MRK Opens Wallet, VRX To Face FDA Panel In July, SPHS Vaults On Trial Data

(RTTNews) - Alnylam Pharmaceuticals Inc. (ALNY) has initiated a phase I clinical trial with ALN-TTRsc02, a subcutaneously administered investigational RNAi therapeutic for the treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis).

The phase 1 trial will be conducted in normal healthy volunteers. Initial clinical data from this study are expected in late 2016, and if positive, a phase III study is planned in 2017.

ALNY closed Thursday's trading at $65.41, down 6.40%.

Merck & Co. Inc. (MRK) is all set to acquire privately-held Afferent Pharmaceuticals in exchange for an upfront payment of $500 million in cash and an additional $750 million associated with certain milestones.

Afferent has two clinical candidates, AF-219 and AF-130. AF-219 is currently being evaluated in a Phase 2b clinical trial for the treatment of refractory, chronic cough as well as in a Phase 2 clinical trial in idiopathic pulmonary fibrosis (IPF) with cough.

The transaction is expected to close in the third quarter of 2016.

Separately, Merck announced that an FDA panel has voted 10 to 5 with one abstention, recommending approval of Bezlotoxumab for the prevention of C. difficile infection recurrence in patients aged 18 years and older. The FDA's final decision is slated for July 23, 2016.

MRK closed Thursday's trading at $57.18, down 0.76%.

Prothena Corp. plc's (PRTA) phase I double blind, placebo controlled, single ascending dose study of PRX003 in healthy volunteers has demonstrated that all doses of PRX003 are safe and well tolerated, meeting the primary objective of the study.

A phase 1b multiple ascending dose study of PRX003 in patients with psoriasis is underway, and data from this study is expected in the second half of 2017.

PRTA closed Thursday's trading at $47.41, down 3.26%.

Shares of Sophiris Bio Inc. (SPHS) were up over 124% in after-hours on Thursday, following encouraging results from a phase 2a proof of concept study of Topsalysin in localized prostate cancer.

According to the study results, the one-time administration of Topsalysin was well tolerated with no serious adverse events and no new safety signals being reported.

Topsalysin demonstrated an ability to ablate tumor cells in 50 percent of patients - in 9 out of 18 patients - six months after treatment in a patient population with pre-identified, clinically significant prostate cancer. The results support advancing Topsalysin into a phase 2 study to confirm dose and optimize delivery, noted the company.

SPHS closed Thursday's trading at $1.17, up 8.33%. In after-hours, the stock was up 124.79% to $2.63.

Lpath Inc. (LPTN) is all set to implement a 1-for-14 reverse split of the company's issued and outstanding common stock, which will become effective as of 5:00 p.m. EDT on June 10, 2016.

The primary purpose of the reverse split is to maintain the company's listing on The NASDAQ Capital Market.

LPTN closed Thursday's trading at $0.16, down 13.70%.

Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) Biologics License Application for Brodalumab is to be reviewed by an FDA panel on July 19, 2016. Brodalumab is proposed for the treatment of patients with moderate-to-severe plaque psoriasis.

The FDA's final decision is slated for November 16, 2016.

Brodalumab is also under review by the European Medicines Agency.

Valeant has a collaboration agreement with AstraZeneca under which Valeant has an exclusive license to develop and commercialise Brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd.

VRX closed Thursday's trading at $25.48, up 6.52%.