FLXN On Fast Track, WMGI Gets FDA Nod, RDHL Gearing Up, NVRO Awaits D-Day

(RTTNews) - Amgen (AMGN) has inked a neuroscience collaboration with Novartis (NVS) in the areas of Alzheimer's disease and migraine.

Under the agreement, Novartis' phase 1/2a BACE inhibitor - CNP520 - will be the lead molecule and each company's pre-clinical BACE inhibitor programs will be potential follow-ons.

CNP520 is an oral drug designed to prevent the production of different forms of amyloid and has the potential to prevent, slow or delay the symptoms associated with Alzheimer's disease.

Amgen will make upfront and milestone payments, and will be responsible for disproportional research and development costs for an agreed-upon period followed by a 50/50 cost and profit share arrangement.

AMGN closed Tuesday's trading at $147.46, down 2.85%.

Flexion Therapeutics Inc.'s (FLXN) drug candidate FX006 has been granted Fast Track status by the FDA for the treatment of osteoarthritis of the knee.

FX006 is currently in a phase 2b pivotal trial, with top-line data expected to be announced soon, as well as in a phase 3 clinical trial for which it expects to share data in the first quarter of 2016.

FLXN closed Tuesday's trading 1.87% higher at $24.66. In after hours, the stock was up 8.51% to $26.65.

Nevro Corp. (NVRO) has submitted its preliminary response to the Patent Trial and Appeals Board, or PTAB, in response to two petitions for inter partes review filed by a unit of Boston Scientific Corp. (BSX), challenging the validity of Nevro's patent no. 8,359,102.

Nevro's patent no. 8,359,102, covers "Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods".

Nevro's Senza chronic pain device, which can deliver up to 10,000 Hz of stimulation, compared with conventional systems that deliver 50-100 Hz, received FDA approval on May 8, 2015, and is labeled as superior to traditional spinal cord stimulation therapy.

The Senza spinal cord stimulation system, which delivers Nevro's proprietary HF10 therapy, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The petitions for Inter Partes Review were filed by a unit of Boston Scientific Corporation challenging Nevro's patent no. 8,359,102, on May 11, 2015.

A decision by the PTAB to either institute or deny review of the petition is expected by December 1st, 2015.

Nevro went public on November 6, 2014, offering its shares at a price of $18.00 each. The stock closed Tuesday's trading at $45.07, up 0.09%.

RedHill Biopharma Ltd. (RDHL) announced that the last patient has completed the final scheduled follow-up visit in the phase I study evaluating its drug candidate YELIVA for the treatment of advanced solid tumors.

Analysis of the study is ongoing, with top-line results expected early in the fourth quarter of 2015. A full analysis and final Clinical Study Report are expected by the end of this year or early 2016.

RDHL closed Tuesday's trading at $12.78, down 0.74%.

Sanofi (SNY) has terminated the option and license agreement for Ardelyx Inc.'s (ARDX) portfolio of NaP2b inhibitors effective September 30, 2015. There was no payment associated with termination and the return of rights.

The option and license agreement between Sanofi and Ardelyx was inked in February 2014, under which Ardelyx granted Sanofi an exclusive worldwide license to conduct research utilizing Ardelyx's small molecule NaP2b inhibitors, also called RDX002, for the treatment of hyperphosphatemia in end stage renal disease patients.

ARDX closed Tuesday's trading at $18.77, down 1.11%.

Shares of Wright Medical Group Inc. (WMGI) rose more than 10% in extended trading on Tuesday following FDA approval for the company's Premarket Approval Application for AUGMENT Bone Graft.

The approval indicates that AUGMENT Bone Graft is safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications. The company expects to begin selling the product in the U.S. in the next several weeks once inventory is moved into its U.S. distribution network.

According to the company, AUGMENT revenue in the U.S. is expected to be in the range of $10 million to $12 million in the first seven to eight months post-approval.

WMGI closed Tuesday's trading at $22.92, down 0.65%. In after-hours, the stock was up 10.38% to $22.92.

Zosano Pharma Corp. (ZSAN) has completed enrollment in a phase I clinical trial - with 20 healthy volunteers - which will test the tolerability and pharmacokinetics of up to five doses of its investigational ZP-Triptan compared to subcutaneous injection of Sumatriptan and oral administration of Zolmitriptan for migraine headaches.

Data from this trial are anticipated by the end of 2015.

ZSAN closed Tuesday's trading at $8.10, unchanged from the previous day's close.