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AKAO Faces FDA In June, TECH Opens Wallet, FPRX's FIGHT Begins, TRVN Soars

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Today's Daily Dose brings you news about Bio-Techne's first acquisition for the year; Tetraphase's submission of NDA for IV Eravacycline; Five prime's progress in phase I/III clinical trial of FPA144, and FDA's acceptance of Trevena's OLINVO NDA for review, to name a few.

Read on...

Achaogen Inc.'s (AKAO) second antibacterial candidate C-Scape, being developed for Multidrug resistant gram-negative infections, has found to be well tolerated across all doses in a phase I trial, with no drug-drug interaction between the previously approved compounds when dosed in combination.

C-Scape is an oral combination of ceftibuten, an approved third generation cephalosporin, and clavulanate, an approved beta-lactamase inhibitor.

C-Scape has been awarded Qualified Infectious Disease Product (QIDP) status by the FDA for the treatment of complicated urinary tract infections (cUTI), which provides incentives for new antibiotic treatments, including priority review and additional market exclusivity.

"The positive top-line results from this first-in-human clinical trial for C-Scape are supportive of further evaluation and we continue to plan for Phase 3 in 2018. FDA has previously indicated that a single Phase 3 study in cUTI, if successful, would be sufficient for licensure, and we plan to meet with the FDA in early 2018 to seek agreement on the details of our development plan," said Kenneth Hillan, Achaogen's President, R&D.

In other news, the Company's New Drug Application for Plazomicin for the treatment of complicated urinary tract infections (cUTI), and bloodstream infections, has been accepted for priority review by the FDA. The regulatory agency's decision on Plazomicin will be known by June 25, 2018.

AKAO closed Tuesday's trading at $11.20, up 4.28%.

Avenue Therapeutics Inc. (ATXI) has dosed the first patient in its phase III safety trial of IV Tramadol for the management of moderate to moderately severe pain.

The trial is designed to enroll approximately 250 patients, who will receive 50 mg of IV Tramadol over 15 minutes at zero, two and four hours, then once every four hours thereafter. This safety study is a key component of the Company's pivotal phase III development program of IV Tramadol.

A pivotal phase III clinical trial of intravenous (IV) Tramadol for the management of moderate to moderately severe pain in patients following bunionectomy surgery is already underway. The Company expects to report topline data from this trial in the second quarter of 2018.

A second phase III trial that will evaluate IV Tramadol in patients following abdominoplasty surgery is expected to begin in the third quarter of 2018.

ATXI closed Tuesday's trading at $3.83, up 5.80%.

Bio-Techne Corp. (TECH) has acquired Atlanta Biologicals Inc. and its affiliated company, Scientific Ventures Inc. This is the Company's second acquisition in 4 months. The transaction is financed through available cash on hand.

Atlanta Biologicals is focused on supplying cell culture sera, media and reagents for the life science research market.

The acquisition is expected to be slightly accretive to Bio-Techne's adjusted earnings per share for its fiscal year 2018.

Last September, Bio-Techne acquired privately-held Trevigen Inc., a provider of reagents and kits for researchers investigating programmed cell death and DNA damage and repair, for cash.

TECH closed Tuesday's trading at $131.46, up 1.47%.

Five Prime Therapeutics Inc. (FPRX) has commenced dosing in phase I portion of its phase I/III clinical trial of FPA144 in combination with chemotherapy in patients with previously untreated, advanced gastric or gastroesophageal cancer, dubbed FIGHT.

About 21 patients with unresectable, locally advanced, or metastatic gastrointestinal cancer will be enrolled during the Phase 1 portion of the FIGHT trial. The study is scheduled to transition to phase III portion in mid-2018.

FPRX closed Tuesday's trading at $22.49, up 2.60%.

HealthSouth Corporation, the nation's leading owner and operator of inpatient rehabilitation hospitals and a leader in home-based care, has changed its name to Encompass Health Corporation.

The Company's stock, which trades on the New York Stock Exchange (NYSE), now gets a new ticker symbol - "EHC." Previously, the shares were trading under the symbol "HLS".

The Company will host a presentation at the 36th Annual J.P. Morgan Healthcare Conference on Jan. 9, 2018.

Neovasc Inc. (NVCN) has been notified that it is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

The Company's stock has been trading below $1 since November 14, 2017.

Neovasc has time until July 2, 2018, to regain compliance with Nasdaq Listing Rule related to minimum bid requirements. To regain compliance, the Company's common shares must have a closing bid price of at least US $1.00 for a minimum of 10 consecutive business days.

NVCN closed Tuesday's trading at $0.60, unchanged from the previous day's close.

Seattle Genetics Inc.'s (SGEN) supplemental Biologics License Application for ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma has been accepted for priority review by the FDA.

The regulatory agency's decision on the expanded use of ADCETRIS will be known by May 1, 2018.

ADCETRIS is already approved for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.

The drug brought home sales of $223.8 million in the nine months of 2017 compared to $195.0 million in the year-ago period, a 15 percent increase.

SGEN closed Tuesday's trading at $56.13, up 4.92%.

Tetraphase Pharmaceuticals Inc. (TTPH) has submitted its New Drug Application to the FDA for intravenous (IV) eravacycline for the treatment of complicated intra-abdominal infections.

The NDA submission includes data from phase 3 clinical trials, dubbed IGNITE1 and IGNITE 4, in which twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates in patients with complicated intra-abdominal infections.

The FDA has a 60-day filing review period to determine whether the NDA is complete.

TTPH closed Tuesday's trading at $6.47, up 2.70%. In after-hours, the stock was up 11.59% to $7.22.

Trevena Inc.'s (TRVN) New Drug Application for OLINVO for the management of moderate to severe acute pain has been accepted for review by the FDA, with a decision expected in the fourth quarter of 2018.

OLINVO has been designated a Breakthrough Therapy by the FDA.

In Phase 2 and Phase 3 clinical trials, OLINVO provided rapid and powerful analgesic efficacy while demonstrating a wider therapeutic window compared to morphine, suggesting it may be highly effective and well-tolerated for patients in need of strong analgesia, according to the Company.

TRVN closed Tuesday's trading at $1.80, up 12.50%. In after-hours, the stock soared 24.44% to $2.24.

by RTTNews Staff Writer

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