Tag: Gilead Sciences (GILD)

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 …

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 …

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 …

A Flashback and Future Projections

Prohost Letter #445 A Flashback and Future Projections 1. A Follow-Up on Recently Posted News from ProhostBiotech 2. Answering Questions 3. Development-Stage Firms to Outperform 4. Oversold Revenue-Generating Firms 5. Tables with FAIR 2021 Targets for the Prohost Selected Firms In This Issue We Discuss the Following Firms: Anixa Biosciences (

Prohost Letter #444

Prohost Letter #444 The End of the Year Issue was delayed because our 2020 Prohost Portfolio stocks’ targets for the year failed to materialize; nobody not even the authorities were capable of predicting the pandemic, which continues to plague the world. As 2021 approached, we were unable to the End of the Year issue on time as we lacked the information required for the fair …

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 …

Acquisitions that Make Sense

Acquisitions  AstraZeneca Acquires Alexion Pharmaceuticals AstraZeneca (AZN) and Alexion Pharmaceuticals (ALXN) entered into a definitive agreement for . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

A New COVID-19 Vaccine is Showing Successful Results. See Also: More Details About the Effective COVID-19 Vaccines

COVID-19 Vaccine Updates Pfizer’s (PFE)/BioNTech’s (BNTX) and Moderna’s (MRNA) COVID-19 vaccines have demonstrated safety at around 95% efficacy.   AstraZeneca (AZN) and Oxford University announced today that their COVID-19 vaccine was 90% effective in preventing infections. The efficacy average, however, was 70%, leading the stock to travel south rather than north.     Regardless of the efficacy differences AstraZeneca stated that it would immediately prepare …

Why Gilead Sciences Product Lenacapavir Deserves the FDA Granted Breakthrough Therapy Designation. See Also: Cellectis and Sanofi

Gilead Sciences News Results from Phase 2/3 CAPELLA trial evaluating Gilead Sciences (GILD) lenacapavir achieved the primary endpoint in heavily treatment-experienced people with multidrug-resistant HIV-1 infection. The study showed that 88% of participants receiving lenacapavir experienced at least a 0.5 log10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as . . . This content is for paid subscribers. Please click here …

The U.S. FDA Approves Gilead Sciences Antiviral Veklury® (remdesivir) for COVID-19

Gilead Sciences Veklury® (Remdesivir) was Approved by the US FDA The U.S. FDA approved Gilead Sciences (GILD) antiviral drug Veklury® (remdesivir) for COVID-19 infected patients who require hospitalization. Veklury halts the SARS-CoV-2 replication that causes COVID-19. Veklury is the first and only approved COVID-19 treatment (not vaccine) in the U.S.. The news announced that the drug is widely available in hospitals across the country. The …

SARS-CoV-2 Virus vs The President of the United States

President Trump, the First Lady and COVID-19 Indeed, the complicated, nasty SARS-CoV-2 virus managed to infect President Trump and the First Lady when we were expecting a vaccine to soon be ready to protect the country and the world from COVID-19. The president’s physicians did not treat the him with any of the investigational vaccines in late-phase trials; vaccines being developed by: Moderna (MRNA), Novavax (NVAX) and …

Gilead Sciences Could Acquire Immunomedics at $20 Billion. See Also: AstraZeneca Vaccine Trial Resumed

Gilead Sciences News Is Not Just Gossip Real news, not just gossip, is spreading today about Gilead Sciences (GILD) nearing a deal to acquire the biotech firm Immunomedics (IMMU) for $20 billion. Immunomedics current market value is around $10 billion which means that Gilead is buying it at double its value. The deal could be announced on Monday, if not sooner, if the talks go …

The FDA’s Complete Response Letters, Creating Investment Opportunities?

Yesterday, under Today’s Highlights, we posted that the U.S. FDA issued a Complete Response Letter (CRL) to Gilead Sciences (GILD) with regard to the New Drug Application (NDA) for filgotinib – the investigational treatment for moderately to severely active rheumatoid arthritis (RA), in collaboration with Galapagos (GLPG). The FDA requested data from the ongoing MANTA and MANTA-RAy studies before completing its review of the NDA. …

The FDA Approved Gilead Sciences CAR T Cell Product Tecartus for Adults with Relapsed or Refractory Mantle Cell Lymphoma

Gilead Sciences CAR T Cell Product Tecartus Gets FDA Approval The U.S. FDA approved Kite - Gilead Sciences (GILD) chimeric antigen receptor (CAR) T cell therapyTecartus™ (brexucabtagene autoleucel). Tecartus has become the first and the only approved CAR T cell therapy for adults with relapsed or refractory mantle cell lymphoma (MCL). The FDA approval of . . . This content is for paid subscribers. Please …