24.05.2016 06:23:20

EXEL Rises On Trial Data, XNPT Agrees To Be Acquired, NVO Faces FDA Panel Today

(RTTNews) - Allergan plc's (AGN) botulinum toxin type A product, referred to as Botox Vista in Japan, has been approved by the Japanese Ministry of Health, Labour and Welfare for the temporary improvement in the appearance of lateral canthal lines in adult patients under the age of 65.

Depending on the country of approval, the company's botulinum toxin type A product is referred to as Botox, Botox Cosmetic, Vistabel, Vistabex or Botox Vista.

Allergan's Botox product was first approved for therapeutic use by the U.S. FDA in 1989, making it the first botulinum toxin type A product to be approved in the world. It has since been recognized by regulatory authorities as an effective treatment for 26 indications in approximately 94 countries worldwide and is in clinical development for a number of other potential aesthetic uses as well.

Botox revenues in the first quarter of 2016 were $638 million compared to $554 million in the year-ago quarter.

AGN closed Monday's trading at $225.51, down 1.73%.

Aeglea BioTherapeutics Inc.'s (AGLE) lead investigational molecule, AEB1102, to treat hyperargininemia secondary to Arginase I deficiency has been granted Fast Track Designation by the FDA.

The company is expected to initiate a clinical trial in the U.S. for AEB1102, in patients with Arginase I deficiency, in the first half of 2016.

AGLE closed Monday's trading at $7.31, down 2.01%. In after hours, the stock was up 14.91% to $8.40.

Dehaier Medical Systems Ltd. (DHRM) is in receipt of the Nasdaq Notification Letter for failing to file its annual report on Form 20-F for the year ended December 31, 2015.

The company has time until July 18, 2016 to submit a plan to Nasdaq setting forth how it plans to regain compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of periodic reports with the Securities and Exchange Commission.

DHRM closed Monday's trading at $1.49, down 1.33%.

Exelixis Inc.'s (EXEL) phase II trial of Cabozantinib in patients with previously untreated advanced renal cell carcinoma, dubbed CABOSUN, has demonstrated a statistically significant and clinically meaningful improvement in progression-free survival.

On March 1st, 2016, Exelixis granted Ipsen an exclusive licensing agreement for the commercialization and further development of Cabozantinib, where Ipsen has exclusive commercialization rights for current and potential future Cabozantinib indications outside the United States, Canada and Japan.

EXEL closed Monday's trading 7.91% higher at $6.00.

Novocure (NVCR) has enrolled the 40th and the last patient in its phase 2 pilot trial testing Tumor Treating Fields plus chemotherapy, dubbed PANOVA, in advanced pancreatic cancer. The final data collection date will be six months after the last patient in.

NVCR closed Monday's trading at $11.52, down 0.69%.

Novo Nordisk A/S' (NVO) IDegLira, which is a combination of an ultralong acting basal insulin analogue Insulin degludec and glucagonlike peptide 1 agonist Liraglutide, for the treatment of type 2 diabetes, is all set to be reviewed by an FDA advisory panel on May 24, 2016.

The FDA's final decision date is not known.

The Insulin degludec/Liraglutide combination has been available in the European Union, under brand name Xultophy, since September 2014.

NVO closed Monday's trading at $53.76, down 0.30%.

XenoPort Inc. (XNPT) is all set to be acquired by privately-held Arbor Pharmaceuticals LLC for $7.03 per share in cash, or a total equity value of approximately $467 million. The purchase price per share represents a 60 percent premium to the closing price of XenoPort shares on May 20, 2016.

XNPT closed Monday's trading at $6.88, up 56.36%.

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Exelixis Inc. 32,25 1,32% Exelixis Inc.
Novo Nordisk (spons. ADRs) 85,80 0,23% Novo Nordisk (spons. ADRs)
NovoCure Limited 30,17 3,32% NovoCure Limited