GMED Outlook Spooks Investors, CYTX Trials Placed On Hold, INCY Gets FDA Date

(RTTNews) - Albany Molecular Research Inc. (AMRI), which reported better-than expected Q2 results, has also upped its full year contract revenue guidance, sending the stock up by more than 7 percent.

The company now expects full year contract revenue to range between $275 million and $283 million, up from its prior outlook of $243 million to $253 million.

AMRI closed Tuesday's trading at $20.29, up 7.98%.

Cytori Therapeutics (CYTX) plummeted in after-hours trading Tuesday following the company's decision to halt its cell therapy heart failure trials.

According to the company, the multi-center, prospective, randomized, double-blind PMA/IDE safety and feasibility (phase I/II) trials investigating adipose-derived stem and regenerative cells in patients who suffer from a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia, dubbed ATHENA and ATHENA II, were placed on hold based on a safety review of reported cerebrovascular events.

CYTX closed Tuesday's trading at $2.10, down 0.47%. In after-hours, the stock was down 22.38% to $1.63.

Globus Medical Inc. (GMED) plunged 19 percent in extended trading on Tuesday as investors were disappointed with downward revision of the company's full-year revenue outlook.

The company now expects full year 2014 net sales to be in the range of $460 million to $465 million, down from its prior estimate of $480-$486 million. The non-GAAP earnings per share guidance for 2014 remained unchanged at $0.90 to $0.92.

GMED closed Tuesday's trading at $22.56, up 1.39%. In after-hours, the stock was down 19.02% to $18.27.

Incyte Corp.'s (INCY) supplemental New Drug Application for Ruxolitinib as a potential treatment for patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea has been assigned priority review by FDA.

Accordingly, the regulatory agency's decision on the sNDA for Ruxolitinib is set for December 5, 2014.

Ruxolitinib is already approved by the FDA to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. The drug is marketed in the U.S. under the brand name Jakafi by Incyte and outside the U.S. as Jakavi by Novartis.

Net product revenue of Jakafi was $235.4 million in 2013, and is expected to be in the range of $315 million to $335 million this year.

INCY closed Tuesday's trading at $47.50, down 1.55%.

Regulus Therapeutics Inc. (RGLS) has entered into a new collaboration agreement with Biogen Idec (BIIB) to expand its research focused on identifying microRNAs as biomarkers for multiple sclerosis (MS) under its Regulus microMarkers division.

The agreement entitles Regulus to receive $2 million upfront and future payments upon achievement of certain milestones related to the identification of potential microRNA signatures.

RGLS closed Tuesday's trading at $7.09, up 6.78%.