First patient dosed with CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute (DFCI) BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, announced today the initiation of...Read more
Single-agent CD19 CAR-NK cell therapy achieved a complete response in third-line Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma Second patient maintains an ongoing complete response at six months with CD19 CAR-NK in combination with rituximab and a third WM patient has been enrolled in the study First study to demonstrate the potential for complete responses with a chemotherapy-free immunotherapy in late-stage WM...Read more
SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that dosing in the Phase 2 B-SUPREME study of its investigational compound ALG-000184 has been initiated in subjects with chronic hepatitis B virus (HBV)...Read more
Phase 3 results position telitacicept as potential best-in-disease profile in primary Sjögren's disease Telitacicept demonstrated a favorable safety profile Vor evaluating timing of global Phase 3 clinical study in primary Sjögren's disease Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming...Read more
The CTMX-2051-101 study has enrolled 73 colorectal cancer patients to-date, aligned with the Company’s goal of providing a Phase 1 data update in Q1 2026 The CTMX-2051-101 study remains active and patients continue to be dosed with CX-2051 across all expansion doses SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally...Read more
Results exceed prespecified primary endpoint of 95% posterior probability of benefit for PMX on 28-day mortality Pooled absolute risk reduction of 8.3%; Relative risk reduction of 18% Key secondary endpoint: 90-day Mortality 17.4% lower with PMX and >99% posterior probability of benefit 38.7% Mortality at 28 days with PMX confirms results of prior trial subset TORONTO, Ontario and DEERFIELD, Ill., Aug. 12, 2025 (GLOBE...Read more
PADCEV plus KEYTRUDA is the first and only regimen to improve survival when used before and after standard of care (surgical cystectomy) in cisplatin-ineligible patients with muscle-invasive bladder cancer Results will be discussed with global health authorities for potential regulatory filings NEW YORK & TOKYO / Aug 12, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki...Read more
Positions IGC at the intersection of biotech innovation and cannabinoid science in one of the largest unmet medical needs in the world Alzheimer's affects over 50 million people globally, with more than 400 million at risk from underlying disease pathology POTOMAC, MARYLAND / ACCESS Newswire / August 12, 2025 / IGC Pharma, Inc. ("IGC" or the "Company") (NYSE American:IGC) today announced promising preclinical results for...Read more
Clinical data confirms elimination of requirement for finger-stick calibration, de-risking pathway to commercialization for the company’s next-generation CGM+ biosensor platform DUBLIN, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced compelling positive clinical...Read more
In a gold-standard model of obesity, treatment with ARD-201 resulted in approximately 19% body weight reduction after 30 days of treatment. ARD-201 was also associated with attenuated weight regain after discontinuation of tirzepatide. In combination with low-dose tirzepatide, ARD-201 improved weight loss compared to high dose tirzepatide alone. Aardvark plans two separate Phase 2 clinical trials for ARD-201: Phase 2 POWER trial to...Read more
Preclinical studies in nonhuman primates naturally infected with T. cruzi have shown AN2-502998's curative potential in chronic Chagas disease No FDA approved treatment for adults with Chagas disease Phase 2 planning underway with recently announced DNDi collaboration; initiation expected in 2026, data in 2027 MENLO PARK, Calif. / Aug 12, 2025 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical...Read more
First and only systemic therapy to improve survival when used before and after surgery for patients with MIBC who are ineligible for cisplatin-based chemotherapy First ever positive Phase 3 study in this cisplatin-ineligible patient population, representing significant advancement in MIBC RAHWAY, N.J. / Aug 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline...Read more
The Phase 1b program is designed to evaluate the clinical activity of NXP900 as a single agent in patients with advanced solid tumors whose cancers harbor specific genetic alterations, and in combination with EGFR and ALK inhibitors in patients with NSCLC whose cancers developed resistance to these treatments Nuvectis will hold a conference call tomorrow, Tuesday, August 12 at 8:30 AM ET to discuss the elements of the Phase 1b program...Read more
Patients treated with Cylembio (imsapepimut and etimupepimut, adjuvanted) plus pembrolizumab achieved improvement in progression free survival (PFS) compared to patients treated with pembrolizumab monotherapy, HR=0.77 (CI 0.58-1.00), (p=0.056), with median PFS (mPFS) of 19.4 months vs. 11.0 months, respectively; the results on the primary endpoint narrowly missed the study’s statistical significance threshold of p≤0.045 In patients...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
Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease BEDFORD, Mass., & CAMBRIDGE, Mass. / Aug 11, 2025 / Business Wire / Stoke Therapeutics, Inc....Read more
Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease CAMBRIDGE, Mass. and BEDFORD, Mass., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq:...Read more
The first patient in Cohort 3, the fifth patient in the trial, has completed the first week of cycle 1 following the successful safety review of Cohort 2 with no safety or tolerability issues observedThe company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts SAN FRANCISCO, CALIFORNIA, Aug. 11, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a...Read more
NEPTUNUS-1 and NEPTUNUS-2 are the first ever global Phase III trials to demonstrate statistically significant reduction in disease activity for Sjögren's disease1 Ianalumab has the potential to become the first and only targeted treatment approved for patients with Sjögren's disease Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren's disease1,2 Novartis plans to present its data at an upcoming...Read more
Exit interviews and clinical results reinforce strong potential for meaningful improvements in sleep quality, cognitive function, and daily life MELBOURNE, Australia and NEW YORK, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company developing innovative combination therapies for prevalent medical conditions, today announced new patient-reported outcome findings from a...Read more
94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo over 29-day evaluation period 94% reduction in genital lesion rate, also statistically significant, observed with 350 mg weekly oral dose compared to placebo over same period Favorable safety and tolerability profile observed...Read more
Epcoritamab in combination with rituximab and lenalidomide (R2) demonstrated statistically significant improvement in Overall Response Rate (ORR; 95.7%, p < 0.0001) and Progression-Free Survival (HR 0.21, p-value <0.0001) versus R2 alone in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL) Results from EPCORE FL-1 form the basis of global regulatory submissions U.S. FDA has accepted for priority review new...Read more
PALI-2108 demonstrated to be safe and well tolerated with no serious adverse events (SAEs) Extended half-life and local bioactivation support convenient once-daily dosing in ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) Colon tissue drug levels exceeded target thresholds 36 hours post-dose in completed Phase 1a MAD cohort Company advancing toward IND submission for Phase 2 study in H1 2026 Carlsbad, CA, Aug. 07,...Read more
66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046) FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting Company responds to FDA correspondences seeking to...Read more
Final Analysis Anticipated by Year-End Upon Occurrence of 80 Events NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the Independent Data Monitoring Committee (IDMC) has completed a...Read more
New data from Eurofins Discovery show that Telomir-1 blocks enzymes that drive disease by turning off critical genes-highlighting its potential to treat cancer, autoimmune conditions, neurodegeneration, and metabolic disorders through epigenetic modulation. MIAMI, FL / ACCESS Newswire / August 7, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a preclinical-stage biotechnology company developing therapies that target the...Read more
Topline results from CATT1 Phase 3 trial expected in second half of 2026 HIGH POINT, N.C., Aug. 07, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced the first study participant has been randomized in the Company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive...Read more
In ATTAIN-1, the investigational once-daily oral pill showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies at 72 weeks Orforglipron achieved the primary and all key secondary endpoints, including demonstrating improvements in a number of cardiovascular risk factors With these results, Lilly is on track to submit orforglipron to global regulatory agencies by year-end and is...Read more
Data to date in single- and multiple-ascending dose cohorts of healthy participants demonstrate a four-day half-life for ABI-6250, supporting target daily oral dosing profile and dose-dependent elevations in biomarker of target engagement Further pharmacological assessment to be conducted in parallel with Phase 2 preparation SOUTH SAN FRANCISCO, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc....Read more
Presented data highlights the potential of Annamycin for treating broad range of human cancers, including high-need oncology indications Annamycin currently in late-stage clinical development in combination with cytarabine for the treatment of AML; Anticipated preliminary data readout in 2H 2025 HOUSTON, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage...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
Vancouver, British Columbia – TheNewswire - August 6, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6) (“MindBio” or the “Company”), a clinical-stage biopharmaceutical company focused on novel treatments for depressive disorders, is pleased to provide an update on clinical trials and corporate activity. The Company is in the completion stages of testing its lead candidate drug MB22001, in a Phase 2B trial in patients...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
Change in the primary endpoint of left ventricular (LV) extracellular volume (ECV) showed a notable improvement (p = 0.0538) favouring CardiolRx™ over placebo. Reduction in ECV was associated with improvements across multiple pre-specified cardiac magnetic resonance imaging (CMR) endpoints, including a significant reduction in LV mass. The ARCHER trial results provide compelling clinical proof of concept for CardiolRx™ and...Read more
First patient successfully completes dosing at Toronto General Hospital St. Michael’s Hospital is expected to be the next Canadian clinical site activated Arch is looking for additional clinical sites in North America to join the trial TORONTO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the first patient has successfully completed...Read more
Proof-of-activity now established for PBGENE-HBV, the first and only clinical modality designed to eliminate covalently closed circular DNA (cccDNA) and inactivate integrated DNA, with the goal of complete cure Cohort 1, the lowest dose cohort (0.2 mg/kg) of ELIMINATE-B, established a safe and well-tolerated profile across multiple dose administrations for all patients PBGENE-HBV demonstrated substantial antiviral activity in all three...Read more
Two-year follow-up in Germany Real-World Registry study showed median 9.6% weight loss and 1.6% HbA1c reduction after a single Revita procedure in participants with type 2 diabetes, with no device- or procedure-related serious adverse events to date New real-world findings are consistent with prior two-year clinical data from studies conducted outside the United States, reinforcing Revita’s potential for long-term metabolic control...Read more
New hope in Alzheimer's: IGC-M3 targets the disease on four fronts, showing promise in cellular models POTOMAC, MD / ACCESS Newswire / August 5, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage pharmaceutical company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders, today announced encouraging preclinical data on its investigational molecule "IGC-M3". The...Read more
Istaroxime was added to currently available inotropes and vasopressors in the study - no new safety signals were identified and physiological improvements were consistent with istaroxime responses in previous trials Cardiogenic shock is a severe presentation of heart failure and SCAI Stage C patients have low blood pressure and signs of organ damage due to low blood flow These data provide the Company confidence to move forward with...Read more
Continued progress positions Company to report topline data for Phase 1 clinical trial of SENTI-202 before year-end SOUTH SAN FRANCISCO, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced it has confirmed the recommended Phase 2 dose (RP2D)...Read more
LIBERATE-1, the first-in-human application of Vivani’s NanoPortalTM implant technology, showed a positive safety and tolerability profile, along with encouraging performance data for NPM-115 that met the study’s primary objectives New NPM-139 (semaglutide implant) preclinical feasibility data showed approximately 20% weight loss maintained longer than 6 months with a single implant, continuing to support the potential for annual...Read more
24-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) PRINCETON, N.J., Aug. 05, 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 the 24-month DOR of 72.2% (95% CI 64.1%,...Read more
TORONTO, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has received the clinical study report (CSR) for the trial entitled “A Phase 1, Randomised, Double-Blind,...Read more
The AMPLIFY-7P study of ELI-002 7P successfully passes event-driven interim analysis for efficacy, futility, and safety by the IDMC The Company views the IDMC’s positive recommendation as an indication that ELI-002 7P has shown preliminary signals of efficacy Final disease-free survival analysis is anticipated to occur in Q4 2025 Elicio previously reached alignment with the FDA on key elements of the planned pivotal Phase 3 study...Read more
Biliary tract cancer (BTC) or cholangiocarcinoma is an aggressive tumor with poor prognosis - KUALA LUMPUR, Malaysia, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative cancer medicines, highlighted a preclinical study from independent investigators titled, “Evaluation of antitumor effects of plogosertib, PLK1...Read more
Treatment with the selective NaV1.8 pain signal inhibitor VX-993 after bunionectomy surgery did not meet the primary endpoint Treatment with VX-993 was generally safe and well tolerated, with safety profile similar to placebo arm BOSTON / Aug 04, 2025 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced topline results from its recently completed Phase 2, randomized, double-blind,...Read more
Sonnet's lead product, SON-1010 (IL12-FHAB), is being evaluated in combination with atezolizumab (Tecentriq®) in patients with advanced platinum-resistant ovarian cancer (PROC) (SB221) Topline safety, cytokine, and efficacy data suggest a strong potential for clinical benefit using the current maximum dose of SON-1010 A second patient with PROC in the E6 combination cohort recently had a confirmed PR, so 2 out of 3 total patients had...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
Successful First-In-Human Use of New Parenchymal Spinal Delivery System First-ever Administration of OPC1 to a Chronic Injury Patient CARLSBAD, Calif. / Aug 04, 2025 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious neurological and ophthalmic conditions, announced today that the first-ever...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
Dosing with vormatrigine over 8 weeks led to 56.3% median reduction in seizure frequency Approximately 22% of patients reached 100% reduction in seizure frequency in the last 28 days on treatment Rapid and sustained response, with over 54% of patients achieving 50% response in the first week Vormatrigine was generally well tolerated and continues to demonstrate favorable safety profile BOSTON, Aug. 04, 2025 (GLOBE NEWSWIRE) --...Read more
Study in a TSC mouse model further demonstrates simufilam’s anti-seizure activity Study conducted in collaboration with TSC Alliance using a well-accepted Tsc1-knockout model First clinical study for simufilam in TSC-related epilepsy expected to begin in H1 2026 AUSTIN, Texas, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on...Read more
Topline results expected H2 2025 REDWOOD CITY, Calif. / Aug 01, 2025 / Business Wire / Exicure, Inc. (Nasdaq: XCUR), a clinical-stage biotechnology company developing therapeutics for hematologic diseases, today announced it has completed the last patient, last visit in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma...Read more
Vast majority of patients dosed completed the full 12-week study Data from more than 2,200 agitation episodes collected Topline data readout anticipated this month NEW HAVEN, Conn., Aug. 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the last patient last visit...Read more
Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in wet AMD, the leading cause of vision loss in people over the age of 60 With two refills per year, Susvimo maintained vision and stabilized the retina for five years, with durability maintained in approximately 95% of patients Susvimo was well tolerated over five years and has a well-characterized safety profile SOUTH SAN FRANCISCO,...Read more
Mounjaro met the primary objective of non-inferiority vs. Trulicity with an 8% lower rate of MACE-3 events, while delivering greater reductions in A1C and weight In the trial, Mounjaro was associated with a 16% lower rate of all-cause death compared to Trulicity, suggesting more comprehensive health benefits Results from the largest and longest Mounjaro trial to date reaffirm its established safety and tolerability profile...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
New Results Reveal Unprecedented Inhibition Rates and First Evidence of SIL204's Efficacy Against Previously Untested KRAS Q61H Mutation in Human Cancer Cells, Significantly Expanding its Pan-KRAS Potential; Company on track for the initiation of a Phase 2/3 clinical trial in Q2 2026 Grand Cayman, July 31, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology...Read more
Biomarkers at 6-week interim analysis show a positive impact on fibrogenesis, fibrolysis and potentially the initiation of a repair response The Independent Data Monitoring Committee (IDMC) has recommended to continue the study as planned as there are no safety concerns seen in the data reviewed Phase 2a study fully enrolled; Topline data on track for Q3 2025 Currently available treatments for IPF are limited to only two approved...Read more
Second patient in the first cohort is now advancing through protocol-defined evaluations as Company provides promising update on first patient pharmacokinetic results SOUTH SAN FRANSCISCO, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ...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
Available data from 13 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer treated with 75 mg/day in the NXP800 Phase 1b study includes 2 partial responses and 3 stable diseases; thrombocytopenia successfully managed with intermittent dosing schedule; observed clinical activity warrants exploration of potential development opportunities in other cancer types NXP900 successfully completed a clinical drug-drug...Read more
Study results support advancing SGX945 in this difficult to treat orphan disease PRINCETON, N.J., July 31, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has completed its Phase 2a proof of concept study evaluating SGX945...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
PHILADELPHIA and VANCOUVER, British Columbia, July 31, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study...Read more
New clinical Precision Medicine population data demonstrates up to 84.6 Weeks (19.5 Months) ‘time saved’ by early-start ADAS-Cog13 difference: −5.43 (P = 0.0035), ADCS-ADL difference: +9.50 (P < 0.0001) Restoring impaired autophagy as early event, preceding amyloid-beta and tau Oral presentation at the Alzheimer’s Association International Conference (AAIC) 2025 NEW YORK, July 31, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences...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
Partial responses observed in 80% of squamous NSCLC front-line patients and in 46% of non-squamous NSCLC front-line patients Safety profile supports further clinical development, with no dose-limiting toxicities observed in patients with front-line NSCLC ImmuneOnco expects to present updated safety and efficacy data at a future medical conference DALLAS and SHANGHAI, July 31, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (Nasdaq: TIL,...Read more
In Study 2 of the pivotal Phase 3 UP-AA clinical program, upadacitinib (RINVOQ®) achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe alopecia areata treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 201 Key secondary endpoints, including improvements in eyebrows and eyelashes, as...Read more
Initiation of additional trial sites and patient enrollment activities ongoing with multiple patients in screening LAWRENCEVILLE, N.J., July 30, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that the first patient has been dosed in the pivotal Phase 3 OVATION 3 Study evaluating the Company’s lead candidate, IMNN-001, for the...Read more
Findings from the TRAILBLAZER-ALZ 2 long-term extension study highlight Kisunla continued to demonstrate slowing of decline, with most participants having completed treatment Data underscores the value of early intervention and supports a limited duration dosing approach with sustained long-term benefits INDIANAPOLIS, July 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results from the long-term extension...Read more
Statistically and clinically significant improvements across key clinical endpoints; IHL-42X reduced AHI by up to 83% from baseline. IHL-42X demonstrates compelling clinical benefit and an outstanding safety profile that exceeded expectations. NEW YORK and MELBOURNE, Australia, July 30, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”) is excited to share positive topline results from its...Read more
Trial Did Not Meet Primary Endpoint or Key Secondary Endpoint of F-VASI50 and F-VASI75 Nominally Statistically Significant Effects Observed in Key Secondary and Exploratory Endpoints of Change from Baseline in F-VASI and T-VASI at 3% Concentration Company Will Terminate Extension Phase of Trial and Seek External Partner for Continued Development of Repibresib BRIDGEWATER, N.J., July 30, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics...Read more
Topical Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and comparable efficacy to injected morphine across both pain phases MIAMI, FLORIDA / ACCESS Newswire / July 30, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic,...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
Hyalofast consistently demonstrated improvements over microfracture, but missed on statistical significance of the pre-specified co-primary endpoints of percent change in KOOS Pain and IKDC function Hyalofast showed statistically significant improvements over microfracture in pre-defined secondary endpoints and other measures that align with prior FDA approvals for cartilage repair products Hyalofast has been used to treat over...Read more
Trial demonstrates 49% confirmed ORR in the 30mg onvansertib dose arm versus 30% confirmed ORR in the control arm in intent-to-treat population (N=110) Early PFS data show a trend favoring 30mg onvansertib dose arm vs. control arm Onvansertib continues to be well-tolerated and demonstrates a dose dependent response for all endpoints including ORR, early tumor shrinkage and depth of response Company will hold a...Read more
Primary Endpoint Analysis Confirms Favorable Tolerability Profile of ATI-2138 Without Certain Risks Associated with Other Agents in the Class Efficacy Results Show Comparable Outcomes to Approved Therapies with Potential for Improved Tolerability, Supporting Exploration of Higher Doses in Future Clinical Trials Pharmacodynamic Results Validate Therapeutic Potential of ITK Inhibition and Corroborate Potential of Aclaris’...Read more
The Company plans to extend its Phase II trial of HT-001 in Cancer Patients with skin toxicities in European Union (EU) Countries NEW YORK, July 29, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, today announced its engagement with ICON Clinical Research Limited ("ICON") to expand it's Phase II Clinical Trial for cancer patients suffering from skin toxicities associated with...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
Pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05 Progression-free survival data was immature, but trending in favor of pirtobrutinib BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients INDIANAPOLIS, July 29, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)...Read more
Robust and clinically meaningful absolute mean fetal hemoglobin (HbF) induction of 8.6% from baseline at 12 weeks of treatment; 7 of 16 patients achieved absolute HbF levels greater than 20% Evidence of pan-cellular induction of HbF based on an increase in F-cells (red blood cells containing HbF) from a mean of 34% at baseline to 67% at 12 weeks of treatment Meaningful improvements in key markers of hemolysis coupled with...Read more
DehydraTECH-semaglutide reduces overall side effects by 36.5% as compared to Rybelsus® DehydraTECH-semaglutide reduces gastrointestinal side effects by 43.5% as compared to Rybelsus® DehydraTECH-GLP-1 study arms evidencing patient safety and tolerability consistent with the primary study endpoint KELOWNA, BC / ACCESS Newswire / July 28, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or...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
NEWTON, Mass., July 28, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced results showing that implementing a blood-based pTau217 screening assay reduced Acumen’s overall clinical trial screening costs by approximately 40% in its...Read more
ATH434 Demonstrated Clinical Benefit on the Unified MSA Rating Scale and Global Measures of Neurological Symptoms Neuroimaging Biomarkers Showed Target Engagement and Slowed Brain Atrophy ATH434 was Well-Tolerated with Favorable Safety Profile Data are Consistent with Phase 2 Double-Blind Trial and Support Advancement of ATH434 in MSA MELBOURNE, Australia and SAN FRANCISCO, July 28, 2025 (GLOBE NEWSWIRE) --...Read more
Based on the primary endpoint of Clinical Dementia Rating Sum of Boxes (CDR-SB), patients treated with neflamapimod showed 54% risk reduction in clinically significant worsening compared to control at Week 32 of treatment (p=0.0037). This risk reduction improved to 64% (p=0.0001) among patients who have minimal evidence of AD co-pathology (ptau181 < 2.2 pg/mL at screening) At week 32 of the Extension phase, patients treated with...Read more
Hazard Ratios and Improvements in Median PFS are Unprecedented in HR+/HER2- Advanced Breast Cancer (“ABC”) Gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) reduced the risk of disease progression or death by 76% vs. fulvestrant (HR=0.24; 95% CI: 0.17–0.35; p<0.0001). Median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant Gedatolisib + fulvestrant (“gedatolisib doublet”) reduced...Read more
BELTSVILLE, Md., July 24, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced the presentation of new preclinical data in a well-established model of osteogenesis imperfecta (OI) demonstrating that treatment with NC605, a novel anti-Siglec-15 antibody, achieved...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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