NPM-115 clinical program utilizes a miniature, GLP-1 (exenatide) implant designed to provide comparable efficacy to semaglutide, with twice-yearly administration Study represents the first clinical application of NanoPortal™, the Company’s proprietary drug implant platform technology ALAMEDA, Calif. / Dec 19, 2024 / Business Wire / Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative biopharmaceutical company...Read more
Sarepta anticipates filing for accelerated approval of SRP-9003 in 2025 CAMBRIDGE, Mass. / Dec 18, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that enrollment and dosing is complete in EMERGENE (Study SRP-9003-301), a Phase 3 clinical trial of SRP-9003 (bidridistrogene xeboparvovec). SRP-9003 is an investigational gene therapy for the...Read more
This open-label Phase 1 study measures safety, peripheral and central inflammation, effects on Treg cell populations, and FTD progression; Five of the 8 planned FTD subjects have been enrolled to date; Results of study will inform Coya’s randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD HOUSTON / Dec 18, 2024 / Business Wire / Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage...Read more
SAGITTARIUS is Natera's first interventional trial using SignateraTM to select patients for targeted therapy in early-stage colon cancer Approximately 700-900 patients expected to be enrolled across more than 20 sites AUSTIN, Texas / Dec 12, 2024 / 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 SAGITTARIUS clinical trial....Read more
Navenibart Demonstrated 6 Months of HAE Attack Prevention with 1 or 2 Doses 90-95% Mean Monthly Attack Rate Reduction Supporting Chronic Dosing 2 or 4 Times Per Year 67% Attack-Free Rate Over 6 Months in Cohorts 2 and 3 Favorable Safety and Well-Tolerated Profile Phase 3 Initiation on Track for Q1 2025 BOSTON / Dec 11, 2024 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical...Read more
TIGeR-PaC is Evaluating the TAMP™ (Trans-Arterial Micro-Perfusion) Therapy Platform for the Treatment of Locally Advanced Pancreatic Cancer Dr. Meredith Pelster, Associate Director for GI Research Across Sarah Cannon Research Institute (SCRI), Appointed Principal Investigator for TIGeR-PaC Study LOS ALTOS, Calif., Dec. 11, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company...Read more
The ongoing obesity Phase 2 trial is a randomized, double-blind, placebo-controlled, dose finding, clinical trial to evaluate the safety and efficacy of KDS2010 in approximately 75 overweight or obese patients currently enrolling in South Korea with a cohort in U.S. to be added in 2025. KDS2010 has shown promising preclinical results with a novel mechanism of blocking MAO-B-dependent aberrant GABA (gamma-aminobutyric acid) production...Read more
ATOM is the only active Phase 3 trial for adjuvant treatment of uveal melanoma The trial will assess whether adjuvant treatment with tebentafusp can decrease the risk of relapse, compared to observation (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 11 December 2024) The European Organisation for Research and Treatment of Cancer (EORTC), an independent clinical cancer research organization focusing on...Read more
BASKING RIDGE, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced the successful completion of patient enrollment in all three cohorts of the Phase 1b/2a CENDIFOX trial. This investigator-initiated trial, led by Dr. Anup Kasi at The...Read more
Multiple clinical trial sites across Taiwan are actively screening patients, following successful site initiation visits. Expansion into Taiwan is particularly significant as over 50% of lung cancer cases in Taiwan occur in never-smokers. DALLAS / Dec 09, 2024 / Business Wire / Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR® AI platform, today...Read more
MIAMI, Dec. 09, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach. The patient...Read more
SAN DIEGO, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced it has reached full planned enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial across clinical sites in the US...Read more
STAR-1 topline results expected in March 2025 Over 30 million acne patients seek treatment in the U.S. each year Phase 2b for DMT310 achieved statistically significant results for all primary endpoints SAN DIEGO, CA / ACCESSWIRE / December 3, 2024 / Dermata Therapeutics, Inc. (NASDAQ:DRMA) (NASDAQ:DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical and...Read more
DENVER, Dec. 03, 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 activation of Sentara Norfolk General Hospital in Norfolk, Virginia as its thirteenth active site in its NEUTRALIZE-AKI pivotal trial. The Company also reports the enrollment of nine critically...Read more
Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care CAMBRIDGE, Mass., Dec. 3, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that in late November U.S. Renal Care (USRC) enrolled the first patient in its Vafseo®...Read more
Early safety and tolerability results from six randomized patients support continued enrollment of pelareorep combined with modified FOLFIRINOX, with or without atezolizumab The study will begin with 30 patients, with an option to expand to an additional 34 participants SAN DIEGO and CALGARY, AB, Dec. 3, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in...Read more
BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the completion of enrollment in the Phase 2 AMPLIFY-7P study (NCT05726864). The randomized Phase 2 study is evaluating a 7-peptide formulation of ELI-002 (ELI-002 7P) in patients with...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine...Read more
GAITHERSBURG, Md., Nov. 26, 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 first patient enrollment and dosing at the UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with...Read more
Strong Interest in Trial Participation Resulted in Enrollment Exceeding Target by 20 Percent and Completion Ahead of Schedule Top-line Data Expected in Q1 2025 THE WOODLANDS, Texas, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup,...Read more
Oral PL8177 may provide a safe, effective, and tolerable treatment option for ulcerative colitis patients prior to immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns Preclinical data demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and to resolve damaging inflammation Data expected 1Q calendar year 2025 CRANBURY, N.J., Nov. 25, 2024...Read more
The Northwell Health Cancer Institute is the Most Recent Clinical Site to Join the TIGeR-PaC Study, and RenovoRx Aims to Reach Full Patient Enrollment in the First Half of 2025 Phase III Clinical Trial is Evaluating the TAMP™ (Trans-Arterial Micro-Perfusion) Therapy Platform for the Treatment of Locally Advanced Pancreatic Cancer LOS ALTOS, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”)...Read more
High responder rate associated with a duration of response ranging as long as 54 months in QUILT-3.032 with 100 patients enrolled Updated data intended to be submitted as part of a European Medicines Agency (EMA) Submission in Q4 2024 Complete response data in 100 patients consistent with CR rate of 71% reported for 82 patients published in NEJM CULVER CITY, Calif. / Nov 19, 2024 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a...Read more
Six sites across the U.S. are now engaged in Phase1b study Marlborough, Massachusetts--(Newsfile Corp. - November 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company exploring new pathways towards a cancer-free future, today announced it has completed the enrollment of its second patient cohort in its PH-762 Phase 1b dose-escalating clinical trial, and added a sixth clinical site in San...Read more
First gamma delta CAR T cell therapy with the potential to address solid tumors entering clinical trials Preliminary Phase 1 clinical data expected in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Nov 18, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the...Read more
SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, today announced that it has achieved more than 50% of targeted patient enrollment for its CBeyond™ Phase 2 clinical trial assessing nimacimab, a differentiated CB1 inhibitor, in patients with overweight or obesity. Skye expects to...Read more
NXP800 demonstrated single agent activity New dosing schedule successfully minimized thrombocytopenia Fort Lee, NJ, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today reported encouraging data from the Phase 1b study evaluating...Read more
108 patients have completed 1-year of treatment Brilaroxazine is generally well tolerated to date in patients with acute and stable schizophrenia Topline data from 1-year open-label extension (OLE) trial now expected in December 2024 CUPERTINO, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing...Read more
INDIGO is the largest clinical trial conducted in patients living with IgG4-RD Topline INDIGO results expected by the end of 2025 WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology-based therapies, today announced the...Read more
Topline data anticipated in Q1 2025 to support potential initiation of a pivotal bacteremia efficacy trial in 2025 LOS ANGELES, Nov. 12, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that it has...Read more
Patient Enrolled at the Cancer Clinical Trial Unit, CALHN, Royal Adelaide Hospital Aethlon's Trial is a Safety, Feasibility, and Dose Finding Study of the Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies SAN DIEGO, Nov. 11, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious...Read more
135 patients enrolled TORONTO, Nov. 04, 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
Topline results expected in 1Q calendar year 2025 Study is assessing the co-administration of bremelanotide and tirzepatide on reducing body weight Data will inform and support the Company's obesity programs using novel, long-acting and highly selective MC4R peptide and small molecule compounds for treating general obesity, weight loss management, and rare/orphan MC4R pathway diseases, including hypothalamic obesity CRANBURY, N.J.,...Read more
ICoN-1 study presentation planned November 1 at NTM Symposium Australia Study is cleared by health authorities to proceed in Australia, U.S., Japan and South Korea, with Taiwan anticipated by end of year DANBURY, Conn., Oct. 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine...Read more
Topline data now anticipated in mid first half of 2025 Management to host virtual KOL event today to discuss the unmet need in hypertension, as well as a review of the ongoing pivotal clinical program for lorundrostat in hypertension RADNOR, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension,...Read more
After successful SEISMiC A and B studies in Early Cardiogenic Shock, SEISMiC C will treat more severe SCAI Stage C cardiogenic shock to complete the assessment of the intended Phase 3 patient population Windtree plans to engage with regulatory authorities in 2025 for Transition to Phase 3 clinical trial WARRINGTON, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a...Read more
WAYNE, Pa., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the first patient enrolled in the latest Barrigel™ rectal spacer randomized, controlled, single-blinded multicenter study: The PPRT Trial. Barrigel™ rectal spacer is the first and only sculptable hyaluronic acid rectal spacer designed to significantly reduce radiation that reaches the...Read more
GAITHERSBURG, Md., Oct. 28, 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 finalized agreements with all six of the planned site enrollment locations to administer the Phase 2 clinical trial of Ropidoxuridine for...Read more
Topline Data from 52-week Phase 3 Study Expected in Late 2025 CAMBRIDGE, Mass., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that enrollment is complete for the Phase 3 RISE UP study. This global, double-blind, randomized, placebo-controlled trial is evaluating the efficacy and...Read more
Positive results from the MAESTRO-NASH OUTCOMES study could make resmetirom the first medication approved for patients with compensated NASH cirrhosis, a population at high risk of progressing to adverse liver-related outcomes Study may also support full approval of RezdiffraTM (resmetirom) in noncirrhotic NASH CONSHOHOCKEN, Pa., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical...Read more
Topline results are expected in the first quarter of 2025 NEW HAVEN, Conn., Oct. 21, 2024 /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 idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed enrollment in its Phase 2a...Read more
Global Phase 1 clinical trial will evaluate the safety and tolerability of ZW171 in treatment of ovarian cancer, non-small cell lung cancer (NSCLC), and other mesothelin (MSLN) expressing cancers VANCOUVER, British Columbia, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for...Read more
Phase 3 DIAMOND-1 and DIAMOND-2 trials enrollment of OCS-01 in diabetic macular edema (DME) accelerated with great momentum DIAMOND program committees expanded with globally renowned retina experts If approved, OCS-01 has the potential to transform the treatment paradigm as the first topical eye drop to treat DME ZUG, Switzerland, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global...Read more
Company Expands Phase 2 trial to Canada POTOMAC, MD / ACCESSWIRE / October 17, 2024 / IGC Pharma, Inc (NYSE American:IGC) ("IGC" or the "Company"), today announced enrollment of patients at the Baycrest Academy for Research and Education in Toronto, Ontario, Canada, as part of the Company's ongoing Phase 2 trial investigating IGC-AD1 as a treatment for agitation in Alzheimer's dementia. Agitation affects between 40-80% of...Read more
NORWOOD, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, announced today that it has completed enrollment of the dose escalation part of its bridging Phase 1 clinical trial of CRB-701 (SYS6002). The dose escalation part of this open label study (NCT06265727) is being conducted in the US and the UK. The...Read more
NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, provides an update regarding key clinical advancements in its Phase 1 trial of lead drug candidate Decoy20. The Safety Review Committee examined weekly administration data at the lower Decoy20 dose and cleared...Read more
Topline Results Expected Q2 2025 WATERTOWN, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the pivotal Phase 3 ENLIGHTEN 2 clinical trial of LYR-210 in adult patients with CRS who have not had prior...Read more
ALAMEDA, Calif., Oct. 14, 2024 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's leading thrombectomy company, announced the completion of enrollment in its THUNDER clinical study for patients with acute ischemic stroke. THUNDER is evaluating the safety and efficacy of the company's latest computer assisted vacuum thrombectomy (CAVT™) technology, Penumbra System™ with Thunderbolt™ Aspiration Tubing, for the removal of blood clots in...Read more
SEATTLE and VANCOUVER, British Columbia, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, announced today an update on the ORCA-OL clinical trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke...Read more
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
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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