Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial Recent EU approval from the European Medicines Agency (EMA) boosts trial profile Enrollment in Part A of MIRACLE reaches seven subjects treated and one additional subject in screening 16 additional clinical sites in Europe and the US expected to begin recruitment by the end of August; building to...Read more
Topline results from the CHASE trial expected by end of Q3 2025 Potential for CHASE to serve as a pivotal trial in support of a Biologics License Application (BLA) submission, contingent on positive results ARLINGTON, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for...Read more
PRINCETON, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent...Read more
500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia SAN DIEGO, July 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment in the...Read more
Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research Foundation Precision medicine approach: The 60-patient Phase 2 study uses the PCPro™ lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combination Led by Professor Lisa Horvath, the study is expected to...Read more
Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival 2- and 6-week interim safety results demonstrated GRI-0621 to be safe and well-tolerated in the first 12 and 24 patients evaluated, respectively Results on track for 6-week interim biomarker analysis (n=24) in July 2025 and topline data in Q3 2025 LA JOLLA, CA,...Read more
PURCHASE, N.Y., July 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study surpasses 50% enrollment. The START Study is being conducted with partners at the Alzheimer’s Clinical Trials Consortium (ACTC), with $81 million in grant support from the National Institute of...Read more
As of June 30th, 16 participants have enrolled in the Phase 1b, ahead of the original goal of at least 15 total participants by 3Q 2025 Analysis of 90-day biomarker activity from cerebrospinal fluid (CSF) in all participants currently enrolled is now expected to also track earlier; available in 4Q 2025 instead of 1Q 2026 Gain will continue screening patients for enrollment through July 31st, 2025, at the request of clinical...Read more
The SEISMiC C Study is the third study in the istaroxime cardiogenic shock development program - SEISMiC C is studying more severely ill SCAI Stage C cardiogenic shock patients Windtree has previously reported two positive early cardiogenic shock Phase 2 studies in SCAI Stage B patients The SEISMiC C interim analysis will provide a preliminary assessment of istaroxime safety in treating more severe cardiogenic shock patients who may...Read more
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder Vancouver, Canada, June 25, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major...Read more
The first CLARITY patient was enrolled at the Texas Back Institute, a world leader in advancing spine technology, science, and education, as well as patient care CLARITY is a randomized clinical trial designed to demonstrate Nociscan’s ability to improve surgical outcomes for chronic low back pain Nociscan aims to become the gold standard in identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence...Read more
Treatment to Evaluate Effect of Food on Overdose Protection of MPAR Grant Funds from NIDA Accelerating Clinical Development Program SAN DIEGO, CALIFORNIA / ACCESS Newswire / June 24, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today...Read more
MOUNTAIN VIEW, Calif., June 24, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and accessories for the treatment of glaucoma and retinal diseases, announced today that the first patient has been successfully enrolled in the independent, investigator-led DAME Trial to evaluate the clinical efficacy, safety, cost-effectiveness,...Read more
Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positive U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designation Laromestrocel HLHS program addresses...Read more
Multi-center, multi-national study builds on existing U.S. PE Clearance and CE Mark to assess mechanical thrombectomy treatment and long-term functional outcomes in intermediate-risk PE patients across Europe LATHAM, N.Y. / Jun 23, 2025 / Business Wire / AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer...Read more
Study completion anticipated in mid-2026 with subsequent data readout and regulatory submissions for treatment of severe hypertriglyceridemia PASADENA, Calif. / Jun 23, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has completed enrollment in SHASTA-3, SHASTA-4, and MUIR-3, the company’s global Phase 3 clinical studies designed to support regulatory submissions for marketing approval of...Read more
Ralinepag has the potential to be the first once-a-day oral prostacyclin agonist for patients with pulmonary arterial hypertension ADVANCE OUTCOMES will continue to accrue clinical worsening events through the end of 2025 and top-line data is expected in the first half of 2026 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Jun 23, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit...Read more
[212Pb]VMT-α-NET Phase 1/2a study is advancing into Cohort 3 with a fixed administered dose that is up to 20% higher (6 mCi) than the dose administered to patients in Cohort 2 Dosimetry sub-study analysis presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting to advance utility of dosimetry in clinical development when considered with clinical data On track to submit further clinical updates...Read more
90th participant enrolled in landmark clinical trial in patients with Major Depressive Disorder Targets October 2025 for initial results presentation Vancouver, British Columbia – TheNewswire - June 18, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharma/biotechnology company dedicated to developing novel and effective mental health treatments, is...Read more
CARDIFF, UNITED KINGDOM / ACCESS Newswire / June 18, 2025 / When it comes to type 1 diabetes, treating this chronic condition can be difficult. After all, with this type of diabetes, the body's immune system attacks and destroys the beta cells that produce insulin. Without the natural ability to produce insulin, glucose from the bloodstream isn't absorbed into cells to provide energy. Since there is no cure, patients with type 1 diabetes...Read more
San Diego, California--(Newsfile Corp. - June 17, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biopharmaceutical company developing sulfur-based therapeutics for serious pediatric and inherited mitochondrial diseases, today announced the recent activation of its French clinical site for Thiogenesis' ongoing Phase 2 clinical trial evaluating TTI-0102 in patients with...Read more
STORM-PE is a first-of-its-kind clinical trial comparing computer assisted vacuum thrombectomy (CAVT™) using Penumbra's Lightning Flash™ with anticoagulation versus anticoagulation alone in the treatment of acute intermediate-high risk pulmonary embolism ALAMEDA, Calif., June 16, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's leading thrombectomy company, announced the completion of enrollment in the...Read more
Enrollment Completed in Ongoing Registrational PROSERA Phase 3 Study in PAH Topline Results Announcement from PROSERA Phase 3 Expected in February 2026 Blinded Preliminary Baseline Characteristics Align with Intended Study Population SAN DIEGO / Jun 16, 2025 / Business Wire / Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of...Read more
Vancouver, British Columbia – TheNewswire – June 11, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharma/biotechnology company dedicated to developing novel and effective mental health treatments, is pleased to announce the enrolment of the 85th participant in its landmark Phase 2B clinical trial evaluating MB22001 for Major Depressive Disorder (MDD). MB22001, MindBio’s...Read more
Four-week Phase 2 study to evaluate investigational, once-daily ZORYVE .05% in infants as young as 3 months to less than 2 years with atopic dermatitis Atopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first year WESTLAKE VILLAGE, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage...Read more
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder Vancouver, Canada, June 05, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major...Read more
Enrollment Completed for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected End of 2026 Additional Data from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Further Supports the Recently Released Positive Top-Line Results and Further Underlines Vidofludimus Calcium's Neuroprotective Potential New CALLIPER Data Regarding Time to 24-Week Confirmed Disability...Read more
June 4, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the recruitment of the first patient in a Phase 2 study of tolimidone in Type 1 Diabetes (“T1D”). The study is an Investigator Initiated Trial (IIT) conducted by the University of Alberta...Read more
SOUTH SAN FRANCISCO, Calif. / Jun 03, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in the rare neurodegenerative disease Ataxia-Telangiectasia (A-T) has...Read more
TARPON SPRINGS, Fla., June 2, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the first patient has been enrolled in its new Phase 2 clinical trial protocol of stenoparib for the treatment of advanced, platinum-resistant or platinum-ineligible...Read more
SAN JOSE, Calif., June 2, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the completion of enrollment in the Phase 1 clinical trial of its breast cancer vaccine. This novel vaccine, invented at Cleveland Clinic, is also being developed in partnership with Cleveland Clinic and the Phase 1 trial is fully funded...Read more
FREDERICK, Md., May 30, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG). Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered...Read more
Topline readout expected in early Q1 2026 SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. "We are...Read more
BHV-8000 is a first-in-clinic, brain-penetrant, and selective inhibitor of TYK2 and JAK1 kinases — a novel investigational therapy with the potential to treat the neuroinflammation and immune dysregulation that drives disease progression in Parkinson's disease (PD) Currently, there are no approved disease-modifying therapies for the more than 10 million people living with PD NEW HAVEN, Conn., May 29, 2025 /PRNewswire/ -- Biohaven...Read more
Target enrollment exceeded with 62 participants enrolled, including approximately 15 percent from U.S. sites Topline data is anticipated in December of 2025 REDWOOD CITY, Calif., May 28, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced that enrollment is complete in the sunRIZE...Read more
Enrollment for SOL-R, the largest retinal TKI trial to date, supports randomization of at least 555 subjects SOL-1, Ocular’s first registrational trial in wet AMD, completed randomization in December 2024 and retention remains exceptional as the trial continues on track for top-line readout in 1Q 2026 These two complementary trials are intended to form the basis of an NDA submission of AXPAXLI in wet AMD BEDFORD, Mass., May 28,...Read more
Over 400 patients enrolled and randomized over a seven-month period, driven by strong physician and patient interest LUCIA pivotal Phase 3 trial continues rapid enrollment pace with 60% of patients randomized; enrollment completion expected in 3Q 2025 Topline 56-week data for LUGANO expected in mid-2026 with LUCIA to follow WATERTOWN, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (Nasdaq:...Read more
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
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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