SUNNYVALE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled at University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial. “CardiAMP cell therapy has shown evidence of benefit for ischemic heart...Read more
Patients treated with RGX-202 demonstrate consistent, robust microdystrophin expression and functional improvement compared to natural history in Phase I/II portion of AFFINITY DUCHENNE® trial supporting potential approval via the accelerated approval pathway REGENXBIO continues to enroll patients in the confirmatory trial First batches intended for commercial supply manufactured at in-house Manufacturing Innovation...Read more
WAYNE, Pa., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced that the Company has completed enrollment in its Phase 2 LOTUS trial of AVTX-009 in adults with hidradenitis suppurativa (HS). The LOTUS trial exceeded target enrollment of 222 patients with approximately...Read more
NEW YORK, Oct. 28, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has completed in the randomized cohort of the Phase 3 ENHANCE trial evaluating a consolidated Day 1 and Day 15 dosing schedule for IV BRIUMVI® (ublituximab-xiiy), the company’s novel, glycoengineered, anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). The primary endpoint of this trial...Read more
Orchestra BioMed’s Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) is the first non-coated drug-eluting balloon system designed to deliver a large liquid dose of proprietary extended-release sirolimus (“SirolimusEFRTM”) The Virtue Trial is the first U.S. investigational device exemption (“IDE”) head-to-head randomized coronary pivotal trial evaluating a sirolimus-eluting balloon versus a commercially available...Read more
Prospective study to evaluate diagnostic performance and generate real-world data for the Mitomic® Endometriosis Test, a non-invasive alternative to surgical diagnosis for endometriosis MOUNTAIN VIEW, Calif. / Oct 27, 2025 / Business Wire / Aditxt, Inc. (Nasdaq: ADTX) ("Aditxt" or the "Company"), a social innovation platform accelerating promising health innovations, today announced that its subsidiary, Pearsanta, Inc. ("Pearsanta"),...Read more
The formal safety review of Cohort 3 (5ug/kg/day) has been successfully completed with no safety or tolerability issues observed, allowing advancement into Cohort 4 with a dose of 10 ug/kg/day Actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks Cohort 4 dose is potentially more reflective of the clinical efficacy threshold given positive trend in observations on multiple immunological...Read more
No targeted treatments are currently FDA approved for high-grade IDH1-mutant gliomas After a favorable meeting with FDA, protocol amendment will make G203 a Phase 3 trial to support potential registration NEW YORK / Oct 23, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced enrollment of the first patient into part 2...Read more
With several patients already enrolled in the study, PRISM PMR is designed to evaluate the Swoop® system’s clinical utility in the operating room. GUILFORD, Conn. / Oct 21, 2025 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced plans for clinical use...Read more
Vancouver, Canada, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the enrollment of the last patient for the first cohort of its Phase I/IIa clinical trial evaluating CMND-100, the Company’s...Read more
SIGNAL-AA Part B exceeded target enrollment based on demand from patients; trial size increased to 33 patients WALTHAM, Mass., Oct. 21, 2025 /PRNewswire/ -- Q32 Bio Inc. (NASDAQ: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata (AA) and other autoimmune and inflammatory diseases, today announced that it has completed enrollment in Part B of its SIGNAL-AA...Read more
SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1...Read more
The Company is well on track with Phase 1 enrollment now that both patients in Cohort 3 have successfully initiated treatment with no evidence of dose-limiting toxicities or tolerability concerns to date The first patient in Cohort 3 has shown promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts; additional update anticipated by year-end Upon...Read more
Over 1,200 participants enrolled in ATMOSPHERE® and ASCENT® pivotal trials, representing largest global gene therapy program ever conducted Subretinal surabgene lomparvovec on track to be first gene therapy for wet AMD Topline pivotal data expected in Q4 2026 ROCKVILLE, Md., Oct. 6, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the completion of enrollment in the ATMOSPHERE® and ASCENT® pivotal studies...Read more
EXPAND is a prospective, blinded, multi-site clinical trial with diagnostic outcomes on all subjects AUSTIN, Texas / Oct 01, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing and precision medicine, today announced a milestone in the EXPAND trial with the enrollment of over 1,600 patients. Initiated in 2023, EXPAND is designed to be the defining prospective clinical trial in the...Read more
Topline results from the EXPLORE-OSA trial are anticipated in 1Q 2026 RADNOR, Pa., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that...Read more
Trial initiation follows the recent approval of IBTROZI™ (taletrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer NEW YORK / Sep 30, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy...Read more
Enrollment Completed in Ongoing Phase III ReSPECT Study in Prophylaxis of Fungal Infections in Adult Patients Undergoing Allogeneic Blood and Marrow Transplant Topline Results from ReSPECT Study Expected in 2Q 2026 BERKELEY HEIGHTS, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for...Read more
Following the positive interim results in 5 patients announced earlier this year, a total of 9 patients have been enrolled as planned The study is progressing according to protocol, and no safety issues have been reported Study completion is anticipated in Q4 2025 with topline to follow HOUSTON, Sept. 29, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company...Read more
Enrollment remains on track with internal interim results expected in Q2 2026 Randomized study to evaluate Nociscan’s ability to improve surgical outcomes for chronic low back pain Nociscan aims to become the gold standard in identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence (AI) BROOMFIELD, Colo., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq:...Read more
POTOMAC, MD / ACCESS Newswire / September 22, 2025 / IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage pharmaceutical company focused on therapies for Alzheimer's disease, today announced it has reached a key enrollment milestone of 50% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease. This milestone marks a significant step in advancing IGC-AD1, the Company's...Read more
Patient Recruitment Closed LA JOLLA, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the successful completion of patient enrollment in its Phase 2/3 clinical trial, COMBAT-ALS, evaluating MN-166 (ibudilast) for the treatment of Amyotrophic Lateral Sclerosis...Read more
On track for first FDA Biologics License Application (BLA) approved cell therapy in orphan indication relapsed/refractory AL Amyloidosis – Los Angeles, CA, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that 50% enrollment milestone has already...Read more
Completed patient enrollment within nine months with nearly half enrolled from the U.S. Expect to report Phase 3 topline data in the first half of 2026 On track to submit BLA in the second half of 2026 for an anticipated U.S. launch in the first half of 2027 Plan to present additional data from the Phase 1/2 study in the fourth quarter of 2025 CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics,...Read more
Enrollment complete in VRDN-003’s phase 3 clinical trials in thyroid eye disease (TED), REVEAL-1 and REVEAL-2, with each study exceeding its enrollment target due to strong patient demand; topline data on track for first half of 2026 VRDN-003 composition of matter patent granted by the USPTO with term to 2041 and potential to extend exclusivity Veligrotug Biologics License Application (BLA) submission on track and...Read more
Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025 New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more
The Trial Evaluates a Combined PCI Approach Using Drug-Coated Balloons and Drug-Eluting Stents WAYNE, Pa., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary...Read more
Top-Line Results Anticipated in March 2026 NEWTON, Mass., Sept. 10, 2025 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients. "We are excited to announce that we have...Read more
European expansion in September across Georgia, Italy, Lithuania, Poland, Romania, Spain, and US 13 subjects recruited (treated, enrolled, or screened) Forecasts total recruitment of 20 or more subjects by end of September On track to recruit to 45 patients in Q4 25 for initial data unblinding HOUSTON, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage...Read more
Topline data announcement expected second quarter of 2026 FOSTER CITY, Calif. / Sep 08, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced the completion of enrollment in the Phase 2b VISTAS study of volixibat, an investigational oral IBAT inhibitor, for the treatment of cholestatic pruritus in patients with primary sclerosing cholangitis (PSC). The trial previously met its pre-specified efficacy and...Read more
CLEVELAND CLINIC ABU DHABI (CCAD) HAS COMMENCED RECRUITMENT IN THIS 36 PARTICIPANT STUDY PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / September 8, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that the SKNJCT-004 phase 2 clinical study, to...Read more
The Phase 2 GAD study has enrolled 36 participants to evaluate the safety and efficacy of CYB004 at 12 weeks after first dose Reaffirms top-line data guidance for Q1 2026 TORONTO / Sep 08, 2025 / Business Wire / Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative...Read more
Phase 3 trial to evaluate two subcutaneous BRIUMVI dosing regimens NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy), the company’s anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). BRIUMVI is currently approved in the United States, as well as...Read more
Recommendation that trial escalate to next dose level of 8mg tablet Initial interim clinical data from first two cohorts expected in Q1 2026 MIAMI, Sept. 08, 2025 (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 today announced that the external Safety Review Committee...Read more
On Track To Be First Mover In $7Bn Addressable Market With No Current Therapeutic Options By: Benzinga Staff Writer CARDIFF, UK / ACCESS Newswire / September 8, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a late clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, has launched its registrational Phase 3 trial of eRapa - its proprietary...Read more
iMDx’s ClinicalTrials.gov listing now names 10 leading transplant centers, up from 5 previously GraftAssureDx remains on track for FDA submission by end of 2025, commercial launch in 2026 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (Nasdaq: IMDX), today announced that it is actively enrolling patients in its clinical trial to assess GraftAssureDx and that last week, it enrolled the...Read more
Topline data anticipated in early Q4 2025 BURLINGTON, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today announced the achievement of target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial evaluating lead candidate BNC-210 as a first-in-class,...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 4, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced they have enrolled their first patient with non-small cell lung cancer (NSCLC) in the ongoing Phase 1/2 combination trial of IDE397, a potential first-in-class, small molecule adenosyltransferase 2a (MAT2a) inhibitor, and Trodelvy® (sacituzumab govitecan-hziy), a Trop2-directed...Read more
Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC) One of the largest randomized phase 3 studies in this patient population will encompass broadest range of patient types per AUA/SUO Guidelines IRVINE, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a...Read more
PURCHASE, N.Y., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study has reached the 75% enrollment mark. The START Study is enrolling approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer’s disease who will be treated with...Read more
POTOMAC, MD / ACCESS Newswire / September 2, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced expansion of its ongoing Phase 2 clinical trial evaluating IGC-AD1, a novel investigational treatment for agitation in Alzheimer's dementia, to a new international site at Island Health's Royal Jubilee Hospital in Victoria, British Columbia, Canada. "Bringing CALMA to Canada is a milestone in our mission to offer innovative solutions...Read more
LA JOLLA, Calif., Aug. 26, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces that it successfully achieved enrollment of the target number of participants in its COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast). MN-166 is currently in development for the treatment of...Read more
SOUTH SAN FRANCISCO, Calif. / Aug 26, 2025 / Business Wire / Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced it has met its targeted enrollment for the NIGHTINGALE trial, which aims to evaluate the clinical utility of its Percepta Nasal Swab test. The milestone marks an important step in Veracyte’s goal of making the novel molecular test widely available and helping clinicians to better guide next steps...Read more
The NEPHRO CRRT pivotal trial has now reached approximately 25% enrollment, driven by the recent acceleration in the recruitment rate from new profile clinical sites On track for planned study completion by the end of 2025 SAN MATEO, Calif., Aug. 25, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in...Read more
Topline results anticipated in Q1 2026 and, if successful, planning for expedited NDA submission If approved, ampreloxetine could address a critical unmet need as the first therapy with the potential to provide durable benefit for the 40,000 patients in the U.S. with symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) Ampreloxetine has Orphan Drug Designation in the U.S.,...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 20, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as a first-line treatment in certain non-small cell lung cancer (“NSCLC”) patients whose tumors harbor epidermal growth factor receptor (“EGFR”)...Read more
August 18, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the enrolment of the first two patients by the Pan American Center for Oncology Trials in San Juan, Puerto Rico into its pivotal Phase 3 Serenta trial of eRapa in patients with...Read more
Enrollment in the planned second dose expansion cohort completed ahead of expectations Topline results expected in Q1 2026 Positive Phase 1b dose escalation data presented at ESMO GI on July 2nd ROCKVILLE, Md., Aug. 11, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that...Read more
Trial now over 60% enrolled with 125 of 200 anticipated patients Recent new site activation brings total clinical trial sites to 16 Interim analysis of first 100 patients remains on track for 3Q 2025 DENVER, Aug. 06, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss...Read more
ECLIPSE registrational program now fully underway, following enrollment of the first patient in ECLIPSE 3 ECLIPSE 3 is designed to compare the combination of tobevibart and elebsiran to bulevirtide in patients with chronic hepatitis delta SAN FRANCISCO / Aug 06, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the enrollment of the first participant in ECLIPSE 3. All three trials in the Company’s...Read more
NEURO PMR study evaluates the clinical utility and patient experience of AI-powered portable MRI in an outpatient setting GUILFORD, Conn. / Aug 04, 2025 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system— today announced the successful enrollment of 100 patients in its...Read more
BOCA RATON, FL, Aug. 04, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, is pleased to report that its Phase I/II trial (the “CaRe PC” trial) of INKmune™ for men with metastatic castration-resistant prostate cancer (mCRPC) has met its primary and secondary endpoints and is now closed to further enrollment. INKmune™ was well tolerated at all three dose...Read more
Company expects to complete Phase 3 Aspire study in the second half of 2026 Aurora study of GTX-102 in additional ages and genotypes on track to initiate in the second half of 2025 NOVATO, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the Phase 3 Aspire study evaluating GTX-102 (apazunersen) as a treatment for Angelman Syndrome is fully enrolled, with approximately 129...Read more
First patient enrolled in ECLIPSE 2 Phase 3 clinical trial evaluating the switch to the combination of tobevibart and elebsiran in patients not achieving undetectable hepatitis delta virus RNA despite bulevirtide treatment ECLIPSE 2 is a pivotal trial designed to support global marketing applications, including in the U.S. and Europe SAN FRANCISCO / Jul 31, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced...Read more
Japanese patient cohort enrollment is completed ahead of schedule at multiple clinical sites including the National Cancer Center in Tokyo The incidence rate of never-smokers with non-small cell lung cancer (NSCLC) in Japan is 35 to 40%, double that of the rates in US and European populations The treatment of never-smoker with NSCLC represents a market opportunity estimated at over $4 billion annually There are no approved therapies...Read more
Initial interim safety, tolerability, biomarker, and preliminary efficacy data expected in Q1 2026 MIAMI, July 31, 2025 (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 MAPK pathway driven indications, today announced the...Read more
Primary endpoint is safety; Namodenoson continues to demonstrate a favorable safety profile Ramat Gan, Israel, July 30, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced that it achieved the over 50% enrollment milestone in its Phase...Read more
LUCIA pivotal Phase 3 trial enrolled and randomized over 400 patients in seven months, demonstrating continued strong enthusiasm for the DURAVYU pivotal program across the global retinal community Over 800 patients enrolled across the LUGANO and LUCIA trials of DURAVYU, representing one of the fastest enrolling Phase 3 pivotal programs for wet AMD Interim analysis by independent Data Safety Monitoring Committee (DSMC)...Read more
Topline data readout from HARBOR study anticipated in Q2 2026 Marketing application submissions for del-desiran including in U.S., EU and Japan anticipated to start in H2 2026; on track to potentially be the first globally approved drug for DM1 On track to share updates from ongoing MARINA-OLE™ trial of del-desiran including long-term 4 mg/kg efficacy and safety data in Q4 2025 SAN DIEGO, July 28, 2025 /PRNewswire/ --...Read more
Trial Investigates Use of Auryon Atherectomy System in Cases with Challenging Below-the-Knee Blockages LATHAM, N.Y. / Jul 28, 2025 / Business Wire / AngioDynamics, Inc. (NASDAQ: ANGO), a 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 enrollment of the first patient in the Randomized Study of the...Read more
Topline Readout Expected in Q3 2026 SOUTH SAN FRANCISCO, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its global LUMUS Phase 2b trial of ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor,...Read more
Expedited Enrollment Surpassing 630 Targeted Participants Underscores the Strong Demand for a Therapy Focused on Vision Preservation Phase 3 ARCHER II Trial Design and Rationale to Be Presented at ASRS, a Leading Meeting for Retina Science and Innovation Topline Pivotal Phase 3 Data Expected in the Second Half of 2026 Potential for Vonaprument to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic...Read more
MN-166 COMBAT ALS trial down to single digit required enrollment while MN-001 hypertriglyceridemia trial in type 2 diabetes patients requires final two patients LA JOLLA, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the “Company”), today provides an update on...Read more
TORONTO, July 22, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the investigator-led Phase II trial titled “Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin” (PONTIAK) has commenced patient recruitment at its primary clinical sites in Alberta, Canada. The Phase II PONTIAK study aims to evaluate the efficacy of cilastatin in...Read more
Compelling new preliminary data consistent with previously reported preclinical findings demonstrating certepetide’s potential ability to enhance the effectiveness of immunotherapy BASKING RIDGE, N.J. and SUBIACO, Australia, July 17, 2025 (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...Read more
SOUTH SAN FRANCISCO, Calif. / Jul 16, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that the company has completed enrollment in its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial to evaluate its lead asset,...Read more
Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial Recent EU approval from the European Medicines Agency (EMA) boosts trial profile Enrollment in Part A of MIRACLE reaches seven subjects treated and one additional subject in screening 16 additional clinical sites in Europe and the US expected to begin recruitment by the end of August; building to...Read more
Topline results from the CHASE trial expected by end of Q3 2025 Potential for CHASE to serve as a pivotal trial in support of a Biologics License Application (BLA) submission, contingent on positive results ARLINGTON, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for...Read more
PRINCETON, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent...Read more
500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia SAN DIEGO, July 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment in the...Read more
Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research Foundation Precision medicine approach: The 60-patient Phase 2 study uses the PCPro™ lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combination Led by Professor Lisa Horvath, the study is expected to...Read more
Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival 2- and 6-week interim safety results demonstrated GRI-0621 to be safe and well-tolerated in the first 12 and 24 patients evaluated, respectively Results on track for 6-week interim biomarker analysis (n=24) in July 2025 and topline data in Q3 2025 LA JOLLA, CA,...Read more
PURCHASE, N.Y., July 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study surpasses 50% enrollment. The START Study is being conducted with partners at the Alzheimer’s Clinical Trials Consortium (ACTC), with $81 million in grant support from the National Institute of...Read more
As of June 30th, 16 participants have enrolled in the Phase 1b, ahead of the original goal of at least 15 total participants by 3Q 2025 Analysis of 90-day biomarker activity from cerebrospinal fluid (CSF) in all participants currently enrolled is now expected to also track earlier; available in 4Q 2025 instead of 1Q 2026 Gain will continue screening patients for enrollment through July 31st, 2025, at the request of clinical...Read more
The SEISMiC C Study is the third study in the istaroxime cardiogenic shock development program - SEISMiC C is studying more severely ill SCAI Stage C cardiogenic shock patients Windtree has previously reported two positive early cardiogenic shock Phase 2 studies in SCAI Stage B patients The SEISMiC C interim analysis will provide a preliminary assessment of istaroxime safety in treating more severe cardiogenic shock patients who may...Read more
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder Vancouver, Canada, June 25, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major...Read more
The first CLARITY patient was enrolled at the Texas Back Institute, a world leader in advancing spine technology, science, and education, as well as patient care CLARITY is a randomized clinical trial designed to demonstrate Nociscan’s ability to improve surgical outcomes for chronic low back pain Nociscan aims to become the gold standard in identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence...Read more
Treatment to Evaluate Effect of Food on Overdose Protection of MPAR Grant Funds from NIDA Accelerating Clinical Development Program SAN DIEGO, CALIFORNIA / ACCESS Newswire / June 24, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today...Read more
MOUNTAIN VIEW, Calif., June 24, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and accessories for the treatment of glaucoma and retinal diseases, announced today that the first patient has been successfully enrolled in the independent, investigator-led DAME Trial to evaluate the clinical efficacy, safety, cost-effectiveness,...Read more
Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positive U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designation Laromestrocel HLHS program addresses...Read more
Multi-center, multi-national study builds on existing U.S. PE Clearance and CE Mark to assess mechanical thrombectomy treatment and long-term functional outcomes in intermediate-risk PE patients across Europe LATHAM, N.Y. / Jun 23, 2025 / 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...Read more
Study completion anticipated in mid-2026 with subsequent data readout and regulatory submissions for treatment of severe hypertriglyceridemia PASADENA, Calif. / Jun 23, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has completed enrollment in SHASTA-3, SHASTA-4, and MUIR-3, the company’s global Phase 3 clinical studies designed to support regulatory submissions for marketing approval of...Read more
Ralinepag has the potential to be the first once-a-day oral prostacyclin agonist for patients with pulmonary arterial hypertension ADVANCE OUTCOMES will continue to accrue clinical worsening events through the end of 2025 and top-line data is expected in the first half of 2026 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Jun 23, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit...Read more
[212Pb]VMT-α-NET Phase 1/2a study is advancing into Cohort 3 with a fixed administered dose that is up to 20% higher (6 mCi) than the dose administered to patients in Cohort 2 Dosimetry sub-study analysis presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting to advance utility of dosimetry in clinical development when considered with clinical data On track to submit further clinical updates...Read more
90th participant enrolled in landmark clinical trial in patients with Major Depressive Disorder Targets October 2025 for initial results presentation Vancouver, British Columbia – TheNewswire - June 18, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharma/biotechnology company dedicated to developing novel and effective mental health treatments, is...Read more
CARDIFF, UNITED KINGDOM / ACCESS Newswire / June 18, 2025 / When it comes to type 1 diabetes, treating this chronic condition can be difficult. After all, with this type of diabetes, the body's immune system attacks and destroys the beta cells that produce insulin. Without the natural ability to produce insulin, glucose from the bloodstream isn't absorbed into cells to provide energy. Since there is no cure, patients with type 1 diabetes...Read more
San Diego, California--(Newsfile Corp. - June 17, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biopharmaceutical company developing sulfur-based therapeutics for serious pediatric and inherited mitochondrial diseases, today announced the recent activation of its French clinical site for Thiogenesis' ongoing Phase 2 clinical trial evaluating TTI-0102 in patients with...Read more
STORM-PE is a first-of-its-kind clinical trial comparing computer assisted vacuum thrombectomy (CAVT™) using Penumbra's Lightning Flash™ with anticoagulation versus anticoagulation alone in the treatment of acute intermediate-high risk pulmonary embolism ALAMEDA, Calif., June 16, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's leading thrombectomy company, announced the completion of enrollment in the...Read more
Enrollment Completed in Ongoing Registrational PROSERA Phase 3 Study in PAH Topline Results Announcement from PROSERA Phase 3 Expected in February 2026 Blinded Preliminary Baseline Characteristics Align with Intended Study Population SAN DIEGO / Jun 16, 2025 / Business Wire / Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of...Read more
Vancouver, British Columbia – TheNewswire – June 11, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharma/biotechnology company dedicated to developing novel and effective mental health treatments, is pleased to announce the enrolment of the 85th participant in its landmark Phase 2B clinical trial evaluating MB22001 for Major Depressive Disorder (MDD). MB22001, MindBio’s...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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