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Regulus Therapeutics Inc (RGLS.OQ)

RGLS.OQ on NASDAQ Stock Exchange Global Market

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21 Apr 2017
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Latest Key Developments (Source: Significant Developments)

Regulus reports Q4 loss per share $0.38
Thursday, 2 Mar 2017 04:10pm EST 

Regulus Therapeutics Inc : Regulus reports fourth quarter 2016 financial results and pipeline update . Q4 loss per share $0.38 . Q4 earnings per share view $-0.37 -- Thomson Reuters I/B/E/S . Qtrly revenue was less than $0.1 million, compared to $10.9 million . Q4 revenue view $917430.00 -- Thomson Reuters I/B/E/S . Has modified PHASE II rg-012 clinical development program in patients with alport syndrome . Regulus Therapeutics - Phase II Rg-012 program will include hera study, a 48-week study in 30 patients with rapid renal function decline .Regulus Therapeutics - hera study objective is to evaluate safety, efficacy of RG-012 for treating renal function decline in patients with alport syndrome.  Full Article

Regulus Therapeutics announces continuation of RG-101 clinical hold
Friday, 27 Jan 2017 04:10pm EST 

Regulus Therapeutics Inc : Regulus announces continuation of RG-101 clinical hold . Received written communication from FDA that clinical development program for RG-101 remains on clinical hold . FDA also requested additional expert review of liver safety data in light of proposed mechanism of hyperbilirubinemia . We plan to continue to work with FDA to address their additional requests as we seek removal of clinical hold of RG-101 . FDA has requested final safety, efficacy data from on-going RG-101 clinical and pre-clinical studies before reconsidering clinical hold .Data from RG-101 trial is anticipated in q4.  Full Article

Regulus Therapeutics q2 loss per share $0.40
Tuesday, 2 Aug 2016 04:10pm EDT 

Regulus Therapeutics Inc : Q2 loss per share $0.40 . On track to deliver follow-up results from rg-101 studies while working to address deficiencies outlined in by fda . Qtrly revenue was $0.5 million compared with $3.8 million .Initiating a phase ii study in alport syndrome for rg-012, and plan to nominate our fourth clinical candidate by year-end.  Full Article

Regulus says working to resolve issues outlined in letter from US FDA about clinical hold
Wednesday, 27 Jul 2016 04:10pm EDT 

Regulus Therapeutics Inc : Received written communication from u.s. FDA outlining information required to resolve clinical hold for its IND for RG-101 . Says On Track To Deliver Follow Up results from on-going RG-101 studies . Working to resolve issues outlined in letter and anticipate a decision from FDA in q4 . "we remain on track to deliver follow-up results from ongoing rg-101 studies" . Fda requested detailed safety data analysis from preclinical and clinical studies among other things . Fda will notify regulus of its decision within 30 days of receipt of complete response to issues .Timelines of on-going studies have not been impacted by clinical hold.  Full Article

Regulus Therapeutics reports clinical hold of RG-101
Monday, 27 Jun 2016 04:10pm EDT 

Regulus Therapeutics Inc : Regulus reports clinical hold of RG-101 . Says Regulus remains on track to deliver follow-up results from these studies at upcoming relevant scientific meetings . Timelines of on-going studies are not expected to be impacted . Regulus anticipates it will receive a formal clinical hold letter from fda within 30 days .FDA initiated clinical hold after regulus reported a second serious adverse event (sae) of jaundice.  Full Article

Regulus secures $30 mln growth capital credit facility
Monday, 20 Jun 2016 07:00am EDT 

Regulus Therapeutics Inc : Says has entered into a $30 million loan and security agreement with Oxford Finance Llc . Says proceeds from loan will be used to provide additional working capital for advancement of clinical and pre-clinical development pipeline .Regulus secures $30 million growth capital credit facility.  Full Article

Regulus Therapeutics rpeorts top-line results
Tuesday, 7 Jun 2016 07:00am EDT 

Regulus Therapeutics Inc : Line results from primary endpoint analysis of phase II studies of RG-101 for treatment of hepatitis C virus infection .Says RG-101 in combination with four weeks of oral daa therapy has been generally well tolerated.  Full Article

Regulus expands clinical trial collaboration with GSK
Wednesday, 1 Jun 2016 08:00am EDT 

Regulus Therapeutics Inc : Ongoing phase ii rg-101 and oral gsk2878175 combination study on track to report interim results by year-end .Regulus expands clinical trial collaboration with gsk.  Full Article

Regulus Therapeutics Inc announces president and chief executive officer change - Form 8-K
Thursday, 4 Jun 2015 05:30pm EDT 

Regulus Therapeutics Inc:Says that on June 1, Kleanthis G. Xanthopoulos, resigned as the company's president and chief executive officer and as a director, effective immediately.Says that on June 1, Paul C. Grint, the company's chief medical officer, was appointed to position of president and chief executive officer and as a director, effective immediately.  Full Article

Regulus Therapeutics initiates phase i clinical study of rg-012
Thursday, 4 Jun 2015 08:00am EDT 

Regulus Therapeutics:Initiates phase i clinical study of rg-012, a microrna therapeutic in development for the treatment of alport syndrome.Says rg-012 is being developed by Regulus in a strategic alliance with genzyme.  Full Article

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BRIEF-Regulus reports Q4 loss per share $0.38

* Regulus reports fourth quarter 2016 financial results and pipeline update