Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) announced that the FDA has granted a fast track designation to its lead pipeline candidate, praliciguat, for the treatment of heart failure with preserved ejection fraction (HFpEF).
Praliciguat (IW-1973), an orally administered soluble guanylate cyclase (sGC) stimulator, is currently being evaluated in a phase II study for the above indication.
The FDA assigns a fast track designation to expedite the development and review process of a candidate, currently under development to treat serious and unmet medical conditions. The fast track status provides more frequent interactions with the regulatory authority for rolling review of the marketing application.
Ironwood plans to enroll (n= 175) patients with HFpEF in the double-blind, placebo-controlled phase II study of praliciguat. While enrolment progresses, the company plans to report top-line results from the study during the second half of 2019.
Shares of Ironwood were up nearly 5% following the news on Thursday. In fact, the stock has rallied 21.4% so far this year compared with the industry’s increase of 0.9%.
Apart from this trial, Ironwood is examining praliciguat for diabetic nephropathy. Top-line outcomes from this program are also expected in the second half of 2019.
Ironwood has another sGC stimulator in its pipeline, IW-1701, which is being developed for the potential treatment of achalasia and sickle cell disease. In July, the FDA granted an orphan drug designation to the candidate for treating sickle cell disease.
We remind investors that Ironwood’s sole marketed drug, Linzess, is indicated for addressing irritable bowel syndrome with constipation and chronic idiopathic constipation. The company co-develops and co-commercializes Linzess and equally shares Linzess’ U.S. collaboration profits/losses as well as development costs with Allergan (AGN - Free Report) .
Ironwoord remains on track to complete its bifurcation into two publicly trading entities in the first half 2019. Earlier this May, the company announced its intention of splitting to achieve greater operational efficiency and strategic flexibility.
One of the entities is set to continue with the current name and focus on the company’s three commercial drugs as well as its gastrointestinal pipeline development. While the other one will focus on developing the sGC pipeline for dealing with serious and orphan diseases.
Zacks Rank & Stocks to Consider
Ironwood currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the healthcare sector are BioSpecifics Technologies Corp. (BSTC - Free Report) and Pacira Pharmaceuticals, Inc. (PCRX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics’ earnings estimates have moved 9.1% north for 2018 and 11.7% for 2019 over the past 60 days. The stock has surged 41.2% year to date.
Pacira’s earnings estimates have been revised 104.2% upward for 2018 and 11.5% for 2019 over the past 60 days. The stock has gained 3.7% so far this year.
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