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 …

Sutro Biopharma Receives Milestone Payment from Merck KGaA, Darmstadt, Germany Sutro Biopharma (STRO) announced that it has received a milestone payment under its collaboration and license agreement with the healthcare division of Merck KGaA, Darmstadt,Germany. The payment is related to a patient enrollment achievement in the Phase 1 dose-escalation and expansion study of M1231 in adult patients . . . This content is for paid …

Amgen Announced FDA Approval of LUMAKRAS™  Amgen (AMGN) announced the news about the FDA approval of LUMAKRAS™ (sotorasib) on May 28, 2021. The firm indicated that the FDA granted approval is for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. LUMAKRAS received . . . This content is for paid subscribers. Please …

GlaxoSmithKline and Vir Biotechnology are Granted an EUA for Sotrovimab GlaxoSmithKline (GSK) and Vir Biotechnology (VIR) announced the U.S. FDA has . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Aptevo Therapeutics Inc in the News Aptevo Therapeutics Inc (APVO) has positive results from the Phase 1 dose-escalation trial evaluating its lead ADAPTIR candidate product APVO436 for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). APVO436 APVO436 - Aptevo's bispecific ADAPTIR that targets CD123 x CD3, is designed to redirect the immune system . . . This content is for paid subscribers. …

Prilenia Therapeutics Prilenia Therapeutics is a clinical-stage biotech company. The firm’s leader, Michael Hayden, MD, PhD., is a world-renowned scientist in Huntington’s Disease (HD) research. Dr. Hayden was the President of Global R&D and Chief Scientific Officer at Teva Pharmaceuticals, where he led the development of 35 new products towards approval in several major markets, predominantly in the central nervous system (CNS). Michael Hayden and …

Recursion Pharmaceuticals Product REC-163964 Recursion Pharmaceuticals Inc (RXRX) announced the initiation of an investigational new drug (IND)-enabling studies for REC-163964, a first-in-class, small molecule toxin inhibitor for possible prevention of recurrent Clostridium difficile (C. difficile) infections and potential prophylactic use in high-risk patients. REC-163964 is a new chemical entity and the first to be . . . This content is for paid subscribers. Please click here …

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.

Reata Pharmaceuticals Good News Reata Pharmaceuticals (RETA) announced it received a communication from the Division of Neurology Products of the U.S. FDA stating, that after a preliminary review of briefing materials for an upcoming Type C meeting, a pre-NDA meeting is the most appropriate format for a discussion of the development program for omaveloxolone in Friedreich’s ataxia The Division suggested that the Company withdraw the …

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

Sanofi and GlaxoSmithKline COVID-19 Vaccine Sanofi (SNY) and GlaxoSmithKline (GSK

AstraZeneca and Amgen Announced Results for Tezepelumab for Severe Asthma Tezepelumab Reduced Exacerbations by 77% in Subgroup of Patients with Elevated Inflammatory Biomarkers in NAVIGATOR  Tezepelumab Reduced Exacerbations Requiring Hospitalization by 85% AstraZeneca (AZN) and Amgen (

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 …

Cassava Sciences Awarded NIH Research Grant for Simufilam Cassava Sciences (SAVA) announced that it has been awarded a new $2.7 million research grant from the National Institutes of Health (NIH). The grant was awarded following a peer review of clinical and scientific data for simufilam, its drug candidate for Alzheimer's disease, and is intended to fund clinical readiness activities . . . This content is …

Sutro Biopharma Inc Sutro Biopharma (STRO) is a clinical-stage drug discovery, development and manufacturing company. Its expertise is in the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics. Sutro Biopharma reported its financial results for the first quarter of 2021 and its recent business highlights, in addition to providing a preview of anticipated selected . . . This content …

ADC Therapeutics First Quarter Financial Results and Business Updates ADC Therapeutics SA (ADCT) is a commercial-stage biotechnology company that creates novel antibody-drug conjugates (ADCs) for the treatment of hematological malignancies and solid tumors.   Today, ADC Therapeutics reported its first-quarter financial results and offered its business updates. It began with Chris Martin, Chief Executive Officer, stating, “We are off to an exciting start to the year …

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 …

Gilead Sciences First-Quarter 2021 Financial Results Conference Call Info Gilead Sciences (GILD) management will host a conference call to discuss the company’s first-quarter 2021 financial results and will provide a business update today, Thursday, April 29, at 4:30 p.m. EST.  Investors can dial 1-877-359-9508 (U.S.) or 1-224-357-2393 (international) to reach . . . This content is for paid subscribers. Please click here to subscribe or here to …