122 Patients Enrolled in Single-arm IDE Study; 30-Day Follow-up LATHAM, N.Y. / Dec 07, 2023 / 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 treatment options and improving patient quality of life, today announced the completion of patient enrollment in the Acute Pulmonary Embolism...Read more
Phase 1 combination dose escalation expected to support planned Phase 2 trial in microsatellite stable colorectal cancer (MSS CRC) Updated Phase 1 monotherapy data for XTX101 at the recommended Phase 2 dose (RP2D) continues to demonstrate minimal treatment-related adverse events, consistent with tumor-activated molecule design, and a 33% disease control rate across a range of late-line and IO refractory advanced solid...Read more
SALT LAKE CITY, Dec. 6, 2023 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced that the Data Safety Monitoring Board (DSMB) overseeing its pivotal Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study...Read more
IMpactMF is the first and only Phase 3 clinical trial to evaluate overall survival as the primary endpoint in R/R MF An interim analysis is expected in the first half of 2025, with a final analysis expected in the first half of 2026 FOSTER CITY, Calif. / Dec 06, 2023 / Business Wire / Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the Phase...Read more
Top-line data expected in Q2 2024 SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company, along with Mundipharma, has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for...Read more
BDC-1001 is a Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) in Phase 2 development for HER2-positive breast, colorectal, endometrial, and gastroesophageal cancers Poster detailing trial design and rationale to be presented at the 2023 San Antonio Breast Cancer Symposium on Wednesday, December 6 REDWOOD CITY, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage...Read more
79 patients enrolled TORONTO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update for the month of November 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...Read more
LONDON and NEW YORK, Dec. 04, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and for neuropathic corneal pain, a severe ocular condition without an FDA approved therapy, is pleased to announce the last patient of a planned 240-patient double-blind...Read more
Highlights: First participants enrolled in the US Naval Medical Research Command Clinical Trial Clinical Study initiated to evaluate the efficacy of a new Immuron clinical product to protecting volunteers against moderate to severe campylobacteriosis New CampETEC product is a prophylactic therapeutic designed to protect against Campylobacter and Enterotoxigenic Escherichia coli (ETEC) infections, two of the major causes of...Read more
The PROGRESS study marks initiation of the late-stage development program for AAK1 inhibitor LX9211, with potential to become the first new, non-opioid drug therapy in high-unmet need neuropathic pain in more than 20 years LX9211 has previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for DPNP THE WOODLANDS, Texas, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)...Read more
NEW YORK, Nov. 29, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the target patient enrollment outside of mainland China in the ongoing Phase 3 REGAL trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who...Read more
First-of-its-kind randomized controlled trial comparing computer assisted vacuum thrombectomy (CAVT) using Penumbra's Lightning Flash™ with anticoagulation versus anticoagulation alone Penumbra's Indigo® Aspiration with Lightning portfolio offers the only CAVT technologies currently available in the U.S. and Lightning Flash is the latest advancement designed to allow physicians to remove large blood clots in the body safely, simply and...Read more
Topline results from FemaSeed® pivotal trial expected in 1H 2024 Commercial launch planned for early 2024 ATLANTA, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead, late-clinical stage product candidate and innovative therapeutic and diagnostic...Read more
IRVINE, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced the first patient enrollment in the PEERLESS II study. This prospective, global, multi-center randomized controlled trial (“RCT”) compares the outcomes of intermediate-risk acute pulmonary embolism (“PE”)...Read more
WINNIPEG, MB / ACCESSWIRE / November 23, 2023 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today announced that the FDA provides complete approval to enroll patients in its pivotal Phase 3 clinical trial to evaluate the use of its investigational...Read more
Topline Phase 2b data expected in June 2024 More than 120 sites around the world actively recruiting in the Phase 3 portion of the IMPAHCT trial WALTHAM, Mass., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced the Phase 2b portion of...Read more
SEATTLE, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that it has reached full enrollment in the Company’s Karisma-Endoxifen clinical trial, the 240-person Phase 2 study investigating (Z)-endoxifen in premenopausal women with...Read more
SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced the Completion of Patient Enrollment in Global Phase III Clinical Trial (BURAN) of Buparlisib (AN2025) in Combination with Paclitaxel for the Treatment of...Read more
Enrollment Completion Signifies Critical Progress to Phase 3 of PF614 Trial Results Expected in December 2023 SAN DIEGO, CA / ACCESSWIRE / November 16, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that the PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover...Read more
DMT310 Phase 3 STAR-1 (Spongilla Treatment of Acne Research) clinical trial will evaluate the efficacy and safety of once-weekly treatments of DMT310 for 12 weeks in moderate-to-severe acne patients Topline results from STAR-1 clinical trial expected in Q1 2025 DMT310, if approved, may be the first once-weekly, topical acne treatment SAN DIEGO, CA / ACCESSWIRE / November 16, 2023 / Dermata Therapeutics, Inc....Read more
Children with Autism Spectrum Disorder are at Risk for Low Bone Density Preliminary Data Suggest that the Administration of Oxytocin May Favorably Impact Bone Formation and Strength Recent Meta-Analysis Reported that Plasma Oxytocin Levels Tend to be Lower in Children with Autism Spectrum Disorder than Controls1 CHATHAM, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the...Read more
ATLANTA, Nov. 9, 2023 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that it has completed enrollment in the PERSEVERE clinical trial. The PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial to determine if patients with acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS Hybrid...Read more
MARLBOROUGH, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced that the first patient has been dosed in the Phase 1b clinical trial of PH-762, an INTASYL compound that reduces the expression of PD-1, a protein that inhibits T...Read more
ATH434-201 is a randomized, double-blind, placebo-controlled study in early-stage MSA Lead clinical development program enrolled 77 participants globally MELBOURNE, Australia and SAN FRANCISCO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today...Read more
Top-line results expected mid 2024 Strong physician interest drove SHINE study completion PURCHASE, N.Y., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), (the “Company” or “Cognition”), today announced that the last participant was randomized in the Phase 2 SHINE study (NCT03507790) of CT1812, the company’s lead candidate for the treatment of age-related neurodegenerative diseases of the...Read more
76 patients enrolled Emory Healthcare latest clinical site addition into the Tigris Trial TORONTO, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that it has enrolled a total of 76 patients for the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of...Read more
1,929 patients randomized in a pair of Phase 3 trials to evaluate oral simufilam in Alzheimer's disease dementia. Top-line results for on-going, 52-week Phase 3 trial expected approximately year-end 2024. Top-line results for on-going, 76-week Phase 3 trial expected approximately mid-year 2025. AUSTIN, Texas, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today announced the...Read more
Rapidly enrolled 141 patients in less than four months Large study will compare A1c from baseline to 17 weeks for adults when switching from injectable insulin or pumps to inhaled insulin (Afrezza® (insulin human) Inhalation Powder) Initial standardized meal data from INHALE-3 on target for presenting in 1Q 2024 followed by primary endpoint analysis in 2Q 2024 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 06, 2023 (GLOBE...Read more
Successful Completion of Recruitment Driven by Strong Clinical Site Participation and Investigator Support Topline Data Expected in Q3 2024 ALPHARETTA, Ga., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today the completion of recruitment in...Read more
Toronto, Ontario--(Newsfile Corp. - November 1, 2023) - 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, is pleased to announce that it has exceeded 50% of the patient enrollment target for its Phase II open-label pilot study...Read more
Up to 60,000 patients in the United States may have PPF, with only one approved therapy available SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Oct 31, 2023 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the first patient has enrolled in the registration-phase TETON PPF study, which will evaluate nebulized Tyvaso® (treprostinil) Inhalation Solution in 698...Read more
GAITHERSBURG, Md., Oct. 31, 2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced the completion of subject enrollment in its Phase 3 clinical trial (the "Phase 3 Trial" or the "Trial") of the...Read more
RESEARCH TRIANGLE PARK, N.C., Oct. 26, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first patient in a proof-of-concept clinical trial evaluating BCX10013, a potential once-daily, oral Factor D inhibitor for the treatment of complement-mediated diseases. The goal of this proof-of-concept trial is to understand the preliminary efficacy and safety profile of once-daily...Read more
Topline Data Expected in Early Q1 2024 NDA Resubmission Expected in Q2 2024 DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the completion of patient...Read more
53 participants enrolled across two sites NEW YORK / Oct 24, 2023 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has completed enrollment of Study MMED007, the Company’s Phase 2a study evaluating repeated low-dose administration of MM-120...Read more
13-Week Study to Evaluate the Safety and Efficacy of VK2735 Dosed Weekly Trial Size Increased from 125 to 176 Patients Due to Elevated Demand SAN DIEGO, Oct. 23, 2023 /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 patient enrollment in its Phase 2 clinical...Read more
Final Enrollment in CAHmelia-203 to Exceed Target Due to Substantial Patient Interest CAHmelia-203 Topline Results Anticipated in the First Quarter of 2024 CAHmelia-204 Completion of Enrollment Anticipated in Early First Quarter of 2024 SOUTH SAN FRANCISCO, Calif. / Oct 18, 2023 / Business Wire / Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies...Read more
The MRD trial will evaluate the effect of this treatment combination on minimal residual disease. LAWRENCEVILLE, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that the first patient in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab...Read more
Providence, Rhode Island, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharma company working to accelerate the development of compelling discoveries from top research scientists, today announced that its joint venture partner, Virion Therapeutics, LLC, is now enrolling patients in its Phase 1b study for a first-in-class treatment of chronic Hepatitis B (Clinicaltrials.gov #NCT06070051) in Hong Kong and...Read more
FREMONT, CA, Oct. 17, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced an update on the Company's eight-week long ADHD Phase IIb clinical study taking place at the University of California San Francisco (UCSF) Medical Center and five Taiwanese medical...Read more
Data show promising early evidence of anti-tumor activity in patients with relapsed/refractory B cell non-Hodgkin lymphoma Full data readout of Phase 1 study expected in Q1 2024 BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced new early data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an...Read more
BOSTON and ATLANTA, Oct. 16, 2023 (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 (“PD”), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today highlighted an analysis of eleven unblinded participants from the 201 Trial evaluating...Read more
SEATTLE, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), today announced the completion of recruitment for the first patient cohort in its Phase 1/2a dose escalation study of 212Pb-VMT01 (clinicaltrials.gov identifier NCT05655312), its targeted alpha-particle therapy, in development for the treatment of MC1R-positive metastatic melanoma. “We are encouraged by...Read more
SUNNYVALE, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces completion of enrollment in its CardiAMP Heart Failure Trial and initiation of a discussion with the FDA on a second pivotal study protocol adapted for the responders in the initial trial with the objective of gaining FDA...Read more
AUDACITY trial to support FDA approval of the Allurion Balloon NATICK, Mass. / Oct 11, 2023 / Business Wire / Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the completion of patient enrollment in its AUDACITY trial. AUDACITY is a randomized, pivotal controlled trial designed to support U.S. Food and Drug Administration (FDA) approval of the Allurion Balloon. The trial enrolled 550...Read more
Company on track to achieve value-driving milestones before year-end HOUSTON, TX / ACCESSWIRE / October 11, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced it has achieved enrollment of 229 of the expected 243 patients in the ongoing...Read more
LEXINGTON, Mass. / Oct 10, 2023 / Business Wire / Agenus Inc. (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers today announced completion of the planned patient enrollment in ACTIVATE-Colorectal, a randomized Phase 2 trial in advanced colorectal cancer (CRC) evaluating the efficacy and safety of botensilimab (BOT) as monotherapy and in combination with balstilimab (BAL) or standard of care in...Read more
49 patients dosed to date; 37 have completed at least 1 post baseline assessment THIO-101 enrollment pace currently exceeds average for similar NSCLC trials CHICAGO / Oct 10, 2023 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, announced today that 49 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO...Read more
The double-blind, placebo-controlled study (funded by the Gates Foundation and Alzheimer’s Association) evaluates the safety and tolerability, biological activity, biomarkers, neuroimaging, and preliminary efficacy of LD IL-2 in 38 patients with mild-to-moderate AD over 30 weeks; Previously reported data from an open-label, proof-of-concept study in 8 AD patients illustrated that treatment with LD IL-2 resulted in a statistically...Read more
18 VenoValve patients enrolled over the final two months of the study Surge in VenoValve demand exceeded the enrollment limit Topline safety and efficacy readout and PMA eligibility now expected to occur in Q4 2023, Q2 2024, and Q3 2024, respectively IRVINE, CA / ACCESSWIRE / October 6, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous...Read more
74 patients enrolled New sites to further accelerate patient enrollment On track to onboard seven new trial sites around the end of November 2023 TORONTO, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the progress of its Tigris trial including patient enrollment...Read more
Top-line Data Anticipated Around Year End WAYNE, Pa., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the completion of enrollment into ATI-1777-AD-202, its Phase 2b trial of its investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor, ATI-1777, in patients with...Read more
Biodexa Completes Recruitment of Cohort A in Study of MTX110 in Patients with Recurrent Glioblastoma Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain, is pleased to announce that it has completed recruitment into cohort A of its ongoing Phase 1 study of MTX110 (also known as MAGIC-G1 study)(NCT 05324501) in...Read more
804 Alzheimer’s Patients Are Enrolled in a Pivotal Phase 3 Clinical Trial A Second Pivotal Phase 3 Clinical Trial Is Expected to Complete Enrollment Q4 2023, With a Target Enrollment of Approximately 1,100 Patients. AUSTIN, Texas, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today announced the completion of patient enrollment in a pivotal Phase 3 clinical trial. Eight hundred...Read more
SAN MATEO, Calif., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, today announced that its license partner, Ascletis Bioscience Co. Ltd. (Ascletis), has enrolled 120 patients in its Phase 3 registration clinical trial of denifanstat combined with bevacizumab for treatment of recurrent...Read more
The first academic center activated to enroll, led by an instrumental investigator who participated in Femasys’ earlier FemBloc studies FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway ATLANTA, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a...Read more
AUSTIN, Texas, Sept. 26, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) Announces that Hutrukin is being developed by XBiotech as a breakthrough therapy to reduce brain injury after stroke. The last subject in a randomized, open-label, placebo-controlled Phase I dose escalation clinical study has been enrolled. XBiotech discovered, manufactures, and is conducting this clinical study of Hutrukin. The primary objective of the...Read more
GAITHERSBURG, Md., Sept. 26, 2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it has enrolled the first subject in its Phase 3 clinical trial (the "Phase 3 Trial" or the "Trial")...Read more
Completed enrollment of patient expansion cohort of 20 patients at the RP2D of 4 mg/kg in combination with KEYTRUDA® (pembrolizumab) in first line (1L) refractory/metastatic HPV+ Head and Neck Cancer patients Data to date from CUE-101 in combination with pembrolizumab demonstrates more than double the historical ORR of pembrolizumab alone, including patients with tumors of low PD-L1 expression Updated data from both the...Read more
Phase 2 topline efficacy data for CYB003 on track for Q4 2023, followed by U.S. Food and Drug Administration (“FDA”) submission of CYB003 Phase 1/2 data for pivotal studies Breakthrough Therapy designation anticipated in late 2023, subject to FDA approval Previously announced acquisition of Small Pharma Inc. expected to close in Q4 2023, creating an international clinical-stage leader in novel psychedelic...Read more
SAN DIEGO / Sep 21, 2023 / Business Wire / Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, announces the full enrollment of 40 subjects with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed leptomeningeal metastases (LM) in the feasibility phase of its prospective FORESEE clinical trial (NCT0414123). This trial is evaluating the performance of Biocept’s...Read more
Data readouts expected before year end Previously reported preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy treatment of STS lung mets with >60% of the subjects exhibiting stable disease after two cycles of treatment Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma HOUSTON, Sept. 21, 2023 /PRNewswire/ -- Moleculin Biotech, Inc.,...Read more
Topline data from Phase 3 trial expected in Q4 2024 Company to present encore 36-month efficacy, safety, and patient-reported outcomes data from the Phase 2 TOPAZ trial extension at the 2023 World Muscle Society (WMS) Annual Congress Apitegromab is the only muscle-targeted therapy candidate with clinical data showing proof of concept in spinal muscular atrophy CAMBRIDGE, Mass. / Sep 19, 2023 / Business Wire / Scholar Rock (NASDAQ:...Read more
Recruitment Accelerating and Full Patient Enrollment Anticipated to be Completed During Q3 2024, up to Six Months Ahead of Schedule Multi-Center, International, Double-blind, Placebo-controlled Trial Randomizing 100 Patients Toronto, Ontario--(Newsfile Corp. - September 19, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research...Read more
Taldefgrobep alfa is the only myostatin inhibitor in clinical development that targets both myostatin and activin A signaling, two key regulators of muscle mass and adipose tissue RESILIENT, the pivotal clinical trial in spinal muscular atrophy, was designed to test the efficacy and safety of taldefgrobep alfa as adjunctive therapy to increase muscle in SMA patients treated with standard of care nusinersen, risdiplam or onasemnogene...Read more
Company announces Phase 2 part of the EBO-301 trial is now fully enrolled with 80 patients; Topline Phase 2 trial results expected in summer 2024 Over 100 sites across four countries (U.S., Japan, S. Korea & Australia) as epetraborole enters Phase 3 portion of EBO-301; expected to enroll ~230 patients MENLO PARK, Calif. / Sep 13, 2023 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical...Read more
SAN DIEGO, Sept. 13, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced it has completed enrollment in the second cohort of patients in the ongoing Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. "The completion of enrollment in our second cohort is...Read more
198 participants dosed across 20 clinical sites On track for topline results in Q4 2023 NEW YORK / Sep 12, 2023 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has completed enrollment and dosing in Study MMED008, the Company’s Phase...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed patient enrollment of a bridging study of tazemetostat in China. The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory...Read more
Multi-antigen Vaccine Designed to Protect Against Evolving SARS-CoV-2 Variants ATLANTA, GA, Sept. 11, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has met the enrollment target for its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster for healthy patients who have...Read more
Full enrollment achieved on September 6th with a total of 240 patients enrolled in study Top-line data planned for release in December 2023 Phase 2 trial is designed as a potential registration trial, with pre-specified primary efficacy endpoints covering both a sign and symptom of dry eye disease LONDON and NEW YORK, Sept. 08, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical stage biopharmaceutical company...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that it has completed enrollment in INVOKE-2, the Phase 2 clinical trial of AL002. INVOKE-2 is evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). Data from the trial are expected in the...Read more
CAMBRIDGE, Mass., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that it has completed enrollment in REACH, a Phase 3 clinical trial evaluating losmapimod in patients with FSHD at sites in the United States, Canada, and Europe. “We are very pleased to have enrolled...Read more
First patient has been enrolled in the Dose Confirmation stage (n=18) of the Phase 2 SPECTRA clinical trial for intravitreal 4D-150 in patients with diabetic macular edema First patient enrolled in Population Extension cohort of Phase 2 stage of PRISM clinical trial in wet AMD (n=up to 45) to evaluate intravitreal 4D-150 in patients with lower anti-VEGF need compared with initial cohorts All PRISM patient cohorts to inform...Read more
Topline data currently expected late 4Q calendar 2023 Interim analysis of first 120 patients demonstrated: Excellent safety and tolerability product profile Potential for PL9643 to address multiple signs and symptoms of dry eye disease CRANBURY, N.J., Sept. 7, 2023 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on...Read more
Completion of enrollment of study on track by end of 2023 Topline data results from interim analysis also on track to announce by end of 2023 HOUSTON, TX / ACCESSWIRE / September 7, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that 200...Read more
MONTREAL, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that all five of the U.S.-based clinical sites participating in the conduct of the Phase 1 clinical trial of the Company’s lead investigational peptide drug conjugate, sudocetaxel...Read more
AUSTIN, Texas, Aug. 30, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. announced today completion of enrollment of the Phase II portion of its 1-BETTER study—a Phase I/II randomized, double-blind, placebo-controlled clinical study for Natrunix in combination with chemotherapy for treating pancreatic cancer. Natrunix is indistinguishable from a naturally occurring antibody present in a healthy human. Natrunix binds and neutralizes a potent...Read more
Full enrollment anticipated by first week of September OKYO on schedule to release top-line data before end of 2023 Phase 2 trial is designed as potential registration trial with pre-specified primary efficacy endpoints covering both a sign and symptom of DED LONDON and NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to...Read more
WATERTOWN, Mass., Aug. 29, 2023 (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 I clinical trial of LYR-210 in adult patients with CRS who have not had prior ethmoid sinus surgery, is fully enrolled....Read more
Program plans to enroll approximately 17,000 participants across three global studies RAHWAY, N.J. / Aug 25, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the company’s Phase 3 clinical program, CORALreef, for MK-0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, being evaluated for the treatment of adults...Read more
FREMONT, CA, Aug. 23, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that 60 subjects had been enrolled and 53 had completed the eight-week study for the Company's ADHD Phase IIb clinical study. These subjects were enrolled at the University of...Read more
Enrolled 52 participants with Developmental and Epileptic Encephalopathies (DEEs) into the PACIFIC Study Participants have a broad range of DEEs including Lennox-Gastaut syndrome, Dravet syndrome, SCN2A-related epilepsies, CDKL5 deficiency disorder, among others PACIFIC topline results remain on track for around year-end 2023 LA JOLLA, Calif. / Aug 23, 2023 / Business Wire / Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a...Read more
402 patients completed enrollment across multiple sites in the US, Europe, and Asia Topline data for Phase 3 RECOVER study expected in October 2023 Completion of 1-year open-label extension clinical study expected in Q3 2024 CUPERTINO, Calif., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies...Read more
Unblinded Interim Biomarker Analysis Expected in the Fall of 2023 Full Data Readout Expected in April 2025 NEW YORK, Aug. 17, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the completion of enrollment of its phase 2 CALLIPER trial of lead...Read more
Company Activates Additional Study Location to Expedite Enrollment Completion Key Opinion Leader Webinar Highlighting the Potential for Lomecel-B™ in the Treatment of HLHS to be held Wednesday, August 16, 2023 at 10:00 AM ET MIAMI, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic...Read more
Trial Results Expected in Mid-2024 WOBURN, MA / ACCESSWIRE / August 10, 2023 / Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces that patient enrollment is now complete in the Phase 3 clinical study evaluating Ameluz®-PDT in combination with the BF-RhodoLED® lamp for the treatment of basal cell carcinoma (BCC). This study is being...Read more
LUNA 14-week data on aflibercept protein levels anticipated in the third quarter of 2023 and preliminary efficacy and safety data anticipated in the fourth quarter of 2023 Combined OPTIC and LUNA trials will follow approximately 90 wet AMD subjects dosed with Ixo-vec out to five years to inform global pivotal trials Cash runway projected into 2025 REDWOOD CITY, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Adverum...Read more
Single-arm Phase III study in Japan evaluating leniolisib in patients aged 12 years and older with APDS, a rare primary immunodeficiency LEIDEN, The Netherlands, Aug. 9, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the first patient has been enrolled in its Phase III clinical trial in Japan evaluating leniolisib for the treatment of activated...Read more
First prescription dispensed in Chinese Hainan Province 93% of patients enrolled completed the Phase 3 trial in premenopausal patients with Hypoactive Sexual Desire Disorder (HSDD) in South Korea Data expected later this year Supports submission to Korean Ministry of Food & Drug Safety (MFDS) for Marketing Approval CRANBURY, N.J., Aug. 8, 2023 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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