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Shares of Regulus Therapeutics Inc (NASDAQ:RGLS) ended Friday session in green amid volatile trading. The shares closed up +0.25 points or 9.62% at $2.85 with 475,098 shares getting traded. Post opening the session at $2.60, the shares hit an intraday low of $2.53 and an intraday high of $2.91 and the price vacillated in this range throughout the day. The company has a market cap of $168.58 million and the numbers of outstanding shares have been calculated to be 52.92 million shares.

Regulus Therapeutics Inc (RGLS) recently stated financial results for the three and nine months ended September 30, 2016 and offered a summary of corporate highlights.

Financial Results

Revenue: Revenue was $0.2 million and $1.2 million for the three and nine months ended September 30, 2016, respectively, contrast to $1.9 million and $9.9 million for the same periods in 2015. Revenue for the three and nine months ended September 30, 2016 and 2015 consisted of amortization of up-front payments from Regulus’ planned alliances and collaborations. Revenue for the three and nine months ended September 30, 2015 included $0.9 million and $4.1 million, respectively, for research services under Regulus’ planned alliances and collaborations.  Preclinical milestones earned under Regulus’ planned alliances and collaborations were $0.3 million and $3.2 million for the three and nine months ended September 30, 2015, respectively.

Research and Development (R&D) Expenses:  R&D expenses were $14.6 million and $49.3 million for the three and nine months ended September 30, 2016, respectively, contrast to $11.0 million and $43.6 million for the same periods in 2015. The increases in R&D expenses were mainly driven by the advancement of our clinical programs and raised investment in our preclinical pipeline.

General and Administrative (G&A) Expenses:  G&A expenses were $4.8 million and $13.6 million for the three and nine months ended September 30, 2016, respectively, contrast to $4.2 million and $13.7 million for the same periods in 2015.

Shares of Shire PLC (ADR) (NASDAQ:SHPG) ended Friday session in red amid volatile trading. The shares closed down -1.25 points or -0.66% at $188.59 with 1.17 million shares getting traded. Post opening the session at $187.27, the shares hit an intraday low of $186.30 and an intraday high of $190.00 and the price vacillated in this range throughout the day. The company has a market cap of $57.17 billion and the numbers of outstanding shares have been calculated to be 910.90 million shares.

Shire PLC (ADR) (SHPG) declared that the European Commission (EC) has granted Marketing Authorization of ONIVYDE® (pegylated liposomal irinotecan hydrochloride trihydrate), also known as nal-IRI or MM-398, for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine-based therapy. ONIVYDE is the first and only approved treatment option for this patient population.

With this approval, Shire is authorized to market ONIVYDE in the 28 Member States of the European Union (EU), in addition to in Iceland, Liechtenstein and Norway. ONIVYDE was formerly approved in the U.S. by the Food and Drug Administration (FDA), in October 2015.

“As the only treatment for metastatic pancreatic cancer following gemcitabine-based therapy that may improve patient survival, ONIVYDE is the first innovation that offers the potential to improve outcomes for this challenging patient population,” said Philip J. Vickers, Ph.D., Global Head of Research and Development at Shire. “The approval of ONIVYDE marks a noteworthystep forward in Shire’s focus to develop and commercialize treatments that represent the most promising science in oncology.”

 

 

 

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