SCLN Withdraws From Auction Block, ZFGN Tumbles, Double Blessing For VRX

(RTTNews) - Shares of Arbutus Biopharma Corp. (ABUS) were up over 9% in extended trading on Tuesday, following positive results from the company's phase I/II clinical study of TKM-PLK1 in patients with advanced Hepatocellular Carcinoma.

According to the study results, TKM-PLK1 was well-tolerated at all dose levels; 51% of subjects showed overall stable disease (SD) according to RECIST criteria; 22% of subjects showed an overall partial response (PR) according to Choi response criteria and tumor density reduced up to 59%.

The company revealed that it is looking forward to finding the right partner to advance the development of TKM-PLK1 for Hepatocellular Carcinoma and maximize the value of the drug candidate for its shareholders.

ABUS closed Tuesday's trading at $4.07, down 3.10%. In after hours, it was up 9.09% to $4.44.

The FDA has approved BELVIQ XR, a once-daily extended release formulation of lorcaserin, an approved chronic weight management treatment, which is a twice-daily immediate release formulation, marketed under the name BELVIQ.

Eisai Inc. and Ildong Pharmaceutical Co., Ltd. market and distribute BELVIQ in the United States and South Korea, respectively, and Arena Pharmaceuticals Inc. (ARNA) manufactures and supplies the finished commercial product from its facility in Switzerland.

BELVIQ XR is expected to be available in the fall of 2016. In connection with the approval, Arena will receive a $10 million milestone payment.

ARNA closed Tuesday's trading at $1.72, up 1.18%. In after hours, the stock was up 2.91% to $1.77.

Ionis Pharmaceuticals Inc. (IONS) has licensed IONIS-JBI1-2.5Rx, an orally delivered antisense drug designed to locally inhibit an undisclosed target in the gastrointestinal tract for the treatment of a GI autoimmune disease, to Janssen Biotech Inc.

Ionis' collaboration with Janssen covers three programs, and IONIS-JBI1-2.5Rx is the first of the three.

As per the agreement terms, Ionis is eligible to receive nearly $800 million in development, regulatory and sales milestone payments and license fees for these programs. In addition, Ionis will receive tiered royalties that on average are double-digits on sales from any product that is successfully commercialized.

In connection with licensing IONIS-JBI1-2.5Rx, Ionis has earned $10 million from Janssen Biotech.

IONS closed Tuesday's trading at $26.66, down 3.72%.

SciClone Pharmaceuticals Inc. (SCLN) plunged over 20% on Tuesday after it announced that it is no longer continuing active discussions with potential acquirers, which were undertaken as part of its strategic review process announced in February of this year.

The company noted that it will remain an independent publicly traded company as it continues to execute on its strategic growth plan for its core commercial business.

SCLN closed Tuesday's trading at $10.50, down 20.81%.

For Valeant Pharmaceuticals International Inc. (VRX), Tuesday was a day of double blessing.

The company has received FDA approval for Oral Relistor for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain, and has also won the panel backing for Brodalumab, its proposed treatment for moderate-to-severe plaque psoriasis.

The sales of Oral Relistor in the U.S. are expected to commence in the third quarter of 2016.

Valeant licensed the development and commercialization rights to Relistor from Progenics Pharmaceuticals Inc. (PGNX).

Relistor in subcutaneous injection formulation was approved by the FDA in 2008 for opioid-induced constipation in patients with advanced illness receiving palliative care, and in 2014 for opioid-induced constipation in patients with chronic non-cancer pain.

Net sales of Relistor injection for full year 2015 totaled $43.8 million, up from $20.3 million in 2014.

As for Brodalumab, an FDA panel voted by a margin of 18 to 0 for the approval of the drug for adult patients with moderate-to-severe plaque psoriasis with conditions related to product labeling and post-marketing/risk management obligations.

The FDA's final decision on Brodalumab is set for November 16, 2016.

VRX closed Tuesday's trading at $23.54, up 0.17%. In after-hours, the stock was up 4.29% to $24.55.

Shares of Zafgen Inc. (ZFGN) plunged over 40% in extended trading on Tuesday, after the company announced that it is suspending the development of its drug candidate Beloranib in Prader-Willi syndrome.

Prader-Willi syndrome, or PWS, is the most common known genetic cause of life-threatening obesity. Many of those affected with PWS become morbidly obese and suffer significant mortality. Currently, there is no cure for this disease.

The FDA issued a complete clinical hold on Beloranib on December 2, 2015, following two deaths due to pulmonary emboli in the pivotal Prader-Willi syndrome trial. The FDA's action sent the company's shares plummeting over 60% that day.

On January 20, 2016, the company reported positive results from the phase III trial of Beloranib in patients with Prader-Willi syndrome, which sent its stock soaring more than 78% to $10.04.

The company, which has been analyzing the clinical data in an effort to find out what would have caused the thrombotic events which led to patient deaths in the trial, has now come to a conclusion that there is not a viable pathway forward for Beloranib that can assure patient safety.

Zafgen is now focusing its resources on ZGN-1061 in severe and complicated obesity.

In order to align with its new priorities, the company's workforce is being reduced by approximately 34%, to a total of 31 employees, by December 2016. The restructuring is expected to result in approximately $4.8 million in reduced annualized workforce expenses once the plan is fully implemented.

The company also expects to incur a non-recurring charge of approximately $2.4 million in the third quarter of 2016 related to the restructuring.

ZFGN closed Tuesday's trading at $6.75, up 1.05%. In after hours, the stock was down 40.89% to $3.99.