Aveo Oncology Received FDA Approval for FOTIVDA for Advanced RCC Aveo Oncology (AVEO) drug FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO plans to make FOTIVDA available to patients in the U.S. by March 31, 2021. …

Vir Biotechnology and GlaxoSmithKline Recommended to Stop Phase 3 COMET-ICE Trial Vir Biotechnology (VIR) and GlaxoSmithKline (

Updated Findings from bluebird bio bluebird bio analyses demonstrate lentiviral vector BB305 unlikely to be the cause of AML in a clinical study of LentiGlobin for SCD bluebird bio initiated a process with regulators to resume clinical studies bluebird bio (BLUE)

The Nonsensical Downgrading of Development-Stage Firms Like Intellia Therapeutics It makes no sense to downgrade a development-stage firm such as CRiSPR gene editing IntelliaTherapeutics (NTLA) when only based on stopping short of attaining analysts’ expectations with regard to revenues and incomes. Development-stage firms yet to have products on the market to generate money, contrarily, serious development-stage firms . . . This content is for paid …

Ovid Therapeutics & Takeda Announce Agreement for Soticlestat Ovid Pharmaceuticals is eligible to receive up to $856M in payments, including a $196M upfront payment, regulatory and commercial milestone payments and tiered double-digit royalties on product sales Potential first-in-class therapy reduced seizure frequency in children with Dravet syndrome and Lennox-Gastaut syndrome in Phase 2 ELEKTRA study Original 2017 collaboration between Ovid and Takeda to conclude; Ovid …

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 …

Aslan Pharmaceuticals  Aslan Pharmaceuticals (ASLN) is a clinical-stage immunology company announced positive interim unblinded data from three dose cohorts of its ongoing randomized, double-blind placebo-controlled multiple ascending dose study of ASLAN-004 for moderate to severe atopic dermatitis.   ASLAN004 was well tolerated across all doses. It demonstrated improvements compared . . . 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 (

Johnson & Johnson COVID-19 Vaccine According to a new analysis posted online by the FDA, the Johnson & Johnson (JNJ) vaccine is providing strong protection against severe disease and death related to COVID-19 infection. The vaccine may reduce the spread of the virus from vaccinated people. The vaccine is said to have a 72% efficacy rate in the U.S. and 64% in South Africa. The …

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 …

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 …

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. Look for them under Impacting News. Cassava Sciences …

Novavax Inc The Novavax (NVAX) COVID-19 Vaccine NVX-CoV2373 is on its way to reaching worldwide markets.  The Serum Institute of India (SII) and the Vaccine Alliance (Gavi) are to ensure equitable access to Novavax’s, NVX-CoV2373, vaccine worldwide across the low-, middle- and high-income countries. Memorandum of Understanding (MOU) between Gavi and Novavax to make available a cumulative volume of 1.1 billion doses of the Novavax vaccine to the COVAX Facility. The …

Immunome, Inc. Immunome, Inc (IMNM) announced today that its discovery engine has isolated potent antibodies capable of neutralizing several SARS-CoV-2 (the virus that causes COVID-19) variants, including the South African Variant (B.1.351), in pseudovirus testing.  This effort is part of the company’s . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Nektar Therapeutics YoYoing Stock Price Investors who exaggerate their enthusiasm, or their apathy, towards buying and selling biotechnology stocks have sent the Nektar Therapeutics (NKTR) stock price to the Moon but wasted no time bringing it back to Earth. This, of course, after we fell in love with it and selected it for investment purposes. We witnessed the stock reach near $80 only . . …

Vir Biotechnology and GlaxoSmithKline Expanded Collaboration  Vir Biotechnology (VIR) and GlaxoSmithKline plc (GSK) announced the signing of a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. The Expanded Collaboration This new collaboration builds on a 2020 agreement to research and develop therapies for coronaviruses and provides GlaxoSmithKline exclusive rights to collaborate …

bluebird bio Suspends LentiGlobin Studies bluebird bio (BLUE) placed its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease (SCD), bb1111, on a temporary suspension due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Regeneron Pharmaceuticals Approval of EvkeezaTM for HoFH Regeneron Pharmaceuticals (REGN) has a series of good news that the market does not seem to be aware of as the stock price has yet to react.   On February 11, 2021 Regeneron announced that the U.S. FDA has approved the firm’s product EvkeezaTM (evinacumab-dgnb) as an adjunct to . . . This content is for paid subscribers. Please …

Cassava Sciences Inc Opened Down Today Cassava Sciences, Inc. (SAVA) - a clinical-stage biotech firm focused on the treatment of Alzheimer’s disease, announced that it has entered into a definitive agreement with several healthcare-focused, and other institutional investors, for the purchase of 4,081,633 shares of its common stock at a purchase price of $49.00 per share for . . . This content is for paid subscribers. …