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BIIB

Biogen

$332.86

4.55 (1.39%)

07:37
02/07/18
02/07
07:37
02/07/18
07:37

Biogen's ACTION 2 study does not meet primary, secondary efficacy endpoints

Biogen announced that in the Phase 2b dose-ranging ACTION 2 study in individuals with acute ischemic stroke, natalizumab did not demonstrate improvement in clinical outcomes compared to placebo. Both doses of natalizumab were generally well-tolerated and no new or important safety signals were observed. The results of the Phase 2b ACTION 2 study do not impact the benefit-risk profile of natalizumab in approved indications, including multiple sclerosis. In the middle of 2018, Biogen plans to initiate a global Phase 3 study of BIIB093 in individuals with large hemispheric infarction, where brain swelling often leads to high morbidity and mortality. Detailed Phase 2b ACTION 2 study findings will be made available in a future scientific forum. ACTION 2 was a Phase 2b multicenter, double-blind, placebo-controlled, randomized, dose-ranging study with a 90 day follow up to evaluate the safety and efficacy of natalizumab primarily in patients with moderate severity acute ischemic stroke. The study investigated natalizumab vs placebo in approximately 270 individuals who had a clinical diagnosis of AIS with last known normal less than or equal to 24 hours prior to treatment initiation. The study evaluated a 300 mg dose and a 600 mg dose versus placebo, both either within 9 hours of LKN or between 9-24 hours after LKN. The primary objective of ACTION 2 was to assess the effects of natalizumab compared to placebo on clinical measures of independence and activities of daily living. The primary endpoint was a composite global measure of functional disability based on a score of 0 to 1 on a modified Rankin scale and a score of greater than or equal to 95 on the Barthel Index at Day 90. The mRS measures independence with specific tasks pre- and post-stroke. BI is a scale that consists of 10 items that measure activities of daily living and mobility. Natalizumab was previously evaluated in AIS in the Phase 2a ACTION study. In this study, although natalizumab did not significantly decrease the primary endpoint of infarct volume at Day 5, secondary and exploratory endpoints suggested natalizumab treatment improved clinical outcomes compared with placebo which warranted further evaluation.

  • 08

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  • 30

    May

BIIB Biogen
$332.86

4.55 (1.39%)

01/31/18
UBSW
01/31/18
UPGRADE
Target $410
UBSW
Buy
Biogen upgraded to Buy from Neutral at UBS
UBS analyst Carter Gould upgraded Biogen to Buy and raised his price target for the shares to $410 from $318. The stock closed yesterday down $5.89 to $352.59. The market is underappreciating Biogen's pipeline opportunity and the potential for additional assets to be added through acquisitions, Gould tells investors in a research note. He thinks both together could add $45 per share. The analyst sees "reduced debate over the core pillars" of Biogen's valuation or 2018 earnings estimates with the multiple sclerosis business stabilized, clarity on Spinraza growth over 2018, and aducanumab pivotal Alzheimer's data weighted to 2019/2020. As the company's mid-stage pipeline comes into focus, Gould believes the stock's risk/reward skews positively.
01/31/18
JEFF
01/31/18
NO CHANGE
JEFF
Jefferies sees neutral impact on Biotech from State of the Union
Jefferies analyst Michael Yee sees a net neutral impact on Biotech stocks from President Trump's State of the Union speech last night. During the speech, Trump made comments about making lower drug prices a "priority" for the year, Yee tells investors in a research not titled "Drug Pricing Comments Not New or Surprising - But a Reminder of Rhetoric." The President, however, also commented on broader access to novel clinical trial drugs, Yee points out. After a "strong biotech rally" in January, the analyst assumes the sector, "at some point," will have some relative near-term pullback either on uncertainty about Trump commentary or some consolidation. Some of the analyst's Buy-rated names include AbbVie (ABBV), Amgen (AMGN), Eli Lilly (LLY) and Gilead Sciences (GILD).
01/31/18
01/31/18
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Foot Locker (FL) upgraded to Outperform from Perform at Oppenheimer with analyst Anna Andreeva saying with Nike's (NKE) "onset" of innovation and adidas' (ADDYY) ongoing momentum, Foot Locker is poised to stabilize as 2018 unfolds. 2. American Airlines (AAL) and United Continental (UAL) were upgraded to Outperform from Market Perform at Bernstein. 3. Biogen (BIIB) upgraded to Buy from Neutral at UBS with analyst Carter Gould saying the market is underappreciating Biogen's pipeline opportunity and the potential for additional assets to be added through acquisitions. 4. Autoliv (ALV) upgraded to Outperform from Neutral at Baird with analyst David Leiker saying the core business appears to be at the inflection of delivering on strong market share gains from airbag recalls. 5. Time Warner (TWX) upgraded to Buy from Neutral at MoffettNathanson. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
02/05/18
JEFF
02/05/18
NO CHANGE
Target $25
JEFF
Hold
Acorda remains takeover candidate after competitor data, says Jefferies
Jefferies analyst Michael Yee believes the positive Phase III topline results from Acorda Therapeutics (ACOR) competitor Sunovion for APL-130277 in Parkinson's patients came in as expected. While APL-130277 data compares favorably over Inbrija's 3.92 point difference at week 12, Yee cautions to compare directly head-to-head since patient baseline characteristics could be different. Acorda remains a "reasonably likely" acquisition candidate in 2018 given its $300M-$500M-plus Parkinson's asset Inbrija, Yee tells investors in a research note. The analyst does not think Biogen (BIIB) should buy the company, but sees other potential suitors in AbbVie (ABBV), Allergan (AGN), Mitsubishi, Roche (RHHBY) and Shire (SHPG). He believes a takeover price could be north of $2B. Yee keeps a Hold rating on Acorda with a $25 price target.

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$32.20

-0.97 (-2.92%)

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ZTCOY

ZTE Corp.

$0.00

(0.00%)

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PLM

PolyMet Mining

$1.02

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