As we near the end of the earnings season, regulatory and pipeline updates are back in focus. While Gilead Sciences (GILD - Free Report) presented encouraging data on its inflammation candidate, Regeneron Pharmaceuticals, Inc. (REGN - Free Report) presented data on Praluent. Regeneron also announced a collaboration with Ziopharm Oncology.
Recap of the Week’s Top Stories:
Gilead Sciences Presents Data on Liver Candidate: Gilead Sciences presented data on pipeline candidate, GS-9674 at the Liver Meeting 2018 in San Francisco. The candidate was evaluated in a phase II, double-blind, placebo-controlled trial in 52 non-cirrhotic patients with primary sclerosing cholangitis (PSC). The data showed that patients were randomized to receive GS-9674 100 mg (n=22), GS-9674 30 mg (n=20), or placebo (n=10) orally once daily for 12 weeks. After 12 weeks of treatment, patients receiving GS-9674 100 mg demonstrated significant improvements in liver biochemistry tests, with a median reduction in serum alkaline phosphatase (ALP) of 20.5% against an increase of 3.4% with placebo (p=0.029).
The candidate was well tolerated and the incidence of Grade 2 or 3 pruritus was numerically lower with GS-9674 100 mg (13.6%) and 30 mg (20%) compared with placebo (40%). Meanwhile, a separate analysis of health-related patient-reported outcome measures (PROs) among patients enrolled in the phase II trial demonstrated significant impairment of PRO scores among PSC patients with pruritus or fatigue. GS-9674 is also being evaluated for the treatment of primary biliary cholangitis (PBC), and advanced fibrosis due to non-alcoholic steatohepatitis (NASH).
Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron/Sanofi Present Data From ODYSSEY OUTCOMES Trial: Regeneron and partner Sanofi (SNY - Free Report) announced the publication of 18,924-patient ODYSSEY OUTCOMES trial on Praluent at the New England Journal of Medicine (NEJM). The trial met its primary endpoint as the results showed that Praluent injection significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered an acute coronary syndrome (ACS), which included a heart attack or unstable angina. Praluent significantly reduced MACE by 15%. The drug was also associated with a 15% lower risk of death.
Both the companies also announced new analyses on mortality from the ODYSSEY OUTCOMES at the American Heart Association (AHA) Scientific Sessions 2018. Praluent resulted in fewer deaths from any cause among patients who had previously experienced a heart attack or unstable angina. The effect of Praluent on cardiovascular morbidity and mortality is currently under review. Data from the ODYSSEY OUTCOMES trial has been submitted to regulatory authorities in the European Union and in the United States with a target action date of Apr 28, 2019.
Cocrystal Pharma Surges on Data: Shares of Cocrystal Pharma, Inc. surged after the company announced positive data on lead molecule CC-42344 at the 6th ISIRV-AVG Conference, Advances in Respiratory Virus Therapeutics (November 13-15) in Washington DC. The candidate demonstrated excellent antiviral activity against influenza A strains and showed a favorable pharmacokinetic and safety profile in preclinical studies. The candidate showed broad-spectrum activity in cell culture against seasonal and pandemic influenza strains.
Ziopharm Oncology Collaborates With Regeneron: Ziopharm Oncology, Inc., (ZIOP - Free Report) announced a clinical supply agreement with Regeneron Pharmaceuticals. Per the agreement, Ziopharma will evaluate its Ad-RTS-hIL-12 plus veledimex in combination with Regeneron’s PD-1 antibody Libtayo to treat patients with recurrent glioblastoma (rGBM).
While Libtayo is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC), Ad-RTS-hIL-12 plus veledimex is an investigational gene therapy designed to induce and control the production of human interleukin 12 (hIL-12) that activates the immune system and recruits cancer-fighting T cells into tumors. Both the companies plan to initiate a phase II study in the first half of 2019 in patients with rGBM to measure preliminary safety and efficacy of Ad-RTS-hIL-12 plus veledimex in combination with Libtayo. While Ziopharm will be responsible for the conduct and costs of the clinical trial, Regeneron will supply Libtayo for the study.
The NASDAQ Biotechnology index lost 4.1% in the last five trading sessions. Among the major biotech stocks, Celgene lost 6.5% in the last five trading sessions. Over the past six months, shares of Biogen have rallied 15.6% while Celgene has lost 14.3%. (See the last biotech stock roundup here: Biotech Stock Roundup: Celgene, Amgen, Vertex Impress in Q3, DRNA Soars on LLY Deal )
What's Next in Biotech?
Stay tuned for more regulatory and pipeline updates.
3 Medical Stocks to Buy Now
The greatest discovery in this century of biology is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating revenue, and cures for a variety of deadly diseases are in the pipeline.
So are big potential profits for early investors. Zacks has released an updated Special Report that explains this breakthrough and names the best 3 stocks to ride it.
See them today for free >>