Jounce Therapeutics Inc: US FDA Cleared IND Application for JTX-1811 Targeting CCR8 Jounce Therapeutics Inc (JNCE) - a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for its product JTX-1811, an anti-CCR8 antibody.

Veracyte Inc Decipher® Prostate Test Veracyte Inc (VCYT): New data that demonstrated the prognostic utility of its Decipher® Prostate genomic classifier in men with non-metastatic castration-resistant prostate cancer (nmCRPC) has been published online in

Vertex Pharmaceuticals Receives FDA Approval for TRIKAFTA® Vertex Pharmaceuticals (VRTX) announced the U.S. FDA approved the expanded use of TRIKAFTA® to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive . . . This content is for paid subscribers. Please click here to …

Clinical Holds on bluebird bio Gene Therapies were Lifted by the FDA The U.S. FDA has lifted the clinical holds on the bluebird bio (BLUE) Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) for adult and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Focus on Intellia Therapeutics Upcoming Presentation for NTLA-2001 Data to offer insight into safety and pharmacodynamics of NTLA-2001, the first-ever systemically administered in vivo CRISPR therapy candidate Late-breaking abstract selected for oral presentation on June 26 Intellia Therapeutics NTLA-2001 for People Living with hATTR-PN Intellia Therapeutics (NTLA) announced that Phase 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

BridgeBio Pharma Granted Fast Track Designation for Encaleret BridgeBio Pharma (BBIO) announced the U.S. FDA granted Fast Track designation for Encaleret – a treatment of autosomal dominant hypocalcemia (ADH1), on World Hypoparathyroidism Awareness Day, an annual global awareness event meant to support people who are living with ADH1 and with other types of hypoparathyroidism. ADH1 is a rare, genetic form of . . . This …

Annovis Bio Inc and Neurodegenerative Diseases Annovis Bio Inc (ANVS), a clinical-stage drug platform company. This firm's focus is the treatment of neurodegenerative diseases. Annovis Bio Inc announced today new results from a double-blind, placebo-controlled study of its product ANVS401, the Company's lead . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Bristol-Myers Squibb and Agenus Agreement for AGEN1777 Bristol-Myers Squibb (BMY) and Agenus (

Compugen Updated Trial Data  Updated data from COM701 Phase 1 combination and monotherapy studies to be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting Milestone rich 2021 to include data readouts from ongoing COM701 triple combination study and COM902 monotherapy study in Q4 2021 Initiation of Phase 1b cohort expansion study of COM701 with Opdivo® in Q2 2021 and Phase 1 …

Editas Medicine Reporting Editas Medicine (EDIT) reported business highlights and financial results for the first quarter of 2021. The reporting started with James C. Mullen, Chairman, President and Chief Executive Officer, Editas Medicine stating that Editas’ team is making tremendous progress towards discovering, developing, and manufacturing novel genome editing medicines, including excellent forward momentum this quarter for the firm’s two . . . This content …

Vertex and CRISPR Granted PRIME Designation from the EMA for CTX001 Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (

Gilead Sciences and Eisai Pharmaceutical Co Submitted an Application to Japan's PMDA for Filgotinib Galapagos NV (GLPG) announced that Gilead Sciences (

European Authorities Recommended Additional Approval of Bristol-Myers Squibb Product Onureg® for AML Bristol-Myers Squibb (BMY): The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Onureg® (azacitidine tablets; CC-486) as maintenance therapy in adult patients with acute myeloid leukemia (AML). The approval is for the AML . . . This content is for paid subscribers. Please click here …

Cassava Sciences Guidance and Financial Results Cassava Sciences (SAVA) announced financial results for the first quarter ended March 31, 2021 as well as its guidance regarding the release of new clinical data with simufilam, the Company’s lead drug candidate to treat Alzheimer’s disease. Investors and shareholders of this firm are impatiently waiting for more news about the firm’s . . . This content is for …

Inovio Pharmaceuticals Promising Results for INO-4800 for COVID-19 Inovio Pharmaceuticals (INO) announces promising results of a study focusing on the human immune responses induced by Inovio DNA vaccine candidate, INO-4800, against COVID-19, and variants of concern. The results demonstrated that INO-4800 induced a robust T . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

vTv Therapeutics Receives Breakthrough Therapy Designation for TTP399 vTv Therapeutics (VTVT) - a clinical-stage biopharmaceutical company focused on the development of oral treatments for type 1 diabetes, psoriasis, and other diseases, announced that the U.S. FDA has granted Breakthrough Therapy designation for TTP399 as adjunctive therapy to insulin for the treatment of type 1 diabetes. About vTv Therapeutics Product TTp399 . . . This content …

Gilead Sciences is Granted FDA Approval for Trodelvy® Gilead Sciences (GILD), a company that has been granted more approvals than many are aware of except for the short analysts and their followers, today announced that the U.S. FDA has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or . . . This content is for paid subscribers. Please click here …

Illumina Acquisition of GRAIL On September 21, 2020, Illumina and GRAIL Inc. announced that they entered into a definitive agreement under which Illumina will acquire GRAIL for cash and stock consideration of $8 billion, upon closing of the transaction. On March 31, 2021, Illumina announced that it disagrees with, and will oppose, the U.S. Federal Trade Commission's (FTC) challenge to its previously announced acquisition of GRAIL. Illumina …

Negative News from Ionis Pharmaceuticals  Ionis Pharmaceuticals (IONS) announced that its partner, Roche (RHHBY),

CureVac CureVac B.V. (CVAC) is a global biopharmaceutical company specializing in messenger RNA (mRNA) technology. The firm has more than 20 years of expertise in developing and optimizing versatile biological molecules for prevention and treatment purposes. CureVac’s proprietary technology principle is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce . . . This content is for …