Vivos Therapeutics Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea
With this unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of...
Day: November 29, 2023
SAB Biotherapeutics Announces Commencement of the HUMAN Phase 1 Clinical Trial with SAB-142, a Potential Disease-Modifying Treatment for Type 1 Diabetes
First subject has been dosed in the first-in-man Phase 1 clinical study of SAB-142, the first fully-human anti-thymocyte immunoglobulin (ATG)...
Eagle Pharmaceuticals Announces Management Change
– CEO and Founder Scott Tarriff Retires – – Chairman Michael Graves to Serve as Interim Executive Chairman – WOODCLIFF...
22nd Century Appoints Larry Firestone as Chairman and CEO
Turnaround Veteran to Focus on Unlocking Shareholder Value in Tobacco AssetsBUFFALO, N.Y., Nov. 29, 2023 (GLOBE NEWSWIRE) -- 22nd Century...
uniQure Announces FDA Clearance of Investigational New Drug Application for AMT-191 Gene Therapy for Fabry Disease
Patient enrollment expected to begin in first half of 2024LEXINGTON, Mass. and AMSTERDAM, Nov. 29, 2023 (GLOBE NEWSWIRE) -- uniQure...
LSL Pharma Group Announces its Results for the Third Quarter of Fiscal 2023
Revenues of $2.5M, up 25% over the last two quarters of the year;Gross margin of 18.6%, up sharply on last...
KSQ Therapeutics Announces FDA Clearance of IND Application for KSQ-001EX, a CRISPR/Cas9 Engineered Tumor Infiltrating Lymphocyte (eTIL®) Therapy
Phase 1/2 clinical study will evaluate the safety, pharmacokinetics, and preliminary efficacy of KSQ-001EX in melanoma, head and neck squamous...
Athira Pharma to Participate in Sidoti December Small Cap Investor Conference
Company Presentation to highlight novel therapeutic candidates targeting the HGF neurotrophic system in late-stage clinical development in neurodegenerative diseases, including...
BioCryst Announces Approval of ORLADEYO® (berotralstat) by the National Administration of Drugs, Foods, and Medical Devices (ANMAT) in Argentina
RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the National Administration...
Verge Genomics Will Use Modality.AI in Its ALS Phase 1b Clinical Trial of Its Lead Drug Candidate VRG50635
Modality’s multimodal AI platform will capture critical speech and language changesSOUTH SAN FRANCISCO, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) --...
BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval
SUNNYVALE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. , a developer of cellular and cell-derived therapeutics for the...
PreludeDx to Present Data for a Novel Molecular Biosignature to Predict Radiation Therapy Benefit in Early-Stage Invasive Breast Cancer at the 2023 San Antonio Breast Cancer Symposium
SABCS Logo San Antonio Breast Cancer Symposium LAGUNA HILLS, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Prelude Corporation (PreludeDx), a...
SpringWorks Therapeutics to Participate in the 6th Annual Evercore ISI HealthCONx Conference
STAMFORD, Conn., Nov. 29, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe...
XORTX Meets Nasdaq Continued Listing Requirements
CALGARY, Alberta, Nov. 29, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX...
Generation Bio Announces Strategic Reorganization to Extend Cash Runway for Development of ctLNP and iqDNA Platforms
Company to invest in highly selective cell-targeted lipid nanoparticle (ctLNP) delivery platform to develop wholly-owned programs for extrahepatic cell typesDevelopment...
BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis
BX004 showed clinically meaningful improvement in pulmonary function as measured in FEV11 and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain in...
Cerevel Therapeutics to Host Investor Webcast on Tavapadon in Parkinson’s Disease
Event will focus on tavapadon, a D1/D5 partial agonist in Phase 3 development for the treatment of Parkinson’s disease Live...
Ascendis Pharma Announces Strategic Partnership with Teijin Limited in Japan
– Teijin to receive exclusive license to further develop and commercialize TransCon™ hGH, TransCon™ PTH, and TransCon™ CNP in Japan...
Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®
The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary...
Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®
The study, assessing pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® (golimumab) in healthy adult subjects, met its primary...