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. …

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 …

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 (

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 …

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 …

AstraZeneca: Tagrisso for Adult Patients with Early-Stage EGFRm NSCLC... AstraZeneca (AZN): Tagrisso (osimertinib) has been recommended for marketing authorization in the European Union for the adjuvant treatment of adult patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Sanofi and AstraZeneca MELODY Trial Results for Nirsevimab In March 2017, Sanofi (SNY) and AstraZeneca (

Humanigen Product Lenzilumab Combination with CAR-T At the recommended Phase 2 dose, lenzilumab in combination with CAR-T demonstrated a 100% objective response rate and no severe cytokine release syndrome or severe neurotoxicity Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and IP-10 (CXCL-10) among others Humanigen now plans to conduct a randomized, potentially registrational, Phase 2 study with lenzilumab combined with all commercially available CD19 CAR-T …

Vir Biotechnology and GlaxoSmithKline in April 2020  In April 2020, Vir Biotechnology and GlaxoSmithKline entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic …

Intellia Therapeutics NTLA-2001 for ATTR Granted Orphan Drug Designation by the EC Intellia Therapeutics (NTLA) announced that the European Commission (EC) has granted its product NTLA-2001 orphan drug designation. The investigational product is being developed as a treatment for transthyretin amyloidosis (ATTR), a rare condition that can impact a number of organs and tissues within the . . . This content is for paid subscribers. Please click here …

Exelixis Boxed in on Good News Exelixis (EXEL) is one of the firms boxed in by rule of thumb traders and short-sellers who put enormous pressure on biotech firms regardless of their good news. We sincerely believe that is what's happening to EXEL. We also believe that these firms, especially the achievers . . . This content is for paid subscribers. Please click here to subscribe …

Rubius Therapeutics Finding small development-stage biotech firms that contribute to biotechnology's limitless revolution of the biological sciences is difficult, but indispensable. Falling on firms that might have the science, the technological capability and the inspiration towards creating new diagnostics and treatments for severe diseases, is rewarding through improving lives.       Learning about Rubius Therapeutics (RUBY) has given us the impression . . . This content …

KemPharm Inc KemPharm Inc (KMPH) - a specialty pharmaceutical focused on the discovery and development of proprietary prodrugs, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for AZSTARYS™, a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Johnson & Johnson Receives an EUA from the U.S. FDA We appreciate the U.S. Food and Drug Administration's emergency use authorization (EUA) for the third vaccine for the prevention of SARS-CoV-2 (the virus that causes COVID-19). Three vaccines are definitely better than two and now, the third vaccine, which belongs to Johnson & Johnson (

QIAGEN and Inovio Pharmaceuticals Partnership QIAGEN (QGEN) and Inovio Pharmaceuticals (

The market is sinking in a furious mood caused by the failure to figure out the pathway of criteria, which is currently controlling the stocks’ volatile performances. Today we are posting good news coming from a few biotech companies with solid fundamentals. Unfortunately, all of these firms are tumbling instead of soaring, or at least performing positively. The first is under News & Comments and …