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
Phase 1b/2a open-label trial in the U.S. of certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers BASKING RIDGE, N.J., June 13, 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, announced...Read more
Clinical Trial Results and Potential New Drug Application Resubmission Expected in the Second Half of 2024 LEXINGTON, Mass. / Jun 13, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the completion of enrollment in a Phase 3 dry eye chamber clinical trial...Read more
MIAMI, June 13, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other indications, announced today that an independent Safety Review Committee (SRC) has completed its safety review of data from the first dose cohort (2mg) treated...Read more
Topline data expected in December 2024 Phase 2b design optimized for success; clear path to market in this high value indication expected with positive result BOSTON, June 11, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced that it has completed enrollment in RewinD-LB, a Phase 2b trial evaluating...Read more
30 Patients Relapsed or Refractory to Venetoclax-Based Regimens Enrolled Ahead of Schedule Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.4 Months vs. 2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg Twice a Week Median OS Have Not Been Reached Yet 100%...Read more
Domvanalimab is the only anti-TIGIT antibody in Phase 3 for upper gastrointestinal (GI) adenocarcinomas with the potential to be first-to-market for this patient population HAYWARD, Calif. / Jun 10, 2024 / Business Wire / Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced the completion...Read more
DALLAS, June 06, 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 50% clinical trial site enrollment at burn centers for its 2024 pivotal study designed to validate the algorithm used by its DeepView™ System for burn...Read more
Established Medium Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial DSMB Recommends Continuing with High-Dose Cohort Dosing with Concurrent Phase 2 Dosing MALVERN, Pa., May 31, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced a positive outcome of...Read more
SAN DIEGO, May 30, 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 fifth 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
REDWOOD CITY, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total of over 260...Read more
TransportNPC™ is the most comprehensive ongoing controlled pivotal study regarding patient size, global footprint, duration and clinical outcomes for the treatment of Niemann-Pick Disease Type C1 (NPC1) Topline data from the 48-week interim analysis of 104 enrolled patients is anticipated for H1 2025 If 48-week data demonstrate significance, submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) and Marketing...Read more
PHILADELPHIA and VANCOUVER, British Columbia, May 30, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™, BriaCell’s personalized off-the-shelf next generation...Read more
60 Degrees Pharmaceuticals has entered an agreement with Tufts Medical Center to conduct a clinical trial that will evaluate the safety and efficacy of tafenoquine for the treatment of babesiosis in humans The study will be the world’s first clinical trial to evaluate tafenoquine in human babesiosis patients Enrollment will begin after a site initiation visit in Boston on June 13, 2024 Agreements are being negotiated with...Read more
ATRN-119 is the first and only macrocyclic ATR inhibitor in the clinic, with best in class potential On track to complete dose escalation in ABOYA-119 clinical trial and potentially generate initial human efficacy data in 2H 2024 Through the first 5 cohorts, ATRN-119 has been found to be safe and well tolerated with no dose limiting toxicities (DLTs) observed DOYLESTOWN, Pa., May 28, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics,...Read more
Phase 3 program enrolled 1,984 patients across COAST and ShORe trials Trials designed to replicate superiority in visual outcomes demonstrated in Phase 2b Topline data from both pivotal trials expected in mid-CY2025 MELBOURNE, Australia and PRINCETON, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly...Read more
Topline data now projected in early Q4 2024 Rohit Loomba, MD, MHSc to serve as Principal Investigator SOUTH SAN FRANCISCO, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has completed enrollment in the ALG-055009 Phase 2a...Read more
VE303 is an orally administered, potential first-in-class live biotherapeutic product candidate being developed to prevent recurrence of Clostridioides difficile infection (CDI) BOSTON / May 21, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Vedanta Biosciences, a clinical-stage company that is developing...Read more
Enrollment complete in Phase 3 TrustTSC trial with topline data anticipated in the first half of Q4 2024 USPTO grants additional method of use patent for ganaxolone in TSC RADNOR, Pa. / May 17, 2024 / Business Wire / Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced completion of enrollment in the global Phase 3...Read more
358 enrolled and 223 patients currently on treatment across sites in the USA, Europe and Asia Brilaroxazine is generally well tolerated to date in patients with acute and stable schizophrenia Topline data from 1-year open-label extension (OLE) trial expected in Q4 2024 CUPERTINO, Calif., May 15, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage...Read more
More than 100 patients enrolled from over 100 clinical trial sites active in 12 countries Delivery of the interim data review to Ono Pharmaceutical Co. Ltd. (Ono) expected during Q3 will trigger Ono’s option exercise period LA JOLLA, Calif. / May 14, 2024 / Business Wire / Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders,...Read more
Company enrolls 85 patients with R/R NPM1-mutant AML in fewer than 16 months Topline data expected in early 2025 Breakthrough Therapy Designation to enable expedited review by FDA SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that...Read more
Topline results anticipated in Q4 2024 for Phase 2 trial evaluating the safety and tolerability of OCS-05 in patients with Acute Optic Neuritis (AON) Oculis also aims to complete an IND submission for OCS-05 in the U.S. in 2024 OCS-05 has been granted orphan drug designation in the United States and Europe for AON, an indication for which there are no approved therapies ZUG, Switzerland, May 08, 2024 (GLOBE NEWSWIRE) -- Oculis...Read more
Clinical Results and Potential New Drug Application Submission Expected in the Second Half of 2024 LEXINGTON, Mass. / May 08, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced enrollment of the first patient in a Phase 3 dry eye chamber clinical trial...Read more
105 patients enrolled April represents a record breaking month for patient enrollment TORONTO, May 06, 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
SOUTH SAN FRANCISCO, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative and lysosomal storage diseases, today announced that the Sean M. Healey & AMG Center in collaboration with the Northeast ALS Consortium (NEALS) completed enrollment...Read more
BOTHELL, Wash., May 01, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces completion of enrollment of 78 subjects who were infected with influenza A in a randomized, double-blind, placebo-controlled Phase 2a human challenge clinical study evaluating the safety, tolerability, antiviral and clinical measurements of its novel, broad-spectrum, oral PB2 inhibitor CC-42344. CC-42344 is a new...Read more
NOVATO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that all patients have been enrolled across the Phase 3 Orbit and Cosmic studies evaluating setrusumab (UX143) in pediatric and young adult patients with osteogenesis imperfecta (OI). The pivotal Phase 3 portion of the Orbit study has randomized 158 patients ages 5 to 25 years, and the Cosmic study has completed enrollment of...Read more
Study Approximately Half Enrolled to the Planned Unblinded Interim Analysis Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up Top-line Results Expected in Second Half of 2024 PETACH TIKVA, Israel, April 30, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced...Read more
MENLO PARK, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in CATALYST, a Phase 4 trial examining the prevalence of hypercortisolism (Cushing’s...Read more
SUNNYVALE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced completion of enrollment and collection of the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial. The Company will report results from this trial...Read more
Full target enrollment of 216 patients achieved Topline data from CARPO expected in 2Q 2024 LA JOLLA, Calif., April 24, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica") (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, today announced that the...Read more
FUROSCIX Auto-injector being developed as a complement to the FUROSCIX On-body Infusor Company anticipates topline data in Q3 2024, followed by a Supplemental New Drug Application (sNDA) by year-end 2024, if successful BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to...Read more
First patient enrolled in the global, 300-patient, Phase 2 adaptive platform trial arm of RHB-107 (upamostat)1 for early COVID-19 outpatient treatment, funded through non-dilutive external sources, including the U.S. Department of Defense The study is expected to be completed by the end of 2024 RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked...Read more
NEW YORK, April 23, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10...Read more
HAMPTON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an attributable...Read more
Topline results are expected in Q4 2024 BOSTON / Apr 16, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary...Read more
MENLO PARK, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in DAZALS, a randomized, double-blind, placebo-controlled Phase 2 trial of its...Read more
LYNX-2 Follows SPA Agreement with FDA Development of PS is Funded by Ocuphire’s Partner Viatris FARMINGTON HILLS, Mich., April 11, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the enrollment of the first subject in the LYNX-2 Phase 3...Read more
NAARDEN, the Netherlands and MIAMI, April 09, 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
Clinical data readout expected end of Q3 2024 SER-155 and other Seres microbiome therapeutic candidates have potential to expand microbiome therapeutic franchise into additional medically vulnerable patient populations CAMBRIDGE, Mass. / Apr 09, 2024 / Business Wire / Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that enrollment is complete in the placebo-controlled Cohort 2 of its...Read more
MENLO PARK, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in ROSELLA, a pivotal Phase 3 trial of its proprietary selective cortisol modulator...Read more
Collaboration follows recent manufacturing/clinical process enhancements that have tripled monthly trial capacity Patient enrollment expected to be completed in 2024 MELVILLE, N.Y., April 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced a collaboration with Galen Patient...Read more
TEL AVIV, Israel, April 02, 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 it has reached the 50% enrollment target for the second part of Phase 3 clinical trial of PRF-110 in bunionectomy. In total, over 200 patients have been enrolled, of up to approximately 400 patients at...Read more
Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., April 1, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the completion of enrollment of Part 1 of its two-part, Phase 2a clinical trial evaluating the efficacy and safety, of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119)...Read more
MENLO PARK, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in GRADIENT, a Phase 3 trial of its proprietary selective cortisol modulator...Read more
Topline data expected in 4Q24 could support sNDA filing in 1H25 Revumenib has the potential to address $2 billion mNPM1 and KMT2Ar R/R acute leukemia U.S. market opportunity WALTHAM, Mass., March 28, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101...Read more
Enrollment Reached Over 2,200 High-Risk Patients in Bemnifosbuvir Monotherapy Cohort Results from SUNRISE-3 Expected in 2H’24 BOSTON, March 27, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the company has completed enrollment of the global...Read more
On track to achieve 250 patient enrollment target in March 2024 Top-line data for 32-week primary endpoint expected in the first quarter of 2025 NEWARK, CA / ACCESSWIRE / March 26, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced it has randomized 241 patients in the ongoing Phase 3 VERIFY clinical trial evaluating rusfertide in polycythemia vera ("PV") as of today and expects to meet the trial's 250...Read more
IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation. “We are pleased with the strong pace of enrollment in our Phase 2 BESTOW trial and believe it speaks...Read more
On track to report pivotal complete response data by mid-4Q 2024 CAMBRIDGE, Mass. / Mar 25, 2024 / Business Wire / Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today announced that the enrollment of 190 patients has been completed in the SELECT-MDS-1 Phase 3 clinical trial evaluating tamibarotene in newly...Read more
LOS ANGELES, CA, March 20, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases, today announced Memorial Sloan Kettering Cancer Center as lead clinical site for its NXC-201 relapsed/refractory AL Amyloidosis multi-site clinical trial. “We are looking forward to...Read more
VALID-ECG Study will Form the Basis of the Company’s Upcoming FDA 510(k) Submission SANTA CLARA, Calif. / Mar 14, 2024 / Business Wire / HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that it has enrolled the first patients in the VALID-ECG (Clinical Validation of the AIMIGo 12-Lead ECG Synthesis Software for Arrhythmia...Read more
MARLBOROUGH, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced the addition of three clinical trial sites for its Phase 1b study of PH-762: The George Washington University—Medical Faculty Associates in Washington,...Read more
Company plans to hold a business update conference call in April DENVER, March 12, 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, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective...Read more
TREK-DX, the first randomized, double-blind, placebo-controlled study to be conducted in a dupilumab-experienced atopic dermatitis (AD) patient population, has started enrolling patients in the US under an updated protocol; new European sites are on track to open in the first half of 2024 In a preliminary review of blinded data from 22 patients treated to date, 45% (10/22) of patients saw at least a 90% reduction in their EASI score...Read more
TEL AVIV, Israel, March 08, 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 announced that the first patient has been enrolled in the Company's clinical trial assessing the efficacy and safety of SCI-210 for the treatment of children with autism spectrum...Read more
LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC). OLC is a next-generation lanthanum-based phosphate...Read more
Over 60 participants dosed in two additional cohorts; initial data expected in the second quarter Approximately 50% of participants have compensated cirrhosis SAN FRANCISCO / Mar 05, 2024 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic...Read more
Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by the End of the First Quarter of 2025, Followed by Topline Data from Booster Dose by the End of 2025 VAX-24, a 24-Valent Pneumococcal Conjugate Vaccine (PCV), is Designed to Cover More Serotypes Than Any Infant Pneumococcal Vaccine On-Market or in U.S. Clinics Today Company’s Potential Best-in-Class,...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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