The major pipeline and regulatory updates in the biotech sector over the past week included positive results from Gilead Sciences’ (GILD - Free Report) pipeline candidate filgotinib. Regeneron/Sanofi’s supplemental application for Praluent was also accepted by the FDA.
Recap of the Week’s Most Important Stories:
Gilead’s Rheumatoid Arthritis Drug Successful in Phase III: Gilead Sciences and partner Galapagos NV (GLPG) announced that the phase III study, FINCH 2, on rheumatoid arthritis candidate, filgotinib, achieved its primary endpoint. The global, randomized, placebo-controlled phase III study evaluated filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents. The candidate met the primary endpoint after it achieved an American College of Rheumatology 20% response (ACR20) at Week 12. Both the doses of filgotinib- 100 mg and 200 mg doses achieved significantly higher ACR20/50/70 responses than placebo in patients with active rheumatoid arthritis and prior inadequate response to biologic agents. Apart from the FINCH trial, the candidate is also being evaluated in the phase III trial, DIVERSITY, in Crohn’s disease (also small bowel and fistulizing Crohn’s disease phase II studies) and the phase III SELECTION trial in ulcerative colitis among others.
Last week, both companies had announced positive results from the randomized, placebo-controlled phase II study, TORTUGA, on filgotinib. The trial is evaluating the safety and efficacy of filgotinib, in adult patients suffering from moderately-to-severely active ankylosing spondylitis (AS). The results show that patients treated with filgotinib achieved significantly greater improvements in AS Disease Activity Score (ASDAS), which is the primary endpoint, at week 12, with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo (p<0.0001).
Gilead carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
FDA Accepts Regeneron and Sanofi’s sBLA For Praluent: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the FDA has accepted a supplemental Biologics License Application (sBLA) for Praluent, a PCSK9 inhibitor. The sBLA is seeking an update to the prescribing information to include the effect of Praluent in reducing the overall risk of major adverse cardiovascular events. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Apr 28, 2019. The sBLA is supported by data from the phase III cardiovascular outcomes trial, ODYSSEY OUTCOMES, that evaluated the impact of Praluent in 18,924 patients who had an acute coronary syndrome (ACS), such as a heart attack, between 1-12 months (median 2.6 months) before enrolling in the trial. The FDA recently approved an update to the drug’s prescribing information to include clinical information regarding its use in patients with heterozygous familial hypercholesterolemia (HeFH), who require additional lowering of LDL-C along with diet and maximally-tolerated statin therapy and are undergoing apheresis treatment.
Incyte Collaborates with Foundation Medicine: Incyte Corporation (INCY - Free Report) entered into an agreement with Foundation Medicine, Inc., for the development, regulatory support and commercialization of companion diagnostics (CDx). Both companies will initially focus on CDx development for pemigatinib (INCB54828), Incyte’s selective FGFR1/2/3 inhibitor, in patients with cholangiocarcinoma. The initial CDx, which will include detection of activating FGFR2 translocations, is expected to be incorporated into FoundationOneCDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay and broad CDx platform.
ProQR Therapeutics Soars on Study Data: Shares of ProQR Therapeutics (PRQR - Free Report) skyrocketed after the company positive results from a planned interim analysis of its phase I/II trial of QR-110 in patients with Leber’s congenital amaurosis 10 (LCA10) due to the p.Cys998X mutation in the CEP290 gene. The results showed QR-110 demonstrated rapid and sustained improvement in vision in patients with LCA10, as measured by visual acuity and the mobility course performance, as well as being well-tolerated with no serious adverse events recorded. The results met the company’s expectations and criteria to stop enrollment in and progress to a pivotal phase II/III trial, which is likely to begin in the first half of 2019.
The NASDAQ Biotechnology Index lost 2.82% over the last five trading sessions. Among the major biotech stocks, Celgene has lost 4.78%. Over the past six months, Gilead has lost 9.5% while Regeneron has rallied 14.3%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN, PBYI Get EC Nod for Their Drugs, MNKD Soars).
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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