Data presented at ESMO 2025 show INCA33890, a TGFβR2×PD-1 bispecific antibody, has the potential to be an effective treatment in microsatellite stable (MSS) colorectal cancer Planned initiation of registrational program for INCA33890 in MSS colorectal cancer in 2026 Maturing data for INCB161734, a KRAS G12D inhibitor, shows a favorable safety profile and evidence of clinical benefit in heavily pre-treated pancreatic ductal...Read more
BRAFTOVI + MEKTOVI continued to show a substantial median overall survival benefit of 47.6 months in treatment-naïve patients with BRAF V600E-mutant metastatic non-small cell lung cancer after approximately four years Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population NEW YORK / Oct 19, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced...Read more
Ivonescimab in Combination with Chemotherapy Is the First Known Regimen to Achieve a Clinically Meaningful Benefit over an anti-PD-(L)1 Antibody Combined with Chemotherapy in a Phase III Clinical Trial in 1L NSCLC: Median PFS of 11.14 Months vs. 6.90 Months, Respectively, for Patients Receiving Ivonescimab Plus Chemotherapy vs. Tislelizumab Plus Chemotherapy; Hazard Ratio of 0.60 Tolerable Safety Profile Reaffirmed for PD-1 / VEGF...Read more
An objective response rate of 50.5% was observed with raludotatug deruxtecan across all dose levels in these patients in the phase 2 part of REJOICE-Ovarian01 Phase 3 part of REJOICE-Ovarian01 to evaluate 5.6 mg/kg dose of raludotatug deruxtecan versus investigator’s choice of chemotherapy BASKING RIDGE, N.J. & RAHWAY, N.J. / Oct 19, 2025 / Business Wire / Results from the phase 2 (dose optimization) part of the REJOICE-Ovarian01...Read more
AstraZeneca and Daiichi Sankyo’s DATROWAY also demonstrated a highly statistically significant and clinically meaningful 43% reduction in patients’ risk of disease progression or death in TROPION-Breast02 DATROWAY is the first and only therapy to significantly improve overall survival vs. chemotherapy in this patient population WILMINGTON, Del. / Oct 19, 2025 / Business Wire / Positive results from the TROPION-Breast02 Phase III trial...Read more
New data from pivotal Phase 3 ROSELLA trial reinforce relacorilant plus nab-paclitaxel improves progression-free and overall survival in patients with platinum-resistant ovarian cancer, with no need for biomarker selection – including in people who progressed while on or after taking a PARP inhibitor, a patient population with particularly poor prognosis Corcept expands BELLA trial to three study arms: (i) platinum-resistant ovarian...Read more
The probability of survival at 8 years was an unprecedented 78.9% with XTANDI plus leuprolide versus 69.5% with leuprolide, in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence1 XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in this patient population, supporting its earlier use in this setting Final results from the Phase 3...Read more
GFH375 resulted in a 41% ORR for patients with heavily pre-treated pancreatic ductal adenocarcinoma (68% had received 2 or more prior lines of therapy) at the 600 mg daily dose At month four, the OS rate was 92.2%; median OS has not been reached 91.5% of patients experienced a reduction in tumors and a disease control rate of 96.7%; nearly half the patients evaluated remain on treatment Low discontinuation rate due to adverse events of...Read more
Late-Breaking ASCENT-03 Data Simultaneously Presented at ESMO 2025 and Published in The New England Journal of Medicine With Two Positive Phase 3 Trials, Trodelvy Has Potential as the First and Only ADC to be a Backbone Standard of Care for All First-Line Metastatic TNBC Patients Regardless of PD-L1 Status FOSTER CITY, Calif. / Oct 19, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today shared positive data from the...Read more
Responses were rapid and durable, and tumor shrinkage was observed in 82 percent of patients New findings from this investigational study build on the strength of RYBREVANT® (amivantamab-vmjw) in non-small cell lung cancer and broadens its potential across additional solid tumors RARITAN, N.J., Oct. 19, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced promising new results from the Phase 1b/2 OrigAMI-4 study...Read more
First and only combination regimen to improve survival when used before and after surgical cystectomy in cisplatin-ineligible patients with muscle-invasive bladder cancer Unprecedented survival results from pivotal Phase 3 EV-303 trial show potential for PADCEV plus KEYTRUDA to redefine standard of care TOKYO and NEW YORK, Oct. 18, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas")...Read more
Conference Call October 20, 8:45am EST QUEENSBURY, N.Y. / Oct 18, 2025 / Business Wire / Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the results of the CHOPIN randomized Phase 2 clinical trial (CHOPIN Trial) presented by Principal Investigator and Lead Author Professor Ellen Kapiteijn, MD, from Leiden University Medical...Read more
More than 92% of patients treated with AstraZeneca and Daiichi Sankyo’s ENHERTU were free of invasive disease at three years DESTINY-Breast05 presented in ESMO Presidential Symposium alongside DESTINY-Breast11 reinforce potential for ENHERTU to become a foundational treatment in curative-intent early breast cancer setting WILMINGTON, Del. / Oct 18, 2025 / Business Wire / Positive results from the DESTINY-Breast05 Phase III trial...Read more
Results from the first and second interim analyses of the Phase 3 KEYNOTE-B96 trial were selected for presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2025 With these results, KEYNOTE-B96 is the first trial of an immune checkpoint inhibitor-based treatment regimen in platinum-resistant recurrent ovarian cancer to show statistically significant improvements in progression-free...Read more
Highest reported pathologic complete response rate seen in a Phase III registrational trial for HER2-positive early breast cancer with favorable safety profile vs. standard treatment DESTINY-Breast11 presented in ESMO Presidential Symposium alongside DESTINY-Breast05 reinforce potential for AstraZeneca and Daiichi Sankyo’s ENHERTU to become a foundational treatment in curative-intent early breast cancer setting WILMINGTON, Del. / Oct...Read more
Encouraging preliminary activity observed across diverse set of advanced ALK-positive solid tumors Global enrollment ongoing for adult and adolescent patients with advanced ALK-positive solid tumors beyond NSCLC in a Phase 2 cohort of the ALKOVE-1 trial CAMBRIDGE, Mass., Oct. 18, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted...Read more
PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled Additional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival (“PFS”) of 14.6 months in patients with HR+/HER2-/PIK3CA-mutated advanced breast cancer (“ABC”) MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc....Read more
Clinical benefit of the gedatolisib regimens was consistent across patient subgroups Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and in 11.5% of patients treated with gedatolisib + fulvestrant (“gedatolisib doublet”) Study treatment discontinuation due to treatment related adverse events was reported in 2.3% of patients treated with the...Read more
CABOMETYX reduced the risk of disease progression or death by 81% versus placebo in patients with advanced lung or thymic neuroendocrine tumors (NET) The lungs are the second most common NET site of origin, yet limited treatment options are available1 ALAMEDA, Calif. / Oct 18, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced results from a subgroup analysis of the CABINET phase 3 pivotal trial evaluating CABOMETYX®...Read more
75% Objective Response Rate as 12 out of 16 advanced melanoma patients had objective clinical responses, with 11 of the 12 responders continuing to respond at 24 months follow-up Immune activation observed in all patients with 81% of EVX-01’s vaccine targets triggering a specific response Treatment was well tolerated Data is presented today at the ESMO Congress and will be discussed at a webinar with key opinion leader Professor...Read more
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
First U.S. patient dosed at a mid-tier dose level where multiple responses have been observed Multi-regional trial to accelerate time to proof-of-concept data in 1H 2026 BELTSVILLE, Md. and SHANGHAI, Oct. 16, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and...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
Findings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA's position in a $70 billion non-opioid pain market. MIAMI, FLORIDA / ACCESS Newswire / October 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders,...Read more
Preliminary clinical data from the Phase 1 trial expected in 2H/2026 REDWOOD CITY, Calif. / Oct 16, 2025 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory RA. “Dosing...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
Calgary, Alberta--(Newsfile Corp. - October 15, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to no-option individuals suffering from angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, in Florida...Read more
ATRN-119 (ATR Inhibitor): RP2D of 1,100 mg once daily identified in ongoing ABOYA-119 dose-escalation study Further ATRN-119 monotherapy enrollment paused with strategic focus on high-value combination Company is prioritizing its lead program, WEE1 kinase inhibitor APR-1051 DOYLESTOWN, Pa., Oct. 15, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical...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
POTOMAC, MD, 1734 / ACCESS Newswire / October 14, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's disease, today announced the expansion of its ongoing Phase 2 CALMA clinical trial evaluating investigational drug candidate IGC-AD1 for agitation in Alzheimer's disease. The trial has officially opened a...Read more
NEEDHAM, Mass., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced encouraging interim data from its ongoing phase 1b clinical trial of CAN-3110 (linoserpaturev) in recurrent glioblastoma, and a publication in the high-impact scientific...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
NUC-3373 Plus Pembrolizumab Continues to Show Favorable Efficacy and Safety Profile in Heavily Pre-treated Patients Latest Data Cut-Off Shows Patient with Melanoma Remains Progression-Free at 23 Months with a Durable Partial Response Preclinical Data Corroborate Immunogenic Effects of NUC-3373 Observed in Patients EDINBURGH, United Kingdom, Oct. 14, 2025 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) (“NuCana” or the “Company”)...Read more
Non-inferiority trial versus PAXLOVID® assessing safety and efficacy, including rates of disease rebound and incidence of Long COVID development, of ratutrelvir, a ritonavir-free anti-viral treatment Separate single-arm trial assessing safety and efficacy in PAXLOVID®-ineligible subjects, who represent a significant, vulnerable population with few available treatment options Top-line data from both trials expected by year-end...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
Study’s Dose Escalation Safety Committee approves initiation of Cohort 2 with fourth patient to receive increase in initial dose pending regulatory approval Company issues correction of recently published article, asserts it is not for sale and is not currently actively seeking partnerships as it continues dose finding clinical activities for CER-1236 SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics...Read more
15 out of 18 complete responders (83%) demonstrate continued complete response with median follow-up of 36 months Reduction in surgeries compared to year prior to treatment with PAPZIMEOS was observed in 86% of patients in Year 1, 91% in Year 2, and 95% in Year 3 No new safety events observed during long-term follow-up GERMANTOWN, Md., Oct. 13, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company...Read more
First overall survival (OS) results from Arm A1 of the Phase 2 EDGE-Gastric study will be presented on October 18 at the European Society for Medical Oncology (ESMO) 2025 Congress These data support the ongoing development of domvanalimab plus zimberelimab and chemotherapy in the Phase 3 STAR-221 study in the same patient population HAYWARD, Calif. / Oct 12, 2025 / Business Wire / Arcus Biosciences, Inc. (NYSE: RCUS), a...Read more
75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001) 100% of patients who achieved 12 month event free survival achieved 2 year overall survival New York, New York--(Newsfile Corp. - October 10, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology...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
MALVERN, Pa., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced new results that demonstrate buntanetap’s ability to attenuate inflammation and improve cellular health in Alzheimer’s patients, suggesting...Read more
Company engaged patients diagnosed with chronic babesiosis via social media in a nationwide naming competition A $5K donation from the Company was split between ILADEF and GLA to recognize the winning name B-FREE, a Phase 2 trial, will commence in early November and run for approximately 12 months WASHINGTON, Oct. 09, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or...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
The Company is well on track with Phase 1 enrollment now that both patients in Cohort 3 have successfully initiated treatment with no evidence of dose-limiting toxicities or tolerability concerns to date The first patient in Cohort 3 has shown promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts; additional update anticipated by year-end Upon...Read more
40-Hz DIFS™ significantly improves cognitive performance and brain connectivity in peer-reviewed clinical trial Results published in Radiology, the flagship journal of the Radiological Society of North America (RSNA) HOUSTON, TX, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the...Read more
Accelerates Warrant Expirations and POSITIVE Communications Extension TORONTO and HAIFA, Israel, Oct. 08, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) a biopharmaceutical company developing exosome-based regenerative therapies, announced new preclinical results showing that its lead candidate ExoPTEN produces a reproducible, dose-dependent therapeutic effect...Read more
Dose expansion phase will determine the recommended Phase 2 dose of R289 for patients with transfusion dependent R/R lower-risk MDS SOUTH SAN FRANCISCO, Calif., Oct. 8, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first patient has been enrolled in the dose expansion phase of the ongoing Phase 1b study...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
Significant improvement relative to placebo on primary outcome measure, change in Clinical Dementia Rating Sum of Boxes (CDR-SB), demonstrated in a within-subject analysis in participants with low likelihood of having Alzheimer’s disease (AD) co-pathology Significant reduction in plasma levels of a well-established biomarker of neurodegeneration, plasma glial fibrillary acidic protein (GFAP), correlated to treatment response assessed...Read more
Clinical data to date supports a potentially transformational approach to treating autoimmune diseases with an off-the-shelf, one-time therapy As of the August 31, 2025 data cut-off date, all seven evaluable LN and SLE patients experienced rapid and sustained reductions in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA) highlighting ADI-001’s potential for durable effect...Read more
SOLANA BEACH, CALIFORNIA / ACCESS Newswire / October 7, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy. The study cohort...Read more
IGC-1C Targets Tau Protein's Liquid-Liquid Phase Separation (LLPS), Posing a Novel Threat to Neurotoxic Tangles; High Binding Affinity Confirmed POTOMAC, MD, 1734 / ACCESS Newswire / October 7, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's disease, today announced in-vitro findings for IGC-1C, a...Read more
Final Clinical Visit Marks Major Milestone in First-in-Human Evaluation of Breast Cancer Vaccine Comprehensive Immune Response and Safety Data to Be Presented at the San Antonio Breast Cancer Symposium in December SAN JOSE, Calif., Oct. 7, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the completion of...Read more
Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated achieving endoscopic improvement and 30.2% achieving clinical remission at the highest dose at Week 12 in the Phase 2b ANTHEM-UC study These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active...Read more
Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated with the highest dose achieving endoscopic improvement at Week 12 in the Phase 2b ANTHEM-UC study These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active ulcerative colitis SPRING HOUSE, Pa.,...Read more
SAN DIEGO, Oct. 7, 2025 /PRNewswire/ -- Aethlon Medical, Inc. ("Aethlon" or the "Company") (Nasdaq: AEMD) today provided observations on the preliminary changes in extracellular vesicle (EV), microRNA and lymphocyte counts in the first patient cohort in its ongoing oncology clinical trial in Australia. The study is a safety, feasibility, and dose-finding trial evaluating the company's Hemopurifier (HP) in patients with cancer not...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
Findings show that Telomir-1 restores the body's natural tumor suppressor defenses by reversing abnormal DNA methylation of MASPIN and RASSF1A - genes that help block invasion, limit metastasis, and improve chemotherapy responsiveness in aggressive prostate cancer models. MIAMI, FLORIDA / ACCESS Newswire / October 7, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology...Read more
Massachusetts General Hospital, Harvard Medical School, actively recruiting chronic hepatitis B patients along with multiple global clinical trial sites Phase 1 ELIMINATE-B trial for PBGENE-HBV is progressing and on track to report additional data from higher dose cohorts in 2025 DURHAM, N.C. / Oct 07, 2025 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its...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
RJVA-002 achieved ~30% weight loss at five weeks in a translational obesity model; weight loss not yet plateaued Preclinical results show that a single point-in-time treatment with RJVA-002 has the potential to achieve significant weight loss that can match or exceed best-in-class chronic drug therapy BURLINGTON, Mass., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics...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
Investigational cell therapy bemdaneprocel continues to demonstrate a favorable safety profile at 36 months in Phase I trial participants Secondary clinical efficacy endpoints related to motor outcomes remain stable compared to 24 months and continue to show positive trends from baseline Data were presented on October 6th at the International Congress of Parkinson’s Disease and Movements Disorders® WHIPPANY, N.J. / Oct 07, 2025 /...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
Robust improvement demonstrated across diverse set of clinical measures Patient-reported outcomes support clinical meaningfulness of improvements in function and strength Meaningful improvements in overall disease burden reported by both patients and physicians WALTHAM, Mass., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people...Read more
Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B) Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of...Read more
OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo.1 The trial also met all six secondary endpoints.2 Results from safety analyses were generally consistent with the well-established safety profile of onabotulinumtoxinA.1 NORTH CHICAGO, Ill., Oct. 6,...Read more
CAMBRIDGE, Mass., Oct. 6, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced new positive findings based on plasma samples from its Phase-2b PARADIGM study. These results indicate that PrimeC produced robust, statistically significant reductions in multiple microRNAs that...Read more
Ra’anana, Israel, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company developing intranasal products based on its proprietary Capture & Contain (C&C) platform, today announced encouraging results from a recent pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation. The study was designed to simulate allergen...Read more
Changes are expected to reduce future study costs, accelerate objective readouts, and extend operating runway under current plans SEATTLE, Oct. 6, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS; "Atossa" or the "Company), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, announces an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in...Read more
Over 1,200 participants enrolled in ATMOSPHERE® and ASCENT® pivotal trials, representing largest global gene therapy program ever conducted Subretinal surabgene lomparvovec on track to be first gene therapy for wet AMD Topline pivotal data expected in Q4 2026 ROCKVILLE, Md., Oct. 6, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the completion of enrollment in the ATMOSPHERE® and ASCENT® pivotal studies...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
Nimacimab monotherapy did not meet its primary endpoint for weight loss; preliminary pharmacokinetic analysis showed lower than expected drug exposure, potentially indicating the need for higher dosing as a monotherapy. Clinically meaningful additional weight loss observed with combination of nimacimab, a peripheral CB1 inhibitor, and semaglutide compared to semaglutide alone. Nimacimab alone and in combination demonstrated a clean...Read more
Tulisokibart, an investigational anti-TL1A monoclonal antibody currently in Phase 3 trials for ulcerative colitis and Crohn’s disease, to be studied in hidradenitis suppurativa, radiographic axial spondyloarthritis and rheumatoid arthritis RAHWAY, N.J. / Oct 06, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced it has initiated three Phase 2b trials evaluating the safety and...Read more
Successful meeting with FDA enables advancement into pivotal development with Privosegtor in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Oculis will launch the PIONEER Program, which includes multiple global trials intended to support registrations in AON and NAION Company to host conference call and webcast at 8:30 AM ET today ZUG, Switzerland, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Oculis...Read more
An expansive biomarker study confirmed OV329 delivered statistically significant inhibition of GABA-AT as measured across multiple metrics OV329 matched or exceeded inhibition demonstrated by therapeutic doses of first-generation GABA-AT inhibitor, vigabatrin (VGB), as measured on transcranial magnetic stimulation (TMS) 1 Findings confirm OV329 penetrates the brain, engages the target and achieves biological modulation as expected of...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
ANAVEX3-71-002 trial achieved its primary endpoint demonstrating safety and tolerability in both male and female adults Oral ANAVEX®3-71 tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on...Read more
ANAVEX3-71-SZ-001 achieved its primary endpoint demonstrating safety and tolerability in adults with schizophrenia Encouraging trends observed in biomarkers support continued development NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative,...Read more
SEATTLE, Oct. 02, 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, today announced that the first patient was treated with [212Pb]PSV359 in a second cohort of the Company’s Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the...Read more
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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