ENZ, LMNX Settle Suit, VSAR Regains Velocity, CATB Hits A High

(RTTNews) - Cardiovascular Systems Inc. (CSII) has received FDA clearance for its new ViperWire Advance Peripheral Guide Wire with Flex Tip for Peripheral Orbital Atherectomy Systems.

The new guide wire provides physicians with improved flexibility, navigation and ease-of-use - particularly in hard-to-reach, tortuous vessels - when treating arterial calcium associated with peripheral artery disease, the company said.

The product is expected to be launched in early August 2015.

For the fiscal 2015 fourth quarter ending June 30, 2015, the company anticipates revenue in the range of $49.0 million to $50.5 million, which represents 24 percent to 28 percent growth over the fourth quarter of fiscal 2014.

CSII closed Monday's trading at $26.95, up 3.42%.

Shares of Catabasis Pharmaceuticals Inc. (CATB) touched a new high on Monday, with the company's drug candidate CAT-1004 receiving Fast Track designation from the FDA for the treatment of Duchenne muscular dystrophy.

Duchenne muscular dystrophy, or DMD, is a rare disease that involves progressive muscle degeneration that eventually leads to death and for which there are no approved therapies in the United States.

CAT-1004 is under a phase 1/2 clinical trial in boys ages 4 to 7 with DMD. The trial, dubbed MoveDMD, is designed to enroll approximately 18 ambulatory boys between ages 4 and 7 with a genetically confirmed diagnosis of DMD, regardless of the specific dystrophin mutation.

Catabasis went public on the NASDAQ Global Market as recently as June 25, 2015, pricing its shares at $12.00 each. The stock touched a new high of $16.96 on Monday before closing the day's trading at $13.64, up 10%.

Enzo Biochem Inc. (ENZ) has reached and finalized a settlement with Luminex Corp. (LMNX) involving payment of $7.1 million to Enzo in a patent infringement case. The settlement resolves one of 12 infringement cases brought by Enzo against various companies, the remainder of which are still pending.

ENZ closed Monday's trading at $3.01, up 3.44%.

Horizon Pharma plc (HZNP) has filed patent infringement lawsuits in the United States District Court for the District of New Jersey against Actavis, Amneal Pharmaceuticals LLC, IGI Laboratories, Inc, Lupin Pharmaceutical Inc. and Taro for filing Abbreviated New Drug Applications with the FDA to market a generic version of PENNSAID 2% w/w (PENNSAID 2%).

Horizon acquired the U.S. rights to PENNSAID 2% w/w from Nuvo Research Inc. for a one-time payment of $45 million in cash last October. PENNSAID 2% is approved in the U.S. for the treatment of the pain of osteoarthritis of the knee.

HZNP closed Monday's trading at $34.54, down 0.95%.

Shares of Versartis Inc. (VSAR) rose more than 29% on Monday as investors welcomed the news of the removal of FDA partial clinical hold on the company's Investigational New Drug Application for VRS-317 in growth hormone deficiency children.

With the partial hold being lifted, the company will now proceed with the phase III registration trial of VRS-317 in children with growth hormone deficiency, dubbed VELOCITY, and remains on track to achieve its previously stated anticipated milestones.

The anticipated milestones for the VELOCITY phase III clinical trial include interim 6-month mean height velocity data by the end of 2016 and top line data on the 12-month mean height velocity primary endpoint by mid-2017, enabling a potential Biologics License Application submission, followed by a potential FDA approval by late-2018.

The VELOCITY trial, which was initiated in January of this year, was placed on partial hold in May after the FDA requested additional bioanalytical data. VSAR closed Monday's trading 29.41% higher at $18.92.

Zosano Pharma Corp. (ZSAN) will no longer be collaborating with Novo Nordisk (NVO) in the development of a transdermal presentation of select NVO glucagon-like peptide-1 (GLP-1) analogues for the treatment of type 2 diabetes as Novo Nordisk has decided to discontinue the collaboration agreement.

The decision relates to a strategic prioritization of Novo Nordisk's research portfolio despite continued progress during the collaboration period. Upon the expected termination of the agreement, all technology rights licensed to Novo Nordisk related to the field of GLP-1 products will revert to Zosano. The collaboration agreement between the two countries was signed in January 2014.

ZSAN closed Monday's trading at $8.10, up 3.71%.