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SEATTLE, May 15, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced that the last patient in the Company’s Karisma-Endoxifen clinical trial received their final dose of study medication. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
GlobeNewswire Inc. • 20h ago
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TARRYTOWN, New York, May 15, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica, Inc. (the “Company” or “PaxMedica”) (OTC:PXMD), a biopharmaceutical company dedicated to advancing treatments for neurological disorders, today announced it has timely filed a formal notice of appeal with the Nasdaq Office of Appeals and Review to reverse the decision of a Nasdaq Hearings Panel to delist the Company from Nasdaq. Following receipt of notification from Nasdaq on April 30th, PaxMedica determined to appeal the decision and intends to maintain that the Hearings Panel did not consider sufficiently or appropriately crucial aspects of PaxMedica’s recent achievements and ongoing actions to regain compliance with all applicable requirements for continued listing. PaxMedica has retained Jacob Frenkel, Dickinson Wright, PLLC as its lead counsel in the appeal, working with the consulting firm that interacted previously with the Hearings Panel.
GlobeNewswire Inc. • 20h ago
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Global pivotal Phase 3 clinical trial would be conducted jointly by Verrica and Torii Pharmaceutical; trial expected to begin in the 1st half of 2025
GlobeNewswire Inc. • 21h ago
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SAN FRANCISCO, May 15, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced interim results from an ongoing Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with CDK4/6 inhibitor ribociclib for the treatment of ER+/HER2- metastatic breast cancer. These results, as of the data cut-off of March 13, 2024, will be presented on May 16, 2024, in a poster session at the 2024 ESMO Breast Cancer Annual Congress in Berlin, Germany (ESMO Breast).
GlobeNewswire Inc. • 21h ago
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MALVERN, Pa., May 15, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the second cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease as a one-time treatment for life.
GlobeNewswire Inc. • 22h ago
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May 15, 2024
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– Data from Phase 3 ENERGIZE Study of Mitapivat in Non-Transfusion-Dependent Thalassemia to be Presented in Plenary Session –
GlobeNewswire Inc. • 1d ago
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SOUTH JORDAN, Utah, May 14, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced US Food and Drug Administration (FDA) 510(k) clearance for its Siege Vascular Plug. Merit also announced the launch of its Bearing nsPVA Express Prefilled Syringe in the United States and Australia.
GlobeNewswire Inc. • 1d ago
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Placental T Cells Demonstrated Greater Persistence, Resistance to Exhaustion and Efficacy Compared To Peripheral Blood Mononuclear Cells Placental T Cells Demonstrated Greater Persistence, Resistance to Exhaustion and Efficacy Compared To Peripheral Blood Mononuclear Cells
GlobeNewswire Inc. • 1d ago
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To learn more about ZyVersa's Inflammasome ASC Inhibitor and Renal Pipelines, schedule a one-on-one meeting on 2024 BIO International Conference's Portal.
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– Company enrolls 85 patients with R/R NPM1-mutant AML in fewer than 16 months –
GlobeNewswire Inc. • 1d ago
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RESEARCH TRIANGLE PARK, N.C., May 14, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) today announced that new data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) will be presented at the European Academy of Allergy and Clinical Immunology (EAACI) meeting in Valencia, Spain from May 31 to June 3, 2024.
GlobeNewswire Inc. • 1d ago
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Strong financial position with $157.3 million; runway into 2H 2026
GlobeNewswire Inc. • 2d ago
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ISELIN, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and Europe, today announced the submission of its Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) seeking authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD).
GlobeNewswire Inc. • 2d ago
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COPENHAGEN, Denmark, May 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced 2-year results from a post-hoc analysis of the Company’s Phase 3 PaTHway Trial demonstrating significant and sustained improvements in renal function in adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide). The data were shared in an oral presentation on May 12 by Peter Schwarz, M.D., Professor of Clinical Medicine at the University of Copenhagen, during the European Congress of Endocrinology 2024 (ECE 2024), the annual meeting of the European Society of Endocrinology.
GlobeNewswire Inc. • 2d ago
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REDWOOD CITY, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced the expansion of its mast cell development portfolio with a Phase 1b/2a study evaluating briquilimab in asthma patients that is expected to begin enrolling in the fourth quarter of 2024.
GlobeNewswire Inc. • 2d ago
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- In a pre-specified Cochran-Mantel-Haenszel sensitivity analysis applied to the entire intention-to-treat (ITT) population of the study (N=632), acoramidis significantly reduced all-cause mortality (p=0.04), with no safety signals of potential clinical concern
GlobeNewswire Inc. • 2d ago
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ASCO has informed the Company that the previously accepted MDNA11 oral abstract has been withdrawn due to alleged violation of their prior publication policy based solely on their review of the abstract presented at AACR 2024.
GlobeNewswire Inc. • 2d ago
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Initiated a Phase 2 clinical trial of APG777, a subcutaneous half-life extended monoclonal antibody targeting IL-13, in patients with moderate-to-severe atopic dermatitis, with 16-week proof-of-concept data from Part A of the trial expected in 2H 2025
GlobeNewswire Inc. • 2d ago
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FRACTYL HEALTH PRESENTS CLINICAL UPDATE ON REVITA® GERMAN REAL- WORLD REGISTRY FOR PATIENTS WITH ADVANCED TYPE 2 DIABETES (T2D)
GlobeNewswire Inc. • 2d ago
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LOS ANGELES, May 13, 2024 (GLOBE NEWSWIRE) -- RadNet, Inc. (NASDAQ: RDNT), a national leader in providing high-quality, cost-effective diagnostic imaging services through a network of fully-owned and operated outpatient imaging centers, today announced that Mark Stolper, Executive Vice President and Chief Financial Officer will be presenting at the Bank of America Securities 2024 Health Care Conference in Las Vegas, NV on Tuesday, May 14, 2024 at 3:00 p.m. Pacific Time.
GlobeNewswire Inc. • 2d ago
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92% (12/13) overall response rate (ORR) for relapsed/refractory AL Amyloidosis patients enrolled in NEXICART-1:
GlobeNewswire Inc. • 5d ago
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SOLANA BEACH, Calif., May 10, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today announced that it will be participating in the 2024 Pharma Partnering Summit being held May 14th – 15th in San Diego, California.
GlobeNewswire Inc. • 5d ago
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Segment to appear on Fox Business News on Sunday, May 12 at 5:30 p.m. ET
GlobeNewswire Inc. • 5d ago
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Research includes the first-ever application of AsCas12a in vivo, optimized LNP delivery, and gene editing RNA guide modifications
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NEW HAVEN, Conn., May 09, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that two posters, including updated clinical trial data, for vepdegestrant will be presented at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress held from May 15-17, 2024, in Berlin, Germany. Vepdegestrant is a novel investigational PROTAC® estrogen receptor (ER) degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
GlobeNewswire Inc. • 6d ago
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Acutus Medical Reports First Quarter 2024 Financial Results
GlobeNewswire Inc. • 6d ago
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-Preclinical findings show exosome-based therapeutic approach for the treatment of arginase-1 deficiency (ARG1-D)-
GlobeNewswire Inc. • 6d ago
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Surrozen Presents Data Demonstrating the Promise of Antibody Based Wnt Mimetics in Treating Cornea Endothelial Dystrophies and Dry Eye Disease at ARVO 2024
GlobeNewswire Inc. • 6d ago
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Pre-treatment Sample of Patient’s Blood Showed Rapid and Potent Depletion of CD19+ B Cells in Ex Vivo Cytotoxicity Assay with FT819
GlobeNewswire Inc. • 6d ago
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- FDA indicated IkT-001Pro can be considered a New Molecular Entity and is eligible for exclusivity designations in Pulmonary Arterial Hypertension –
GlobeNewswire Inc. • 6d ago
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MALVERN, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced successful completion of data cleaning for its Phase III study of buntanetap in patients with early Parkinson’s disease (PD). Topline efficacy data is expected in June.
GlobeNewswire Inc. • 6d ago
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SOUTH SAN FRANCISCO, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that management will participate in the following upcoming investor conferences:
GlobeNewswire Inc. • 6d ago
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$125 million of non-dilutive capital extends projected cash runway into late 2025, excluding expected commercial sales from XOLREMDI™ (mavorixafor)
GlobeNewswire Inc. • 6d ago
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Plus Therapeutics to Host Investor Call to Discuss Leptomeningeal Cancer Related Acquisition and Topline Clinical Trial Data from the FORESEE Trial
GlobeNewswire Inc. • 1w ago
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NEW YORK and WALTHAM, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced its participation in the Bank of America Securities 2024 Health Care Conference. Marino Garcia, Chief Executive Officer, will present a corporate overview on Tuesday, May 14, 2024 at 4:20 p.m. PT in Las Vegas.
GlobeNewswire Inc. • 1w ago
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- Company announces positive initial Phase 1a dose escalation data for monotherapy CX-904 (EGFRxCD3 T-cell engager) in solid tumors -
GlobeNewswire Inc. • 1w ago
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- CX-904 demonstrated a favorable safety profile with no cytokine release syndrome (CRS) of any grade observed in step-dosing cohorts and no grade >1 CRS observed overall -
GlobeNewswire Inc. • 1w ago
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ZUG, Switzerland, May 08, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced results for the three-month period ended March 31, 2024, and an overview of the Company’s progress.
GlobeNewswire Inc. • 1w ago
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DUBLIN, Ireland, May 08, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) a commercial stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced the appointment of Avinash Kale as Continuous Glucose Monitor (CGM) Programme Director. His appointment is a critical step forward in advancing the Company’s recently acquired CGM technology and in driving its innovation and development to bring an advanced CGM solution to the global market.
GlobeNewswire Inc. • 1w ago
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JUPITER, Fla., May 08, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial platforms to address the growing demand for global protein bioproduction and to develop and manufacture prophylactic, therapeutic, and nutritional biopharmaceutical products for human and animal health and wellness, today announced that its management will be attending the following industry and investor events during the month of May 2024.
GlobeNewswire Inc. • 1w ago
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CHARLOTTESVILLE, Va., May 08, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that the first patient has been dosed with sabirnetug (ACU193) in the ALTITUDE-AD Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of sabirnetug in patients with early AD.
GlobeNewswire Inc. • 1w ago
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Prime Medicine Presents Preclinical Data Demonstrating Ability of PM359 to Efficiently, Reproducibly and Durably Correct Causative Mutation of Chronic Gran
GlobeNewswire Inc. • 1w ago
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- ATH434-201 Trial on Track to Complete in November 2024 –
GlobeNewswire Inc. • 1w ago
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LONDON, May 08, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2024 and provided an update on recent business progress.
GlobeNewswire Inc. • 1w ago
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LONDON, May 08, 2024 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies.
GlobeNewswire Inc. • 1w ago