Category: News & Comments

ADC Therapeutics: Moving from a Development-Stage Firm to a Revenue-Generating Firm

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: Continuing to Offer Promising Results in Treating ALS

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 …

Gilead Sciences: Another Accelerated Cancer Approval from the FDA

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. See Also: TransMedics Group May Improve on Heart Transplants

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 …

Intellia Therapeutics’ Important Current Presentations

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 Announced Positive Results of Phase 3 Study Using 177Lu-PSMA-617 in Advanced Prostate Cancer Patients

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: Evaluating the Safety and Efficacy of Eftilagimod Alpha in Combination with Merck’s KEYTRUDA

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: The FDA Approved FOTIVDA for Adults with Relapsed or Refractory Advanced RCC

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 Voting Tomorrow with Expected Approval on Saturday

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 …

Cassava Sciences: Good News During Bad Market Days

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 is Bringing its COVID-19 Vaccine to the World’s Markets

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 …

Vir Biotechnology and GlaxoSmithKline Expanded Agreement

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 …

Researchers at the Children’s Hospital of Philadelphia are Improving Gene Therapy Vectors

The Children’s Hospital of Philadelphia: Improving Gene Therapy Vectors Improving gene therapy vectors seems to have come at the hands of researchers at Children’s Hospital of Philadelphia (CHOP). A gene therapy vector was developed for blood disorders like sickle cell disease (SCD) and beta-thalassemia, stating that this vector is potentially safer and more effective than those currently used in gene therapy trials for those conditions. …

Moderna COVID-19 Vaccine Produced Neutralizing Titers Against Key Emerging Variants Tested

Moderna COVID-19 Vaccination News A vaccination with the Moderna (MRNA) COVID-19 produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and the Republic of South Africa, respectively. The study showed no significant impact on neutralizing titers against the B.1.1.7 variant relative to prior variants. A six-fold reduction in neutralizing titers was observed with the B.1.351 variant …

Exelixis: The FDA Approved Cabometyx in Combination with Opdivo as a First Line Treatment of RCC

Exelixis: FDA Approval for Cabometyx in Combination with Opdivo  Exelixis (EXEL) announced that the United States FDA has approved CABOMETYX (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for patients with advanced renal cell carcinoma (RCC). RCC is among the 10 most frequently diagnosed cancers in the U.S. annually. Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and The …

Regenxbio: Advancing its Gene Therapy Pipeline and its Rare Neurodegenerative Disease Platform with Non-Dilutive Capital

Regenxbio Regenxbio (RGNX) announced that it is selling a portion of its royalty rights from the net sales of Zolgensma® by Novartis to entities managed by Healthcare Royalty Management, LLC (HCR) for $200 million. This transaction provides immediate, non-dilutive capital to Regenxbio in order continue the development of its gene therapy pipeline products and complete its internal manufacturing capabilities. Morgan Stanley & Co. LLC served …

Gilead Sciences has Good News for Relapsed or Refractory Mantle Cell Lymphoma and More

Gilead Sciences Company, Kite Pharma, News Kite Pharma, a Gilead Company (GILD), announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional …

Regenxbio Announced the First Patient has been Dosed in the Phase I/II trial of RGX-111 for MPS I

Regenxbio Dosed First Patient with RGX-111 for MPS I Regenxbio (RGNX) has dosed the first patient with RGX-111 in the Phase I/II trial for the treatment of Mucopolysaccharidosis Type I (MPS I). About Regenxbio Product RGX-111 RGX-111 is an investigational one-time gene therapy designed to deliver the α-l-iduronidase (IDUA) gene directly to the central nervous system (CNS) using the NAV AAV9 vector. RGX-111 is a …

Moderna’s Successful COVID-19 Vaccine Results

Moderna Has Successful COVID-19 Vaccine Results and News Moderna’s Phase 3 study met statistical criteria with a vaccine efficacy of 94.5%. Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months. Moderna (MRNA) announced that …

Moderna’s Future Growth

Moderna Inc COVID-19 Vaccine Candidate Moderna Inc (MRNA) announced the completion of the case accrual for the first interim analysis of Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate. The firm announced a significant increase in the rate of case identification across sites in the last week. As a result, the Company expects the first interim analysis will include substantially more than 53 …