MDXG Revises Q3 Outlook, Two Down, One To Go For BLPH, TECH Opens Wallet

(RTTNews) - Today's Daily Dose brings you news about Atara's orphan drug status for its drug candidate ATA230; Bellerophon's positive top line data from phase II trial of INOpulse; BioCryst's encouraging phase II hereditary angioedema trial results; Bio-Techne's acquisition of Trevigen; EnteroMedics' post-approval study of vBloc therapy; Ligand Pharma's encouraging results from phase II trial of LGD-6972 in type-2 diabetes; MiMedx Group's revised revenue outlook for Q3, 2017 and conclusion of federal investigation concerning sales and marketing practices for Novo Nordisk's type 2 diabetes drug Victoza.

Read on...

Atara Biotherapeutics Inc.'s (ATRA) drug candidate ATA230 has been granted orphan drug designation for the treatment of cytomegalovirus viremia and disease in immunocompromised patients by the FDA.

ATA230, an allogeneic T-cell immunotherapy targeting antigens expressed by CMV, has been investigated in one Phase 1 and two Phase 2 clinical studies in patients with CMV viremia and disease who are refractory or resistant to antiviral drug treatment.

ATRA closed Tuesday's trading at $15.05, down 1.31%.

Bellerophon Therapeutics Inc. (BLPH) has announced positive top line data from a Phase 2 clinical trial evaluating INOpulse in patients with Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease.

INOpulse is also under a phase III trial for the treatment of pulmonary arterial hypertension, with interim and top-line data expected in 2018.

BLPH closed Tuesday's trading at $1.18, up 4.42%.

BioCryst Pharmaceuticals Inc.'s (BCRX) final results from its Phase 2 clinical trial of BCX7353 in hereditary angioedema, dubbed APeX-1, have been found to be encouraging.

APeX-1 was a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of orally administered once-daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients. This final analysis evaluated data from all patients in Parts 1, 2 and 3 of the trial.

According to the trial results, there was a 73% reduction in overall attack frequency at 125mg dose.

BCRX closed Tuesday's trading at $4.93, down 1.40%. In after-hours, the stock was up 4.46% to $5.15.

Bio-Techne Corp. (TECH) has acquired all of the stock of privately-held Trevigen Inc. for cash.

Trevigen is a provider of reagents and kits for researchers investigating programmed cell death and DNA damage and repair.

The acquisition is a good strategic fit between the two companies given that both companies share the passion to empower cutting-edge science with quality reagents noted Trevigen CEO Michael Elliot.

TECH touched an all-time high of $124 on Tuesday before closing the day's trading at $121.15.

EnteroMedics Inc. (ETRM) has begun ReNEW, a post-approval study for the treatment of Obesity with vBloc therapy.

ReNEW is a five-year, multi-center trial that will provide 200 patients with vBloc Neurometabolic Therapy at approximately 10-15 centers across the United States. The primary safety objective of ReNEW is to demonstrate that the rate of serious adverse events (SAEs) related to implanting vBloc is statistically lower than 25% at five years. Primary efficacy endpoints for ReNEW will examine various measures of excess weight loss and total body weight loss.

The Company's vBloc vagal blocking therapy was approved by the FDA in 2015 for the treatment of obese adults with a Body Mass Index (BMI) of 40 and 45 kg/m2, or BMI between 35 and 39.9 kg/m2, and with a weight-related health condition, such as high cholesterol levels, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years. This therapy is delivered through the Maestro System.

ETRM closed Tuesday's trading at $1.72, down 7.03%. In after-hours, the stock was up 2.91% to $1.77.

The FDA has approved Guerbet LLC USA's Dotarem for intravenous use with magnetic resonance imaging in pediatric patients under two years old to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Dotarem was previously approved by the FDA for use in patient populations over the age of two.

To date, Dotarem is approved in 79 countries worldwide.

Intellipharmaceutics International Inc. (IPCI) is working on initiating a previously planned Category 3 study shortly to support certain label claims of its investigational opioid painkiller Rexista.

An FDA panel, in July of this year, recommended against approving Rexista stating that the Company has not demonstrated that Rexista has properties that can be expected to deter intravenous abuse. In addition, the Company was asked to provide additional safety and efficacy data for Rexista from human abuse potential studies for the oral and intranasal routes of administration.

The FDA's final decision on Rexista is slated for September 25, 2017.

IPCI closed Tuesday's trading at $0.97, unchanged from the previous day's close.

Lannett Co. Inc. (LCI) has received approval from the FDA for its Abbreviated New Drug Application for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, the therapeutic equivalent to "the purple pill" of AstraZeneca Pharmaceuticals LP.

For the 12 months ended July 2017, total U.S. sales of Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, at Average Wholesale Price (AWP) were approximately $1.4 billion, according to IMS.

LCI closed Tuesday's trading at $17.70, unchanged from the previous day's close.

Ligand Pharmaceuticals Inc.'s (LGND) phase II clinical study evaluating the efficacy and safety of LGD-6972, as an adjunct to diet and exercise, in subjects with type 2 diabetes mellitus robust, has demonstrated statistically significant, dose-dependent reductions from baseline in hemoglobin A1c after 12 weeks of treatment.

LGD-6972 has also been found to be safe and well tolerated, with no drug-related serious adverse events.

LGND touched a new 52-week high of $132.49 on Tuesday, before closing the day's trading at $130.87, up 1.50%.

MEI Pharma Inc. (MEIP) has entered into a license agreement with Presage Biosciences Inc. for Voruciclib, a phase I cancer drug candidate.

Under the terms of the agreement, MEI Pharma receives exclusive worldwide rights to develop, manufacture and commercialize Voruciclib. In exchange, Presage will receive near-term payments of $2.9 million and additional potential payments of up to $181 million upon the achievement of certain development, regulatory and commercial milestones. Presage will also receive mid-single-digit tiered royalties on the net sales of any product successfully developed.

"Voruciclib is a promising drug candidate with the potential to overcome mechanisms of drug resistance and significantly improve patient outcomes," said David Johnson, Chairman of Presage.

MEIP closed Tuesday's trading at $2.75, up 5.36%. In after-hours, the stock was up 5.09% to $2.89.

MiMedx Group Inc. (MDXG) now expects revenue for the third quarter of 2017 to exceed $80 million. The Company was previously expecting third quarter revenue to range between $79 million and $80 million.

The revised outlook is based on the strength of the Company's July and August revenue performance.

MDXG closed Tuesday's trading at $16.73, up 1.21%.

Novo Nordisk (NVO) has agreed to pay approximately $46.5 million to settle the federal investigation concerning sales and marketing practices for the Company's Victoza, a medicine used to treat type 2 diabetes.

The investigation, which was launched in February 2011, has now concluded.

Additionally, Novo Nordisk will pay $12.15 million to resolve a complaint filed by the government on behalf of the FDA in federal court. In connection with this settlement, the Company has also resolved several private whistle-blower cases related to the government's investigation.

NVO closed Tuesday's trading at $46.98, down 0.55%.

Rexahn Pharmaceuticals Inc. (RNN) will present updated preliminary data from the Phase IIa study of RX-3117 in advanced and metastatic bladder cancer and also the final data on the Supinoxin Phase I clinical study on September 10th and September 11th, respectively.

The Company will also present the data from preclinical studies evaluating RX-3117 in combination with other anticancer agents including Abraxane and immuno-oncology agents.

RNN closed Tuesday's trading at $2.74, up 17.09%.

Skyline Medical Inc. (SKLN) has entered into an innovative technology partnership with Intalere Corp. for the STREAMWAY System.

Skyline Medical's STREAMWAY system is an FDA-cleared direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures.

The partnership provides access to more than 90,000 members, including 3,733 hospitals.

SKLN closed Tuesday's trading at $1.41, up 0.71%. In after-hours, the stock was up another 16.67% to $1.61.

Ortho Dermatologics, a division of Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO), has submitted a New Drug Application to the FDA for IDP-118 lotion.

IDP-118 is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene for the treatment of plaque psoriasis.

In phase III studies, IDP-118 met the primary efficacy endpoint achieving a "clear" to "almost clear" score and at least a 2 grade improvement based on an Investigator Global Assessment (IGA) at 8 weeks, and clear to almost clear and at least 2 grade improvement during a 4 week follow up visit at week 12.

VRX closed Tuesday's trading at $13.10, down 1.73%.