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IRWD

Ironwood

$16.01

-0.06 (-0.37%)

, AGN

Allergan

$193.99

2.66 (1.39%)

07:08
12/22/16
12/22
07:08
12/22/16
07:08

Ironwood says Phase IIb data suppor advancement of linaclotide CR1 in IBS-C

Ironwood Pharmaceuticals (IRWD) and Allergan plc (AGN) announced positive topline data from a Phase IIb clinical trial evaluating the investigational linaclotide colonic release-1, or CR1, formulation in adult patients with irritable bowel syndrome with constipation, or IBS-C. Topline data in this trial demonstrated numerically greater abdominal pain improvement with CR1 300 mcg compared to placebo and to the 290 mcg immediate release formulation of linaclotide. The companies intend to engage with the U.S. Food and Drug Administration to discuss Phase III development plans, with trials in adults with IBS-C expected to begin in the second half of 2017. The double-blind, placebo-controlled, dose-ranging Phase IIb trial randomized 532 adult patients with IBS-C into one of eight possible treatment arms. The trial was exploratory in nature and comparisons to placebo were evaluated using nominal p-values. In the trial, CR1 300 mcg demonstrated improvement on the three prespecified key efficacy endpoints. In this trial, CR1 300 mcg showed a numerically greater reduction in abdominal pain than IR 290 mcg each week beginning at week 5 and continuing for the remainder of the 12 week study, with a mean percent reduction from baseline at week 12 of 49.5% for CR1 300 mcg compared to 26.2% for placebo and 40.6% for IR 290 mcg. Additionally, patients treated with linaclotide CR1 300 mcg reported improvement in other abdominal and bowel symptoms commonly experienced by IBS-C patients, including abdominal discomfort and bloating. The most common adverse event was diarrhea, which was reported in 10.4% of patients on CR1 300 mcg compared to 1.5% of patients on placebo and 13.6% of patients on IR 290 mcg. All diarrhea adverse events reported were mild or moderate in severity, with discontinuation resulting from diarrhea occurring in 3.0% of CR1 300 mcg patients compared to no placebo patients and 6.1% of IR 290 mcg patients. 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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