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Last $10.98 USD
Change Today -0.02 / -0.18%
Volume 903.2K
IRWD On Other Exchanges
Symbol
Exchange
NASDAQ GS
Berlin
As of 2:35 PM 09/1/15 All times are local (Market data is delayed by at least 15 minutes).

ironwood pharmaceuticals inc (IRWD) Key Developments

Ironwood and Allergan Enter Agreement to Co-Promote VIBERZI for Irritable Bowel Syndrome with Diarrhea (IBS-D) in the U.S

Ironwood Pharmaceuticals, Inc. announced an agreement with Allergan plc for the U.S. co-promotion of VIBERZI™ (eluxadoline), Allergan’s new treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). This arrangement is separate from and complementary to the companies’ ongoing co-development and co-commercialization of LINZESS® (linaclotide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). This collaboration enables Ironwood and Allergan to work together to bring forward two innovative medicines demonstrated to improve the abdominal pain and bowel dysfunction that define IBS-C and IBS-D, two types of IBS that impact nearly 30 million adult Americans. Under the terms of the agreement, Ironwood’s clinical sales specialists will detail VIBERZI to the approximately 25,000 health care practitioners to whom they currently detail LINZESS and Cologuard. LINZESS will remain the first-position product for the Ironwood sales team. Ironwood’s promotional efforts will be compensated based on the volume of calls delivered by Ironwood’s sales force, as well as agreed upon performance metrics. Allergan will be responsible for all other costs relating to the commercialization of VIBERZI. The co-promotion will begin as soon as VIBERZI is commercially available.

Ironwood Pharmaceuticals, Inc. Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015

Ironwood Pharmaceuticals, Inc. announced unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported revenue of $27.744 million against $6.840 million a year ago. Loss from operations was $42.009 million against $55.119 million a year ago. Net loss was $48.020 million or $0.34 per basic and diluted share against $60.357 million or $0.44 per basic and diluted share a year ago. The company used approximately $26 million of cash for operations as compared to approximately $36 million in the second quarter of 2014. For the six months, the company reported revenue of $56.676 million against $21.445 million a year ago. Loss from operations was $70.076 million against $99.506 million a year ago. Net loss was $81.242 million or $0.57 per basic and diluted share against $109.983 million or $0.82 per basic and diluted share a year ago.

Ironwood Pharmaceuticals, Inc. Progresses sGC Stimulator Platform with Positive Top-Line Phase I Data on IW-1973

Ironwood Pharmaceuticals, Inc. announced positive top-line data from a Phase I study of IW-1973, its lead investigational soluble guanylate cyclase (sGC) stimulator. In the study, IW-1973 demonstrated cardiovascular pharmacodynamic effects, extensive tissue distribution, proof of mechanism for sGC stimulation, and a dose range that was well tolerated in healthy volunteers. The totality of clinical and preclinical data generated to date strongly support continued development of IW-1973 as a potential once-daily oral therapy. Ironwood intends to initiate a Phase Ib multiple ascending dose study of IW-1973 in the fourth quarter of 2015. This study will inform the selection of doses and priority indications for the Phase II program, which will focus on areas with the unmet need and optimal path to market. Ironwood intends to initiate at least two Phase II proof of concept studies for IW-1973 in 2016. The randomized, double-blind, placebo-controlled, single ascending dose Phase I study enrolled 46 healthy volunteers. Participants were randomized 3:1 to receive a single dose of IW-1973 or placebo administered via an oral capsule. Top-line clinical data were consistent with preclinical findings and included cardiovascular pharmacodynamic effects, dose-proportional pharmacokinetics, biomarker-based confirmation of target engagement, and evidence of extensive distribution to tissues. No serious adverse events were reported. Reported adverse events were consistent with the mechanism of action. Data from clinical and preclinical studies of IW-1973 are expected to be presented at a future medical conference.

Ironwood Pharmaceuticals, Inc., Q2 2015 Earnings Call, Aug 05, 2015

Ironwood Pharmaceuticals, Inc., Q2 2015 Earnings Call, Aug 05, 2015

AstraZeneca Pharmaceuticals Co., Ltd. and Ironwood Pharmaceuticals, Inc. Reports Positive Top-Line Data from Phase III IBS-C Trial Designed to Support Linaclotide Approval in China

AstraZeneca Pharmaceuticals Co., Ltd. and Ironwood Pharmaceuticals, Inc. announced that top-line data demonstrate linaclotide met all primary and secondary endpoints, covering multiple abdominal and constipation symptoms, in a Phase III clinical trial of adults with irritable bowel syndrome with constipation (IBS-C). The trial was conducted primarily in China and the companies intend to file in early 2016 for China Food and Drug Administration (CFDA) approval to market linaclotide. Linaclotide is currently approved in the United States for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC) and in a number of other countries for adults with IBS-C. Top-line data from the Phase III trial indicate linaclotide-treated patients showed statistically significant improvement compared to placebo-treated patients for both co-primary endpoints. 60.0% of linaclotide-treated patients were Abdominal Pain/Discomfort Responders, compared to 48.8% of placebo-treated patients (p=0.001). 31.7% of linaclotide-treated patients were IBS Degree of Relief Responders, compared to 15.4% of placebo-treated patients ($125 million in additional commercial milestone payments from AstraZeneca contingent on the achievement of certain sales targets.

 

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