12.05.2017 08:26:04
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AKTX Falls To Disgrace, CATB Awaits Data In Q3, CORI Surges On Trial Data
(RTTNews) - Today's Daily Dose brings you news about Akari's CEO fall into disgrace; Cancer Genetics' Q1 financial results, Corium's encouraging results from its pilot bioequivalence study and the upcoming catalyst of Catabasis.
Read on.
Shares of Akari Therapeutics Plc (AKTX) plunged over 19% in extended trading on Thursday after the Company announced that its CEO Gur Roshwalb has been placed on administrative leave.
The Company's Board of Directors is reviewing whether Roshwalb had any involvement with a research report titled "Akari's Coversin matches Soliris in Phase II" by Edison Investment Research Ltd, the investment research and advisory company.
On April 27, 2017, Edison withdrew the report stating that there were material errors in it, and also suspended coverage of Akari Therapeutics.
Coversin, Akari's lead drug candidate, is a next-generation C5 inhibitor, and is derived from the saliva of the Ornithodoros moubata tick.
Coversin's potential is being explored in the indications of paroxysmal nocturnal haemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).
Coversin is under two phase II clinical trials in the indication of paroxysmal nocturnal haemoglobinuria.
Soliris is the first and only approved C5 inhibitor to treat patients with PNH and atypical hemolytic uremic syndrome.
AKTX closed Thursday's trading at $11.49, up 4.45%. In after-hours, the stock fell 19.93% to $9.20.
Cancer Genetics Inc. (CGIX) has reported a 15% revenue growth in its first quarter of 2017 and a 16% decline in adjusted net loss over the comparable year-ago period.
On a non-GAAP basis, the net loss for the first quarter of 2017, narrowed to $2.1 million or $0.11 per share from $5.3 million or $0.39 per share in Q1 2016. Total revenues were $7.0 million in Q1, 2017, up from $6.1 million in the year-ago first quarter.
The total operating expenses for Q1, 2017 declined 21% to $5.6 million from $7.1 million in Q1 2016.
CGIX closed Thursday's trading at $4.10, down 2.38%. In after-hours, the stock fell another 6.22% to $3.85.
Catabasis Pharmaceuticals Inc. (CATB) expects to report Part C of its MoveDMD trial in the third quarter of this year.
The MoveDMD trial is a three-part phase I/II clinical trial investigating the safety and efficacy of Edasalonexent in boys ages 4-7 affected with Duchenne muscular dystrophy (any confirmed mutation).
Part A of the MoveDMD trial evaluated the safety, tolerability and pharmacokinetics of Edasalonexent and showed positive results. Sixteen of the 17 boys enrolled in Part A continued to Part B of the trial, which is a phase II trial that evaluated the safety and efficacy of Edasalonexent in DMD over a 12-week period in approximately 30 boys.
On January 31, 2017, after the market close, the Company reported that Part B of the MoveDMD trial did not meet the primary efficacy endpoint. The news sent the stock tumbling more than 70% to $1.18 the following day.
Part C, which is an open-label extension that includes dosing with Edasalonexent for 36 weeks beyond the 12-week placebo-controlled portion of the trial (Part B), is ongoing. Part C will evaluate longer term safety and efficacy with the same clinical end points as Part B.
The Company's net loss was $7.9 million or $0.41 per share, for the three months ended March 31, 2017, compared to a net loss of $9.4 million in the year-ago quarter.
CATB closed Thursday's trading at $1.40, up 2.19%. In after-hours, the stock was up 5.71% to $1.48.
Corbus Pharmaceuticals Holdings Inc. (CRBP) has completed enrollment of subjects in its phase II clinical study of Anabasum (formerly known as JBT-101) for the treatment of skin-predominant dermatomyositis.
The top line results from the study are expected to be available in the fourth quarter of 2017.
CRBP closed Thursday's trading at $6.15, up 3.36%.
Shares of Corium International Inc. (CORI) rose more than 16% on Thursday, following preliminary positive results from its recently completed pilot bioequivalence study of Corplex Donepezil.
Corplex Donepezil is a proprietary once-weekly transdermal patch for delivery of the most commonly prescribed treatment for all stages of Alzheimer's disease.
In the study, Corplex Donepezil successfully met the criteria for bioequivalence to oral Aricept.
Aricept is an approved drug to treat mild to moderate dementia caused by Alzheimer's disease.
CORI closed Thursday's trading at $5.49, up 16.07%.
NeuroMetrix Inc. (NURO) has implemented a one-for-eight reverse split of its common stock effective in order to satisfy the $1.00 minimum bid price requirement for continued listing on the NASDAQ Capital Market.
The shares will begin trading on a split-adjusted basis on May 12, 2017.
NURO closed Thursday's trading at $0.49, up 4.26%.
Xencor Inc.'s (XNCR) drug candidate XmAb5871 has been granted orphan drug designation by the FDA for the treatment of IgG4-Related Disease.
IgG4-Related Disease, or IgG4-RD, is a newly defined fibro-inflammatory autoimmune disorder that is estimated to impact up to 40,000 patients in the United States.
XmAb5871 is under phase II testing in patients with IgG4-RD. Preliminary data from the phase II study had showed promising activity. Top line results from the study are expected to be reported by the end of this year.
XNCR closed Thursday's trading at $21.93, down 1.13%.
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