Positive Data IGNITEs TTPH, MDCO Makes A Good TANGO, Wait Continues For EGRX

(RTTNews) - Today's Daily Dose brings you news about BioTime's progress in dry-AMD trial; Exact Sciences' stellar Q2 results; Incyte's delay in re-submitting Baricitinib NDA; Tetraphase's positive phase III trial results of intravenous Eravacycline in complicated intra-abdominal infections and Neuralstem's disappointing results from major depressive disorder trial.

Read on...

BioTime Inc. (BTX) has been given the go-ahead by the Data Safety Monitoring Board to start third patient cohort in the Company's phase I/IIa OpRegen clinical trial in the advanced form of dry-AMD.

The Company noted that it will start enrolling patients in cohort 3 in the coming weeks in both Israel and the U.S. This cohort is expected to be completed during the fourth quarter of 2017.

BTX closed Tuesday's trading at $2.92, down 0.68%.

The FDA is yet to announce whether or not Eagle Pharmaceuticals Inc.'s (EGRX) Ryanodex for the treatment of exertional heat stroke is approved. The decision was supposed to have been announced by July 23, 2017.

Commenting on the delay, the Company noted that it has not yet received correspondence from the FDA regarding its New Drug Application for RYANODEX for the treatment of exertional heat stroke.

Ryanodex is already approved for the treatment of malignant hyperthermia, a potentially fatal, inherited disorder causing a rapid rise in body temperature (fever) and severe muscle contractions associated with administration of certain general anesthetics and/or the drug succinylcholine.

The drug brought in sales of $11.7 million for Eagle Pharma last year.

EGRX closed Tuesday's trading at $70.04, down 3.79%.

The resubmission of Eli Lilly and Co. (LLY) and Incyte Corp.'s (INCY) New Drug Application for Baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis, is going to take a minimum of 18 months.

The FDA issued a Complete Response Letter for Baricitinib in April of this year, indicating that additional clinical data are needed to determine the most appropriate doses and to further characterize safety concerns across treatment arms.

Christi Shaw, president of Lilly Bio-Medicines said, "We disagree with the FDA's conclusions, and believe the existing comprehensive clinical data demonstrate there is a positive benefit/risk profile that supports Baricitinib's approval as a new treatment option for people suffering from RA in the United States. We are disappointed that resubmission will not occur this year, but are committed to bringing baricitinib to people with RA and we will work with the FDA on the path forward."

Baricitinib was approved in the European Union, under trade name Olumiant, as recently as February of this year for the treatment of moderate-to-severe active rheumatoid arthritis.

LLY closed Tuesday's trading at $82.19, down 3.01%.

Shares of Exact Sciences Corp. (EXAS) were up over 4% in extended trading on Tuesday, following 172% growth in its second quarter revenue.

In the second quarter ended June 30, 2017, the Company generated revenue of $57.6 million compared to $21.2 million in the year-ago quarter. Net loss was $30.8 million or $0.27 per share in Q2, 2017 compared to $44.8 million or $0.46 per share during the same period of 2016.

The Company completed approximately 135,000 Cologuard tests during the recent second quarter, up 149 percent from the comparable year-ago period.

EXAS closed Tuesday's trading at $37.33, down 5.35%. In after-hours, the stock was up 4.47% to $39.00.

The Medicines Co.'s (MDCO) phase III trial of Vabomere in patients with serious infections due to confirmed or suspected carbapenem-resistant Enterobacteriaceae, dubbed TANGO 2, has been stopped early for superior benefit-risk compared to the best available therapy.

The decision to stop the trial early was based on a recommendation by an independent Data and Safety Monitoring Board.

Previously, Vabomere (meropenem-vaborbactam) was commonly referred to as "Carbavance."

MDCO closed Tuesday's trading at $38.73, down 1.25%.

Shares of Neuralstem Inc. (CUR) slumped nearly 50% on Tuesday, following disappointing top-line results from its exploratory phase II clinical trial examining the efficacy of NSI-189 at 40 mg once daily (QD) and 40 mg twice daily (BID) compared to placebo for the treatment of major depressive disorder.

The study did not meet its primary efficacy endpoint of a statistically significant reduction in depression symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS).

CUR closed Tuesday's trading at $2.81, down 49.64%.

Japanese ophthalmic pharmaceutical company Santen Pharmaceutical Co. Ltd. has initiated a phase IIa clinical study of DE-122 in patients with wet age-related macular degeneration.

Santen licensed the global development rights to DE-122 in ophthalmology from TRACON Pharmaceuticals Inc. (TCON) in 2014.

The initiation of the phase IIa clinical study triggers a US$7 million milestone payment from Santen to TRACON.

TCON closed Tuesday's trading at $2.20, unchanged from the previous day's close.

Shares of Tetraphase Pharmaceuticals Inc. (TTPH) climbed more than 25% in extended trading on Tuesday, following positive top line results from its phase III trial of intravenous (IV) Eravacycline in complicated intra-abdominal infections (cIAI), dubbed IGNITE4.

The IGNITE4 trial evaluated the efficacy and safety of intravenous (IV) Eravacycline against Meropenem in complicated intra-abdominal infections. According to the study results, Eravacycline achieved high clinical cure rates in patients with complicated intra-abdominal infections, comparable to patients in the Meropenem group.

In a previous phase III study, dubbed IGNITE1, the results of which were reported in December 2014, Eravacycline met the primary endpoint of statistical non-inferiority of clinical response at the test-of-cure (TOC) visit.

Tetraphase plans to submit a New Drug Application for intravenous (IV) Eravacycline, based on data from the IGNITE1 and IGNITE4 clinical trials, to the FDA in the first quarter of 2018. The Company also remains on track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) during the third quarter of 2017.

TTPH closed Tuesday's trading at $6.90, down 5.48%. In after-hours, the stock was up 25.36% to $8.65.