FPRX Gets A High Five, XBIT Rises On Ebola Research, ZSPH Files NDA For ZS-9

(RTTNews) - Amicus Therapeutics' (FOLD) Migalastat HCl monotherapy for Fabry patients has been granted Accelerated Assessment by the Committee for Medicinal Products for Human Use, or CHMP.

Under Accelerated Assessment, the CHMP may shorten the Marketing Authorisation Assessment review period from 210 days, under standard review, to 150 days under Accelerated Assessment. The CHMP opinion is then reviewed by the European Commission, which generally issues a final decision on EU approval within three months.

Amicus is on track to submit the MAA to request full approval for migalastat monotherapy in the EU in the second quarter of 2015.

FOLD closed Tuesday's trading at $11.71, up 2.81%.

bluebird bio Inc. (BLUE) and Five Prime Therapeutics Inc. (FPRX) have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor T cell therapies using Five Prime's proprietary human antibodies to an undisclosed cancer target for hematologic malignancies and solid tumors.

The agreement entitles Five Prime to a $1.5 million upfront payment and subsequent milestone payments which together could total over $130 million per licensed product if certain milestones are met. Five Prime is also eligible to receive tiered royalties on product sales. bluebird bio will conduct and fund clinical development as well as regulatory and commercial activities.

FPRX closed Tuesday's trading at $19.67, down 1.90%. In after hours, the stock soared 20.08% to $23.62. BLUE touched a new high of $189.06 before closing the day's trading 2.98% higher at $183.69.

Intellipharmaceutics International Inc.'s (IPCI) (I.TO) abuse deterrent Rexista Oxycodone XR, incorporating its Paradoxical OverDose Resistance Activating System, has been granted Fast Track designation by the FDA.

Last week, the company was notified by the FDA that phase III studies for Rexista Oxycodone XR are not required to be conducted if bioequivalence to Oxycontin is demonstrated. Accordingly, the company intends to file a New Drug Application for Rexista Oxycodone XR with the FDA within the next 6 to 12 months.

IPCI closed Tuesday's trading 6.77% higher at $3.31.

Sophiris Bio Inc. (SPHS) has enrolled the first patients in a phase 2a proof of concept trial of PRX302 as a treatment for localized low to intermediate risk prostate cancer.

The study is designed to enroll approximately 20 patients. Although the primary objective of the study is safety and tolerability, the key efficacy variable is the change in the treated clinically significant lesion on biopsy after six months.

SPHS closed Tuesday's trading at $0.88, up 4.73%. In after hours, the stock was up 10.73% to $0.98.

Synageva BioPharma Corp. (GEVA) has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan for Kanuma as a treatment for patients with lysosomal acid lipase deficiency (LAL Deficiency). Upon approval, Kanuma would be the first approved therapy for these patients.

In the U.S., Kanuma is under priority review, with the FDA's decision slated for September 8, 2015.

GEVA closed Tuesday's trading at $213.99, down 1.89%.

The FDA has granted Thoratec Corp. (THOR) conditional approval for a U.S. IDE clinical trial to investigate HeartMate PHP acute catheter-based heart pump in patients undergoing a high-risk percutaneous coronary intervention.

Outside the U.S., Thoratec continues to expect CE Mark approval for HeartMate PHP during the third quarter.

THOR touched a high of $45.98 on Tuesday before closing the day's trading 1.11% higher at $45.48.

Shares of XBiotech Inc. (XBIT) rose more than 11% in extended trading on Tuesday after the company announced that it has successfully isolated and cloned an anti-Ebola product candidate using its True Human antibody discovery platform.

The company's lead drug candidate is MABp1, with the proposed trade name Xilonix, for the treatment of advanced colorectal cancer, under two phase III studies — one launched in the U.S. and another in Europe.

XBIT was trading around $18.63 when we alerted our readers to it on May 8, 2015. The stock closed Tuesday's trading at $20.22, down 1.80%. In after hours, the stock gained 11.47% to $22.54.

ZS Pharma Inc. (ZSPH) has submitted a New Drug Application to the FDA for ZS-9 for the treatment of hyperkalemia.

Hyperkalemia is a condition in which the amount of potassium in the blood exceeds the normal limit, and if untreated, may become fatal. The blood potassium level is normally 3.5 to 5.0 milliequivalents per liter (mEq/L). Renal failure, Addison's disease (disease of the adrenal gland), alcoholism, tissue damage, uncontrolled diabetes and acidosis are some of the causes for hyperkalemia.

ZSPH was trading around $28 when we alerted our premium subscribers to it last August. The stock touched a new high of $59.99 on Tuesday before closing the day's trading at $58.90.