Every Friday, Seeking Alpha's Biotech Weekly highlights the editors' picks of the week's Seeking Alpha analysis, as well as a review of the top Breaking News stories. This week, contributors geared up for earnings season, highlighted several small-cap opportunities, and continued to ponder Gilead's valuation. Read on for a quick glance at the week's news and commentary.
Seeking Alpha Analysis You Should Check Out
- Celgene: A Pre-Earnings Discussion Based On Recent News by DoctoRx
- Gilead Sciences Reminds Me Of Apple Circa June 2013 by Bret Jensen
- Concert Pharmaceuticals: The Deuterated Drug Platform, A Profitable Way To Reinvent The Wheel by Kanak Kanti De (SA PRO Article)
- Actinium Pharmaceuticals: An Undervalued Biotech Revolutionizing AML Treatment by Stock Doctor
- Buy Arrowhead Research Corporation On The Dip by Clinically Sound Investor
- Progress At Synergy Pharmaceuticals, But Not Enough To Really Please Investors by Stephen Simpson, CFA
- Celgene's Play In Cell-Based Therapy/Regenerative Medicine Is Very Good News For Mesoblast by Keith Williams
- InVivo Therapeutics: Time To Double Down by JMY Investments
- Matinas' Pipeline Is Ready To Shine by Jason Napodano, CFA (SA PRO Article)
Here are some of the top breaking news items of the week.
Based on an assessment by the independent Data Monitoring Committee, a Phase 3 clinical trial, CheckMate-057, evaluating Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) versus docetaxel was stopped early after the study met its primary efficacy endpoint. Patients with advanced non-squamous non-small cell lung cancer who received Opdivo demonstrated superior overall survival compared to those who received docetaxel. The company intends to share the data with health authorities soon.
A Phase 2 clinical trial, published today in the New England Journal of Medicine, showed that Celgene's (CELG -1.4%) Otezla (apremilast) was effective in reducing the mean number of oral ulcers in patients with Behcet's disease, a rare, chronic inflammatory disorder characterized by recurrent oral and genital ulcers. Joint inflammation and recurrent skin and eye lesions may also occur.
Based on an interim analysis of its ongoing AURA study, AstraZeneca's (NYSE:AZN) experimental cancer drug, AZD9291, demonstrated a median progression-free survival (NYSE:PFS) of 13.5 months in patients with advanced epidermal growth factor receptor mutation positive (EGFR+) non-small cell lung cancer (NSCLC) who also have the T790M mutation. T790M-positive NSCLC patients with disease progression do not have effective treatment options. Management is usually limited to chemotherapy or re-challenge with EGFR tyrosine kinase inhibitors (TKI) like erlotinib (Roche's Tarceva) or gefitinib (AZN's Iressa).
The USPTO's Patent Trial and Appeal Board (PTAB) declares an interference between Forward Pharma's (FWP -1.3%) patent application 11/576,871 and Biogen's (BIIB -0.6%) issued patent No. 8,399,514. Both contain claims to methods of treating multiple sclerosis with 480 mg of dimethyl fumarate per day. Biogen's pertains to Tecfidera, which generated $2.9B in sales the past four quarters while Forward's pertains to its lead product candidate, FP187.
Coherus BioSciences (CHRS -3%) and Baxter International (BAX +0.4%) amend their August 2013 collaboration agreement pertaining to the development and commercialization of CHS-0214, a biosimilar to Amgen's (AMGN +1%) Enbrel(etanercept). Certain milestones and funding obligations have been revised and the partnership has been expanded to include select pre-commercialization activities. The revised milestone payments may increase Baxter's funding obligations by ~$12M. It also has agreed to buy Coherus common stock in a private transaction.
After the close yesterday, the American Academy of Neurology released data on GW Pharmaceuticals' (GWPH +10.1%) investigational Epidiolex (cannabidiol) from an FDA-authorized "expanded access" program for children and young adults with treatment-resistant epilepsy who have exhausted available treatment options. The company will present the full data during a poster session on April 22.
Looking to grab a bigger chunk of a burgeoning healthcare analytics market by offering more industry-specific solutions, IBM is buying Phytel, a provider of cloud-based patient data aggregation/analysis software, and Explorys, provider of a massive clinical database (said to consist of 315B datapoints) and a slew of analytics apps that run on top of them. Terms are undisclosed.
Other stories of note:
- Discovery Labs completes enrollment in AEROSURF study; SURFAXIN to be discontinued
- Phase 3 stopped early in expanded indication for Pfizer's Ibrance
- Phase 3 study shows efficacy of brexpiprazole in schizophrenia
- Sunshine Heart close to resuming patient enrollment in C-Pulse study
- Athersys's MultiStem therapy fails to meet primary endpoint
- Mr. Klarman bullish on Atara Bio
- FDA clears generic version of Teva's Copaxone
- AbbVie's 2-DAA HCV-1 candidate gets priority peview in Japan
- Celgene's Otezla successful in Phase 2 label expansion study
- Glaxo to amend U.S. sales comp scheme amid falling sales and internal complaints
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