safety in its third dose cohort in its Phase 1b dose escalating...Read more
The eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial is evaluating the efficacy and safety of a single dose of BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression The open-label extension stage of the Phase 2b clinical trial continues to enroll patients to evaluate the safety and efficacy of a second dose of BPL-003 As previously reported, the Phase 2a study of BPL-003...Read more
CARMEL, Ind., March 03, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced the completion of enrollment in its Phase 2 Avail™ trial of MBX 2109 (canvuparatide), the Company’s parathyroid hormone (PTH) peptide prodrug. Canvuparatide is...Read more
SAN FRANCISCO, Feb. 26, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the company has completed target enrollment in its REZOLVE-AA Phase 2b study of rezpegaldesleukin in patients with severe-to-very-severe alopecia areata. Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as...Read more
Initial Data from this Phase 2 Trial Demonstrates Early Evidence of Clinical Activity of Elraglusib (9-ING-41) in Combination with FOLFIRINOX and Losartan in Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) The Final Results from the Trial are Anticipated in 2026 CHICAGO and FORT WORTH, Texas, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage...Read more
Topline results continue to be expected in the first half of 2025 NEW HAVEN, Conn., Feb. 25, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed...Read more
MELBOURNE, Australia and INDIANAPOLIS, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) announces that the Biogenix Molecular Research Center in Miami, FL, is recruiting and dosing patients in the ProstACT Global Phase 3 trial1 of TLX591 for patients with advanced prostate cancer, as part of a wider United States (U.S.) roll-out. ProstACT Global is trialling a...Read more
White Bear Lake, Minnesota--(Newsfile Corp. - February 24, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on providing hearing loss sufferers with innovative solutions today announces the successful enrollment of the first two participants in its pivotal clinical study. The purpose of the study is to investigate the safety and efficacy of the fully implanted Acclaim® cochlear implant and...Read more
SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that Northwestern University/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product. Calidi Biotherapeutics has completed the shipment of the first batch...Read more
Patient enrollment set to begin at leading U.S. clinical trial sites, new drug product already delivered Trial will advance stenoparib and the stenoparib-DRP Companion Diagnostic toward FDA approval Two patients in the ongoing phase 2 trial have now exceeded 17 months on stenoparib treatment Boston (February 24, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical...Read more
Focus on Patients with Elevated Markers of Heart Stress and Inflammation Procedural enhancement using FDA Approved Morph DNA steerable guide for therapeutic delivery SUNNYVALE, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today completion of enrollment and dosing in the low...Read more
BOSTON, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell...Read more
First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Recently amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects, expected in the...Read more
Company remains on track to report Phase 1a data from both the Single- and Multiple-Ascending Dose (SAD and MAD) cohorts in the healthy volunteer portion of the study in 1Q 2025 at an upcoming major medical meeting The Phase 1b portion of the trial, in DMD patients, is underway with the intention of enrolling up to 10 adult volunteers with genetically confirmed DMD during 1Q 2025 Phase 2 IND filing on track to be submitted by end of 1Q...Read more
Following DSMB recommendation, the Company has voluntarily paused enrollment and dosing in the BEACON-IPF Phase 2b trial and will monitor current patients while data is reviewed SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following a prespecified data review and recommendations by the trial’s independent Data Safety Monitoring Board (DSMB), the Company...Read more
Expansion of the waveLINE clinical development program demonstrates company’s progress in advancing research in hematologic malignancies RAHWAY, N.J. / Feb 06, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and...Read more
RADNOR, Pa., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorundrostat for...Read more
Over 100,000 patients in the United States have IPF, with only two approved therapies available that only slow the course of disease progression Top line data expected in the first half of 2026 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Feb 04, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced full enrollment of the TETON 1 study evaluating the use of Tyvaso®...Read more
HOUSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that patient enrollment will resume in the investigator-initiated Phase 1/2 clinical trial evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). The trial is being conducted at the University of Texas MD Anderson Cancer Center (MDACC) and is...Read more
Independent Data Monitoring Committee recommends proceeding with dosing of second cohort after planned safety assessment Company expects to initiate enrollment of second dose cohort in the first quarter of 2025 LEXINGTON, Mass. and AMSTERDAM, Feb. 03, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today...Read more
HB-500 is a next-generation therapeutic vaccine being developed in collaboration with Gilead Sciences, Inc. (Gilead) as a potential component of a curative regimen for human immunodeficiency virus (HIV) Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial Primary completion expected H2 2025 NEW YORK and VIENNA, Jan. 30, 2025 (GLOBE NEWSWIRE) --...Read more
LONDON and NEW YORK, Jan. 29, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease (DED), a multi-billion-dollar market, today announces a clinical update and its interim results for the six months ended 30...Read more
Phase II trial evaluating efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) in patients with soft tissue sarcoma reaches enrolment target of 40 patients Data updates from EFTISARC-NEO expected in 2025 SYDNEY, AUSTRALIA, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and...Read more
GAITHERSBURG, Md., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that it has achieved 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of...Read more
128 enrolled participants, as of December 31, 2024, exceeds initial target of 90 participants 150 maximum participant enrollment projected by end of January The stroke registrational program is intended to demonstrate the safety and effectiveness of the novel Portable Neuromodulation Stimulator (PoNS®) for improving balance and gait deficits in stroke survivors On track for FDA submission for stroke authorization in the second...Read more
ADDIS ABABA, Ethiopia and KINSHASA, Democratic Republic of the Congo and WASHINGTON and PARIS, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Africa CDC’s support for the MOSA, a pan-African randomized platform adaptive trial for the MpOx Study, adding to the initial EU funding, has enabled the enrollment of the first patients at Mbandaka Hospital in Equateur Province, Democratic Republic of Congo (DRC). These patients have been randomized in this...Read more
311 subjects enrolled across various stages of loading and randomization in SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, as of January 10, 2024 First wet AMD registrational trial, SOL-1, completed randomization in December 2024 with topline data anticipated in Q4 2025 Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR BEDFORD, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) --...Read more
601 patients have been enrolled in the double-blind portion of the SYNCHRONY Real-World study since initiation in November 2023 Data from SYNCHRONY Real-World study anticipated in the first half of 2026 SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked...Read more
SAN FRANCISCO, Jan. 10, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the company has completed target enrollment in its REZOLVE-AD Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis. Rezpegaldesleukin is a first-in-class interleukin-2 receptor (IL-2R) agonist that proliferates and activates regulatory T cells (Tregs) with promising dose-dependent clinical activity in...Read more
Phase 3 ABTECT Trial evaluating obefazimod for moderately to severely active ulcerative colitis (“UC”) reaches 1,003 of 1,224 participants, representing 82% of target enrollment. Enrollment completion expected in Q2 2025. Top-line results for the 8-week induction trial anticipated in Q3 2025, with 44-week maintenance data on track for Q2 2026 and, if successful, NDA submission planned for H2 2026. Blinded baseline characteristics...Read more
Enrollment Completed Ahead of Schedule Initial Data Expected in 2025 NEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, completed enrollment in its neoadjuvant/adjuvant Phase 2 basket trial (IOB-032/PN-E40). The trial is studying IO102-IO103, the company’s lead investigational...Read more
Targeted enrollment of 168 RRMS patients achieved in December 2024 The last patient is expected to complete the trial in the third quarter of 2025 SAN DIEGO--(BUSINESS WIRE)-- Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that it...Read more
Case reports published in medical literature suggest that tafenoquine combined with standard-of-care treatment exhibits a high cure rate in immunosuppressed patients who have relapsing babesiosis and for whom prior treatment has failed. Babesiosis, a tick-borne disease, is potentially life-threatening if not treated early. The incidence of babesiosis has been increasing in the Northeast U.S. and elsewhere. Total cumulative accessible...Read more
WOBURN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the first patients have been enrolled in studies evaluating RP2 in two different settings: checkpoint naïve metastatic uveal melanoma; and second-line recurrent or metastatic hepatocellular carcinoma (HCC). “On the heels of our BLA...Read more
Successfully dosed 6 patients in safety run-in segment, now accelerating enrollment Positive data from first four patients announced December 2024 NXC-201 is the only one-time CAR-T therapy in development for AL Amyloidosis Next program update Q1 2025 AL Amyloidosis is a life-threatening disorder of plasma cells in the bone marrow affecting ~33,000 patients in the U.S. LOS ANGELES, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Immix...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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