BOSTON, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that the first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients...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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
ARCHER is designed to assess the impact of CardiolRx™ on cardiac magnetic resonance imaging parameters that measure heart dysfunction and edema/fibrosis-key measurements used to predict prognosis in myocarditis patients. Acute myocarditis is a potentially life-threatening condition affecting the heart muscle (myocardium) and is characterized by chest pain, shortness of breath, fatigue, rapid or irregular heartbeat (arrhythmias),...Read more
Alixorexton Demonstrated Clinically Meaningful and Statistically Significant Improvements in Wakefulness at All Doses Tested Compared to Placebo in Patients With Narcolepsy Type 1 Alixorexton Demonstrated Robust and Consistent Improvements in Patient-Reported Outcomes Related to Disease Severity, Fatigue and Cognition at All Doses Tested Alixorexton Was Generally Well Tolerated at All Doses Tested Detailed Results to Be Presented at...Read more
The pivotal Phase IIb ALIENTO study met the primary endpoint of a statistically significant reduction in the annualized exacerbation rate (AER) at 52 weeks when astegolimab was given every two weeks The Phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks The safety profile of astegolimab was consistent with previously reported data, with no new safety signals...Read more
Conference Call Today July 17, 2025 at 4:30 PM Eastern Time / 3:30 PM Central Time DM199 Demonstrated Highly Statistically Significant and Clinically Meaningful Reductions in Systolic and Diastolic Blood Pressure for Combined Cohorts 6-9 DM199 Did Not Cross the Placental Barrier and was Generally Safe and Well Tolerated Highly Statistically Significant Reduction in Uterine Artery Pulsatility Index Robust Evidence Supports a Potential...Read more
BUOY-1 builds on successful Phase 1 and Phase 2a data with GlyphAllo – a novel oral prodrug of allopregnanolone and a potential first-in-class treatment for MDD Allopregnanolone has demonstrated rapid antidepressant and anxiolytic activity in clinical settings, but its clinical scope was previously constrained by limitations that Glyph™ is specifically designed to solve BOSTON / Jul 17, 2025 / Business Wire / PureTech Health plc...Read more
After 12 weeks of treatment, 75% of per-protocol patients receiving 0.05% urcosimod showed greater than 80% reduction in neuropathic corneal pain (NCP), as measured by Visual Analogue Scale (VAS), demonstrating highly effective treatment. Urcosimod (0.05%) demonstrated a marked reduction in pain scores as early as Week 4, with sustained efficacy maintained throughout the trial. A statistically significant reduction in mean pain scores...Read more
LOS ANGELES / Jul 15, 2025 / Business Wire / Kairos Pharma, Ltd. (NYSE American:KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces positive safety results from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). The interim safety analysis of the trial demonstrated that ENV-105, a first-in-class CD105...Read more
The Trial Exceeded Target Overall Response Rate (ORR) of 20%, with 44% Response Rate Among Patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML MR) Treated at Optimal Dose of 30 mg Twice a Week (BIW) and 50% in AML MR with Myelomonocytic/Myelomonoblastic (M4/M5) Subtype Median Overall Survival (mOS) of 8.9 Months in Patients with AML MR and 8.8 mOS in Relapsed or Refractory to Venetoclax-Based Regimens at 30 mg BIW...Read more
First patient dosing in Company’s Phase 2b trial marks pivotal milestone in phage therapy development program targeting antibiotic-resistant lung infections in Cystic Fibrosis patients; topline results are expected in Q1 2026 Prior Phase 1b/2a efficacy findings demonstrated complete bacterial clearance in 14.3% of patients after just 10 days of treatment Feedback from U.S. Food and Drug Administration (FDA) anticipated in H2 2025,...Read more
Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy designation, underway in post-bariatric hypoglycemia; completion of recruitment expected in 2025, with topline data anticipated in first half of 2026 In the Phase 2b trial, avexitide 90 mg once daily led to a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in...Read more
Median Overall Survival (OS) of 13.9 months in triple negative breast cancer (TNBC) exceeds Trodelvy (11.8 months) and doubles control (6.9 months) OS of 17.3 months in HR+ metastatic breast cancer surpasses Trodelvy (14.4 months) and control (11.2 months) No treatment related discontinuations reported PHILADELPHIA and VANCOUVER, British Columbia, July 11, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW,...Read more
Metastatic Colorectal Cancer Cohort in NCI-Led Multi-Cohort Study Demonstrates Promising Response Rate, Triggering Enrollment Expansion Under Simon Two-Stage Design PRINCETON, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced patient...Read more
[IMAGES BELOW] Sustained complete resolution of temporal lobe brain metastasis and continued orbital tumor reduction after >18 months of treatment “Eye bulging” metastatic breast cancer patient had failed 8 prior regimens, including antibody-drug conjugate (ADC) therapy Patient remains on BriaCell’s Phase 2 study with 29 treatment cycles completed PHILADELPHIA and VANCOUVER, British Columbia, July 10, 2025 (GLOBE NEWSWIRE) --...Read more
CHICAGO / Jul 09, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced dosing of the first patient in Taiwan in the expansion phase of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly...Read more
Bivamelagon achieved BMI reductions in patients with acquired hypothalamic obesity of -9.3% and -7.7% in 600mg and 400mg cohorts, respectively, at 14 weeks Post-hoc analysis showed BMI reductions in bivamelagon trial were consistent with BMI reductions achieved by setmelanotide in past trials in similar patient populations Patients in both 600mg and 400mg cohorts achieved mean reduction of -2.8 points in most hunger...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
GAITHERSBURG, Md., July 09, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD). Pemvidutide is a novel,...Read more
52% of BriaCell’s most-recent 25-patient cohort* have surpassed the one-year survival milestone, exceeding current standard of care in similar patients 11 patients remain alive as of recent contact, including one patient at 38.3 months and another at 30.3 months Survival benefit observed in heavily pre-treated patients, including those who failed treatment with checkpoint inhibitors (CPIs) and antibody-drug conjugates (ADCs)...Read more
Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trial In Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last...Read more
Dosing of the first patient in Phase 2b marks an important transition of the RESOLVE trial from a Phase 2a open-label study to a Phase 2b placebo-controlled study. This is a critical step required prior to proceeding to pivotal clinical trials necessary for regulatory approval Eupraxia plans to enroll a minimum of 60 patients in the Phase 2b portion of the RESOLVE study in up to 25 sites globally, assessing tissue health measured by...Read more
Global Phase 2 clinical trial, VENTURE, to evaluate the efficacy and safety of verekitug administered every 12 or 24 weeks in moderate-to-severe COPD Broadens global development program for verekitug into third indication, strengthening pipeline across severe respiratory diseases including chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and COPD Program updates also include completion of enrollment in...Read more
LEXINGTON, Mass. / Jul 07, 2025 / Business Wire / Agenus Inc. (Nasdaq: AGEN) a leader in immuno-oncology innovation, today announced that its botensilimab and balstilimab (BOT/BAL) combination achieved a two-year survival rate of 42% along with a now more mature 21-month median overall survival (OS) in an expanded cohort of 123 patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases...Read more
Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks (-24.3 points vs. -15.4 points, -8.91 point placebo-adjusted difference; p=0.0002), compared to patients treated with placebo, establishing new benchmarks for placebo-adjusted and absolute symptomatic improvement for this patient population Bezuclastinib demonstrated a powerful effect on mast cell burden, with 87.4% of patients...Read more
APEX Part A met all primary and key secondary endpoints and exceeded trial objectives, including 71.0% decrease from baseline in EASI at Week 16 APG777 demonstrated EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study Exposure-response relationship observed across multiple key endpoints; APEX Part B is testing higher exposures with readout...Read more
JERSEY CITY, N.J. / Jul 02, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, which Organon acquired through its acquisition...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
Study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single dose Both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8 BPL-003 was generally well-tolerated at all doses, with 99% of...Read more
ARCT-810 significantly and consistently reduces biomarker glutamine to levels within normal range 15N-ureagenesis data provide first evidence of an mRNA therapeutic improving urea cycle function Ammonia remained stable and within normal range Multiple administrations of ARCT-810 continue to be safe and well tolerated at all tested dose levels Virtual KOL Presentation at 12:00 p.m. ET Today SAN DIEGO / Jun 30, 2025 / Business Wire /...Read more
As recently announced, initial proof-of-concept results from this ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome patient by up to 12.5% The first two patients in this IIT were taken off crofelemer after 12 weeks of treatment for a period...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
Expansion of study into additional indications doubles the potential addressable market beyond pancreatic cancer pain PoC 2 phase builds on early success and positive results demonstrated in PoC 1 in patients with severe pancreatic cancer pain, supporting multi-indication growth strategy THE WOODLANDS, TX, June 30, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device...Read more
TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC Initial 3-month complete response (CR) data expected to be reported in 1H 2026 CARLSBAD, Calif., June 30, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor...Read more
In the Phase 2 MINDFuL trial of XPro™ in patients with early Alzheimer’s Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100), a benefit of XPro™ treatment over placebo was observed in cognitive, behavioral and...Read more
In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (“mCRPC”),the six-month radiographic progression free survival (“rPFS”) rate was 66% In a Phase 2 clinical trial of gedatolisib plus trastuzumab-pkrb as 3L+ therapy in patients with HER2+ metastatic breast cancer (“mBC”), the objective response rate (“ORR”) was 43% No patients...Read more
TARPON SPRINGS, Fla., June 27, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor today announced that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or...Read more
The Independent Data Monitoring Committee (“IDMC”) has recommended to continue the study as planned as there are no safety concerns demonstrated in the data reviewed Interim results to date demonstrate GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated 6-week interim biomarker data (n=24) expected in July 2025 and topline data expected in Q3 2025 Currently available treatments for IPF are limited to only two...Read more
Initiation of patient recruitment marks a key milestone in the development of VAR 200, a potential first-in-class treatment for kidney disease addressing renal lipotoxicity. There are no available drugs targeting renal lipotoxicity that damages the kidneys’ filtration system, causing protein leakage into the urine (proteinuria) and disease progression. VAR 200, designed to alleviate renal lipid accumulation, has preclinical data in...Read more
Demonstrated target engagement and response prediction for ALTO-203 by theta/beta ratio, a commonly used EEG index of cortical arousal and attentional control ALTO-203, a non-stimulant compound which demonstrated pro-cognitive and wake-promoting effects, has the potential to address sustained attention abnormalities in EEG biomarker characterized patients Pharmacodynamic activity is aligned with the proposed mechanism of...Read more
First product candidate to demonstrate significant MASH effects and weight loss at 24 weeks Trial met its primary endpoint with statistically significant MASH resolution without worsening of fibrosis in up to 59.1% of participants in an ITT analysis Fibrosis improvement without worsening of MASH in up to 34.5% of participants in an ITT analysis Supplemental AI-based analysis demonstrated statistically significant reductions in liver...Read more
New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings Ongoing pivotal and FDA Type C meeting provide clear path to potential sevasemten registration as the first ever therapy for Becker Encouraging Phase 2 observations in Duchenne define the dose and inform design for Phase 3 Edgewise leadership to discuss these updates on Thursday, June 26...Read more
Near doubling of 1-year overall survival (OS), increased median OS of 4 months (12.5 vs 8.5 months), and 43% reduction in risk of death in patients treated with at least one cycle (4 weeks) of elraglusib plus gemcitabine/nab-paclitaxel (GnP) vs GnP alone Patients with liver metastases experienced a 2.5x improvement in 1-year OS with a 38% reduction in risk of death when treated with elraglusib plus GnP CHICAGO and FORT WORTH, Texas,...Read more
During the Maintenance Period of 12 weeks after discontinuing semaglutide (GLP-1 receptor agonist), placebo group regained 43% of body weight that was previously lost during Phase 2b QUALITY study; on average, enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo The enobosarm treated groups showed up to 93% greater fat loss and 100% lean mass preservation compared to the...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
Achieved statistical significance on primary endpoint at week 16 for mean percent change in EASI score from baseline for all rezpegaldesleukin arms versus placebo Achieved statistical significance for key secondary endpoints at week 16 of disease reduction, including EASI-75, EASI-90, Itch NRS, vIGA-AD and BSA Rapid onset of EASI reduction and magnitude of itch improvement show potential differentiation of this novel regulatory...Read more
At Week 144, 92.3% of Patients Remained Free of 12-Week Confirmed Disability Worsening (CDW) With 92.7% Remaining Free of 24-Week CDW Vidofludimus Calcium Continues to Demonstrate Favorable Safety and Tolerability Profile; Long-Term Data Now Available up to 5.5 Years NEW YORK, June 24, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally...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
MariTide, the First Monthly or Less Frequently Dosed Obesity Treatment, Demonstrated Up to ~20% Average Weight Loss Without a Weight Loss Plateau, and Delivered Significant Cardiometabolic Improvements at 52 Weeks In People Living With Obesity With Type 2 Diabetes, MariTide Demonstrated Up to ~17% Average Weight Loss and Robust HbA1c Improvements Dose Escalation With Lower Starting Doses Substantially Improved Gastrointestinal...Read more
New pharmacokinetic and cardiac biomarker data further demonstrate ifetroban's potential to protect the heart and reduce cardiac damage in DMD patients NASHVILLE, Tenn., June 23, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company committed to developing new products for rare diseases, shared the latest positive results from its Phase 2 FIGHT DMD trial evaluating ifetroban, a...Read more
Enrollment in company's first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for microvillus inclusion disease (MVID) in pediatric patients has reached approximately 25% As recently announced, initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in patients with intestinal failure due to MVID and short...Read more
POTOMAC, MD / ACCESS Newswire / June 23, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced the addition of a new clinical trial site at Tekton Research in Yukon, Oklahoma, for its Phase 2 CALMA study evaluating IGC-AD1 for agitation in Alzheimer's dementia. This expansion into the Oklahoma City metropolitan area underscores IGC's commitment to diversifying its trial population and addressing regional...Read more
Updated data from DeFianCe study continue to demonstrate statistically significant improvements in PFS among the DKK1-high, VEGF-naïve and liver metastasis subgroups Board of Directors has initiated process to explore strategic alternatives to maximize shareholder value CAMBRIDGE, Mass., June 23, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and...Read more
The study met its primary and all secondary efficacy endpoints for all dose groups Single doses of 450mg, 300mg and 150mg of CD388 conferred 76%, 61% and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo CD388 was well-tolerated with no safety signals observed End of Phase 2 meeting request has been submitted to the U.S. Food and Drug Administration (FDA) Cidara will host a conference call...Read more
Cancer Detection and Positive Predictive Value Substantially Higher Than the Previously Published PATHFINDER Study MENLO PARK, Calif., June 18, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL's registrational...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
Top-line results expected July 2025 as development of first-in-class OSA drug advances NEW YORK and MELBOURNE, Australia, June 18, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, is pleased to announce that it has achieved database lock for the RePOSA Phase 2 clinical trial of...Read more
Patients receiving apitegromab with tirzepatide over 24 weeks showed a 54.9% preservation of lean mass (+4.2 lbs of lean mass) versus tirzepatide alone (p=0.001) Patients receiving apitegromab with tirzepatide over 24 weeks lost 18.8 lbs of fat mass while those on tirzepatide alone lost 17.7 lbs of fat mass Patients receiving apitegromab with tirzepatide over 24 weeks lost 12.3% of body weight while those on tirzepatide alone lost 13.4%...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
Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily achieved a 9.3 mmHg reduction in systolic blood pressure, and a 7.5 mmHg placebo-adjusted reduction (p=0.0024) at four weeks Lorundrostat showed a clinically meaningful reduction in the pre-defined endpoint spot urine albumin-to-creatinine ratio of 31% (p<0.0001) Lorundrostat demonstrated a favorable safety and tolerability profile Conference...Read more
Phase 2 study, led by Dr. Antonio Jimeno at the University of Colorado Anschutz Medical Campus will evaluate NT219 in combination with either pembrolizumab or cetuximab as a strategy to overcome tumor resistance REHOVOT, Israel, June 17, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune...Read more
The study met its primary goal of establishing safety and tolerability of VTX3232 in patients with early-stage Parkinson’s disease CSF and plasma exposures reinforce VTX3232’s potential as a once-daily oral therapy for neurodegenerative diseases VTX3232 treatment resulted in significant reductions in NLRP3-related biomarkers in CSF and plasma, demonstrating sustained target engagement VTX3232 is also being studied in a...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
CLICK TO LEARN MORE