It was a choppy and hesitant week for biotech stocks, with the iShares NASDAQ Biotechnology Index ETF (IBB) and SPDR S&P Biotech ETF (XBI) looking as of late afternoon trading Friday to close the week with losses of around 1%-1.5%. With both indices up substantially year-to-date and over the 52-week period, contributors continue to find promising ideas even as some eye risk-management strategies amid a heady longer-term bull run. Gilead (GILD) bulls celebrated as shares hit new highs after months of range-bound action. Elsewhere, the SA community discussed newcomers to the biotech big stage such as Sorrento Therapeutics (OTC:SRNE). As only seems natural, debate about the prospects of MannKind (MNKD) and Afrezza continued apace.
Seeking Alpha Analysis You Should Check Out
- Gilead Sciences: Approaching 52-Week Highs And Going Higher by Bret Jensen
- Sorrento Therapeutics And L.A.'s Richest Man Ally, Target Celgene's Blockbuster Abraxane by DoctoRx
- Gilead: So Much More Than HCV by Anthony Clarke
- NASH - The Silent Killer You've Never Heard Of... But You Will by Nasser Khan, MD
- My Top 3 Fabulous Pharma Stocks by Chuck Carnevale
- Tokai Pharmaceuticals: The Small Cap Biotech With The Billion Dollar Prostate Cancer Drug by Stock Doctor
- Alnylam's CC5 Data More Like A Long Foul Than A Home Run Or Strikeout by Stephen Simpson, CFA
- My Updated Thoughts On MannKind by David Butler
Here are some of the top breaking news items of the week.
Novartis' Arzerra extends progression-free survival by 54% in blood cancer
Data from a Phase 3 study, called COMPLEMENT 2, show that Novartis' (NVS) Arzerra (ofatumumab) plus fludarabine and cyclophosphamide improved median progression-free survival (PFS) by 54% compared to treatment with fludarabine and cyclophosphamide alone in patients with relapsed chronic lymphocytic leukemia (CLL). Median PFS in the Arzerra arm was 28.9 months compared to 18.8 months the chemo-only arm (p=0.0032). The data were presented at the 20th Congress of the European Hematology Association in Vienna, Austria.
Ad Comm gives thumbs up to Amgen's Repatha
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee votes 11-4 supporting the approval of Amgen's (AMGN +0.6%) Repatha (evolocumab). The vote on the specific patient populations is next.
Lilly's ixekizumab successful in two late-stage trials
Eli Lilly (LLY -0.5%) announces the results from two Phase 3 studies, just published in The Lancet, evaluating ixekizumab in patients with moderate-to-severe plaque psoriasis. Both trials, called UNCOVER 2 & 3, met all primary and secondary endpoints, demonstrating superiority to etanercept [Amgen's (NASDAQ:AMGN) Enbrel] and placebo.
Late-stage trials show Biogen's biosimilar candidates equivalent to branded products
Biogen (BIIB) and Samsung Bioepis announce results from separate Phase 3 trials comparing their biosimilar candidates to their respective reference products. The data were presented at the European League Against Rheumatism Annual Congress in Rome, Italy.
Ad Comm give thumbs up to Regeneron and Sanofi's Praluent
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee votes 13-3 recommending approval of Praluent (SNY) (REGN) (alirocumab).
Ad Comm green lights Glaxo's mepolizumab for eosinophilic asthma, but only for adults
The FDA's Pulmonary-Allergy Drugs Advisory Committee votes 14-0 in favor of approval for GlaxoSmithKline's (GSK +0.8%) mepolizumab for the treatment of adult patients with eosinophilic asthma, but votes 10-4 against approving it in adolescents ages 12-17.
Pfizer's Pristiq flunks Phase 3 MDD trial
A 340-subject Phase 3 study evaluating Pfizer's (PFE +0.5%) Pristiq (desvenlafaxine succinate sustained-release formulation) in pediatric patients ages 7-17 with major depressive disorder (MDD) failed to achieve its primary endpoint of a statistically significant difference in treatment effect compared to placebo. The trial is the first completed study of four being conducted as part of the company's FDA post-marketing commitment under the Pediatric Research Equity Act (PREA). Pristiq was first approved by the FDA in February 2008.
Alnylam sues Dicerna Pharma over trade secrets
Alnylam Pharmaceuticals (ALNY) files a lawsuit in Massachusetts against Dicerna Pharmaceuticals (DRNA) accusing it of misappropriating trade secretsAlnylam acquired via its buyout of Sirna Therapeutics from Merck in January 2014.
Other stories of note:
- FDA publishes draft guidance for firms developing Duchenne muscular dystrophy drugs; current front-runners OK
- Alnylam's ALN-CC5 shows positive results in early-stage study
- Novartis' Cosentyx effective in treating plaque psoriasis in difficult-to-treat locations
- SAGE Therapeutics up 20% premarket on results from four-patient exploratory trial of SAGE-547 for postpartum depression
- One year data show Novartis' Cosentyx effective in ankylosing spondylitis
- FDA approves new indication for Promacta; rare blood disorder in children
- Arrowhead Research's ARC-AAT an Orphan Drug for rare genetic liver disease
- AVEO has some work to do before moving to Phase 3 with tivozanib in colorectal cancer
- Tonix Pharma presents additional data supporting TNX-102 SL for fibromyalgia
- Agios Pharma's AG-120 an Orphan Drug for a type of blood cancer
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