FDA Nod For COLL, INGN Ups View, Positive News Dimmed By Earnings Miss At KERX

(RTTNews) - Today's Daily Dose brings you news about regulatory decision on Collegium's pain drug and Keryx's kidney drug; upcoming events of Xeneon, and Q3 financial results of medical technology company Inogen.

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The FDA has approved Collegium Pharmaceutical Inc.'s (COLL) supplemental New Drug Application seeking to enhance the label for Xtampza ER.

Xtampza ER, a twice-daily, oxycodone medication, received its FDA approval last April for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Now that the sNDA has been approved, comparative OxyContin data and oral human abuse deterrent claim have been added to the Xtampza ER label.

Net product revenues for Xtampza ER were $5.7 million in the first half of 2017 compared to none in the year-ago same period.

COLL closed Tuesday's trading at $10.10, up 1.10%.

Shares of medical technology company Inogen Inc. (INGN) were up over 5% in extended trading on Tuesday, following record results for the third quarter of 2017 and rosy outlook for the year.

Net income for the third quarter of 2017 increased to $7.3 million or $0.33 per share from $5.2 million or $0.25 per share in the third quarter of 2016. Likewise, total revenue in the recent third quarter rose 26.8% to $69.0 million from $54.4 million in the same period in 2016.

Analysts polled by Thomson Reuters were expecting an EPS of $0.29 and revenue of $63.6 million for Q3, 2017.

For full year 2017, the Company has boosted its revenue outlook to a range of $244 million to $248 million, up from its previous guidance range of $239 million to $243 million.

INGN closed Tuesday's trading at $101.65, up 0.50%. In after-hours, the stock was up 5.76% to $107.50.

Keryx Biopharmaceuticals Inc.'s (KERX) supplemental new drug application of Auryxia for the treatment of patients with iron deficiency anemia and non-dialysis-dependent chronic kidney disease patients has been approved by the FDA.

Auryxia was approved by the FDA in September 2014 for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

In the first nine months of 2017, Auryxia had net U.S. sales of $38 million compared to $18.9 million in the year-ago period.

However, this good news of FDA approval failed to enthuse investors as they were more concerned about the Company's lower-than-expected financial performance in the third quarter of 2017.

Net loss for the quarter ended September 30, 2017 was $23.5 million or $0.20 per share on total revenue of $15.0 million. Analysts polled by Thomson Reuters expected the Company to incur a narrower loss of $0.18 per share and revenue of $18.04 million.

The Company had reported a net loss of $41.7 million or $0.39 per share and revenue of $6.3 million during the third quarter of 2016.

KERX closed Tuesday's trading at $5.15, down 17.34%.

Xenon Pharmaceuticals Inc. (XENE) has a couple of events lined up for the coming months.

The Company expects to file an IND equivalent for XEN901, a selective Nav1.6 inhibitor for the treatment of epilepsy, in the fourth quarter of 2017.

A phase I first-in-human clinical trial of single ascending doses and multiple ascending doses of XEN1101 in healthy subjects is underway. XEN1101 is a next-generation Kv7 potassium channel opener for the potential treatment of epilepsy.

The Company also revealed that GDC-0310, its partnered program with Genentech, which has completed phase I testing, will not enter a phase II clinical trial for the potential treatment of pain in the first quarter of 2018, as previously guided.

XENE closed Tuesday's trading at $3.15, unchanged from the previous day's close.