Major pipeline and regulatory updates dominated biotech sector headlines over the past week. Viking Therapeutics’ fatty liver drug succeeded in a phase II study. Both Regeneron Pharmaceuticals (REGN - Free Report) and Celgene Corporation (CELG - Free Report) presented positive results at the 27th European Academy of Dermatology and Venereology (EADV) Congress in France.
Recap of the Week’s Most Important Stories:
Viking Soars on Successful Fatty Liver Drug Study: Shares of Viking Therapeutics soared after the company announced positive top-line results from a 12-week phase II study on its novel liver-selective thyroid receptor beta agonist, VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C). The study achieved its primary endpoint, as statistically significant reductions in LDL-C were observed in patients receiving VK2809. In the study, 57% to 60% median liver fat reduction was observed in VK2809-treated patients. In addition, the trial's secondary endpoint was achieved with VK2809-treated patients experiencing statistically significant reductions in liver fat content compared with placebo.
Celgene Presents Data on Psoriasis Drug: Celgene announced encouraging results from two post hoc sub-analyses of clinical trials for psoriasis drug, Otezla at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. The data indicate that usage of Otezla resulted in meaningful improvements in outcomes important to patients with moderate to severe plaque psoriasis, which may not be captured by common measures of treatment efficacy that focus only on skin clearance ,such as Psoriasis Area Severity Index (PASI) 75. Meaningful improvements in skin, itch and quality-of-life measures were observed in treatment with Otezla. In addition, a separate post hoc sub-analysis of data from the phase III ESTEEM 1 and 2 and phase IV UNVEIL trials showed improvement in areas such as scalp and nails with Otezla compared to placebo.
Regeneron/Sanofi Report Positive Data on Dupixent: Regeneron Pharmaceuticals and partner Sanofi (SNY - Free Report) presented positive detailed results from a phase III trial on Dupixent for atopic dermatitis in adolescents at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. The phase III trial evaluated the efficacy and safety of Dupixent monotherapy in adolescent patients with moderate-to-severe atopic dermatitis. Per the company, this is the first phase III trial of a biologic in this patient population. The trial enrolled 251 patients who were 12 years to 17 years of age with moderate-to-severe atopic dermatitis and whose disease could not be adequately controlled with topical medications or for whom topical treatment was medically inadvisable. The results show that Dupixent monotherapy demonstrated a significant improvement in signs and symptoms of atopic dermatitis and certain quality of life measures in adolescent patients.
Earlier, Regeneron had announced that the FDA accepted for review the supplemental Biologics License Application (sBLA) of flagship ophthalmology drug, Eylea injection for the treatment of diabetic retinopathy (DR) and set a target action date of May 13, 2019. The sBLA submission is based on positive results from the phase III PANORAMA trial announced in Mar 2018.
Gilead Collaborates With Precision Biosciences: Gilead Sciences, Inc. (GILD - Free Report) entered into a strategic collaboration with privately held Precision BioSciences to develop therapies aimed at eliminating hepatitis B virus (HBV) using the latter’s gene editing platform ARCUS. Per the agreement, Precision will be responsible for developing, formulating and preclinical evaluation of the investigational nucleases while Gilead will take care of clinical development of any therapies emerging from the deal and commercialization of potential therapies. Gilead will fund the entire research and development program. Gilead is entitled to pay up to $445 million to Precision BioSciences as potential milestone payments and tiered royalties up to the mid-teens on commercial sales.
Gilead currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The NASDAQ Biotechnology Index was flat over the last five trading sessions. Among the major biotech stocks, Alexion gained 2.8%. Over the past six months, Gilead has lost 3% while Biogen has rallied 21%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD's Arthritis Drug Successful in Phase III, PRQR Soars).
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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