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IRWD

Ironwood

$19.35

0.74 (3.98%)

12:14
06/23/18
06/23
12:14
06/23/18
12:14

Ironwood announced Praliciguat phase IIa study data

Ironwood Pharmaceuticals presented additional data from an exploratory Phase IIa study of praliciguat in patients with type 2 diabetes and hypertension during an oral session at the American Diabetes Association's 78th Scientific Sessions in Orlando, Florida. Praliciguat is an oral, once-daily soluble guanylate cyclase stimulator that is currently being studied in Phase II clinical trials in patients with diabetic nephropathy and in patients with heart failure with preserved ejection fraction. Building on previously announced top-line data from the Phase IIa randomized, placebo-controlled, 14-day study, which showed that treatment with praliciguat led to reductions in blood pressure, fasting plasma glucose, cholesterol levels and triglycerides in patients on a stable regimen of medicines to manage their disease, the newly reported findings also suggested that praliciguat improved insulin sensitivity. Insulin resistance is a hallmark of diabetes and often linked to hypertension. In addition, the data suggested that praliciguat decreased levels of apolipoprotein B, a key lipid parameter that - when elevated - is associated with increased cardiac events. The effect of praliciguat on ApoB in this Phase IIa study was shown within the context of broader lipid effects, including a reduction in total cholesterol and low-density lipoprotein cholesterol, the component of total cholesterol associated with long-term cardiovascular risk. The study was not designed or powered to assess efficacy, but the data yielded clear and consistent trends indicating a positive effect of praliciguat on blood pressure, metabolic parameters and endothelial function biomarkers. These improvements were seen in patients who were taking a stable regimen of therapies to manage their disease; all participating patients were taking at least one medication to manage their hypertension and at least one medication to manage their diabetes, and a majority were also taking additional medications to manage their cholesterol and serum lipid levels. The study also confirmed a pharmacokinetic profile of praliciguat supporting once-daily dosing and suggested broad distribution to relevant tissues, offering the potential to maximize anti-inflammatory, anti-fibrotic and metabolic effects. Praliciguat was generally well-tolerated. Nausea was the only adverse event present in the praliciguat group at a greater incidence rate than placebo. There was a single serious AE, an upper gastrointestinal hemorrhage in a participant with erosive esophagitis receiving praliciguat. Across all five clinical studies of praliciguat to date, praliciguat was found not to impair platelet function or blood clotting, either on its own or when co-administered with aspirin. No other serious bleeding episodes have been observed. All other AEs in this Phase IIa study were characterized as mild.

  • 25

    Jun

IRWD Ironwood
$19.35

0.74 (3.98%)

05/09/18
MSCO
05/09/18
DOWNGRADE
MSCO
Underweight
Ironwood downgraded to Underweight from Equal Weight at Morgan Stanley
05/09/18
05/09/18
DOWNGRADE
Target $13

Underweight
Ironwood downgraded to Underweight on Linzess growth concerns at Morgan Stanley
As previously reported, Morgan Stanley analyst David Lebowitz downgraded Ironwood to Underweight from Equal Weight as he believes management's target of Linzess U.S. sales exceeding $1B by 2020 could be a challenge given the recent deceleration in volume growth. Also, while the company has multiple mid-to-late stage pipeline products, Lebowitz is not yet comfortable enough with them to incorporate them into his valuation, he tells investors. He lowered his price target on Ironwood shares to $13 from $15.
05/09/18
05/09/18
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Crocs (CROX) downgraded to Hold from Buy at Stifel with analyst Jim Duffy saying he believes the stock has "adequately" re-rated to discount fiscal 2019 earnings power. 2. Monster Beverage (MNST) downgraded to Neutral from Overweight at JPMorgan with analyst Andrea Teixeira saying she sees a "difficult road ahead" for the company following its first quarter results. 3. Adient (ADNT) downgraded to Equal Weight from Overweight at Morgan Stanley with analyst Armintas Sinkevicius saying that recent management commentary appears to have taken the potential for strategic action involving the underperforming metals business off the table. 4. Ironwood (IRWD) downgraded to Underweight from Equal Weight at Morgan Stanley with analyst David Lebowitz saying he believes management's target of Linzess U.S. sales exceeding $1B by 2020 could be a challenge given the recent deceleration in volume growth. 5. Papa John's (PZZA) downgraded to Neutral from Buy at Longbow with analyst Alton Stump saying he is concerned Papa John's may not have a recovery in comps in the near-term and recommends investors wait for a significant pullback and or evidence same-store-sales being to recover in the coming quarters before becoming constructive on shares. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
05/30/18
WELS
05/30/18
NO CHANGE
Target $22
WELS
Outperform
Ironwood price target raised to $22 from $18 at Wells Fargo
Wells Fargo analyst David Maris raised his price target on Ironwood to $22 and kept his Outperform rating, saying he is updating his model following the company's Q1 earnings as well as its announcement of separating its soluble guanylate cyclase business. While the analyst also lowers his FY18 EPS view to (67c) from (38c) to reflect the separation, he adds that future commercial/GI-focused IRWD earnings should no longer be depressed by R&D spending on the sGC assets.

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PZZA

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