With the SPDR S&P Biotech Index up 31% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
Consider this the calm before the earnings season storm as there wasn't an overwhelming amount of clinical data and dealings to absorb this week in the biotech sector. Still, five key stories caught my attention and are certainly worth noting.
Johnson & Johnson (NYSE: JNJ ) continued its recent string on exciting pharmaceutical news, when its subsidiary Janssen Pharmaceuticals announced on Thursday that the Food and Drug Administration had approved the expanded indication of Simponi Aria for infusion for the treatment of moderately to severely active rheumatoid arthritis, or RA. About 1.3 million people in the U.S. suffer from chronic RA, and Simponi Aria with methotrexate drastically improved signs, symptoms, and function at 24 weeks. Trial results showed significant improvement of 59% for patients taking Simponi Aria plus methotrexate compared to only 25% significant improvement among patients on the control drug.
Biopharmaceutical company Alkermes (NASDAQ: ALKS ) also did its best to excite shareholders by unveiling a huge expansion to its product line. On its analyst day, Alkermes outlined its plan to focus on treating chronic diseases moving forward and pointed to three specific early-stage compounds that will help it achieve its goals. The first is an MMF prodrug modeled after Biogen Idec's Tecfidera that it anticipates could be taken less frequently and have fewer side effects. The second, ALKS-7106, is a pain treatment that will incorporate anti-abuse technology. The third is RBD-1419, an anti-cancer immunotherapy booster that could be effective against metastatic cancer types. You can read a more thorough synopsis of my take on the "new Alkermes" here.
Not all clinical news was good news, though, with Novartis (NYSE: NVS ) delivering disappointing late-stage results for once-promising kidney cancer drug dovitinib this week. The drug, which had been hailed as a potential successor to Onyx Pharmaceuticals' Nexavar in treating kidney cancer, failed to meet its primary endpoint in a head-to-head trial against Nexavar. Thankfully, Novartis has such a diverse pipeline that it didn't represent a huge blow to shareholders. The real disappointment comes for patients with metastatic renal cell carcinoma who were hoping for a new breakthrough treatment.
Not all of this week's news was clinical in nature. Consider Quest Diagnostics (NYSE: DGX ) , for instance, which took the opportunity on Thursday to sell its small single-digital royalty stake in Pharmacyclics and J&J's experimental rare blood cancer drug ibrutinib for $485 million in cash to Royalty Pharma. It certainly wasn't a bad deal for Quest which acquired its royalties to ibrutinib through its acquisition of Celera in 2011. The sale netted Quest a gain after taxes, which it will record as a one-time gain in its upcoming quarter results and use to help fuel diagnostic research.
Also of note (and don't say I didn't warn you!), Regulus Therapeutics (NASDAQ: RGLS ) lost nearly 17% of its value this week after pricing a dilutive secondary offering of 4.5 million shares at $9.50 -- roughly 20% below its closing value when the week started. Considering that Regulus' entire pipeline is currently in the preclinical stage of its existence, now is a poor time for shareholders to be chasing shares higher. I'd suggest waiting until we receive at least some early-stage clinical results before betting on the promise of its pipeline.
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