SAN DIEGO / Dec 23, 2025 / Business Wire / Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies based on its proprietary Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today provided a program update on its ongoing Phase 1 study evaluating JANX008, its...Read more
DehydraTECH-semaglutide reduced overall side effects by 48% as compared to Rybelsus® DehydraTECH-semaglutide reduced gastrointestinal side effects by 55% as compared to Rybelsus® Recent financings create runway for prospective new 2026 development opportunities KELOWNA, BC / ACCESS Newswire / December 23, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in...Read more
LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function Top-line results in healthy volunteers anticipated in 2H’26 Dianthus to provide update on indication prioritization in 1H’26 LBL-047 (DNTH212) has the potential to be a first-line biologic in multiple autoimmune...Read more
Four autoimmune patients treated to date demonstrate deep B-cell depletion sustained for at least 28 days; initial efficacy data suggest significant clinical improvement in patients dosed at the 100 million cell dose, with the first systemic lupus erythematosus (SLE) patient achieving Definitions of Remission in SLE (DORIS) remission through Month 6 An additional Phase 1 basket trial has been initiated for zugo-cel in refractory...Read more
Single-ascending dose portion of study has successfully completed 2.5 and 7 mg / kg levels Dose dependent immunosuppressive effect against a strong foreign antigen observed with continued favourable safety profile Substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases Given encouraging efficacy and safety, the trial will continue as planned and further updates are...Read more
OV350 showed a good safety profile, supporting the advancement of the Company’s KCC2 portfolio, including the first oral direct activator, OV4071 There were no treatment-related laboratory findings, no safety findings, and no treatment-related serious adverse events (SAEs) Exploratory quantitative electrophysiology results suggest OV350 had central activity and spectral power consistent with expected physiological effects of KCC2...Read more
Large, well-powered Phase 1b study, designed to generate clinically and biologically meaningful insights in early Alzheimer’s disease Clear and near-term value inflection points, with blinded 6-month interim data expected in Q2 2026 and final unblinded top-line results anticipated in Q4 2026 Cambridge, Massachusetts, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company...Read more
Results showed CNS target engagement with reduction in GCase substrate glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), a prespecified endpoint The reduction in GluSph in CSF, a first-ever observation following the administration of a GCase modulator to PD patients, suggests increased GCase activity in the brain, which is expected to impact the progression of Parkinson’s disease (PD) KOL event planned for early January to...Read more
The combination of denifanstat and resmetirom was generally well-tolerated Pharmacokinetic (PK) results support further development of the combination A Phase 2 trial of a denifanstat/resmetirom combination in F4 MASH patients is planned to initiate in 2H 2026 SAN MATEO, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics...Read more
Emory University physician-sponsored clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta Results demonstrated WP1066 induces anti-tumor immune responses and were recently published in the Journal of Clinical Investigation Insight WP1066 found to be safe and effective, warranting a Phase 2 trial HOUSTON, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX)...Read more
SAN FRANCISCO, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced that it has initiated a first-in-human Phase 1 clinical study of ACCG-2671, the company’s lead oral small molecule amylin receptor agonist for the treatment of obesity. ACCG-2671 was...Read more
Clinically meaningful lung function activity, measured by ppFEV1 and LCI2.5, with follow-up through 1 year at dose selected for Phase 2 Durable CFTR transgene expression within target therapeutic range with follow-up through at least 1 year Data support 4D-710’s potential to be a durable, redosable, variant-agnostic, disease-modifying treatment for people with cystic fibrosis lung disease with high unmet need Webcast today at...Read more
NESS ZIONA, Israel, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today provided an update following the unblinding of clinical data from its vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease. Following unblinding, the data from the vehicle-controlled Phase 1b proof-of-concept...Read more
The study is designed to evaluate the safety and clinical activity of NXP900 in combination with osimertinib in patients with epidermal growth factor receptor mutated (EGFR mut+) non-small cell lung cancer (NSCLC) whose cancers initially responded to treatment with osimertinib but subsequently acquired resistance to treatment Fort Lee, NJ, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical stage...Read more
First-in-human trial of candidate from the next-generation ATTC platform Simultaneous China and global clinical development strategy to expedite development process HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the initiation of its global Phase I clinical development program for HMPL-A251, a first-in-class...Read more
Vaccine Was Safe and Well Tolerated at the Maximum Tolerated Dose Results Support Advancement of the Program into Phase 2 Development Combination of Keytruda® and the vaccine generated T cell responses and showed no major additional side effects, supporting plans for a Phase 2 neoadjuvant combination study in newly diagnosed breast cancer patients SAN JOSE, Calif., Dec. 11, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa"...Read more
CRB-913 was safe and well-tolerated across all doses studied Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative for all participants A placebo-adjusted mean weight loss of 2.9% was observed at Day 14 in a dedicated cohort of people with obesity (n=12) A 12-week dose-finding study in people with obesity initiated with completion expected in summer 2026 Company to host conference call and live webcast today...Read more
First patient from TNBC trial demonstrated 76% tumor volume shrinkage with corresponding reductions in circulating tumor cells (CTC) and clusters Reinvigoration of immune system + turning cold tumors hot Preliminary ex-vivo data in HER2+ patients demonstrates immune reinvigoration and reductions in CTC and clusters SYDNEY, Dec. 10, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") (NASDAQ: KZIA) today...Read more
VTP-1000, an antigen-specific immunotherapy to treat celiac disease, showed a dose-dependent pharmacological effect in the SAD portion of the trial VTP-1000 was well-tolerated with no treatment-related SAEs The MAD portion of the trial, which includes a gluten challenge, is ongoing GERMANTOWN, Md., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and...Read more
Findings support advancement into Phase 2 to explore a first-in-class pathway aimed at stress-related neuropsychiatric conditions NEW YORK CITY, NEW YORK / ACCESS Newswire / December 9, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing therapeutics that target the biology of chronic stress and its downstream psychiatric and neurologic effects, today reported positive topline safety results from its...Read more
ASH 2025 oral presentation on SENTI-202 in 20 Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients (18 response evaluable) shows high efficacy: 50% ORR and 42% CR/CRh (100% of CRs and 83% of all responses were MRD negative) at RP2D, 7.6 months median duration of composite Complete Remission across all patients, and a favorable safety profile Pharmacodynamic data from these patients validate SENTI-202’s novel OR/NOT Logic Gate...Read more
98% reduction in HSV-2 shedding rate, >99% reduction in high viral load shedding rate and 91% reduction in virologically confirmed genital lesion rate observed in 50 mg weekly oral dose of ABI-1179, exceeding expectations for the study 76% reduction in HSV-2 shedding rate, 81% reduction in high viral load shedding rate and 88% reduction in virologically confirmed genital lesion rate observed in proof-of-concept test of monthly...Read more
64% MMR achievement by 24 weeks across all efficacy evaluable patients 75% MMR achievement by 24 weeks in efficacy evaluable patients at doses >320mg QD Encouraging safety/tolerability profile maintained with longer duration of treatment Company to host investor update call today at 4:30pm ET FOSTER CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a...Read more
CLN-049 monotherapy demonstrates promising efficacy, including multiple complete responses and encouraging response durability, in a heavily pretreated all-comer population of patients with R/R AML 31% CR/CRh rate observed at the highest target dose tested to date; initial dose escalation results in 45 patients demonstrate a favorable safety profile across all doses assessed CLN-049 recently granted Fast Track designation by the U.S....Read more
Patients in 200 mg BID cohort had median progression free survival of 6.2 months and median overall survival of 28.1 months, comparing favorably to results with other therapies Data supports ongoing registration Phase 3 trial in r/r PTCL, Phase 1 trial in atopic dermatitis and potential expansion into other immune and inflammatory diseases Highlights ITK inhibition novel mechanism of action affecting T cell receptor signaling and T...Read more
86% (32/37) CRc and 73% (27/37) CR in newly diagnosed NPM1-m AML, with 68% (17/25) of CRc responders achieving molecular MRD negativity by central NGS Median duration of complete response and overall survival not yet reached in newly diagnosed NPM1-m patients as of data cutoff 65% (31/48) ORR in R/R NPM1-m AML, 83% (19/23) ORR in venetoclax-naïve 41% (13/32) ORR in R/R KMT2A-r AML, 70% (7/10) ORR in venetoclax-naïve Triplet...Read more
Following a single subcutaneous 240 mg dose, WVE-007 (INHBE GalNAc-siRNA) improved body composition at three months compared to baseline, with a 9.4% reduction in visceral fat (p=0.02), a 4.5% reduction in total body fat (3.5 lbs; p=0.07), and a 3.2% increase in lean mass (4.0 lbs; p=0.01), with no statistically significant changes in the placebo group Sustained and robust suppression of serum Activin E supports expectations for...Read more
ZL-1503, a promising treatment for moderate-to-severe atopic dermatitis and other Type 2 helper T-cell (Th2)-driven diseases, strengthens Zai Lab’s growing global pipeline ZL-1503 originated from Zai Lab’s in-house discovery and development engine SHANGHAI & CAMBRIDGE, Mass. / Dec 08, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the dosing of the first participant in a global Phase 1/1b...Read more
KT-621 achieved deep STAT6 degradation across both the 100 mg and 200 mg dose groups tested, with median reductions of 94% and 98% in skin and blood, respectively, demonstrating strong translation from healthy volunteers to atopic dermatitis (AD) patients KT-621 achieved strong reductions in disease-relevant Type 2 biomarkers in blood, including TARC (median reduction of 74% in patients with baseline TARC levels comparable to dupilumab...Read more
R289 continues to be generally well tolerated and at doses of ≥500 mg QD preliminary efficacy was observed in elderly, heavily pre-treated lower-risk MDS patients RBC-TI was achieved by 33% (6/18) of evaluable transfusion dependent patients receiving R289 doses ≥500 mg QD, including 40% (2/5) in the 500 mg BID dose group SOUTH SAN FRANCISCO, Calif., Dec. 7, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a...Read more
Clear dose-response observed, with a robust and clinically meaningful fetal hemoglobin (HbF) induction at the Week 6 timepoint (n=12): mean absolute HbF in the 20 mg cohort increased by 9.9% at Week 6 (vs. 5.6% at Week 6 in the 12 mg cohort); 7 of 12 patients in the 20 mg cohort (58%) achieved absolute HbF levels ≥20% >3.75-fold mean induction of HbF at Week 12 in the 20 mg cohort among patients who reached the Week 12 visit as of...Read more
Treatment arm continues to demonstrate favorable relapse-free survival (HR=0.50; p=0.23) and overall survival (HR=0.61; p=0.52) 3/3 (100%) of TSC-101-treated patients who reached two-year follow-up remained relapse-free vs. 1/4 (25%) in the control arm TSC-101 was well-tolerated with no dose-limiting toxicities observed Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc. on Monday, December 8, at 8:00 a.m....Read more
Objective response rate (ORR) of 83% including two complete responses in CLL patients in Phase 1a study with median progression free survival (PFS) of 22.1 months across all doses tested Emerging data from randomized Phase 1b cohorts points to higher ORR and longer progression free survival at the 600 mg recommended Phase 2 dose (RP2D) compared to the 200 mg dose Bexobrutideg was well tolerated with a consistent safety profile between...Read more
Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates consistent overall response rate and safety profile comparable to 1500mg QW dose, further derisking pivotal FORTIFI-HN01 study interim analysis Totality of data demonstrates that greater TGF-β inhibition, observed at 1500mg of ficerafusp alfa, drives deeper tumor responses that translate to more durable outcomes for patients Pivotal FORTIFI-HN01 optimal dose...Read more
AMX0114 was generally well-tolerated, with no treatment-related serious adverse events Amylyx will proceed with opening enrollment of second cohort Data are being presented at the 36th International Symposium on ALS/MND CAMBRIDGE, Mass. / Dec 05, 2025 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the presentation of early safety and tolerability data from its Phase 1 LUMINA...Read more
BGE-102 was well-tolerated in SAD and initial MAD cohorts, with a pharmacokinetic profile supporting once-daily oral dosing Strong target engagement: BGE-102 achieved 90-98% suppression of IL-1β, a cytokine directly downstream of NLRP3, at Day 14 High brain penetration: BGE-102 doses of 60 mg and higher exceeded target IC90 levels in cerebrospinal fluid (CSF) at Day 14 Company is expanding the Phase 1 trial to include MAD cohorts in...Read more
One complete response and three partial responses observed in heavily pretreated ICI-secondary refractory patients in high dose cohorts Deep and durable ongoing responses with median time on treatment of 15 months Company to accelerate development of PLN-101095 with initiation of a Phase 1b expansion trial in 2026 Strong cash position supports planned operations through 2028 SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE...Read more
Biomarker-activated cancer drug-candidate LP-184 demonstrates encouraging efficacy signals in DNA damage repair deficient tumors with an acceptable safety and tolerability profile – meeting all primary endpoints. LP-184 demonstrated clinical benefit in multiple highly aggressive cancers with a 54% disease control rate at or above therapeutic dose levels. Multiple Phase 1b/2 clinical trials are now being planned across cancer indications...Read more
Initial clinical data expected mid-2026 SOUTH SAN FRANCISCO, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that the patients in the first cohort have been dosed in its Phase 1 trial evaluating STRO-004 in a range of Tissue Factor (TF) expressing...Read more
ZYNLONTA® in combination with glofitamab (COLUMVI®) demonstrated an 89.8% ORR and 77.6% CR across the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up Combination continues to be generally well-tolerated with a manageable safety profile LOTIS-7 trial is on track for complete patient enrollment in 1H 2026; plan to share full data at a medical meeting and submit for publication by end of 2026 Company to host...Read more
BANGALORE, India / Dec 02, 2025 / Business Wire / Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology, today announced initial clinical results from 1st two cohorts of its ongoing Phase 1 clinical trial evaluating AUR112 in patients with relapsed or refractory lymphoid malignancies. Early findings show that AUR112 is safe, well tolerated, demonstrating meaningful clinical activity,...Read more
Reductions in airway hyperresponsiveness and suppressed eosinophilic response at both 6 weeks and 12 weeks observed after a single 180mg dose of Briquilimab in the ETESIAN Study Preliminary data from ETESIAN study supports further development of briquilimab in asthma Jasper also announces completion of internal BEACON study investigation noting no deviations or issues with drug product utilized Jasper to host conference call and...Read more
Phase 1 data demonstrates durable responses and rPFS coupled with a manageable safety profile rPFS of 7.9-8.9 months in heavily pre-treated mCRPC patients Preliminary results are encouraging with deep PSA reductions and a promising CRS profile in taxane-naïve Phase 1b expansion study Initial results support a patient-friendly Q2W dosing schedule Janux to host virtual investor event today at 4:30 PM Eastern Time SAN DIEGO /...Read more
King of Prussia, Pennsylvania--(Newsfile Corp. - November 25, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today the completion of enrollment in its ongoing Phase 1b clinical trial of INTASYL siRNA PH-762. In connection with completing enrollment, Phio continues to...Read more
Zero Treatment Related Adverse Events observed during Cohort 7 (37mg capsules) DLT period Cohort 7 Pharmacokinetic (PK) profile continues to demonstrate dose-proportionality and Cmax/Cmin ratio <2. Achieved exposures (AUC) of 6,690 ng·h/mL Pharmacodynamic (PD) data support continuous suppression of MAPK pathway throughout the 24-hour cycle Safety Review Committee recommended that trial escalate to the next dose...Read more
Company Announces Approximately $30 Million in Cash and Short-Term Investments Following Its October 27th Registered Direct Offering MILAN, Italy and NEW YORK, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a clinical-stage biotechnology company developing a cell-based platform for targeted delivery of therapeutic payloads in oncology, today announced an update from its ongoing TEM-GBM study in newly diagnosed...Read more
Tablet PK exposure increases proportionally with an increase in dose More favorable PK properties in tablets enable a lower dose to achieve the same exposure as the capsule formulation, with improved predictability and reduced variability Tablet steady state showing Cmax/Cmin ratio <2 MIAMI, Nov. 21, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a...Read more
Evidence of Monotherapy Activity: Partial response observed in a MEK-rechallenge 3rd-line melanoma patient with BRAF V600E mutation who remains on trial for more than 11 months A second MEK-rechallenge 3rd-line melanoma patient with BRAF V600E mutation has achieved stable disease and remains on trial for more than 6 months Initial Disease Control Rate in efficacy evaluable patients of 71.4% with BRAF-mutated tumors: 5 of 7...Read more
BP1.15205 is a differentiated chemical scaffold, demonstrating high potency and selectivity in preclinical studies with a favorable safety profile and the potential for once-daily dosing Topline clinical data expected in 2026 PLYMOUTH MEETING, Pa. / Nov 19, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced dosing of the first participant in a Phase 1 clinical trial of BP1.15205, an...Read more
The top-line results showed that bioavailability of Aramchol meglumine 400mg and 200mg granules is considerably greater, higher by 5-fold and 3-fold respectively, that of the Aramchol free acid 300mg tablets The new unexpected PK profile allows for a once daily therapeutic regimen thus potentially improving long term adherence and expected to significantly reduce the drug cost of goods RAMAT-GAN, Israel, Nov. 18, 2025 /PRNewswire/...Read more
In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectively In the subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectively Neladalkib demonstrated...Read more
Efficacy data remain consistent with prior disclosure and continue to demonstrate broad and deep PSA responses, with 55% PSA50 response rate and 20% PSA90 response rate Rapid and deep ctDNA reductions were observed in 76% of patients and ctDNA clearance was observed in 59% of patients, underscoring potential for long-term treatment and survival benefit PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels...Read more
NEW YORK CITY, NY / ACCESS Newswire / November 13, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing novel therapeutics for stress-related neuropsychiatric and neurodegenerative disorders, today announced the successful completion of enrollment and dosing in its Multiple Ascending Dose (MAD) Phase 1 study evaluating its lead compound, known as PT00114. The study, conducted in healthy volunteers, was...Read more
32 patients with autoimmune disease treated with AlloNK plus anti-CD20 monoclonal antibody (mAb) as of October 1, 2025, data cutoff All patients received AlloNK as outpatients, and the majority were treated in community rheumatology trial sites with no specialized oncology oversight, demonstrating the feasibility of administering this regimen outside the hospital setting No cytokine release syndrome (CRS), or immune effector...Read more
Company to host conference call and webcast today, November 12, at 8:30 am EST/2:30 pm CET IMA402 and IMA401 TCR Bispecifics showed favorable tolerability at RP2D as well as deep and durable responses in heavily pre-treated, last-line patients with a range of solid tumors IMA402 PRAME Bispecific at RP2D range resulted in a 30% cORR (6/20) across all indications, including 29% (4/14) in melanoma and 2/3 confirmed responses in ovarian...Read more
PBGENE-HBV, the first gene editing therapy designed to treat chronic Hepatitis B by directly targeting HBV cccDNA and integrated HBV DNA, showcased as the final oral presentation in the late-breaking AASLD session at 5:45pm EST on Monday, November 10, 2025 PBGENE-HBV was well-tolerated across pre-planned repeat administrations at doses of 0.2mg/kg, 0.4 mg/kg, and 0.8mg/kg with no dose-limiting toxicities Data to date from the Phase 1...Read more
One-time treatment of nex-z led to consistently rapid, deep and durable reduction in serum TTR through three years of follow-up Consistent trend in disease stability or improvement in multiple measures of cardiomyopathy, regardless of NYHA Class, at 24 months compared to baseline Longer-term safety data consistent with previously reported Phase 1 data CAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc....Read more
Interim Phase 1 results for APG333 exceeded trial objectives, demonstrated a half-life of approximately 55 days, and suppressed key biomarkers for 6 months following a single dose, supporting potential 3- and 6- month dosing Results support development of a quarterly or less frequently dosed co-formulation of APG273 (APG777+APG333) for respiratory indications APG333 was well tolerated across all cohorts with doses of up to 1,000 mg...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
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
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
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
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
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
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
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
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
Initial Clinical Data Expected in the First Half of 2026 SAN CARLOS, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that the first patient has been dosed in a Phase I clinical trial of BMF-650, the Company’s investigational, next-generation oral small molecule glucagon-like peptide-1...Read more
NMRA-898 is structurally distinct from NMRA-861 and is the second M4 PAM in Neumora’s M4 franchise; both programs have potential best-in-class pharmacology No convulsions observed in pre-clinical studies conducted in multiple species, including rabbits Neumora plans to provide a comprehensive M4 franchise update by mid-2026 WATERTOWN, Mass., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a...Read more
As of a September 25, 2025 data cut-off-date, 10 patients with treatment-refractory, moderate-to-severe Systemic Lupus Erythematosus (SLE) were treated with a single dose of FT819 with less-intensive or no conditioning chemotherapy Favorable safety profile with no dose-limiting toxicities supports plan to enable same-day discharge post FT819 treatment broadening patient accessibility All patients surpassing a 3-month post-treatment...Read more
Positive, early results from 71 patients treated across three disease cohorts – systemic sclerosis, systemic lupus erythematosus and idiopathic inflammatory myopathies – are being disclosed Across all cohorts, results support potential for immune reset, with 94% of evaluable patients remaining off chronic immunosuppressive therapy at the time of analysis Results demonstrate BMS’ steady advancement toward its goal of bringing the science...Read more
XmAb819 is well-tolerated in heavily pretreated patients with advanced ccRCC 25% overall response rate (ORR) observed within the target dose range First dose-expansion cohort has been selected; dose escalation continues to identify dose for second expansion cohort Management hosting webcast and conference call today at 1:30 p.m. ET / 10:30 a.m. PT PASADENA, Calif. / Oct 24, 2025 / Business Wire / Xencor, Inc. (NASDAQ:XNCR), a...Read more
Robust responses observed in heavily pre-treated patients with a 68% ORR for 1.6 mg/kg in second-line setting Compelling activity in patients with baseline brain metastases (n=32), including an 80% ORR for patients without prior brain radiotherapy Duration of response of 6.1 months across all doses and all lines of therapy; enrollment continuing for 1.2 mg/kg and 1.6 mg/kg, with nearly half of responders ongoing at data...Read more
3 out of 4 patients achieved stable disease (per RECIST v1.1) at the 100 mg APR-1051 dose level in heavily pretreated gastrointestinal and gynecologic malignancies Disease stabilization observed in patients with tumors harboring mutations relevant to WEE1 kinase inhibition (FBXW7, CCNE1, KRAS G12V and TP53) Dose escalation continues, with patients now enrolling in 150 mg cohort Preliminary results from ACESOT-1051 trial through...Read more
Advancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration MIAMI, FLORIDA / ACCESS Newswire / October 24, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced...Read more
Ozekibart meets its primary endpoint in chondrosarcoma, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival compared to placebo Key secondary endpoints reinforce the primary benefit, demonstrating meaningful improvements in disease control and patient quality of life Inhibrx plans to file a BLA in Q2 of 2026 Interim data from expansion cohorts in patients with...Read more
The formal safety review of Cohort 3 (5ug/kg/day) has been successfully completed with no safety or tolerability issues observed, allowing advancement into Cohort 4 with a dose of 10 ug/kg/day Actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks Cohort 4 dose is potentially more reflective of the clinical efficacy threshold given positive trend in observations on multiple immunological...Read more
MELBOURNE, Australia and INDIANAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has dosed the first patient in a Phase 1 clinical trial of TLX090 (153Samarium (Sm)-DOTMP), a therapeutic radiopharmaceutical candidate for treating pain associated with bone metastasis. TLX090 is designed to deliver targeted radiation to bone tumors while minimizing damage to...Read more
Company completes first tranche of a $7 million financing to increase cash runway and maintain Nasdaq compliance SOUTH SAN FRANCISCO, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company developing novel T cell therapeutics that incorporate phagocytic mechanisms, today announced that investigators have been authorized under...Read more
Study to Explore Maintenance Dosing Regimens Following Initial Weight Loss with VK2735 Monthly Subcutaneous, Weekly Oral, and Daily Oral Regimens to be Evaluated SAN DIEGO, Oct. 21, 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 the initiation of an exploratory...Read more
First returning adult patient from Phase 1b study recently dosed; additional returning patients being scheduled 11-month open-label study will evaluate functional outcomes, safety, muscle composition by MRI, and serum biomarkers Results following initial 3 months of treatment anticipated in early 2026, quarterly thereafter Planning underway to broaden LT-001 study protocol to enroll new adult patients in Australia and open the study in...Read more
First dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, a condition with no approved therapies Topline safety, PK, and PD data anticipated in Q1 2026 Advances ongoing development of PALI-2108 across fibrostenotic Crohn’s disease and ulcerative colitis, with Phase 2 IND submission planned for H1 2026 Carlsbad, CA, Oct. 20, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or...Read more
LONDON and Gaithersburg, Md., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the first patient has been dosed in its Phase 1 BOBCAT trial of obecabtagene autoleucel (obe-cel) in patients with progressive multiple sclerosis (PMS). The patient was treated at...Read more
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
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
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
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
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
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
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
CLICK TO LEARN MORE