Analysis of RISE-PD presented at AAN 2025 showed CREXONT treatment significantly improved patients’ Parkinson’s Disease Sleep Scale-2 (PDSS-2) total and sub-scale scores Treatment with CREXONT also resulted in significantly more patients waking up in an “On” state compared to immediate-release CD/LD patients, as part of separate study analysis Sleep disturbances affect up to 80% of patients with Parkinson’s disease1, highlighting the...Read more
REDWOOD CITY, Calif. / Apr 07, 2025 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced the start of BELLA, a Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab evaluating efficacy and...Read more
BRIDGEWATER, NJ / ACCESS Newswire / April 7, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company focused on immunology and inflammation, today announced preclinical data from its expanded pipeline with HS1940, a dual-target multispecific biologic engineered to bind to both Programmed Death-1 (PD-1) and Vascular Endothelial Growth Factor (VEGF), and HS3215, a dual-target biologic...Read more
Patient Diagnosed with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ Treated Once with Light-Activated Ruvidar(TM) Demonstrates 7 Year Complete Response Toronto, Ontario--(Newsfile Corp. - April 7, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation,...Read more
Non-human primate pharmacokinetics data suggests IBIO-600, a potentially best-in-class long-acting anti-myostatin antibody, could have a human half-life as long as 130 days Additional interim in vivo data for a first-in-class Activin E antibody shows muscle sparing weight loss alone and in combination with a GLP-1 receptor agonist iBio remains on track to submit a regulatory submission for IBIO-600 in Q1 2026 SAN DIEGO, April 07,...Read more
Patients with acquired hypothalamic obesity on setmelanotide therapy (n=81) achieved mean BMI change of -16.5% compared with +3.3% for placebo (n=39) at 52 weeks (p<0.0001) -19.2% placebo-adjusted BMI reduction achieved in adult patients 18 years old and older (n=49) at 52 weeks -20.2% placebo-adjusted BMI reduction achieved in patients younger than 18 years old (n=71) at 52 weeks Regulatory submissions in the...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
ATTENTION-AD trial data through 192 weeks presented at AD/PDTM 2025 Conference Prespecified delayed-start analysis indicate disease-modifying effect of oral blarcamesine and importance of early and continued long-term treatment of chronic Alzheimer’s disease Blarcamesine exhibited a favorable safety profile with no treatment-related deaths NEW YORK, April 05, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the...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
TREMFYA® demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA® as a first-line treatment option for patients with active psoriatic arthritis SPRING HOUSE, Pa., April 4, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today...Read more
Late-breaking oral presentation of results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation Presentation featuring network meta-analysis of SYMBRAVO® versus oral CGRPs NEW YORK, April 04, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced multiple...Read more
On track to announce primary endpoint result from ORIGIN 3 trial this quarter (2Q 2025) U.S. FDA BLA submission for accelerated approval planned for 2H 2025 BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it...Read more
Temporomandibular joint (TMJ) osteoarthritis is a degenerative, debilitating and progressive disease, the second most common musculoskeletal condition affecting five to 12% of the population globally TMJ causes pain and stiffness in the jaw, making it difficult to chew TMJ osteoarthritis currently has no long-term effective treatments Ness-Ziona, Israel, April 03, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV,...Read more
CAMBRIDGE, Mass., April 03, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced the first patient has been dosed in MAGNITUDE-2, a global, pivotal Phase 3 trial of nexiguran ziclumeran (nex-z) for the treatment of hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN). “We are pleased to have...Read more
NEW YORK and MELBOURNE, Australia, April 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing new oral combination medicines, today announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose...Read more
MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals...Read more
Company plans to submit for regulatory approval later this year SAN RAFAEL, Calif., April 2, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the Phase 3 PEGASUS trial evaluating PALYNZIQ® (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically significant lowering in blood Phe levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone....Read more
HOUSTON, TX, April 02, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that it has successfully enrolled the first patients in its clinical trial at the University of California, San Diego (UCSD), in collaboration with the VA San Diego Healthcare System (San Diego VA). The company began treatment...Read more
NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced dosing has commenced at Johns Hopkins University (JHU) Autoimmunity Center of Excellence, the third clinical site in its Phase 2...Read more
Results underscore the dual-action profile of HT-ALZ—impacting both pathology and symptomology. NEW YORK, April 2, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on developing innovative treatments for unmet medical needs, today announced groundbreaking preclinical data supporting the therapeutic potential of its lead Alzheimer's candidate, HT-ALZ, in improving cognitive...Read more
Continued Clear Visual Evidence of Almost Completely Healed Skin After 6 weeks Treatment High Durability of Treatment Effect of QRX003 with Continuous Daily Dosing Patient Continues Not to Require Previously Necessary Medications With Patient’s Pruritus Almost Completely Eliminated, Patient Continues to Experience Zero Nightly Sleep Disturbance No Adverse Events Reported from 6 Weeks of Whole Body Treatment with QRX003 Approval...Read more
Phase 2 trial of EDG-7500 demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM Four-week treatment with EDG-7500 demonstrated substantial improvements in measures of feel and function, reductions in key cardiac biomarkers and positive trends in measures of diastolic function EDG-7500 was generally well-tolerated; clinical activity was observed without meaningful...Read more
Active immunotherapy with ACI-7104.056 induces high anti-a-synuclein (a-syn) antibody levels on average over 20-fold higher than placebo after 4 immunizations Repeated immunizations amplify the anti-a-syn antibody response, supporting boostability and the potential to further increase antibody titers ACI-7104.056 is well tolerated with no safety issues reported to date Lausanne, Switzerland, April 2, 2025 – AC Immune SA (NASDAQ:...Read more
STAFFORD, Texas, April 02, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the following update on FLAMINGO-01 open label immune response data. FLAMINGO-01 Immune Response Data Summary The Company has...Read more
MELBOURNE, Australia, April 02, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; NASDAQ: TLX, Telix, the Company) today announces that a first patient has been dosed in the Phase 1 ZOLAR1 trial of TLX300-CDx (89Zr-olaratumab) in patients with advanced, metastatic soft tissue sarcoma (STS) at the Melbourne Theranostic Innovation Centre (MTIC) in Melbourne, Australia. ZOLAR is a first-in-human, proof-of-concept and...Read more
POTOMAC, MARYLAND / ACCESS Newswire / April 1, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer's dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company's efforts to accelerate the trial's completion and builds on promising interim data suggesting the...Read more
The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with...Read more
Revenues from RenovoCath Expected to Grow Sequentially During 2025 with Expansion of New Customer Purchase Orders and Customer Reorders Completion of TIGeR-PaC Clinical Trial Enrollment and Review of Second Interim Analysis by Data Monitoring Committee on Target for 2025 Reports 2024 Financial Results Including $7.2 Million Cash Position as of December 31, 2024, with Additional $12.1 Million in Gross Proceeds Raised in February...Read more
Initial data readout on track for second half of 2025 HOUSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the first patient has been dosed in its Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine (also known as...Read more
MIAMI, FLORIDA / ACCESS Newswire / April 1, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing breakthrough therapeutics for neurologic and neuropsychiatric disorders, today announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain. The Phase 1 trial is being conducted at the...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
Tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel achieved a 17.1% overall response rate (ORR), including one complete response, compared to 5.3% ORR for paclitaxel alone, in patients with biliary tract cancer (BTC) treated in the second-line setting. The difference in ORR between the two treatment arms, the primary endpoint of the study, was statistically significant (p=0.031), and all responses have been...Read more
Results support continued development in MDD with concomitant EDS; Phase 3 trial planned in 2025 Approximately 50 percent of MDD patients experience EDS1, highlighting high unmet need NEW YORK, April 01, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced results of the PARADIGM Phase 3...Read more
DUBLIN, April 1, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the initiation of Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with idiopathic hypersomnia (IH). ALKS 2680 is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy type 1, narcolepsy type 2 and IH...Read more
New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation REMAIN-1 pivotal study now more than 50% enrolled; midpoint data analysis anticipated in Q3 2025 BURLINGTON, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today...Read more
More than 92% of schizophrenia patients taking TEV-'749 in the SOLARIS survey were satisfied or very satisfied with the initiation regimen, dosing schedule and trial medication1 New data from UZEDY® (risperidone) evaluated predictors of response in schizophrenia with efficacy observed across patient demographic and clinical characteristics in the Phase 3 RISE trial Teva continues its commitment to generating clinical insights that...Read more
New late-breaking clinical trial data presented at ACC and published simultaneously in JACC show benefit of investigational medicine AZD0780 on top of standard of care WILMINGTON, Del. / Mar 31, 2025 / Business Wire / Positive results from the PURSUIT Phase IIb trial for AstraZeneca’s AZD0780 demonstrated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care...Read more
TRILUMINATE™ Pivotal data presented at the American College of Cardiology's Annual Scientific Session (ACC.25) and simultaneously published in Circulation show the Abbott TriClip system reduces heart failure hospitalizations The latest results highlight significant improvements in tricuspid regurgitation and quality of life through two years ABBOTT PARK, Ill., March 31, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced...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
DOYLESTOWN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today announced that a patient with HPV+ head and neck squamous cell carcinoma (HNSCC) has been dosed in the ongoing ACESOT-1051 clinical trial...Read more
Increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide, despite primary composite efficacy endpoint not reaching statistical significance Statistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell...Read more
Relacorilant plus nab-paclitaxel improved progression-free and overall survival and did not increase side effect burden Results will support a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in Europe Relacorilant plus nab-paclitaxel has the potential to become a new standard of care for patients with platinum-resistant ovarian cancer REDWOOD CITY, Calif. / Mar 31, 2025 / Business Wire...Read more
ROCKVILLE, Md., March 31, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that a second Independent Data Monitoring Committee (IDMC) review of data from the VIRAGE Phase 2b clinical trial in newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) found that...Read more
Primary endpoint met in the 8-week treatment study (highly statistically significant). Co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001). Primary analysis for the co-administered group in the 8-week treatment study showed: 40% of patients achieved 5% reduction in weight (p<0.05). 27% achieved 6% reduction in weight (p<0.05). 19% achieved 7% reduction in...Read more
At All Doses Evaluated, VAX-24 Was Well-Tolerated and Demonstrated a Safety and Tolerability Profile Similar to Prevnar 20® (PCV20) At All Doses Evaluated, VAX-24 Elicited Substantial Immune Responses Following Primary Three-Dose Immunization Series; Topline Results Also Include Interim Booster Dose IgG Data Showing Robust Memory Responses Across All Doses Dose-Dependent Immune Responses Consistently Demonstrated and...Read more
Company expects safety data readout in 2025 as Randomized Arm continues enrollment at key medical centers LOS ANGELES / Mar 31, 2025 / Business Wire / Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company (the “Company’”), announces the completion of the safety lead-in of its Phase 2 clinical trial of ENV105 for the treatment of metastatic, castration-resistant prostate cancer. The trial, titled, “Phase...Read more
BX211 was safe and well-tolerated BX211 produced sustained and statistically significant1 Percent Area Reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10 Compared to placebo, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at...Read more
Trial achieved key objectives for safety, tolerability, pharmacokinetics and pharmacodynamics Clinical data from this trial, together with preclinical data, support the therapeutic potential of KER-065 for broad impact in Duchenne muscular dystrophy (“DMD”) and other neuromuscular indications Keros plans on advancing KER-065 into a Phase 2 clinical trial in DMD, subject to positive regulatory interaction Keros to host a conference...Read more
In Phase 2 ALPACA results, lepodisiran significantly reduced levels of genetically inherited cardiovascular risk factor, with some patients sustaining reductions for nearly 1.5 years These data were presented at the American College of Cardiology 2025 Scientific Sessions and simultaneously published in the New England Journal of Medicine (NEJM) INDIANAPOLIS, March 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
Rybelsus® reduced major adverse cardiovascular events by 14% vs placebo in adults with type 2 diabetes and cardiovascular and/or chronic kidney disease in the SOUL cardiovascular outcomes trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in New England Journal of Medicine2. Rybelsus®, the only approved oral GLP-1...Read more
Lorundrostat 50 mg dose achieved a 15.4 mmHg absolute reduction and 7.9 mmHg placebo-adjusted reduction (p=0.001), assessed by 24hr ABPM at week 12, with favorable safety and tolerability profile Lorundrostat is a highly selective aldosterone synthase inhibitor that disrupts aldosterone biosynthesis rather than blocking the mineralocorticoid receptor Data from Advance-HTN support the potential of lorundrostat as a best-in-class...Read more
New Data Follow Recent U.S. FDA Approval of AMVUTTRA® (vutrisiran) as First RNAi Therapeutic to Reduce Cardiovascular Death, Cardiovascular Hospitalizations and Urgent Heart Failure Visits in Patients with ATTR-CM Vutrisiran Favorably Impacted Echocardiographic Systolic and Diastolic Function Vutrisiran Treatment Led to Maintenance or Improvement in Functional Capacity, Health Status, and Quality of Life, Compared to Placebo Benefits...Read more
Ozempic® improved maximum walking distance by 13% vs placebo in adults with type 2 diabetes and peripheral artery disease (PAD) in the phase 3 STRIDE trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in The Lancet2. Approximately 230 million people globally have PAD, a severe form of atherosclerotic cardiovascular...Read more
VX-264 Phase 1/2 enrollment and dosing complete in Parts A and B: VX-264 was generally safe and well tolerated; efficacy data are not supportive of further clinical advancement Zimislecel (VX-880) pivotal trial on track to complete enrollment and dosing in H1 2025; Vertex expects to submit marketing applications to global regulators in 2026 Continue to progress multiple novel, research-stage immunoprotective approaches BOSTON / Mar...Read more
PONTE VEDRA, Fla., March 28, 2025 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today announced the presentation of updated interim data for the ALIGN3D™ and Mini3D™ Lapiplasty®...Read more
CB1 inverse agonism is a clinically validated mechanism to induce weight loss CRB-913 is markedly more peripherally restricted compared to monlunabant and rimonabant SAD/MAD Phase 1 trial scheduled for completion Q3 2025 and Phase 1b dose-range finding scheduled for completion H2 2026 NORWOOD, Mass., March 28, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and...Read more
Clinical Remission: Achieved in 33% of PL8177-treated patients versus 0% on placebo after eight weeks of treatment. Clinical Response (statistically significant): Demonstrated in 78% of PL8177-treated patients versus 33% on placebo after eight weeks of treatment (p<0.005). Symptomatic Remission: Achieved in 56% of PL8177-treated patients versus 33% on placebo after eight weeks of treatment. Safety and Tolerability: Excellent, with...Read more
First patient in Cohort four has been treated with TTX-MC138 Ten patients have been treated with TTX-MC138 at escalating dose levels Additional patients being evaluated for eligibility for expanded enrollment No significant safety or dose limiting toxicities have been reported BOSTON, March 27, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer...Read more
DOVER, Del., March 27, 2025 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of innovative therapeutics, presented new preclinical data for PORT-7 (TT-4), a selective Adenosine A2B receptor inhibitor, generated by Dr. Luciano Mutti, Gruppo Italiano Mesotelioma e Oncologia Ambientale, at the 2025 European Lung Cancer Congress (ELCC), held in Paris, France March 26-29. The...Read more
Preclinical data demonstrates that SPY003 is highly potent and has potential for quarterly or biannual dosing, suggesting opportunity for improved efficacy and convenience over first-generation anti-IL-23 monoclonal antibodies Interim pharmacokinetic and safety data from healthy volunteers for SPY003 anticipated in the second half of 2025 Subject to interim results, Spyre expects to incorporate SPY003 into its...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
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy A time and motion descriptive analysis shows nearly 50% reductions in patient chair and treatment room time, and in total active healthcare professional time related to treatment...Read more
2,000+ Average-Risk Patient Study Seeks to Confirm Mainz Biomed’s Industry-Leading Results in the Detection of Advanced Precancerous Lesions (APL) in Independent Samples Study is on Track to Report Top-Line Results in Fourth Quarter 2025 BERKELEY, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of...Read more
Reinforces potential of nebokitug to become the first approved drug with disease-modifying activity for PSC--a deadly disorder that currently has no effective treatments Treatment in PSC patients with moderate/advanced disease for 48 weeks resulted in continued improvements across key biomarkers of liver injury, inflammation and fibrosis, including ELF score, fibrosis-related ELF score components and PRO-C3 Patients treated with...Read more
XYNGARI™ achieved its primary endpoints, demonstrating highly statistically significant and clinically meaningful improvement in acne XYNGARI™ is the first once-weekly topical product candidate to demonstrate clinical benefit in a Phase 3 clinical trial for moderate-to-severe acne Over 30 million acne patients seek treatment in the U.S. each year SAN DIEGO, March 26, 2025 /PRNewswire/ -- Dermata...Read more
ATH434 is a Disease Modifying Drug Candidate Targeting Parkinsonian Disorders Topline Data Expected Mid-Year 2025 MELBOURNE, Australia and SAN FRANCISCO, March 27, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that the last patient in...Read more
Treatment with itolizumab did not improve complete or overall response rates at Day 29 Itolizumab achieved statistical significance in multiple secondary endpoints demonstrating compelling clinical benefit in longer-term outcomes, including complete response at Day 99, duration of complete response and failure-free survival Breakthrough Therapy designation and meeting requests to discuss potential for Accelerated Approval submitted to...Read more
Positive Topline Data from the Fourth Cohort of Patients Consistent demonstration of polycystin (PC) biomarker impact confirming 300 mg fixed dose selection to achieve optimal kidney exposure Patients receiving 300 mg farabursen demonstrated a mean halting of height-adjusted total kidney volume (htTKV) growth over 4 months Exploratory analysis of patients from high-dose cohorts demonstrates statistical significance...Read more
Experimental treatment with CAN-2409 was associated with a median overall survival (mOS) of 24.5 months in patients with advanced NSCLC who had an inadequate response to ICI treatment, failed several chemotherapy regimens, and presented with multiple negative prognostic factors at enrollment (90% of the patients had stage IV disease, most patients had low or undetectable PDL-1 expression, > 90% were current or former smokers, and...Read more
RT-114 yielded a relative bioavailability of 111% compared to PG-102 delivered subcutaneously with comparable PK profiles, meeting the primary endpoint of demonstrating bioequivalence Both groups demonstrated comparable weight loss with less variability observed with RT-114 compared to subcutaneous PG-102 Phase 1 clinical trial of subcutaneous PG-102 demonstrated weight loss in obese patients, with an average reduction of...Read more
SON-1010 is being studied as a combination therapy with trabectedin (Yondelis®), the first FDA-approved treatment for two types of advanced soft tissue sarcoma after failure of standard chemotherapy, due to the potential for immune mechanism synergies and enhancement of progression-free survival (PFS) The Safety Review Committee found no unexpected toxicities in early dosing of SON-1010 in the first 7 patients at the maximum tolerated...Read more
IGC-AD1 Could Offer Safer Alternative to Existing Sleep Medications for Alzheimer's POTOMAC, MD / ACCESS Newswire / March 26, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced additional positive interim results from its ongoing Phase 2 clinical trial on IGC-AD1, an investigational treatment for agitation in dementia due to Alzheimer's disease. Based on the interim analysis at week 2...Read more
48 hour at-home dosing Patient dosing expected in Q2/2025 SALT LAKE CITY, March 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD)....Read more
SAN DIEGO and LOS ANGELES, March 26, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, and City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, are pleased to jointly announce progress from a phase 1 clinical trial utilizing Calidi’s...Read more
NEWTON, Mass., March 26, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced the completion of enrollment in its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer’s disease. Acumen completed...Read more
NanoPortal™ technology successfully delivers semaglutide, the active ingredient in Ozempic®/Wegovy®, in a preclinical study with NPM-139 (semaglutide implant) NPM-139 treatment resulted in nearly 20% placebo-adjusted weight loss from a single administration with expected once or twice-yearly dosing NPM-139 is a miniature, subdermal implant in development for chronic weight management designed to guarantee medication adherence and...Read more
Statistically significant and clinically meaningful improvement of 3.8 seconds in Time-to-Rise vs. natural history with largest effect observed relative to any approved dystrophin restoration therapy at 48 weeks; additional functional benefits observed in other outcome measures including NSAA First-ever demonstration of substantial improvements in muscle health with exon skipping – statistically significant reduction in fibrosis driven...Read more
13-Week Study Evaluating the Safety and Efficacy of Oral VK2735 Dosed Once Daily Results Expected in 2H25 SAN DIEGO, March 26, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of subject enrollment in its Phase 2 clinical trial of the oral tablet...Read more
Updated data confirms statistically significant 32% higher ORR and 3.5 month longer PFS in second-line CRC patients with high DKK1 levels treated with sirexatamab plus bevacizumab and chemotherapy Statistically significant 22% higher ORR and 2.6 month longer PFS in patients who had not had prior anti-VEGF therapy Leap to host a conference call to present clinical data today, March 26, 2025, at 8:00 a.m. ET CAMBRIDGE,...Read more
Highlights: Screening closed for all sites and final participants being scheduled for dosing On track for top-line 6-week primary endpoint results in late Q2 LONDON & NEW YORK / Mar 26, 2025 / Business Wire / Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced the completion of recruitment in the COMP005 phase 3 trial for treatment...Read more
Median overall survival not yet reached with projected improvement of more than one year versus osimertinib RARITAN, N.J., March 26, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™...Read more
AGOURA HILLS, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), ”), a leader in RNA-based therapeutics, announced today the successful completion of a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101,an antisense therapeutic targeting...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
Simufilam did not show a significant reduction in co-primary endpoints of cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease Simufilam continued to demonstrate an overall favorable safety profile Cassava’s Alzheimer’s disease development program with simufilam will be completely discontinued by the end of Q2 2025 AUSTIN, Texas, March 25, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences,...Read more
Berubicin showed clinically relevant outcomes comparable to Lomustine across multiple endpoints, but not a statistically significant difference in overall survival, the primary endpoint. The safety profile continues to be favorable, including the absence of anthracycline related cardiotoxicity. Analysis of outcomes are ongoing, including advanced imaging review, PK, and clinical endpoints. The company also continues development of a...Read more
NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced dosing of new patients at Yale MS Center which is participating in our multicenter Phase 2 clinical trial evaluating intranasal...Read more
ATLANTA, March 25, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment...Read more
First patient safely dosed at Calvary Mater Newcastle Hospital in Australia, marking a significant milestone for Immutep Global Phase III with efti will enrol approximately 756 patients at more than 150 clinical sites Trial results will inform potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology SYDNEY, AUSTRALIA, March 25, 2025 (GLOBE NEWSWIRE) -- Immutep...Read more
Company-hosted conference call and webcast to be held today at 8:00 a.m. ET Zetomipzomib treatment results in steroid-sparing biochemical remissions in accordance with AASLD treatment guidelines in a difficult-to-treat, refractory AIH patient population. In relapsed, steroid-dependent AIH patients, of the 21 of 24 entering screening on steroid-based therapy, 36% (5 of 14) of zetomipzomib-treated patients achieved a complete biochemical...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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