LOS ANGELES / Nov 20, 2024 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA™-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in combination with endocrine therapy for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast...Read more
SAN DIEGO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces that its oral presentation of its lead clinical stage drug FXR314 by Dr. Eric Lawitz of the Texas Liver Institute and the University of Texas Health San Antonio was featured at The Liver...Read more
DiffuSphere™ is designed to enable precise drug delivery at therapeutic dose levels directly into target tissues, enhancing efficacy while minimizing systemic drug levels to optimize safety In clinical trials, a single administration of DiffuSphere™ successfully delivered fluticasone propionate for at least six months in patients with eosinophilic esophagitis or osteoarthritis DiffuSphere™ has shown its versatility with various...Read more
The Phase 2 DIMENSION Study did not meet its primary endpoint Dalzanemdor was generally well-tolerated; no new safety signals were observed Based on these data, the Company does not plan further development of dalzanemdor CAMBRIDGE, Mass. / Nov 20, 2024 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive...Read more
Oral Late Breaker Presentation Summarizes Positive Results Including Successful Achievement of Study's Primary and Secondary Endpoints Data Support VK2809's Best-in-Class Profile Highlighted by Robust Liver Fat Reductions, Histologic Results Demonstrating NASH/MASH Resolution and Fibrosis Improvement, and Promising Tolerability and Safety SAN DIEGO, Nov. 19, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a...Read more
GEO-CM04S1 Improved Immune Response vs mRNA Vaccine ATLANTA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19...Read more
Ten clinical trial sites across Japan and Taiwan are actively screening patients, with additional sites expected to also begin patient enrollment in the coming months U.S. clinical sites continue to actively screen and dose patients in both the LP-300 combination arm and the standard-of-care control arm of the Harmonic trial Non-small cell lung cancer (NSCLC) in never smokers occurs at rates 2 to 3 times higher in East Asian countries...Read more
Monthly tobevibart and elebsiran combination achieves rapid 100% virologic suppression at Week 24, sustained through Week 60 Undetectable HDV RNA in 41% of participants at Week 24, increasing to 64% by Week 36 and up to 80% by Week 60 across cohorts Combination well-tolerated: no treatment-related severe AEs, treatment-related discontinuations or ALT flares Following a recent FDA meeting, Phase 3 ECLIPSE registrational program to begin...Read more
Muvalaplin, an oral, once-daily treatment that inhibits lipoprotein(a) formation via a novel mechanism, achieved positive results in a 12-week Phase 2 study These data were published in the Journal of the American Medical Association (JAMA) and simultaneously presented today at the American Heart Association (AHA) Scientific Sessions 2024 INDIANAPOLIS, Nov. 18, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
Marked and rapid reductions in both pericarditis pain and inflammation maintained throughout the 26-week study Episodes of pericarditis per year substantially reduced MAvERIC-Pilot results support advancing CardiolRx™ into the Phase II/III MAVERIC-2 and the Phase III MAVERIC-3 clinical trials Toronto, Ontario--(Newsfile Corp. - November 18, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol"...Read more
Two patients exceed 14 months on treatment in Phase 2 trial of advanced ovarian cancer Allarity maintains a cash balance of $18.5 million, sufficient to advance and accelerate stenoparib’s clinical development toward FDA approval Expansion of Allarity Medical Laboratory into revenue-generating services for external biotech clients Continued focus on advancing stenoparib to address critical unmet needs in ovarian...Read more
100% of participants were responsive to treatment and 71% of participants were in remission at 12 months after just two 16 mg doses of CYB003 Robust, long-term efficacy with ~23-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score compared to baseline at 12 months after two 16 mg doses of CYB003 Findings validate dosing regimen and confirm that CYB003’s effects are highly durable and offer sustained...Read more
52-week LUNA data combined with follow-up from OPTIC at 4 years continue to support long-term potential best-in-class product profile of Ixo-vec 6E10 dose in LUNA maintains visual and anatomic endpoints and demonstrates potential best-in-class injection-free rates and reduction in injection burden No LUNA patients who received local steroid prophylaxis had inflammation at week 52 or at any subsequent visit, and 100% of OPTIC 2E11...Read more
WILMINGTON, Del. / Nov 18, 2024 / Business Wire / Incyte (Nasdaq:INCY) today announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was made following the observation of certain in vivo preclinical toxicology findings. These data have been shared with the U.S. Food and Drug Administration (FDA) and Incyte will work closely with the FDA to determine...Read more
Eight participants achieved HBsAg loss at any time. Two participants met criteria for functional cure. Two participants who discontinued NUC therapy seroconverted to HBsAb positivity. OXFORD, United Kingdom, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), today announced the most significant data so far from the ongoing Phase 2b HBV003 clinical trial. The data will be presented by Dr. Chun-Jen Liu...Read more
Significantly greater mean declines in HBsAg levels (p <0.017) were seen in those receiving imdusiran, VTP-300 and low-dose nivolumab compared to other cohorts assessed previously 23% of participants receiving imdusiran, VTP-300 and low-dose nivolumab reached HBsAg loss by Week 48 WARMINSTER, Pa. and OXFORD, United Kingdom, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), (“Arbutus” or the...Read more
Adults with moderately-to-severely active Sjögren's disease who received investigational FcRn blocker nipocalimab had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease based on results from the Phase 2 DAHLIAS...Read more
Study DUS-AUBD-01 opens patient enrollment PRINCETON, N.J., Nov. 14, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has opened patient enrollment for its Phase 2 study (protocol number DUS-AUBD-01) evaluating SGX945...Read more
SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, today announced that it has achieved more than 50% of targeted patient enrollment for its CBeyond™ Phase 2 clinical trial assessing nimacimab, a differentiated CB1 inhibitor, in patients with overweight or obesity. Skye expects to...Read more
Active immunotherapy with ACI-7104.056 induces high anti-a-synuclein antibody levels on average 16-fold higher than placebo after 3 immunizations 100% of patients receiving ACI-7104.056 responded against the target antigen ACI-7104.056 is well tolerated with no clinically relevant safety issues reported to date Lausanne, Switzerland, November 14, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company...Read more
MINNEAPOLIS / Nov 13, 2024 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for severe ischemic diseases, today announced that the first patient has been dosed in DiaMedica’s investigator-sponsored Phase 2 trial of DM199 for the treatment of preeclampsia (PE). DiaMedica anticipates top line data for Part 1A in the first half of 2025 which is...Read more
Phase 2b ACCESS study designed to evaluate multiple doses up to 120 mg of GSBR-1290 over 36 weeks Comprehensive development program also includes Phase 2 ACCESS II study to evaluate even higher doses of GSBR-1290 over 36 weeks; first patient expected to be dosed by end of 2024 Topline data from both ACCESS and ACCESS II studies expected in the fourth quarter of 2025 Company to host conference call today at 4:30 p.m....Read more
42% of people with advanced or metastatic synovial sarcoma or MRCLS had clinical responses with lete-cel Results include six complete responses (6/64); twenty-one partial responses (21/64) Data to be presented at Connective Tissue Oncology Society 2024 Annual Meeting Company plans to initiate a rolling BLA submission for lete-cel for the treatment of advanced or metastatic synovial sarcoma and MRCLS by end of 2025 Company to host...Read more
Boca Raton, Florida, Nov. 13, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc.(NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease announced today that it completed randomization of patients for its Phase 2 trial on Monday, November 11th. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is...Read more
Blinded preliminary data demonstrate a positive trend and clear signal in Primary and Secondary endpoints Patient reported efficacy outcomes show a material decrease in pain and increase in function If positive trends continue, Company confident that the Phase 2 trial will meet its Primary and Secondary end points The blinded preliminary BRTX-100 data to be described in a podium presentation this morning at the ORS...Read more
Mavorixafor durably and meaningfully elevated participants’ mean absolute neutrophil counts (ANC) Mavorixafor enabled substantial reductions in G-CSF dosing while maintaining mean ANC at normal levels Phase 2 study results and new analysis confirming functionality of neutrophils in sub-study participants bolster confidence in achieving success in Phase 3 4WARD trial Company conference call and webcast today at 8:00 am...Read more
Nes-Ziona, Israel, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of the Company’s multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis. The initiation of patient dosing follows the...Read more
Primary endpoint met with CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R mNPM1 AML patients (p-value = 0.0014) 47% (30/64) ORR in a heavily pre-treated population, including 75% with prior venetoclax exposure in the efficacy population Favorable safety and tolerability profile; only 5% of patients discontinued due to treatment-related adverse events Results highlight consistency of revumenib's compelling clinical...Read more
EMPOWER-1 and EMPOWER-2 Phase 2 clinical trials did not meet their primary endpoint Emraclidine was well-tolerated with an adverse event profile consistent with Phase 1b trial NORTH CHICAGO, Ill., Nov. 11, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute...Read more
FLORHAM PARK, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, today announced that phase 2 IIT (Investigator-initiated) data on the first 30 patients dosed with plinabulin in the 303 Study of patients with non-small cell lung cancer (NSCLC) after disease progression on PD-1/PD-L1 inhibitors...Read more
TORONTO, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing have begun in Canada for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The clinical team at the University of Calgary Cumming School of Medicine has started screening...Read more
Orphan Drug Designation has been granted lately by US FDA RAMAT GAN, Israel, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announces the dosing of the first patient in the Phase IIa clinical trial in patients with advanced pancreatic...Read more
NKTR-255 administered post completion of concurrent chemoradiation and in combination with durvalumab demonstrated statistically significant lymphocyte recovery compared to historical controls at week 8 Pharmacodynamic data show NKTR-255 increased NK cell proliferation and markers of NK cell activation SAN FRANCISCO, Nov. 7, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) and collaborators at The University of...Read more
IMNN-001 immunotherapy plus standard-of-care chemotherapy resulted in 35% improvement in overall survival and 25% improvement in progression-free survival versus standard-of-care alone Treatment was generally well tolerated, with no reports of cytokine release syndrome or any other serious immune related adverse events Company plans to initiate Phase 3 pivotal trial of IMNN-001 in Q1 2025 LAWRENCEVILLE, N.J., Nov. 07, 2024 (GLOBE...Read more
Metastatic non-small cell lung cancer (NSCLC) patients treated in the first line setting with IO102-IO103 in combination with Keytruda® demonstrated promising activity with an overall response rate of 55% unconfirmed/48% confirmed, disease control rate of 81%, and approximately 50% of patients without disease progression at 12 months; median duration of response not reached Safety profile consistent with prior studies with the...Read more
Topline Data Readout From Part 1 and Part 2 Expected in December 2024 CAMBRIDGE, Mass., Nov. 4, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the completion of the last patient last visit in its two-part, Phase 2a clinical trial evaluating the efficacy and safety of DA-1241, a novel G-Protein-Coupled...Read more
Data from the AscenD-LB Phase 2a trial in DLB confirm recent scientific literature indicating that plasma glial fibrillary acid protein (GFAP) is a robust measure of neurodegenerative disease activity in DLB Neflamapimod treatment previously led to significant reduction in plasma GFAP levels (p=0.015 versus placebo) and these reductions were associated with an improvement in clinical outcomes The RewinD-LB Phase 2b clinical study...Read more
Up to 6.8% Placebo-Adjusted Mean Weight Loss (8.2% from Baseline) After 28 Days of Dosing with Oral Tablet of VK2735 Encouraging Tolerability Through 100 mg Daily Dosing with Oral VK2735; Mild GI-Related Adverse Event Profile Updated Results from VENTURE Phase 2 Study of Subcutaneous VK2735 Show Durable Effects and Support Potential Monthly Dosing Regimen SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Viking...Read more
(Z)-Endoxifen Shown to Significantly Reduce Mammographic Breast Density, Potentially Paving the Way for Innovative Cancer Prevention Strategies SEATTLE, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today released positive topline data from the KARISMA-Endoxifen Phase 2 study of...Read more
Participants in the Phase 2a study experienced rapid and meaningful decreases in depressive symptoms Suicidal ideation decreased by 80% SPN-820 was well-tolerated with few adverse events SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression ROCKVILLE, Md., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing...Read more
Testing the efficacy and safety of Intensity's lead drug candidate, INT230-6, when combined with Standard-of-Care versus Standard-of-Care alone The endpoint is the change in pathological complete response rates SHELTON, Conn. and BERN, Switzerland, Oct. 31, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and...Read more
Late-breaking presentation highlights the pTau217 assay as an effective and efficient tool to screen participants for ALTITUDE-AD that reduces unnecessary amyloid PET scans and lumbar puncture procedures for those who are not eligible NEWTON, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta...Read more
(Z)-endoxifen at 10 mg once daily met the primary endpoint with 19/20 (95%) receiving > 75 % of planned treatment in I-SPY-2 Phase 2 Trial Low dose (Z)-endoxifen was well tolerated and demonstrated promising rapid activity in reducing 3-wk Ki-67 and FTV Biomarkers SEATTLE, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), today released a preliminary analysis from a phase 2...Read more
Topline results expected in 1Q calendar year 2025 Study is assessing the co-administration of bremelanotide and tirzepatide on reducing body weight Data will inform and support the Company's obesity programs using novel, long-acting and highly selective MC4R peptide and small molecule compounds for treating general obesity, weight loss management, and rare/orphan MC4R pathway diseases, including hypothalamic obesity CRANBURY, N.J.,...Read more
After successful SEISMiC A and B studies in Early Cardiogenic Shock, SEISMiC C will treat more severe SCAI Stage C cardiogenic shock to complete the assessment of the intended Phase 3 patient population Windtree plans to engage with regulatory authorities in 2025 for Transition to Phase 3 clinical trial WARRINGTON, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a...Read more
Study done in collaboration with Memorial Sloan Kettering and led by Dr. Winston Wong, Head and Neck Oncologist and Dr. Alan Ho, Chief of the Head and Neck Oncology Service IIT will evaluate eseba-vec in patients who are HPV16+ after treatment for curative intent Potential to expand the eseba-vec HNSCC opportunity into adjuvant care Initial safety and efficacy data from IIT expected in 2026 NEW YORK and VIENNA, Oct. 30, 2024...Read more
Phase 2a proof-of-concept study of SPR720 for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) did not meet its primary endpoint, based on planned interim analysis of 16 patients Phase 3 PIVOT-PO trial of tebipenem HBr remains on track for enrollment completion in 2H 2025 Cash runway extended into mid-2026 following a reduction in workforce and restructuring of operations; Unaudited Q3 2024 ending cash balance...Read more
GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been...Read more
Study met Primary and Secondary Endpoints for Safety and Regulatory T cell (Treg) Cell Population Enhancement, respectively, with no off-target effects on T effector lymphocytes, providing further evidence of target engagement Exploratory Endpoints demonstrated cognitive stabilization on treatment vs. cognitive declines on placebo for LD IL-2 dosing every 4 weeks (LD IL-2 q4wks), which was associated with significant improvement in...Read more
GAITHERSBURG, Md., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today it has finalized agreements with all six of the planned site enrollment locations to administer the Phase 2 clinical trial of Ropidoxuridine for...Read more
DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a gain of +8.9 letters compared to baseline DURAVYU 2.7mg demonstrated an early and sustained anatomical improvement mirroring BCVA results with a 68 micron reduction in CST Favorable safety profile continues with no DURAVYU-related ocular or systemic SAEs to date Full topline data anticipated in Q1 2025 WATERTOWN, Mass., Oct. 28,...Read more
The detailed study results confirmed interim findings, showing stable kidney function and sustained treatment effect more than 18 months after the last dose of felzartamab Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development IgA Nephropathy (IgAN) is a leading cause of chronic...Read more
Long-term improvements observed in the quartet of findings defining disease modification supports atacicept’s potential to prevent kidney failure in patients with IgAN; Long-term results from the ORIGIN Phase 2b study were simultaneously published in the Journal of the American Society of Nephrology; Company will host an investor call and webcast on Monday October 28 at 8:00 AM ET BRISBANE, Calif., Oct. 26, 2024 (GLOBE NEWSWIRE) --...Read more
First to demonstrate clinical benefit in patients with chronic inducible urticaria (CIndU) in large, randomized, placebo-controlled study Favorable safety and tolerability Plan to advance CIndU into Phase 3 development Company to host webcast call Monday at 8:00 am ET HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company’s Phase 2...Read more
Groundbreaking PARADIGM Trial Offers New Hope for ALS Treatment CAMBRIDGE, Mass., Oct. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced transformative findings from its PARADIGM clinical trial of PrimeC. These results illuminate a new frontier in the treatment of ALS...Read more
ZUG, Switzerland, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced data from seven posters that will be presented at the 2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI). Pharvaris mourns our distinguished...Read more
One of two Phase 2B trials currently dosing and underway: Phase 2B trialing MB22001 in patients with Major Depressive Disorder, and; Phase 2B trialing MB22001 in patients with Advanced Stage Cancer Vancouver, British Columbia – October 24, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development,...Read more
OK-101 is the first drug candidate to enroll patients specifically diagnosed with Neuropathic Corneal Pain (NCP) in a clinical trial The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients OK-101 is the first IND granted by FDA to treat patients with NCP LONDON and NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an...Read more
Treatment with ALTO-100 did not demonstrate improvement in depressive symptoms compared to placebo in patients with a memory-based cognitive biomarker ALTO-100 demonstrated a favorable safety and tolerability profile, consistent with previously reported studies Strong cash position expected to fund Alto’s planned operations through multiple near-term milestones across pipeline of independent programs MOUNTAIN VIEW,...Read more
VIRO-25 trial to assess efficacy & safety of olvimulogene nanivacirepvec (Olvi-Vec) & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in recurrent non-small cell lung cancer Trial represents second indication in the clinic for Olvi-Vec via systemic administration Interim readout expected mid-2025 WESTLAKE VILLAGE, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Genelux...Read more
Vancouver, British Columbia – TheNewswire - 22 OCTOBER, 2024 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (the “Company” or “MindBio”), is pleased to report that the final milestone in the Company’s Phase 2A Microdosing Depression Clinical Trial, the 6-month post treatment milestone measuring the “severity of depression” has been completed. The completion of this important milestone comes as the Company progresses more...Read more
REC-3964 is Recursion’s first new chemical entity developed using the RecursionOS. REC-3964 represents a novel, non-antibiotic approach with a unique mechanism of action that binds and blocks catalytic activity of the toxin's innate glucosyltransferase in order to inhibit the toxin produced by C. diff. in the gastrointestinal tract. There are up to 175,000 cases of recurrent C. diff. each year and more than 29,000 patients die in the...Read more
Top-line Data Now Anticipated in Q1 2025 LX9211 has previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for DPNP THE WOODLANDS, Texas, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has closed screening and expects to complete enrollment ahead of schedule in PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind,...Read more
55% of BriaCell patients1 remained alive one year since enrollment in BriaCell’s Phase 2 study, markedly exceeding the survival rate of current standard of care for similar patients Multiple outperforming patients with overall survival of over 2 years Survival benefit observed even in heavily pre-treated patients who failed treatment with checkpoint inhibitors (CPIs) and/or antibody-drug conjugates (ADCs) Final median overall...Read more
Enhanced protection of vision with ANX007 treatment in healthier eyes Greater preservation of EZ in the central fovea by ANX007 in patients with less advanced GA Pivotal Phase 3 ARCHER II Data Expected Second Half 2026 BRISBANE, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on upstream C1q to advance therapies for neuroinflammatory diseases of the body, brain and eye,...Read more
Topline results are expected in the first quarter of 2025 NEW HAVEN, Conn., Oct. 21, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed enrollment in its Phase 2a...Read more
97% reduction in treatment burden at nine months after treatment with ABBV-RGX-314 Data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profile Well tolerated with zero cases of intraocular inflammation in a setting of no prophylactic steroids Data highlight the potential of ABBV-RGX-314 to treat both eyes in wet AMD ROCKVILLE, Md., Oct. 21, 2024 /PRNewswire/ -- REGENXBIO...Read more
The data presented indicate a favorable gut bile acid profile which may contribute to ibezapostat's beneficial anti-recurrence effect in patients with C. difficile Infection (CDI) Ibezapolstat treatment of patients with CDI is associated with the restoration of beneficial bacterial classes in the gut Preparation continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection...Read more
Novel Investigational Combination Regimen is Advancing to Phase 3 and has the Potential to Become the First Weekly Oral HIV Treatment FOSTER CITY, Calif., & RAHWAY, N.J. / Oct 19, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new results from a Phase 2 clinical study evaluating the investigational combination of islatravir, an...Read more
Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms SPN-820 was well-tolerated with few adverse events SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression Company to host webcast today at 4:30 p.m. ET to discuss the topline data Topline results from Phase 2b randomized double-blind placebo-controlled study of SPN-820 in adults with treatment-resistant...Read more
Improvement observed in pancreatic function, as measured by C-peptide response, following 24 weeks of treatment with AMX0035; worsening is typically expected with disease progression based on natural history studies of Wolfram syndrome Longer-term data for all participants who have completed Week 36 and Week 48 assessments showed sustained improvement over time Improvements or stabilization observed across all secondary endpoints,...Read more
Company Expands Phase 2 trial to Canada POTOMAC, MD / ACCESSWIRE / October 17, 2024 / IGC Pharma, Inc (NYSE American:IGC) ("IGC" or the "Company"), today announced enrollment of patients at the Baycrest Academy for Research and Education in Toronto, Ontario, Canada, as part of the Company's ongoing Phase 2 trial investigating IGC-AD1 as a treatment for agitation in Alzheimer's dementia. Agitation affects between 40-80% of...Read more
Part A of the placebo-controlled Phase 2 study has been completed ANAVEX®3-71 demonstrates a dose-dependent pharmacodynamic effect on objective EEG biomarkers of schizophrenia Patients are currently being dosed in Part B of the Phase 2 study which will investigate a longer treatment duration NEW YORK, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage...Read more
Robust overall response rates observed (31% overall, 44% in KRAS mutant, 17% in KRAS wild-type) in patients whose cancer had progressed despite prior treatment with chemotherapy and/or MEK inhibitors and/or bevacizumab Patients on avutometinib and defactinib achieved a median progression free survival of more than one year (12.9 months); 22 months in KRAS mutant population The Company recently met with the FDA to review the mature data...Read more
Achieved proof-of-mechanism for Wave’s RNA editing platform; restoring levels of wild-type (edited) M-AAT that are consistent with the heterozygous “MZ” genotype with low risk of AATD lung and liver disease A single subcutaneous dose of WVE-006 in the first two patients with homozygous “ZZ” AATD resulted in mean plasma total AAT levels of ~11 micromolar, with mean wild-type M-AAT representing more than 60% of total AAT; durable editing...Read more
Data confirm the positive topline results announced in June 2023 identifying a maximum tolerated dose as assessed by an independent safety review committee Identified dose is unlikely to require lithium therapeutic drug monitoring Data will guide upcoming “Lithium in Brain” Phase II clinical trials in partnership with Massachusetts General Hospital, which were announced in August 2024 ATLANTA / Oct 16, 2024 / Business Wire / Alzamend...Read more
Neuropathic corneal pain (NCP) is listed in the National Organization for Rare Disorders (NORD) as an orphan disease OKYO is the first company to have an IND application granted by the FDA for NCP The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients OK-101 demonstrated statistically significant pain relief in a recently completed Phase 2 trial of dry eye disease LONDON...Read more
New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer MET is a common biomarker in this setting for patients who develop resistance to EGFR targeted therapies HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 16, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces positive high-level...Read more
On track to report topline data from the Phase 2b trial in December 2024 Neflamapimod has the potential to restore function and improve cognitive and motor functions in DLB patients 96% of patients enrolled in RewinD-LB completed the 16-week portion of the study, of which 98% continued into the open label extension BOSTON, Oct. 15, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing...Read more
GAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced the presentation of data from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG) during the 2024 Myasthenia Gravis Foundation of America (MGFA) Scientific Session of the American...Read more
Maintained Stable Visual Acuity and Anatomical Control Over 9 Months Positive Safety Profile with No Ocular or Treatment-Related Serious Adverse Events 67% of CLS-AX Participants Did Not Require Any Additional Treatment up to 6 Months Reduced Treatment Burden by 84% Over 6 Months Webcast and Conference Call Today at 8:00 A.M. ET with Management and Key Opinion Leader and Board-Certified Retinal...Read more
Vancouver, British Columbia – TheNewswire - October 8, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines, is delighted to report its microdosing formulation MB22001 has achieved shelf stability at room temperature for 12 months. MB22001 is a proprietary and self-titratable form of...Read more
Global study in approximately 180 adults with hidradenitis suppurativa to assess the efficacy and safety of two dose regimens of AVTX-009 compared to placebo Topline data expected in 2026 WAYNE, Pa. and ROCKVILLE, Md., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced that the first patient has been dosed in the Company’s Phase 2 LOTUS trial of AVTX-009 in hidradenitis suppurativa (HS)....Read more
In the Phase 2 LIGHTWAVE Study, dalzanemdor (SAGE-718) did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint Dalzanemdor was generally well-tolerated and no new safety signals were observed Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington’s Disease expected later this year CAMBRIDGE, Mass. / Oct 08, 2024 /...Read more
Efficacy and Safety Data Demonstrated 96% Reduction in HIV Infections with Lenacapavir Compared to Background HIV Incidence Among a Geographically Diverse Population of Cisgender Men and Gender-Diverse People Gilead to Begin Regulatory Filings for Lenacapavir for PrEP by End of 2024 Gilead Recently Announced Voluntary Licensing Partners to Expand Future Access in High-Incidence, Resource-Limited Countries FOSTER CITY, Calif. / Oct...Read more
TORONTO, ON / ACCESSWIRE / October 7, 2024 / Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, is pleased to announce that it is providing an...Read more
Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) chronic cough reaches 50% enrollment milestone; sample size re-estimation results expected in December 2024 Human Abuse Potential (HAP) study dosing complete; topline results expected in December 2024 NEW HAVEN, Conn., Oct. 3, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy...Read more
PARIS, France, October 3, 2024 – 10:00 p.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX; Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the first patient was enrolled in its Phase 2b ENHANCE-CD (NCT06456593)...Read more
Company to ring Closing Bell at NYSE on Thursday, October 3, 2024 Interviews scheduled with Fintech.TV and Schwab Network NEW YORK / Oct 03, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2...Read more
Improved precision of the AI-Immunology™ platform in predicting clinically relevant vaccine targets boosts the potential of its AI-derived vaccine candidates The improvement has been achieved through iterative learning and the integration of advanced bioinformatics and machine learning techniques In the ongoing phase 2 trial with personalized cancer vaccine EVX-01, 79% of the AI-Immunology™ predicted vaccine targets triggered a...Read more
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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