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
Statistically significant 100% reduction (p = 0.0027) in new-onset severe respiratory failure and 64.2% reduction (p = 0.0476) in new-onset persistent respiratory failure in combined high and medium dose Auxora patients versus combined low dose Auxora and placebo patients Statistically significant stratified win ratio of 1.640 (p = 0.0372) for high dose Auxora compared to placebo Clinically meaningful reduction observed for high dose...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
SYDNEY, AUSTRALIA, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial. The Phase II enrolled 65 metastatic hormone...Read more
Patients treated with a de-escalated dose of 25 mg of obefazimod once daily demonstrated maintenance of clinical remission at weeks 48 and 96 Efficacy and safety demonstrated out to six years of treatment The treatment was well-tolerated, with a safety profile consistent with previous studies and no new safety signals detected PARIS, France, October 3, 2024, 8:30 a.m. CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax”...Read more
Phase 2 trial is an adaptive designed randomized study comparing NGC-Cap to monotherapy capecitabine Results from this Phase 2 trial will evaluate NGC-Cap’s safety-efficacy profile and help to define the optimal dosage regimen in patients with metastatic breast cancer HANOVER, Md., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company...Read more
100% 36-month overall survival (OS) and progression-free survival (PFS) rates in patients fully treated with Versamune® HPV combined with chemoradiation (N=8) 88% (15/17) of patients had a complete metabolic response IMMUNOCERV Phase 2 clinical trial results presented at ASTRO Annual Meeting 2024 PRINCETON, N.J., Oct. 02, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a...Read more
Investigational immunotherapy, VTP-300, is being evaluated as part of a potential functional cure regimen for chronic Hepatitis B. Interim data update for HBV003 anticipated in Q4 2024. Data update for PCA001 anticipated in H1 2025. OXFORD, United Kingdom, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that...Read more
Dramatic anti-tumor response includes complete resolution of right temporal lobe brain metastasis in patient with “Eye-Bulging” metastatic breast cancer Heavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continues to receive BriaCell treatment PHILADELPHIA and VANCOUVER, British Columbia, Oct. 01, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX:...Read more
400 subject sentinel portion of Phase 2b study will evaluate the safety, immunogenicity and efficacy of Vaxart’s next generation oral pill COVID-19 vaccine compared to an approved mRNA vaccine comparator The sentinel cohort is being funded as part of the Phase 2b NextGen COVID-19 clinical trial, valued at up to $456 million through the Rapid Response Partnership Vehicle under the U.S. government’s Project NextGen SOUTH...Read more
Encouraging progression-free survival data in overall population; continued follow-up needed to allow data to mature further, especially in low ctDNA subgroup where events accrue more slowly 21% relative risk reduction of progression or death with GRANITE vs. control in all treated population (HR=0.79 [95% CI, 0.42-1.50]) 38% relative risk reduction of progression or death with GRANITE vs. control in low ctDNA subgroup (HR=0.62 [95%...Read more
SOUTH SAN FRANCISCO, Calif. / Sep 30, 2024 / Business Wire / Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing a novel small molecule to treat unmet needs in immune-mediated diseases, today announced the voluntary cessation in enrollment of new patients and dosing of ongoing patients in the Phase 2b PALIZADE clinical trial, pending further evaluation. PALIZADE is a global, placebo-controlled,...Read more
COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) shared 3-year results from the Company’s ongoing Phase 2 PaTH Forward Trial of 57 adults with hypoparathyroidism showing that long-term treatment with TransCon™ PTH (palopegteriparatide; marketed as YORVIPATH®) through Week 162 drove bone remodeling into the normal range. Deficiency of parathyroid hormone is associated with low rates of bone...Read more
Istaroxime treatment significantly improved systolic blood pressure as well as cardiac output and renal function without increasing heart rate or clinically significant arrythmias NYHA heart failure classification was improved up to 72 hours with a serious adverse event profile generally similar to placebo WARRINGTON, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM:...Read more
Boca Raton, Florida, Sept. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), announced today that it closed enrollment for its Phase 2 trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on...Read more
Achieves primary endpoint showing a linear relationship between adherence to PoNS Therapy® in Phase 2 and improvement in DGI scores from Phase 1 to end of treatment at week 14 Confirms the therapeutic benefits of PoNS Therapy for gait deficit improvement in people with MS NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company...Read more
Biohaven initiated a pivotal Phase 2 trial evaluating BHV-2100 in the acute treatment of migraine BHV-2100 is a potential first-in-class, potent, orally administered Transient Receptor Potential Melastatin-3 (TRPM3) antagonist— a novel, highly selective, and non-opioid investigational treatment being developed for migraine and other pain disorders Despite recent treatment advances, migraine remains a leading cause of disability and...Read more
IMPACT trial is evaluating the safety and efficacy of pemvidutide in approximately 190 subjects with MASH; top-line efficacy data expected in Q2 2025 End-of-Phase 2 Meeting for the obesity program with U.S. Food and Drug Administration (FDA) has been scheduled for early November 2024 Company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning in Q4...Read more
CAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that enrollment of 188 patients has been completed in the randomized controlled Part B of the DeFianCe study evaluating DKN-01, Leap's anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy as a...Read more
28-week data show ESK-001 was generally well tolerated and most patients treated with the top dose of 40 mg twice daily achieved PASI 75 Three additional data presentations further support ESK-001’s potential to offer a highly differentiated and best-in-class treatment profile for people with moderate-to-severe plaque psoriasis Full 52-week Phase 2 OLE dataset expected 1H 2025; Phase 3 clinical program ongoing SOUTH SAN FRANCISCO,...Read more
New analyses extend data on beneficial effects of ibezapolstat on the gut microbiome Confirmed ibezapolstat's favorable pharmacokinetics showing low systemic exposure and high colonic concentrations Selected ACX-375 analogues demonstrated in vitro activity against Anthrax (B. anthracis), a Bioterrorism Category A pathogen, including activity against ciprofloxacin resistant Anthrax. Planning is underway for an Anthrax bioterrorism...Read more
Treatment With Once-Daily EDP-323 Met Primary and Secondary Endpoints, Achieving Highly Statistically Significant Reductions in Both Viral Load and Clinical Symptoms Compared to Placebo Favorable Safety and Tolerability Observed Conference Call and Webcast to Discuss Data at 8:30 a.m. ET Today WATERTOWN, Mass. / Sep 26, 2024 / Business Wire / Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated...Read more
71% of patients (150 mg Q4W) achieved complete response at Week 52 Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks Robust improvement across omalizumab-experienced/refractory/naïve disease Well tolerated through 52 weeks Enrollment to Global Phase 3 CSU trials underway Company to host webcast today at 12:00 pm ET/6:00 pm CEST HAMPTON, N.J., Sept. 25, 2024 (GLOBE...Read more
Patients are preselected for CDKN2A and/or CDKN2B abnormalities Safety and efficacy data to be reported at an upcoming oncology medical conference BERKELEY HEIGHTS, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative cancer medicines, today announced that enrollment of 12 patients has been completed as...Read more
Istaroxime significantly improved primary endpoint of the systolic blood pressure profile over six hours and showed significant improvements in many secondary endpoint assessments Study results to be presented at the Heart Failure Society of America Medical Conference on September 30, 2024 WARRINGTON, Pa., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a...Read more
On track to announce topline data in Q1 2025 Virtual KOL event scheduled on October 30th to discuss the unmet need in hypertension, as well as a review of the ongoing pivotal clinical program for lorundrostat in hypertension RADNOR, Pa., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic...Read more
PITTSBURGH, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on addressing serious diseases with significant unmet needs, today announced an update on its ongoing multi-center Phase 2a clinical trial evaluating LP-310 for the treatment of Oral Lichen Planus (OLP). The Company reported that three participants have completed the...Read more
Mean muscle content-adjusted dystrophin expression of 9.0% and unadjusted dystrophin of 5.5%, with high consistency across participants, in a prespecified analysis; dystrophin was comprised of two isoforms consistent with Becker muscular dystrophy patients who display milder disease Data demonstrated meaningful improvement in serum biomarkers for muscle health, with localization of WVE-N531 in myogenic stem cells and regeneration of...Read more
Toronto, Ontario--(Newsfile Corp. - September 24, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced it has achieved the target patient enrollment of 100 patients in "ARCHER", its Phase II randomized,...Read more
Vancouver, British Columbia – TheNewswire - September 23, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development, is delighted to report it has enrolled its 25th participant into its landmark clinical trial of MB22001 in patients with Major Depressive Disorder. The Company has entered multiple Phase 2B trials with confidence,...Read more
SAN DIEGO, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure...Read more
Target of 92 evaluable patients (46 in each of the control and VCN-01 treatment arms) enrolled across 15 sites in Spain and the USA within 21 months ROCKVILLE, Md., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today...Read more
BDTX-1535 dose of 200 mg daily selected for pivotal development; favorable tolerability profile and no new safety signals observed Preliminary ORR of 42% in 19 patients at 200 mg with on-target resistance EGFR mutations Encouraging durability with DOR of approximately 8 months or more for first 3 patients with a PR; 14 of 19 patients remain on treatment Regulatory feedback on registration path anticipated in Q1 2025 Initial results...Read more
Phase 2 company-sponsored and IST neoadjuvant uveal melanoma (UM) clinical data update in 49 evaluable patients, demonstrates ~49% of patients with >30% tumor shrinkage by product of diameters, and ~61% eye preservation rate for enucleation patients Targeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDA Clinical endpoints supportive of full approval...Read more
Bagsværd, Denmark, 20 September 2024 – Novo Nordisk today announced headline results from a phase 2a clinical trial with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. Monlunabant, formerly INV-202, was part of the acquisition of Inversago Pharmaceuticals Inc. announced in August 2023 [Link]. The trial investigated the efficacy and safety of a once-daily 10 mg, 20 mg and 50 mg dose of monlunabant...Read more
HOUSTON / Sep 19, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announced today that the Deltacel-01 Safety Monitoring Committee (SMC) has unanimously voted in favor of proceeding with the expansion phase of the Deltacel-01 clinical trial. This trial is evaluating Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic...Read more
ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF Placebo-adjusted median relative reductions in liver fat were up to 46.2% with a clear dose response ALG-055009 was well-tolerated with no serious adverse events or dose reductions. Importantly, ALG-055009 dose groups had a similar incidence of gastrointestinal-related adverse events with less...Read more
Overall survival (OS) results from BRACELET-1 corroborate results of previous randomized IND-213 breast cancer study Together, these two studies support the compelling potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer Oncolytics Biotech is moving forward to secure funding for a registration-enabling study of pelareorep-based therapy in advanced or metastatic...Read more
In a Phase 1 in healthy subjects, EDG-7500 was well-tolerated without meaningful changes in left ventricle ejection fraction (LVEF) CIRRUS-HCM single-dose trial of EDG-7500 in obstructive HCM demonstrated robust left ventricular outflow tract (LVOT) gradient reductions without meaningful changes in LVEF Company announced dosing of first patients in CIRRUS-HCM 28-day trial Edgewise to host webcast event on Thursday,...Read more
Company symposium to highlight case reports from 11 patients with stiff-person syndrome, myasthenia gravis and multiple sclerosis reinforcing KYV-101's initial efficacy and safety profile and broad potential in B cell-driven neuroinflammatory diseases Key biomarkers indicate potential for KYV-101 to durably modify neuroinflammatory diseases with immune system reset Kyverna to present posters on design and methods for...Read more
Vidofludimus Calcium Consistently Reduced Neurofilament Light Chain Levels, Compared to Placebo, in the Interim Analysis of the Phase 2 CALLIPER Trial, Across Age and Disability Levels at Baseline For All Progressive Multiple Sclerosis Subtypes Clinical Signal Shown for Vidofludimus Calcium on Post COVID Fatigue May Be Related to Epstein-Barr Virus Reactivation; Preventing This Reactivation May Contribute to Fatigue...Read more
High CEACAM1 and low PDL1 expression in tumors, as well as their combination identified as potential biomarkers associated with improved overall survival (OS) of pancreatic ductal adenocarcinoma (PDAC) patients (HR=0.1 and prolongation of 4.1 months in median OS, p value 0.01, for the combination), which support the CM24/nivolumab combined treatment. Improved OS is demonstrated for patients with serum neutrophil extracellular trap...Read more
BOCA RATON, Fla., Sept. 17, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, today announced that results of additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease (AD) trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical...Read more
BASKING RIDGE, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced treatment of the first patient in the second-line cholangiocarcinoma (“CCA”) cohort of the BOLSTER trial. This follows the recently announced successful...Read more
CRANBURY, N.J. / Sep 17, 2024 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that all patients have been enrolled in the global, pivotal Phase 2 clinical trial evaluating RP-A501 to treat male patients with Danon disease. After the two-patient safety run-in,...Read more
WAYNE, Pa., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3, for the...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...
CLICK TO LEARN MORE