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BIIB

Biogen

$305.59

-0.4 (-0.13%)

, IONS

Ionis Pharmaceuticals

15:58
10/09/16
10/09
15:58
10/09/16
15:58

Biogen, Ionis report multiple data sets on nusinersen in spinal muscular atrophy

New data from the clinical program for nusinersen, an investigational treatment for spinal muscular atrophy, were presented by Biogen (BIIB) and Ionis Pharmaceuticals (IONS) at the 2016 World Muscle Society Congress. The presentations included safety results from the interim analysis of the Phase 3 ENDEAR study in infantile-onset SMA, "encouraging" preliminary results from NURTURE, a Phase 2 open-label study in pre-symptomatic infants, and a recent analysis of the ongoing Phase 2 open-label study in patients with later-onset SMA. Specifically, in the interim analysis of the Phase 3 ENDEAR study in infantile-onset SMA, infants treated with nusinersen demonstrated a statistically and clinically significant improvement in the primary endpoint, defined as the proportion of motor milestone responders as measured by the Hammersmith Infant Neurological Examination. Nusinersen was generally well-tolerated, with an acceptable safety profile. No adverse events were considered related to treatment. Based on the results of the positive interim analysis, patients who elect to do so will be transitioned to SHINE, an open-label extension study, in which they will be able to receive nusinersen. Following the transition of patients, the ENDEAR study will close. Detailed efficacy data will be presented at a future medical conference once participants complete their final study visit in ENDEAR. Separately, the interim analysis of the ongoing 30-month, Phase 2 NURTURE study showed that nusinersen-treated infants exhibited improvements in motor function and motor milestones such as full head control, independent sitting, standing with support, standing unaided, and walking with support, as measured by validated scales. The primary endpoint was defined as time to respiratory intervention or death. At the time of the interim analysis all patients were alive and did not require respiratory intervention. This analysis included data from 13 genetically diagnosed, pre-symptomatic SMA patients who had been enrolled for a minimum of 64 days and up to 13 months. Three infants experienced AEs considered possibly related to nusinersen, all of which were resolved. In addition, no infants have discontinued or withdrawn from the study and no new safety concerns have been identified. In addition, exploratory efficacy and safety data from the open-label Phase 2 trials -- CS2/CS12 -- in twenty-eight patients with later-onset SMA consistent with Types 2 or 3 showed that children with SMA treated with nusinersen exhibited improvement on several measures of motor function for up to nearly three years. These results contrast to the stable or slow decline in scores typically observed in patients with later-onset SMA over time. Overall, most AEs were mild to moderate and not considered related to nusinersen and there were no serious adverse events related to the study drug. Biogen has completed the rolling submission of a New Drug Application to the U.S. Food and Drug Administration for the approval of nusinersen. Submission of the Marketing Authorization Application to the European Medicines Agency is planned in the next week. Biogen will initiate regulatory filings in other countries in the coming months.

BIIB

Biogen

$305.59

-0.4 (-0.13%)

IONS

Ionis Pharmaceuticals

  • 09

    Oct

  • 26

    Oct

  • 06

    Nov

BIIB Biogen
$305.59

-0.4 (-0.13%)

09/28/16
JEFF
09/28/16
NO CHANGE
Target $50
JEFF
Buy
Jefferies parent survey shows interest in AveXis pivotal trial
Jefferies analyst Biren Amin conducted a survey of parents of spinal muscular atrophy patients amid investor questions surrounding AveXis' (AVXS) ability to enroll a pivotal trial with AVXS-101 given the open access program with nusinersen, the investigational drug being developed by Ionis Pharmaceuticals (IONS) and Biogen (BIIB). Parents value the option of nusinersen treatment but are also willing to enroll in clinical trials of AVXS-101, Amin tells investors in a research note, citing his survey of seven parents. A single arm trial of AVXS-101 was the most preferred clinical trial design for the upcoming Phase 3 of AVXS-101, he added. The analyst believes his parent responses suggest excitement over nusinersen but also a willingness to enroll into the AVXS-101 trials, especially if it is a single-arm trial. Parents were also attracted to AVXS-101 intravenous delivery, which could be a "meaningful advantage," Amin contends. The analyst keeps a Buy rating on AveXis with a $50 price target. The stock closed yesterday up 88c to $41.00. Amin caused a rally in AveXis shares on September 19 when writing about finding a video online of a spinal muscular atrophy baby walking that he believed to be a patient in the company's trial of AVXS-101.
09/28/16
BERN
09/28/16
NO CHANGE
BERN
Biogen likely to benefit from Lilly Alzheimer's drug results, says Bernstein
Bernstein analyst Aaron Gal says that the results of a trial of Eli Lilly's (LLY) Alzheimer's drug, solanezumab, due out in late 2016 or early 2017, are likely to impact perceptions of Biogen's (BIIB) Alzheimer's drug, aducanumab. The analyst expects Lilly's solanezumab "to show at least directional evidence" of cognitive improvement, although he is "less convinced" that the impact will be clearly statistically significant. The best results from Biogen's perspective will be if Lilly's drug shows "marginal success," according to Gal. However, statistically significant results are also good for Biogen, as they will show that reducing amyloid beta does mitigate Alzheimer's symptoms, the analyst stated. And if Lilly's drug completely fails, Biogen's drug "could well succeed," given the significant differences between them, wrote Gal,who gives Biogen's aducanumab a 65% chance of success. He keeps a $345 price target and Outperform rating on Biogen.
10/03/16
BMOC
10/03/16
NO CHANGE
Target $304
BMOC
Biogen potential trading opportunity into year-end, says BMO Capital
BMO Capital hosted a call with an expert on Alzheimers that may present a trading opportunity in Biogen (BIIB) shares as we approach sola Phase 3 and aducanumab titration data expected at year end. The expert said evidence supports the amyloid hypothesis of AD outweighs the evidence that undercuts it, but suggested that patient selection and trial design/execution key to demonstrating benefit to support regulatory approval. He estimated that Lilly's (LLY) EXPEDITION-3 trial has a ~60% probability of success, with Biogen's aducanumab greater than70% as long as rates of ARIA-E can be reduced with titration. Analyst Ian Somaiya believes positive Phase III Sola data could provide a positive read through to aducanumab and results in Biogen shares trading up 20-25%. If Sola misses, aducanumab's ability to clear beta amyloid oligomers & plaques and in our opinion a better trial design could limit downside in shares to approximately 10%. Somaiya rates Biogen a Market Perform with a $304 price target.
10/04/16
RBCM
10/04/16
NO CHANGE
Target $375
RBCM
Outperform
Biogen could rise $20 or more per share on SMA success, says RBC Capital
RBC Capital analyst Michael Yee expects the first presentation of data from Biogen's (BIIB) Phase III ENDEAR trial studying nusinersen, an investigational treatment for spinal muscular atrophy, or SMA, this week, potentially during the late breaker session at the WMS Congress on October 8. Biogen and partner Ionis Pharmaceuticals (IONS) already announced in August that the study in Type I infants hit the interim analysis and stopped early for positive data. The much larger opportunity in older children has data expected to read out in Spring 2017, noted Yee, who thinks Biogen can have upside from $10 to over $20 per share based on its SMA opportunity. Yee keeps an Outperform rating and $375 price target on Biogen shares.
IONS Ionis Pharmaceuticals

10/06/16
PIPR
10/06/16
NO CHANGE
Target $46
PIPR
Overweight
Piper thinks Alnylam failure is positive for Ionis
Piper Jaffay analyst Joshua Schimmer thinks Alnylam Pharmaceuticals' (ALNY) "abrupt halt" of revusiran for TTR cardiomyopathy is likely a positive for Ionis Pharmaceuticals' (IONS) transthyretin program. The move "knocks out a competitive drug" while Ionis and GlaxoSmithKline (GSK) remain on their previously indicated timeline, Schimmer tells investors in a research note. The analyst at this point believes Alnylam's setback will be limited to revusiran and not read-through to other Gal-Nac programs or other TTR cardiomyopathy or polyneuropathy programs. He keeps an Overweight rating on Ionis with a $46 price target,
10/06/16
RBCM
10/06/16
NO CHANGE
RBCM
Alnylam news not a negative read through on other RNAi drugs, says RBC Capital
After Alnylam (ALNY) announced that it was discontinuing one of its Phase III RNAi drugs due to poor clinical outcomes, RBC Capital analyst Michael Yee does not thinks that the news indicates problems with all RNAi drugs. Rather, he thinks that RNAi was not the proper treatment for the disease that Alnylam was targeting. Other companies with RNAi treatments include The Medicines Company (MDCO0, Ionis Pharmaceuticals (IONS), Arrowhead (ARWR), and Arbutus Biopharma (ABUS).
10/06/16
WELS
10/06/16
NO CHANGE
WELS
Ionis has no read through from negative Alnylam data, says Wells Fargo
After Ionis (IONS) competitor Alnylam Pharmaceuticals (ALNY) announced that it was terminating the development of its revusiran RNAi drug due to poor outcomes in clinical trials, Wells Fargo thinks that the news is "a significant positive" for Ionis because it eliminates a competitor. The firm says that Ionis' drug is significantly different than Alnylam's product, and it believes that Ionis' treatment appears to be superior. The firm keeps an Outperform rating on Ionis.
10/06/16
BMOC
10/06/16
UPGRADE
BMOC
Outperform
Ionis Pharmaceuticals upgraded on reduced competition, valuation at BMO Capital
As noted earlier, BMO Capital upgraded Ionis (IONS) to Outperform from Market Perform. After Alnylam (ALNY) announced that it was discontinuing one of its Phase III RNAi drugs due to poor clinical outcomes, BMO Capital analyst Do Kim expects Ionis to benefit from the reduced competition. Kim recommends buying Ionis' stock on weakness today. Target to $48 from $42.

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