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
Placebo-subtracted mean weight loss up to 14.1% after 28 weeks with no plateau Potential for best-in-class tolerability with minimal diarrhea signal, 13% nausea, and 11% vomiting High study and treatment retention in both VESPER-1 and VESPER-3 trials Data support Phase 3 initiation in late 2025 NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), today announced positive topline data from VESPER-1 and...Read more
Patients who switched from placebo or pirfenidone to deupirfenidone in the open-label extension study achieved stabilization of lung function with favorable tolerability Findings further substantiate safety and efficacy results from the randomized, placebo- and active-controlled 26-week trial and highlight opportunity to address patients inadequately served by current therapies Regulatory engagement underway; update on Phase 3 trial...Read more
6.7-Day Improvement in Time to Complete Resolution of All RSV Symptoms for Patients with Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), or Age ≥75 Statistically Significant Improvement in Patient Global Impression of Severity Score Lower Hospitalization Rate for Patients Treated with Zelicapavir (1.7%) vs. Placebo (5%) 4- to 5-Day Faster Median Time to Undetectable Viral Load with Zelicapavir vs....Read more
POTOMAC, MD / ACCESS Newswire / September 29, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the addition of a new clinical trial site to its ongoing Phase 2 study evaluating IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease. The new site, Ichor Research, located in Syracuse, New York, is led by Principal Investigator Dr. Karl F. Hafner, M.D. Dr. Hafner brings years of experience in...Read more
Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance KPI-012 was well-tolerated with no treatment-related serious adverse events observed KALA to cease clinical development of KPI-012, preserve cash and explore strategic options ARLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage...Read more
86% overall survival (OS) observed at 9 months; standard of care benchmark is ~47% 53% progression-free survival (PFS) observed at 9 months; standard of care benchmark is ~29% Company expects regulatory feedback on pivotal trial plans in Q4 2025 and, subject to that feedback, expects to initiate pivotal trial by the end of 2025 and begin dosing patients by mid-2026 NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) --...Read more
FG-3246 Phase 2 dose optimization trial to enroll 75 patients with metastatic castration-resistant prostate cancer (mCRPC) in the post-androgen receptor signaling inhibitor (ASRI) and pre-chemotherapy setting FG-3180 to be evaluated in the Phase 2 trial as a companion PET imaging agent and a potential predictive patient selection biomarker Interim analysis expected in 2H 2026 SAN FRANCISCO, Sept. 24, 2025 (GLOBE NEWSWIRE) --...Read more
Open-label study evaluated a two-dose induction regimen of BPL-003 (8 mg followed by 12 mg two weeks later) in patients with treatment-resistant depression and demonstrated rapid, clinically meaningful and durable antidepressant effects, which are sustained for up to 3 months The second dose of BPL-003 led to further reductions in MADRS scores from baseline, indicating that this regimen has the potential to enhance the clinical...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
SAN DIEGO, Sept. 22, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new data from the Phase 2 SAVITRI™ study, which showed statistically significant and clinically meaningful improvement in depression severity at Day 28 and Day 56 with once-daily oral administration of 1 mg osavampator (NBI-1065845). In recognition of the data presentation, Neurocrine was honored with the...Read more
ZUG, Switzerland and BOSTON and SAN DIEGO and SHANGHAI, Sept. 22, 2025 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Sirius Therapeutics, a clinical stage biotech company developing innovative small interfering RNA (siRNA) therapies for global markets, today announced that the first...Read more
The ALSTARS Trial is a well powered randomized, multi-center, double-blind, placebo-controlled, 24-week study of COYA 302 in people with Amyotrophic Lateral Sclerosis (ALS) Patients completing the initial 24-week treatment will be invited to participate in a 24-week blinded extension period, during which all participants will receive COYA 302 The ALSTARS Trial will enroll 120 ALS participants at approximately 25 centers in...Read more
Statistically significant responder rate achieved at 12 weeks with zero contribution from rescue therapy (PRN) and further improvement sustained in open-label extension (OLE) Positive findings in bone and kidney biomarkers All patients completed the 12-week AvailTM trial and 94% entered the OLE Once-weekly canvuparatide was generally well tolerated, with no treatment-related serious adverse events or discontinuations during the...Read more
First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda® (pembrolizumab) alone (10.8 months) and Keytruda® + chemotherapy (12.3 months) in patients with CPS 1-19* Encouraging efficacy signal observed in difficult to treat category of advanced head and neck cancer patients PRINCETON, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech”...Read more
Interim efficacy analysis highlights potential value of combination therapy of apalutamide and ENV105 following positive safety data Company to host virtual KOL discussion today to provide additional perspective on data and the Company’s lead program LOS ANGELES / Sep 18, 2025 / Business Wire / Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today...Read more
Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss Numeric improvements in metabolic and lipid parameters including waist circumference, blood pressure, cholesterol, triglycerides and A1C, were observed across all treatment groups TARRYTOWN, N.Y., Sept. 17, 2025 (GLOBE...Read more
ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results T cell responses included both mKRAS-specific CD4 and CD8 T cells in 85% of patients BOSTON,...Read more
SPY072 is a potential first- and best-in-class anti-TL1A antibody for rheumatic diseases targeting quarterly or twice-yearly subcutaneous dosing SKYWAY study is evaluating SPY072 in patients with moderate-to-severely active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) Proof-of-concept data for all three indications are expected in 2026 SKYLINE and SKYWAY trials are expected to provide 9...Read more
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small...Read more
No decline in lung function observed at 6-week interim analysis builds upon positive safety and biomarker data Phase 2a study fully enrolled; Topline data on track for Q3 2025 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 LA JOLLA, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI...Read more
FREMONT, Calif. / Sep 10, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced its collaboration with a leading breast cancer team from Yale Cancer Center for a clinical trial titled “A single arm phase II trial of circulating tumor DNA-guided adjuvant therapy with elacestrant in hormone receptor positive HER2 negative breast cancers at risk for late recurrence...Read more
A pathological complete response ("pCR") has been observed in the first patient evaluated in Cohort A, where each patient receives two doses of INT230-6 eight days apart, followed by the standard of care immunochemotherapy ("SOC") Safety looks favorable in Cohort A Some INT230-6 patients begin to show localized skin irritation, and new patient enrollment has been paused to implement modifications to resolve the issue Patients being...Read more
PYNNACLE Phase 2 pivotal clinical trial interim data include confirmed responses observed in eight tumor types spanning ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma 33% overall response rate (ORR) observed among 97 evaluable patients across all cohorts with a median duration of response of 6.2 months 43% ORR observed among 44 evaluable patients in ovarian cancer cohort with a...Read more
Phase 1 data for efarindodekin alfa (XTX301) demonstrate promising anti-tumor activity in patients with advanced solid tumors Achievement of milestone extends anticipated cash runway into first quarter of 2027 WALTHAM, Mass., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with...Read more
PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients with extensive-stage small cell lung cancer (”ES-SCLC”), expanding evidence for its potential to set a new standard of care in first-line ES-SCLC and beyond Global interim Phase 2 data showed a 76.3% confirmed objective response rate (cORR), 100% disease control rate (DCR), a median progression...Read more
Severe lymphopenia, an adverse treatment effect associated with chemotherapy, radiotherapy, and immunotherapy, significantly lowers overall survival in non-small cell lung cancer and multiple types of cancer.1,2 With ANKTIVA, the first FDA-approved lymphocyte-stimulating agent, 80% of patients exceeded or maintained absolute lymphocyte count (ALC) above 1,000 cells/µL. With ALC counts greater than 1,500 cells/µL, statistically...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
Claseprubart 300mg and 600mg Q2W doses both achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at Week 13 Claseprubart demonstrated a rapid and sustained onset of action, with both doses achieving statistically significant improvements in MG-ADL and QMG scores at Week 1 Claseprubart 300mg Q2W dose was also...Read more
Treatment with darovasertib resulted in robust ocular tumor shrinkage, lower simulated radiation doses to the eye and meaningful visual gains and reduced long-term risk of blindness for patients in the neoadjuvant setting of primary uveal melanoma Manageable safety profile with mostly Grade 1 and 2 treatment-related adverse events Phase 3 registration-enabling OptimUM-10 trial of darovasertib in neoadjuvant primary UM initiated during...Read more
Trial met primary long episode endpoints with high statistical significance, and RAP-219 was generally well tolerated Patients achieved 77.8% reduction in clinical seizures (p=0.01), with 24% achieving seizure freedom for the 8-week treatment period (p<0.0001) Data support advancement of RAP-219 into Phase 3 registrational trials Company to host a conference call today at 8:00 a.m. ET BOSTON and SAN DIEGO, Sept. 08, 2025 (GLOBE...Read more
An objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated patients Discussions with global regulatory authorities underway BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 07, 2025 / Business Wire / Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small...Read more
Sustained durability of responses demonstrated in both TRUST-I and TRUST-II with additional follow-up time TKI-naïve patients in TRUST-I achieved a median progression-free survival of 44.6 months; more than half of TKI-naïve patients in TRUST-II were still progression-free at data cut-off The findings showed a favorable safety and tolerability profile for IBTROZI with manageable adverse events Results are from one of the largest global...Read more
80% of post-surgical hypoparathyroidism participants achieved concomitant blood and 24-hour urine calcium in the normal reference range within 5 days of encaleret treatment initiation compared to 0% of participants on conventional therapy at baseline Encaleret was well-tolerated with no serious adverse events reported over the study period Based on these findings, BridgeBio intends to initiate a registrational clinical study of...Read more
VT-1953 continues to significantly improve the primary endpoint Co-founder Dr. Shiladitya Sengupta to discuss over a live video conference VT-1953 treatment significantly reduced malignant fungating wound-associated malodor (primary endpoint) (P<0.001). Patients also reported significant improvements in lesion pain (P<0.001) and Quality of Life (P<0.001), both secondary and exploratory endpoints, respectively. CAMBRIDGE,...Read more
Catalyst for Advancing Discussions with Pharmaceutical Companies that have Expressed Interest in ART27.13 for CACS Consistent Improvements in Weight Gain, Lean Body Mass, and Activity were Observed Across Treated Patients including +6.4% Mean Weight Gain at 12 Weeks vs −5.4% Mean Weight Loss on Placebo Safety Results Showed ART27.13 was Well Tolerated SOLANA BEACH, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences,...Read more
Data presented at 13th Society of Hematologic Oncology (SOHO) Annual Meeting NORTH CHICAGO, Ill., Sept. 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously,...Read more
Trial demonstrated the feasibility of treating and monitoring adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in an outpatient setting Results showed that 92% of patients with R/R DLBCL received the first full dose of epcoritamab monotherapy in an outpatient setting Adverse event profile and efficacy were consistent with previously reported studies in R/R DLBCL patients Data also demonstrated 64.3%...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
VAX-31 Optimized Dose, with Majority of Serotypes Dosed at 4.4mcg and Balance at 3.3mcg, is Designed to Elicit Even Stronger Immune Responses in Infant Population to Protect Against Invasive Pneumococcal Disease (IPD) Company Intends to Release Topline Data from Primary Immunization Series and Booster Dose Either Sequentially or Together by End of First Half of 2027 VAX-31 is Designed to Provide Greater Coverage Against Both Currently...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
Skye also announces completion of enrollment of 26‑week extension study; 52‑week data planned, with post‑extension 13‑week follow‑up SAN DIEGO, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that the last patient has completed 26 weeks of treatment in...Read more
Positive results were observed across all subgroups Study meets several key secondary endpoints with statistical significance SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Sep 02, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its TETON-2 study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic...Read more
In this 24-week study, VIBRANT met its primary endpoint, with verekitug dosed every 12 weeks leading to a statistically significant and clinically meaningful reduction from baseline in placebo-adjusted endoscopic nasal polyp score (NPS) of -1.8 (p<0.0001) Significant and clinically meaningful improvements were observed in key secondary endpoints, including -0.8 (p=0.0003) reduction in nasal congestion score and 76% (p=0.03)...Read more
Poster presentation highlights the consistency of reductions in high-sensitivity C-reactive protein with pacibekitug across clinically-meaningful subgroups Pacibekitug demonstrated concordant, statistically significant reductions in secondary pharmacodynamic biomarkers of IL-6 pathway activity including lipoprotein(a), fibrinogen, and serum amyloid A NEW YORK, Aug. 31, 2025 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline)...Read more
Psi-GAD delivers statistically significant and clinically meaningful improvements across validated measures of anxiety, mood, disability, and quality of life; results establish PSX-001 as a leading psilocybin-assisted therapy in development globally MELBOURNE, Australia and NEW YORK, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”) is pleased to report positive data from its...Read more
POTOMAC, MD / ACCESS Newswire / August 25, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its ongoing Phase 2 clinical trial evaluating IGC-AD1, an investigational drug candidate for treating agitation in patients with Alzheimer's disease. The Company has added a clinical site at the Lynn Health Science Institute (LHSI) in Oklahoma City, Oklahoma. Dr. Carl Griffin, MD, will serve as the Principal...Read more
Median Overall Survival (mOS) of 39.3 months in patients with CPS ≥ 1 – best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months* VERSATILE-003 Phase 3 trial in progress PRINCETON, N.J., Aug. 25, 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...Read more
Final patient visit marks key milestone for Biofrontera, with top-line results expected Q1 2026 Company plans FDA discussion in Q3 2026 to advance Phase 3 program and potential label expansion More than 50 million people affected by acne in US each year, with market valued at $5.7 billion in 2024 WOBURN, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical...Read more
Dabogratinib is the only oral FGFR3-selective inhibitor in clinical development for achondroplasia Initial results from safety sentinel cohort expected in 2H 2026 CARLSBAD, Calif., Aug. 21, 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 (FGFR) biology,...Read more
CRANBURY, N.J. / Aug 20, 2025 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s pivotal Phase 2 trial of RP-A501 for the treatment of Danon disease. The hold was lifted in...Read more
Study met primary endpoint demonstrating barzolvolimab’s ability to potently deplete mast cells in the gastrointestinal tract Profound mast cell depletion did not result in improved clinical outcomes providing direct evidence that mast cells are not a primary driver in EoE Favorable safety profile demonstrated for barzolvolimab 300 mg Q4 weekly dosing regimen Company to host webcast today at 4:30 pm ET HAMPTON, N.J., Aug. 19,...Read more
90-day trial measuring change in general fatigue in chronic babesiosis patients Enrollment expected to commence Q4 2025 and to be completed by Q2 2026 Site has clinical expertise in infectious disease trials and access to a robust patient population with tick-borne illness, including chronic babesiosis No FDA-approved treatment exists for chronic babesiosis, a debilitating illness WASHINGTON, Aug. 19, 2025 (GLOBE NEWSWIRE) -- 60...Read more
QUEENSBURY, N.Y. / Aug 19, 2025 / Business Wire / Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the first patient has been dosed at the City of Hope National Medical Center in its global Phase 2 Clinical Trial evaluating HEPZATO™ in combination with standard of care (SOC) treatment for liver-dominant metastatic colorectal cancer...Read more
Approximately one in five American adults who had COVID-19 still experience symptoms of long COVID, a serious illness that can result in chronic conditions and disability1.2 Long COVID remains a significant public health challenge with no currently available established treatments Study explores ANKTIVA’s therapeutic potential as an IL-15 agonist in boosting NK cell responses against viral infections CULVER CITY, Calif. / Aug 19,...Read more
U.S. FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on third-party nebulizer used to deliver BX004; no concerns were raised in the clinical hold notification regarding the BX004 drug candidate Enrollment and dosing of patients outside the US is continuing in accordance with protocol NESS ZIONA, Israel, Aug. 19, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the...Read more
Study Achieves Primary and Secondary Endpoints, Demonstrating Statistically Significant Reductions in Body Weight with Once-Daily VK2735 Dosing as Compared to Placebo Up to 12.2% (26.6 lbs) Mean Weight Loss Observed After 13 Weeks of VK2735 Treatment Compared with 1.3% (2.9 lbs) for Placebo Exploratory Assessment of Low Dose Maintenance Treatment Demonstrates Positive Proof of Concept VK2735 Shown to be Safe and Well-Tolerated in...Read more
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
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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