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
No dose-limiting toxicities or cytokine release syndrome observed in RAINIER to date; mipletamig shows consistently favorable safety and tolerability Trial progressing efficiently, Cohort 4 open for enrollment SEATTLE, WA / ACCESS Newswire / September 16, 2025 / Aptevo Therapeutics ("Aptevo" or "the Company") (NASDAQ:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology...Read more
LP-184 achieves all primary endpoints and demonstrates a favorable safety and tolerability profile positioning it for both monotherapy or synergistic combinations with PARP inhibitors and immunotherapies. Clinical benefit observed in 48% of evaluable cancer patients at or above the therapeutic dose threshold. Durable clinical benefits were observed in hard-to-treat tumors like glioblastoma multiforme (GBM), gastrointestinal stromal...Read more
COYA 303 is an investigational proprietary combination of LD-IL-2 and GLP-1RA for subcutaneous administration, under development for the treatment of diseases, including Alzheimer's Disease, driven by chronic and sustained inflammation; COYA 303 demonstrated significant attenuation of neuroinflammation in cortex and hippocampus brain regions and upregulation of anti-inflammatory markers, and significant improvement of systemic Treg...Read more
First patient in South Korea dosed MIAMI, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced activation of two South Korean clinical trial sites participating in its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and...Read more
SAN DIEGO, Sept. 16, 2025 /CNW/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced updates on enrollment progress, U.S. site expansion, and expected data readouts from the ongoing GOBLET trial evaluating pelareorep in gastrointestinal cancers. The study is supported in part by a grant from the Pancreatic Cancer Action Network...Read more
Study to evaluate whether a new approach to pacing the heart can improve the lives of patients with heart failure with preserved ejection fraction (HFpEF) who have limited treatment options today GALWAY, Ireland, Sept. 15, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the initiation of a pivotal study evaluating the use of elevated and personalized cardiac pacing rates for...Read more
SPY072 is a potential first- and best-in-class anti-TL1A antibody for rheumatic diseases targeting quarterly or twice-yearly subcutaneous dosing SKYWAY study is evaluating SPY072 in patients with moderate-to-severely active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) Proof-of-concept data for all three indications are expected in 2026 SKYLINE and SKYWAY trials are expected to provide 9...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
First patient dosed with [212Pb]VMT01 3.0 mCi in combination with nivolumab [212Pb]VMT01 3.0 mCi single agent dose Cohort re-opened SEATTLE, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatments for cancers throughout the body, announced today that the first patient was dosed in a new cohort...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
Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025 New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small...Read more
No decline in lung function observed at 6-week interim analysis builds upon positive safety and biomarker data Phase 2a study fully enrolled; Topline data on track for Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival LA JOLLA, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI...Read more
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces new evidence and market updates that highlight the clinical performance of its REGENETEN Bioinductive Implant and support its further adoption. Substantial investment into research to expand access and indications have led to these important results designed to help surgeons treat more patients who suffer from rotator cuff tears and other tendon and...Read more
Phase 1 data in healthy volunteers exceed expectations and support best-in-class potential, enabling Phase 2 advancement for both intended indications of PKU and CKD Dose-dependent urinary amino acid excretion demonstrated across all SAD and MAD cohorts, including up to a 42-fold increase in urinary phenylalanine (Phe) excretion, a well-validated biomarker for PKU and predictive for CKD Dose-dependent initial eGFR dip similar to SGLT2...Read more
GlyphAgo is an oral prodrug of agomelatine, a medicine with established clinical efficacy in generalized anxiety disorder (GAD) GlyphAgo is designed to overcome a key limitation of agomelatine by shifting absorption toward the intestinal lymphatics, avoiding first-pass liver metabolism, and increasing systemic exposure of the drug Phase 1 proof-of-concept study will evaluate the safety, tolerability, and pharmacokinetics of GlyphAgo and...Read more
New Positive Preclinical Data Shows Succesful Drug Distribution to Liver, Peritoneum, and Lung with Measurable Reductions in Tumor Burden at Clinically Relevant Doses Results Provide Further Validation of the Systemic Component of a Dual-Route Administration Strategy Enabeling Potential Targeting of Both Primary Tumors and Metastatic Disease Silexion Remains on Track for Phase 2/3 Trial Initiation in H1 2026 Following Planned Q4...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
The Trial Evaluates a Combined PCI Approach Using Drug-Coated Balloons and Drug-Eluting Stents WAYNE, Pa., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary...Read more
Second-generation constructs induce robust increases in fecal IgA, which was shown to be correlated with protection against infection in the company’s previous Phase 2b challenge study SOUTH SAN FRANCISCO, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today reported...Read more
FREMONT, Calif. / Sep 10, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced its collaboration with a leading breast cancer team from Yale Cancer Center for a clinical trial titled “A single arm phase II trial of circulating tumor DNA-guided adjuvant therapy with elacestrant in hormone receptor positive HER2 negative breast cancers at risk for late recurrence...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
A pathological complete response ("pCR") has been observed in the first patient evaluated in Cohort A, where each patient receives two doses of INT230-6 eight days apart, followed by the standard of care immunochemotherapy ("SOC") Safety looks favorable in Cohort A Some INT230-6 patients begin to show localized skin irritation, and new patient enrollment has been paused to implement modifications to resolve the issue Patients being...Read more
In preclinical studies presented today at the RNA Leaders USA Congress 2025, investigational ARO-MAPT demonstrated potent and long-lasting MAPT mRNA and Tau protein suppression with uniform distribution throughout the CNS after subcutaneous administration in non-human primates PASADENA, Calif. / Sep 10, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed a request for regulatory...Read more
Unprecedented improvement compared to baseline and natural history in multiple functional measures including Time to Rise from Floor (TTR), 4-Stair Climb (4SC), Performance of Upper Limb (PUL) and 10-Meter Walk/Run Test (10mWRT) at approximately one year Unprecedented rapid reduction in creatine kinase (CK) to near normal levels maintained over 16 months of follow-up and 25% increase of normal in dystrophin production, reflecting...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
PYNNACLE Phase 2 pivotal clinical trial interim data include confirmed responses observed in eight tumor types spanning ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma 33% overall response rate (ORR) observed among 97 evaluable patients across all cohorts with a median duration of response of 6.2 months 43% ORR observed among 44 evaluable patients in ovarian cancer cohort with a...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
Gemini normalized the inflammatory response at the cellular level in stage 3 and 4 CKD patients Gemini could potentially revolutionize the treatment of acute and chronic inflammatory disease Data discussion webcast/conference call will be held on Wednesday, September 10th at 8:30 am Eastern Time SAN DIEGO, CA / ACCESS Newswire / September 9, 2025 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or...Read more
New preclinical findings highlight Telomir-1's ability to reverse CDKN2A gene silencing by DNA methylation, reactivating this gene - often called the body's natural "cell cycle brake." These results build on prior STAT1 data, supporting Telomir-1's profile as a potential first-in-class broad-spectrum DNA methylation reset therapy. MIAMI, FLORIDA / ACCESS Newswire / September 9, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a...Read more
HCW Biologics conducted investigative study to show safe dose levels of its lead drug candidate in non-human primates that were well tolerated at a level significantly higher than the identified efficacious dose level Program has addressed key challenges for first generation T-cell engagers related to manufacturability, preclinical safety profile, and ability to treat a wide spectrum of solid tumors Program is positioned...Read more
Phase 1 data for efarindodekin alfa (XTX301) demonstrate promising anti-tumor activity in patients with advanced solid tumors Achievement of milestone extends anticipated cash runway into first quarter of 2027 WALTHAM, Mass., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with...Read more
New clinical Precision Medicine population 48-week data demonstrates unprecedented cognitive stabilization in early Alzheimer’s disease Cognitive outcomes observed in the oral blarcamesine 30 mg Precision Medicine cohort move toward normal aging profiles across validated clinical scales, supporting its relevance in early-stage Alzheimer’s care 84.7% reduction in decline at 48 weeks of blarcamesine treatment vs placebo on the primary...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
PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients with extensive-stage small cell lung cancer (”ES-SCLC”), expanding evidence for its potential to set a new standard of care in first-line ES-SCLC and beyond Global interim Phase 2 data showed a 76.3% confirmed objective response rate (cORR), 100% disease control rate (DCR), a median progression...Read more
CID-103 is a potential best-in-class, clinical stage anti-CD38 monoclonal antibody Safety profile observed in first four dose cohorts supports continued development No serious adverse events or dose-limiting toxicities have been reported SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / September 8, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative...Read more
Study investigator of Phase 1 trial presented poster at Society of Hematologic Oncology 13th annual conference highlighting original study protocol SOUTH SAN FRANSCISCO, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic...Read more
Severe lymphopenia, an adverse treatment effect associated with chemotherapy, radiotherapy, and immunotherapy, significantly lowers overall survival in non-small cell lung cancer and multiple types of cancer.1,2 With ANKTIVA, the first FDA-approved lymphocyte-stimulating agent, 80% of patients exceeded or maintained absolute lymphocyte count (ALC) above 1,000 cells/µL. With ALC counts greater than 1,500 cells/µL, statistically...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
Continue to observe a positive safety profile—no dose limiting toxicities, cytokine release syndrome or immune effector cell-associated neurotoxicity SAN JOSE, Calif., Sept. 8, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced it has completed dosing of the fourth cohort in its ongoing Phase 1 clinical...Read more
Overall response rate (ORR) of 57% (4/7; 3cPR+1uPR) in patients treated with a combination of 30 mg IDE397 plus 7.5mg/kg Trodelvy® (Dose level 2); ORR of 33% (3/9; 3cPR) at 15 mg IDE397 plus 10mg/kg Trodelvy® (Dose level 1) Manageable safety profile at both expansion doses, consistent with known adverse events observed with each agent alone, with no treatment related serious adverse events observed at the IDE397 30mg and Trodelvy® 7.5...Read more
Topline data announcement expected second quarter of 2026 FOSTER CITY, Calif. / Sep 08, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced the completion of enrollment in the Phase 2b VISTAS study of volixibat, an investigational oral IBAT inhibitor, for the treatment of cholestatic pruritus in patients with primary sclerosing cholangitis (PSC). The trial previously met its pre-specified efficacy and...Read more
CLEVELAND CLINIC ABU DHABI (CCAD) HAS COMMENCED RECRUITMENT IN THIS 36 PARTICIPANT STUDY PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / September 8, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that the SKNJCT-004 phase 2 clinical study, to...Read more
The Phase 2 GAD study has enrolled 36 participants to evaluate the safety and efficacy of CYB004 at 12 weeks after first dose Reaffirms top-line data guidance for Q1 2026 TORONTO / Sep 08, 2025 / Business Wire / Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative...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
In KRAS mutant 2L mCRC, pelareorep delivers prolonged survival benefit with a median PFS and median OS approximately 2.5x the current standard of care Translational data from multiple studies confirm pelareorep replication in CRC tumors and immune activation Company to define regulatory pathway and advance potential IST in KRAS mutant CRC patient population SAN DIEGO, Sept. 8, 2025 /CNW/ -- Oncolytics Biotech® Inc....Read more
Recommendation that trial escalate to next dose level of 8mg tablet Initial interim clinical data from first two cohorts expected in Q1 2026 MIAMI, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced that the external Safety Review Committee...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
iMDx’s ClinicalTrials.gov listing now names 10 leading transplant centers, up from 5 previously GraftAssureDx remains on track for FDA submission by end of 2025, commercial launch in 2026 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (Nasdaq: IMDX), today announced that it is actively enrolling patients in its clinical trial to assess GraftAssureDx and that last week, it enrolled the...Read more
Claseprubart 300mg and 600mg Q2W doses both achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at Week 13 Claseprubart demonstrated a rapid and sustained onset of action, with both doses achieving statistically significant improvements in MG-ADL and QMG scores at Week 1 Claseprubart 300mg Q2W dose was also...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
In separate cat and birch allergen-challenge trials, single doses of allergen-specific antibody blockers significantly reduced allergy symptoms compared to placebo Data from these trials will support further Phase 3 development TARRYTOWN, N.Y., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced results evaluating its first-in-class investigational allergen-blocking antibodies in...Read more
Treatment with darovasertib resulted in robust ocular tumor shrinkage, lower simulated radiation doses to the eye and meaningful visual gains and reduced long-term risk of blindness for patients in the neoadjuvant setting of primary uveal melanoma Manageable safety profile with mostly Grade 1 and 2 treatment-related adverse events Phase 3 registration-enabling OptimUM-10 trial of darovasertib in neoadjuvant primary UM initiated during...Read more
Trial met primary long episode endpoints with high statistical significance, and RAP-219 was generally well tolerated Patients achieved 77.8% reduction in clinical seizures (p=0.01), with 24% achieving seizure freedom for the 8-week treatment period (p<0.0001) Data support advancement of RAP-219 into Phase 3 registrational trials Company to host a conference call today at 8:00 a.m. ET BOSTON and SAN DIEGO, Sept. 08, 2025 (GLOBE...Read more
80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR in 2L SCLC; a 73.7% (14/19) ORR and 57.9% (11/19) confirmed ORR (1 pending confirmation) were observed across all lines of SCLC at the 2.4 mg/kg expansion dose of IDE849 77.1% (27/35) ORR and 60.0% (21/35) confirmed ORR (4 pending confirmation) in 2L SCLC; a 73.2% (52/71) ORR and 47.9% (34/71) confirmed ORR (10 pending confirmation) were observed across all lines of SCLC at all expansion...Read more
An objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated patients Discussions with global regulatory authorities underway BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 07, 2025 / Business Wire / Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small...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
Sustained durability of responses demonstrated in both TRUST-I and TRUST-II with additional follow-up time TKI-naïve patients in TRUST-I achieved a median progression-free survival of 44.6 months; more than half of TKI-naïve patients in TRUST-II were still progression-free at data cut-off The findings showed a favorable safety and tolerability profile for IBTROZI with manageable adverse events Results are from one of the largest global...Read more
Rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC initiated under FDA's RTOR program, with completion on track for the third quarter of 2025 CAMBRIDGE, Mass., Sept. 7, 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 presented pivotal...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
80% of post-surgical hypoparathyroidism participants achieved concomitant blood and 24-hour urine calcium in the normal reference range within 5 days of encaleret treatment initiation compared to 0% of participants on conventional therapy at baseline Encaleret was well-tolerated with no serious adverse events reported over the study period Based on these findings, BridgeBio intends to initiate a registrational clinical study of...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
All patients in the first cohort achieved between 27- to 208-fold increases in α-Gal A activity relative to mean normal level All patients in first cohort discontinued enzyme replacement therapy Preliminary data show AMT-191 has a manageable safety profile at the highest dose Updated clinical results expected in the first half of 2026 LEXINGTON, Mass. and AMSTERDAM, Sept. 05, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a...Read more
Decoy20 monotherapy induces Partial Response in patient with urothelial cancer and liver metastases Decoy20 combination with PD-1 inhibitor, tislelizumab, demonstrates safety profiles consistent with each agent NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection...Read more
VT-1953 continues to significantly improve the primary endpoint Co-founder Dr. Shiladitya Sengupta to discuss over a live video conference VT-1953 treatment significantly reduced malignant fungating wound-associated malodor (primary endpoint) (P<0.001). Patients also reported significant improvements in lesion pain (P<0.001) and Quality of Life (P<0.001), both secondary and exploratory endpoints, respectively. CAMBRIDGE,...Read more
NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (NASDAQ: DRUG) today announced compelling preclinical results for its investigational compound BMB‑201, in a validated isosorbide dinitrate (ISDN) rat model of vascular headache. BMB-201 produced statistically significant reductions in facial mechanical allodynia across both male and female cohorts at 1 and 2 hours post-dose, compared to vehicle, and demonstrated...Read more
Preclinical data support the potential for improved weight loss and tolerability with once-monthly administration of MBX 4291 CARMEL, Ind., Sept. 04, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced dosing of the first participant...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
Skye shares new preclinical DIO data at virtual KOL event Nimacimab + tirzepatide demonstrates over 40% weight loss in multiple preclinical DIO studies Nimacimab demonstrates durable post-treatment weight loss compared to tirzepatide Nimacimab reduced rebound weight gain following treatment with tirzepatide or nimacimab + tirzepatide Nimacimab outperformed monlunabant head-to-head, and is uniquely positioned as a well-tolerated...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 4, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced they have enrolled their first patient with non-small cell lung cancer (NSCLC) in the ongoing Phase 1/2 combination trial of IDE397, a potential first-in-class, small molecule adenosyltransferase 2a (MAT2a) inhibitor, and Trodelvy® (sacituzumab govitecan-hziy), a Trop2-directed...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
Catalyst for Advancing Discussions with Pharmaceutical Companies that have Expressed Interest in ART27.13 for CACS Consistent Improvements in Weight Gain, Lean Body Mass, and Activity were Observed Across Treated Patients including +6.4% Mean Weight Gain at 12 Weeks vs −5.4% Mean Weight Loss on Placebo Safety Results Showed ART27.13 was Well Tolerated SOLANA BEACH, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences,...Read more
Data presented at 13th Society of Hematologic Oncology (SOHO) Annual Meeting NORTH CHICAGO, Ill., Sept. 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously,...Read more
Trial demonstrated the feasibility of treating and monitoring adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in an outpatient setting Results showed that 92% of patients with R/R DLBCL received the first full dose of epcoritamab monotherapy in an outpatient setting Adverse event profile and efficacy were consistent with previously reported studies in R/R DLBCL patients Data also demonstrated 64.3%...Read more
New longer-term post hoc analysis results of responders (n=6)1 showed long-lasting, durable pain reduction of nearly 66%, or a mean 5.08 reduction on the VAS pain scale, in patients with severe pancreatic cancer pain 100% of responders (n=7) 1 showed zero opioid use at their 3-month post-procedure follow-up2 Quality of life markers further improved including sleep quality, energy level and ability to lead normal daily and leisure time...Read more
No Serious Adverse Events or Unanticipated Device Effects Reported; Company Confirms Program Remains On Track White Bear Lake, Minnesota--(Newsfile Corp. - September 3, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted technologies, today announced that the patients in the first stage of its pivotal clinical trial for the investigational Acclaim®...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
PURCHASE, N.Y., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study has reached the 75% enrollment mark. The START Study is enrolling approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer’s disease who will be treated with...Read more
Achieved durable production of serum AAT protein at levels associated with a lower risk of AATD liver and lung diseases following repeat 200 mg doses of WVE-006 (11.9 µM total AAT, 7.2 µM M-AAT) First-ever demonstration of therapeutically restored physiological serum AAT production in a Pi*ZZ individual during a non-drug related acute phase response (20.6 µM total AAT, 10.3 µM M-AAT) Single dose of 400 mg achieved 12.8 µM total...Read more
VAX-31 Optimized Dose, with Majority of Serotypes Dosed at 4.4mcg and Balance at 3.3mcg, is Designed to Elicit Even Stronger Immune Responses in Infant Population to Protect Against Invasive Pneumococcal Disease (IPD) Company Intends to Release Topline Data from Primary Immunization Series and Booster Dose Either Sequentially or Together by End of First Half of 2027 VAX-31 is Designed to Provide Greater Coverage Against Both Currently...Read more
Cohort 2 fully enrolled; enrollment and dosing now underway for Cohort 3 (final dose level); No cases of amyloid-related imaging abnormalities (ARIA) observed to date; The trial, expected to enroll 128 patients, remains on track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026. Cambridge, Massachusetts, Sept. 03, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a...Read more
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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