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ALNY

Alnylam

$120.13

2.41 (2.05%)

07:07
12/17/19
12/17
07:07
12/17/19
07:07

Alnylam announces ILLUMINATE-A trial meets primary, secondary endpoints

Alnylam announced that the ILLUMINATE-A Phase 3 study of lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase, or GO, in development for the treatment of primary hyperoxaluria type 1, or PH1, met its primary efficacy endpoint and all tested secondary endpoints. Specifically, lumasiran met the primary efficacy endpoint of percent change from baseline, relative to placebo, in 24-hour urinary oxalate excretion averaged across months three to six. The study also achieved statistically significant results for all six tested secondary endpoints. Lumasiran also demonstrated an encouraging safety and tolerability profile. Based on these results, the company plans to submit a new drug application, or NDA, and file a marketing authorization application, or MAA, for lumasiran in early 2020. ILLUMINATE-A, a randomized, double-blind, placebo-controlled trial, designed to enroll approximately 30 patients with PH1 ages six and above, at 16 study sites, in eight countries around the world, is the largest interventional study conducted specifically in PH1. Patients were randomized 2:1 to lumasiran or placebo, with lumasiran administered at 3 mg/kg monthly for three months followed by quarterly maintenance doses. The primary endpoint for the study was the percent change from baseline in 24-hour urinary oxalate excretion averaged across months three to six in patients treated with lumasiran as compared to placebo. At six months, lumasiran met the primary endpoint in patients with PH1 and achieved statistically significant results for all six hierarchically-tested secondary endpoints, including the proportion of lumasiran patients that achieved near-normalization or normalization of urinary oxalate levels, relative to placebo. There were no serious or severe adverse events in the study, and results showed that lumasiran was generally well tolerated with an overall profile generally consistent with that observed in Phase 1/2 and open-label extension studies of lumasiran. Full ILLUMINATE-A study results will be presented in an oral plenary session on March 31, 2020 at OxalEurope International Congress. The company is also conducting ILLUMINATE-B - a global Phase 3 study of lumasiran in PH1 patients less than six years of age, with results expected in mid-2020, and ILLUMINATE-C - a global Phase 3 study of lumasiran in PH1 patients of all ages with advanced renal disease, with results expected in 2021.

  • 04

    Feb

ALNY Alnylam
$120.13

2.41 (2.05%)

11/21/19
BMOC
11/21/19
NO CHANGE
Target $138
BMOC
Outperform
Alnylam price target raised to $138 from $128 at BMO Capital
BMO Capital analyst Do Kim raised his price target on Alnylam to $138 and kept his Outperform rating after yesterday's approval of Givlaari came nearly 3 months ahead of its February 2020 PDUFA data. The analyst notes that while he already modeled a 100% probability of success, his raised price target reflects a one-quarter sales contribution pull forward as well as the higher price point of $575K/year vs. $450K he forecast.
11/22/19
NOMU
11/22/19
NO CHANGE
Target $62
NOMU
Reduce
Alnylam should be sold on 'unwarranted' strength, says Nomura Instinet
Nomura Instinet analyst Christopher Marai recommends selling shares of Alnylam Pharmaceuticals into the recent strength, which he says is "unwarranted." While the early approval moves of Givlaari moves initial sales estimates up one quarter, the "limited opportunity" in acute hepatic porphyria "ultimately does little to our valuation estimates," Marai tells investors in a research note. Further, the analyst point out Givlaari's approval is actually more than six months late, as the FDA did not accept the initial surrogate endpoint path proposed by Alnylam. In addition, further strength in the shares is likely to trigger a "dilutive financing event into what looks like a difficult 2020," contends the analyst. He keeps a Reduce rating on Alnylam with a $62 price target.
11/25/19
BMOC
11/25/19
NO CHANGE
Target $143
BMOC
Outperform
Alnylam price target raised to $143 from $138 at BMO Capital
BMO Capital analyst Do Kim raised his price target on Alnylam to $143 and kept his Buy rating after its R&D Day highlighted the company's commercial and pipeline plans. With Lumasiran Phase 3 trial data expected next month and his estimated "likely approval" for the drug in late-2020, the analyst also adds its projected revenue to his model, assigning an 80% probability-of-success to the program while also citing Alnylam's global Onpattro expansion driving further top-line growth.
11/25/19
STFL
11/25/19
NO CHANGE
Target $136
STFL
Buy
Alnylam one of few mid-caps with 'plausible large-cap aspirations,' says Stifel
Stifel analyst Paul Matteis raised his price target on Alnylam shares to $136 from $126 citing earlier than expected Givosiran approval, higher than anticipated pricing and "promising advancements" in the company's early stage pipeline. A major theme of the company's analyst day was Alnylam's confidence in pursuing larger, non-orphan indications, said Matteis, who also noted that 2019 "was framed as a peak operating loss year" although no guidance was given during the event. The analyst, who sees a "compelling case" for Alnylam being "one of the few mid-caps with plausible large-cap aspirations," keeps a Buy rating on the stock.

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