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
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
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
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
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
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
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
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
Initial clinical data for BDC-4182 Phase 1 dose escalation study now expected in 3Q 2026 Company is implementing a 50% workforce reduction to extend cash runway into 2027 REDWOOD CITY, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced an update on the ongoing Phase 1 dose escalation...Read more
Dosing has successfully commenced with healthy volunteers Primary endpoints for the Phase 1 trial include safety, tolerability, and pharmacokinetic (PK) profile of the combination Topline data are anticipated in the first half of 2026 SAN MATEO, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional...Read more
WATERTOWN, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. Under the terms of the agreement, Pfizer will supply elranatamab (ELREXFIO®), a B-cell maturation antigen CD3 targeted bispecific...Read more
No safety concerns or dose limiting toxicities observed SCY-247 was able to achieve target exposures at doses lower than our first-generation fungerp Safety, tolerability, and pharmacokinetic profile support the continued clinical development of SCY-247 JERSEY CITY, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent...Read more
Study will evaluate ELI-002 7P in combination with chemotherapy and a checkpoint inhibitor (“CPI”) in the neoadjuvant setting Trial is anticipated to begin enrolling in H1’2026 BOSTON, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the planned...Read more
One dose of nex-z led to rapid, deep and durable TTR reductions, with mean reductions of at least 90% from baseline sustained through three years Stabilization or improvement in disease-related clinical measures observed at 24 months Continue to observe generally favorable safety data with no new drug-related events within the follow-up period Data presented today at the 5th International ATTR Amyloidosis Annual Meeting for Patients...Read more
Interim Data Support Advancing RLYB116 as a Differentiated Therapeutic and Enable Progression to Cohort 2 Data Readouts for Completed Study Expected in 4Q 2025 NEW HAVEN, Conn. / Sep 25, 2025 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the completion of...Read more
AUSTIN, Texas / Sep 25, 2025 / Business Wire / Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid-induced toxicities (the “Company” or “Anebulo”), today announces the first subjects dosed in its Phase 1 single ascending dose (“SAD”) study of intravenous (IV) selonabant in healthy young adults. The study is supported by a...Read more
53.7% mean splicing correction observed following a single 15 mg/kg dose of PGN-EDODM1, with all patients showing an improvement in splicing PGN-EDODM1 was generally well-tolerated at 15 mg/kg, with drug-related adverse events mild or moderate in severity BOSTON / Sep 24, 2025 / Business Wire / PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company developing the next generation of oligonucleotide therapies...Read more
Third patient in the first cohort is now advancing through protocol-defined evaluations as Company anticipates additional results from second dosing of second patient in the cohort SOUTH SAN FRANCISCO, Calif, Sept. 22, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company, today announced that it has dosed the third patient in the starting dose...Read more
Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable duration of action supporting once-daily dosing, and no CNS side effects typically seen with ketamine. MIAMI, FLORIDA / ACCESS Newswire / September 22, 2025 / MIRA Pharmaceuticals,...Read more
PIPE-791 achieved high LPA1 brain receptor occupancy (RO) in healthy volunteers and progressive multiple sclerosis (PrMS) patients PIPE-791 showed a safety and tolerability profile consistent with previous clinical studies Topline data affirms planned doses for future Phase 2 clinical proof-of-concept trials SAN DIEGO / Sep 18, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a...Read more
Extension of the Phase 1b study will allow participants to continue dosing with GT-02287 for an additional nine months after completing the first 90-day dosing schedule The Phase 1b study enrolled 21 subjects and the last participants will complete 90 days of dosing in December 2025 Early results from the Phase 1b study to be presented at the International Congress of Parkinson’s Disease (PD) and Movement Disorders in...Read more
PALI-2108 demonstrated favorable safety, with no serious adverse events, lab abnormalities, or EKG concerns Phase 1b data demonstrated 100% clinical response and promising signals regarding the efficacy of PALI-2108 in ulcerative colitis (UC) using FDA-defined endpoints Biomarker analyses showed normalization of 186 genes linked to fibrosis and Crohn’s disease strictures, supporting translational potential in fibrostenotic Crohn’s...Read more
Results Support Potential for STAR-0310 to be Best-in-Class OX40 Antagonist STAR-0310 Exhibits Longest-in-Class Half-Life of 68 Days and Cytokine Suppression Lasting At Least 20 Weeks After a Single 300 mg SC Injection, Supporting Potential Every-Six-Month Administration STAR-0310 Was Well-Tolerated, with no ADCC-Related Treatment-Emergent Adverse Events, Supporting a Wider Therapeutic Window with the Potential to Drive...Read more
LP-184 achieves all primary endpoints and demonstrates a favorable safety and tolerability profile positioning it for both monotherapy or synergistic combinations with PARP inhibitors and immunotherapies. Clinical benefit observed in 48% of evaluable cancer patients at or above the therapeutic dose threshold. Durable clinical benefits were observed in hard-to-treat tumors like glioblastoma multiforme (GBM), gastrointestinal stromal...Read more
First patient in South Korea dosed MIAMI, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced activation of two South Korean clinical trial sites participating in its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and...Read more
Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025 New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more
Phase 1 data in healthy volunteers exceed expectations and support best-in-class potential, enabling Phase 2 advancement for both intended indications of PKU and CKD Dose-dependent urinary amino acid excretion demonstrated across all SAD and MAD cohorts, including up to a 42-fold increase in urinary phenylalanine (Phe) excretion, a well-validated biomarker for PKU and predictive for CKD Dose-dependent initial eGFR dip similar to SGLT2...Read more
GlyphAgo is an oral prodrug of agomelatine, a medicine with established clinical efficacy in generalized anxiety disorder (GAD) GlyphAgo is designed to overcome a key limitation of agomelatine by shifting absorption toward the intestinal lymphatics, avoiding first-pass liver metabolism, and increasing systemic exposure of the drug Phase 1 proof-of-concept study will evaluate the safety, tolerability, and pharmacokinetics of GlyphAgo and...Read more
Second-generation constructs induce robust increases in fecal IgA, which was shown to be correlated with protection against infection in the company’s previous Phase 2b challenge study SOUTH SAN FRANCISCO, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today reported...Read more
Gemini normalized the inflammatory response at the cellular level in stage 3 and 4 CKD patients Gemini could potentially revolutionize the treatment of acute and chronic inflammatory disease Data discussion webcast/conference call will be held on Wednesday, September 10th at 8:30 am Eastern Time SAN DIEGO, CA / ACCESS Newswire / September 9, 2025 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or...Read more
CID-103 is a potential best-in-class, clinical stage anti-CD38 monoclonal antibody Safety profile observed in first four dose cohorts supports continued development No serious adverse events or dose-limiting toxicities have been reported SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / September 8, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative...Read more
Study investigator of Phase 1 trial presented poster at Society of Hematologic Oncology 13th annual conference highlighting original study protocol SOUTH SAN FRANSCISCO, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic...Read more
Continue to observe a positive safety profile—no dose limiting toxicities, cytokine release syndrome or immune effector cell-associated neurotoxicity SAN JOSE, Calif., Sept. 8, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced it has completed dosing of the fourth cohort in its ongoing Phase 1 clinical...Read more
Recommendation that trial escalate to next dose level of 8mg tablet Initial interim clinical data from first two cohorts expected in Q1 2026 MIAMI, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced that the external Safety Review Committee...Read more
80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR in 2L SCLC; a 73.7% (14/19) ORR and 57.9% (11/19) confirmed ORR (1 pending confirmation) were observed across all lines of SCLC at the 2.4 mg/kg expansion dose of IDE849 77.1% (27/35) ORR and 60.0% (21/35) confirmed ORR (4 pending confirmation) in 2L SCLC; a 73.2% (52/71) ORR and 47.9% (34/71) confirmed ORR (10 pending confirmation) were observed across all lines of SCLC at all expansion...Read more
Decoy20 monotherapy induces Partial Response in patient with urothelial cancer and liver metastases Decoy20 combination with PD-1 inhibitor, tislelizumab, demonstrates safety profiles consistent with each agent NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection...Read more
Preclinical data support the potential for improved weight loss and tolerability with once-monthly administration of MBX 4291 CARMEL, Ind., Sept. 04, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced dosing of the first participant...Read more
New longer-term post hoc analysis results of responders (n=6)1 showed long-lasting, durable pain reduction of nearly 66%, or a mean 5.08 reduction on the VAS pain scale, in patients with severe pancreatic cancer pain 100% of responders (n=7) 1 showed zero opioid use at their 3-month post-procedure follow-up2 Quality of life markers further improved including sleep quality, energy level and ability to lead normal daily and leisure time...Read more
Cohort 2 fully enrolled; enrollment and dosing now underway for Cohort 3 (final dose level); No cases of amyloid-related imaging abnormalities (ARIA) observed to date; The trial, expected to enroll 128 patients, remains on track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026. Cambridge, Massachusetts, Sept. 03, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a...Read more
As previously communicated, Prothena plans to explore potential partnership interest to advance PRX012 and its preclinical PRX012-TfR (transferrin receptor) antibody Phase 1 ASCENT clinical program established proof-of-mechanism for PRX012 as a once-monthly, subcutaneous anti-amyloid beta antibody with high binding potency, dose- and time-dependent reduction of amyloid plaque, although with a non-competitive ARIA-E profile in...Read more
ABCL575 is an Fc-silenced, half-life extended investigational antibody therapy that is being developed for the treatment of atopic dermatitis VANCOUVER, British Columbia / Aug 27, 2025 / Business Wire / AbCellera (Nasdaq: ABCL) today announced it has dosed the first participants in its Phase 1 clinical trial of ABCL575, a next-generation investigational antibody therapy being developed for the treatment of moderate-to-severe atopic...Read more
First chemotherapy-free trial combining ANKTIVA, an IL-15 agonist, natural killer (NK) cell therapy, and Optune immune-stimulating device for patients with glioblastoma (GBM) brain tumors who have failed current standard of care Encouraging early results observed to date, including response in 3 of the subjects with 2 responders at near complete response and 2 with ongoing stable disease, representing 100 percent disease...Read more
Ongoing Phase 1 APOLLO study investigating MT-601 in patients with relapsed B cell lymphoma showed 66% of Non-Hodgkin Lymphoma (NHL) patients achieving objective response rates, with 50% demonstrating complete response (CR) Favorable safety profile observed in study participants with no dose limiting toxicities (DLTs) or immune-effector cell associated neurotoxicity syndrome (ICANS) in the dose escalation cohort Dose expansion phase...Read more
Safety and Pharmacokinetic Data Support Dosing of ART26.12 in Fed or Fasted Conditions Completion of Positive Single Ascending Dose Study with a Preliminary Food Effect Assessment Advances ART26.12 Toward Multiple Ascending Dose Trial SOLANA BEACH, Calif., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop...Read more
Dosing Completion Expected by End of August; Phase 2 Trial Expected to Begin in 1Q 2026 NEW YORK, NY / ACCESS Newswire / August 21, 2025 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical company developing novel neuro-active peptide therapies, today announced completion of first dose injection for all study subjects in the multiple-dose portion of its ongoing Phase I clinical trial of PT00114. The company expects to...Read more
Trial Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SEP-631 in Healthy Volunteers SOUTH SAN FRANCISCO, Calif., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a selective...Read more
Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025 MIAMI, FL / ACCESS Newswire / August 19, 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 the successful completion of the Single Ascending...Read more
- A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first half 2026 SOUTH SAN...Read more
Fourth Cohort Receiving 30x Initial Dose with No Dose-Limiting Toxicities Observed to Date SAN JOSE, Calif., Aug. 18, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the second patient in the fourth dose cohort has been treated in the ongoing Phase 1 clinical trial evaluating the Company's novel...Read more
First-in-human trial of Capricor’s StealthX™ vaccine initiated under HHS’s Project NextGen Trial conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID) SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the first subjects have been dosed in a...Read more
SHELTON, CONNECTICUT / ACCESS Newswire / August 18, 2025 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, reports that its broad-spectrum antiviral drug NV-387 could help reduce resurgence of metastatic cancer caused by awakening of...Read more
First-in-human study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102, an orally available small molecule with potential best-in-class profile Initial development planned in obesity; BGE-102 demonstrated robust weight loss in preclinical models, both as monotherapy and in combination with GLP-1 receptor agonists Initial Phase 1 SAD data anticipated by end of 2025, with top-line readout of obesity...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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