Enlicitide, designed to deliver antibody-like efficacy, has the potential to be the first approved oral PCSK9 inhibitor to lower LDL-C with a safety profile comparable to placebo Enlicitide may help address unmet needs in ASCVD, a key driver of the ongoing cardiovascular (CV) epidemic RAHWAY, N.J. / Nov 08, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first...Read more
Treatment with telitacicept for 39 weeks resulted in a rapid, clinically meaningful, and statistically significant reduction in proteinuria, with a favorable safety profile Telitacicept demonstrated a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared with placebo; statistically significant benefits also achieved across all key secondary endpoints Data presented as late-breaking oral...Read more
MyPEAK-1 Data Presented During Late-Breaking Session at AHA Scientific Sessions 2025 with Simultaneous Publication in Cardiovascular Research TN-201 Has Been Generally Well Tolerated at Both Doses Longer-term Follow Up of Cohort 1 Patients Showed Consistent, Deeper, and Durable Improvement in Measures of Hypertrophy Initial Cohort 2 Data Demonstrated Early Dose Responsive Increases in TN-201 Transduction and MyBP-C Protein...Read more
Proof-of-concept trials confirm robust anti-clotting effects for Regeneron’s two mechanistically-distinct antibodies against factor XI, in patients undergoing total knee replacement Trial results consistent with prospective design of these antibodies to have distinct profiles – one to provide stronger anticoagulation and the other to have a lower risk of bleeding – potentially allowing physicians to tailor anticoagulant therapy for...Read more
Study Also Shows 36% Reduction in Risk of Heart Attack Repatha is the First and Only PCSK9 Inhibitor to Significantly Reduce the Risk of First Heart Attack and Stroke THOUSAND OAKS, Calif., Nov. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced detailed results from the Phase 3 VESALIUS-CV clinical trial, which showed that Repatha® (evolocumab) achieved statistically significant and clinically meaningful reductions...Read more
Data presented in a late-breaking presentation at the American Heart Association (AHA) Scientific Sessions 2025 Phase 1 clinical data for CTX310® demonstrate robust, dose-dependent reductions in circulating ANGPTL3 with a mean reduction from baseline of -73% (maximum -89%), a mean reduction in triglycerides (TG) of -55% (maximum -84%), and a mean reduction of low-density lipoprotein (LDL) of -49% (maximum -87%) at the highest...Read more
Up to 72% placebo-adjusted mean reduction in fasting triglyceride levels at six months, with reductions sustained through 12 months 86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL, below the risk threshold for acute pancreatitis First and only investigational treatment for sHTG to significantly reduce acute pancreatitis events Data simultaneously published in The New England Journal of Medicine Ionis...Read more
40% ORR in heavily pre-treated patients with MSS mCRC without liver metastases and with high plasma tumor mutational burden (TMB) Estimate 55% of patients with MSS CRC have high plasma TMB, representing a meaningful population with high unmet need Company to host conference call and webcast on Monday, November 10, 2025, at 4:30 p.m. ET with leading cancer experts to review the data WALTHAM, Mass., Nov. 07, 2025 (GLOBE NEWSWIRE) --...Read more
FASENRA also demonstrated a greater improvement in fatigue symptom relief in a single monthly dose compared to placebo WILMINGTON, Del. / Nov 07, 2025 / Business Wire / Positive full results from the NATRON Phase III trial showed AstraZeneca’s FASENRA (benralizumab) demonstrated a statistically significant delay in the time to first worsening or flare in hypereosinophilic syndrome (HES),1 a rare disease driven by elevated eosinophils.2...Read more
SITC abstracts highlight updated immunogenicity results from the Phase 2 AMPLIFY-7P trial of ELI-002 7P and preclinical data on the use of intratumoral ELI-004 (AMP-CpG) for solid tumor immunotherapy ELI-002 7P induced mKRAS-specific T cell responses in 99% of evaluable patients (89/90), demonstrating potent and consistent immune activation Robust immune responses were elicited across all seven mKRAS antigens, with >80% response...Read more
FOSTER CITY, Calif. / Nov 07, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the Phase 3 ASCENT-07 study investigating Trodelvy® (sacituzumab govitecan-hziy) versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR)...Read more
COPENHAGEN, Denmark, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that a new pooled analysis showed sustained and clinically meaningful improvements in renal function in adults with hypoparathyroidism treated with TransCon PTH (palopegteriparatide) through Year 3 of the Company’s Phase 2 PaTH Forward and Phase 3 PaTHway trials. The data, which confirm results for each individual trial presented at...Read more
Single ascending dose data show IMC-I109V has manageable safety profile and antiviral activity IMC-I109V is a bispecific T cell receptor targeting a peptide derived from HBsAg that is presented by HLA-A*02:01 on the surface of infected hepatocytes (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, November 7, 2025) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage...Read more
Phase 1b data demonstrating favorable safety and tolerability profile and potent reductions in viral nucleic acids highlighted in late-breaking poster presentation SOUTH SAN FRANCISCO, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced Phase 1b clinical data for its next-generation...Read more
Phase 3 data to be presented at ACAAI demonstrate Dupixent significantly reduced key nasal signs and symptoms including sinus opacification, nasal congestion and nasal polyps in patients aged 6 years and older compared to placebo Dupixent sBLA accepted for priority review by the U.S. FDA with a target action date of February 28, 2026 If approved, Dupixent would be the first and only medicine indicated specifically for AFRS, which...Read more
Data from patients who remained on tegoprubart for a year post transplant showed an overall mean 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73 m² Tegoprubart demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus Supports advancement into Phase 3 development as a potential...Read more
A post hoc analysis of REDEFINE 1 demonstrated a 10.9 mmHg reduction in systolic blood pressure with investigational CagriSema (2.4 mg/2.4 mg), allowing 40% of people on blood pressure medications to reduce or stop their medication1 CagriSema treatment demonstrated a nearly 70% reduction in a key inflammatory marker associated with increased cardiovascular risk2 Data showed that fewer people on CagriSema were at intermediate-to-high...Read more
In patients with advanced chronic kidney disease (CKD) and diabetes, treatment with rilparencel resulted in statistically significant and clinically meaningful slowing of CKD progression Bilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m2 (78%) improvement in the annual decline of estimated glomerular filtration rate (eGFR) slope in Group 1 (n=24) patients No rilparencel-related serious adverse events were...Read more
Atacicept met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) The safety profile of atacicept across the ORIGIN program appears favorable, and comparable to placebo Biologics License Application (BLA) submission through the Accelerated Approval Program to the U.S. FDA expected in...Read more
Vancouver, British Columbia – TheNewswire - Nov 6, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a clinical stage biopharma company developing novel take-home microdose formulations for treating depressive disorders, is delighted to announce dosing in its landmark Phase 2B clinical trial in patients with Major Depressive Disorder (MDD) has completed. The trial and the Company’s two...Read more
All 84 clinical sites across the U.S. are fully activated, enrolling, and treating patients The first group of participants reached the 6-month treatment milestone The study is now 25% complete, keeping Annovis on track for data readout MALVERN, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for...Read more
ATLANTA, Nov. 6, 2025 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced the treatment of the first patient in the ARTIZEN pivotal trial, evaluating the safety and effectiveness of the Arcevo™ LSA Hybrid Stent Graft System ("Arcevo LSA") in the treatment of acute and chronic arch pathologies. The trial is designed to support the Company's...Read more
Final ALPHA-STAR Phase 1b/2 Results from the Full-Enrollment Population (n=29) Remain Highly Consistent with Prior Results from the Target-Enrollment Population (n=16), Demonstrating Strong Efficacy, Favorable Safety, and Potential for Infrequent Dosing Phase 3 ALPHA-ORBIT Trial for Navenibart is Progressing as Planned with Topline Results Anticipated in Early 2027; First Patient Now Enrolled in the ORBIT-EXPANSE Long-Term...Read more
HAMPTON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data on exploratory endpoints (UCT7) further demonstrating barzolvolimab’s ability to improve urticaria control from the Company’s recently completed Phase 2 study in chronic spontaneous urticaria (CSU). The data (presentation #R080) are being presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting...Read more
PRINCETON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced robust preliminary results from its ongoing Phase 3 UTOPIA trial, demonstrating a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%) with UGN-103 (mitomycin) for intravesical solution in...Read more
Single trial to support future BLA submission for NGN-401 in patients ages ≥ 3 years Rapid trial execution underway with 12 of 13 clinical sites initiated Expect to complete trial enrollment in three to six months Neurogene management to present Phase 1/2 interim data update at Stifel Healthcare Conference on November 12 NEW YORK / Nov 06, 2025 / Business Wire / Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to...Read more
VENTURE Study Exploratory Analysis Shows VK2735 Improved Cardiometabolic Parameters After 13 Weeks; Reducing Prediabetes and Metabolic Syndrome SAN DIEGO, Nov. 6, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that new clinical data from the company's VK2735...Read more
Mind Medicine Australia clinic joins Psyence BioMed’s expanding network of clinical sites as enrollment accelerates in the landmark Phase IIb study for Adjustment Disorder in palliative care NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today...Read more
Based on these trial results, Lilly will begin enrolling Phase 3 clinical studies for the treatment of obesity next month INDIANAPOLIS, Nov. 6, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive results from a Phase 2 trial evaluating the safety and efficacy of eloralintide, an investigational once-weekly, selective amylin receptor agonist, in 263 adults with obesity or overweight with at least one...Read more
4D-150 demonstrated consistent and durable benefit across all three patient cohorts as evidenced by maintenance of visual acuity, control of retinal anatomy and reduction of treatment burden at all time points with up to 2 years of follow-up Strong dose response in favor of Phase 3 dose (3E10 vg/eye) continues to be demonstrated 4D-150 continues to be well tolerated with no new safety or intraocular inflammation findings, consistent...Read more
The investigational FINE-ONE trial met its primary endpoint, demonstrating that finerenone led to a significant reduction in urine albumin-to-creatinine ratio (UACR), an important marker of cardiovascular risk and kidney disease progression, from start of trial through six months, for people living with type 1 diabetes (T1D) and chronic kidney disease (CKD) versus those receiving standard of care plus placebo1 These data were presented...Read more
Calgary, Alberta – TheNewswire - November 5, 2025 - Ocumetics Technology Corp. (“Ocumetics” or the “Company”) (TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO), a leader in next generation ophthalmic technology, today announced encouraging one-month results from all patients in Group 1 of its first-in-human clinical study evaluating the Ocumetics Accommodating Intraocular Lens (the “Ocumetics Lens”). Ocumetics completed Group 1 surgeries in August...Read more
The target lesion primary patency (TLPP)1 and access circuit primary patency (ACPP)2 of the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) remain superior to percutaneous transluminal angioplasty (PTA) through 24 months The clinical improvements associated with the WRAPSODY CIE are projected to improve the interventional landscape for hemodialysis patients who experience venous outflow obstructions SOUTH JORDAN, Utah, Nov. 05, 2025...Read more
TORONTO, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the Fraser Health Research Ethics Board (“REB”) has granted approval for the Royal Columbian Hospital (RCH) to participate in Arch’s ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). With this ethics...Read more
Milestone advances two-part study evaluating novel, locally administered gene therapy designed to increase anti-inflammatory IL-1Ra production in the knee joint BRISBANE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced that it has concluded patient...Read more
Meaningful vision gains are rapidly achieved as early as week 4 and showed continued improvement in best corrected visual acuity (BCVA) through week 20, with more than half of patients achieving improvement of 3-lines or more on the eye chart (≥15 letter gain). ≥90% of patients in the top two dose levels achieved and sustained real dryness of the retina, as demonstrated by absence of intraretinal fluid (IRF) as well as subretinal fluid...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with epidermal growth factor receptor (“EGFR”)-mutated, MET-overexpressed and/or amplified, locally advanced or...Read more
SPY003 was well tolerated and exhibited an ~85-day half-life, supporting potential quarterly or twice annual maintenance dosing SPY003 positive interim results unlock development of SPY130 (α4β7 + IL-23) and SPY230 (TL1A + IL-23) investigational combination therapies for IBD with potential for indication-leading efficacy, safety, and dosing profiles SPY003 expected to advance to the ongoing Part A of the SKYLINE Ph2 platform...Read more
Data from Catalent’s preclinical studies evaluating certepetide as a SMARTag® ADC payload showed both improved tumor selective penetration and efficacy BASKING RIDGE, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today highlighted...Read more
Trial achieved biological proof-of-concept, dose discovery and biomarker improvement San Diego, California--(Newsfile Corp. - November 4, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biotechnology company developing sulfur-based therapeutics for pediatric diseases, predominantly those involving mitochondrial dysfunction, today announced interim results from its...Read more
Rapid patient enrollment underscores strong market interest and reinforces commercialization opportunity for fully implanted cochlear implants White Bear Lake, Minnesota--(Newsfile Corp. - November 4, 2025) - Envoy Medical, Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that the first three patients have been enrolled in the final stage of...Read more
First patient dosed, with topline results expected in 2027 pHalcon-EoE-201 is the first large, well-controlled clinical trial of an acid secretory treatment in EoE FLORHAM PARK, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the first patient has been dosed...Read more
LA JOLLA, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announces the completion of patient enrollment in its Phase 2 clinical trial, MN-001-NATG-202, evaluating MN-001 (Tipelukast) for the treatment of hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD)...Read more
Platinum sponsorship of NF Caregivers Symposium reinforces commitment to NF1 community MIAMI, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, today announced activation of a new U.S. clinical trial site at the University of Alabama at Birmingham (“UAB”) for its...Read more
SOL-R, the second registrational trial of AXPAXLI™ in wet AMD, remains on track for topline data in 1H 2027 Together with SOL-1, these complementary trials are expected to form the basis of a potential NDA submission for AXPAXLI in wet AMD BEDFORD, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today...Read more
Post Marketing Study to Evaluate the Role of CYTOGAM in the Reduction of Risk of Late CMV Disease Following the Conclusion of Standardly Prescribed Antiviral Treatment in High-Risk Kidney Transplant Recipients REHOVOT, Israel, and HOBOKEN, N.J. , Nov. 04, 2025 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious...Read more
FRANKLIN LAKES, N.J., Nov. 4, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced full enrollment of the iliac artery patient cohort in its pivotal AGILITY Investigational Device Exemption (IDE) study, a prospective, multi-center study evaluating the Revello™ Vascular Covered Stent in patients with peripheral arterial disease (PAD). The announcement was made in...Read more
Montreal, Quebec--(Newsfile Corp. - November 4, 2025) - Defence Therapeutics Inc. (CSE: DTC) (FSE: DTC) (OTCQB: DTCFF) ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, is pleased to announce and to present today at the World ADC Conference in San Diego, USA, highly encouraging results from its latest preclinical in vivo study evaluating Accum®-Kadcyla, a novel version of...Read more
Improvements across all patient reported outcomes (PROs) were observed from baseline to Week 8 in all PRO instruments utilized in the ABTECT induction trials evaluating bowel urgency, sleep interruption, fatigue, quality of life, and work productivity for both 50mg and 25mg once-daily obefazimod. At week 8 in the ABTECT 1 & 2 trials, 37% of patients taking once daily 50mg obefazimod reported no bowel urgency (BU) compared to 18.1%...Read more
LONDON, Nov. 3, 2025 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases, today announced that it has successfully completed patient recruitment for its United Kingdom-based, multi-centre clinical study evaluating the performance of the ViraxImmune™ assay in detecting T cell dysfunction in...Read more
Topline results for the trial are expected by year end SOUTH SAN FRANCISCO, Calif. / Nov 03, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that the last patient has completed the randomized, double-blind, placebo-controlled...Read more
EMERYVILLE, Calif. / Nov 03, 2025 / Business Wire / Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced the successful completion of the second dose cohort in Phase I portion of its STARLIGHT-1 Phase I/II clinical trial of EB103, a CD19-redirected ARTEMIS®...Read more
ECLIPSE 1 estimated date of last participant reaching primary endpoint (primary completion) in the fourth quarter of 2026, and topline data expected in the first quarter of 2027 ECLIPSE registrational program on target, with ECLIPSE 2 and 3 enrolling well and in line with the Company’s expectations Swift recruitment underscores high unmet medical need for effective and convenient chronic hepatitis delta treatment SAN FRANCISCO / Nov...Read more
Pathologic Clearance: 100% Tumor Clearance (Complete Response) in One Patient, Greater than 90% (Near Complete Response) in Second Patient, Greater than 50% (Partial Response) in Third Patient Pathologic Results Assessed at Approximately 5 Weeks Safety Monitoring Committee Issues Favorable Review of Safety Data at the Maximum Dose King of Prussia, Pennsylvania--(Newsfile Corp. - November 3, 2025) - Phio Pharmaceuticals Corp....Read more
FDA lifts clinical hold following review of Company’s Complete Response submission. Company expects to restart U.S. enrollment in late 2025 or early 2026 across 20 clinical sites. Early data suggests that LTI-03 may not only slow fibrosis but also promote lung healing. AUSTIN, Texas, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class...Read more
Enrollment completed ahead of schedule, underscoring strong interest from patient community in a potential new therapeutic option On track to complete the 24-week treatment period and announce topline results in 2026 GAITHERSBURG, Md., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic...Read more
Fast Track Designation was granted for BB-301 following FDA review of positive interim clinical study results and proprietary Responder Analysis planned for use in pivotal study for BB-301 BB-301 has also been granted Orphan Drug Designation from both FDA and EMA All six patients enrolled into Cohort 1 met the formal statistical criteria for response to BB-301, representing a 100% response rate Following the...Read more
CAMBRIDGE, MA / ACCESS Newswire / November 3, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, the Company's investigational mRNA-based T-cell engager (TCE) for participants with relapsed or refractory multiple myeloma (RRMM). The first dose was administered at SCRI Oncology Partners in Nashville, Tennessee, in collaboration with Sarah Cannon Research Institute...Read more
Toronto, Ontario--(Newsfile Corp. - November 3, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses, is pleased to share a scientific poster which demonstrates the effectiveness of X-Ray-activated Rutherrin® for numerous cancers...Read more
First clinical data disclosure for CB-011 highlights its potential as a best-in-class allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma 450 million cell dose is the recommended dose for expansion (RDE); dose expansion to initiate by year end and data expected in 2026 92% ORR, 75% ≥CR rate, 91% MRD negativity in the 12-patient, BCMA-naïve cohort treated at the RDE with the selected lymphodepletion...Read more
26% Objective Response Rate Median Duration of Response Not Reached after 25 Months Follow Up Lifileucel Launch in Previously Treated Advanced NSCLC Expected in Second Half of 2027 SAN CARLOS, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies...Read more
Findings Reinforce QDENGA’s Long-Term Safety Profile and Two-Dose Vaccination Schedule QDENGA is the Longest-Studied Dengue Vaccine and the Only Approved for Use Regardless of Prior Disease Exposure Takeda is Expanding Global Access to QDENGA in Partnership with National Immunization Programs, Private Payors and Public Health Coalitions, with 18.6 Million Doses Distributed in 11 Endemic Countries OSAKA, Japan & CAMBRIDGE, Mass. /...Read more
Ongoing EXPAND Study is the First Clinical Trial to Evaluate Xenotransplantation in End-Stage Renal Disease SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Nov 03, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR) today announced the first clinical xenotransplantation in its EXPAND study of the UKidney™ in patients with end-stage renal disease (ESRD). The successful transplant operation was performed at NYU...Read more
Data demonstrate efficacy and durability of vispa-cel, an allogeneic anti-CD19 CAR-T cell therapy, are on par with autologous CAR-T cell therapies in the confirmatory cohort (N=22) and with longer-term follow-up on patients who received optimized vispa-cel (N=35) 82% ORR, 64% CR rate, 51% PFS at 12 months in patients prospectively enrolled in partial HLA matching confirmatory cohort (N=22) 86% ORR, 63% CR rate, 53% PFS at 12 months...Read more
Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva, an anti-CD20 monoclonal antibody designed for enhanced B cell depletion Gazyva has the potential to be a transformative new standard of care for up to 3.4 million people affected by systemic lupus erythematosus (SLE) worldwide If approved, Gazyva would be the first anti-CD20 therapy for SLE to directly target B cells, a key driver of...Read more
Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm Company anticipates trial completion in early 2027, and potential updates in 2026 Additional updates from the ongoing Phase 1b/2 trial with muzastotug, previously...Read more
Data from Phase 1 Study in healthy volunteers presented at CIA Biennial Symposium HAMPTON, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today positive data from the ongoing Phase 1 study of CDX-622, a novel bispecific antibody that targets two non-redundant, complementary pathways implicated in inflammation and fibrosis—mast cell depletion via stem cell factor (SCF) starvation and neutralization of the...Read more
NOVATO, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the first patient has been dosed in the Aurora study (NCT07157254) evaluating the efficacy and safety of GTX-102 (apazunersen), an investigational antisense oligonucleotide (ASO) for Angelman syndrome (AS). Data from the Aurora study will expand the population of Angelman patients treated to include both younger and...Read more
SUNNYVALE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled at University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial. “CardiAMP cell therapy has shown evidence of benefit for ischemic heart...Read more
Milestone advances MEAI-based therapy targeting a global Alcohol Use Disorder treatment market projected to surpass $20 billion by 2032 Vancouver, Canada, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today...Read more
Patients treated with RGX-202 demonstrate consistent, robust microdystrophin expression and functional improvement compared to natural history in Phase I/II portion of AFFINITY DUCHENNE® trial supporting potential approval via the accelerated approval pathway REGENXBIO continues to enroll patients in the confirmatory trial First batches intended for commercial supply manufactured at in-house Manufacturing Innovation...Read more
Previously reported data showed that in a diet-induced obesity mouse model, IBIO-610 drives fat-selective, GLP-1-synergistic weight loss and prevents weight regain following GLP-1 treatment discontinuation New non-human primate data projects a human half-life of up to 100 days, potentially enabling treatment with only twice-yearly dosing Extended half-life data and differentiated mechanism of action reinforce IBIO-610’s potential as a...Read more
Dose-dependent mean reductions of Activin E of up to 85% one month post single dose of WVE-007 in INLIGHT clinical trial, exceeding levels that led to weight loss in preclinical models; WVE-007 is generally safe and well tolerated to date Activin E reduction in lowest dose cohort of INLIGHT was sustained through 6 months, supporting once or twice a year dosing Multiple clinical data updates from INLIGHT, including body composition and...Read more
Telitacicept delivered consistent quality-of-life improvement across both treatment and placebo crossover arms 100% of patients on telitacicept for 48 weeks achieved ≥2-point Myasthenia Gravis Activities of Daily Living (MG-ADL) improvement, with a mean reduction of -7.5 points Sustained efficacy and favorable safety extension data support potential global best-in-disease profile in generalized myasthenia gravis (gMG) BOSTON, Oct....Read more
In two replicate Phase 3 studies, upadacitinib (RINVOQ®) achieved the co-primary endpoints of 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 481 Both studies met key ranked secondary endpoints1 NORTH CHICAGO, Ill., Oct. 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from...Read more
NEW YORK, Oct. 29, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, today announced that The Ohio State University has been added as a new clinical site in the ongoing Phase 1 trial of the Company’s INB-100, a donor-derived allogeneic gamma-delta T cell therapy for patients with leukemias undergoing...Read more
ADAS-Cog13 difference −12.78 (P < 0.0001) with oral blarcamesine treatment compared to ADNI control group at Week 144 77.4 Weeks (17.8 Months) ‘time saved’ with oral blarcamesine compared to ADNI Restoring impaired Autophagy − preceding amyloid-beta and tau NEW YORK, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on...Read more
WAYNE, Pa., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced that the Company has completed enrollment in its Phase 2 LOTUS trial of AVTX-009 in adults with hidradenitis suppurativa (HS). The LOTUS trial exceeded target enrollment of 222 patients with approximately...Read more
The CALIBRATE study of encaleret for patients with ADH1 met all pre-specified primary and key secondary efficacy endpoints The primary endpoint was met with 76% of participants administered encaleret achieving both serum and urine calcium within the respective target ranges at Week 24 compared to 4% when on conventional therapy at Week 4 (p<0.0001)\ In a key secondary analysis, 91% of participants administered encaleret...Read more
RAHWAY, N.J. & NUTLEY, N.J. / Oct 29, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization...Read more
Compelling results set new clinical standard in generalized myasthenia gravis (gMG), increasing confidence in the Company’s registrational KYSA-6 Phase 3 MG trial 100% of patients achieved clinically meaningful responses in MG-ADL and QMG -- the co-primary endpoints of the Phase 3 trial -- with mean reductions of -8.0 pts and -7.7 points at 24 weeks KYV-101 was well-tolerated with no high-grade CRS and no ICANS observed, further...Read more
RLF-OD032 demonstrated bioequivalence to KUVAN® Powder Study results support planned 505(b)(2) NDA submission in early 2026 GENEVA, SWITZERLAND / ACCESS Newswire / October 29, 2025 / RELIEF THERAPEUTICS Holding SA (SIX:RLF) (OTCQB:RLFTF) (OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced...Read more
MINNEAPOLIS, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”; the “Company”) (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today announced the presentation of new six-month clinical data during the late-breaking poster session at the American Congress of Rehabilitation Medicine (ACRM) 102nd Annual Fall Conference demonstrating sustained clinical...Read more
First patient dosed in Phase 1/2a study with novel immune rejuvenator, a trispecific antibody-fusion protein Two MDX2004 abstracts accepted for poster presentation at SITC Annual Meeting 2025 WESTON, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced the initiation and recent dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) with...Read more
Trial will evaluate the safety and effectiveness of the AtriCure Isolator® Synergy™ EnCompass® clamp and AtriClip® Left Atrial Appendage Exclusion System to reduce the occurrence of new-onset atrial fibrillation in cardiac surgery patients MASON, Ohio / Oct 28, 2025 / Business Wire / AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA)...Read more
Study met primary and secondary endpoints Paridiprubart demonstrated a relative reduction in the risk of death of 25% Treatment provided patients with clinically meaningful improvement in survival and recovery Paridiprubart exhibited consistent safety and tolerability profile TORONTO, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed...Read more
Pelareorep plus atezolizumab achieves 30% ORR in second-line or later (≥2L) squamous cell anal carcinoma (SCAC) relative to 13.8% for the FDA-approved 2L treatment The median duration of response was 15.5 months compared to 9.5 months for the current standard of care Company expects to discuss single-arm accelerated approval study with FDA in Q1 2026 SAN DIEGO, Calif., Oct. 28, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ:...Read more
NEW YORK, Oct. 28, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has completed in the randomized cohort of the Phase 3 ENHANCE trial evaluating a consolidated Day 1 and Day 15 dosing schedule for IV BRIUMVI® (ublituximab-xiiy), the company’s novel, glycoengineered, anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). The primary endpoint of this trial...Read more
Reqorsa® Gene Therapy is a Potential Treatment for ALK-EML4 Positive Translocated Non-Small Cell Lung Cancer Combining REQORSA with Alectinib Further Increased Apoptosis and Improved Treatment Outcomes in a Mouse Model AUSTIN, Texas, Oct. 28, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer...Read more
Findings underscore strength of Natera’s technology for early cancer detection (ECD) AUSTIN, Texas / Oct 28, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced another successful readout for its ECD program, which is evaluating a blood-based screening test for the detection of CRC and advanced adenomas (AA). This latest analysis from the U.S. based, prospective...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
CLICK TO LEARN MORE