Observed reductions of 11% and 12% in 24- and 27-hydroxycholesterol in cerebrospinal fluid (“CSF”), respectively, indicating potential improvement of cholesterol metabolism in the brain Observed 8% increase in Aβ42/40 ratio, a key biomarker of AD risk, suggesting improvement in disease pathology NAARDEN, The Netherlands and MIAMI, Sept. 21, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or...Read more
Initiation of Phase 1 clinical trial marks Entrada’s transition into a clinical company Data anticipated in the second half of 2024 BOSTON, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today announced that the first...Read more
FILSPARI® (sparsentan) achieved a clinically meaningful difference vs. irbesartan in eGFR total slope (1.0 mL/min/1.73m2 per year) [p= 0.058] and eGFR chronic slope (1.1 mL/min/1.73m2 per year) [p=0.037]. Patients treated with FILSPARI over two years exhibited one of the slowest annual rates of kidney function decline seen in a clinical trial of IgAN patients (-2.7 to -2.9 mL/min/1.73m2 per year) eGFR chronic slope was statistically...Read more
52 Relapsed and Refractory Lymphoma Patients Enrolled: 96% Alive at Last Assessment Indicating Favorable Survival Benefit Responses Observed Across Dose Levels with a 14.7% Clinical Response Rate Overall, 35.3% Overall Disease Control Rate, and 36.4% Clinical Response Rate in PTCL Patients Decrease in MCL1 and/or MYC Biomarkers Observed in 100% of Patients in a Dose-Dependent Manner in Once Per Week Administration...Read more
Phase 2 topline efficacy data for CYB003 on track for Q4 2023, followed by U.S. Food and Drug Administration (“FDA”) submission of CYB003 Phase 1/2 data for pivotal studies Breakthrough Therapy designation anticipated in late 2023, subject to FDA approval Previously announced acquisition of Small Pharma Inc. expected to close in Q4 2023, creating an international clinical-stage leader in novel psychedelic...Read more
SAN DIEGO / Sep 21, 2023 / Business Wire / Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, announces the full enrollment of 40 subjects with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed leptomeningeal metastases (LM) in the feasibility phase of its prospective FORESEE clinical trial (NCT0414123). This trial is evaluating the performance of Biocept’s...Read more
Data readouts expected before year end Previously reported preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy treatment of STS lung mets with >60% of the subjects exhibiting stable disease after two cycles of treatment Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma HOUSTON, Sept. 21, 2023 /PRNewswire/ -- Moleculin Biotech, Inc.,...Read more
Based on a novel human cytomegalovirus vector platform, VIR-1388 was designed with the goal of creating a novel HIV vaccine Phase 1 trial supported by the Bill & Melinda Gates Foundation, the National Institute of Allergy and Infectious Diseases and conducted by the HIV Vaccine Trials Network SAN FRANCISCO, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first...Read more
NEW YORK, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that dosing is now underway in its Phase 1b/2 ADVANCED-2 trial evaluating intravesical instillation of TARA-002, the Company’s investigational cell-based therapy, for the treatment of high-grade non-muscle invasive bladder...Read more
SLS-002 demonstrated early and persistent clinically meaningful reductions in symptoms of depression and acute suicidality Robust Response and Remission Rates were observed using the Montgomery-Åsberg Depression Rating Scale (MADRS) Results demonstrate the therapeutic potential of SLS-002 to address imminent suicidality SLS-002 was well-tolerated, with no evidence of new or unique adverse events and there were no deaths reported in...Read more
Statistically significant increase in urinary polycystin 1(PC1) after treatment with RGLS8429 Urinary polycystin exhibits anticipated pharmacokinetics/pharmacodynamics (PK/PD) correlation in patients with ADPKD Company to hold conference call at 8:30 a.m. EDT today SAN DIEGO, Sept. 20, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative...Read more
Patients newly treated with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment Long-term dosing with REL-1017 was well-tolerated, with low rates of adverse events and discontinuations due to adverse events, and no new safety signals were detected CORAL GABLES, Fla., Sept. 20, 2023 /PRNewswire/ -- Relmada Therapeutics, Inc....Read more
PDS0202 (Infectimune® + COBRA influenza antigens) vaccination also prevented illness/weight loss Vaccine protected against replication of the virus in the lungs of ferrets after challenge with the H1N1 virus Data from Cleveland Clinic’s Ted Ross Lab presented at the 9th ESWI Influenza Conference PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a...Read more
ATLANTA, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including two lead revolutionary late-clinical stage product candidates and FDA-cleared, innovative diagnostic products, today announced the achievement of First-Patient-In for its pivotal clinical trial evaluating FemBloc®, a...Read more
The Phase 1b Clinical Trial Focuses on Assessing the Safety and Efficacy of the Two-Drug Combination in a Cancer Associated with Longer Survival to Immunotherapy When Genetically Deficient in PP2A PASADENA, CA, Sept. 20, 2023 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”), today announced a Phase 1b collaborative clinical trial to assess whether adding Lixte’s LB-100 to GSK’s programmed death...Read more
Pre-IND submission to FDA targeted for first quarter 2024 Silo partners with Kymanox for SPC-15 ENGLEWOOD CLIFFS, NJ, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced that based on positive SPC-15 pre-clinical data, it is working with Kymanox as its...Read more
Study met the primary endpoint and all secondary endpoints, highly consistent with rapid response from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trials For the primary endpoint, 25.4% of children treated once daily with roflumilast cream 0.05% achieved Investigator Global Assessment (IGA) Success compared to 10.7% of children treated with vehicle (P<0.0001) at Week 4, with significant improvements seen as early as Week 1 39.4% of...Read more
Late-breaking data presented at 9th ESWI Influenza Conference in Valencia SAN DIEGO / Sep 19, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the results of a phase 1/2 study showing that...Read more
KRASG12D(ON) Inhibitor with highly differentiated mechanism of action being evaluated in patients with cancers harboring the KRASG12D mutation, the most common driver of RAS-addicted human cancers REDWOOD CITY, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced the first patient was dosed in its...Read more
Topline data from Phase 3 trial expected in Q4 2024 Company to present encore 36-month efficacy, safety, and patient-reported outcomes data from the Phase 2 TOPAZ trial extension at the 2023 World Muscle Society (WMS) Annual Congress Apitegromab is the only muscle-targeted therapy candidate with clinical data showing proof of concept in spinal muscular atrophy CAMBRIDGE, Mass. / Sep 19, 2023 / Business Wire / Scholar Rock (NASDAQ:...Read more
Recruitment Accelerating and Full Patient Enrollment Anticipated to be Completed During Q3 2024, up to Six Months Ahead of Schedule Multi-Center, International, Double-blind, Placebo-controlled Trial Randomizing 100 Patients Toronto, Ontario--(Newsfile Corp. - September 19, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research...Read more
NEW YORK, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”) announces dosing of the first patient in the second cohort of patients to receive a single dose of Decoy20 in the INDP-D101 trial. This cohort dose is a dose reduction from the previous cohort based on the significant pharmacodynamic effect seen with the first cohort and anticipated optimal Decoy20 safety profile for both...Read more
Investigational VVD-130037 is highly specific, potent Kelch-like ECH Associated Protein 1 (KEAP1) activator developed for treatment of advanced solid tumors Major milestone for Vividion’s chemoproteomics innovative technology platform First-in-class clinical candidate to target cancers with activation of KEAP1-NRF2 pathway Berlin, Germany, San Diego, CA, USA, September 18, 2023 – Vividion Therapeutics, Inc. (Vividion), announced...Read more
All primary and secondary endpoints were met for second Phase 3 study (M21-310) and results were consistent with findings from first Phase 3 study (M21-309). Results support onabotulinumtoxinA as a potential treatment option for moderate to severe platysma prominence. Data will be included as part of an upcoming U.S. Food and Drug Administration regulatory submission expected near the end of the year. If approved,...Read more
BioNTech is initiating a Phase 1/2 clinical trial of the mRNA-based mpox vaccine program, BNT166 The Coalition for Epidemic Preparedness Innovations (CEPI) commits funding of up to $90 million for the development of vaccine candidates Data generated by this partnership will contribute to CEPI’s 100 Days Mission, a global effort to accelerate the development of well-tolerated and effective vaccines against future viral threats with...Read more
An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Simufilam in On-Going Phase 3 Clinical Trials. The DSMB Recommended the Phase 3 Trials of Simufilam Continue as Planned, Without Modification AUSTIN, Texas, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced a positive...Read more
Initiation of Clinical Study at Lenox Hill Hospital Seeks to Provide New Option for Treatment of Newly Diagnosed Unmethylated Glioblastoma WESTON, Fla. and NEW YORK, Sept. 18, 2023 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, and Lenox Hill...Read more
Recommended Phase 2 dose regimen identified as masofaniten 600mg BID combined with enzalutamide 160mg QD Phase 2 head-to-head portion of the study to commence enrollment immediately Updated Phase 1 results selected for a poster presentation at ESMO 2023 SOUTH SAN FRANCISCO, Calif. and VANCOUVER, Canada, Sept. 18, 2023 /CNW/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage...Read more
TORONTO, ON / ACCESSWIRE / September 18, 2023 / FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE) (FRA:0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders, today announced that an interim report has been received for the first-in-human ("FIH") single ascending dose Phase I clinical...Read more
Preliminary Data Support Progression to Phase 2a Proof of Concept Trials in T cell-mediated Autoimmune Diseases WAYNE, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the...Read more
Topline results from this study are expected in early Q1 2024 Celltrion has a right of first negotiation for RT-111 following positive Phase 1 results SAN JOSE, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced the initiation of a Phase 1 clinical...Read more
Highly regarded renal pathologist and transmission electron microscopy (TEM) expert independently confirms previously reported qualitative assessment by Mayo Clinic of TEM biopsy scans All three patients treated with ELX-02 showed a visual improvement in podocyte foot process effacement post-treatment in kidney biopsies demonstrating the disease modifying effect of ELX-02 Podocyte foot process effacement is a hallmark of Alport...Read more
Encinitas, California--(Newsfile Corp. - September 18, 2023) - Kiora Pharmaceuticals (NASDAQ: KPRX) today announced the completion of the final patient's last endpoint evaluation from the ABACUS study of KIO-301. KIO-301 is A molecular photoswitch being evaluated in a Phase 1B clinical trial for vision restoration in late-stage Retinitis Pigmentosa (RP). Topline study results will be reported November 4 at the upcoming American Academy of...Read more
SAN DIEGO, Sept. 18, 2023 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced that the ENVASARC Phase 2 pivotal trial more than satisfied the futility threshold of 3 responses out of 46 based...Read more
Interventional study compares VitaGraft to current transplant rejection monitoring protocols Oncocyte's VitaGraft assay detects antibody-mediated transplant rejection 10 months sooner than commonly used monitoring protocols (p<0.001) IRVINE, CA / ACCESSWIRE / September 18, 2023 / Oncocyte Corporation (NASDAQ:OCX), a precision diagnostics company, today announced the presentation of significant new clinical data at the European...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 15, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, today announced dosing of the first patients with small cell lung cancer (SCLC) in an ongoing Phase 1/2 trial of HPN328, a DLL3 targeting TriTAC®, in combination with atezolizumab (Tecentriq®). Harpoon previously entered a Master Clinical Supply Agreement with...Read more
Two-Part Design Provides Optionality for Interim Analysis in First Half of 2024 Full Data Readout Expected in the Second Half of 2024 BOSTON, Sept. 15, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced dosing of the first patient in its two-part, Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled...Read more
VANCOUVER, British Columbia, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a Canadian psychedelics drug research and formulation company, is pleased to see the positive and encouraging outcomes from the MAPS Phase 3 MDMA-Assisted Therapy (MDMA-AT) Clinical Trial published today on Nature Medicine. The Company considers the results to be a substantial step forward in the treatment of...Read more
Taldefgrobep alfa is the only myostatin inhibitor in clinical development that targets both myostatin and activin A signaling, two key regulators of muscle mass and adipose tissue RESILIENT, the pivotal clinical trial in spinal muscular atrophy, was designed to test the efficacy and safety of taldefgrobep alfa as adjunctive therapy to increase muscle in SMA patients treated with standard of care nusinersen, risdiplam or onasemnogene...Read more
NEW YORK, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that a follow-on analysis of the landmark Phase 2b/3 study to treat early Alzheimer’s disease with the investigational drug blarcamesine (ANAVEX®2-73) did...Read more
PALO ALTO, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC)(“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported that the first patient has been dosed in the Phase 1 trial evaluating VIP943 in patients with relapsed/refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS), and...Read more
JERUSALEM, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that a patient with advanced inoperable pancreatic cancer has been treated in a clinical trial at Hadassah Medical Center in Jerusalem, Israel. The trial is designed for a broad range of solid tumor patients who do not qualify...Read more
DVX201, a first-ever allogeneic, cord-blood derived, natural killer (NK) cell therapy, has been administered to 16 patients with no dose limiting toxicities, cytokine release syndrome or infusion toxicities to date at all dose levels WEXFORD, Pa., Sept. 14, 2023 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for...Read more
EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator that has the potential to benefit a broad spectrum of HCM and other cardiomyopathy patients BOULDER, Colo. / Sep 14, 2023 / Business Wire / Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced initial dosing in a Phase 1 trial of EDG-7500. EDG-7500 is a first-in-class oral, selective, cardiac...Read more
Scilex Holding Company announced completion of its SP-103 Phase 2 study to evaluate the safety and efficacy in subjects with acute LBP. The Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study evaluated the safety and efficacy of SP-103 (lidocaine topical system 5.4%) in subjects with moderate to severe acute LBP. The trial enrolled 75 patients at 10 sites across the U.S. SP-103 received Fast Track...Read more
Fresh data from randomized controlled NASAR clinical trial further demonstrate efficacy and tolerability of Bentrio® nasal spray in treatment of seasonal allergic rhinitis Study meets both primary and secondary efficacy endpoints of improvement in reflective and instantaneous Total Nasal Symptom Scores (p = 0.013 and 0.039) Corroborated by statistically significant improvement in health-related quality of life...Read more
Company's flu vaccine, mRNA-1010, met its primary endpoint in Phase 3 trial; separate Phase 1/2 data demonstrated higher HAI titers than Fluzone HD Vaccine pipeline advancing rapidly with Company announcing the completion of RSV BLA filing (mRNA-1345), completion of adult enrollment in the Phase 3 trial of mRNA-1647, a first-in-class vaccine against CMV, and the Phase 3 trial of mRNA-1283, a next-generation COVID-19 vaccine With its...Read more
Alopecia areata is the second autoimmune indication being evaluated for bempikibart WALTHAM, Mass. and DUBLIN, Sept. 13, 2023 /PRNewswire/ -- Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), today announced that the first patient has been dosed in a randomized, double-blind, placebo-controlled, Phase 2...Read more
New Statistically Significant Results Reported for Clinical Efficacy Endpoints of BSA, DLQI and POEM from Phase 1b Study New Phase 2a Study Also Being Planned for Rezpegaldesleukin in Alopecia Areata SAN FRANCISCO, Sept. 13, 2023 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced new data for rezpegaldesleukin in patients with atopic dermatitis, including new clinical efficacy endpoints from the Phase 1b study....Read more
Company announces Phase 2 part of the EBO-301 trial is now fully enrolled with 80 patients; Topline Phase 2 trial results expected in summer 2024 Over 100 sites across four countries (U.S., Japan, S. Korea & Australia) as epetraborole enters Phase 3 portion of EBO-301; expected to enroll ~230 patients MENLO PARK, Calif. / Sep 13, 2023 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical...Read more
Favorable safety and tolerability profile of OCU400 investigational drug product in RP and LCA subjects to date Clinical study update suggests continued positive trends in Best-Corrected Visual Acuity (BCVA) and Multi-Luminance Mobility Testing (MLMT), as well as positive trends in Low-Luminance Visual Acuity (LLVA) among treated eyes 83% (10/12) of subjects demonstrated stabilization or improvement in treated eye either on BCVA or...Read more
Gastrointestinal Stromal Tumors Cells Rapidly Died Between 48 and 72 Hours After Exposure to HT-KIT. HT-KIT Shows Positive Results in AML Positive Preclinical Results of Novel HT-KIT Therapeutic Performed at NC State University NEW YORK, Sept. 13, 2023 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that HT-KIT, a new molecular entity, for the...Read more
SAN DIEGO, Sept. 13, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced it has completed enrollment in the second cohort of patients in the ongoing Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. "The completion of enrollment in our second cohort is...Read more
Multiple novel mRNA biomarkers identified for potential integration into pivotal FDA PMA clinical trial (ReconAAsense) BERKELEY, Calif. and MAINZ, Germany, Sept. 13, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today positive topline results from its ColoFuture study. The ColoFuture study is...Read more
Scinai’s NanoAbs downregulated key molecular markers overexpressed in plaque psoriasis Stratum corneum regained normal appearance in laboratory 3D skin model Results from ex-vivo study in human psoriatic skin anticipated in Q4 2023; In-vivo animal study results anticipated in early 2024 JERUSALEM, Sept. 13, 2023 (GLOBE NEWSWIRE) -- via IBN – Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) a biopharmaceutical company...Read more
PALO ALTO, Calif., Sept. 12, 2023 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases, today announced its decision to discontinue the Phase 3 LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta (CHD). The decision is based on the recommendation of the Data Safety Monitoring...Read more
CAHtalyst™ Met Primary Endpoint Demonstrating a Statistically Significant Decrease from Baseline Daily Glucocorticoid Dose with Androgen Control Key Secondary Endpoint Achieved Statistically Significant Decrease in Androstenedione at Week 4 versus Placebo Key Secondary Endpoint Demonstrated a Statistically Significant Number of Patients on Crinecerfont Achieved a Reduction to a Physiologic Glucocorticoid Dose versus...Read more
Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks BLA planned to be filed with FDA in 4th Quarter 2023 Conference call and live webcast with Key Opinion Leaders at 8:00 a.m. ET today DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage...Read more
Phase 2a double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 in combination with standards of care versus standards of care alone in subjects with advanced solid tumors including cholangiocarcinoma, head and neck squamous cell carcinoma, or esophageal squamous cell carcinoma First patient treated in the head and neck squamous cell carcinoma cohort BASKING RIDGE, N.J., Sept. 12, 2023 (GLOBE NEWSWIRE) --...Read more
Study demonstrates statistically significant and clinically relevant improvements in 3 Cardinal Symptoms and SNOT-22 scores at 24 weeks Statistically significant improvements in efficacy were observed as early as 2 weeks Primary endpoint met with no serious adverse events observed LYR-220, Lyra’s second product candidate, is a long-acting anti-inflammatory therapy in development for CRS patients with and without polyps who have...Read more
GAITHERSBURG, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the completion of dosing (last subject last dose) in its 48-week Phase 2 MOMENTUM trial evaluating the efficacy and safety of pemvidutide in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of...Read more
Fort Lee, NJ, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the initiation of a Phase 1a dose escalation clinical trial of NXP900, its novel inhibitor of the SRC/YES1 kinase family (“SFK”)....Read more
Data presented at the 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Singapore BELTSVILLE, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the presentation of...Read more
198 participants dosed across 20 clinical sites On track for topline results in Q4 2023 NEW YORK / Sep 12, 2023 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has completed enrollment and dosing in Study MMED008, the Company’s Phase...Read more
PH80 nasal spray demonstrated statistically and clinically significant improvement versus placebo in an exploratory double-blind, placebo-controlled Phase 2A study (n=52) in subjects with a history of premenstrual dysphoric disorder (PMDD) PH80 was well-tolerated with an adverse event profile similar to placebo Data builds on the previously reported vasomotor symptoms (hot flashes) due to menopause study, reinforcing the potential of...Read more
First drug candidate identified with Gain’s proprietary computational drug discovery platform SEE-Tx® to enter clinical development phase BETHESDA, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that the Company has received approval...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed patient enrollment of a bridging study of tazemetostat in China. The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory...Read more
Progressing development of hepatitis B virus (HBV) compounds imdusiran (AB-729) and AB-101, an oral PD-L1 inhibitor Discontinuing all coronavirus and oral RNA destabilizer programs, including AB-343 and AB-161 Extending cash runway through Q3 2025 WARMINSTER, Pa., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its...Read more
The primary endpoint of HiSCR75 at week 16 did not meet statistical significance in the Non-Responder Imputation (NRI) primary analysis. HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis. HiSCR response rates of izokibep 160mg weekly (QW) were consistent with Part A open label results, demonstrating early onset of HiSCR100 at week 4, increasing through week 12 to 38%...Read more
First head-to-head trial of biologics in EGPA, comparing a single monthly injection of FASENRA to three injections per month of mepolizumab WILMINGTON, Del. / Sep 11, 2023 / Business Wire / Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s FASENRA (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic...Read more
Complete topline results confirm treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC) Planned Phase 2 study in early-stage TNBC to determine if CKM including Ampligen may be a safe and effective alternative to pembrolizumab or in addition to pembrolizumab/NAC Results now available...Read more
Data from longest reported follow-up for a Phase 3 trial with immunotherapy in metastatic non-small cell lung cancer demonstrate consistent, durable benefits of Opdivo plus Yervoy vs. chemotherapy at six years, regardless of PD-L1 expression Opdivo plus Yervoy combination more than tripled overall survival rate at six years compared to chemotherapy in patients with PD-L1 expression <1% in an exploratory analysis Updated data to be...Read more
Combination reduced the risk of disease progression by 38% versus TAGRISSO monotherapy, the current 1st-line global standard of care WILMINGTON, Del. / Sep 11, 2023 / Business Wire / Positive results from the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to...Read more
AstraZeneca and Daiichi Sankyo’s ENHERTU showed objective response rates of 49% and 56% with 5.4mg/kg and 6.4mg/kg doses respectively in primary analysis ENHERTU provided a median progression-free survival of 9.9 months at 5.4mg/kg dose and 15.4 months at 6.4mg/kg dose with a median duration of response of 16.8 months seen at the 5.4mg/kg dose and not reached at the 6.4mg/kg dose Favorable safety profile confirms 5.4mg/kg as optimal...Read more
Topline Results for TAK-279 Show that a Significantly Greater Proportion of Psoriatic Arthritis Patients Achieved at Least an ACR20 Response Compared to Placebo at Week 121 Based on the Positive Results, Takeda Intends to Initiate a Phase 3 Study of TAK-279 in Psoriatic Arthritis Full Clinical Results Will be Presented at an Upcoming Medical Meeting OSAKA, Japan & CAMBRIDGE, Mass. / Sep 11, 2023 / Business Wire / Takeda...Read more
SAN DIEGO, Sept. 11, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117570 in healthy adult participants. NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological...Read more
SAD data confirm best-in-class potential for INF904 as orally administered C5aR inhibitor: Safety and tolerability with no signals of concern over entire dose range Pharmacokinetics (PK): favorable dose-proportional systemic exposure with overall PK profile confirming pre-clinical data Desired blocking activity (>90%) of C5a-induced neutrophil activation at disease relevant C5a levels 24 hours post administration for doses of 30...Read more
Initiated IDE161 Phase 1 expansion based on preliminary tumor shrinkage observed in multiple HRD solid tumor patients, including an endometrial cancer subject with a first imaging assessment of a partial response and an 87% reduction of the CA-125 tumor marker Phase 1 expansion focus in ER+, Her2(-), HRD+ breast cancer representing ~10% to ~14% of breast cancer as well as HRD+ ovarian cancer and other HRD-associated solid...Read more
Multi-antigen Vaccine Designed to Protect Against Evolving SARS-CoV-2 Variants ATLANTA, GA, Sept. 11, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has met the enrollment target for its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster for healthy patients who have...Read more
Overall response rates of 12.5% are observed in the enobosarm group in a heavily pretreated population versus no responses in the standard of care active control arm. On average, enobosarm or active control was given in the 4th line treatment in the metastatic setting which included a prior CDK 4/6 inhibitor combination Overall response rate was 20% for enobosarm monotherapy versus 0% for standard of care active control in patients who...Read more
CTx-1301 Demonstrated Clinically Meaningful Improvements in Permanent Product Measure of Performance (PERMP) and Clinical Global Impression Scale (CGI-S) Scores, with Investigators Observing Trend Toward Significance Treatment Effect Size of 1.41 and 0.98 Observed at 30 Minutes and at Hour 16, Respectively; Currently Available Long-Acting Stimulants Range from 0.5 to 0.91 CTx-1301 Demonstrated a Favorable Safety Profile in the Trial...Read more
WALTHAM, Mass., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the first participant has been dosed in the CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody, for the prevention of symptomatic COVID-19. This clinical...Read more
Company to present BDTX-1535 dose escalation data in NSCLC at the AACR-NCI-EORTC Conference in October 2023 CAMBRIDGE, Mass. and NEW YORK, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced the first patients dosed in mutation...Read more
Interim analysis of masked data shows EYP-1901 is well tolerated with no reported drug-related ocular or systemic serious adverse events in Phase 2 PAVIA clinical trial in non-proliferative diabetic retinopathy Updated interim analysis of masked safety data of Phase 2 DAVIO 2 trial in wet AMD continues to show a positive safety profile with no reported drug-related ocular or systemic SAEs Company remains on-track to report...Read more
Marker Therapeutics reports clinical updates in APOLLO trial for the treatment of lymphoma patients who have relapsed after anti-CD19 CAR T cell therapy Patient with Non-Hodgkin’s Lymphoma who relapsed after anti-CD19 CAR T cell therapy tolerated initial dose level well and achieved complete response after MT-601 treatment HOUSTON, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR) is a clinical-stage...Read more
PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 11,2023 / Biophytis SA (Nasdaq CM:BPTS) (Euronext Growth Paris:ALBPS), («Biophytis»), a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients...Read more
Post-hoc analysis from Phase 1b/2a study in pulmonary sarcoidosis presented at the European Respiratory Society (ERS) International Congress 2023. 7.7% of patients in the 3.0 and 5.0 mg/kg efzofitimod group relapsed following steroid taper, compared to 54.4% in the placebo and efzofitimod 1.0 mg/kg group (p=0.017). Rate of change for forced vital capacity (FVC) was significantly improved for the 3.0 and 5.0 mg/kg efzofitimod group...Read more
DURHAM, N.C., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced the presentation of results from a Food and Drug Administration (FDA)-regulated, investigator-sponsored clinical study conducted at the Mayo Clinic. In the study the investigational HAV is being evaluated in patients...Read more
Demonstrating potential safety and efficacy of WEE1 inhibitor, ATRN-1051, in the treatment of ovarian cancer Company anticipates submitting an IND by the end of 2023 Data to be presented at an upcoming 2023 scientific conference, with KOL event planned for the fall DOYLESTOWN, Pa., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical stage biopharmaceutical company...Read more
Targeting to commence second part of Phase 3 clinical trial in mid-Q4 2023 Trial completion and results expected in mid-2024 TEL AVIV, Israel, Sept. 11, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced plans to commence the second part of the Company’s phase 3 trial to...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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