NEW YORK CITY (dpa-AFX) - Today's Daily Dose brings you news about what's in store for Antares' XYOSTED; BioDelivery Sciences' Settlement Agreement with Teva; reverse stock split of CHF Solutions; FDA approval of Pfizer's LYRICA CR; and FDA panel recommendation for approval of Spark's gene therapy for blindness.
Shares of Antares Pharma Inc. (ATRS) were down over 40% in extended trading on Thursday after the Company announced that the FDA has identified deficiencies in the New Drug Application for XYOSTED injection.
XYOSTED, which is under FDA review, is proposed for the treatment of adult men with testosterone deficiency.
The Company anticipates receiving further clarification from the FDA on or before the decision date of October 20, 2017.
ATRS closed Thursday's trading at $3.73, down 5.33%. In after-hours, the stock was down 41.02% to $2.20.
BioDelivery Sciences International Inc. (BDSI) has entered into a Settlement Agreement with Teva Pharmaceuticals Industries Ltd. (Teva) related to Bunavail, a medicine for the maintenance treatment of opioid dependence.
BioDelivery Sciences received FDA approval for Bunavail in 2014, and its patents are said to expire in 2027.
Teva has been seeking approval to market in the United States a generic version of Bunavail, which led to filing of patent infringement suit against the Israeli pharmaceutical company by BioDelivery Sciences in February of this year.
Now, as part of the Settlement Agreement, BDSI has entered into a non-exclusive license agreement with Teva that permits Teva to first begin selling its generic version of BUNAVAIL in the U.S. on July 23, 2028 or earlier under certain circumstances. Other terms of the agreement are confidential.
BDSI closed Thursday's trading at $2.92, down 0.85%.
CHF Solutions Inc. (CHFS), formerly known as Sunshine Heart Inc., has implemented a 1-for-20 reverse split of its common stock.
The Company's stock will trade on a split adjusted basis beginning October 13, 2017.
CHFS closed Thursday's trading at $0.48, down 14.61%.
Ortho Dermatologics, a division of Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO), has announced two-year findings from its pivotal phase III study of SILIQ Injection, dubbed AMAGINE-2.
According to the trial results, SILIQ provided sustained high levels of skin clearance (PASI 100) over more than two years in patients with moderate-to-severe psoriasis. Siliq was approved by the FDA for the treatment of plaque psoriasis on February 15, 2017.
VRX closed Thursday's trading at $13.83, down 3.29%.
The FDA has approved Pfizer Inc.'s (PFE) LYRICA CR extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. LYRICA CR did not receive approval for the management of fibromyalgia.
LYRICA CR with its once-daily dosing regimen may offer convenience to patients compared to Lyrica, which is taken three times a day, according to the Company.
The total Lyrica revenues in 2016 were $4.9 billion compared to $4.8 billion in 2015.
PFE closed Thursday's trading at $36.35, down 0.26%.
ResMed (RMD) has won the German patent infringement case brought by Fisher & Paykel.
The Munich District Court has ruled that ResMed's AirSense 10, AirCurve 10, Lumis and their humidifiers do not infringe a Fisher & Paykel German utility model (a short-term patent), DE 20 2013 012 358 U1.
RMD closed Thursday's trading at $77.59, up 1.36%.
Spark Therapeutics Inc. (ONCE) rose more than 7% in after-hours on Wednesday, following FDA panel's unanimous recommendation of approval for LUXTURNA, the Company's treatment for biallelic RPE65-mediated inherited retinal disease.
The FDA's final decision on LUXTURNA is scheduled for January 12, 2018. The regulatory agency usually follows the recommendations of its advisory panels, although it is not required to do so.
ONCE closed Thursday's trading at $86.20. In after-hours, the stock was up 7.25% to $92.45.