AERI's Rocket Hits Target, ENTL Gets FDA Nod, NOVN Jumps On Positive Trial Data

(RTTNews) - Aevi Genomic Medicine Inc. (GNMX) is slated to present updated results from its phase 2/3 efficacy study of AEVI-001 in adolescent patients with ADHD (attention-deficit/hyperactivity disorder), dubbed SAGA, on April 21, 2017.

The initial results of the SAGA trial were reported on March 20th, 2017. The study did not meet the primary endpoint of reduction on the ADHD rating scale (ADHD-RS) compared to placebo. The news sent the stock plunging 59.38% that day to $2.21.

GNMX closed Wednesday's trading at $1.71, up 5.56%. In after-hours, the stock gained another 9.94% to $1.88.

Aerie Pharmaceuticals Inc. (AERI) on Wednesday reported the successful six-month top line safety and efficacy results from a phase III trial of its glaucoma candidate Rhopressa, dubbed Rocket 4.

The objective of the Rocket 4 clinical trial is to provide six-month safety data adequate for regulatory filing in Europe and is not required for U.S. FDA approval. The Company is expected to file for European approval of Rhopressa in the second half of 2018.

Another glaucoma therapy of the Company is Roclatan, which is under two phase III trials known as Mercury-1 and Mercury-2.

The 90-day efficacy readout from the Mercury 2 trial is expected later this quarter. The 12-month safety data from Mercury 1 are expected in the third quarter of this year.

AERI closed Wednesday's trading at $42.55, down 1.39%.

Shares of Entellus Medical Inc. (ENTL) were up more than 4% in extended trading on Wednesday, following FDA clearance for use of its XprESS ENT Dilation System in patients with persistent Eustachian tube dysfunction.

The FDA clearance follows assessment of a prospective, multicenter, randomized trial of the XprESS balloon dilation device in 60 patients with persistent Eustachian tube dysfunction.

Collection of follow-up data from the study subjects is continuing, and the trial is expected to be completed in September 2017.

ENTL closed Wednesday's trading at $13.45, down 0.44%. In after-hours, the stock was up 4.09% to $14.00.

Immune Pharmaceuticals Inc. (IMNP) has implemented a 1-for-20 reverse stock split that will come into effect at opening of trading on April 13, 2017.

The primary purpose of the reverse stock split is to enable Immune to regain compliance with the $1.00 minimum bid price requirement for continued listing on Nasdaq.

IMNP closed Wednesday's trading at $0.13, down 5.48%.

Shares of Novan Inc. (NOVN) were up more than 20% on Wednesday, following positive top-line results from a phase II study of SB208.

SB208 is an investigational broad-spectrum antifungal gel for the treatment of superficial cutaneous fungal infections of the skin and nails, including tinea pedis and onychomycosis.

In the phase II trial, SB208 Gel, at both the 4% and 16% concentrations, demonstrated a statistically significant effect compared to vehicle in a clinical trial in patients with tinea pedis, or athlete's foot.

The Company plans to initiate a phase II trial of SB208 Gel in patients with onychomycosis, as early as the second half of 2017.

NOVN closed Wednesday's trading at $6.29, up 20.96%.

Shares of Protalix BioTherapeutics Inc. (PLX) plunged more than 15% on Wednesday, despite reporting positive results from a phase II trial of alidornase alfa (AIR DNase) for the treatment of Cystic Fibrosis.

Although the results were positive in a number of clinically relevant parameters, suggesting improved lung function with alidornase alfa, investors were disappointed that the lung function improvement as demonstrated by a mean absolute increase in the percent predicted forced expiratory volume in one second (ppFEV1) was only 3.4 points from baseline in the phase II study.

In January of this year, the interim results of the same phase II trial of alidornase alfa (AIR DNase) for the treatment of Cystic Fibrosis had shown an improvement of 4.1 points from baseline.

PLX closed Wednesday's trading at $1.11, down 15.27%.

An end of phase II meeting with the FDA has been scheduled for the third quarter of 2017 at which Ritter Pharmaceuticals Inc. (RTTR) will discuss the results of its recently completed phase 2b/3 trial of RP-G28 for the treatment of lactose intolerance.

In the phase 2b/3 trial, the results of which were reported on March 29th, RP-G28 showed a clinically meaningful beneficial effect on patients in both symptom reduction and global patient assessments of benefit.

During the meeting, the Company also plans to consult with the FDA on finalizing the Phase 3 clinical program and remaining NDA-enabling package necessary for obtaining commercial approval of RP-G28 for the treatment of lactose intolerance.

RTTR closed Wednesday's trading at $1.06, down 3.64%.

Synergy Pharmaceuticals Inc. (SGYP) has been issued three new patents covering its drug TRULANCE, which is approved for the treatment of chronic idiopathic constipation in adults.

The first patent relates to the method for manufacturing TRULANCE and will expire March 1, 2032. The two other patents relate to formulations and methods of using TRULANCE for treating chronic idiopathic constipation and irritable bowel syndrome with constipation at 3mg or 6 mg dose. These two patents will expire September 15, 2031.

SGYP closed Wednesday's trading at $4.50, up 2.04%.