With second quarter earnings season drawing to a close, focus is back on pipeline and regulatory updates. Companies like Vertex (
VRTX Quick Quote VRTX - Free Report) , OncoGenex and Aurinia ( AUPH Quick Quote AUPH - Free Report) were in focus this week with the companies losing ground on pipeline updates. Recap of the Week’s Most Important Stories 1. Vertex’s shares slipped on news that the company will be stopping a late-stage study evaluating a VX-661 - ivacaftor (trade name: Kalydeco) combination for cystic fibrosis. While the news came as a disappointment, it was not very surprising as expectations were low from this study (Read more: Vertex To Stop VX-661-Ivacaftor Study, Stock Down). 2. Aurinia’s shares plunged 55.7% on data from a 24-week analysis of a mid-stage study on the company’s experimental lupus treatment, voclosporin. Although voclosporin met the primary endpoint, a high number of deaths in the study left investors jittery. The next step is for the company to meet the FDA in the fourth quarter to discuss the next stage of clinical development (Read more: Aurinia Stock Falls on Poor Phase II Lupus Study Data). 3. OncoGenex’s shares plunged 41% on news that the company’s experimental cancer treatment, custirsen, failed to meet the primary endpoint in a late-stage study in men with metastatic castrate-resistant prostate cancer. OncoGenex is now looking to enter discussions with the FDA to evaluate options related to an early analysis of the phase III ENSPIRIT study investigating custirsen in combination with docetaxel as second-line chemotherapy in patients with non-small cell lung cancer (NSCLC). 4. Cancer-focused AVEO has started an early-stage study that will evaluate its lead pipeline candidate, tivozanib (an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)) in combination with Bristol-Myers’ anti-PD-1 therapy, Opdivo, in advanced renal cell carcinoma (RCC). The goal is to combine VEGF inhibitors with immune checkpoint inhibitors to improve outcomes with tolerable safety profiles. We note that AVEO’s efforts to develop tivozanib have not exactly been successful with the company receiving a complete response letter (CRL) from the FDA in Jun 2013 for the first-line treatment of advanced RCC. The company is currently conducting a new phase III study on tivozanib for the third-line treatment of patients with refractory RCC to address the concerns raised by the agency in its CRL. Meanwhile, tivozanib is currently under regulatory review in the EU for front-line RCC. 5. Results from a study on the cost-effectiveness of PCSK9 inhibitors and their potential effect on U.S. health care spending were published in The Journal of the American Medical Association (JAMA). PCSK9 inhibitors include Amgen’s ( AMGN Quick Quote AMGN - Free Report) Repatha and Sanofi/Regeneron’s Praluent. According to the study findings, the use of PCSK9 inhibitors as indicated could substantially reduce myocardial infarctions (MIs), strokes, and cardiovascular deaths. However, even if they prove highly effective in preventing atherosclerotic cardiovascular disease (ASCVD), they are not cost-effective at 2015 prices. In fact, in order to achieve commonly accepted cost-effectiveness thresholds, price would have to be reduced by more than two-thirds. Performance
The NASDAQ Biotechnology Index declined 1.3% over the last five trading days. Among major biotech stocks, Amgen was up slightly while Vertex declined 2.8% reflecting the impact of the discontinuation of the phase III study on VX-661 and ivacaftor.
Over the last six months, Biogen (
BIIB Quick Quote BIIB - Free Report) was up 22.2% while Gilead ( GILD Quick Quote GILD - Free Report) lost 13.1% (See the last biotech stock roundup here: Earnings in Focus, AbbVie Takes Steps to Block Humira Copycat). What's Next in the Biotech World? Watch out for the usual pipeline and regulatory updates from biotech companies. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>