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
Multiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation associated with exacerbations in asthma, with a robust maximal FeNO decrease from baseline of 53% APG808 demonstrated the potential for durable disease control in asthma with sustained FeNO decrease from baseline of 50% at 12 weeks APG808's optimized formulation and potential best-in-class pharmacokinetic (PK) profile, combined with...Read more
Data continue to demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2 Data to be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting Company to discuss data today on its first quarter 2025 business update conference call and webcast at 4:30 pm ET / 1:30 pm PT SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE...Read more
15 patients treated across four escalating dose levels of TTX-MC138 No significant safety or dose limiting toxicities reported 10 patients remain on study with no evidence of disease progression PD analysis at 24 hours post-dosing provides evidence of miR-10b target engagement BOSTON, May 8, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer...Read more
Complete Pathologic Response reported in 2 patients in the Third Cohort with cutaneous squamous cell carcinoma, complementing results in prior cohort Phio to present trial results to date at a podium presentation at Society for Investigative Dermatology (SID) Annual Meeting on May 10th Marlborough, Massachusetts--(Newsfile Corp. - May 7, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA...Read more
PAS-004 shows up to 91% inhibition of pERK, confirming substantial target engagement One patient in cohort 4A with stage 4 KRAS G12R mutated pancreatic cancer achieves over 5 months of stable disease with tumor volume reduction of -9.8% MIAMI, May 06, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a...Read more
Phase 1b expansion study initiated in taxane-naïve mCRPC patients Updated data from Phase 1a dose escalation support initiation of Phase 1b dose expansion Updates on JANX007 and JANX008 expected in the second half of 2025 Janux to host R&D Day in mid-2025 highlighting preclinical pipeline progression to the clinic SAN DIEGO / May 05, 2025 / Business Wire / Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage...Read more
A total of 13 patients treated with four escalating doses of TTX-MC138 No significant safety or dose limiting toxicities reported Two patients have so far maintained stable disease on treatment for at least seven months PD analysis at 24 hours post-dosing provides evidence of miR-10b target engagement BOSTON, May 1, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more...Read more
CARLSBAD, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today announced favorable data from a Phase 1 single- and multiple-ascending dose (SAD/MAD) trial of DT-168 in healthy volunteers, which will be presented on May 2, 2025 at Eyecelerator @ Park City 2025, an event backed by the American Academy...Read more
Initial trial phase (“PoC 1”) achieved key learnings and met all study objectives Clinically meaningful pain reduction with 100% of responders achieving zero opioid use at 7 days post-procedure and 73% of responders remaining opioid free at 4-6 week follow-up Company has initiated market expansion study (“PoC 2”) of additional visceral cancers, and earlier stage pancreatic cancer, to begin in Q2 2025 Additional indications...Read more
Topline data expected in mid-2025 SOUTH SAN FRANCISCO, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it completed enrollment of its Phase 1 clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. “Completing enrollment in this trial bring us one step closer in our development of a norovirus vaccine,...Read more
XENITH-UC, a Phase 2b study of XmAb942 in participants with ulcerative colitis, to begin in the second half of 2025 Single and multiple doses of XmAb942 are well tolerated and safety profile is consistent with the anti-TL1A drug class XmAb942 half-life supports a 12-week maintenance dosing interval in XENITH-UC Lead selection for XmAb TL1A x IL23p19 program on track for first-in-human study start in...Read more
MIAMI, April 29, 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 cancer indications, today announced the Company has completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg...Read more
LOS ANGELES / Apr 28, 2025 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that clinical data on neratinib were presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2025. The AACR Annual Meeting is currently taking place at the McCormick Place in Chicago, Illinois. The poster is entitled, “CT071: Phase I trial of trastuzumab deruxtecan in...Read more
CHS-114 demonstrates clinical efficacy and proof of mechanism in HNSCC in combination with toripalimab Confirmed partial response in heavily pretreated PD-1 refractory patient supports expansion in HNSCC and gastric cancer in combination with toripalimab A second-line Phase 1 dose optimization study in HNSCC and gastric cancer is ongoing; results expected in the first half of 2026 Coherus to host investor and analyst call with study...Read more
PCRX-201 demonstrated two years of clinically meaningful improvements in pain, stiffness and function across all structural severity subgroups, including advanced disease Study Findings Presented at 2025 OARSI World Congress BRISBANE, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives...Read more
Phase 1 dose-escalation study to evaluate ziftomenib in combination with imatinib in patients with advanced GIST after imatinib failure Combination of ziftomenib and imatinib shows robust and durable antitumor activity in imatinib-sensitive and imatinib-resistant GIST preclinical models SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed...Read more
Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 Dose Finding completed with no dose limiting toxicities and preliminary recommended Phase 2 dose (RP2D) identified 5 of 7 best overall response evaluable patients achieved ORR (3 CR, 1 CRh and 1 morphologic leukemia-free state) across all dose cohorts, including 1 CR and 1 CRh in 3 patients in preliminary RP2D cohort 4 of 4 cCR patients were...Read more
UGN-301 was tolerated across all dose levels, with no dose-limiting toxicities or adverse events leading to treatment discontinuation UGN-301 formulated in a reverse thermal gel allowed sustained exposure in the bladder Some patients receiving UGN-301 (zalifrelimab) intravesical solution showed clinical activity at the week 12 disease assessment Data presented at the 2025 American Urological Association Annual Meeting in Las Vegas,...Read more
NEW YORK, April 25, 2025 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that the first patient has been administered both the first protein dose and the 177Lu-DOTA imaging dose in its Phase 1...Read more
Data from the BroADen Phase 1b atopic dermatitis (AD) patient trial expected to be reported in 4Q25 Completed SAD/MAD dosing in KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025 Two parallel Phase 2b trials in AD and asthma planned to start in 4Q25 and 1Q26, respectively WATERTOWN, Mass., April 22, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical...Read more
BOSTON, April 21, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, announced the first patient has been dosed in an Investigator Sponsored Trial (IST) to evaluate tovecimig (CTX-009, a DLL4 x VEGF-A bispecific antibody) for the first time in the front-line setting for patients with biliary tract cancer (BTC)....Read more
Additional Evidence of PF614-MPAR Overdose Protection after Completion of Part 1 of Clinical Study SAN DIEGO, CA / ACCESS Newswire / April 15, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced completion of Part 1 of its second...Read more
Single infusion of VERVE-102 led to dose-dependent decreases in blood PCSK9 and LDL-C, with mean reduction in LDL-C of 53% and a maximum reduction of 69% observed in the 0.6 mg/kg dose cohort VERVE-102 was well-tolerated with no treatment-related serious adverse events and no clinically significant changes in ALT or platelets observed at any dose level among 14 participants VERVE-102 utilizes a proprietary GalNAc-LNP which has...Read more
AM-001 Study represents a pivotal milestone in Galmed's transition to Aramchol Meglumine, an improved formulation of its lead compound in advanced clinical development Aramchol Meglumine, a New Chemical Entity (NCE) protected by patents until 2035, is being developed both as a standalone agent and in novel drug combinations for multiple indications influenced by fatty acid metabolism Initial findings suggest that the new Aramchol...Read more
SRC recommended that the trial escalate to the next dose level of 30mg capsule No dose-limiting toxicities (DLT’s) or rash observed to date MIAMI, April 10, 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 cancer...Read more
Sustained positive preliminary data from all completed single ascending dose (SAD) cohorts, multiple ascending dose (MAD) cohorts, and food effects crossover, further supporting the safety and tolerability of PALI-2108 No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs observed to date Screening for Phase 1b UC cohort ongoing; On track to report topline data in the first...Read more
Phio's lead clinical siRNA compound PH-762 demonstrates supportive safety profile in third cohort, permitting escalation in next dose concentration Marlborough, Massachusetts--(Newsfile Corp. - April 9, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® siRNA gene silencing technology to eliminate cancer. Phio announced today...Read more
CT-95 is a mesothelin x CD3 T cell engaging bispecific antibody CT-95 is Context’s second T cell engaging bispecific antibody to enter the clinic in 2025 PHILADELPHIA, April 09, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in the Phase 1 clinical trial of CT-95,...Read more
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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