Month: April 2021

Gilead Sciences Conference Call Information. See Also: Compugen Announcements

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 Recommended for Marketing Authorization in the EU for Early Stage EGFRm NSCLC

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.

Celldex Therapeutics See Also: More of Your Questions Answered

Prohost Portfolio PLUS #4 Celldex Therapeutics Celldex Therapeutics (CLDX) stock is gaining momentum. On April 12, 2021 Celldex announced its presentation of promising data from its growing bispecific platform at the American Association of Cancer Research (AACR) Annual Meeting 2021 held between April 10th – 15th. The Company described the discovery . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Bristol-Myers Squibb: CHMP of the EMA Recommended Additional Approval of Onureg® as Maintenance Therapy for AML

European Authorities Recommended Additional Approval of Bristol-Myers Squibb Product Onureg® for AML Bristol-Myers Squibb (BMY): The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Onureg® (azacitidine tablets; CC-486) as maintenance therapy in adult patients with acute myeloid leukemia (AML). The approval is for the AML . . . This content is for paid subscribers. Please click here …

Humanigen Inc Product Lenzilumab Combination with CAR T in DLBCL Protects from Severe Cytokine Syndrome

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 …

Cassava Sciences Guidance for Simufilam. See Also: Its First Quarter 2021 Financial Results

Cassava Sciences Guidance and Financial Results Cassava Sciences (SAVA) announced financial results for the first quarter ended March 31, 2021 as well as its guidance regarding the release of new clinical data with simufilam, the Company’s lead drug candidate to treat Alzheimer’s disease. Investors and shareholders of this firm are impatiently waiting for more news about the firm’s . . . This content is for …

Vir Biotechnology and GlaxoSmithKline: The European Medicines Agency Started a Review of VIR-7831 for COVID-19

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 …

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 …

CureVac N.V.

Prohost Portfolio PLUS #3 CureVac N.V. We were looking forward to learning more important details about the German firm, CureVac N.V. (CVAC), when the company announced business updates and financial results for its fourth quarter and full-year 2020. The reason for our interest was the fact that the U.S. was looking to take over this firm two years ago to no avail. A more important …

Inovio DNA Vaccine Candidate INO-4800 has Promising Results. Read Also: Sutro Biopharma Good News

Inovio Pharmaceuticals Promising Results for INO-4800 for COVID-19 Inovio Pharmaceuticals (INO) announces promising results of a study focusing on the human immune responses induced by Inovio DNA vaccine candidate, INO-4800, against COVID-19, and variants of concern. The results demonstrated that INO-4800 induced a robust T . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 …

The FDA Granted Breakthrough Therapy Designation to vTv Therapeutics for Type 1 Diabetes Product TTP399

vTv Therapeutics Receives Breakthrough Therapy Designation for TTP399 vTv Therapeutics (VTVT) - a clinical-stage biopharmaceutical company focused on the development of oral treatments for type 1 diabetes, psoriasis, and other diseases, announced that the U.S. FDA has granted Breakthrough Therapy designation for TTP399 as adjunctive therapy to insulin for the treatment of type 1 diabetes. About vTv Therapeutics Product TTp399 . . . This content …

Re-Working Some Evaluated Biotechnology Firms

Prohost Portfolio PLUS #2 Re-Working Some Evaluated Biotechnology Firms Exelixis: 2020 and 2021 Wondering why Exelixis’ (EXEL) stock has looked paralyzed for more than two years? To know better about Exelixis the entrepreneur and Exelixis the creative scientific institution, we decided to go to the recorded Exelixis history, financial results and scientific . . . This content is for paid subscribers. Please click here to subscribe …

Gilead Sciences: FDA Fully Approves Trodelvy for Metastatic TNBC

Gilead Sciences is Granted FDA Approval for Trodelvy® Gilead Sciences (GILD), a company that has been granted more approvals than many are aware of except for the short analysts and their followers, today announced that the U.S. FDA has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or . . . This content is for paid subscribers. Please click here …

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 Announces More Good News

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 CABOMETYX: Now Approved in Europe for First-Line Treatment of Renal Cell Carcinoma

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 …