Gilead Leaps to First with Phase 3 Success for All-Oral Hepatitis C Drug Program

Source: Ryan McBride, Fierce Biotech (11/27/12)

"Gilead Sciences is sprinting ahead with initial positive results from a Phase 3 study for what could be a first all-oral combination therapy for certain patients with chronic hepatitis C virus in the U.S."

Gilead Sciences ($GILD) is sprinting ahead with initial positive results from a phase 3 study for what could be a first all-oral combination therapy for certain patients with chronic hepatitis C virus in the U.S. The company reported clinical cures for about three quarters of patients with genotypes 2 or 3 of the liver-damaging virus on a combination of its experimental "nuc" sofosbuvir or GS-7977 and standard ribavirin.

In a crowded and fast-moving contest to grab a piece of a potential $20 billion market for interferon-free treatments, Gilead has established the lead spot with all-oral cocktails built around sofosbuvir. Its latest trial results come from the first of three late-stage studies of the once-daily nucleotide analog polymerase inhibitor in patients with genotypes 2/3, and Gilead aims to file for FDA approval of the drug in mid-2013. Results from the other late-stage studies are due early next year. . .View Full Article

Novavax Shares Shoot 65% Higher on Phase 3 COVID-19 Vaccine Trial's 89.3% Effectiveness
Source: Streetwise Reports (01/29/2021)

Novavax Inc. shares established a new 52-week high after the firm's COVID-19 vaccine demonstrated an 89.3% efficacy rate in a Phase 3 trial in the U.K. and also showed efficacy against the South African variant in a Phase 2b trial.

Sorrento Shares Rise 35% After Firm Posts Positive Data from Phase 1b ICU COVID-19 Trial
Source: Streetwise Reports (01/27/2021)

Shares of Sorrento Therapeutics traded higher after the company released positive preliminary results from it of Phase 1b COVI-MSC™ Study for treatment of hospitalized ICU COVID-19 patients.

Life Sciences Co. Receives Large Livestock Feed Order from New Client in Mexico
Source: Streetwise Reports (01/27/2021)

Avivagen Inc. reported it has secured a six tonne order for OxC-beta™ Livestock from a new customer in Queretaro City, Mexico.

Coverage Initiated on Biotech 'Improving Drugs Via Prodrug'
Source: Streetwise Reports (01/27/2021)

KemPharm's key near-term catalyst, lead value driver and other pipeline drug candidates are discussed in a ROTH Capital Partners report.

Vir Shares Climb 48% on Initial Phase 1 Chronic Hepatitis B Trial Data
Source: Streetwise Reports (01/26/2021)

Vir Biotechnology shares traded higher after the company reported data from its Phase 1 Chronic Hepatitis B Study that showed VIR-3434 significantly and rapidly reduced hepatitis B surface antigen.

Aurinia Pharma Shares Open at 52-Week High as FDA Approves Adult Lupus Nephritis Drug
Source: Streetwise Reports (01/25/2021)

Shares of Aurinia Pharmaceuticals traded 30% higher after the company reported that the U.S. Food and Drug Administration approved its LUPKYNIS™ (voclosporin) for use in treating adults with active lupus nephritis.

AzurRx Doses First Two People in Expanded Phase 2b Trial of Cystic Fibrosis Patients
Source: Streetwise Reports (01/22/2021)

AzurRx BioPharma shares traded 45% higher after the firm advised it had dosed the first two patients in its Phase 2b OPTION 2 Extension Study of MS1819 for treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.

Gritstone Oncology Licenses LNP Platform from Genevant Sciences to Develop COVID-19 Vaccine
Source: Streetwise Reports (01/20/2021)

Shares of Gritstone Oncology reached a new 52-week high price after the company advised it entered into a non-exclusive licensing agreement with Genevant Sciences to develop and commercialize self-amplifying RNA vaccines for use against SARS-CoV-2.

Biotech Given Go-Ahead to Proceed with Phase 3 COVID-19 Study
Source: Streetwise Reports (01/20/2021)

Algernon Pharmaceuticals reported that it has been granted approval from the Data and Safety Monitoring Board to conduct a Phase 3 Study of Ifenprodil for SARS-CoV-2.

Aclaris Shares Triple in Value on Positive Topline Data from Phase 2a Rheumatoid Arthritis Trial
Source: Streetwise Reports (01/19/2021)

Shares of Aclaris Therapeutics Inc. soared to a new 52-week high after the company reported positive preliminary topline data from its Phase 2a trial of oral ATI-450 for moderate to severe rheumatoid arthritis.