The biotech sector was on a bumpy ride over the week as shares of Spectrum surged on positive data from a phase II study, while that of Incyte plunged on the failure of melanoma study. In an effort to bolster its presence in the gene therapy space Swiss giant Novartis announced the acquisition of AveXis Inc.
Spectrum Surges on Lung Cancer Data: Shares of Spectrum Pharmaceuticals, Inc. (SPPI - Free Report) surged after the company reported encouraging results from a phase II study on poziotinib in EGFR Exon 20 Mutant non-small cell lung cancer patients. The results show that the confirmed objective response rate was 64% in the first 11 patients, better than the expectations of 20% and 30%.
These early data suggest that poziotinib may have a meaningful impact on outcomes for patients who have limited treatment options. The median progression-free survival rate has still not been reached after a median follow up period of 6.5 months. Meanwhile, the original cohort of 30 EGFR patients is fully enrolled and the expanded cohort of 20 patients is nearing the completion of enrollment.
AveXis Skyrockets on Novartis Deal: AveXis, Inc.’s shares skyrocketed on the news of a merger with Swiss pharma giant Novartis (NVS - Free Report) . Per the agreement, Novartis will pay $8.7 billion for this clinical stage gene therapy company. AveXis lead product candidate, AVXS-101, is being evaluated as one-time gene replacement therapy for spinal muscular atrophy, a disease which results in early death or life-long disability with considerable healthcare costs. The acquisition will poise Novartis in the promising gene therapy space. The acquisition will be completed in mid-2018.
The candidate enjoys a breakthrough therapy designation in the United States and Prime designation in Europe. The FDA also granted AVXS-101, a fast track status for the treatment of SMA Type 1. A regulatory filing in the United States is expected in the second half of this year with a launch anticipated in 2019. (Read more: Novartis Inks $8.7 Billion Gene Therapy Deal to Buy AveXis)
Incyte Plunges on Study Failure: Shares of Incyte Corporation (INCY - Free Report) plunged after an external Data Monitoring Committee review of the phase III study, ECHO-301/KEYNOTE-252 evaluating Incyte’s epacadostat in combination with Merck’s Keytruda in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population when compared to Keytruda monotherapy. Moreover, the second primary endpoint of overall survival is not expected to reach statistical significance either. Hence, the study will be stopped.
The failure of the late-stage candidate disappointed investors as Incyte had pinned hopes on the success given the improved response rates in mid-stage studies. (Read more: Incyte's Epacadostat Fails in Melanoma Study, Shares Plunge)
Conatus Pharmaceuticals Sinks on Study Failure: Conatus Pharmaceuticals (CNAT - Free Report) plummeted after it reported that its pipeline candidate, emricasan, failed in a phase IIB study – POLT-HCV-SVR. The candidate did not achieve primary endpoint in the study, which evaluated patients with fibrosis or cirrhosis undergoing liver transplant. Data from the POLT-HCV-SVR study showed that emricasan did not achieve a better overall response rate compared to placebo in the overall patient population.
However, in patient subset with advanced fibrosis or early cirrhosis, emricasan provided evidence of an anti-fibrotic treatment effect in 95% of the patients compared to 58.3% for placebo. The company may evaluate emricasan further in this particular subset. (Read more: Conatus' Emricasan Fails in Phase II Study, Shares Sink)
Biogen Settles Litigation With AbbVie For Humira Biosimilar: Biogen Inc. (BIIB - Free Report) and partner Samsung Bioepis announced an agreement with AbbVie (ABBV - Free Report) for the commercialization of Imraldi, a biosimilar of Humira. Per the terms, AbbVie will grant patent licenses for the use and sale of Imraldi in Europe, on a country-by-country basis, and Biogen and Samsung Bioepis will make royalty payments to AbbVie. Both companies have agreed to dismiss all pending patent litigation. Biogen plans to launch the biosimilar in Europe in October 2018.
Samsung Bioepis entered into a settlement agreement with AbbVie, which would allow the former to bring Humira biosimilar into the U.S. market by Jan 31, 2023. (Read more: Biogen Cracks the Case With AbbVie for Humira Biosimilar)
Biogen carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The NASDAQ Biotechnology Index lost 0.05% over the last four trading sessions. Among major biotech stocks, Alexion fell 2.81%%. Over the last six months, Celgene lost 35.97% while Vertex gained 4.30% (see the last biotech stock roundup here: Biotech Stock Roundup: EDGE Falls, ALKS Down, FDA OK's AMGN Drug Label Expansion).
What's Next in the Biotech World?
Stay tuned for more regulatory and pipeline updates.
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