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IRWD

Ironwood

$16.01

-0.06 (-0.37%)

, AGN

Allergan

$193.99

2.66 (1.39%)

07:06
12/22/16
12/22
07:06
12/22/16
07:06

Ironwood says linaclotide CR2 numerically improved abdominal pain in IBS-C trial

Ironwood Pharmaceuticals (IRWD) and Allergan plc (AGN) announced topline data from a Phase IIb clinical trial evaluating an investigational linaclotide colonic release-2, or CR2, formulation in adult patients with irritable bowel syndrome with constipation, IBS-C. The data showed that CR2, as intended, numerically improved abdominal pain and other abdominal symptoms, such as bloating and discomfort, relative to placebo, with no apparent effect on bowel movement function. These findings support further investigation of CR2 in specific GI indications where patients experience abdominal pain but are not necessarily constipated, such as IBS-Mixed, IBS with diarrhea, ulcerative colitis and diverticulitis. The companies plan to engage with the U.S. Food and Drug Administration to discuss next steps for advancing CR2 into a Phase IIb dose-ranging clinical trial in patients with non-constipation subtypes of IBS. The double-blind, placebo-controlled, dose-ranging Phase IIb trial randomized 532 adult patients with IBS-C into one of eight possible treatment arms. This trial was exploratory in nature and comparisons to placebo were evaluated using nominal p-values. In the trial, the average weekly change in Bristol Stool Form Scale scores and frequency of complete spontaneous bowel movements from baseline to week 12 were comparable for CR2 and placebo, indicating no apparent effect on bowel movement function in this study. In contrast, the average weekly change in abdominal pain from baseline to week 12 ranged from -1.63 to -1.83 across the CR2 dose range studied versus -1.37 for placebo, using an 11-point scale. Reduction from baseline at week 12 in abdominal pain was -33.8% to -36.6% for the CR2 doses compared to -26.2% for placebo. Together these data suggest the potential for CR2 to reduce abdominal pain in GI indications not associated with constipation. The most common adverse event in CR2 patients in this trial was upper respiratory tract infection/nasopharyngitis, which was reported in 3% of CR2-treated patients and 4.5% of placebo-treated patients. The rate of diarrhea reported in the trial ranged from 0%-3% for CR2-treated patients compared to 1.5% for placebo. Additional data from the Phase IIb trial are expected to be shared at upcoming scientific meetings and via peer-reviewed publications.

IRWD

Ironwood

$16.01

-0.06 (-0.37%)

AGN

Allergan

$193.99

2.66 (1.39%)

IRWD Ironwood
$16.01

-0.06 (-0.37%)

04/26/16
JPMS
04/26/16
NO CHANGE
JPMS
Ironwood Linzess safety concerns overblown, says JPMorgan
04/26/16
COWN
04/26/16
NO CHANGE
COWN
Outperform
Ironwood short report does not discuss any new information, says Cowen
Cowen analyst Boris Peaker,commented on the short report on Ironwood (IRWD) issued by Phase Five Research and said it doesn't appear to discuss any new data. Peaker said the analysis ignores the co-morbidities of patients that are on Linzess, which has been in 2M patients, many with significant other illnesses and on multiple other background therapies. Additionally, the report overlooked the acquisition of Zurampic today from AstraZeneca (AZN) that was favorably structured with a $100M upfront payment to Ironwood, the analyst said. Peaker said feedback on Linzess from consultants at Cowen's Healthcare Conference was positive and reiterates his Outperform rating.
04/27/16
UBSW
04/27/16
NO CHANGE
Target $8
UBSW
Sell
Ironwood had no new safety concerns with Linzess, says UBS
UBS said the FDA had no new safety concerns and there were no regulatory actions required for Ironwood's Linzess drug. The firm expects the noise from yesterday's short report, which suggested the FDA had issues with Linzess, to subside as the safety concerns pointed to were not justified. UBS acknowledges they have not given much credit for the company's pipeline, but they prefer to stay on the sidelines and take a "wait and see" attitude. UBS maintained its Sell rating and $8 price target on Ironwood shares.
12/13/16
EVER
12/13/16
NO CHANGE
Target $296
EVER
Buy
Evercore says Linzess trial an 'under the radar' potential catalyst for Allergan
Evercore ISI analyst Umer Raffat said the readout of the Phase 2b trial of colonic-release Linzess, which is due before year end according to Ironwood (IRWD), is a "wayyy under the radar" potential catalyst for Allergan (AGN), which he notes is partnered on the drug. Expectations are "basically" for the trial to fail completely, but if formulation 1 of colonic release delivers Linzess-like efficacy or has better pain relief than Linzess, it would extend the tail or possibly grow the franchise, he said. In a "blue sky scenario," formulation 2 of colonic release would show good abdominal pain relief, which would open up several new indications for the drug, added Raffat, who has a Buy rating and $296 price target on Allergan shares.
AGN Allergan
$193.99

2.66 (1.39%)

12/09/16
SBSH
12/09/16
NO CHANGE
SBSH
Buy
Citi sees favorable setup for Allergan heading into 2017
After hosting meetings with management, Citi analyst Liav Abraham sees a favorable setup for Allergan shares heading into 2017. The analyst highlights the lowered revenue expectations following the recent Q3 results, ongoing "strong" performance from key franchises as well as pipeline and M&A optionality. Abraham keeps a Buy rating on the shares.
12/15/16
GSCO
12/15/16
DOWNGRADE
GSCO
Buy
Allergan downgraded to Buy from Conviction Buy at Goldman
12/21/16
BERN
12/21/16
NO CHANGE
BERN
Allergan acquisition has positive aspects, says Bernstein
After Allergan agreed to buy LifeCell, analyst Aaron Gal says that LifeCell seems to "merge well" with Allergan's aesthetics business. The analyst thinks that the acquisition should have "a fair number of synergies," while "LifeCell is another long duration asset that is not protected solely via patent protection." The analyst believes that the cost of the deal is "reasonable." He keeps a $275 price target and an Outperform rating on Allergan.

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