Single-agent CD19 CAR-NK cell therapy achieved a complete response in third-line Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma Second patient maintains an ongoing complete response at six months with CD19 CAR-NK in combination with rituximab and a third WM patient has been enrolled in the study First study to demonstrate the potential for complete responses with a chemotherapy-free immunotherapy in late-stage WM...Read more
First patient dosed with CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute (DFCI) BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, announced today the initiation of...Read more
The CTMX-2051-101 study has enrolled 73 colorectal cancer patients to-date, aligned with the Company’s goal of providing a Phase 1 data update in Q1 2026 The CTMX-2051-101 study remains active and patients continue to be dosed with CX-2051 across all expansion doses SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally...Read more
Preclinical studies in nonhuman primates naturally infected with T. cruzi have shown AN2-502998's curative potential in chronic Chagas disease No FDA approved treatment for adults with Chagas disease Phase 2 planning underway with recently announced DNDi collaboration; initiation expected in 2026, data in 2027 MENLO PARK, Calif. / Aug 12, 2025 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical...Read more
The Phase 1b program is designed to evaluate the clinical activity of NXP900 as a single agent in patients with advanced solid tumors whose cancers harbor specific genetic alterations, and in combination with EGFR and ALK inhibitors in patients with NSCLC whose cancers developed resistance to these treatments Nuvectis will hold a conference call tomorrow, Tuesday, August 12 at 8:30 AM ET to discuss the elements of the Phase 1b program...Read more
Enrollment in the planned second dose expansion cohort completed ahead of expectations Topline results expected in Q1 2026 Positive Phase 1b dose escalation data presented at ESMO GI on July 2nd ROCKVILLE, Md., Aug. 11, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that...Read more
The first patient in Cohort 3, the fifth patient in the trial, has completed the first week of cycle 1 following the successful safety review of Cohort 2 with no safety or tolerability issues observedThe company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts SAN FRANCISCO, CALIFORNIA, Aug. 11, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a...Read more
94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo over 29-day evaluation period 94% reduction in genital lesion rate, also statistically significant, observed with 350 mg weekly oral dose compared to placebo over same period Favorable safety and tolerability profile observed...Read more
PALI-2108 demonstrated to be safe and well tolerated with no serious adverse events (SAEs) Extended half-life and local bioactivation support convenient once-daily dosing in ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) Colon tissue drug levels exceeded target thresholds 36 hours post-dose in completed Phase 1a MAD cohort Company advancing toward IND submission for Phase 2 study in H1 2026 Carlsbad, CA, Aug. 07,...Read more
Data to date in single- and multiple-ascending dose cohorts of healthy participants demonstrate a four-day half-life for ABI-6250, supporting target daily oral dosing profile and dose-dependent elevations in biomarker of target engagement Further pharmacological assessment to be conducted in parallel with Phase 2 preparation SOUTH SAN FRANCISCO, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc....Read more
Proof-of-activity now established for PBGENE-HBV, the first and only clinical modality designed to eliminate covalently closed circular DNA (cccDNA) and inactivate integrated DNA, with the goal of complete cure Cohort 1, the lowest dose cohort (0.2 mg/kg) of ELIMINATE-B, established a safe and well-tolerated profile across multiple dose administrations for all patients PBGENE-HBV demonstrated substantial antiviral activity in all three...Read more
Continued progress positions Company to report topline data for Phase 1 clinical trial of SENTI-202 before year-end SOUTH SAN FRANCISCO, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced it has confirmed the recommended Phase 2 dose (RP2D)...Read more
LIBERATE-1, the first-in-human application of Vivani’s NanoPortalTM implant technology, showed a positive safety and tolerability profile, along with encouraging performance data for NPM-115 that met the study’s primary objectives New NPM-139 (semaglutide implant) preclinical feasibility data showed approximately 20% weight loss maintained longer than 6 months with a single implant, continuing to support the potential for annual...Read more
TORONTO, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has received the clinical study report (CSR) for the trial entitled “A Phase 1, Randomised, Double-Blind,...Read more
Successful First-In-Human Use of New Parenchymal Spinal Delivery System First-ever Administration of OPC1 to a Chronic Injury Patient CARLSBAD, Calif. / Aug 04, 2025 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious neurological and ophthalmic conditions, announced today that the first-ever...Read more
Second patient in the first cohort is now advancing through protocol-defined evaluations as Company provides promising update on first patient pharmacokinetic results SOUTH SAN FRANSCISCO, Calif., July 31, 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...Read more
Available data from 13 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer treated with 75 mg/day in the NXP800 Phase 1b study includes 2 partial responses and 3 stable diseases; thrombocytopenia successfully managed with intermittent dosing schedule; observed clinical activity warrants exploration of potential development opportunities in other cancer types NXP900 successfully completed a clinical drug-drug...Read more
Initial interim safety, tolerability, biomarker, and preliminary efficacy data expected in Q1 2026 MIAMI, July 31, 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 for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications, today announced the...Read more
Robust and clinically meaningful absolute mean fetal hemoglobin (HbF) induction of 8.6% from baseline at 12 weeks of treatment; 7 of 16 patients achieved absolute HbF levels greater than 20% Evidence of pan-cellular induction of HbF based on an increase in F-cells (red blood cells containing HbF) from a mean of 34% at baseline to 67% at 12 weeks of treatment Meaningful improvements in key markers of hemolysis coupled with...Read more
DehydraTECH-semaglutide reduces overall side effects by 36.5% as compared to Rybelsus® DehydraTECH-semaglutide reduces gastrointestinal side effects by 43.5% as compared to Rybelsus® DehydraTECH-GLP-1 study arms evidencing patient safety and tolerability consistent with the primary study endpoint KELOWNA, BC / ACCESS Newswire / July 28, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or...Read more
Phase 1 clinical trial designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5525 alone or in combination with pembrolizumab in a variety of EGFR-expressing solid tumors such as NSCLC, CRC, HNSCC and cSCC VIR-5525, the Company’s third dual-masked T-cell engager leveraging the PRO-XTEN™ technology, is designed to expand the therapeutic index by selectively activating in the tumor microenvironment Dose escalation...Read more
Phase 1 clinical trial of ADI-001 in autoimmune diseases actively enrolling patients with lupus nephritis (LN), systemic lupus erythematosus (SLE) and SSc Preliminary clinical data from Phase 1 trial of ADI-001 in autoimmune diseases expected in 2H/2025 REDWOOD CITY, Calif. & BOSTON / Jul 24, 2025 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma...Read more
AI-guided, synthetic lethal therapy achieves complete metabolic response after just two cycles in patient who failed three prior state-of-the-art treatment regimens. Complete response in an aggressive, recurring B-cell cancer underscores how AI development can accelerate meaningful patient outcomes in global oncology therapeutic markets where billions are spent on therapies. DALLAS / Jul 23, 2025 / Business Wire / Lantern Pharma Inc....Read more
SINGAPORE, July 21, 2025 (GLOBE NEWSWIRE) -- Further to our announcement filed on Form 6-K on November 20, 2024, CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the affordable treatment of blood and solid cancers, is pleased to announce...Read more
MRT-8102 Phase 1 study includes single and multiple ascending dose cohorts in healthy volunteers and is designed to evaluate safety, pharmacokinetics, NEK7 protein degradation, and other key downstream pharmacodynamic markers; initial results anticipated in H1 2026 Additional Phase 1 cohort designed to evaluate potential early proof of concept in subjects with increased cardiovascular disease (CVD) risk and elevated CRP BOSTON,...Read more
Announces Completion of Phase 1 Study of Elraglusib in Pediatric Patients Prolonged and Durable Complete Responses (CRs) Observed in Two of Ten Refractory Ewing Sarcoma Patients Two Additional Patients Had Durable Stable Disease in Notoriously Difficult-to-Treat Cancer Confirmed Partial Response (PR) in a patient with a desmoplastic small-round-cell tumor (DSRCT) Company Initiating Planning of Phase 2 Trial of Elraglusib in...Read more
Sample analysis and data collection ongoingData expected during Q3 2025 SAN DIEGO / Jul 16, 2025 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company focused on rebalancing inflammation to optimize health, today announced dosing has been completed for the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of escalating doses of...Read more
Additional complete response (CR) observed in patient with multiple tumors Confirmed overall response rate (ORR) of 50% in patients with combined positive score (CPS) ≥1, including 50% ORR in patients with low CPS (1-19) 12-month overall survival of 88% and median overall survival (mOS) of 32 months BOSTON, July 16, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company...Read more
End of Phase 2 Meeting with FDA scheduled for August 27, 2025 to review OST-HER2 recurrent, pulmonary metastatic osteosarcoma program Scientific Advice Meetings confirmed with global regulators in major markets - including the United Kingdom and European Union All patients enrolled in its Phase 1 clinical study of OST-504 in second line prostate cancer have completed treatment, with data expected to be announced later in 2025 New...Read more
SYDNEY, July 9, 2025 /PRNewswire/ -- Kazia Therapeutics (NASDAQ: KZIA) is pleased to announce preliminary results from the first patient in its Phase 1b trial evaluating a combination regimen of Paxalisib, pembrolizumab (Keytruda®), and standard chemotherapy after completing Cycle 1 (21 days) of dosing. The patient, a 61-year-old woman with metastatic triple-negative breast cancer localized to the left upper lobe of the lung, has shown...Read more
NMRA-861 has potential best-in-class pharmacology, which may enable a more favorable therapeutic profile No convulsions observed in pre-clinical studies conducted in multiple species, including rabbits WATERTOWN, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including three...Read more
Investigator initiated exploratory clinical study being conducted in Israel pursuant to agreement with collaboration partner, PeriNess Company evaluating systemic recombinant human DNase I (DNase I) in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors FRAMINGHAM, MA / ACCESS Newswire / July 8, 2025 / Xenetic...Read more
SAN DIEGO, June 30, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of investigational compound NBIP-01435 in healthy adult participants. NBIP-01435 is a long-acting corticotropin-releasing factor type 1 receptor antagonist administered as a subcutaneous...Read more
As of June 30th, 16 participants have enrolled in the Phase 1b, ahead of the original goal of at least 15 total participants by 3Q 2025 Analysis of 90-day biomarker activity from cerebrospinal fluid (CSF) in all participants currently enrolled is now expected to also track earlier; available in 4Q 2025 instead of 1Q 2026 Gain will continue screening patients for enrollment through July 31st, 2025, at the request of clinical...Read more
No treatment-related neuropsychiatric events seen to date in SAD portion of Phase 1 MAD study on track for completion in Q3 2025 NORWOOD, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical-stage company focused on oncology and obesity, today announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1...Read more
Study will evaluate safety and antiviral activity of ABI-1179 in participants with recurrent genital herpes ABI-1179 IND cleared to support study expansion to sites in United States Phase 1b studies for ABI-1179 and ABI-5366 running concurrently with interim data for both candidates on track for fall 2025 SOUTH SAN FRANCISCO, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a...Read more
First Orally Active Fatty Acid Binding Protein 5 Inhibitor Evaluated in Humans First-in-Class Approach Targets Unmet Need in Multibillion-Dollar Pain Management Market SOLANA BEACH, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological or...Read more
Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins Pharmacodynamic Effects Supportive of Once-Monthly Dosing Plan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year Aurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET ROCKVILLE, Md. & EDMONTON, Alberta / Jun 30, 2025 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today...Read more
New Phase 1 clinical data for CTX310™ continues to demonstrate dose-dependent reductions in triglycerides (TG) and low-density lipoprotein (LDL), with peak reduction of up to 82% in TG and up to 86% in LDL, with a well-tolerated safety profile Complete Phase 1 data presentation for CTX310 anticipated at a medical meeting in the second half of 2025 Data update for CTX320™, targeting the LPA gene, now expected in the first half of...Read more
SAN DIEGO / Jun 25, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced an update on its Phase 1b positron emission tomography (PET) trial of PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1)...Read more
Favorable safety and tolerability profile, as well as pharmacokinetics supporting once-daily oral dosing, continued to be observed in final 400 mg cohort Mean plasma HBV DNA reductions of 3.2 logs IU/mL over 28 days of treatment for 400 mg cohort consistent with findings in 150 mg cohort, supporting ability of 150 mg dose to achieve saturated inhibition of viral replication, as anticipated Trial completion triggers opt-in...Read more
Combination cohort initiated following successful review of monotherapy cohort Over 100 participants dosed to-date in monotherapy cohort Priority are Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer Data update on schedule for later this year NORWOOD, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage company...Read more
Phio's lead clinical siRNA compound PH-762 demonstrates supportive safety profile in fourth cohort, permitting dose escalation in expected final cohort Marlborough, Massachusetts--(Newsfile Corp. - June 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 that...Read more
Salanersen (BIIB115/ION306) is a novel antisense oligonucleotide (ASO) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy (SMA) Interim Phase 1 data show children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersen Based on these encouraging Phase 1...Read more
Groundbreaking First-in-Human Study Establishes Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression Six-Month Patient Follow-up Results Demonstrate that Sana’s Transplanted Pancreatic Islet Cells Modified with its Hypoimmune (HIP) Technology are Safe and Well-tolerated, Survive, Evade Detection by the Immune System, and Continue to Produce Insulin in the Patient Function and...Read more
SOUTH SAN FRANSCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an immunotherapy company developing the next generation of engineered T cell therapeutics targeting TIM4L with phagocytic mechanisms, today announces the completion of the initial evaluation of the first patient in its Phase 1 clinical trial of lead compound CER-1236. Following an evaluation from the...Read more
Fourth cohort dose is three million CAR positive cells; thirty times higher than the first cohort dose SAN JOSE, Calif., June 23, 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 it has dosed its first patient in the fourth dosage cohort in the ongoing Phase 1 clinical trial evaluating its novel...Read more
Initial pharmacological data from placebo-controlled, double-blind Phase I study shows significant T cell suppression and a favourable safety profile at dosing level of 0.9 mg/kg The substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases Single ascending dose levels will continue with 2.5, 7 and 14 mg/kg Additional data from the Phase I to follow in second half of...Read more
12 of 13 participants maintained or lost weight at 3 months, with 6 of 13 losing additional weight after stopping GLP-1 therapy and undergoing Revita procedure Median weight remained stable through 3 months (0.46% / ~ 1 pound weight change within the margin of error for daily weight measurement), compared to expected 5–6% weight regain (10–15 pounds) after stopping GLP-1 therapy Revita continued to demonstrate excellent tolerability...Read more
Phase 2 Celiac Disease Trial Initiating with Topline Readout Expected in 2026 Forte will be Hosting a Conference Call to Discuss the Results at 8:30 am ET DALLAS / Jun 23, 2025 / Business Wire / Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced positive data from a Phase 1b trial in celiac disease for lead...Read more
16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patients Robust central nervous system (CNS) activity; 41% (7/17) confirmed complete response (CR) and 53% confirmed overall response (ORR) in CNS evaluable disease patients by BICR in overall cohort Enrollment of first patient in a randomized, global pivotal Phase 3 (ALPACCA) study in first-line...Read more
Potential Best-In-Class Bispecific Antibody ATI-052 Targets Both Thymic Stromal Lymphopoietin (TSLP) and Interleukin-4 Receptor (IL-4R) WAYNE, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that it has initiated a placebo-controlled Phase 1a/1b program for...Read more
Drug candidate ATR12-351 has been generally safe and well-tolerated with occasional, transient, mild to moderate symptoms at application site Trial is 50% enrolled; six patients have received ATR12-351, a live precision dermatology therapeutic candidate Azitra presenting at the 2025 BIO International Convention BRANFORD, Conn., June 17, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical...Read more
SPY002 and SPY072 were well tolerated, exhibited PK that supports quarterly or less frequent dosing, and fully engaged TL1A through up to 20 weeks of follow-up; ~75 day half-life demonstrated, more than 3-fold greater than first-generation anti-TL1A antibodies SKYLINE-UC platform study evaluating three optimized monotherapies and three potentially paradigm-changing combinations in ulcerative colitis, initiated in May 2025 SKYWAY-RD...Read more
Phase 1b study suggests a promising safety profile and highlights the potential of a novel dual-targeting CD19/CD20 CAR T in patients with relapsed or refractory disease 75-80% complete response rate among evaluable patients at the recommended Phase 2 dose MILAN, June 13, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the first clinical data from an ongoing Phase 1b study for JNJ-90014496...Read more
Reported cumulative MMR rate of 47% (25 of 53) by 24 weeks with 32% (13 of 41) of patients achieving MMR by 24 weeks, which continues to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all dose levels with 90 patients enrolled and a median treatment duration of ~29 weeks at cutoff Enliven will host a webcast...Read more
Bleximenib, an investigational selective menin inhibitor, shows potential as combination therapy for the treatment of relapsed or refractory AML and newly diagnosed, intensive chemo-ineligible AML Phase 1b data show low rate of differentiation syndrome and no cardiac safety signal of QTc prolongation MILAN, June 12, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new Phase 1b data showing...Read more
Potential to Address a Broad Range of Complement-Mediated Diseases with Initial Focus on Immune Platelet Transfusion Refractoriness and Refractory Antiphospholipid Syndrome Data Readouts Expected from Cohort 1 in 3Q 2025 and Cohort 2 in 4Q 2025 NEW HAVEN, Conn. / Jun 12, 2025 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative...Read more
All three patients treated with FT819 following fludarabine-free conditioning regimen for severe lupus nephritis achieve Primary Efficacy Renal Response (PERR); first patient to reach 1-year follow-up continues in drug-free Definition of Remission in SLE (DORIS) First extrarenal SLE patient on maintenance therapy treated with FT819 in the absence of conditioning achieves Low Lupus Disease Activity State (LLDAS) at 3-month follow-up and...Read more
In Patients Receiving a Minimum of 55 mCi an Average 5.4 Months of PFS was Observed: Twice the Reported 2.25 Median FLORHAM PARK, N.J., June 11, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced initial results as of June 10, 2025, from the CLOVER-2 Phase 1 clinical trial...Read more
PCRX-201 demonstrated sustained clinical efficacy with improvements in pain, stiffness, and function for up to three years – BRISBANE, Calif., June 11, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced new long-term follow-up data from its Phase 1 clinical trial evaluating PCRX-201...Read more
Second-generation norovirus constructs produce statistically significant increases in GI.1 and GII.4 norovirus blocking antibodies (141% and 94%, respectively) compared with first-generation constructs, supporting potential for improved protection against infection Vaccine candidates were safe and well-tolerated across all dose groups with no vaccine-related serious adverse events reported Conference call today at 8:30...Read more
SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A (“ETA”) receptor antagonist, for the treatment of pulmonary...Read more
Placebo-subtracted mean weight loss up to 8.4% at Day 36 19-day observed half-life supports once-monthly dosing as monotherapy and potential first-in-category monthly GLP-1 + Amylin combination Well-tolerated with no safety signals Company to host conference call and webcast today at 8:00 A.M. ET NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), today announced positive topline data from the Phase 1...Read more
Patient with a grade 4, IDH-mutant, MGMT-methylated glioma remains alive and progression-free for four years after receiving treatment with the INB-200 gamma-delta T cell therapy in glioblastoma trial NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, announced that Patient 009 in the...Read more
Trial is expected to provide key insights on how paxalisib therapy can be combined with established immunotherapies and standard of care chemotherapy to improve patient outcomes in advanced breast cancer SYDNEY, June 5, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing innovative therapies for difficult-to-treat cancers, today...Read more
Cohort 3 demonstrates earlier and deeper responses compared to cohorts 1-2 All three cohorts show separation from placebo with statistically significant difference from placebo at day 28 Cohort 3 demonstrates clinically meaningful reduction in itch as early as day 8 Enrollment initiated in extension cohort study exploring the same cohort 3 dose (200 mg BID) for a longer 8-week treatment period SOUTH SAN FRANCISCO, Calif., June...Read more
Oral presentation of CARTITUDE-1 study data showcases long-term outcomes after a single infusion of CARVYKTI® with one-third of patients with relapsed/refractory multiple myeloma progression-free for ≥5 years CARTITUDE-4 subgroup analyses featured in a poster presentation highlight consistent, durable progression-free and overall survival benefit vs. standard therapies across cytogenetic risk groups as early as second-line...Read more
Phase 1 trial demonstrates encouraging clinical activity of investigational immunotherapy for relapsed or refractory multiple myeloma Novel investigational dual-antigen-targeting immunotherapy binds to B-cell maturation antigen (BCMA) and GPRC5D on myeloma cells, as well as CD3 on T-cells CHICAGO, June 3, 2025 /PRNewswire/ -- Johnson & Johnson announced today initial Phase 1 results of JNJ-79635322 (JNJ-5322), a...Read more
SAN JOSE, Calif., June 2, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the completion of enrollment in the Phase 1 clinical trial of its breast cancer vaccine. This novel vaccine, invented at Cleveland Clinic, is also being developed in partnership with Cleveland Clinic and the Phase 1 trial is fully funded...Read more
Phase 1 healthy volunteer data of KT-621, a once-a-day STAT6 degrader, surpass Kymera’s target product profile, significantly derisking program and further validating its oral, biologics-like profile >90% mean STAT6 degradation in blood achieved at all doses above 1.5 mg Complete STAT6 degradation achieved in both blood and skin at all MAD doses ≥50 mg KT-621 impact on Th2 biomarkers in line or superior to dupilumab with median...Read more
Median DOR of 21.7 months with 80% of responders achieving a deep response (≥80% tumor shrinkage) Depth and durability translating to prolonged OS with median OS of 21.3 months and 2-year OS of 46% in HPV-negative HNSCC Conference call and webcast today at 3:00 p.m. CT / 4:00 p.m. ET BOSTON, June 01, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing...Read more
Data Highlights Transformative Promise of CAR T in Solid Tumors Phase 1 Trial with ALLO-316 Demonstrated Potential to Provide Meaningful Clinical Benefit in Patients with CD70 TPS ≥ 50% Advanced or Metastatic RCC A Single Dose of ALLO-316 Achieved a 31% Confirmed Response Rate Four of Five Confirmed Responders Remain in Response Including One Ongoing Remission Over 12 Months Robust Expansion, Persistence, and Tumor...Read more
Extended Phase 1b trial follow-up on IMA203 PRAME cell therapy in 33 heavily pretreated patients with metastatic melanoma demonstrates favorable tolerability and promising clinical activity with ongoing deep and durable objective responses up to >2.5 years IMA203 PRAME cell therapy one-time infusion in all melanoma patients shows cORR of 56%; mDOR of 12.1 months at mFU of 13.4 months; mPFS of 6.1 months; mOS of 15.9...Read more
Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations RAHWAY, N.J. / May 30, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today safety and efficacy results from the open-label Phase 1 KANDLELIT-001 study, a clinical trial evaluating MK-1084, an investigational next-generation KRAS...Read more
Broad and deep PSA responses achieved, with 59% PSA50 response rate (confirmed rate of 47%, and one additional response pending confirmation) and 24% PSA90 response rate (all confirmed) in patients with mCRPC PSA responses were observed across all ORIC-944 dose levels and at comparable rates in combination with apalutamide and with darolutamide; majority of patients are still ongoing with multiple patients...Read more
Study met its primary endpoints of safety, tolerability, and pharmacokinetics (PK) No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs observed across SAD/MAD cohorts Management releases a “What This Means” segment discussing the topline Phase 1a data; Access here Carlsbad, CA, May 27, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”,...Read more
First results to be presented in two ASCO oral presentations Data in both combinations demonstrate high response rates TARRYTOWN, N.Y., May 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with...Read more
Phase 1b data shows treatment with SAT-3247 was safe and well-tolerated Pharmacokinetic (PK) profile of SAT-3247 translated as expected to Duchenne Muscular Dystrophy (DMD) patients taking concurrent steroids Potential trend to improved grip strength observed, with average strength across the study participants doubling from ~2kg to ~4kg Study participants will have the option to enroll into an 11-month, long-term follow-up...Read more
There are nearly 40,000 U.S. cases of cutaneous squamous cell carcinoma each year that advance to stages that are difficult to treat and life-threatening Skin Cancer Awareness Month in May shines a spotlight on the growing burden of advanced skin cancers The investigational drug is designed to be activated in the tumor microenvironment, including in cutaneous squamous cell carcinoma SCOTTSDALE, Ariz., May 20, 2025 (GLOBE NEWSWIRE)...Read more
Preconditioning with lymphodepletion linked to stronger MAR-T cells response and suggests enhanced anti-tumor activity Highest enrollment since study launch underscores momentum and signals a positive trial trajectory Clinical data readout from Phase 1 APOLLO study expected later this year HOUSTON, May 20, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on...Read more
Following the formal safety review of Cohort 1, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2. The company plans on releasing more detailed results from Phase 1 later in 2025 following completion of additional dose cohorts. SAN FRANCISCO, CALIFORNIA, May 19, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused...Read more
SOUTH SAN FRANCISCO, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that the first patient has been dosed with CX-801 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in the ongoing Phase 1 dose escalation study (NCT06462794) evaluating safety and initial clinical activity in patients with...Read more
Treatment with ELEVIDYS for Duchenne muscular dystrophy resulted in mean protein expression of 93.87% as measured by western blot in study participants (n=6) Safety profile consistent with prior studies of ELEVIDYS and real-world experience CAMBRIDGE, Mass. / May 16, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported new results from Study...Read more
RP-A601 was generally well-tolerated at a dose of 8.0E13 GC/kg with no dose-limiting toxicities in all three patients with up to 12 months follow-up RP-A601 promoted increased protein expression and desmosomal localization of Plakophilin-2 (PKP2), Desmocollin-2, and Cadherin-2 in all three patients Improvement or stabilization observed in arrhythmia burden, heart function, and quality of life in all patients No further dose escalation...Read more
Company’s PlaCCine® technology platform demonstrates better durability and other advantages compared to mRNA vaccines Results further validate PlaCCine as a novel vaccine platform with potential applications in COVID-19 and other infectious diseases with epidemic implications LAWRENCEVILLE, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated...Read more
Reported cumulative MMR rate of 44% (16 of 36) by 24 weeks with 26% (7 of 27) of patients achieving MMR by 24 weeks, which continues to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all dose levels with 74 patients enrolled and a median treatment duration of ~26 weeks at cutoff Presentation at EHA will include updated data...Read more
First patient expected to be dosed during Q2 2025 Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas Starting dose of 4mg tablet QD (once daily) First trial site in Australia. Four additional sites planned for Australia, South Korea, and U.S. Australian R&D Tax Incentive refund of up to 48.5% of...Read more
Absci becomes clinical stage company with ABS-101, first AI-designed biologic for IBD, beginning Phase 1 trial Preclinical data for ABS-101 demonstrates high potency and potential for quarterly dosing, an improvement in efficacy and convenience over first-generation anti-TL1As Interim data anticipated in the second half of 2025 VANCOUVER, Wash., May 13, 2025 (GLOBE NEWSWIRE) -- Absci Corporation (NASDAQ: ABSI) a clinical-stage...Read more
28% confirmed response rate (5/18) per RECIST v1.1 in unselected patients across doses prioritized for expansion (7.2, 8.6 and 10 mg/kg Q3W) 3 of 7 evaluable patients (43%) with confirmed responses at upper expansion dose (10 mg/kg Q3W) Median progression free survival of 5.8 months as of April 7th 2025 data cutoff Encouraging initial safety profile with no dose limiting toxicities at data cutoff Planning...Read more
Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
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