Enlicitide, designed to deliver antibody-like efficacy, has the potential to be the first approved oral PCSK9 inhibitor to lower LDL-C with a safety profile comparable to placebo Enlicitide may help address unmet needs in ASCVD, a key driver of the ongoing cardiovascular (CV) epidemic RAHWAY, N.J. / Nov 08, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first...Read more
Treatment with telitacicept for 39 weeks resulted in a rapid, clinically meaningful, and statistically significant reduction in proteinuria, with a favorable safety profile Telitacicept demonstrated a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared with placebo; statistically significant benefits also achieved across all key secondary endpoints Data presented as late-breaking oral...Read more
Study Also Shows 36% Reduction in Risk of Heart Attack Repatha is the First and Only PCSK9 Inhibitor to Significantly Reduce the Risk of First Heart Attack and Stroke THOUSAND OAKS, Calif., Nov. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced detailed results from the Phase 3 VESALIUS-CV clinical trial, which showed that Repatha® (evolocumab) achieved statistically significant and clinically meaningful reductions...Read more
Up to 72% placebo-adjusted mean reduction in fasting triglyceride levels at six months, with reductions sustained through 12 months 86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL, below the risk threshold for acute pancreatitis First and only investigational treatment for sHTG to significantly reduce acute pancreatitis events Data simultaneously published in The New England Journal of Medicine Ionis...Read more
FASENRA also demonstrated a greater improvement in fatigue symptom relief in a single monthly dose compared to placebo WILMINGTON, Del. / Nov 07, 2025 / Business Wire / Positive full results from the NATRON Phase III trial showed AstraZeneca’s FASENRA (benralizumab) demonstrated a statistically significant delay in the time to first worsening or flare in hypereosinophilic syndrome (HES),1 a rare disease driven by elevated eosinophils.2...Read more
FOSTER CITY, Calif. / Nov 07, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the Phase 3 ASCENT-07 study investigating Trodelvy® (sacituzumab govitecan-hziy) versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR)...Read more
Phase 3 data to be presented at ACAAI demonstrate Dupixent significantly reduced key nasal signs and symptoms including sinus opacification, nasal congestion and nasal polyps in patients aged 6 years and older compared to placebo Dupixent sBLA accepted for priority review by the U.S. FDA with a target action date of February 28, 2026 If approved, Dupixent would be the first and only medicine indicated specifically for AFRS, which...Read more
A post hoc analysis of REDEFINE 1 demonstrated a 10.9 mmHg reduction in systolic blood pressure with investigational CagriSema (2.4 mg/2.4 mg), allowing 40% of people on blood pressure medications to reduce or stop their medication1 CagriSema treatment demonstrated a nearly 70% reduction in a key inflammatory marker associated with increased cardiovascular risk2 Data showed that fewer people on CagriSema were at intermediate-to-high...Read more
Atacicept met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) The safety profile of atacicept across the ORIGIN program appears favorable, and comparable to placebo Biologics License Application (BLA) submission through the Accelerated Approval Program to the U.S. FDA expected in...Read more
All 84 clinical sites across the U.S. are fully activated, enrolling, and treating patients The first group of participants reached the 6-month treatment milestone The study is now 25% complete, keeping Annovis on track for data readout MALVERN, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for...Read more
PRINCETON, N.J., Nov. 06, 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 robust preliminary results from its ongoing Phase 3 UTOPIA trial, demonstrating a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%) with UGN-103 (mitomycin) for intravesical solution in...Read more
The investigational FINE-ONE trial met its primary endpoint, demonstrating that finerenone led to a significant reduction in urine albumin-to-creatinine ratio (UACR), an important marker of cardiovascular risk and kidney disease progression, from start of trial through six months, for people living with type 1 diabetes (T1D) and chronic kidney disease (CKD) versus those receiving standard of care plus placebo1 These data were presented...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with epidermal growth factor receptor (“EGFR”)-mutated, MET-overexpressed and/or amplified, locally advanced or...Read more
SOL-R, the second registrational trial of AXPAXLI™ in wet AMD, remains on track for topline data in 1H 2027 Together with SOL-1, these complementary trials are expected to form the basis of a potential NDA submission for AXPAXLI in wet AMD BEDFORD, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today...Read more
Improvements across all patient reported outcomes (PROs) were observed from baseline to Week 8 in all PRO instruments utilized in the ABTECT induction trials evaluating bowel urgency, sleep interruption, fatigue, quality of life, and work productivity for both 50mg and 25mg once-daily obefazimod. At week 8 in the ABTECT 1 & 2 trials, 37% of patients taking once daily 50mg obefazimod reported no bowel urgency (BU) compared to 18.1%...Read more
Topline results for the trial are expected by year end SOUTH SAN FRANCISCO, Calif. / Nov 03, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that the last patient has completed the randomized, double-blind, placebo-controlled...Read more
ECLIPSE 1 estimated date of last participant reaching primary endpoint (primary completion) in the fourth quarter of 2026, and topline data expected in the first quarter of 2027 ECLIPSE registrational program on target, with ECLIPSE 2 and 3 enrolling well and in line with the Company’s expectations Swift recruitment underscores high unmet medical need for effective and convenient chronic hepatitis delta treatment SAN FRANCISCO / Nov...Read more
Findings Reinforce QDENGA’s Long-Term Safety Profile and Two-Dose Vaccination Schedule QDENGA is the Longest-Studied Dengue Vaccine and the Only Approved for Use Regardless of Prior Disease Exposure Takeda is Expanding Global Access to QDENGA in Partnership with National Immunization Programs, Private Payors and Public Health Coalitions, with 18.6 Million Doses Distributed in 11 Endemic Countries OSAKA, Japan & CAMBRIDGE, Mass. /...Read more
Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva, an anti-CD20 monoclonal antibody designed for enhanced B cell depletion Gazyva has the potential to be a transformative new standard of care for up to 3.4 million people affected by systemic lupus erythematosus (SLE) worldwide If approved, Gazyva would be the first anti-CD20 therapy for SLE to directly target B cells, a key driver of...Read more
NOVATO, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the first patient has been dosed in the Aurora study (NCT07157254) evaluating the efficacy and safety of GTX-102 (apazunersen), an investigational antisense oligonucleotide (ASO) for Angelman syndrome (AS). Data from the Aurora study will expand the population of Angelman patients treated to include both younger and...Read more
SUNNYVALE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled at University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial. “CardiAMP cell therapy has shown evidence of benefit for ischemic heart...Read more
Telitacicept delivered consistent quality-of-life improvement across both treatment and placebo crossover arms 100% of patients on telitacicept for 48 weeks achieved ≥2-point Myasthenia Gravis Activities of Daily Living (MG-ADL) improvement, with a mean reduction of -7.5 points Sustained efficacy and favorable safety extension data support potential global best-in-disease profile in generalized myasthenia gravis (gMG) BOSTON, Oct....Read more
In two replicate Phase 3 studies, upadacitinib (RINVOQ®) achieved the co-primary endpoints of 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 481 Both studies met key ranked secondary endpoints1 NORTH CHICAGO, Ill., Oct. 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from...Read more
The CALIBRATE study of encaleret for patients with ADH1 met all pre-specified primary and key secondary efficacy endpoints The primary endpoint was met with 76% of participants administered encaleret achieving both serum and urine calcium within the respective target ranges at Week 24 compared to 4% when on conventional therapy at Week 4 (p<0.0001)\ In a key secondary analysis, 91% of participants administered encaleret...Read more
RAHWAY, N.J. & NUTLEY, N.J. / Oct 29, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization...Read more
Study met primary and secondary endpoints Paridiprubart demonstrated a relative reduction in the risk of death of 25% Treatment provided patients with clinically meaningful improvement in survival and recovery Paridiprubart exhibited consistent safety and tolerability profile TORONTO, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed...Read more
NEW YORK, Oct. 28, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has completed in the randomized cohort of the Phase 3 ENHANCE trial evaluating a consolidated Day 1 and Day 15 dosing schedule for IV BRIUMVI® (ublituximab-xiiy), the company’s novel, glycoengineered, anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). The primary endpoint of this trial...Read more
First combination regimen to demonstrate improvement in DFS compared to KEYTRUDA monotherapy for these patients in the adjuvant setting LITESPARK-022 is the second positive Phase 3 study for WELIREG as part of a combination regimen in RCC RAHWAY, N.J., / Oct 28, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 LITESPARK-022 trial...Read more
First treatment regimen to demonstrate a statistically significant improvement in PFS for patients whose disease progressed following anti-PD-1/L1 therapy compared with cabozantinib in a Phase 3 study LITESPARK-011 marks the first positive Phase 3 study of a HIF-2 alpha inhibitor in combination with a multi-targeted VEGF tyrosine kinase inhibitor RAHWAY, N.J. & NUTLEY, N.J. / Oct 28, 2025 / Business Wire / Merck (NYSE: MRK), known...Read more
Gazyva versus mycophenolate mofetil shows significantly more children and young adults achieved sustained complete remission at week 52 If approved, Gazyva could help children and young adults sustain remission, potentially with a reduced need for steroids to manage their disease INShore is the first global Phase III study of a targeted therapy in this chronic kidney disease commonly diagnosed in early...Read more
Clinical remission rates were over 85% for both TREMFYA® maintenance doses at 96 weeks in both the Phase 3 GRAVITI and GALAXI studies TREMFYA® is the only IL-23 inhibitor to demonstrate durable endoscopic and clinical remission with a fully subcutaneous regimen in moderately to severely active Crohn's disease PHOENIX, Oct. 27, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new 96-week data from the long-term...Read more
Conference call today at 8:30 a.m. ET CAMBRIDGE, Mass., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that the company has temporarily paused patient dosing and screening for its MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nex-z for patients with transthyretin...Read more
All primary and secondary interim analysis endpoints in FORTIFY Phase 3 study successfully achieved with well-tolerated safety profile consistent with the Company’s prior studies Primary interim analysis endpoint, glycosylated αDG, significantly increased by 1.8x change from baseline at 3 months (p<0.0001), and improvements were sustained at 12 months (p<0.0001) in BBP-418 treated individuals versus placebo Average reduction in...Read more
Phase 3b LUCENT-URGE is the first study in inflammatory bowel disease to assess bowel urgency across three measures — severity, frequency and stool deferral time — reflecting the spectrum of its burden on patients By Week 12, patients experienced a 55% reduction in daily episodes of bowel urgency from baseline, with severity reduced by more than half by Week 28 At Week 28, nearly one-third of patients were able to delay using the...Read more
Eight-week results from the TRuE-AD4 trial demonstrate treatment with Opzelura® (ruxolitinib cream) significantly improved the clinical signs of atopic dermatitis (AD), including improved itch as early as Day 2, and was well tolerated in adults with moderate AD who had an inadequate response, intolerance or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) At Week 8, 70% of patients treated with...Read more
FDA-approved Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) is available in the United States for the treatment of inflammatory lesions of rosacea in adults DFD-29 demonstrated superior efficacy in IGA success rates and inflammatory lesion counts versus both placebo and doxycycline (P<0.001 for all comparisons) Poster Presented on Efficacy of Oral DFD-29, a...Read more
This trial is the first and largest study specifically designed to evaluate children and adolescents with severe alopecia areata, a population often underrepresented in clinical trials New data show 71% of adolescents with severe disease treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year, with continuous improvements observed throughout those 52 weeks Lilly intends to submit the BRAVE-AA-PEDS data...Read more
In areas of high impact, 72% of patients with scalp psoriasis and 85% with genital psoriasis treated with icotrokinra achieved site-specific clear or almost clear skin at Week 52 in Phase 3 ICONIC-TOTAL study 67% of patients treated with icotrokinra achieved overall rates of clear or almost clear skin by Week 24, which was maintained through Week 52 Icotrokinra continues to show potential with its standout combination of exceptional...Read more
Company to discontinue development of mRNA-1647 in congenital CMV Company will continue to evaluate mRNA-1647 in ongoing Phase 2 trial in bone marrow transplant patients Company does not anticipate any impact to its 2025 financial guidance or its expectation of achieving breakeven in 2028 CAMBRIDGE, MA / ACCESS Newswire / October 22, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced topline results from a Phase 3 pivotal trial...Read more
Independent DSMB has identified no safety concerns, and recommends continuation of BriaCell’s pivotal Phase 3 study of Bria-IMT™ plus immune check point inhibitor Fourth consecutive positive DSMB recommendation supports the favorable safety profile observed to date Phase 3 study is being conducted under FDA Fast Track Designation, reflecting the significant unmet need in metastatic breast cancer PHILADELPHIA and VANCOUVER, British...Read more
SOUTH SAN FRANCISCO, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today announced results from the Phase 3 INFRONT-3 clinical trial evaluating latozinemab (AL001) in individuals with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). In the 96-week,...Read more
MIAMI, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary, today announced that Crystalys Therapeutics, Inc. (“Crystalys”), in which Urica maintains an equity position, dosed first patients in its two randomized, double-blind, multicenter global Phase 3 trials, the RUBY study (NCT07089875) and the TOPAZ study (NCT07089888), evaluating...Read more
79 clinical sites across 23 US states are currently enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC) Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University have now joined BriaCell’s extensive national network PHILADELPHIA and VANCOUVER, British Columbia, Oct. 21, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW)...Read more
Data presented at IDWeek 2025 after study stopped early for efficacy Primary endpoint met, demonstrating non-inferiority of oral tebipenem HBr compared to intravenous treatment1 Data will be shared with regulatory authorities to support regulatory filings CAMBRIDGE, Mass., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) and GSK plc (LSE/NYSE: GSK) today announced efficacy and safety results of the...Read more
AFFIRM-1 trial did not meet primary endpoint or secondary endpoints Company to conduct strategic review of portfolio and business operations BURLINGTON, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today announced that the AFFIRM-1 Phase 3 trial of BNC210 for...Read more
Five-year exploratory follow-up analysis of KEYNOTE-671 continued to show clinically meaningful improvements in overall survival and event-free survival with KEYTRUDA plus chemotherapy before surgery, and then continued as a single agent after surgery Eight and 10-year findings from analyses of KEYNOTE-001, KEYNOTE-010, KEYNOTE-024 and KEYNOTE-042 show that KEYTRUDA monotherapy continued to improve survival for certain patients with...Read more
Upadacitinib demonstrated superiority versus adalimumab for primary endpoint of achieving low disease activity (DAS28-CRP≤3.2) and ranked secondary endpoint of remission (DAS28-CRP<2.6) at week 121 SELECT-SWITCH is the first Phase 3b/4 head-to-head trial comparing TNF inhibitor cycling with switching to upadacitinib in adults with moderate to severe rheumatoid arthritis and inadequate response or intolerance to a TNF...Read more
Data demonstrated that vepdegestrant maintained patients’ quality of life for statistically significantly longer and delayed worsening of overall health, daily functioning, and symptoms, including pain, compared to fulvestrant – NEW HAVEN, Conn., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced new patient-reported outcomes (PRO) data from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating...Read more
Zanzalintinib in combination with atezolizumab improved median overall survival to 10.9 months versus 9.4 months with regorafenib, and significantly reduced the risk of death by 20% in the intention-to-treat population Exelixis plans to complete its first new drug application submission for zanzalintinib in the U.S. in 2025 ALAMEDA, Calif. / Oct 20, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced...Read more
Data to be featured in Presidential Symposium at ESMO Signatera™ changes the paradigm by expanding the adjuvant decision window, with up to 7 tests in the first year post-surgery, enabling effective initiation of treatment only after a positive test result, and allowing patients with persistently negative results to avoid unnecessary treatment AUSTIN, Texas / Oct 20, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader...Read more
Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo IMvigor011 is the first global Phase III study to read out pioneering a ctDNA-guided approach to post-surgery treatment in muscle-invasive bladder cancer Data being presented as part of the Presidential Symposium at the ESMO Congress 2025 SOUTH SAN FRANCISCO, Calif. / Oct 20, 2025 / Business Wire /...Read more
Ivonescimab in Combination with Chemotherapy Is the First Known Regimen to Achieve a Clinically Meaningful Benefit over an anti-PD-(L)1 Antibody Combined with Chemotherapy in a Phase III Clinical Trial in 1L NSCLC: Median PFS of 11.14 Months vs. 6.90 Months, Respectively, for Patients Receiving Ivonescimab Plus Chemotherapy vs. Tislelizumab Plus Chemotherapy; Hazard Ratio of 0.60 Tolerable Safety Profile Reaffirmed for PD-1 / VEGF...Read more
AstraZeneca and Daiichi Sankyo’s DATROWAY also demonstrated a highly statistically significant and clinically meaningful 43% reduction in patients’ risk of disease progression or death in TROPION-Breast02 DATROWAY is the first and only therapy to significantly improve overall survival vs. chemotherapy in this patient population WILMINGTON, Del. / Oct 19, 2025 / Business Wire / Positive results from the TROPION-Breast02 Phase III trial...Read more
New data from pivotal Phase 3 ROSELLA trial reinforce relacorilant plus nab-paclitaxel improves progression-free and overall survival in patients with platinum-resistant ovarian cancer, with no need for biomarker selection – including in people who progressed while on or after taking a PARP inhibitor, a patient population with particularly poor prognosis Corcept expands BELLA trial to three study arms: (i) platinum-resistant ovarian...Read more
The probability of survival at 8 years was an unprecedented 78.9% with XTANDI plus leuprolide versus 69.5% with leuprolide, in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence1 XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in this patient population, supporting its earlier use in this setting Final results from the Phase 3...Read more
Late-Breaking ASCENT-03 Data Simultaneously Presented at ESMO 2025 and Published in The New England Journal of Medicine With Two Positive Phase 3 Trials, Trodelvy Has Potential as the First and Only ADC to be a Backbone Standard of Care for All First-Line Metastatic TNBC Patients Regardless of PD-L1 Status FOSTER CITY, Calif. / Oct 19, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today shared positive data from the...Read more
First and only combination regimen to improve survival when used before and after surgical cystectomy in cisplatin-ineligible patients with muscle-invasive bladder cancer Unprecedented survival results from pivotal Phase 3 EV-303 trial show potential for PADCEV plus KEYTRUDA to redefine standard of care TOKYO and NEW YORK, Oct. 18, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas")...Read more
More than 92% of patients treated with AstraZeneca and Daiichi Sankyo’s ENHERTU were free of invasive disease at three years DESTINY-Breast05 presented in ESMO Presidential Symposium alongside DESTINY-Breast11 reinforce potential for ENHERTU to become a foundational treatment in curative-intent early breast cancer setting WILMINGTON, Del. / Oct 18, 2025 / Business Wire / Positive results from the DESTINY-Breast05 Phase III trial...Read more
Results from the first and second interim analyses of the Phase 3 KEYNOTE-B96 trial were selected for presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2025 With these results, KEYNOTE-B96 is the first trial of an immune checkpoint inhibitor-based treatment regimen in platinum-resistant recurrent ovarian cancer to show statistically significant improvements in progression-free...Read more
Highest reported pathologic complete response rate seen in a Phase III registrational trial for HER2-positive early breast cancer with favorable safety profile vs. standard treatment DESTINY-Breast11 presented in ESMO Presidential Symposium alongside DESTINY-Breast05 reinforce potential for AstraZeneca and Daiichi Sankyo’s ENHERTU to become a foundational treatment in curative-intent early breast cancer setting WILMINGTON, Del. / Oct...Read more
PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled Additional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival (“PFS”) of 14.6 months in patients with HR+/HER2-/PIK3CA-mutated advanced breast cancer (“ABC”) MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc....Read more
Clinical benefit of the gedatolisib regimens was consistent across patient subgroups Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and in 11.5% of patients treated with gedatolisib + fulvestrant (“gedatolisib doublet”) Study treatment discontinuation due to treatment related adverse events was reported in 2.3% of patients treated with the...Read more
CABOMETYX reduced the risk of disease progression or death by 81% versus placebo in patients with advanced lung or thymic neuroendocrine tumors (NET) The lungs are the second most common NET site of origin, yet limited treatment options are available1 ALAMEDA, Calif. / Oct 18, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced results from a subgroup analysis of the CABINET phase 3 pivotal trial evaluating CABOMETYX®...Read more
Verzenio is the first contemporary therapy in over two decades to demonstrate a significant overall survival benefit in adjuvant HR+, HER2−, high-risk early breast cancer Seven-year results from the Phase 3 monarchE trial also show Verzenio plus endocrine therapy demonstrated sustained benefits in invasive disease-free survival and distant relapse-free survival These data were simultaneously published in Annals of Oncology and...Read more
More than two thirds of patients treated with IMFINZI-based perioperative regimen were alive at three years First and only perioperative immunotherapy approach to show survival benefit in this setting WILMINGTON, Del. / Oct 17, 2025 / Business Wire / Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil,...Read more
Adding one year of IMFINZI treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone WILMINGTON, Del. / Oct 17, 2025 / Business Wire / Positive results from the POTOMAC Phase III trial showed adding one year of treatment with AstraZeneca’s IMFINZI® (durvalumab) to BCG induction and maintenance therapy demonstrated a statistically...Read more
FREMONT, Calif. / Oct 16, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal®, is a useful tool in assessing the maintenance treatment response post-CRT in patients with unresectable...Read more
Company preparing FDA meeting package to align on a single, well-controlled Phase 3 study under 505(b)(2); Pharma partner discussions ongoing Toronto, Ontario--(Newsfile Corp. - October 16, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine, today announced that it has begun preparing its...Read more
First Phase 3 study (MajesTEC-3) of an investigational combination to show benefit in PFS and OS in relapsed/refractory multiple myeloma as early as second line Independent Data Monitoring Committee (IDMC) recommended unblinding the study based on statistically significant results RARITAN, N.J., Oct. 16, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma therapies, today announced...Read more
Patients treated with ulixacaltamide in the parallel-group study (Study 1) showed a mean improvement from baseline in the Modified Activities of Daily Living 11 at Week 8, the pre-specified primary endpoint, of 4.3 points (p<0.0001) All key secondary endpoints in Study 1 - rate of disease improvement over 12 weeks, PGI-C and CGI-S - were also statistically significant (p<0.001) Study 2 met its pre-specified primary...Read more
KEYNOTE-B96 is the first trial of an immune checkpoint inhibitor-based treatment regimen in platinum-resistant recurrent ovarian cancer to show a statistically significant improvement in OS versus placebo plus chemotherapy with or without bevacizumab for patients whose tumors express PD-L1 and in all comers These data add to previous results for the primary endpoint of progression-free survival and key secondary endpoint of OS RAHWAY,...Read more
SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1...Read more
In ACHIEVE-2, orforglipron lowered A1C by up to 1.7% compared to 0.8% with dapagliflozin, meeting the primary endpoint In ACHIEVE-5, orforglipron lowered A1C by an additional 2.1% when taken with insulin glargine, meeting the primary endpoint INDIANAPOLIS, Oct. 15, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. ACHIEVE-2, the...Read more
DOR/ISL data presented show minimal changes in weight and body composition and no clinically meaningful effect on fasting lipids and the homeostatic model assessment of insulin resistance (HOMA-IR) across clinical trials RAHWAY, N.J. / Oct 15, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the presentation of additional data from the Phase 3 studies of the...Read more
DURAVYU now in Phase 3 for the two largest, multi-billion-dollar retinal disease markets, wet AMD and DME with first patient dosing in pivotal Phase 3 DME trials anticipated in Q1 2026 New preclinical data demonstrates that vorolanib, the active drug in DURAVYU, inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, key contributors to wet AMD and DME IL-6 finding supports the compelling efficacy...Read more
Telitacicept met primary and all secondary endpoints, demonstrating clinically meaningful improvements in disease activity versus placebo ~71.8% of patients receiving telitacicept 160mg achieved ≥3-point ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) reduction vs 19.3% on placebo at 24 weeks Sustained efficacy and favorable safety profile through 48 weeks support potential best-in-disease profile in primary Sjögren’s disease...Read more
NEW YORK / Oct 14, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 HER2CLIMB-05 trial of first-line combination therapy with the tyrosine kinase inhibitor TUKYSA® (tucatinib) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). HER2CLIMB-05 is evaluating TUKYSA versus placebo, both in combination with first-line standard-of-care...Read more
Phase 1 clinical trial designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in combination with androgen receptor pathway inhibitors in first-line mCRPC Clinical trial builds on encouraging Phase 1 data of monotherapy VIR-5500 in late-line patients presented in January 2025 SAN FRANCISCO / Oct 09, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has...Read more
Global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysis Over 100 clinical sites across 24 countries now activated and open for recruitment Futility analysis remains on track for completion in the first quarter of CY2026 SYDNEY, AUSTRALIA, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP)...Read more
STAFFORD, Texas, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Austria. The Company's application to European regulators has been formally...Read more
BOSTON, Mass. / Oct 08, 2025 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the initiation of the Phase 3 ORBIT-EXPANSE long-term trial of navenibart in people living with hereditary angioedema (HAE). “The initiation of ORBIT-EXPANSE marks exciting progress in the development of navenibart,” said...Read more
Protocol Expansion to Ages 10+ Aligned with FDA Guidance, Broadening Patient Population SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, announces alignment with the U.S. Food and Drug Administration (FDA)...Read more
FLASH2 Study Interim Efficacy Analysis Targeted for 1H2026 Enrollment Update Remains on Track for 4Q2025 PRINCETON, N.J., Oct. 7, 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 its first Data Monitoring Committee (DMC) meeting for...Read more
Baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in 24-hour ambulatory systolic blood pressure compared with placebo WILMINGTON, Del. / Oct 07, 2025 / Business Wire / Positive high-level results from the Bax24 Phase III trial showed baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure (SBP)...Read more
Approximately 80% of Omvoh-treated patients in the LUCENT-3 study who achieved clinical remission at one year maintained long-term, corticosteroid-free clinical and endoscopic remission At four years, nearly all patients who achieved clinical remission at one year had improvements in bowel urgency, one of the most disruptive symptoms for patients INDIANAPOLIS, Oct. 7, 2025 /PRNewswire/ -- New data from Eli Lilly and Company (NYSE:...Read more
Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study Clinical and endoscopic outcomes were demonstrated across both biologic-naïve and biologic-refractory sub-groups TREMFYA® is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults...Read more
DATROWAY demonstrated statistically significant and clinically meaningful improvement in overall survival as 1st-line therapy for patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option in TROPION-Breast02 AstraZeneca and Daiichi Sankyo’s DATROWAY is the first and only therapy to significantly improve overall survival vs. chemotherapy in this patient population DATROWAY also demonstrated a highly...Read more
Adding Repatha to Standard Therapy of Statins or Other LDL-C Lowering Treatments Significantly Reduces Cardiovascular Events Compared with Standard Therapy Alone Repatha is Now the First and Only PCSK9 Inhibitor to Demonstrate Significant Reduction of Cardiovascular Events as Both Primary and Secondary Prevention THOUSAND OAKS, Calif., Oct. 2, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 VESALIUS-CV...Read more
STAFFORD, Texas, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Belgium. The Company's application to European regulators has been formally...Read more
Global Cardiovascular Outcomes Trial will Enroll ~11,000 Patients Across 35 Countries to Evaluate Zilebesiran as a Novel Biannual Treatment Trial to Assess Zilebesiran in Patients with Uncontrolled Hypertension with Either Established or at High Risk of Cardiovascular Disease Milestone Payment of $300 Million Triggered Under Global Collaboration and License Agreement with Partner Roche CAMBRIDGE, Mass. / Oct 01,...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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