Continues to drive enrollment with increase to 78% now consentedBlinded response activity tracking within expected range Consented subjects now across seven countries supporting the expansion of the MIRACLE trial HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an update on enrollment from its November report with an increase to 78% of the target number...Read more
Engineered to Deliver Potent Pain Relief with Unique, Built-In, Abuse Protection SAN DIEGO, CA / ACCESS Newswire / December 9, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced that the first patient has been enrolled in the Company's pivotal Phase 3 clinical...Read more
No advanced therapies approved to treat ColdU and SD—diseases of misery that dramatically impact all aspects of patient life Barzolvolimab is the only drug in development to demonstrate clinical benefit in patients in ColdU and SD in a large, randomized, placebo-controlled study--all primary and secondary endpoints met with high statistical significance at 12 weeks and sustained through end of treatment period (20 weeks) in Phase 2...Read more
TECVAYLI® and DARZALEX FASPRO® combination led to a statistically significant progression-free survival and overall survival advantage compared to standard treatment after three years of follow-up Combination regimen granted Breakthrough Therapy Designation by U.S. FDA ORLANDO, Fla., Dec. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma, today announced new data from the...Read more
The risk reduction observed in BRUIN CLL-313 is among the most compelling observed for a single agent BTK inhibitor in a front-line CLL study These data will be simultaneously published in the Journal of Clinical Oncology and highlighted in a late-breaking oral presentation at the 2025 American Society of Hematology Annual Meeting and Exposition, and were featured as part of the meeting's press...Read more
Over 230 patients screened and over 160 patients enrolled in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC) Enrollment exceeding expectations with strong clinical site and patient interest Topline interim data readout expected in 1H2026 Phase 3 combination regimen continues under FDA Fast Track designation PHILADELPHIA and VANCOUVER, British Columbia, Dec. 09, 2025 (GLOBE NEWSWIRE) -- BriaCell...Read more
By the end of 3 induction cycles, the best minimal residual disease (MRD) negativity rate and the MRD-negative complete response (CR) rate were 66.0% and 64.2%, respectively High-risk IKZF1plus patients showed 90% molecular response rate Low-intensity chemotherapy combination achieved deep responses with favorable safety profile ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group...Read more
6 Years Long-term survival data reinforce potential benefit to patient survival in treating recurrent or metastatic nasopharyngeal carcinoma with LOQTORZI in combination with chemotherapy REDWOOD CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (NASDAQ: CHRS) today announced compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI® (toripalimab-tpzi)...Read more
Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive (PCV21) and Prevnar 20 (PCV20), the Current Standards of Care Company Expects to Report Topline Safety, Tolerability and Immunogenicity Data for OPUS Phase...Read more
Based on the Results of a Planned Interim Futility Analysis the Inhaled AAT Trial is Unlikely to Demonstrate a Statistically Significant Benefit in its Primary Endpoint Kamada Continues to Supply GLASSIA®, its AAT-IV Treatment, Marketed Internationally Including in the U.S. and Canada Through a License Agreement with TAKEDA Kamada Reiterates its 2025 Full-Year Revenue Guidance of $178 Million-$182 Million and Adjusted EBITDA of...Read more
In addition to meeting the primary endpoint of non-inferiority for overall response rate (ORR) in the BRUIN CLL-314 study, pirtobrutinib achieved a numerically higher ORR of 87.0% compared to 78.5% for ibrutinib in the intent-to-treat (ITT) population Progression-free survival data were immature but trended in favor of pirtobrutinib with a 43% reduction of the risk of disease progression or death in the ITT population, and...Read more
93% overall response and 76% complete response rates with median progression-free survival of 18 months in patients with large B-cell lymphoma in the 3L+ setting 83% overall response and 61% complete response rates in cohort comprised predominantly of patients with primary refractory large B-cell lymphoma in the 2L setting Manageable safety profile appropriate for outpatient administration; no high-grade CRS and ≤ 5% of patients with...Read more
Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 alone EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line...Read more
Findings from the Phase 3 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition and published in Blood NEW YORK / Dec 06, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. The results demonstrated the superiority of HYMPAVZI...Read more
Selective Treg modulator gotistobart (BNT316/ONC-392) showed a reduction in the risk of death by more than half compared to standard of care chemotherapy and a manageable safety profile in the first of two stages of the global Phase 3 trial PRESERVE-003 in patients with squamous non-small cell lung cancer (“sqNSCLC”) who have progressed on prior immunotherapy plus chemotherapy Median OS with gotistobart has not been reached at almost...Read more
Triple-class exposed patients with three prior lines of therapy in CARTITUDE-1 and CARTITUDE-4 achieved a median PFS of 50.4 months after a single infusion of CARVYKTI® Translational analyses show stronger immune fitness and a more immunocompetent TME when CARVYKTI® is used earlier in the treatment journey Eighty percent of as-treated patients in CARTITUDE-4 with standard-risk cytogenetics remained progression-free and off treatment...Read more
Follow-up data from CARTITUDE-4 show at least 80 percent of as-treated standard-risk patients remained progression and treatment-free following a single infusion as early as second line Data suggest stronger immune fitness in earlier lines may be associated with longer progression free survival ORLANDO, Fla., Dec. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today updated results from the Phase 3...Read more
Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 Disease in BOND-003 Cohort P CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety with optimized administration Robust clinical pipeline that spans multiple late-stage studies across intermediate- and high-risk NMIBC IRVINE, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc....Read more
ROCKVILLE, Md. and SUZHOU, China, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance from the US Food and Drug Administration (FDA) and the...Read more
Pivotal Phase 3 randomized, double-blind, placebo-controlled study (n=106) met the primary endpoint (PUL v2.0) and the key secondary cardiac endpoint (LVEF), both achieving statistical significance (p=0.03 and p=0.04, respectively) Statistical significance was achieved in all type 1 error controlled secondary endpoints Results demonstrate clinically meaningful and statistically significant skeletal and cardiac benefits, supporting...Read more
Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee BMS Remains Blinded to Study Data PRINCETON, N.J. / Dec 03, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY, “BMS”) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2...Read more
Primary endpoint met; median time to onset of symptom relief achieved in 1.28 hours, significantly faster versus placebo (p<0.0001) All secondary efficacy endpoints met (p<0.0001), including End of Progression™1 (median 17.47 minutes) and complete symptom resolution (median 11.95 hours) Well-tolerated safety profile of deucrictibant confirmed Efficacy and safety outcomes consistent across all HAE subtypes represented (HAE...Read more
STAFFORD, Texas, Dec. 03, 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 provided the following global update on FLAMINGO-01. Flamingo-01 Progress to Date The Company has achieved a major milestone by screening...Read more
Bayer revealed first results of the pediatric study from the pivotal clinical development program QUANTI for its low-dose MRI contrast agent QUANTI Pediatric evaluated the pharmacokinetics and safety of gadoquatrane in children (birth to <18) at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight Data are part of...Read more
TOKYO and CAMBRIDGE, Mass., Dec. 2, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name: LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in...Read more
Study further expands clinical development program of Bayer’s long-acting reversible intrauterine system Mirena® (levonorgestrel-releasing intrauterine system) 52 mg. Approximately 121 out of every 100,000 women develop nonatypical endometrial hyperplasia (NAEH), a benign form of endometrial thickening, each year.1 Currently, there are no approved medical treatment options for NAEH in the U.S. Mirena is globally available in more than...Read more
Biodexa Announces Enrolment of First European Patients into Pivotal Phase 3 Serenta Trial in FAP December 1, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the enrolment of the first three patients by the University of Bonn,...Read more
Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in a global Phase 3 trial for Stargardt disease, achieving a statistically significant p-value of 0.0033 Tinlarebant met the primary efficacy endpoint, demonstrating clinical benefit by significantly reducing the lesion growth rate by 36% compared to placebo, as measured by retinal imaging Tinlarebant was well tolerated throughout the trial Stargardt...Read more
November 24, 2025 - Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announced today that the University of Bonn, Germany is now actively screening patients for the Phase 3 Serenta clinical trial evaluating eRapa in familial adenomatous polyposis (FAP). This marks the first European site activation for the registrational Serenta trial, representing a major milestone in expanding FAP treatment options to European patients who currently have no...Read more
Target enrollment of 6,000 participants completed in the Northern Hemisphere Planned interim analysis in Q1 2026 will determine potential need for additional enrollment during Southern Hemisphere flu season SAN DIEGO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced it has...Read more
First patient randomized into HELIOS-3, which along with HELIOS-2 form the basis of AXPAXLI’s registrational program in non-proliferative diabetic retinopathy (NPDR) HELIOS-2 and HELIOS-3 are global, complementary superiority trials using a novel ordinal diabetic retinopathy severity scale (DRSS) primary endpoint Targeting a broad diabetic retinopathy (DR) label by including patients with non-center-involved diabetic macular edema...Read more
OCEANIC-STROKE demonstrates superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor Bayer will globally engage with health authorities in preparation for the submission of marketing authorization...Read more
CAREFNDR underscores the potential clinical value of paltusotine beyond acromegaly, and demonstrates progress in Crinetics’ commitment to addressing unmet needs in the neuroendocrine tumor community SAN DIEGO, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the first patient has been randomized in the pivotal Phase 3 CAREFNDR trial, a multicenter, randomized, double-blind,...Read more
50 of 80 patients enrolled in FLASH2 study Blinded Response Rate to Date Exceeds Trial Estimate PRINCETON, N.J., Nov. 19, 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 the planned enrollment...Read more
No changes in protocol recommended for LUGANO and LUCIA clinical trials Masked safety data continues to show no safety signals, consistent with previous clinical trials for DURAVYU On track to report topline 56-week data for LUGANO in mid-2026 with LUCIA data to closely follow WATERTOWN, Mass., Nov. 19, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and...Read more
Trial met primary endpoint of hemoglobin response and key secondary endpoints of change from baseline in hemoglobin concentration and indirect bilirubin Trial showed trend favoring mitapivat but did not meet statistical significance in primary endpoint of annualized rate of SCPCs (pain crises), and the key secondary endpoint of change from baseline in PROMIS Fatigue was not met Patients in the mitapivat arm who achieved hemoglobin...Read more
Investigational DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority to BIC/FTC/TAF in a Phase 3 clinical trial in treatment-naïve adults with HIV-1 infection RAHWAY, N.J. / Nov 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug,...Read more
78-Week Study Evaluating Subcutaneous VK2735 in Adults with Obesity Enrollment Completed Ahead of Schedule and Above Target Size, Indicating Strong Interest in VK2735 SAN DIEGO, Nov. 19, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of patient...Read more
Per the Drug Safety Monitoring Board (DSMB) meeting evaluating one-third of planned participants, study to continue as planned More than half of planned participants have completed dosing with no dose reductions, discontinuations, drug-related SAEs, loss of consciousness, or excessive sedation reported Topline results are on track for the second quarter of 2026 SALT LAKE CITY, Nov. 18, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ:...Read more
At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy These unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage setting Data to be presented at an upcoming medical meeting and shared with health authorities around the world lidERA is the second positive Phase III readout for...Read more
First-line treatment with TREMFYA® shows significant inhibition of radiographic progression at Week 24, which was sustained through Week 48, preserving joint health with a well-established safety profile More than half of TREMFYA®-treated patients across both dose groups achieved a 50% improvement in signs and symptoms of psoriatic arthritis by Week 48 in the Phase 3b APEX study NEW YORK, Nov. 17, 2025 /PRNewswire/...Read more
Buntanetap significantly improves cognition in all Parkinson’s patients, with those exhibiting Alzheimer’s co-pathology showing a three-times greater response New data demonstrate reductions in plasma biomarkers pTau217, total tau, and brain-derived tau following buntanetap treatment Findings support buntanetap's potential to address cognitive decline in Parkinson's disease, show disease-modifying efficacy, and inform future clinical...Read more
Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis Ziihera plus the PD-1 inhibitor Tevimbra® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS...Read more
Ziihera® plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis Ziihera plus Tevimbra® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS and PFS versus trastuzumab...Read more
Completion of treatment for the first 45 patients on pace for Q1 2026 with initial unblinded data thereafter; blinded response activity tracking within expected range HOUSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an enrollment update with 60% of the target number of subjects for the first planned interim unblinding of data having consented to its...Read more
The Novel HIV Therapy has the Potential to Expand Options for Virologically Suppressed Adults Treated with Complex ART Regimens Phase 3 Results from ARTISTRY-1 and 2 Trials will Form the Basis of Regulatory Submissions FOSTER CITY, Calif. / Nov 13, 2025 / Business Wire / Gilead Sciences, Inc. (NASDAQ: GILD) today announced positive topline results from the Phase 3 ARTISTRY-1 trial. The open-label trial evaluated the...Read more
WALTHAM, Mass., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced data from a post hoc analysis of the GALE extension study following five years of continuous treatment with SYFOVRE® (pegcetacoplan injection), the leading treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The results demonstrate that both every-other-month and monthly SYFOVRE...Read more
Company remains on track for VITESSE topline data in Q4 of this year Châtillon, France, November 11, 2025 - DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today announced that the last patient visit has been completed in the Company’s Phase 3 VITESSE clinical trial of the VIASKIN® Peanut patch in peanut allergic children aged 4-7...Read more
No safety concerns identified by independent data and safety monitoring board, which recommends continuation of study without any modifications SOUTH SAN FRANCISCO, Calif. / Nov 10, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced the positive outcome of its pre-planned...Read more
SUNNYVALE, Calif., Nov. 10, 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 Henry Ford Health in its ongoing Phase 3 CardiAMP® HF II clinical trial for patients with ischemic heart failure of reduced ejection fraction (“HFrEF”). “The CardiAMP-HF trial, in which...Read more
MannKind has made the decision to discontinue the ICoN-1 Phase 3 clinical trial evaluating nebulized clofazimine inhalation suspension for nontuberculous mycobacterial (NTM) lung disease, following a futility determination based on medical monitoring data This outcome does not impact the development of MNKD-102, MannKind’s dry powder inhalation (DPI) formulation of clofazimine, which remains under consideration for future clinical...Read more
16.5 months median progression free survival (mPFS) for bezuclastinib plus sunitinib compared to 9.2 months mPFS for sunitinib monotherapy (HR=0.50, CI: 0.39-0.65; p<0.0001) 46% Objective Response Rate (ORR) reported for bezuclastinib combination compared to 26% ORR for sunitinib monotherapy (p<0.0001) Safety profile of bezuclastinib combination was well tolerated with no unique risks observed with the combination when compared...Read more
The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to teriflunomide In a pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as Ocrevus, the only approved therapy in PPMS Full data from both studies will be shared at upcoming medical meetings; once the second RMS study (FENhance...Read more
Baxdrostat demonstrated a statistically significant placebo-adjusted reduction of 13.9 mmHg in night-time ambulatory systolic blood pressure at 12 weeks with a safety profile consistent with the BaxHTN trial Full results presented at the American Heart Association Scientific Sessions 2025 WILMINGTON, Del. / Nov 09, 2025 / Business Wire / Positive full results from the Bax24 Phase III trial showed baxdrostat demonstrated a...Read more
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
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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