Verzenio is the first contemporary therapy in over two decades to demonstrate a significant overall survival benefit in adjuvant HR+, HER2−, high-risk early breast cancer Seven-year results from the Phase 3 monarchE trial also show Verzenio plus endocrine therapy demonstrated sustained benefits in invasive disease-free survival and distant relapse-free survival These data were simultaneously published in Annals of Oncology and...Read more
More than two thirds of patients treated with IMFINZI-based perioperative regimen were alive at three years First and only perioperative immunotherapy approach to show survival benefit in this setting WILMINGTON, Del. / Oct 17, 2025 / Business Wire / Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil,...Read more
Adding one year of IMFINZI treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone WILMINGTON, Del. / Oct 17, 2025 / Business Wire / Positive results from the POTOMAC Phase III trial showed adding one year of treatment with AstraZeneca’s IMFINZI® (durvalumab) to BCG induction and maintenance therapy demonstrated a statistically...Read more
FREMONT, Calif. / Oct 16, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal®, is a useful tool in assessing the maintenance treatment response post-CRT in patients with unresectable...Read more
Company preparing FDA meeting package to align on a single, well-controlled Phase 3 study under 505(b)(2); Pharma partner discussions ongoing Toronto, Ontario--(Newsfile Corp. - October 16, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine, today announced that it has begun preparing its...Read more
First Phase 3 study (MajesTEC-3) of an investigational combination to show benefit in PFS and OS in relapsed/refractory multiple myeloma as early as second line Independent Data Monitoring Committee (IDMC) recommended unblinding the study based on statistically significant results RARITAN, N.J., Oct. 16, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma therapies, today announced...Read more
Patients treated with ulixacaltamide in the parallel-group study (Study 1) showed a mean improvement from baseline in the Modified Activities of Daily Living 11 at Week 8, the pre-specified primary endpoint, of 4.3 points (p<0.0001) All key secondary endpoints in Study 1 - rate of disease improvement over 12 weeks, PGI-C and CGI-S - were also statistically significant (p<0.001) Study 2 met its pre-specified primary...Read more
KEYNOTE-B96 is the first trial of an immune checkpoint inhibitor-based treatment regimen in platinum-resistant recurrent ovarian cancer to show a statistically significant improvement in OS versus placebo plus chemotherapy with or without bevacizumab for patients whose tumors express PD-L1 and in all comers These data add to previous results for the primary endpoint of progression-free survival and key secondary endpoint of OS RAHWAY,...Read more
SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1...Read more
In ACHIEVE-2, orforglipron lowered A1C by up to 1.7% compared to 0.8% with dapagliflozin, meeting the primary endpoint In ACHIEVE-5, orforglipron lowered A1C by an additional 2.1% when taken with insulin glargine, meeting the primary endpoint INDIANAPOLIS, Oct. 15, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. ACHIEVE-2, the...Read more
DOR/ISL data presented show minimal changes in weight and body composition and no clinically meaningful effect on fasting lipids and the homeostatic model assessment of insulin resistance (HOMA-IR) across clinical trials RAHWAY, N.J. / Oct 15, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the presentation of additional data from the Phase 3 studies of the...Read more
DURAVYU now in Phase 3 for the two largest, multi-billion-dollar retinal disease markets, wet AMD and DME with first patient dosing in pivotal Phase 3 DME trials anticipated in Q1 2026 New preclinical data demonstrates that vorolanib, the active drug in DURAVYU, inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, key contributors to wet AMD and DME IL-6 finding supports the compelling efficacy...Read more
Telitacicept met primary and all secondary endpoints, demonstrating clinically meaningful improvements in disease activity versus placebo ~71.8% of patients receiving telitacicept 160mg achieved ≥3-point ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) reduction vs 19.3% on placebo at 24 weeks Sustained efficacy and favorable safety profile through 48 weeks support potential best-in-disease profile in primary Sjögren’s disease...Read more
NEW YORK / Oct 14, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 HER2CLIMB-05 trial of first-line combination therapy with the tyrosine kinase inhibitor TUKYSA® (tucatinib) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). HER2CLIMB-05 is evaluating TUKYSA versus placebo, both in combination with first-line standard-of-care...Read more
Phase 1 clinical trial designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in combination with androgen receptor pathway inhibitors in first-line mCRPC Clinical trial builds on encouraging Phase 1 data of monotherapy VIR-5500 in late-line patients presented in January 2025 SAN FRANCISCO / Oct 09, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has...Read more
Global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysis Over 100 clinical sites across 24 countries now activated and open for recruitment Futility analysis remains on track for completion in the first quarter of CY2026 SYDNEY, AUSTRALIA, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP)...Read more
STAFFORD, Texas, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Austria. The Company's application to European regulators has been formally...Read more
BOSTON, Mass. / Oct 08, 2025 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the initiation of the Phase 3 ORBIT-EXPANSE long-term trial of navenibart in people living with hereditary angioedema (HAE). “The initiation of ORBIT-EXPANSE marks exciting progress in the development of navenibart,” said...Read more
Protocol Expansion to Ages 10+ Aligned with FDA Guidance, Broadening Patient Population SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, announces alignment with the U.S. Food and Drug Administration (FDA)...Read more
FLASH2 Study Interim Efficacy Analysis Targeted for 1H2026 Enrollment Update Remains on Track for 4Q2025 PRINCETON, N.J., Oct. 7, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its first Data Monitoring Committee (DMC) meeting for...Read more
Baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in 24-hour ambulatory systolic blood pressure compared with placebo WILMINGTON, Del. / Oct 07, 2025 / Business Wire / Positive high-level results from the Bax24 Phase III trial showed baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure (SBP)...Read more
Approximately 80% of Omvoh-treated patients in the LUCENT-3 study who achieved clinical remission at one year maintained long-term, corticosteroid-free clinical and endoscopic remission At four years, nearly all patients who achieved clinical remission at one year had improvements in bowel urgency, one of the most disruptive symptoms for patients INDIANAPOLIS, Oct. 7, 2025 /PRNewswire/ -- New data from Eli Lilly and Company (NYSE:...Read more
Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study Clinical and endoscopic outcomes were demonstrated across both biologic-naïve and biologic-refractory sub-groups TREMFYA® is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults...Read more
DATROWAY demonstrated statistically significant and clinically meaningful improvement in overall survival as 1st-line therapy for patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option in TROPION-Breast02 AstraZeneca and Daiichi Sankyo’s DATROWAY is the first and only therapy to significantly improve overall survival vs. chemotherapy in this patient population DATROWAY also demonstrated a highly...Read more
Adding Repatha to Standard Therapy of Statins or Other LDL-C Lowering Treatments Significantly Reduces Cardiovascular Events Compared with Standard Therapy Alone Repatha is Now the First and Only PCSK9 Inhibitor to Demonstrate Significant Reduction of Cardiovascular Events as Both Primary and Secondary Prevention THOUSAND OAKS, Calif., Oct. 2, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 VESALIUS-CV...Read more
STAFFORD, Texas, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Belgium. The Company's application to European regulators has been formally...Read more
Global Cardiovascular Outcomes Trial will Enroll ~11,000 Patients Across 35 Countries to Evaluate Zilebesiran as a Novel Biannual Treatment Trial to Assess Zilebesiran in Patients with Uncontrolled Hypertension with Either Established or at High Risk of Cardiovascular Disease Milestone Payment of $300 Million Triggered Under Global Collaboration and License Agreement with Partner Roche CAMBRIDGE, Mass. / Oct 01,...Read more
One-Third of Patients Randomized; Topline Results Expected in 2Q 2026 DSMB Safety Review Update Planned for 4Q 2025 SALT LAKE CITY, Sept. 30, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 (oral...Read more
Trial initiation follows the recent approval of IBTROZI™ (taletrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer NEW YORK / Sep 30, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced it has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy...Read more
STAFFORD, Texas, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Portugal. The Company's application to European regulators has been formally...Read more
Results showed the benefits of early initiation of WINREVAIR within the first year after PAH diagnosis HYPERION results were presented today at ERS 2025 and simultaneously published in the New England Journal of Medicine RAHWAY, N.J. / Sep 30, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 HYPERION trial evaluating WINREVAIR™...Read more
KOMET-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated and full approval KOMET-017-NIC trial of venetoclax / azacitidine combination will assess CR and OS as dual-primary endpoints to support potential U.S. accelerated and full approval SAN DIEGO and TOKYO, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Kura Oncology,...Read more
Treatment with Vutrisiran Led to 37- 49% Lower Rates of Gastrointestinal Events, a Multisystem Manifestation of ATTR-CM, Across Multiple Treatment Groups, Compared to Placebo Additional Analyses Reinforce Vutrisiran’s Safety and Efficacy Profile as a Monotherapy and Illustrate Consistent Benefit from Treatment with Vutrisiran Across a Range of Patients’ Baseline Health Status and Quality of Life Findings Presented at the Heart Failure...Read more
Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s ENHERTU in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting Results from the DESTINY-Breast05 and DESTINY-Breast11 trials will be presented at ESMO 2025 in a Presidential Symposium WILMINGTON, Del. / Sep 29, 2025 / Business Wire / Positive high-level results from a planned interim analysis...Read more
Enrollment Completed in Ongoing Phase III ReSPECT Study in Prophylaxis of Fungal Infections in Adult Patients Undergoing Allogeneic Blood and Marrow Transplant Topline Results from ReSPECT Study Expected in 2Q 2026 BERKELEY HEIGHTS, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for...Read more
VELA-1 and VELA-2 are two identical trials to evaluate the efficacy and safety of sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (HS) and the first Phase 3 program using the higher clinical response level of HS Clinical Response (HiSCR) 75 as primary endpoint at week 16 Data was analyzed, as per protocol and in accordance with regulatory agency feedback, using a composite strategy as the primary...Read more
Phase 3 study expected to enroll 6,000 participants starting in the Northern Hemisphere Participants will include adults over 65 years of age in addition to individuals with high-risk co-morbidities and immune compromised status SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC)...Read more
Company maintains confidence in ReNu as innovative pain management therapy Second Phase 3 trial demonstrates numerical improvement in baseline pain reduction over the first Phase 3 trial despite not meeting the primary endpoint Statistically significant maintenance of function (p<0.0001) Company will request pre-BLA meeting with FDA to discuss submission pathway CANTON, Mass., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Organogenesis...Read more
During year 6 of continuous treatment with BRIUMVI the annualized relapse rate was 0.012, equivalent to one relapse occurring every 83 years of patient treatment Overall safety profile of BRIUMVI remained consistent over 6 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated data...Read more
PLYMOUTH MEETING, Pa. / Sep 24, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced topline results from its Phase 3 registrational clinical trial (the RECONNECT Study) of ZYN002 in Fragile X syndrome (FXS). The RECONNECT Study did not meet the primary endpoint of improvement in social avoidance primarily due to a higher than expected placebo response rate. Kumar Budur, M.D., M.S., Chief Medical and...Read more
SAN DIEGO / Sep 24, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the Phase 3 COMPASS PWS trial evaluating the efficacy and safety of intranasal carbetocin (ACP-101) in patients with hyperphagia in Prader-Willi syndrome (PWS). Intranasal carbetocin did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, change from baseline to Week 12...Read more
PRINCETON, N.J. / Sep 23, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD™), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma (RRMM) demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity...Read more
Screening closing ahead of expectations, with full enrollment now anticipated in 4Q 2025 (previously 1Q 2026) ARTEMIS topline data readout accelerated to 1Q 2027 REDWOOD CITY, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of intravitreal gene therapy as a potential One And DoneTM treatment to preserve sight for life, today announced it has...Read more
evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in ITT and ESR1-mutated populations in the post-CDK inhibitor setting, compared with standard of care plus everolimus The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed evERA is the first positive...Read more
Through Week 56 in the SOLARIS trial, there were no suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events observed with olanzapine LAI (TEV-'749) and its long-term systemic safety profile was consistent with other olanzapine formulations1 Additional new data comparing initiation of UZEDY® (risperidone) versus Invega Sustenna® (paliperidone palmitate) in hospitalized patients found that UZEDY was associated with...Read more
Completed patient enrollment within nine months with nearly half enrolled from the U.S. Expect to report Phase 3 topline data in the first half of 2026 On track to submit BLA in the second half of 2026 for an anticipated U.S. launch in the first half of 2027 Plan to present additional data from the Phase 1/2 study in the fourth quarter of 2025 CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics,...Read more
The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for AIRSUPRA WILMINGTON, Del. / Sep 18, 2025 / Business Wire / AIRSUPRA’s US Prescribing Information now includes clinically meaningful evidence from the BATURA study in patients with mild asthma.1 The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed AIRSUPRA compared to...Read more
STAFFORD, Texas, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Ireland. The Company's application to European regulators has been formally...Read more
In SURPASS-PEDS, Mounjaro met the primary and all key secondary endpoints at 30 weeks and showed sustained improvement in glycemic control and continued BMI reduction through the study's 52-week extension The safety and tolerability profile of Mounjaro was generally consistent with previous adult studies INDIANAPOLIS, Sept. 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from...Read more
For the primary endpoint, orforglipron lowered A1C by 2.2% vs. 1.4% with oral semaglutide at the highest doses Participants taking the highest dose of orforglipron lost an average of 19.7 lbs (9.2%) vs. 11.0 lbs (5.3%) with oral semaglutide, a 73.6% relative improvement, in a key secondary endpoint The safety and tolerability of orforglipron were consistent with previous trials INDIANAPOLIS, Sept. 17, 2025 /PRNewswire/ -- Eli...Read more
Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies Icotrokinra also showed sustained skin clearance and favorable safety profile in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study Robust findings continue to demonstrate the potential of icotrokinra to disrupt the treatment paradigm to set a new...Read more
Subcutaneous administration of first-in-class biologic SAPHNELO demonstrates statistically significant and clinically meaningful reduction in disease activity WILMINGTON, Del. / Sep 17, 2025 / Business Wire / Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed that the subcutaneous (SC) administration of AstraZeneca’s SAPHNELO®...Read more
FOP is a disease in which muscles, tendons and ligaments are progressively replaced by bone, leading to eventual incapacitation Garetosmab is the first and only treatment to demonstrate a dramatic reduction in both number and volume of abnormal bone lesions (heterotopic ossification, or HO lesions) in adults with FOP Primary endpoint was met, showing a 90% or greater reduction in new HO lesions at 56 weeks, and garetosmab also led to...Read more
Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo...Read more
Across both STOP-HS1 and STOP-HS2, povorcitinib treatment resulted in continued clinically meaningful and statistically significant improvements for patients with active moderate to severe hidradenitis suppurativa (HS) through Week 24 At Week 24, nearly 60% of efficacy-evaluable patients among both povorcitinib treatment groups achieved HiSCR50 Additionally, patients treated with povorcitinib achieved HiSCR75 (31.0%-40.3%), HiSCR90...Read more
The investigational once-daily oral pill led to an average weight loss of 27.3 lbs (12.4%) at the highest dose at week 72 in the Phase 3 study Orforglipron demonstrated significant improvements across key cardiometabolic risk factors, supporting its potential as a treatment option for millions living with obesity INDIANAPOLIS, Sept. 16, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results...Read more
All 172 patients have now entered the 12-month follow-up phase Trial involves larger surface areas, building on the approval in October 2024 for use of up to 3 tubes of Ameluz® per treatment Study results expected to form the basis of a supplemental New Drug Application (sNDA) planned for submission in Q2 2026 WOBURN, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a...Read more
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
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
CLICK TO LEARN MORE