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Prelude Therapeutics Announces First Quarter 2023 Financial Results and Operations Update
5/8/2023
Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the first quarter ended March 31, 2023, and provided an update on recent clinical and development pipeline progress.
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Scholar Rock to Present New Data Evaluating Apitegromab at 36 Months from the Phase 2 TOPAZ trial at the 2023 Annual Cure SMA Conference
5/8/2023
Scholar Rock announced today it will present extension data from the Phase 2 TOPAZ trial evaluating patient outcomes after 36 months of treatment with apitegromab.
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BioXcel Therapeutics Reports First Quarter 2023 Financial Results and Recent Operational Highlights
5/8/2023
BioXcel Therapeutics, Inc. today announced its financial results for the first quarter ended March 31, 2023, and provided an update on key strategic initiatives.
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Viatris Reports Strong Financial and Operational Results for First Quarter 2023 and Reaffirms Full-Year 2023 Guidance Ranges[1]
5/8/2023
Viatris Inc. (NASDAQ: VTRS) today reported strong results for the first quarter of 2023 reflecting another robust operational performance and instilling further confidence in the Company's ability to return to growth as it prepares to enter Phase 2 of its strategic plan in 2024.
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Marker Therapeutics Appoints Monic Stuart, M.D., as Chief Medical Officer
5/8/2023
Marker Therapeutics, Inc. today announced the appointment of Monic Stuart, M.D., as its new Chief Medical Officer.
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Zevra Announces Board of Directors and Leadership Changes
5/8/2023
Zevra Therapeutics, Inc. today announced changes to the Company’s Board of Directors (“Board”) and leadership. At the Company’s recent 2023 Annual Meeting of Stockholders (“Annual Meeting”), Zevra shareholders elected John B. Bode, Douglas W. Calder and Corey Watton to Zevra’s Board.
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FibroGen Enters into Exclusive License for FOR46 with Fortis Therapeutics
5/8/2023
FibroGen, Inc. (Nasdaq: FGEN) and Fortis Therapeutics announced that FibroGen has entered into an exclusive license with Fortis Therapeutics for FOR46, a potential first-in-class Phase 1 antibody-drug conjugate (ADC) targeting a novel epitope on CD46.
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Pulmonary Fibrosis Foundation Urges Patients to Use Only FDA-Approved Oxygen Delivery Devices
5/8/2023
The medical advisory board of the Pulmonary Fibrosis Foundation (PFF), the nation's leading pulmonary fibrosis (PF) research, education, and advocacy organization, has issued a position statement on non-prescription supplemental oxygen.
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Nephros Announces CEO Retirement and Succession Plan
5/8/2023
Nephros, Inc. today announced that Andy Astor, President and Chief Executive Officer, will retire in the coming months, and that Robert Banks will be named President and Chief Executive Officer effective on the first business day after the filing of Nephros’ Form 10-Q for the quarter ended March 31, 2023.
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ConcertAI's TeraRecon Expands AI Model and Clinical Collaboration Capabilities of Eureka Clinical AI
5/8/2023
ConcertAI's TeraRecon, the advanced visualization and clinical AI SaaS category leader, announced the launch of its enhanced, next-generation Eureka Clinical AI platform.
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Chance Pharmaceuticals and Acorda Therapeutics Announce Agreement to Provide INBRIJA® in Greater China
5/8/2023
Chance Pharmaceuticals and Acorda Therapeutics, Inc. today announced that they have entered into distribution and supply agreements to provide INBRIJA ® in Greater China (Mainland China , Taiwan , Hong Kong , and Macao ). INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
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Trefoil Therapeutics’ Lead Investigational Candidate TTHX1114 Improves Rate of Visual Recovery after Descemet Stripping Only (DSO) in Phase 2 STORM Data Presented at ASCRS Annual Meeting
5/8/2023
Trefoil Therapeutics today announced that TTHX1114 was found to improve the rate of visual recovery and corneal deturgescence (state of relative dehydration maintained by the normal cornea that is necessary for transparency) after Descemet Stripping Only (DSO) in a dose-responsive manner in the Phase 2 STORM study.
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Singlera Genomics Receives FDA Breakthrough Device Designation for PDACatch, a Liquid Biopsy Assay for Pancreatic Cancer Detection in High-Risk Individuals
5/8/2023
Singlera Genomics today announced that it had received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its PDACatch assay, a novel DNA methylation-based liquid biopsy assay for the detection of pancreatic adenocarcinoma in individuals at high risk for the disease.
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MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System
5/8/2023
MCRA, LLC is pleased to announce its role in assisting Noctrix Health obtain marketing authorization via a De Novo Request from the U.S. Food and Drug Administration (FDA) for the NTX100 Tonic Motor Activation (NTX100 TOMAC) System.
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Catalent Delays Third Quarter Results and Conference Call and Provides Update on Fiscal 2023 Guidance
5/8/2023
Catalent, Inc. today announced that it will be delaying the release of its third fiscal quarter results and investor conference call, previously scheduled for Tuesday, May 9, 2023.
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Enanta Pharmaceuticals Reports Positive Topline Results from Phase 2 SPRINT Trial Evaluating EDP-235 in Standard Risk Patients with COVID-19
5/8/2023
Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA) today announced topline data from SPRINT (SARS-Cov-2 PRotease INhibitor Treatment), a double-blind, placebo-controlled Phase 2 clinical trial of EDP-235, Enanta’s oral, 3CL protease inhibitor, in non-hospitalized, symptomatic adults with mild or moderate COVID-19 who were not at high risk for severe disease.
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Illumina Sends Letter to Shareholders Highlighting Board Strength, Weakness of Icahn's Plan
5/8/2023
Illumina (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today issued a shareholder letter highlighting the strength of its Board and noting that Carl Icahn's "plan" for Illumina is sloppy and uninformed.
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Sana Biotechnology Announces Preclinical Data Published in Nature Biotechnology Demonstrating its Hypoimmune-Engineered Cells Escape Immune Detection and Survive While Remaining Fully Functional
5/8/2023
Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that Nature Biotechnology has published a paper titled “Hypoimmune induced pluripotent stem cells survive long term in fully immunocompetent, allogeneic rhesus macaques.”
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Viridian Therapeutics Announces Partnership with Drug Delivery Innovator Enable Injections
5/8/2023
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced a new partnership with Enable Injections, a company developing and manufacturing the enFuse® innovative wearable drug delivery system for volumes of up to 25mL.
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Akebia Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights
5/8/2023
Akebia to host conference call on May 8 at 8:30 a.m. ET.