Tag: Gilead Sciences (GILD)

Positive News for Two Undervalued Firms in the Prohost Portfolio

Exelixis CABOMETYX Approval Exelixis (EXEL) partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), which is refractory or not eligible to radioactive iodine (RAI . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Gilead Sciences: Remdesivir is the First and Only Approved Treatment for Pediatric Patients with COVID-19. See Also: Cassava Sciences

Gilead Sciences Receives sNDA from the FDA for Remdesivir for Pediatric Patients with COVID-19 Gilead Sciences (GILD) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury®, aka remdesivir, for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and . . . This content is for paid subscribers. …

Gilead Sciences: The FDA Lifts Partial Clinical Hold on MDS and AML Magrolimab Studies. See Also: BioNTech

FDA Lifts Partial Clinical Hold on Gilead Sciences Studies of Magrolimab On April 12, 2022, Gilead Sciences (GILD) announced that the U.S. FDA lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. The FDA removed the partial hold after reviewing the comprehensive safety data from each trial. Enrollment in the U.S. can resume . . . This …

Gilead Sciences: The FDA Approved Yescarta® – The First CAR T-Cell Therapy for Initial Treatment of Relapsed or Refractory LBCL

Gilead Sciences' Product Yescarta Kite - a Gilead Sciences (GILD) Company, announced the U.S. FDA has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) refractory to first-line chemo-immunotherapy or that which relapses within 12 months of first-line chemo-immunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant . . . This content is for paid subscribers. Please click here to subscribe or …

Some Ideas About the Falling Stock Market Day

The Stock Market Today Before the end of 2021 we recognized that investors were not going to swallow what was reiterated about the strong economy. The fact was there were no criteria for a strong economy. Instead, the unparalleled inflation problem was confirmed, which, normally, is expected to negatively impact most of the criteria of a strong economy. The stock market looked to be outperforming …

We Are Back

We Are Back! Thanks to God. Hello to all our subscribers. Our sickness was unanticipated, making our year start in February rather than January. We will tackle the sickness later in another article. Now it is time to appreciate and offer our love and thanks from the bottom of our hearts for those who wished us well, prayed for our recovery and made it happen. …

The Omicron Variant and the Bizarre Stock Market Chaos

The Bizarre Assessment of Biotech Firms in the Stock Market The Clinical-Stage Biotechnology Firms  We are witnessing inexplicable evaluations of clinical-stage biotechnology companies. Bizarre is the best description of this group’s assessment which is based on incomes that do not exist in biotech firms that are yet to have approved and marketed products anywhere in the world. Unfortunately, the most impacted firms by the bizarre …

Let’s Talk About 3 Firms with Important News: Cassava Sciences, Vertex Pharmaceuticals and Gilead Sciences

Cassava Sciences, Vertex Pharmaceuticals and Gilead Sciences All Have Good News Cassava Sciences & Alzheimer's Disease Cassava Sciences (SAVA) announced the initiation of a second Phase 3 trial of simufilam, its investigational drug for Alzheimer’s disease. This second Phase 3 study is designed to evaluate the safety and efficacy of simufilam over 78 weeks in approximately 1,000 Alzheimer’s . . . This content is for …

Gilead Sciences and Merck Initiate Phase 2 Study Evaluating Lenacapavir and Islatravir for HIV-1

Gilead Sciences and Merck Collaboration to Develop Long-Acting HIV Treatment  Gilead Sciences (GILD) and Merck (MRK) announced the start of a Phase 2 clinical study evaluating an investigational, once-weekly oral combination treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy. From Gilead Sciences and Merck Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences, …

Gilead Sciences: New Data Demonstrate Trodelvy Survival Benefit in Metastatic TNBC. See Also: Galapagos NV News

Gilead Sciences New Data from Trodelvy® Study Gilead Sciences (GILD) has recently announced new data from the Phase 3 ASCENT study evaluating Trodelvy® in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy has shown to improve progression-free survival (PFS . . . This content is for paid …

Vir Biotechnology: Promising Clinical Data from Ongoing Trials of VIR-2218 and VIR-3434 for Chronic HBV Infection  

Vir Biotechnology Announced Positive Safety Findings from its Ongoing Trials for Chronic HBV Vir Biotechnology (VIR) announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. The results comprised positive safety findings in addition to a reduction in hepatitis . . . This content is for paid …

Gilead Sciences CAR-T Cell Yescarta Became the First and Only FDA Approved Treatment for Patients with Relapsed or Refractory Indolent Follicular Lymphoma

Gilead Sciences Yescarta for Relapsed or Refractory Indolent Follicula Lymphoma If Kite Pharma - a Gilead Sciences (GILD) company, had been acquired by any firm other than Gilead the stock would have gained at least 20% because of the news announced a few days ago. Kite Pharma announced outstanding Yescarta® (axicabtagene ciloleucel) results from the pivotal ZUMA-5 trial. At a minimum follow . . . This …

Jounce Therapeutics Inc Achieves First Milestone in Exclusive License Agreement with Gilead Sciences for JTX-1811

Jounce Therapeutics Inc: US FDA Cleared IND Application for JTX-1811 Targeting CCR8 Jounce Therapeutics Inc (JNCE) - a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for its product JTX-1811, an anti-CCR8 antibody.

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 …

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 …

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 …