Sutro Biopharma Inc Granted Fast Track Designation for STRO-002 by the US FDA Sutro Biopharma Inc (STRO) announced that the U.S. FDA granted Fast Track designation for its STRO-002 – a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior lines of systemic therapy. From …

BeiGene Ltd and EUSA Pharma Receive Approval from China NMPA for QARZIBA®  BeiGene Ltd (BGNE) and EUSA Pharma announced that China National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response followed by myeloablative therapy and stem cell …

Cassava Sciences Inc Press Release Related to Positive Biomarker Data  Cassava Sciences Inc (SAVA) announced today, in a press release, positive biomarker data from an open-label study of simufilam, the Company’s investigational drug for the treatment of Alzheimer’s disease. In a clinical study funded by the National Institutes of Health (NIH), simufilam significantly improved all measured biomarkers in patients with Alzheimer’s disease following 6 months of open-label …

Cassava Sciences: Positive Clinical Data with SavaDX Cassava Sciences (SAVA) today announced positive clinical data with SavaDx, an investigational diagnostic/biomarker to detect Alzheimer’s disease with a simple blood test. SavaDx was used to measure plasma levels of altered filamin A before and after simufilam treatment in patients with Alzheimer’s disease. In this Phase 2b randomized, controlled trial sponsored by the National Institutes of Health (NIH), simufilam significantly reduced …

Immunome Inc: Neutralizing SARS-C0V-2 Delta Variant Immunome Inc (IMNM) is a small biotech firm whose stock soared after announcing today that its three-antibody cocktail (IMM-BCP-01) demonstrated potent neutralizing activity against the SARS-CoV-2 (the virus that cause COVID-19) Delta variant in pre-clinical pseudovirus testing. The IMM-BCP-01 cocktail demonstrated in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance. From the …

Celldex Therapeutics is Soaring Celldex Therapeutics (CLDX) stock soared following the firm’s announcement of updated data from its ongoing, open-label Phase 1b clinical trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism, which are the two most common forms of chronic inducible urticaria. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and …

TRxADE HEALTH Inc TRxADE HEALTH Inc (MEDS) is a health service IT company focused on digitalizing the retail pharmacy experience by optimizing drug procurement, the prescription journey, and patient engagement in the U.S.. The firm operates the TRxADE drug procurement marketplace serving a total of 12,100+ members nationwide, fostering price transparency. Under the Bonum Health brand, the firm offers patient-centric telehealth services. For more information, please visit …

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 …

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 …

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 …

Amylyx Pharmaceuticals Updated Plans to Advance AMX0035 Amylyx Pharmaceuticals, Inc. provided an update on its plans to advance AMX0035 through the clinical development process for the treatment of amyotrophic lateral sclerosis (ALS). The company intends to submit a Marketing Authorization Application (MAA) for AMX0035 to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) by the end of 2021. And, as …

FDA Grants Accelerated Approval for Gilead Sciences Trodelvy® The United States Food and Drug Administration (FDA) has granted accelerated approval of Gilead Sciences (GILD) product Trodelvy® (sacituzumab govitecan-hziy). The approval is for use of the product in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 …

Exelixis Latest News The latest news announced by Exelixis (EXEL) is the FDA acceptance of its New Drug Application (NDA) that evaluates the safety, tolerability, pharmacokinetics and preliminary antitumor activity of the firm’s investigational product XB002 in advanced solid tumors. XB002 is an antibody-drug conjugate (ADC) composed of a human monoclonal antibody against tissue factor. After binding to tissue factor on tumor cells, XB002 is …

Current Presentations from Intellia Therapeutics  Intellia Therapeutics (NTLA) is presenting the first preclinical data set on its novel cytosine deaminase base editor technology at the seventh Cold Spring Harbor Laboratory (CSHL) virtual scientific meeting on Nucleic Acid Therapies. The data shows how the Company’s proprietary base editors can expand its genome editing capabilities by enabling the introduction of multiple gene knockouts simultaneously with no detectable increase in …

Novartis Positive Results for Radioligand Therapy, 177Lu-PSMA-617, for mCRPC Novartis (NVS) reported the first interpretable results of evaluating the efficacy and safety of 177Lu-PSMA-617, a targeted radioligand therapy, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) compared to the best standard of care alone. The good news is that the trial has met both primary endpoints of overall survival (OS) and radiographic progression-free …

Immutep Ltd and Merck Announce Second Clinical Trial Collaboration Immutep (IMMP) develops novel immunotherapy treatments for cancer, infectious disease and autoimmune diseases. Today, Immutep announced a second clinical trial collaboration and supply agreement with Merck & Co (MRK) subsidiaries, Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada). Immutep will conduct a new Phase IIb clinical trial in 1st line head and …

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. …

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. 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 …