XENT Breathes Easy, PTCT Suffers Translarna Snub, RTTR To Report Data In Q1

(RTTNews) - Intersect ENT Inc.'s (XENT) pivotal phase III study of its investigational RESOLVE steroid releasing implant has met both primary efficacy endpoints namely, reduction in nasal congestion and polyp burden.

The study, dubbed RESOLVE II, evaluated the implant in 300 adult chronic sinusitis patients, all of whom were indicated for revision sinus surgery at study entry due to recurrent symptoms and obstructive inflammation.

The company plans to submit a New Drug Application for the RESOLVE steroid releasing implant in the first quarter of 2017.

XENT closed Monday's trading at $17.20, up 3.61%.

Omeros Corp. (OMER) on Monday reported positive data from its phase II clinical trial of OMS721 for the treatment of kidney disorders, such as IgA nephropathy, membranous nephropathy, lupus nephritis, and complement component 3 glomerulopathy.

According to the trial data, the IgA nephropathy patients demonstrated a clinically meaningful and statistically significant decrease in uACRs (urine albumin-to-creatinine ratios). Lower uACRs are associated with improved renal survival. The two patients with membranous nephropathy also demonstrated reductions in uACR during treatment.

OMER closed Monday's trading at $7.60, up 3.54%.

Shares of PTC Therapeutics Inc. (PTCT) slumped over 39% on Monday as its first appeal of "refuse to file letter" issued by the FDA regarding Translarna has been denied.

The company has been seeking approval of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy. The FDA issued the Refuse to File letter in February saying that the application was not sufficiently complete to permit a substantive review.

The company submitted an appeal against the FDA's Refuse to File decision in June of this year. Now that its first appeal has been denied, the company intends to escalate its appeal to the next supervisory level of the FDA.

As for the European regulatory approval of Translarna, the CHMP issued a request for supplemental information, including a request categorized as a major objection.

Translarna, which was given conditional approval by the European Medicines Agency for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older in August 2014, has been available in the European Union since December 2014.

PTCT closed Monday's trading at $7.97, down 39.94%.

Ritter Pharmaceuticals Inc. (RTTR) expects topline results of its phase 2b/3 trial of RP-G28 for the treatment of lactose intolerance to be announced in the first quarter of 2017.

The last patient has completed dosing, and all monitoring visits in the trial have been completed. A total of 377 subjects have been enrolled in the trial with 18 clinical sites participating throughout the United States.

RTTR closed Monday's trading at $1.87, up 10.00%.

Veracyte Inc. (VCYT) has reported encouraging preliminary financial results for the third quarter ended September 30, 2016, thanks to its reimbursement strategy.

Net loss for the quarter is expected to be $5.6 million to $5.9 million, or $0.20 to $0.21 per share on revenue of $18.6 million. This compares with a net loss of $8.9 million or $0.32 per share and revenue of $12.3 million in the third quarter of 2015. Analysts polled by Thomson Reuters were expecting the company to report a loss per share of $0.39 and revenue of $15.72 million.

The company is slated to report its detailed Q3 results on November 3, 2016.

VCYT closed Monday's trading at $7.59, up 0.13%.

Versartis Inc. (VSAR) has been granted regulatory approval in Japan to initiate enrollment for its phase III study of Somavaratan in pediatric patients with growth hormone deficiency.

Enrollment in the phase III trial is expected to be completed in the third quarter of 2017, with topline data scheduled for 2018.

VSAR closed Monday's trading at $12.10, up 4.13%.