RARE's Seizure Study Fails, HTGM Soars After-hours, NTEC Awaits Data In Q3

(RTTNews) - AVEO Oncology (AVEO) has a couple of catalysts coming its way this year.

A pre-planned interim futility analysis of phase III trial comparing investigational drug Tivozanib to approved drug Nexavar (sorafenib) in subjects with refractory advanced renal cell carcinoma, dubbed TIVO-3, is expected around mid-year 2017.

Enrollment in the TIVO-3 trial is anticipated to be completed in June 2017, ahead of its prior guidance of August 2017. Top line data from the trial is expected in the first quarter of 2018.

A Phase 1/2 trial evaluating Tivozanib in combination with Bristol-Myers Squibb's (BMY) Opdivo in advanced renal cell carcinoma, known as TiNivo, is underway. The Phase 1 portion of the trial is expected to be completed in the first half of 2017.

In Europe, Tivozanib is under review by the European Medicines Agency. The Marketing Authorisation Application for Tivozanib was submitted to the European Medicines Agency by AVEO's partner EUSA Pharma.

Last month, EUSA received the Day 180 List of Outstanding Issues (LOI) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). EUSA expects to submit written responses to the Day 180 LOI next month, and the EMA has tentatively scheduled EUSA to provide an oral explanation to the CHMP in May 2017.

AVEO closed Wednesday's trading at $0.84, down 0.02%.

HTG Molecular Diagnostics Inc. (HTGM) has obtained CE marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU.

The HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay intended to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer.

HTGM closed Wednesday's trading at $2.14, up 8.63%. In after-hours, the stock was up 69.63% to $3.63.

Intec Pharma Ltd. (NTEC) has initiated a Phase I clinical trial of AP-CBD/THC, which is being developed for various indications, including low back pain and Fibromyalgia.

AP-CBD/THC refers to Accordion Pill with the two primary cannabinoids in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC).

The top line results from this trial are expected in the third quarter of 2017.

NTEC closed Wednesday's trading at $5.00, up 3.09%.

Moleculin Biotech Inc.'s (MBRX) lead candidate, Annamycin, has been granted Orphan Drug Designation by the FDA for the treatment of acute myeloid leukemia.

A phase II trial evaluating Annamycin as a potential treatment for relapsed or refractory acute myeloid leukemia is underway - with top line data expected to be reported by the second half of 2017.

MBRX closed Wednesday's trading at $1.33, up 24.30%.

Sunesis Pharmaceuticals Inc. (SNSS) has submitted its responses to the European Medicine Agency Day 180 List of Outstanding Issues issued by the Committee for Medicinal Products for Human Use (CHMP) related to the Marketing Authorization for Vosaroxin.

The company is seeking approval of Vosaroxin for the treatment of relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older.

The CHMP decision on Vosaroxin is expected decision by mid-year 2017.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the Vosaroxin.

SNSS closed Wednesday's trading at $4.02, down 5.63%.

Shares of Ultragenyx Pharmaceutical Inc. (RARE) were down more than 6% in extended trading on Wednesday, following the failure of its phase II UX007 Glucose Transporter Type-1 Deficiency Syndrome seizure study.

Glucose Transporter Type-1 Deficiency Syndrome is a severely debilitating disease characterized by seizures, developmental delay, and movement disorders.

The phase II study did not meet the primary endpoint of reducing the frequency of total number of observable and absence seizures among patients treated from baseline to Week 8 with UX007 compared to placebo.

RARE closed Wednesday's trading at $78.36, up 0.82%. In after-hours, the stock fell 6.58% to $73.20.