17:36 , Feb 3, 2017 |  BC Week In Review  |  Clinical News

RG-101 regulatory update

Regulus said FDA requested additional safety and efficacy data from ongoing clinical and preclinical studies of RG-101 to treat HCV infection to lift the June clinical hold on the program. The company, which said it...
07:00 , Aug 15, 2016 |  BC Week In Review  |  Clinical News

RG-101 regulatory update

Regulus said FDA issued a request for information related to the clinical hold on RG-101. The agency requested a detailed safety data analysis from preclinical and clinical trials; exploration of potential mechanisms of hepatotoxicity in...
07:00 , Jul 18, 2016 |  BC Week In Review  |  Clinical News

RG-101: Additional Phase II data

Data from 78 evaluable treatment-naive patients with chronic HCV genotype 1 or 4 infection in an open-label, European Phase II trial showed that a single subcutaneous injection of 2 mg/kg RG-101 followed by an approved...
07:00 , Jul 11, 2016 |  BC Week In Review  |  Clinical News

RG-101: FDA hold

FDA placed a full clinical hold on RG-101 after Regulus reported a second severe adverse event of jaundice in an RG-101-treated patient. An HCV-infected patient with end-stage renal disease (ESRD) on dialysis developed jaundice 117...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Shedding red

Steve Edelson, Senior Editor   Brexit nearly wiped out what looked to be a rebound quarter for biotech. Only two market cap segments finished in positive territory, and smaller companies continued to get pounded. Big...
01:43 , Jun 29, 2016 |  BC Extra  |  Company News

Regulus shares fall after clinical hold news

Regulus Therapeutics Inc. (NASDAQ:RGLS) plummeted $2.47 (49%) to $2.54 on Tuesday after announcing late Monday that FDA placed a full clinical hold on HCV candidate RG-101 . Regulus has now reported two cases of jaundice,...
01:28 , Jun 28, 2016 |  BC Extra  |  Top Story

Regulus sinks on clinical hold

Regulus Therapeutics Inc. (NASDAQ:RGLS) said FDA placed a full clinical hold on RG-101 after the company reported a second case of jaundice, a severe adverse event (SAE), in an ongoing Phase I study to treat...
07:00 , Jun 6, 2016 |  BC Week In Review  |  Company News

GlaxoSmithKline, Regulus deal

The companies will add a second Phase II HCV trial to a 2015 deal. In 4Q16, the companies will start a trial combining a long-acting formulation of GlaxoSmithKline’s GSK2878175 with Regulus’ RG-101. The partners expect...
07:00 , Apr 25, 2016 |  BC Week In Review  |  Clinical News

RG-101: Additional Phase II data

Interim data from 41 evaluable treatment-naive patients with chronic HCV genotype 1 or 4 infection in a Phase II trial showed that a single subcutaneous injection of 2 mg/kg RG-101 followed by an approved once-daily...
02:34 , Apr 16, 2016 |  BC Extra  |  Clinical News

Regulus slips after latest round of HCV data

Regulus Therapeutics Inc. (NASDAQ:RGLS) presented updated interim HCV data on Friday from a 79-patient Phase II trial of a four-week regimen of RG-101 plus a direct-acting antiviral (DAA). The company shed $0.90 (11%) to $7.23...