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
Accelerated pace of enrollment supports speed to market strategy Topline results from Stage 1 expected to be presented in the second quarter of 2024 followed by Stage 2 data in the third quarter of 2024 SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide,...Read more
Trial will evaluate the effect of this combination therapy on minimal residual disease LAWRENCEVILLE, N.J., Feb. 27, 2024 (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 Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2...Read more
SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company”), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel classes of therapeutic drugs that modulate the endocannabinoid system, with an emphasis on obesity and ocular indications, has dosed 56 patients using SBI-100 Ophthalmic Emulsion ("OE") in its Phase 2a study and completed...Read more
NES-ZIONA, ISRAEL / ACCESSWIRE / February 21, 2024 / Mike Williams made a name for himself making difficult endzone catches for the Tampa Bay Buccaneers. Around the corner from the stadium where he once dazzled crowds as a receiver for the NFL team, Williams died in September 2023 at the age of 36. His cause of death was bacterial sepsis. Featured photo by National Cancer Institute on Unsplash A life-threatening emergency, sepsis...Read more
Topline Results Expected in Q2 2024 Toronto, Ontario--(Newsfile Corp. - February 21, 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 completion of patient enrollment in its Phase II open-label pilot study...Read more
REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors. A total of 156 patients were enrolled. ”Completion of enrollment in RINGSIDE represents a significant milestone in the development of AL102,” said Kenneth...Read more
On track to complete enrollment of the chronic cohort in Q2 2024 Data readout from chronic cohort expected in Q3 2024 Planning underway to make NVG-291 available to placebo-treated subjects following cohort completion Vancouver, British Columbia--(Newsfile Corp. - February 15, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of...Read more
TORONTO, Feb. 15, 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 announced a major milestone by reaching its Interim Enrollment target of patient 90 in its TIGRIS trial. Under the terms of the Company’s Exclusive Distribution Agreement with Baxter International (“Baxter”) (NYSE:BAX), at Interim...Read more
Study milestone further extends momentum for Company’s lead PDC candidate and oncology clinical development program MONTREAL, Feb. 15, 2024 (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 completion of enrollment of the first six participants in Part 3 of its...Read more
Reached enrollment goal of 305 patients living with Type 1 or Type 2 diabetes Primary endpoint analysis expected in 4Q 2024 Data dissemination and FDA submission expected in 2025 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung...Read more
Successful Stage 1 data showed a near tripling of Objective Response Rate compared to checkpoint inhibitor monotherapy, including a Complete Response, and supports expansion SAN DIEGO and CALGARY, Alberta, Feb. 14, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the...Read more
COAST trial is evaluating the superiority of sozinibercept combined with EYLEA® (aflibercept) over EYLEA alone in wet AMD Enrollment of second pivotal trial (ShORe) to complete in calendar Q2 2024 COAST and ShORe top-line results expected by mid-2025 MELBOURNE, Australia, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT), a clinical-stage biopharmaceutical company developing novel therapies to treat highly...Read more
Activation of four U.S. sites for Phase 1 clinical trial of PAS-004 to evaluate safety, dose, key biomarker data and preliminary efficacy Plans to open three additional sites in Eastern Europe in the coming months Preliminary interim data expected in 2H 2024 SOUTH SAN FRANCISCO, Calif. and MIAMI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a...Read more
Approximately 40 Centers Currently Open 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 Recent Successful $16 Million Financing Extends Company’s Cash Runway Through Late Q3 2024 and Beyond Expected Timing of Unblinded Interim Analysis; Potential Additional $19 Million if Warrants are Exercised to Fund PolyPid to the Start of a...Read more
Enrolled patients allowed to continue on study MENLO PARK, Calif. / Feb 12, 2024 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced the company’s decision to voluntarily pause Phase 3 enrollment in the seamless Phase 2/3 clinical trial (EBO-301) evaluating...Read more
Preliminary results from HELIOS anticipated in the second half of 2024 CAMBRIDGE, Mass. / Feb 08, 2024 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced it has completed enrollment of its Phase 2 HELIOS trial of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO]) for the treatment of Wolfram syndrome (WS), a rare genetic disease that typically results in...Read more
Over 40 sites (U.S. and Canada) have agreed to participate in the LEVEL study LEVEL is a randomized, controlled Phase 3 trial of 152 patients, and will recruit patients primarily from leading research centers with large PH-HFpEF populations Tenax forecasts topline LEVEL data will be available second half of 2025 CHAPEL HILL, N.C., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical...Read more
SEATTLE, Feb. 07, 2024 (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 the (Z)-endoxifen arm of the ongoing Phase 2 I-SPY 2 clinical trial has fully enrolled. In the study, (Z)-endoxifen, Atossa’s proprietary Selective Estrogen Receptor Modulator...Read more
Completed enrollment in cohort 2 of the Phase I/II AFFINITY DUCHENNE® trial of RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne that includes an optimized transgene for a novel microdystrophin New three-month assessment in third patient at dose level 1 demonstrates largest increase in microdystrophin expression Patient aged 6.6 years old had expression level at 83.4% of control On track to initiate...Read more
Human proof of concept portion of the trial expected to begin in H1 2024; led by Georgetown Lombardi Comprehensive Cancer Center BXCL701 in combination with checkpoint inhibitor in preclinical studies demonstrated encouraging results in pancreatic cancer Initial study data expected in 2024 NEW HAVEN, Conn., Feb. 06, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial...Read more
60 Patients Completed Enrollment in Under 9 Months Study Results Expected in the Second Half of 2024 LYON, France, February 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis. The...Read more
FLORHAM PARK, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the first patient has been enrolled in its Phase 1b clinical trial evaluating iopofosine I 131, a novel phospholipid radiotherapeutic conjugate, in pediatric patients with relapsed...Read more
Topline Safety, Tolerability and Immunogenicity Data from VAX-31 Phase 1/2 Study (n=1,015) Expected in Third Quarter of 2024 VAX-31 is Designed to Provide Coverage for Approximately 95% of IPD Circulating in the U.S. Adult Population Company’s Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise, VAX-24 and VAX-31, Intended to Deliver the Broadest-Spectrum of Coverage Against IPD SAN CARLOS,...Read more
The clinical trial for SCI-210 will be conducted in Israel, after which the company aims to move forward with the commercialization process of SCI-210 first in the Israeli market TEL AVIV, Israel, Jan. 29, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today...Read more
UC Davis Medical Center, a top regional and nationally ranked medical center, is the third academic center to participate in the FemBloc pivotal trial since enrollment began last quarter UC Davis Professor of the Obstetrics and Gynecology (OB/GYN) Department and Director of the Complex Family Planning Fellowship, Mitchell Creinin, M.D. has been an initial advisor for FemBloc FemBloc is being developed as a first-of-its-kind,...Read more
Interim Data Analysis Anticipated in Mid-2024 Expects Full Enrollment by Q1 2025 MINNEAPOLIS, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced it has reached 50% enrollment for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic...Read more
MOUNTAIN VIEW, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Iridex Corporation, headquartered in Mountain View, California, and Imperial College Healthcare NHS Trust in London, today announced the first patient enrollment in a collaborative medical research study and registry evaluating the treatment of glaucoma with MicroPulse® Transscleral Laser Therapy (TLT) using Iridex’ Cyclo G6® Laser and the MicroPulse P3® Delivery Device. This...Read more
University of Utah Hospital, Lori Gawron, M.D. of the Obstetrics and Gynecology (OB/GYN) Department, was an instrumental investigator in Femasys’ earlier FemBloc study FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway ATLANTA, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet...Read more
OCALA, Fla., Jan. 22, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the first subject has been enrolled at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC...Read more
100 Patients Enrolled, Exceeding Target Enrollment of 90 Patients Topline Results for CAHmelia-204 Anticipated in the Third Quarter of 2024 SOUTH SAN FRANCISCO, Calif. / Jan 22, 2024 / Business Wire / Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today announced completion of...Read more
Exceeded originally target enrollment (70) with n=74 Last patient, last visit expected in approximately six weeks; data to follow shortly thereafter Positive data triggers milestone payment from Alvogen, as previously announced. RADNOR, Pa., Jan. 22, 2024 /PRNewswire/ -- NRx Pharmaceuticals,...Read more
Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., Jan. 18, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive pre-clinical safety data of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in combination with sitagliptin, a DPP4 inhibitor. Additionally, having satisfied...Read more
HOUSTON, TX / ACCESSWIRE / January 17, 2024 / 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 completion of planned enrollment in its global potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline...Read more
SEATTLE, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), today announced that it began patient recruitment for the second dosing cohorts (Cohort 2) in clinical studies for both of its lead product candidates, [212Pb]VMT-α-NET and [212Pb]VMT01, after the safety monitoring committees for each study unanimously recommended moving forward. In addition, the first patient in cohort 2 of the [212Pb]VMT01...Read more
SOUTH JORDAN, Utah, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the successful enrollment of the first patient in its multicenter, prospective, randomized, controlled trial comparing genicular artery embolization (GAE) using Embosphere® Microspheres to corticosteroid injections for the treatment of symptomatic knee...Read more
DALLAS, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (NASD:MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in clinical wound care, announces the enrollment of the first patient in the pivotal study to validate DeepView AI® using its proprietary imaging technology for burn size and healing assessment. This pivotal...Read more
First enrollment and first subject dosing expected soon at Erasmus Medical Center in Rotterdam, Netherlands Management discusses the announcement and what this means here: video OCALA, Fla., Jan. 10, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that enrollment is open at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen®...Read more
New patient enrollment sites accelerating screening activity Screening activity exceeding 100 patients per week Approaching interim enrollment target of 90 patients TORONTO, Jan. 10, 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...Read more
Toronto, Ontario--(Newsfile Corp. - January 9, 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, is pleased to announce that it has exceeded 50% patient enrollment for ARCHER, the Company's Phase II, multi-center, international,...Read more
Final data from the TRIDENT trial anticipated in 2026 ROOT, Switzerland / Jan 09, 2024 / Business Wire / Novocure (NASDAQ: NVCR) today announced that the final patient has been enrolled in the global phase 3 TRIDENT clinical trial evaluating the safety and efficacy of initiating Optune Gio® (formerly known as Optune®) concurrent with radiation therapy and temozolomide (TMZ) for the treatment of adult patients with newly diagnosed...Read more
The ABILITY-1 Study will evaluate MDNA11, a highly selective long-acting IL-2 Superkine, in combination with KEYTRUDA® (pembrolizumab) for treatment of patients with advanced solid tumors MDNA11 continues to demonstrate encouraging single-agent activity from the dose escalation portion of the ABILITY-1 Study MDNA11 is generally well tolerated with no dose-limiting toxicities or vascular leak syndrome reported in any of the dose...Read more
SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the fourth patient has now been enrolled into its Phase 1/2 study of ONCT-534, its dual-action androgen receptor inhibitor, for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved...Read more
Therapy Demonstrated Safety, Stabilization/Shrinkage of Treated Tumors Expanded Development for Monotherapy and Combination Therapy Anticipated ATLANTA, GA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the closure of patient enrollment for the Phase 1/2 clinical study...Read more
ATLANTA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announces that it has completed enrollment for the company’s Synchronicity Study, a prospective, open-label clinical study evaluating the safety and efficacy of YUTIQ...Read more
Phase 3 hypothalamic obesity top-line data expected in 1H2025 Positive reimbursement decision achieved for IMCIVREE® (setmelanotide) to treat patients with Bardet-Biedl syndrome and POMC/LEPR deficiencies in Spain IND application for RM-718 accepted by the FDA BOSTON, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on...Read more
HOUSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that the hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD Anderson Cancer Center (MDACC or MD Anderson) is now listed as active and recruiting on clinical trials.gov – trial NCT04734990. Salarius also announces that an additional Ewing sarcoma patient treated with seclidemstat, topotecan and...Read more
NOVATO, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, today announced the completion of patient enrollment in its Phase 1/2 clinical trial of GTX-102 for the treatment of pediatric patients with Angelman syndrome (AS). The dose-expansion cohorts (Cohorts...Read more
FOSTER CITY, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, today announced the completion of enrollment in its Phase 3 bridging study evaluating uproleselan (APL-106), an investigational, first-in-class E-selectin antagonist, added to a standard chemotherapy regimen for the...Read more
Topline data from LIFT-AD on track for second half of 2024 Previously reported independent, unblinded interim analysis supports trial continuation and potential clinically meaningful activity of fosgonimeton Potential first-in-class approach focused on HGF modulation for treatment of neurodegenerative diseases BOTHELL, Wash., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage...Read more
Expected Topline Data Readout Accelerated to Midyear 2024 Following Early Completion of Patient Enrollment in Phase 2 Primary Sclerosing Cholangitis (PSC) SPRING Trial CM-101's Unique Dual Anti-Fibrotic and Anti-Inflammatory Activity Has Disease Modifying Potential in PSC, Which Often Results in Liver Transplant or Death and Lacks Any FDA-Approved Treatments TEL AVIV, Israel, Jan. 3, 2024 /PRNewswire/ -- Chemomab...Read more
SAN DIEGO, Jan. 2, 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 in the third cohort of patients in the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD. "The completion of our third and final randomized...Read more
Topline results expected 2Q 2024 Study enrolled a total of 241 patients; 109 catheter failures observed First-and-only antibiotic lock solution in development to salvage catheters in patients with CRBSI CRANFORD, N.J., Jan. 2, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class...Read more
Topline data remains on track for second quarter of 2024 MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal...Read more
CAMBRIDGE, Mass. , Jan. 2, 2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that enrollment has been completed in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01, Leap's anti-Dickkopf-1 (DKK1) antibody, in combination with tislelizumab, BeiGene's anti-PD-1 antibody, and chemotherapy in...Read more
DENVER, Dec. 28, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in...Read more
EQ101 Phase 2 study in alopecia areata is fully enrolled with topline data expected in Q2 2024 EQ302, an orally delivered multi-cytokine inhibitor of IL-15 & IL-21, will be advanced in place of further clinical development of EQ102 based on EQ302’s optimal delivery and increased potency LA JOLLA, Calif. / Dec 21, 2023 / Business Wire / Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel...Read more
NAUTILUS is the first and only pivotal clinical study to evaluate neuromodulation therapy for treating drug refractory idiopathic generalized epilepsy Neuromodulation therapy is not currently indicated for patients with drug refractory generalized epilepsy If successful, NeuroPace’s RNS System would represent the first neuromodulation indication in idiopathic generalized epilepsy MOUNTAIN VIEW, Calif., Dec. 21, 2023 (GLOBE...Read more
Alignment with FDA on Best Corrected Visual Acuity ≥ 15-Letter Loss as Primary Outcome Measure - Representing the Highest Value Outcome to Patients and Physicians ARCHER II, a Global Sham-Controlled Trial Supporting a Potentially Faster Path to Registration, Expected to Initiate in Mid-2024 ARROW, a Head-to-Head Trial using SYFOVRE® as an Injection Comparator to Differentiate Vision Protection from Slowing of Lesion Growth, Expected...Read more
About 550 patients will be treated once weekly for 12 weeks STAR-1 topline results expected in first quarter of 2025 Acne affects about 50 million patients in the U.S. SAN DIEGO, CA / ACCESSWIRE / December 20, 2023 / Dermata Therapeutics, Inc. (Nasdaq:DRMA, DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced...Read more
Enrollment completed in placebo-controlled, randomized, dose-finding, multi-country, multi-center Phase II sepsis study Topline Data Expected in late Q1 2024 Nes-Ziona, Israel, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enrollment of all 120 patients in its Phase II trial of...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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