Kineta has completed enrollment in the monotherapy cohorts of the Phase 1 VISTA-101 clinical trial. The ongoing Phase 1 study is now enrolling patients into cohorts evaluating KVA12123 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The company will present additional scientific data in 2024 at an upcoming scientific meeting. SEATTLE, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (OTC Pink: KANT)...Read more
SAN DIEGO, Oct. 8, 2024 /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 of 26 patients in the fourth cohort in the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD. "The completion of enrollment of our final cohort marks an...Read more
FDA Grants Fast Track Designation for Ivonescimab in 2L+ EGFRm NSCLC HARMONi Completed Enrollment for Summit’s First Sponsored Study Evaluating Ivonescimab Topline data from the HARMONi Trial Is Expected in Mid-2025 MIAMI / Oct 03, 2024 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that we have completed enrollment in our HARMONi clinical trial, a multi-regional Phase III...Read more
Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) chronic cough reaches 50% enrollment milestone; sample size re-estimation results expected in December 2024 Human Abuse Potential (HAP) study dosing complete; topline results expected in December 2024 NEW HAVEN, Conn., Oct. 3, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy...Read more
PARIS, France, October 3, 2024 – 10:00 p.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX; Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the first patient was enrolled in its Phase 2b ENHANCE-CD (NCT06456593)...Read more
Company to ring Closing Bell at NYSE on Thursday, October 3, 2024 Interviews scheduled with Fintech.TV and Schwab Network NEW YORK / Oct 03, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2...Read more
132 patients enrolled TORONTO, Oct. 03, 2024 (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 update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic...Read more
SYDNEY, AUSTRALIA, Oct. 03, 2024 (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 autoimmune disease, today announces patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial. The Phase II enrolled 65 metastatic hormone...Read more
Potential best-in-class targeted treatment for Netherton syndrome is company’s first protein therapeutic to advance to the clinic Initial data from trial expected by end of 2025 RESEARCH TRIANGLE PARK, N.C., Oct. 02, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first participant in a Phase 1 trial evaluating BCX17725, a potent and selective investigational...Read more
Perimeter OCT B-Series is the first system designed to combine AI with optical coherence tomography for margin assessment, with the aim of reducing the unacceptably high reoperation rates associated with BCS Recent study1 published in the Annals of Surgical Oncology revealed reoperation rates of 21.1% among commercially insured women and 14.9% among the Medicare cohort Primary endpoint results from OCT B-Series pivotal...Read more
Investigational immunotherapy, VTP-300, is being evaluated as part of a potential functional cure regimen for chronic Hepatitis B. Interim data update for HBV003 anticipated in Q4 2024. Data update for PCA001 anticipated in H1 2025. OXFORD, United Kingdom, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that...Read more
Unblinded Interim Analysis to be Conducted During the Current Quarter Top-line Results Anticipated in First Quarter of 2025 PETACH TIKVA, Israel, Oct. 01, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has enrolled the last patient required in order to conduct the planned unblinded interim analysis in its...Read more
Confirms the Company on Track for FDA 510(k) Submission by end of 2024 Completes All IDE required Tests and Receives Final IDE Approval from the FDA for the ACCESS-PVI Study BRAINTREE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it is currently experiencing an acceleration of patient enrollment for...Read more
Boca Raton, Florida, Sept. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), announced today that it closed enrollment for its Phase 2 trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on...Read more
Study exceeded target enrollment, with an expected topline data readout from the interim analysis expected in 2025 BridgeBio believes there is an opportunity to pursue Accelerated Approval in the U.S. for BBP-418 in LGMD2I/R9 based on a potential biomarker surrogate endpoint of glycosylated alpha-dystroglycan (αDG) at time of the interim analysis If successful, BBP-418 could be the first approved therapy for individuals living with...Read more
IMPACT trial is evaluating the safety and efficacy of pemvidutide in approximately 190 subjects with MASH; top-line efficacy data expected in Q2 2025 End-of-Phase 2 Meeting for the obesity program with U.S. Food and Drug Administration (FDA) has been scheduled for early November 2024 Company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning in Q4...Read more
Activated clinical sites for Phase 1 trial of ADI-001 in autoimmune diseases, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) Enrollment open for patients with LN; enrollment in SLE, SSC, and AAV expected to open in the fourth quarter of 2024 REDWOOD CITY, Calif. & BOSTON / Sep 30, 2024 / Business Wire /...Read more
CAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that enrollment of 188 patients has been completed in the randomized controlled Part B of the DeFianCe study evaluating DKN-01, Leap's anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy as a...Read more
EMERYVILLE, Calif. / Sep 27, 2024 / Business Wire / Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial has achieved a complete response (CR) one month after receiving an...Read more
Patients are preselected for CDKN2A and/or CDKN2B abnormalities Safety and efficacy data to be reported at an upcoming oncology medical conference BERKELEY HEIGHTS, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative cancer medicines, today announced that enrollment of 12 patients has been completed as...Read more
DENVER, Sept. 25, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the enrollment of four additional subjects in a 10-day period in its pivotal NEUTRALIZE-AKI trial, bringing total trial enrollment to 46. This trial is evaluating the safety and efficacy of SeaStar...Read more
On track to announce topline data in Q1 2025 Virtual KOL event scheduled on October 30th to discuss the unmet need in hypertension, as well as a review of the ongoing pivotal clinical program for lorundrostat in hypertension RADNOR, Pa., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic...Read more
PRINCETON, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that patient enrollment has been completed in the Company’s Phase 3 STRIVE-ON safety trial (the STRIVE-ON...Read more
DALLAS, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that it has achieved 25% patient enrollment at Emergency Departments (“ED”) for its U.S. Burn Pivotal Study and added two new ED Clinical Trial Sites for this study: MedStar...Read more
Toronto, Ontario--(Newsfile Corp. - September 24, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced it has achieved the target patient enrollment of 100 patients in "ARCHER", its Phase II randomized,...Read more
Vancouver, British Columbia – TheNewswire - September 23, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development, is delighted to report it has enrolled its 25th participant into its landmark clinical trial of MB22001 in patients with Major Depressive Disorder. The Company has entered multiple Phase 2B trials with confidence,...Read more
Target of 92 evaluable patients (46 in each of the control and VCN-01 treatment arms) enrolled across 15 sites in Spain and the USA within 21 months ROCKVILLE, Md., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today...Read more
Cohort 2 will evaluate high-dose LTI-03 (5 mg BID) Previously announced Cohort 1 data demonstrated positive trends in seven of the eight biomarkers evaluated, suggesting a potential therapeutic effect AUSTIN, Texas, Sept. 23, 2024 /PRNewswire/ -- Aileron Therapeutics, Inc. ("Aileron") (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in...Read more
BRAINTREE, Mass., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial, enrolling and completing the follow up of 50% of the patients participating in the trial to evaluate the LIBERTY® Endovascular Robotic Surgical System. The Company...Read more
CRANBURY, N.J. / Sep 17, 2024 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that all patients have been enrolled in the global, pivotal Phase 2 clinical trial evaluating RP-A501 to treat male patients with Danon disease. After the two-patient safety run-in,...Read more
GAITHERSBURG, Md., Sept. 16, 2024 (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 it has entered into agreements with two additional site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment...Read more
On track to announce topline results from ORIGIN 3 trial in Q2 2025 Expect to present 96-week data from ORIGIN Phase 2b clinical trial of atacicept in IgAN in Q4 2024 BRISBANE, Calif., Sept. 12, 2024 (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...Read more
Topline results expected in 2Q 2025 CAMBRIDGE, Mass. / Sep 10, 2024 / Business Wire / Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced it has completed enrollment in the Phase 2 EMBRAZE trial designed to show...Read more
ARQ-255 is a topical Janus kinase 1 (JAK1) inhibitor suspension formulated as a potential topical treatment for alopecia areata Proprietary Deep Dermal Drug Delivery (4D) technology formulated to deliver drug deep into the skin to the base of the hair follicle where alopecia areata inflammation occurs Phase 1b results expected first half of 2025 WESTLAKE VILLAGE, Calif., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics,...Read more
First trial in Rigel's multi-year strategic development alliance with MD Anderson Phase 1b/2 trial of decitabine and venetoclax in combination with Rigel's targeted mIDH1 inhibitor REZLIDHIA for patients with mIDH1 AML SOUTH SAN FRANCISCO, Calif., Sept. 5, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first...Read more
Topline results from NORSE EIGHT expected in Q4 CY2024 ISELIN, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the...Read more
WARRINGTON, Pa., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced it has successfully completed enrollment in its SEISMiC Extension Phase 2b study of istaroxime in early cardiogenic shock caused by heart failure. The study is evaluating...Read more
IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has successfully completed enrollment for its Phase 2 BESTOW clinical trial, which is designed to assess the safety and efficacy of its investigational immunosuppression therapy tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation. The trial reached its target...Read more
Investigator Study Sponsored by Goethe University Frankfurt (Germany), Funded via a German Government Grant; Study Drug Vidofludimus Calcium Provided by Immunic In Addition to Post COVID Readouts, Study Designed to Deliver Important Data on the Activity of Vidofludimus Calcium Suppressing Epstein-Barr Virus Reactivation and Related Fatigue Symptoms; Third-Party Research Identified Epstein-Barr Virus Reactivation as Potential...Read more
413 patients enrolled in PEAK Phase 3 GIST trial, exceeding enrollment target; top-line results expected by end of 2025 PEAK interim futility analysis completed with no changes to study Registration-directed SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) now on track to complete enrollment in Q1 2025; top-line results expected 2H 2025 WALTHAM, Mass. and BOULDER, Colo., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cogent...Read more
LEXINGTON, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that the Company has closed screening...Read more
NEW YORK / Aug 29, 2024 / Business Wire / OS Therapies Incorporated (NYSE American: OSTX) (“OS Therapies” or “the Company”), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, today announced that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2 in recurred, resected Osteosarcoma (OS) - has received its last treatment dose. This last patient is expected to...Read more
The clinical study will randomize up to 60 patients across 6 trial sites in the United States Toronto, Ontario--(Newsfile Corp. - August 27, 2024) - Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) ("Medicus" or the "Company") announces the enrollment of the first patient in its Phase 2 clinical trial SKNJCT-003 for the treatment of nodular basal cell carcinoma (nBCC). Clinical Trial Design The clinical study, SKNJCT-003, is designed...Read more
BRANFORD, Conn. / Aug 20, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a precision dermatology company announced that it has successfully screened the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The patient is scheduled to initiate treatment by the end of the month. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days,...Read more
CATALYST is a Phase 2 single-blind, placebo-controlled, proof-of-concept study in patients presenting to the emergency department More than 27,569 individuals in the U.S. died from drug overdose deaths involving cocaine in 2022; there is currently no FDA-approved product for cocaine intoxication Topline results are expected in the first half of 2025 CHATHAM, N.J., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding...Read more
The clinical trial for SCI-210 is conducted in Israel, after which the Company aims to move forward with the commercialization process of SCI-210, first in the Israeli market TEL AVIV, Israel, Aug. 19, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today...Read more
Effective immediately, clinical sites in the VISTA-101 Phase 1/ Phase 2 clinical trial can resume screening of patients for enrollment in the clinical study 30 patients have been enrolled in the clinical trial to date, including a monotherapy arm with KVA12123 and a combination arm utilizing KVA12123 together with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) Kineta anticipates the trial to be fully enrolled by the end of 2024...Read more
The safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational trial in 166 patients at up to 14 clinical sites Primary endpoint in the NEPHRO CRRT study is measured over the first 24 hours, with patients completing the study after 72 hours Dr. Stuart Goldstein, a world-renowned nephrologist, is the first physician to enroll a patient in the NEPHRO CRRT study SAN MATEO, Calif., Aug. 19, 2024...Read more
GAITHERSBURG, Md., Aug. 14, 2024 (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 it has entered into agreements with two of the six site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of...Read more
Phase III clinical trial is evaluating RenovoGem™ for the treatment of Locally Advanced Pancreatic Cancer UNMC opened enrollment of TIGeR-PaC in June 2024 and joins esteemed clinical sites throughout United States participating in the study LOS ALTOS, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology...Read more
No Significant Issues Encountered During the Single Ascending Dose (SAD) Study, Allowing for Previously Reported Accelerated Start to Multiple Ascending Dose (MAD) Part 2 Top Line Data Readout from SAD Part 1 Expected in the Third Quarter of 2024, and from the MAD Part 2 in the First Quarter of 2025 CAMBRIDGE, Mass., Aug. 13, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company...Read more
Completed enrollment of the planned 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced Metastatic or Recurrent Biliary Tract Cancers (BTC) Approved an Investigator Sponsored Trial (IST) of CTX-009 in the first-line setting in patients with Biliary Tract Cancer BOSTON, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc....Read more
Phase 3 ABTECT Trial evaluating obefazimod in moderately to severely active ulcerative colitis (UC) surpassed the 600-patient enrollment milestone confirming ABTECT currently on pace to reach full enrollment in early Q1 2025 To date, baseline participants baseline characteristics and trial trends in line with observations from Phase 2b trial PARIS, France, August 6, 2024, 8:30 a.m. CEST – Abivax SA (Euronext Paris & Nasdaq:...Read more
CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials CREST-2 included 23 cases implanted with CGuard TEL AVIV, Israel and MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid...Read more
125 patients enrolled Record July patient enrollment to start the second half of 2024 TORONTO, Aug. 01, 2024 (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 update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in...Read more
Alcyone's ThecaFlex is an implantable medical device under investigation for routine subcutaneous administration of therapeutics to the cerebrospinal fluid (CSF). The first stage of the pivotal IDE PIERRE trial has been completed. 10 spinal muscular atrophy (SMA) patients have undergone ThecaFlex implantation and have received nusinersen through the device. No device-related adverse events, including infections, were observed in the...Read more
SOL-R evaluates repeat AXPAXLI™ dosing for wet age-related macular degeneration (wet AMD) Global non-inferiority study comparing AXPAXLI, dosed every six months, to 2 mg aflibercept every eight weeks BEDFORD, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and...Read more
IRVINE, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has enrolled the 80th participant in its ongoing Phase 2 BESTOW trial assessing tegoprubart for the prevention of rejection in kidney transplantation. “As of this week, we have already enrolled two-thirds of the projected study participants across sites in the United States, Europe and Latin America,” said...Read more
PITTSBURGH, July 29, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the enrollment of the first patients in its multi-center Phase 2a clinical trial evaluating LP-310 for the treatment of Oral Lichen Planus (OLP). This chronic inflammatory condition, which affects over 6...Read more
THRIVE-2 exceeded its enrollment target due to patient demand; 188 patients enrolled with approximately 40% from US sites THRIVE topline readout in patients with active TED on track for September 2024 THRIVE-2 topline readout on track for year-end 2024 WALTHAM, Mass. / Jul 25, 2024 / Business Wire / Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential...Read more
SUNNYVALE, Calif., July 25, 2024 (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 that the confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF) has commenced enrollment in the United...Read more
Virios projects releasing top line results from this groundbreaking Proof of Concept study in October 2024 Published data indicates increased Epstein-Barr herpes virus in Long-COVID patients, highlighting potential for antiviral therapy to treat fatigue and other Long-COVID symptoms ATLANTA, July 23, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology...Read more
SEATTLE, July 22, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced that the 12-patient 80mg pharmacokinetic (PK) run-in cohort of the Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study has fully enrolled. EVANGELINE is a randomized non-inferiority trial of Atossa’s patented Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, and exemestane plus goserelin...Read more
Study enrolled 268 patients, exceeding target enrollment. Largest interventional study ever to be conducted in pulmonary sarcoidosis. Topline data are expected in the third quarter of 2025. SAN DIEGO, July 22, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today...Read more
NEW YORK, July 21, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years duration...Read more
Community Health Network Has Begun Enrollment of the Prospective, Multi-Center Study to Assess the Real-World Clinical Impact of Galleri® in Addition to Currently Recommended Cancer Screenings Study Enrollment Includes Focus on Diverse and Underrepresented Populations Costs of Galleri and Related Items and Services for Study Participants Will be Covered by Medicare MENLO PARK, Calif., July 18, 2024 /PRNewswire/ -- GRAIL,...Read more
BRAINTREE, Mass., July 18, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces it has received Institutional Review Board (IRB) approval and signed a clinical trial agreement with Memorial Sloan Kettering Cancer Center, located in New York City, New York. Memorial Sloan Kettering Cancer Center will conduct the clinical trial as part of...Read more
Zilganersen is the first investigational medicine in clinical development for people with Alexander disease, a rare, life-threatening neurological condition CARLSBAD, Calif., July 18, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that it has completed enrollment in the pivotal trial of zilganersen (ION373), an investigational RNA-targeted medicine in development for the treatment of children...Read more
STAR-1 topline results expected in first quarter of 2025 About 30 million acne patients seek treatment in the U.S. each year DMT310, if approved, could be the first once-weekly topical product for the treatment of acne SAN DIEGO, CA / ACCESSWIRE / July 17, 2024 / Dermata Therapeutics, Inc. (Nasdaq:DRMA)(Nasdaq:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of...Read more
Complete enrollment achieved nearly six months ahead of plan Top-line data now anticipated mid-2025 Addition of second-line cholangiocarcinoma arm to BOLSTER trial BASKING RIDGE, N.J., July 16, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases,...Read more
300 patients enrolled in the study, including patients with and without the cognitive biomarker On track to report topline data in October 2024 Alto to host investor day focused on ALTO-100 on September 9, 2024 MOUNTAIN VIEW, Calif. / Jul 16, 2024 / Business Wire / Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for...Read more
SAN DIEGO, July 15, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that enrollment has been completed and dosing initiated for the sixth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to...Read more
Tailwind is evaluating inhaled AP-PA02 in non-cystic fibrosis bronchiectasis (NCFB), its second patient population, following successful evaluation in patients with cystic fibrosis (SWARM-P.a.) in 2023 Phase 2 Topline data anticipated in 2H 2024 followed by potential initiation of a pivotal bronchiectasis trial in 2025 LOS ANGELES, July 11, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the...Read more
Over 100,000 patients in the United States have IPF, with two approved therapies available that only slow the course of disease progression Top line data expected in the second half of 2025 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Jul 10, 2024 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced full enrollment of the TETON 2 study evaluating the use of Tyvaso®...Read more
Baptist Hospital of Miami is the second site to perform clinical procedures as part of the Company’s Pivotal Human Clinical Trial. The clinical trial is expected to support the future submission to the FDA for the commercialization of the LIBERTY® Endovascular Robotic Surgical System. BRAINTREE, Mass., July 09, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced that Baptist Hospital of Miami, which...Read more
Development of Auxora in AKI is supported by both clinical and pre-clinical evidence Topline data expected in 2025 LA JOLLA, Calif., July 9, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses,...Read more
Exceeded enrollment target due to patient demand; trial size increased to 121 patients Bempikibart topline results remain on track to be released in Q4'24 WALTHAM, Mass., July 9, 2024 /PRNewswire/ -- Q32 Bio Inc. (NASDAQ: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced that it has completed enrollment in the SIGNAL-AD...Read more
WILMETTE, Ill., July 09, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced the enrollment of the first patient in its first-in-human Phase 1 dosimetry and imaging clinical trial of MNPR-101-Zr. This novel radiopharmaceutical imaging agent combines MNPR-101, Monopar’s antibody that selectively targets the...Read more
The first clinical case was performed at Brigham and Women’s Hospital The clinical trial is expected to support the future submission to the FDA for the commercialization of the LIBERTY® Endovascular Robotic Surgical System BRAINTREE, Mass., July 08, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) today announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical...Read more
NAARDEN, The Netherlands and MIAMI, July 08, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today...Read more
116 patients enrolled June represents a new record breaking month for patient enrollment TORONTO, July 02, 2024 (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 update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a...Read more
Patient Screening is Underway at Rocky Mountain Cancer Centers, Part of the US Oncology Network and Sarah Cannon Research Institute; Astera Cancer Care, Part of the OneOncology Network; and Norton Cancer Institute ALPHA3 Will be the First Pivotal Trial to Offer CAR T as Part of First Line (1L) Treatment at Community Cancer Centers, Where 80% of Patients Receive Care ALPHA3 Expected to Complete Enrollment in 1H 2026; Potential BLA...Read more
PRINCETON, N.J., June 27, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company’s pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405) has exceeded the 50%...Read more
The efficacy and safety of tafenoquine in treating human babesiosis will be evaluated in a randomized, double-blind, placebo-controlled trial conducted at Tufts Medical Center in Boston. Endpoints are time to sustained clinical resolution of symptoms of babesiosis, and molecular cure as determined by an FDA-approved nucleic acid test (NAT). Study is the world’s first and only clinical trial evaluating tafenoquine in human...Read more
LOS ALTOS, Calif., June 26, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, announced today that the University of Nebraska Medical Center (UNMC) is now enrolling patients with Locally Advanced Pancreatic Cancer (LAPC) in the Company’s ongoing pivotal Phase III TIGeR-PaC...Read more
TEL AVIV, Israel, June 26, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced a major milestone on the way to registration - the successful completion of patient enrollment in its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate designed for the treatment of...Read more
To date Sernova reports 7 patients in its Phase I/II type 1 diabetes clinical trial achieved freedom from insulin injections and demonstrate blood sugar control in the non-diabetic range (HbA1c 6.5%); 6 patients have reached between 5.5 and 50 months of sustained insulin independence and freedom from severe hypoglycemic episodes; Completion of enrollment in Cohort 2 LONDON, Ontario; BOSTON, Massachusetts...Read more
Company to begin enrollment of patients aged 1-3 years Expects data from younger cohort to be part of pivotal plans and BLA filing for broad label End-of-Phase II meeting with FDA scheduled for late July to finalize pivotal program design Based on recent commercial landscape, confirmed accelerated approval pathway remains available given ongoing unmet need and RGX-202 differentiated design Remains on track to...Read more
BridgeBio has surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418 in individuals living with LGMD2I/R9, with top-line results from the interim analysis expected in 2025 Recent Type C interactions with U.S. Food and Drug Administration (FDA) focused on the validated glycosylated alpha-dystroglycan (αDG) bioassay and our interim analysis plans reinforce BridgeBio's belief that there is potential to...Read more
BOSTON and ATLANTA, June 17, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the company has completed enrollment in the Phase 2 ‘201’ trial evaluating the...Read more
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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