Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis 50 mg once-daily dose of obefazimod led to a compelling pooled 16.4% (p<0.0001) placebo-adjusted clinical remission rate at Week 8 in the ABTECT-1 (Study 105) and ABTECT-2 (Study 106) trials. Individually, the 50 mg dose...Read more
Longer-term follow up in the FLAURA2 Phase III trial confirms the favorable benefit-risk profile of this combination Overall survival results reinforce TAGRISSO as the backbone therapy in EGFRm lung cancer across stages WILMINGTON, Del. / Jul 21, 2025 / Business Wire / Positive high-level results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) with the addition...Read more
CAMBRIDGE, Mass., July 21, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the first patient has been dosed in ALKAZAR, the company's global Phase 3 randomized, controlled trial evaluating neladalkib for TKI-naïve patients with advanced ALK-positive non-small cell...Read more
PRINCETON, N.J. / Jul 18, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 INDEPENDENCE trial evaluating Reblozyl® (luspatercept-aamt) with concomitant janus kinase inhibitor (JAKi) therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC) transfusions did not meet its primary endpoint of RBC transfusion independence during any consecutive 12-week period, starting within...Read more
PITTSBURGH, July 18, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing. Viatris Chief R&D Officer...Read more
Milestone payment of $10 million triggered under the global license agreement with Takeda LEXINGTON, Mass., July 17, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”)...Read more
FDA Protocol Review Completed Rho, Inc. Selected as Clinical Research Partner SAN DIEGO, CA / ACCESS Newswire / July 16, 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 the initiation of its pivotal Phase 3 study of PF614, the Company's lead product...Read more
SOUTH SAN FRANCISCO, Calif. / Jul 16, 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 that the company has completed enrollment in its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial to evaluate its lead asset,...Read more
PHILADELPHIA and VANCOUVER, British Columbia, July 15, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to announce the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612) in...Read more
COPENHAGEN, Denmark, July 14, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from Week 156 of its Phase 3 PaTHway Trial confirming that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism regardless of its cause (post-surgical, autoimmune, genetic, or idiopathic), including improvements in biochemistries, kidney...Read more
Interim Phase 3 Results Support Ovaprene’s Differentiation as a First-in-Category, Hormone-Free, Intravaginal Monthly Contraceptive SAN DIEGO, July 14, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial...Read more
Baxdrostat demonstrated a statistically significant and clinically meaningful reduction of systolic blood pressure compared with placebo WILMINGTON, Del. / Jul 14, 2025 / Business Wire / Positive high-level results from the BaxHTN Phase III trial showed baxdrostat at two doses (2mg and 1mg) demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at...Read more
Both Phase 3 Studies Met all Primary and Secondary Endpoints Demonstrating Statistically Significant Improvements Across Symptoms at All Doses, Building Upon Phase 2b Results Oveporexton was Generally Well-Tolerated in Phase 3 Safety Profile Takeda is Rapidly Advancing Regulatory Submissions and Launch Preparedness with the Aim to Bring Oveporexton to People Living with Narcolepsy Type 1 as Quickly as Possible These Results Mark a...Read more
In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally RAHWAY, N.J. / Jul 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the EXPrESSIVE Phase 3 clinical trials, evaluating the safety and efficacy of MK-8527, an investigational once-monthly, oral nucleoside reverse transcriptase...Read more
XTANDI: the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR) NEW YORK & TOKYO / Jul 10, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the overall...Read more
Data from Orbit and Cosmic studies expected around the end of the year NOVATO, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (NASDAQ: MREO), today announced that the randomized, placebo-controlled Phase 3 portion of the Orbit study evaluating UX143 (setrusumab) in pediatric and young adult patients with osteogenesis imperfecta (OI) is progressing toward a final...Read more
Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial Recent EU approval from the European Medicines Agency (EMA) boosts trial profile Enrollment in Part A of MIRACLE reaches seven subjects treated and one additional subject in screening 16 additional clinical sites in Europe and the US expected to begin recruitment by the end of August; building to...Read more
Zodasiran targets ANGPLT3, an emerging therapeutic target to treat HoFH and other dyslipidemias YOSEMITE Phase 3 study further enhances Arrowhead’s late-stage pipeline of RNAi-based cardiometabolic candidates PASADENA, Calif. / Jul 08, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subject in the YOSEMITE Phase 3 clinical trial of zodasiran, the company’s...Read more
PRINCETON, N.J., July 07, 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 that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent...Read more
The GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing GCA1 Safety in GCA patients was consistent with known safety profile of Cosentyx® (secukinumab)1 EAST HANOVER, N.J., July 3, 2025 /PRNewswire/ -- Novartis today announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing...Read more
4FRONT-1 Phase 3 expected data readout accelerated from H2 2027 to H1 2027 4FRONT-2 Phase 3 trial initiated ahead of schedule Streamlined late-stage clinical and pre-commercial organization aligns with focused pipeline shift, as announced in January 2025 EMERYVILLE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing...Read more
Together, Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven add 30 satellite locations to enroll patients in BriaCell’s pivotal Phase 3 study BriaCell’s Phase 3 study currently has 58 active clinical sites across 15 states, including Smilow Cancer Hospital, Los Angeles Cancer Network, University of Arizona, DHR Health Oncology Institute, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology...Read more
500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia SAN DIEGO, July 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment in the...Read more
DSMB recommended the continuation of trial as planned Topline data expected in Q3 2025 NEW HAVEN, Conn., July 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without...Read more
At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone SHANGHAI & CAMBRIDGE, Mass. / Jun 30, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival...Read more
At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone THOUSAND OAKS, Calif., June 30, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim...Read more
Global Phase 3 PROMINENT study will evaluate the efficacy and safety of felzartamab, as compared to tacrolimus, in adults with primary membranous nephropathy (PMN) There are currently no therapies specifically approved for PMN, a rare immune-mediated disease affecting the kidneys with an estimated prevalence of ~36k patients in the U.S.1 Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potentially differentiated...Read more
mRNA-1010 demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older CAMBRIDGE, MA / ACCESS Newswire / June 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the...Read more
Study demonstrates superiority, showing both statistically significant and clinically meaningful reduction in annualized bleeding rate with a generally well-tolerated safety profile compared to on-demand treatment in patients 12 years and older HYMPAVZI was administered with a straightforward, once-weekly subcutaneous injection that required minimal preparation NEW YORK / Jun 26, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today...Read more
Phase 3 Top Line Results Expected Q2 2026 SALT LAKE CITY, June 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum...Read more
MR-141 Met Primary And All Secondary Endpoints, Demonstrating Rapid And Sustained Improvement In Near Visual Acuity Without Compromising Distance Vision Safety Profile Consistent With Previous Clinical Trials And No Treatment-Related Serious Adverse Events Reported In This Study Targeting Application To U.S. FDA In Second Half of 2025 PITTSBURGH, June 26, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global...Read more
June 25, 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 activation of the first clinical study site for its Serenta trial in patients with familial adenomatous polyposis (FAP). The trial, which is now enrolling, represents a significant...Read more
Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety...Read more
VANQUISH-1 and VANQUISH-2 Studies to Evaluate Subcutaneous VK2735 in Obese Adults with and without Type 2 Diabetes SAN DIEGO, June 25, 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 initiation of the VANQUISH Phase 3 clinical program for VK2735, the company's dual...Read more
C-FORWARD is the Second Phase 3 Trial in the Global HCV Development Program; the First Phase 3 Trial, C-BEYOND, is Currently Enrolling Patients in the US and Canada Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People...Read more
Intra-patient, double-blind, multicenter, placebo-controlled study with crossover design Repeat administration under compassionate use was previously shown to be well tolerated and associated with full corneal healing by 3 months as well as significant visual acuity improvement from hand motion to 20/25 at 8 months PITTSBURGH, June 24, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced...Read more
Study completion anticipated in mid-2026 with subsequent data readout and regulatory submissions for treatment of severe hypertriglyceridemia PASADENA, Calif. / Jun 23, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has completed enrollment in SHASTA-3, SHASTA-4, and MUIR-3, the company’s global Phase 3 clinical studies designed to support regulatory submissions for marketing approval of...Read more
Ralinepag has the potential to be the first once-a-day oral prostacyclin agonist for patients with pulmonary arterial hypertension ADVANCE OUTCOMES will continue to accrue clinical worsening events through the end of 2025 and top-line data is expected in the first half of 2026 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Jun 23, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit...Read more
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy HYPERION, third Phase 3 study to demonstrate significant efficacy in adults with PAH, was previously stopped early based on review of available data from clinical program RAHWAY, N.J. / Jun 23, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United...Read more
A single administration of COMP360 demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity as measured by MADRS1 with a mean difference of -3.6 comparing 25 mg to placebo (p<0.001)2 Independent Data Safety Monitoring Board (DSMB) reviewed safety data for COMP360 and found no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation between treatment and...Read more
Zanzalintinib in combination with atezolizumab demonstrated a statistically significant reduction in risk of death versus regorafenib in intent-to-treat population ALAMEDA, Calif. / Jun 22, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq®) demonstrated a statistically significant...Read more
New FRONTIER5 data show that a direct switch to investigational Mim8 (denecimig) prophylaxis treatment from emicizumab, without the need for a washout period, was well-tolerated with no safety concerns in adults and adolescents with haemophilia A, with or without inhibitors1. Switching to Mim8 led to a sustained increase in thrombin generation into the normal range, but without causing thrombin levels that might pose a thrombotic...Read more
Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year INDIANAPOLIS, June 22, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1,...Read more
The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint The safety profile of orforglipron was consistent with the established GLP-1 class INDIANAPOLIS, June 21, 2025...Read more
Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA Results from the phase 3b STEP UP trial showed that a higher dose of Wegovy® (semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo1 Safety and tolerability of the higher...Read more
Pivotal Phase III SUNMO study demonstrated an 11.5 month median progression-free survival – three times longer than R-GemOx This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community care Results will be submitted to global health authorities including the U.S. Food and Drug Administration SOUTH SAN FRANCISCO, Calif. / Jun 20, 2025 / Business Wire / Genentech,...Read more
Global Phase 3 BRAVE study will evaluate the efficacy and safety of omaveloxolone in children 2 to <16 years old with Friedreich ataxia, a rare neurodegenerative disorder BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population Omaveloxolone is currently marketed under the brand name SKYCLARYS® for the treatment of adults and adolescents aged 16 years and older...Read more
TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month1 Atogepant met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / Jun 18, 2025 / Business Wire / The first patient has been dosed in the IDeate-Prostate01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. Ifinatamab deruxtecan is a...Read more
NORTH CHICAGO, Ill., June 16, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0.908; stratified log-rank, p=0.3772. No new safety signals were observed.1 Results from the VERONA trial...Read more
NEW YORK, June 16, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced new survival data from 10 participants in its Expanded Access Program (EAP) for NurOwn® (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). The EAP enrolled 10 participants who had previously completed the Phase 3 clinical trial. The...Read more
Enrollment Completed in Ongoing Registrational PROSERA Phase 3 Study in PAH Topline Results Announcement from PROSERA Phase 3 Expected in February 2026 Blinded Preliminary Baseline Characteristics Align with Intended Study Population SAN DIEGO / Jun 16, 2025 / Business Wire / Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of...Read more
Bagsværd, Denmark, 12 June 2025 – Novo Nordisk today announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management. “We are very...Read more
MOBILIZE-1 is the first Phase 3 study being initiated for V181 as part of a planned robust clinical development program Study will evaluate a single dose of V181 for the prevention of dengue disease caused by any of the four serotypes of the dengue virus regardless of previous exposure RAHWAY, N.J. / Jun 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation...Read more
TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis BARCELONA, June 11,...Read more
Completion of enrollment anticipated in 2026 CARLSBAD, Calif. / Jun 11, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the first participant has been dosed in the global Phase 3 REVEAL study, which is designed to evaluate the efficacy and safety of ION582, an investigational medicine for the treatment of people living with Angelman syndrome (AS), a serious and rare neurodevelopmental...Read more
Both vaccine candidates induced robust immune responses across all antigens tested No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials Novavax continues to pursue partnering opportunities to advance further development of these programs GAITHERSBURG, Md., June 11, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its...Read more
D-PLEX100 successfully met the primary efficacy endpoint, with statistically significant results (p<0.005) in 798 patients with large abdominal surgery incisions. The trial successfully met all key secondary efficacy endpoints, including a 58% reduction in the rate of surgical site infections (“SSI”) in patients treated with D-PLEX100 arm versus standard of care (“SoC”) arm (p<0.005). The Company expects to submit a New Drug...Read more
Pre-specified analyses show that obicetrapib treatment leads to statistically significant and clinically meaningful reductions in the primary outcome measure of Alzheimer’s disease biomarker in both the full ITT population (p<0.002) and in ApoE4 carriers (p=0.0215), supporting the emerging link between CETP-inhibition and prevention of AD pathology NewAmsterdam to present results during the AAIC conference in...Read more
Enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C in both Phase 3 CORALreef HeFH and CORALreef AddOn trials Enlicitide, a novel macrocyclic peptide, has the potential to be the first approved oral PCSK9 inhibitor RAHWAY, N.J. / Jun 09, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the first two...Read more
Robust proteinuria reduction and stable kidney function were maintained across a broad population of patients No new safety signals were observed New data presented at late-breaking session at the European Renal Association Congress Marketing applications for EMPAVELI are under review with the FDA and EMA WALTHAM, Mass. and STOCKHOLM, June 06, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi®...Read more
Enrollment Completed for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected End of 2026 Additional Data from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Further Supports the Recently Released Positive Top-Line Results and Further Underlines Vidofludimus Calcium's Neuroprotective Potential New CALLIPER Data Regarding Time to 24-Week Confirmed Disability...Read more
Denifanstat met all primary and secondary endpoints versus placebo Denifanstat was well tolerated Oral FASN inhibitors offer a novel mechanism of action for the potential treatment of moderate to severe acne Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S. SAN MATEO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc....Read more
SOUTH SAN FRANCISCO, Calif. / Jun 03, 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 that its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in the rare neurodegenerative disease Ataxia-Telangiectasia (A-T) has...Read more
Results from the Phase 3 AMPLITUDE study show the potential of AKEEGA® (niraparib and abiraterone acetate dual-action tablet) to delay cancer progression and worsening of symptoms Data show a nearly 50 percent reduction in disease progression in BRCA-altered mCSPC vs. current standard of care CHICAGO, June 3, 2025 /PRNewswire/ -- Johnson & Johnson announced today first results from the Phase 3, randomized, double-blind,...Read more
More than half of patients maintained minimal residual disease (MRD) negativity (10-5) with DARZALEX FASPRO® for 24 months or longer in the Phase 3 PERSEUS study Data from Phase 3 CEPHEUS study show 60 percent overall MRD negativity (10−5) and improved PFS with DARZALEX FASPRO® in transplant-ineligible newly diagnosed patients CHICAGO, June 3, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from two...Read more
First-line maintenance combination therapy reduced the risk of disease progression or death by 46%, with a median overall survival of 13.2 months vs 10.6 months for atezolizumab alone from the point of randomization First Phase 3 study to demonstrate statistically significant and clinically meaningful improvements in both progression-free and overall survival in ES-SCLC first-line maintenance Results presented at the ASCO 2025...Read more
Relacorilant plus nab-paclitaxel improves progression-free and overall survival in patients with platinum-resistant ovarian cancer, with no need for biomarker selection Addition of relacorilant did not increase side-effects, compared to nab-paclitaxel monotherapy Results presented in late-breaking podium presentation at ASCO 2025 with simultaneous publication in The Lancet REDWOOD CITY, Calif. / Jun 02, 2025 / Business Wire / Corcept...Read more
MR-142 Achieved Primary Endpoint of ≥15-letter (≥3-line) Gain in Mesopic Low Contrast Distance Visual Acuity in Comparison to Placebo Results Showed Patient-Reported Functional Benefit in Treating Significant Chronic Night Driving Impairment in Keratorefractive Patients With Reduced Mesopic Vision, a Condition With No Current FDA-Approved Therapies No Evidence of Tachyphylaxis Was Observed In This Study Over The 6-Week Period Study...Read more
AstraZeneca and Daiichi Sankyo’s ENHERTU plus pertuzumab showed a median progression-free survival greater than three years First trial in more than a decade to demonstrate an improvement in outcomes in the 1st-line setting for a broad population of patients with HER2-positive metastatic breast cancer WILMINGTON, Del. / Jun 02, 2025 / Business Wire / Positive results from the DESTINY-Breast09 Phase III trial showed ENHERTU®...Read more
First pivotal trial to use a circulating tumor DNA (ctDNA)-guided approach to detect and treat emerging resistance in 1st-line therapy ahead of disease progression in breast cancer Trial showed AstraZeneca’s camizestrant reduced risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumor mutation as detected by Guardant360 CDx PALO ALTO, Calif. / Jun 02, 2025 / Business...Read more
ENLIGHTEN 2 trial met primary endpoint with LYR-210 demonstrating statistically significant improvement in the composite of the three cardinal symptoms (3CS) of CRS at 24 weeks (p=0.0078) ENLIGHTEN 2 trial also showed statistically significant improvement in key secondary endpoints in the full population of 3CS at 24 weeks (p=0.0209) and SNOT-22 score at 24 weeks (p=0.0101) Additionally, in pooled data from ENLIGHTEN 2 and ENLIGHTEN 1...Read more
Robust broad-spectrum efficacy sustained over 1-year across all symptom domains including negative symptoms Generally well-tolerated with low rates of adverse events and discontinuation Brilaroxazine improved multiple neuroinflammatory markers reported to enhance efficacy and mitigate side effects Virtual investor webcast today at 8:00 a.m. EDT CUPERTINO, Calif., June 02, 2025 (GLOBE NEWSWIRE) --...Read more
Atacicept ORIGIN Phase 3 trial 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) Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3...Read more
Two-thirds (67.4%) of patients treated with IMFINZI-based perioperative regimen remained event-free at two years First and only immunotherapy to demonstrate statistically significant event-free survival in a global Phase III trial in this setting WILMINGTON, Del. / Jun 01, 2025 / Business Wire / Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination...Read more
Rusfertide plus current standard of care more than doubled clinical response rates across high- and low-risk PV groups, significantly reducing phlebotomy eligibility compared to placebo plus current standard of care, which was the primary endpoint All key secondary endpoints met with statistical significance, including a nearly three-fold reduction in the proportion of patients requiring phlebotomy and a four-fold improvement in...Read more
First pivotal trial to demonstrate clinical value of monitoring circulating tumor DNA to detect and treat emerging resistance in 1st-line therapy ahead of disease progression in breast cancer First and only next-generation oral SERD and complete ER antagonist to demonstrate consistent progression-free survival benefit in combination with widely approved CDK4/6 inhibitors in 1st-line advanced breast cancer WILMINGTON, Del. / Jun 01,...Read more
TTFields therapy concomitant with gemcitabine and nab-paclitaxel is the first treatment to show a clinically meaningful and statistically significant improvement in overall survival (OS) for patients with unresectable, locally advanced pancreatic adenocarcinoma in a Phase 3 trial The OS benefit observed with TTFields therapy is supported by significantly improved quality of life and extended pain-free survival, a key outcome for patients...Read more
Pivotal Phase 3 VERITAC-2 clinical trial results presented at ASCO demonstrate 2.9-month improvement in median progression-free survival when compared to fulvestrant in second line-plus patients with an estrogen receptor 1 mutation Vepdegestrant was generally well tolerated, with few discontinuations and low rates of gastrointestinal-related adverse events Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC)...Read more
First pivotal Phase 3 trial to show superiority of KEYTRUDA plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC RAHWAY, N.J. / May 31, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that KEYTRUDA® (pembrolizumab) plus Trodelvy® (sacituzumab govitecan-hziy) reduced the risk of disease progression or death by 35% (HR=0.65,...Read more
First Pivotal Phase 3 Trial to Show Superiority of a TROP-2 Antibody-Drug Conjugate, Trodelvy, Plus Keytruda Versus Standard of Care in 1L Metastatic TNBC Early Trend in Improvement in Overall Survival Observed FOSTER CITY, Calif. / May 31, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) reduced the risk of disease progression or death by...Read more
The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis New data are being presented in an oral session at the 2025 American Society of Clinical Oncology...Read more
Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001) Libtayo also demonstrated 80% and 65% reductions in the risk of locoregional and distant recurrence, respectively, compared to placebo Detailed results presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting and simultaneously published in the New England...Read more
Real-world claims studies evaluating UZEDY® (risperidone) also show improved adherence and persistence rates, fewer inpatient, outpatient and emergency department (ED) visits versus second-generation daily oral options Latest Phase 3 SOLARIS data show no suspected or confirmed PDSS events with TEV-'749 after more than 3,400 subcutaneous injections in study participants to date As a leader in neuroscience, Teva is committed to...Read more
Pivotal results from the Phase 3 BREAKWATER trial showed 51% risk reduction in death compared to standard-of-care treatment BRAFTOVI combination regimen also demonstrated 47% risk reduction in disease progression or death compared to standard-of-care treatment, meeting the trial’s dual primary endpoint of progression-free survival First and only combination regimen with targeted therapy to improve survival outcomes for treatment-naïve...Read more
FREDERICK, Md., May 30, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG). Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered...Read more
Consistent Results Noted between Single Region HARMONi-A and Multiregional HARMONi Studies; Favorable Trends in Sub-Populations from North America and China for Both Primary Endpoints Were Observed Ivonescimab in Combination with Chemotherapy Reduces the Risk of Disease Progression or Death by 48% Compared to Chemotherapy Alone; Positive Overall Survival Trend Observed with Hazard Ratio of 0.79 HARMONi Represents the First Phase III...Read more
AERIFY-1 trial met the primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit AERIFY-2, a second Phase 3 trial, did not meet the primary endpoint despite a benefit seen earlier in the trial Itepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2, with safety consistent with prior...Read more
Topline readout expected in early Q1 2026 SOUTH SAN FRANCISCO, Calif., May 29, 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 pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. "We are...Read more
Streamlined U.S.-only study design builds on Phase 2 momentum for IHL-42X in obstructive sleep apnea NEW YORK and MELBOURNE, Australia, May 29, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company developing novel combination therapies, today announced that the Phase 3 component of the RePOSA clinical trial will proceed. The U.S. Food and Drug Administration (FDA) previously...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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