Author: Prohost

Annovis Bio Inc: Very Encouraging Trial Results in Neurodegenerative Diseases

Annovis Bio Inc and Neurodegenerative Diseases Annovis Bio Inc (ANVS), a clinical-stage drug platform company. This firm's focus is the treatment of neurodegenerative diseases. Annovis Bio Inc announced today new results from a double-blind, placebo-controlled study of its product ANVS401, the Company's lead . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Reata Pharmaceuticals: Good News from the FDA Regarding Omaveloxolone for Friedreich’s Ataxia

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 …

Compugen: First Quarter Financial Results, Accomplishments and Future Plans

Compugen Updated Trial Data  Updated data from COM701 Phase 1 combination and monotherapy studies to be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting Milestone rich 2021 to include data readouts from ongoing COM701 triple combination study and COM902 monotherapy study in Q4 2021 Initiation of Phase 1b cohort expansion study of COM701 with Opdivo® in Q2 2021 and Phase 1 …

Cassava Sciences Awarded NIH Grant. See Also: Intellia Therapeutics Presentations at the 24th ASGCT Meeting

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: First Quarter Financial Results, Business Highlights and More

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 …

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 …

Editas Medicine: Business Highlights and Financial Results Reported

Editas Medicine Reporting Editas Medicine (EDIT) reported business highlights and financial results for the first quarter of 2021. The reporting started with James C. Mullen, Chairman, President and Chief Executive Officer, Editas Medicine stating that Editas’ team is making tremendous progress towards discovering, developing, and manufacturing novel genome editing medicines, including excellent forward momentum this quarter for the firm’s two . . . This content …

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.

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 …