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

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.

Read on…

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…

Read the full article from the Source…

Leave a Reply

Your email address will not be published. Required fields are marked *