Study did not meet primary endpoint in change from baseline in mean daily oral corticosteroid (OCS) dose at week 48, although clinical benefit for efzofitimod observed across multiple study parameters. 52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal at week 48 vs 40.2% on placebo (p=0.0919). Clinical improvement in King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 observed in the...Read more
Enrollment complete in VRDN-003’s phase 3 clinical trials in thyroid eye disease (TED), REVEAL-1 and REVEAL-2, with each study exceeding its enrollment target due to strong patient demand; topline data on track for first half of 2026 VRDN-003 composition of matter patent granted by the USPTO with term to 2041 and potential to extend exclusivity Veligrotug Biologics License Application (BLA) submission on track and...Read more
Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for Stargardt disease Last subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt disease Topline data expected in Q4 2025 SAN DIEGO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio...Read more
Results from the Phase 3 STRIDE-13 trial presented at the 6th ESCMID Conference on Vaccines Merck to share STRIDE-13 results with global regulatory authorities RAHWAY, N.J. / Sep 11, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society...Read more
Long-term follow-up data for daraxonrasib monotherapy in second line metastatic pancreatic ductal adenocarcinoma reinforces promising clinical activity and durability Highly encouraging initial clinical results for daraxonrasib monotherapy and daraxonrasib plus chemotherapy in first line metastatic pancreatic ductal adenocarcinoma support planned initiation of three-arm Phase 3 trial in Q4 2025 Revolution Medicines to host webcast...Read more
Top-Line Results Anticipated in March 2026 NEWTON, Mass., Sept. 10, 2025 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients. "We are excited to announce that we have...Read more
BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (p<.0001) BXCL501 showed a similar reduction in agitation symptoms over both the duration of the trial and number of treated episodes, demonstrating continued...Read more
MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis. BiPASS™ (Biopsy of the Prostate Avoidance Stratification...Read more
European expansion in September across Georgia, Italy, Lithuania, Poland, Romania, Spain, and US 13 subjects recruited (treated, enrolled, or screened) Forecasts total recruitment of 20 or more subjects by end of September On track to recruit to 45 patients in Q4 25 for initial data unblinding HOUSTON, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage...Read more
Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone In a five-year analysis, consistent efficacy was observed across histologies with especially notable benefit in the squamous patient population where median overall survival was 22.3 months TARRYTOWN, N.Y., Sept. 09, 2025 (GLOBE...Read more
THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD). The ongoing ASCEND study, which includes approximately 2,600...Read more
At Week 96 participants experienced even greater reductions in daily cornstarch intake while maintaining low levels of hypoglycemia, improved levels of euglycemia and improved fasting tolerance Phase 3 results are further supported by early data from open-label Japanese cohort (n=3) where all participants were able to eliminate daily cornstarch while maintaining or improving glycemic control DTX401 was well tolerated with an...Read more
Spain site opens with two R/R AML subjects enrolled; One treated On track to recruit 45 subjects in 4Q25 for initial data unblinding HOUSTON, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced that it has enrolled the first two...Read more
Phase 3 trial to evaluate two subcutaneous BRIUMVI dosing regimens NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy), the company’s anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). BRIUMVI is currently approved in the United States, as well as...Read more
On Track To Be First Mover In $7Bn Addressable Market With No Current Therapeutic Options By: Benzinga Staff Writer CARDIFF, UK / ACCESS Newswire / September 8, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a late clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, has launched its registrational Phase 3 trial of eRapa - its proprietary...Read more
In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine plus rituximab, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study BRUIN CLL-313 is the third positive Phase 3 study from the pirtobrutinib development program...Read more
Phase 3 clinical trial cohort of adults 65+ and 18-64 with at least one underlying risk condition shows at least a 4-fold increase in LP.8.1-neutralizing antibody titers after receiving the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula First LP.8.1 sublineage clinical findings reinforce pre-clinical data supporting recent FDA approval of 2025-2026 Formula of Pfizer-BioNTech COVID-19 Vaccine Companies have submitted these data to the...Read more
FLAURA2 final overall survival analysis reinforces the favorable benefit-risk profile of this combination Results underscore TAGRISSO as 1st-line standard of care and backbone therapy in EGFRm lung cancer across stages WILMINGTON, Del. / Sep 07, 2025 / Business Wire / Positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) with the addition of...Read more
With Longer-Term Follow-Up of Western Patients, Ivonescimab Plus Chemotherapy Demonstrated Improving Global OS Trend with Nominal p-value of 0.0332 vs. Chemotherapy Alone; North American Patients’ OS HR=0.70 Consistent Median Overall Survival Observed in Western, Asian Patients in Longer-Term Follow-Up Analysis of Western Patients Presented at Presidential Symposium at WCLC 2025 Conference Call to be Held at 8:00am ET on Monday,...Read more
New data from Phase 3 PEGASUS study demonstrates a 49.7% decrease in mean blood Phe levels in adolescents aged 12-17 treated with PALYNZIQ BioMarin's planned submission to global health authorities on track for second half of 2025 SAN RAFAEL, Calif., Sept. 6, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced new data characterizing the efficacy and safety of PALYNZIQ® (pegvaliase-pqpz) for the...Read more
RYBREVANT® combination extends survival and significantly reduces common EGFR and MET resistance mutations seen with osimertinib-based treatment BARCELONA, Spain, Sept. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new analyses from the Phase 3 MARIPOSA study showing that first-line treatment with RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) significantly reduces the development of...Read more
Topline data anticipated in early Q4 2025 BURLINGTON, Mass., Sept. 04, 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 the achievement of target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial evaluating lead candidate BNC-210 as a first-in-class,...Read more
FREMONT, Calif. / Sep 03, 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 (NeoADAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal®, is a strong predictor of outcomes in patients with stage II-IIIb, EGFR-mutated non-small cell lung...Read more
Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC) One of the largest randomized phase 3 studies in this patient population will encompass broadest range of patient types per AUA/SUO Guidelines IRVINE, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a...Read more
PiNACLE - H2H will evaluate rondecabtagene autoleucel (ronde-cel) versus investigator’s choice of approved CD19 CAR T-cell therapies in patients with aggressive large B-cell lymphoma receiving treatment in the second line (2L) setting Ronde-cel is Lyell’s next-generation, dual-targeting CD19/CD20 CAR T-cell therapy designed to deliver improved complete response rates and longer duration of responses over currently approved CD19 CAR...Read more
Up to 72% (p<0.0001) placebo-adjusted mean reduction in fasting triglycerides 85% (p=0.0002) reduction in acute pancreatitis events, the first and only time achieved for the treatment of sHTG Favorable safety and tolerability profile sNDA submission planned by end of year Ionis to host webcast today at 8:30 a.m. ET CARLSBAD, Calif. / Sep 02, 2025 / Business Wire / Ionis Pharmaceuticals, Inc....Read more
Enlicitide is the first oral PCSK9 inhibitor to demonstrate statistically significant and clinically meaningful reductions in LDL-C compared to placebo in Phase 3 trials Enlicitide had a favorable safety profile, with comparable rates of discontinuation between treatment groups RAHWAY, N.J. / Sep 02, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results...Read more
Sustained Benefit of Vutrisiran Across Mortality, Cardiovascular Events, Quality of Life and Cardiac Biomarkers Observed Through Up to 48 Months, Including 12 Months from the Ongoing Open-Label Extension, Reinforce Potential as First-Line Treatment for ATTR-CM Vutrisiran, which Delivers Rapid Knockdown of Transthyretin, Reduced the Risk of Composite of All-Cause Mortality or First Cardiovascular Event by 37% in the Overall Population and...Read more
Baxdrostat 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-adjusted) from baseline, and was generally well tolerated with no unanticipated safety findings Full results presented at the European Society of Cardiology Congress 2025 and published in the New England Journal of Medicine WILMINGTON, Del. / Aug 30, 2025 / Business Wire / Positive full results from the BaxHTN Phase III trial showed baxdrostat demonstrated...Read more
Positive Trial Demonstrates Superiority of Aficamten to Standard-of-Care Beta-Blocker Metoprolol Primary Endpoint Result Consistent Across All Prespecified Subgroups Company to Host Investor Event and Webcast Tuesday September 2, 2025, at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., Aug. 30, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that primary results from MAPLE-HCM (Metoprolol...Read more
Results from the Phase 3 VICTOR trial and a pooled analysis of the VICTOR and VICTORIA trials were presented today at the ESC Congress 2025 and simultaneously published in The Lancet RAHWAY, N.J. / Aug 30, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results evaluating VERQUVO® (vericiguat) in adult patients with stable chronic heart failure and reduced ejection fraction...Read more
Randomized study aims to reduce treatment burden for patients and utilizes Signatera to monitor for disease recurrence AUSTIN, Texas / Aug 28, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the activation of the NRG Oncology trial, ARCHER (NRG-GU015), a randomized, phase III study in muscle-invasive bladder cancer (MIBC). The study is evaluating whether a...Read more
BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for tolerability in the BXCL501 arm While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial Following...Read more
Results reinforce telitacicept’s potential across multiple autoimmune diseases Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in Stage A...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / Aug 27, 2025 / Business Wire / The first patient has been dosed in the HERTHENA-Breast04 phase 3 trial evaluating the efficacy and safety of investigational patritumab deruxtecan (HER3-DXd) versus investigator’s choice of treatment in patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer with disease...Read more
BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for tolerability in the BXCL501 arm While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial Following...Read more
Treatment with Verzenio plus endocrine therapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to endocrine therapy alone In the seven-year landmark analysis of monarchE, treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit Results reinforce two years of Verzenio plus endocrine therapy as the standard of...Read more
In ATTAIN-2, orforglipron met the primary and all key secondary endpoints, with compelling efficacy results and a safety profile consistent with injectable GLP-1 medicines Participants with obesity or overweight and type 2 diabetes, a population with increased difficulties losing weight, lost an average of 22.9 lbs (10.5%) on the highest dose, with A1C reduced by an average of 1.8% INDIANAPOLIS, Aug. 26, 2025 /PRNewswire/ --...Read more
Cemdisiran monotherapy, dosed subcutaneously every three months, met the primary and key secondary endpoints, showing a 2.3-point placebo-adjusted improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score U.S. regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026, pending discussions with the FDA TARRYTOWN, N.Y., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron...Read more
Topline results anticipated in Q1 2026 and, if successful, planning for expedited NDA submission If approved, ampreloxetine could address a critical unmet need as the first therapy with the potential to provide durable benefit for the 40,000 patients in the U.S. with symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) Ampreloxetine has Orphan Drug Designation in the U.S.,...Read more
Study met primary endpoint (p-value=0.0068) First global phase 3 study to demonstrate clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, triple seronegative Supplemental Biologics License Application (sBLA) to be submitted to U.S. Food and Drug Administration (FDA) by end of 2025 August 25, 2025, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a...Read more
In the second replicate study (Study 1) of the pivotal Phase 3 UP-AA clinical program, upadacitinib (RINVOQ®) achieved the primary endpoint, demonstrating that 45.2% and 55.0% of patients with severe alopecia areata treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 201 Key secondary endpoints, including improvements in...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 20, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as a first-line treatment in certain non-small cell lung cancer (“NSCLC”) patients whose tumors harbor epidermal growth factor receptor (“EGFR”)...Read more
Data from more than 2,600 agitation episodes collected Topline data readout is on track for August NEW HAVEN, Conn., Aug. 19, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the database lock for its SERENITY At-Home...Read more
August 18, 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 two patients by the Pan American Center for Oncology Trials in San Juan, Puerto Rico into its pivotal Phase 3 Serenta trial of eRapa in patients with...Read more
Topline results from the trial show that Signatera-positive patients treated with atezolizumab (Tecentriq®) had statistically significant and clinically meaningful improvements in disease-free survival and overall survival IMvigor011 is the first prospective phase III study in muscle-invasive bladder cancer to read out that uses a personalized, ctDNA MRD*-guided approach AUSTIN, Texas / Aug 18, 2025 / Business Wire / Natera, Inc....Read more
Phase 3 results position telitacicept as potential best-in-disease profile in primary Sjögren's disease Telitacicept demonstrated a favorable safety profile Vor evaluating timing of global Phase 3 clinical study in primary Sjögren's disease Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming...Read more
Results exceed prespecified primary endpoint of 95% posterior probability of benefit for PMX on 28-day mortality Pooled absolute risk reduction of 8.3%; Relative risk reduction of 18% Key secondary endpoint: 90-day Mortality 17.4% lower with PMX and >99% posterior probability of benefit 38.7% Mortality at 28 days with PMX confirms results of prior trial subset TORONTO, Ontario and DEERFIELD, Ill., Aug. 12, 2025 (GLOBE...Read more
PADCEV plus KEYTRUDA is the first and only regimen to improve survival when used before and after standard of care (surgical cystectomy) in cisplatin-ineligible patients with muscle-invasive bladder cancer Results will be discussed with global health authorities for potential regulatory filings NEW YORK & TOKYO / Aug 12, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki...Read more
First and only systemic therapy to improve survival when used before and after surgery for patients with MIBC who are ineligible for cisplatin-based chemotherapy First ever positive Phase 3 study in this cisplatin-ineligible patient population, representing significant advancement in MIBC RAHWAY, N.J. / Aug 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline...Read more
Patients treated with Cylembio (imsapepimut and etimupepimut, adjuvanted) plus pembrolizumab achieved improvement in progression free survival (PFS) compared to patients treated with pembrolizumab monotherapy, HR=0.77 (CI 0.58-1.00), (p=0.056), with median PFS (mPFS) of 19.4 months vs. 11.0 months, respectively; the results on the primary endpoint narrowly missed the study’s statistical significance threshold of p≤0.045 In patients...Read more
Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease BEDFORD, Mass., & CAMBRIDGE, Mass. / Aug 11, 2025 / Business Wire / Stoke Therapeutics, Inc....Read more
Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease CAMBRIDGE, Mass. and BEDFORD, Mass., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq:...Read more
NEPTUNUS-1 and NEPTUNUS-2 are the first ever global Phase III trials to demonstrate statistically significant reduction in disease activity for Sjögren's disease1 Ianalumab has the potential to become the first and only targeted treatment approved for patients with Sjögren's disease Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren's disease1,2 Novartis plans to present its data at an upcoming...Read more
Epcoritamab in combination with rituximab and lenalidomide (R2) demonstrated statistically significant improvement in Overall Response Rate (ORR; 95.7%, p < 0.0001) and Progression-Free Survival (HR 0.21, p-value <0.0001) versus R2 alone in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL) Results from EPCORE FL-1 form the basis of global regulatory submissions U.S. FDA has accepted for priority review new...Read more
Final Analysis Anticipated by Year-End Upon Occurrence of 80 Events NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the Independent Data Monitoring Committee (IDMC) has completed a...Read more
Topline results from CATT1 Phase 3 trial expected in second half of 2026 HIGH POINT, N.C., Aug. 07, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced the first study participant has been randomized in the Company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive...Read more
In ATTAIN-1, the investigational once-daily oral pill showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies at 72 weeks Orforglipron achieved the primary and all key secondary endpoints, including demonstrating improvements in a number of cardiovascular risk factors With these results, Lilly is on track to submit orforglipron to global regulatory agencies by year-end and is...Read more
24-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) PRINCETON, N.J., Aug. 05, 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 the 24-month DOR of 72.2% (95% CI 64.1%,...Read more
Vast majority of patients dosed completed the full 12-week study Data from more than 2,200 agitation episodes collected Topline data readout anticipated this month NEW HAVEN, Conn., Aug. 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the last patient last visit...Read more
Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in wet AMD, the leading cause of vision loss in people over the age of 60 With two refills per year, Susvimo maintained vision and stabilized the retina for five years, with durability maintained in approximately 95% of patients Susvimo was well tolerated over five years and has a well-characterized safety profile SOUTH SAN FRANCISCO,...Read more
Mounjaro met the primary objective of non-inferiority vs. Trulicity with an 8% lower rate of MACE-3 events, while delivering greater reductions in A1C and weight In the trial, Mounjaro was associated with a 16% lower rate of all-cause death compared to Trulicity, suggesting more comprehensive health benefits Results from the largest and longest Mounjaro trial to date reaffirm its established safety and tolerability profile...Read more
Company expects to complete Phase 3 Aspire study in the second half of 2026 Aurora study of GTX-102 in additional ages and genotypes on track to initiate in the second half of 2025 NOVATO, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the Phase 3 Aspire study evaluating GTX-102 (apazunersen) as a treatment for Angelman Syndrome is fully enrolled, with approximately 129...Read more
First patient enrolled in ECLIPSE 2 Phase 3 clinical trial evaluating the switch to the combination of tobevibart and elebsiran in patients not achieving undetectable hepatitis delta virus RNA despite bulevirtide treatment ECLIPSE 2 is a pivotal trial designed to support global marketing applications, including in the U.S. and Europe SAN FRANCISCO / Jul 31, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced...Read more
PHILADELPHIA and VANCOUVER, British Columbia, July 31, 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, announces the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study...Read more
In Study 2 of the pivotal Phase 3 UP-AA clinical program, upadacitinib (RINVOQ®) achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe alopecia areata treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 201 Key secondary endpoints, including improvements in eyebrows and eyelashes, as...Read more
Initiation of additional trial sites and patient enrollment activities ongoing with multiple patients in screening LAWRENCEVILLE, N.J., July 30, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that the first patient has been dosed in the pivotal Phase 3 OVATION 3 Study evaluating the Company’s lead candidate, IMNN-001, for the...Read more
Findings from the TRAILBLAZER-ALZ 2 long-term extension study highlight Kisunla continued to demonstrate slowing of decline, with most participants having completed treatment Data underscores the value of early intervention and supports a limited duration dosing approach with sustained long-term benefits INDIANAPOLIS, July 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results from the long-term extension...Read more
Hyalofast consistently demonstrated improvements over microfracture, but missed on statistical significance of the pre-specified co-primary endpoints of percent change in KOOS Pain and IKDC function Hyalofast showed statistically significant improvements over microfracture in pre-defined secondary endpoints and other measures that align with prior FDA approvals for cartilage repair products Hyalofast has been used to treat over...Read more
LUCIA pivotal Phase 3 trial enrolled and randomized over 400 patients in seven months, demonstrating continued strong enthusiasm for the DURAVYU pivotal program across the global retinal community Over 800 patients enrolled across the LUGANO and LUCIA trials of DURAVYU, representing one of the fastest enrolling Phase 3 pivotal programs for wet AMD Interim analysis by independent Data Safety Monitoring Committee (DSMC)...Read more
Pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05 Progression-free survival data was immature, but trending in favor of pirtobrutinib BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients INDIANAPOLIS, July 29, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)...Read more
Topline data readout from HARBOR study anticipated in Q2 2026 Marketing application submissions for del-desiran including in U.S., EU and Japan anticipated to start in H2 2026; on track to potentially be the first globally approved drug for DM1 On track to share updates from ongoing MARINA-OLE™ trial of del-desiran including long-term 4 mg/kg efficacy and safety data in Q4 2025 SAN DIEGO, July 28, 2025 /PRNewswire/ --...Read more
Hazard Ratios and Improvements in Median PFS are Unprecedented in HR+/HER2- Advanced Breast Cancer (“ABC”) Gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) reduced the risk of disease progression or death by 76% vs. fulvestrant (HR=0.24; 95% CI: 0.17–0.35; p<0.0001). Median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant Gedatolisib + fulvestrant (“gedatolisib doublet”) reduced...Read more
MINNEAPOLIS, July 24, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the first patient has been dosed in VIKTORIA-2, its Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer (“ABC”) who are endocrine therapy...Read more
Expedited Enrollment Surpassing 630 Targeted Participants Underscores the Strong Demand for a Therapy Focused on Vision Preservation Phase 3 ARCHER II Trial Design and Rationale to Be Presented at ASRS, a Leading Meeting for Retina Science and Innovation Topline Pivotal Phase 3 Data Expected in the Second Half of 2026 Potential for Vonaprument to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic...Read more
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
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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