NVRO Gets FDA Nod, ZFGN's Obesity Drug Proves Its Worth, HRTX Awaits MAGIC

(RTTNews) - Shares of GTx Inc. (GTXI) rose more than 11% on Friday as investors welcomed the progress, which the company is making in its clinical studies with investigational drug Enobosarm.

The company plans to commence enrollment in an open-label, proof-of-concept phase II clinical trial of Enobosarm in patients with advanced androgen receptor positive triple negative breast cancer next month. The study will enroll up to 55 patients with the primary efficacy objective defined as clinical benefit at 16 weeks.

Enrollment in an open-label phase II clinical trial of Enobosarm in patients with estrogen receptor positive/androgen receptor positive advanced breast cancer is expected to commence in the third quarter. The study will enroll up to 118 patients with the primary efficacy objective defined as clinical benefit at 24 weeks.

GTXI closed Friday's trading at $0.85, up 11.71%.

Heron Therapeutics Inc. (HRTX), which completed enrollment in a phase III study of SUSTOL for the prevention of delayed-onset chemotherapy induced nausea and vomiting following administration of highly emetogenic chemotherapy agents, expects top line data from the study, dubbed MAGIC, late this month.

The company is planning to resubmit its NDA for SUSTOL to the FDA around the middle of this year. This is SUSTOL's third go around with the regulatory agency.

The original New Drug Application, seeking approval for SUSTOL, which was filed with the FDA in May 2009, was issued a Complete Response Letter in March 2010. A second attempt was also not successful, as the SUSTOL NDA, resubmitted in September 2012, was issued a Complete Response Letter in March 2013.

It remains to be seen if SUSTOL will be able to clear the regulatory hurdle this time.

HRTX closed Friday's trading at $12.26, up 3.46%.

Medical device company Nevro Corp. (NVRO) has received FDA approval for its Senza spinal cord stimulation system delivering HF10 therapy as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The Senza system delivering HF10 therapy has already been in use in Europe and Australia over the past 5 years.

The company is scheduled to report first quarter financial results on May 11, 2015. Historically, the company's revenue has been derived entirely from sales of Senza in Europe and Australia.

Nevro's annual revenue was $18.2 million in 2012, $23.5 million in 2013 and $32.6 million in 2014.

NVRO closed Friday's trading at $45.36, down 0.70%.

pSivida Corp. (PSDV), which has completed enrollment in the first phase III trial with its lead development product Medidur for posterior uveitis, expects top-line data in the second quarter of 2016.

The company has also initiated the second phase III trial of Medidur, and it is designed to enroll up to 150 patients in India. If all goes well as planned, pSivida expects to file the NDA for Medidur in the first half of 2017.

PSDV closed Friday's trading at $3.93, down 10.68%.

Vical Inc. (VICL) is scheduled to report topline data, including genital viral shedding rates and lesion rates, from a phase I/II trial of its therapeutic herpes simplex virus (HSV-2) vaccine by the middle of this year.

In other related news, the company expects enrollment in the multinational phase II trial of ASP0113 in approximately 140 kidney transplant recipients to be completed by the end of the second quarter of this year.

ASP0113 is a therapeutic vaccine designed to prevent cytomegalovirus reactivation and infection in hematopoietic stem cell transplant (HCT) recipients and solid organ transplant recipients.

VICL closed Friday's trading at $0.93, up 3.33%.

Zafgen Inc.'s (ZFGN) phase II trial of obesity drug Beloranib has demonstrtaed that 12 weeks of treatment led to sustained, progressive, and dose-dependent weight loss of up to roughly 11 kg from baseline. Additionally, Beloranib treatment significantly reduced sense of hunger and prospective food intake, and known markers of beloranib response, including major cardiovascular risk factors and markers of inflammation, were also improved at 12 weeks, according to the company.

In a proof of concept study of Beloranib in patients with Prader-Willi syndrome, or PWS, the drug candidate appeared safe and well-tolerated, and led to dose-dependent body and total fat mass reductions despite 50% increase in total daily calorie intake. Treatment with Beloranib also reduced hyperphagia-related behaviors typical of patients with PWS, and improved biomarkers associated with cardiovascular disease risk and adipose tissue function.

ZFGN closed Friday's trading at $34.70, up 3.18%.