As we approach the tail end of earnings results, regular pipeline updates and data read outs take centerstage in the biotech sector. Key among those include Intercept ICPT, which surges on the back of positive data from the phase III trial on NASH drug, and Vertex, which too reports favorable outcomes on Symdeko.
Recap of the Week’s Top Stories:
Intercept Soars on NASH Drug Trial Results: Shares of Intercept Pharmaceuticals jumped after the company announced upbeat findings from its late stage study — REGENERATE — of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). The study results show that once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) without any worsening signs of NASH during the planned 18-month interim analysis. Moreover, a greater proportion of patients under both OCA treatment arms compared with placebo achieved the primary endpoint of NASH resolution with no deterioration of liver fibrosis noticed even though the evaluation did not reach any statistical significance. Nevertheless, the study was required to attain one of the two primary goals per the FDA which it did. Intercept intends to file for regulatory approval in the United States and Europe in the second half of 2019. The news significantly boosted investor sentiments given the market potential of NASH and the fact that biotech bigwig Gilead Sciences, Inc. GILD announced the failure of a late-stage study on selonsertib involving patients with compensated cirrhosis (F4) due to NASH. This in turn, puts Intercept ahead in the race to get a drug approved for NASH.
Vertex Reports Positive Data on Symdeko: Vertex Pharmaceuticals Incorporated VRTX announced that the late-stage study on Symdeko, conducted in Europe and Australia, was successful. The phase III study was performed on children aged 6 to 11 years with cystic fibrosis (CF), who have either two copies of the F508del mutation or a single one of the F508del mutation and one residual function mutation. The study met its primary endpoint of absolute change in lung clearance index (LCI2.5) through an 8-week regime as it demonstrated a statistically significant improvement in LCI2.5 among patients treated with Symdeko. The investigation was under way to seek Symdeko’s label expansion for the patient population enrolled in Europe. We note that Vertex had earlier submitted an sNDA to the FDA for Symdeko, based on a previously completed phase III safety study on 6-11 year-old children in the United States and Canada.
Gilead Clinches Approval for Yescarta in Canada: Gilead Sciences notified that Health Canada has granted a Notice of Compliance (NOC) to chimeric antigen receptor T (CAR T) cell therapy, Yescarta axicabtagene ciloleucel). The therapy has been approved for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL, arising from follicular lymphoma (transformed follicular lymphoma, or TFL).
Alkermes Collaborates With Clovis: Alkermes plc ALKS entered into a research collaboration pact with Clovis Oncology CLVS. Both companies will evaluate ALKS 4230, Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, combined with Rubraca — Clovis' approved PARP inhibitor — and lucitanib, Clovis' investigational tyrosine kinase inhibitor. Per the terms of the agreement, Alkermes and Clovis will perform preclinical studies to examine the mechanism of action and efficacy of the combinations of ALKS 4230 with Rubraca and ALKS 4230 with lucitanib on multiple tumor models. Both entities will share costs related to the preclinical probes.
Alkermes currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Intec Pharma Reports Positive Data From Study: Shares of Intec Pharma NTEC gained after the company released encouraging preliminary results from a pharmacokinetic (PK) study comparing its Accordion Pill Carbidopa/Levodopa (AP-CD/LD) 50/500mg, dosed three times daily (TID), to 1.5 tablets of CD/LD immediate release (Sinemet) 25/100, dosed five times per day in Parkinson's disease (PD) patients. AP-CD/LD met the primary endpoint of reducing plasma levodopa variability compared with the standard oral CD/LD displaying statistical significance. Intec Pharma plans to submit full data, set for potential presentation and publication at a major medical meeting.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index inched up 1.7% in the past five trading sessions. Among the major biotech biggies, Biogen rose 4.2%. Over the past six months, shares of Regeneron have rallied 12.2% while the Gilead stock has declined 6.2% (See the last biotech stock roundup here: Biotech Stock Roundup: Regeneron Impresses in Q4, Gilead Slumps, MacroGenics Soars)
What's Next in Biotech?
Stay tuned for more earnings news along with regular pipeline updates.
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Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Intercept Pharmaceuticals, Inc. (ICPT) : Free Stock Analysis Report
Clovis Oncology, Inc. (CLVS) : Free Stock Analysis Report
Alkermes plc (ALKS) : Free Stock Analysis Report
Intec Pharma Ltd. (NTEC) : Free Stock Analysis Report
Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report
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