[IMAGES BELOW] Complete resolution maintained at 6 months in first patient treated with BriaCell’s Bria-OTS in Phase 1/2a study No treatment limited toxicities observed Patient remains on study with stable disease elsewhere PHILADELPHIA and VANCOUVER, British Columbia, July 09, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology...Read more
Eye drop administration of KB801 designed to enable sustained expression of NGF in the front of the eye Investor call and webcast to be held July 9 at 8:30 am ET to discuss program and trial design PITTSBURGH, July 09, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the first patient has been dosed in its Phase 1/2 clinical trial (“EMERALD-1”), a 2:1 randomized, double-masked,...Read more
In April 2025 the Sixth and Final Subject of Cohort 1 was Safely Treated with the Low Dose of BB-301 in the Phase 1b/2a Clinical Treatment Study (NCT06185673) Independent Data Safety Monitoring Board Review Has Been Completed for All Six Subjects Enrolled into Cohort 1, and the Data Safety Monitoring Board Recommended Continuation of Subject Enrollment for the Phase 1b/2a Clinical Treatment Study Following the Positive Data Safety...Read more
National Footprint of NEXICART-2 Trial Sites Expanded On track for first Biologics License Application (BLA) approved cell therapy in unaddressed orphan indication NEXICART-2 interim results were presented at ASCO 2025 LOS ANGELES, CA, July 07, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL...Read more
8 of 9 participants (89%) treated in the 240mg and 360mg single dose cohorts achieved a complete response 8 of 11 participants (73%) enrolled in the 180mg Q8W open label extension study achieved a complete response at 12 weeks Results from the 240mg Q8W and the 240mg followed by 180mg Q8W cohorts appear to be confounded by issues with one drug product lot ETESIAN study in asthma to be stopped due to same drug product lot...Read more
Vancouver, Canada, June 30, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced a historic milestone: the first participant has been dosed with CMND-100, its proprietary MEAI-based oral drug candidate, in its...Read more
BOSTON, June 27, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the Phase 1/2 trial of TNG462 and Revolution Medicines’ daraxonrasib (RAS(ON) multi-selective inhibitor) or zoldonrasib (RAS(ON) G12D-selective inhibitor) in patients with MTAP-deleted...Read more
Attractive safety profile demonstrated across all dosing cohorts and routes of administration (IV, SC, and IM); all reported adverse events (AEs) deemed unrelated or classified as mild to moderate and largely related to injection site and infusion reactions with no serious or severe adverse events observed Following a single dose, serum concentrations of VYD2311 remained high at six months with an observed half-life of the IM dose...Read more
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder Vancouver, Canada, June 25, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major...Read more
Phase 1 dose-escalation study to evaluate VS-7375 in the U.S., with plans to expand as monotherapy into pancreatic cancer and non-small cell lung cancer cohorts, along with colorectal cancer in combination with cetuximab BOSTON / Jun 24, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the...Read more
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as primary basis of approval Isaralgagene civaparvovec showed a favorable safety and tolerability profile Sangamo intends to submit a Biologics License Application (BLA) in 2026 RICHMOND, Calif. / Jun 24, 2025 /...Read more
Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025 In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 prior ROS1 TKIs ± chemotherapy, ORR by BICR was 44% (95% CI: 34, 53) with initial...Read more
Vancouver, Canada, June 23, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the addition of Tel Aviv Sourasky Medical Center (TASMC), Tel Aviv, Israel, as an additional clinical site for its ongoing Phase...Read more
PBFT02 continued to demonstrate robust, durable elevation in CSF PGRN levels and improvement in plasma NfL, a disease progression biomarker, compared to natural history Dose 2, 50% lower than Dose 1, substantially increased CSF PGRN levels at 30-days, reaching the upper limit of a healthy adult reference range Plan to amend upliFT-D protocol to include a prophylactic course of low dose anticoagulation and modify inclusion criteria to...Read more
[212Pb]VMT-α-NET Phase 1/2a study is advancing into Cohort 3 with a fixed administered dose that is up to 20% higher (6 mCi) than the dose administered to patients in Cohort 2 Dosimetry sub-study analysis presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting to advance utility of dosimetry in clinical development when considered with clinical data On track to submit further clinical updates...Read more
85% remission rate observed in evaluable frontline AML patients Mipletamig combination enables rare pathway to transplant in a previously ineligible unfit patient No dose-limiting toxicities observed among evaluable patients; safety profile remains strong Evidence mounts for mipletamig as a potentially transformational addition to standard of care in frontline AML as targeted CD123 x CD3 approach showing power and precision, limited...Read more
LYL314 demonstrated robust clinical responses, with an 88% overall response rate and a 72% complete response rate in patients treated in the third- or later-line setting (N = 25) 71% of patients with complete response remained in complete response at ≥ 6 months Manageable safety profile appropriate for outpatient administration with no Grade ≥ 3 cytokine release syndrome and low rates of Grade ≥ 3 ICANS with rapid resolution Pivotal...Read more
With up to three years of follow-up, a single dose of lonvo-z led to a 98% mean reduction in monthly HAE attack rate in all 10 patients All 10 patients were attack-free and treatment-free for a median of 23 months through the latest follow-up, demonstrating the potential of lonvo-z to become the first one-time therapy for most HAE patients Lonvo-z was well tolerated and continues to demonstrate a favorable safety profile The global...Read more
Results from the EPCORE® NHL-2 trial show investigational treatment with epcoritamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) led to an overall response rate (ORR) of 87 percent and a complete response (CR) rate of 65 percent in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Data further demonstrates the potential of epcoritamab in combination with salvage...Read more
11 of 12 participants (92%) enrolled in the 180mg cohort achieved a complete response 12 of 12 participants (100%) in the 180mg cohort achieved a clinical response Tryptase levels below the lower limit of quantification observed in 10 of 12 participants (83%) No serious adverse events and no grade 3 or higher adverse events reported in the 180mg cohort Company to host conference call and webinar on Monday, June 16, at 8:00 a.m....Read more
Updated Data from 17 Patients Consistent with Previously Presented Data; All Patients Treated with BEAM-101 Achieved Hemoglobin F (HbF) Induction of >60%, Hemoglobin S (HbS) Reduction to <40%, and Resolution of Anemia Patients Required a Median of One Mobilization Cycle and Experienced Rapid Neutrophil and Platelet Engraftment Safety Profile Remained Consistent with Busulfan Conditioning, Autologous Hematopoietic Stem Cell...Read more
Unprecedented data from FORTITUDE™ dose escalation cohorts for del-brax treated participants, compared to placebo, demonstrate improvement in function, strength and PROs as well as rapid and significant reduction in biomarkers Data support planned accelerated approval BLA submission in H2 2026 Data being presented at the 32nd Annual FSHD Society International Research Congress (IRC); Investor and analyst webcast event...Read more
EMERYVILLE, Calif. / Jun 05, 2025 / Business Wire / Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS® T-cell therapy, in...Read more
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder Vancouver, Canada, June 05, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major...Read more
RGX-202 demonstrating consistent evidence of positively changing disease trajectory for Duchenne All dose level 2 participants exceeded external natural history controls on all functional measures Biomarker data demonstrate consistent, robust microdystrophin expression and transduction levels across all treated ages One new participant aged 2 years at dosing had expression level at 118.6% compared to...Read more
Annamycin delivering better performance 7th line than would be expected even in 2nd line for monotherapy Responders (Stable Disease or Partial Response) after 2 cycles of Annamycin showed improvement in OS and Progression Free Survival (“PFS”) Clinical Benefit Rate (“CBR”) was 59.4% (n=32), comprised of 18 subjects with stable disease and 1 subject with a partial response Potential to address 13,500 new incidents of STS each year...Read more
Initial Data from the Ongoing, Blinded Phase 1 Single-Ascending Dose Trial Has Demonstrated Favorable Safety and Pharmacokinetics IND Application Submitted to Expand RESTORE-FA Trial to U.S. Sites; Notice Received from FDA Placing Clinical Hold on IND Application to Open U.S. Sites CARLSBAD, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company...Read more
Immix Biopharma today presented results at ASCO from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201, meeting its primary endpoint. NXC-201 met primary endpoint with a complete response (CR) rate of 70% (7/10 patients) No relapses recorded to-date; no safety signals identified Immix plans Biologics License Application (BLA) for FDA approval Results were presented by Heather Landau, MD, of Memorial Sloan...Read more
New long-term CARTITUDE-1 data show one-third of patients treated with CARVYKTI® remain progression-free CARTITUDE-4 analysis shows compelling overall survival and progression-free benefits in standard and high-risk subgroups across prior lines of treatment CHICAGO, June 3, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today new long-term follow-up data from the Phase 1b/2 CARTITUDE-1 study demonstrating...Read more
New data showed that rinatabart sesutecan (Rina-S®) 100 mg/m2 led to a confirmed objective response rate (ORR) of 50.0 percent, including two complete responses (CR), and median duration of response (mDOR) was not reached after a median follow-up of 7.7 months Continued evaluation of single-agent Rina-S 100 mg/m2 in patients with advanced endometrial cancer (EC) is ongoing in the Phase 2 RAINFOL™-01 trial and will be further evaluated in...Read more
New trial arm to evaluate safety, dosing and preliminary anti-tumor activity of the combination therapy in advanced solid tumors NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial...Read more
ARO-ALK7 is the first investigational RNAi therapeutic to enter clinical studies that targets a gene expressed in adipose tissue Study initiation highlights Arrowhead’s leadership in the delivery of siRNA to multiple tissues and cell types throughout the body utilizing its proprietary and differentiated Targeted RNAi Molecule (TRiM™) platform In preclinical studies, ARO-ALK7 silenced Activin receptor-like kinase 7 (ALK7) expression in...Read more
Study met its primary endpoint by achieving statistical significance on one of its two pre-specified co-primary endpoints, demonstrating increased electrical connectivity between the brain and hand muscle in individuals with a cervical level spinal cord injury (SCI). Study also showed a positive trend in the secondary endpoint evaluating change in “GRASSP” score, a measure designed specifically to assess hand function in people with...Read more
PRINCETON, N.J. and CAMBRIDGE, Mass., June 1, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO). REZILIENT1 is a Phase 1/2, global, multicenter study of zipalertinib (development code: CLN-081/TAS6417) in patients with non-small cell lung cancer (NSCLC) harboring epidermal...Read more
Updated interim results with an additional ~16 weeks of follow-up on nine patients in Cohort 1 (2.5 mCi) and Cohort 2 (5.0 mCi) and initial safety findings in an additional 33 patients treated in Cohort 2 from the ongoing Phase 1/2a study were presented [212Pb]VMT-α-NET continued to have a favorable safety profile, with no dose-limiting toxicities and no discontinuations due to adverse events observed among a total of 42 patients...Read more
EMERYVILLE, Calif. / May 29, 2025 / Business Wire / Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that the first patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103, a CD19-redirected ARTEMIS®...Read more
Phase 1/2 H5 avian flu vaccine study shows positive interim results Company has been notified that HHS will terminate Moderna's award for late-stage development of pre-pandemic influenza vaccines CAMBRIDGE, MA / ACCESS Newswire / May 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic...Read more
Natural history data analysis established patients ≥ six years of age are in developmental plateau, with a ~0% likelihood of gaining/regaining developmental milestones across the core functional domains of Rett syndrome Written alignment from FDA supports single-arm, open label pivotal trial with primary endpoint of developmental milestone gain/regain in the developmental plateau population (≥ 6 years, intend N=15) with each patient...Read more
Bria-OTS has cleared its safety evaluation in the Phase 1/2 study monotherapy dosage setting Phase 1/2 study has now transitioned to dosing patients in combination with checkpoint inhibitor in metastatic breast cancer First Bria-OTS monotherapy patient remains on study with confirmed resolution of lung metastasis PHILADELPHIA and VANCOUVER, British Columbia, May 27, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq:...Read more
Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90% Additional results from dose-finding cohorts will also be presented ALAMEDA, Calif. / May 22, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced results from an expansion cohort of the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab...Read more
Selected recommended Phase 2 dose: Dose level 1 demonstrated an ORR of 83% (10/12) in frontline metastatic pancreatic ductal adenocarcinoma Plans for registrational Phase 3 study underway in frontline metastatic pancreatic ductal adenocarcinoma Company will host an R&D investor webcast on Monday, June 2 at 11:00 am CDT to review the updated RAMP 205 data as well as updated data on VS-7375 presented at ASCO BOSTON / May 22, 2025 /...Read more
Immix Biopharma today reported ASCO abstract results from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201 demonstrating strong efficacy and favorable safety. NXC-201 demonstrated a complete response (CR) rate of 71% (5/7 patients) No relapses recorded to-date; no safety signals identified Updated results with a later data cutoff, including endpoint analysis, will be presented at ASCO by lead...Read more
BOSTON, May 21, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the TNG456 Phase 1/2 trial in patients with MTAP-deleted solid tumors, with a focus on glioblastoma (GBM). TNG456 is a next-generation, brain-penetrant, MTA-cooperative PRMT5...Read more
First ever clinical data supporting safety and efficacy of Prime Editing in humans Initial data from first patient dosed in Phase 1/2 trial finds single dose of PM359 led to 58% DHR positivity by Day 15 and 66% by Day 30, well above levels believed to be potentially curative Rapid engraftment observed in both neutrophils and platelets Encouraging safety profile; no serious adverse events related to...Read more
All primary endpoints for safety, tolerability, and clinical response in the intent-to-treat population met AP-SA02 arm significantly improved clinical outcomes and prevented relapse compared to best available antibiotic therapy No treatment-related serious adverse events were observed with repetitive intravenous dosing LOS ANGELES, May 19, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the...Read more
64% (9/14) complete response rate with AlloNK + rituximab in heavily pretreated patients that were naïve to prior CAR-T cell therapy, in line with approved auto-CAR-T therapies in aggressive B-NHL Median duration of response for AlloNK + rituximab not yet reached and is at least 19.4 months, in line with approved auto-CAR-T therapies in aggressive B-NHL AlloNK’s activity and well-tolerated safety profile in aggressive B-NHL patients...Read more
Aptose is developing TUS+VEN+AZA as a one-of-a-kind safe and mutation agnostic frontline triple drug therapy for newly diagnosed AML patients First two dose cohorts of TUS+VEN+AZA triplet demonstrate safety, complete remissions, and MRD negativity across patients with diverse mutations, including TP53-mutated/CK AML and FLT3-wildtype AML patients SAN DIEGO and TORONTO, May 05, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc....Read more
Eupraxia continues to observe positive treatment outcomes in its ongoing Phase 1b/2a trial, including for the first time clinical responses measured 9 months after dosing with EP-104GI At 9 months active drug continued to be released into the esophagus in patients at a rate similar to what was seen at the 3- and 6-month time points. This is an unprecedented result with an injectable delivery system in patients with EoE Also, at 9...Read more
In the Phase 2 open-label study, REC-4881 (4 mg QD) led to a median 43% reduction (n=6 patients) in polyp burden at the Week 13 assessment at time of data cutoff. Five of six patients (83%) experienced reductions in polyp burden ranging from 31% to 82%, however, one patient showed a substantial increase from baseline. At Week 13, 50% of patients (3 out of 6) achieved ≥1-point improvement in Spigelman stage, a measure of upper GI...Read more
SEATTLE, April 29, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, announced today that the first patient was treated with [212Pb]PSV359 in a Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients...Read more
Data to be presented at AACR 2025 Annual Meeting suggest the combination of ALX Oncology’s investigational CD47-blocker, evorpacept, plus rituximab and lenalidomide (R2) was well-tolerated and demonstrated promising anti-tumor activity Combination generated complete responses (CR) in 83% of patients with indolent relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) comparing favorably to 34% historical CR rate with R2 alone...Read more
(IMAGES BELOW) Complete resolution of lung metastasis confirmed at 4 month follow-up in hormone receptor positive (HR+) breast cancer patient Treatment well-tolerated and patient remains on study with stable disease elsewhere Sustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy approach in Phase 1/2a metastatic breast cancer study PHILADELPHIA and VANCOUVER, British Columbia, April 24, 2025 (GLOBE...Read more
The Company is now preparing for the enrollment of the first patient to receive Clearmind’s innovative treatment as part of the trial Vancouver, Canada, April 23, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today...Read more
Nes-Ziona, Israel, April 21, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and...Read more
Vancouver, Canada, April 16, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, recently announced it has initiated its Phase I/IIa clinical trial at its first U.S. clinical site, the Johns Hopkins University School of...Read more
Independent Data Safety Monitoring Board (DSMB) recommends that the study proceeds as designed based on 30-day data safety assessment of participants treated in low dosage group. The company plans to progress the trial to enrollment of 39 participants in the United States. SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the...Read more
SEATTLE, April 11, 2025 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, announced today that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), as monotherapy in patients with histologically...Read more
Vancouver, Canada, April 10, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced today that it has initiated its Phase I/IIa clinical trial at its first U.S. clinical site, the Johns Hopkins University School of...Read more
Initiated Phase 1/2 study expansion for IDE397, IDEAYA's MAT2A inhibitor, in combination with Trodelvy®, Gilead's Trop-2 directed ADC, in MTAP-deletion urothelial cancer based on preliminary safety and clinical efficacy data MTAP-deletion prevalence in urothelial cancer is estimated to be approximately 26% SOUTH SAN FRANCISCO, Calif., April 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine...Read more
Participants with abnormal left ventricular mass index (LVMI) at baseline achieved 25% mean reduction in LVMI by 12 months or sooner Clinically meaningful improvements in majority of participants across cardiac biomarkers and functional measures All SUNRISE-FA participants achieved meaningful increases in frataxin expression at 3-months post treatment; 115% average cardiac frataxin expression increase in high dose cohort,...Read more
New Data Demonstrate Proportion of Corrected M-AAT Reached a Mean of 91% of Total AAT in Circulation at Day 28 Following BEAM-302 Treatment in 60 mg Cohort (n=3) Mean Decrease of 79% in Mutant Z-AAT Observed at Day 28 in 60 mg Cohort (n=3) Fourth Cohort Evaluating 75 mg of BEAM-302 Initiated, with Updated Data from Part A of the Phase 1/2 Trial Expected to be Presented at a Medical Conference in Second Half of 2025 CAMBRIDGE,...Read more
Topline safety data in SB221 study suggest clinical benefit of SON-1010 in combination with atezolizumab (Tecentriq®) The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg in combination with atezolizumab in patients with platinum-resistant ovarian cancer (PROC), without dose-limiting toxicity or evidence of cytokine release syndrome at any dose level Stable disease (SD) at four months post-initiation of dosing was seen...Read more
DSMB supports advancement for Sernova’s clinical trial Study is on track to meet key clinical trial endpoints LONDON, Ontario and BOSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing it’s Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today provided an update on its ongoing clinical...Read more
Del-brax FORTITUDE biomarker cohort designed for potential accelerated approval; plan to share regulatory update in Q2 2025 Regulatory alignment on global Phase 3 del-brax trial design and study initiation anticipated in Q2 2025 Plan to present topline data from FORTITUDE dose escalation cohorts in Q2 2025 On track to be first globally approved drug for FSHD SAN DIEGO, March 31, 2025 /PRNewswire/ -- Avidity Biosciences, Inc....Read more
Initial clinical activity in a PD-(L)1 resistant population, with an ORR almost three times higher than historical PD-(L)1 rechallenge response rates, with data still maturing One durable complete response in a Merkel Cell Carcinoma (MCC) patient and two partial responses (PR), including one in a second MCC patient and one in a microsatellite instability-high (MSI-H) Colorectal Cancer (CRC) patient, all of whom were previously treated...Read more
Systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved a 71% disease control rate (5/7) with two partial responders. All participants with disease control experienced a reduction in all target lesions, with one participant achieving a tumor reduction of approximately 79%. Additionally, three participants, including one individual with three prior lines of treatment, achieved stable disease at lower dose...Read more
Across two trials, 9 of 10 frontline AML patients achieved remission when treated with mipletamig in combination with the standard of care Triplet Combination with mipletamig continues to outperform doublet combination benchmark No Cytokine Release Syndrome (CRS) has been observed in the RAINIER trial to date Cohort 2 enrollment nears completion SEATTLE, WA / ACCESS Newswire / March 20, 2025 / Aptevo Therapeutics ("Aptevo")...Read more
Positive biomarker data in patient aged 1-3 add to consistent, robust microdystrophin and transduction levels across all treated ages Patient aged 3 years at dosing had expression level at 122.3% compared to control With a differentiated novel construct and proactive short course immune modulation regimen, RGX-202 continues to demonstrate encouraging safety profile with no SAEs or AESIs Phase III portion of AFFINITY DUCHENNE®...Read more
Durable, Clinically Significant Improvements in Swallowing Function Achieved 12-months Post-Treatment with BB-301 for Subject 1 Durable, Clinically Significant Improvements in Swallowing Function Achieved 12-months Post-Treatment with BB-301 for Subject 2, with Subject 2 Achieving a Clinically Normal Swallowing Profile Following the Significant Reduction in Total Dysphagic Symptom Burden Clinically Significant Improvements in...Read more
NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, today announced that it has advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20. This expansion will evaluate the combination of Decoy20 with BeiGene’s PD-1 checkpoint inhibitor, tislelizumab, with a focus on...Read more
Study represents the first clinical application of CMND-100, the Company’s proprietary drug platform Vancouver, Canada, March 18, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announces today that it initiated its...Read more
Results from Phase 2 RAINFOLTM-01 trial (B1 cohort) showed that with a median on-study follow-up of 48 weeks, Rina-S 120 mg/m2 led to a confirmed objective response rate (ORR) of 55.6% and median duration of response (mDOR) was not reached Phase 2 RAINFOLTM-01 and Phase 3 RAINFOLTM-02 trials evaluating the safety and efficacy of Rina-S at 120 mg/m2 in patients with platinum resistant ovarian cancer (PROC) are actively...Read more
On track for year end 2025 BLA submission for accelerated approval of 5 mg/kg every six weeks of del-zota in DMD44 Consistent favorable safety and tolerability across del-zota dose cohorts Plan to present functional data in fourth quarter of 2025 Investor and analyst webcast event today at 8:00 a.m. ET SAN DIEGO, March 17, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company...Read more
SEATTLE, March 17, 2025 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, announced today that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), in patients with...Read more
Continued favorable safety profile for DYNE-251 DELIVER Registrational Expansion Cohort is fully enrolled; data from this cohort planned for late 2025 Potential for Biologics License Application submission for U.S. accelerated approval in early 2026 WALTHAM, Mass., March 16, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on advancing life-transforming...Read more
Clinical trial Safety Review Committee (SRC) approved opening of Cohort 4 based on favorable safety data from the three patients comprising Cohort 3 No significant safety or dose limiting toxicities reported in Cohorts 1, 2, or 3 Patients currently being evaluated for Cohort 4 eligibility PK and PD data from patients in Cohort 1 and Cohort 2 consistent with preclinical results and results from Phase 0 clinical trial BOSTON, March...Read more
ARO-C3 achieved deep and sustained reductions in alternative pathway complement activity and proteinuria Mean sustained reductions in C3 of ≥87%, AH50 of ≥76%, Wieslab AP of ≥89% through week 24 Mean reduction in spot urine protein-to-creatinine ratio (UPCR) of 41% by week 24 PASADENA, Calif. / Mar 10, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced topline results from Part 2 of a Phase 1/2...Read more
Single Dose of BEAM-302 Led to Durable, Dose-dependent Increases in Total and Functional Alpha-1 Antitrypsin (AAT), Production of Corrected M-AAT, and Decreases in Mutant Z-AAT in Circulation Across Initial Three Dose Levels Third Dose Level of BEAM-302 (60 mg, N=3) Achieved Mean Total AAT of 12.4µM at Day 28, Exceeding Protective Therapeutic Threshold, and Reduced Mutant Z-AAT up to 78% Initial Safety Findings Demonstrated BEAM-302...Read more
Histological scores and symptom scores continue to improve as EP-104GI dose, and area of esophageal coverage, increase Cohort 6 showed the greatest symptom relief scores ("SDI") of all cohorts to date at 12 weeks Cohort 6 had the greatest magnitude and percentage change in tissue health scores ("EoEHSS") of any cohort to date at 12 weeks Cohort 6 saw the greatest reduction in Peak Eosinophil Count ("PEC") of any cohort to...Read more
As presented at ARO, 10 of 11 children with at least one post-treatment assessment showed notable improvements in hearing Speech and development progress followed dramatic improvements in hearing in first child treated in the trial TARRYTOWN, N.Y., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial...Read more
SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that Northwestern University/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product. Calidi Biotherapeutics has completed the shipment of the first batch...Read more
EMERYVILLE, Calif. / Feb 21, 2025 / Business Wire / Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced the successful completion of the first dose cohort in its ongoing STARLIGHT-1 Phase I/II clinical trial. Following a review of safety and efficacy data, the...Read more
TUS+VEN+AZA triplet achieves complete responses (CRs) in difficult-to-treat TP53-mutated/CK AML and FLT3-wildtype AML patients, including a measurable residual disease (MRD) negative remission Dosing of initial 40 mg cohort complete; no prolonged myelosuppression or dose-limiting toxicities No dose reductions to the standard-of-care components of the regimen (AZA/VEN) in first cohort CSRC endorses escalation to 80 mg dosing,...Read more
Data reinforce dose-dependent mechanism with IMNN-001 100mg/m2 dose associated with 20% increase in IL-12 levels compared to 79mg/m2 dose Results from OVATION 2 Study continue to validate TheraPlas® technology, demonstrating DNA-mediated production of key anti-cancer immune cytokines following treatment IMNN-001 continues to show favorable safety profile, with no reports of serious immune-related adverse events LAWRENCEVILLE, N.J.,...Read more
Clinical efficacy continued to deepen over time with three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major TIS improvement; each of these patients discontinued all immunosuppressants and are off steroids as of the latest follow-up Safety profile continues to suggest favorable risk-benefit in the first 10 patients dosed; 90% of...Read more
Day 90 biopsy data reported from first 3 participants dosed in Phase 1/2 INSPIRE DUCHENNE trial Average microdystrophin expression of 110% (N=3) and significant improvements in multiple additional muscle health biomarkers observed support the potential of SGT-003 as a next-generation, best-in-class Duchenne muscular dystrophy gene therapy candidate Encouraging early signals of potential cardiac benefit...Read more
Focus on Patients with Elevated Markers of Heart Stress and Inflammation Procedural enhancement using FDA Approved Morph DNA steerable guide for therapeutic delivery SUNNYVALE, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today completion of enrollment and dosing in the low...Read more
TUS+VEN+AZA triplet achieves Cycle 1 complete remission (CR) in TP53-mutated/CK AML TUS+VEN+AZA triplet achieves Cycle 1 complete remissions in FLT3-wildtype AML patients TUS+VEN+AZA triplet shows favorable safety with no alteration of VEN and AZA dosing PK levels of TUS in the triplet remain equivalent to levels as TUS or TUS+VEN therapy SAN DIEGO and TORONTO, Feb. 12, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or...Read more
Medical review of Phase 1 cohorts demonstrated no safety issues Data to be presented at the 10th Annual Innate Killer Summit, March 3-5 BOCA RATON, Fla, Feb. 12, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, continues to advance its Natural Killer (NK) cell therapy, INKmune™, in a Phase I/II trial (the “CaRe PC” trial) for men with metastatic...Read more
Long-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in hearing, cognition and adaptive behavior Long-term safety data with median follow-up of two years, and out to more than four years, demonstrate that tividenofusp alfa was generally well tolerated Regulatory submission for accelerated approval is planned for early 2025; U.S. launch...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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