These five stocks posted big moves lower last week on above average volume.
BioSante Pharmaceuticals (BPAX) tumbled 78% after it announced top-line results from its two pivotal Phase III LibiGel (testosterone gel) efficacy trials. Initial analysis of the data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences in the endpoints, all results were in the appropriate directions. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
Subjects in the first trial, called BLOOM-1, who were treated with LibiGel, showed an increase of 1.47 days with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.26 days with a satisfying sexual event compared to baseline. The difference between these increases demonstrated a p value of 0.463. In BLOOM 1 there was an increase in the total number of satisfying sexual events of 3.87 from baseline (an increase of 83 percent) in the LibiGel group and in the placebo group there was an increase of 3.52 satisfying sexual events from baseline (an increase of 65%) for a p value of 0.698.
Endocyte (ECYT) collapsed, falling 72%, after it announced the results of supplemental analyses of its Phase 2b PRECEDENT trial. PRECEDENT was a randomized trial of EC145 in combination with pegylated liposomal doxorubicin (PLD) in women with platinum-resistant ovarian cancer. Results confirmed the reliability of its companion imaging diagnostic EC20 to select targeted patients. In addition, the blinded independent review committee (IRC) and numerous sensitivity analyses confirmed the robustness of the progression-free survival (PFS) results, particularly in the FR(++) patient population, patients whose tumors are all positive for the targeted folate receptor. The overall survival results were inconclusive as the trial was not sufficiently powered to show an overall survival advantage and there was no trend toward benefit in either arm.
InterMune (ITMN) fell 36% after it reported that the private Institute for Quality and Efficiency in Health Care (IQWiG) published its report on the benefit assessment of Esbriet (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). Pirfenidone is the first Orphan Drug to be reviewed by IQWiG since new healthcare legislation known as AMNOG was enacted in January of 2011.
Despite its approval by the EU regulatory authorities, IQWiG concluded that no additional benefit could be found for pirfenidone. However, by German law, Orphan Drugs are deemed as having an additional benefit, leading IQWiG to assess the Esbriet additional benefit as given but not quantifiable. The company has a number of important concerns with the methodology applied by IQWiG and plans to vigorously challenge the IQWiG assessment during the 90-day review period that has now begun.
K12 (LRN) tumbled 34% following a negative New York Times article. The company said that the New York Times article is unfair and one-sided, and advances an anti-parent choice policy agenda. Instead of presenting a factually accurate look at K12's online and blended learning products and education programs, the writer mostly editorializes, selectively picking and choosing some facts and omitting many others to satisfy a pre-determined narrative. The article omitted important information on the structure of online schools, student performance, teacher training and professional development, and the full scope of education programs and services provided by K12. It liberally quotes well-known critics but gives no room for leading voices supportive of technology-based education reforms.
Hyperdynamics (HDY) closed 31% lower after it announced an operational update of the Sabu-1 exploration well in its concession offshore the Republic of Guinea. The Sabu-1 exploration well has drilled to its current depth of 1,440 meters, which the company discussed in its operational update on November 9th. Since that update, the 20-inch casing has been set, and there have been several mechanical and operational issues that have curtailed drilling activities. Hyperdynamics believes the issues are being resolved and it expects resumption of drilling activities in approximately 10 days.
Ray Leonard, Hyperdynamics President and CEO, commented,
Although these repairs have delayed the Sabu-1, they are necessary for the safe and efficient completion of the well. We look forward to the results of our first exploration well in the New Year.