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BIIB

Biogen

$341.91

-1.2 (-0.35%)

, IONS

Ionis Pharmaceuticals

$48.76

1.28 (2.70%)

12:58
10/07/18
10/07
12:58
10/07/18
12:58

Biogen presents new Spinraza data in Spinal Muscular Atrophy

Biogen (BIIB) announced new interim results from NURTURE, an ongoing open-label, single-arm efficacy and safety study of Spinraza in 25 presymptomatic infants with SMA. The interim analysis evaluated survival and respiratory intervention rates in infants who were genetically diagnosed with SMA and began treatment in the presymptomatic stage of the disease. As of May 2018 all patients in the study were alive and none required tracheostomy or permanent ventilation. Additionally, 22 of the 25 participants were able to walk either with assistance or independently according to the motor milestone standard of the World Health Organization and all 25 were able to sit without support. The motor skills of study participants were also evaluated using the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders, an assessment which considers 16 different types of movement to create an overall score between zero and 64. The mean CHOP INTEND scores were 62.6 for study participants with three copies of the SMN2 gene and 61.0 for those with two copies of the gene. All NURTURE study participants were 14 months or older at the time of the analysis. Participants included infants with two copies of the SMN2 gene who are likely to develop a fatal, early-onset form of SMA known as Type 1, and infants with three copies of the SMN2 gene who typically develop SMA Type 2 or 3. People living with SMA Types 2 and 3 may never be able to walk or will lose that ability over time. No new safety concerns were identified. Additional research presented compared levels of phosphorylated neurofilament heavy chain in plasma in more than 300 patients from Spinraza clinical trials, including those in the NURTURE study, and a control group of people without SMA. The data demonstrated that treatment with Spinraza is associated with a rapid decline followed by stabilization of pNF-H in plasma at levels close to those of healthy controls. The results are part of Biogen's ongoing work to identify and validate biomarkers that could provide insight on the disease progression of SMA. Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals (IONS). Biogen and Ionis conducted an innovative clinical development program, the largest of its kind in SMA, that moved Spinraza from its first dose in humans in 2011 to its first regulatory approval in five years.

BIIB

Biogen

$341.91

-1.2 (-0.35%)

IONS

Ionis Pharmaceuticals

$48.76

1.28 (2.70%)

  • 08

    Oct

  • 22

    Oct

  • 27

    Nov

BIIB Biogen
$341.91

-1.2 (-0.35%)

10/01/18
CANT
10/01/18
UPGRADE
Target $400
CANT
Overweight
Biogen assumed with an Overweight from Neutral at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young upgraded Biogen to Overweight after taking over coverage from Louise Chen. The analyst raised Cantor's price target for the shares to $400 from $293.
10/01/18
10/01/18
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. UPS (UPS) upgraded to Outperform from Market Perform at BMO Capital with analyst Fadi Chamoun saying his meetings with institutional investors give him a more constructive outlook as the company proceeds with efforts to "add capacity across its network, implement automation," and (perform) other cost efficiency initiatives with medium-term benefits. 2. LogMeln (LOGM) upgraded to Outperform from Perform at Oppenheimer analyst Shaul Eyal saying in light of a soft 1H18 performance, the analyst views the company's recent retention concerns as gradually stabilizing per his industry checks. 3. Noble Corp. (NE) upgraded to Neutral from Underweight at Piper Jaffray with analyst Ian Macpherson saying he views the stock's risk/reward as balanced at current share levels. 4. Biogen (BIIB) assumed with an Overweight from Neutral at Cantor Fitzgerald. 5. Teva (TEVA) upgraded to Conviction Buy from Buy at Goldman Sachs and to Market Perform from Underperform at Leerink. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/03/18
PIPR
10/03/18
NO CHANGE
PIPR
Overweight
PTC, Roche data add uncertainty to Biogen drug outlook, says Piper Jaffray
The risdiplam spinal muscular atrophy data released this morning by PTC Therapeutic (PTCT) and Roche (RHHBY) stack up fairly well to Biogen's (BIIB) Spinraza clinical data, Piper Jaffray analyst Christopher Raymond tells investors in a research note. Even taking into account all of the usual caveats regarding cross-trial comparisons, risdiplam is shaping up well compared to Spinraza, the analyst contends. He sees the new data as adding uncertainty to the Spinraza trajectory. Nonetheless, Raymond keeps an Overweight rating on shares of Biogen. The analyst made no changes to his Biogen model, but he admits risdiplam, if the data holds up, may impact Spinraza's ultimate market potential. Biogen in midday trading is up 2% to $351.41.
10/03/18
BARD
10/03/18
NO CHANGE
Target $348
BARD
Neutral
Risdiplam data incrementally negative for Biogen, says Baird
Biogen analyst Brian Skorney views this morning's risdiplam data for use in treating spinal muscular atrophy patients as incrementally negative for Biogen (BIIB). The data from PTC Therapeutics (PTCT) and PTC Therapeutics (RHHBY) are compelling so far, and suggest that risdiplam could impact the market share of Biogen's Spinraza, if it comes to market, Skorney tells investors in a research note. He highlights risdiplam's convenience as an oral small molecule and says the Phase II data "continues to impress." The analyst keeps a Neutral rating on Biogen with a $348 price target. The stock in afternoon trading is up $6.90, or 2%, to $352.31.
IONS Ionis Pharmaceuticals
$48.76

1.28 (2.70%)

08/28/18
STFL
08/28/18
NO CHANGE
STFL
Hold
CRL for Waylivra 'somewhat of a surprise,' says Stifel
Stifel analyst Paul Matteis said the complete response letter for Ionis Pharmaceuticals (IONS) and Akcea Therapeutics' (AKCA) Waylivra was "somewhat of a surprise" given the positive advisory committee decision, though he also noted that "safety was acutely in focus" during the committee meeting. The basis of the CRL is not yet known and Akcea was "close to the vest" on its nature, leading Matteis to remove Waylivra from his valuations for the two stocks. Doing that lowered his Akcea price target to $25 from $33 and cut his Ionis target to $45 from $47. However, he thinks the main investor question will be regarding read-through to Tegsedi and Matteis' assumption for its approval remains unchanged, he added. The analyst keeps Hold ratings on Ionis and Akcea shares, which are down 12.5% and 29%, respectively, in pre-market trading.
09/18/18
NEED
09/18/18
INITIATION
Target $45
NEED
Buy
Akcea Therapeutics initiated with a Buy at Needham
Needham analyst Chad Messer initiated Akcea Therapeutics (AKCA) with a Buy rating and a price target of $45, saying it is an "attractive" way for investors to leverage "decades of innovation" by the parent Ionis Pharma (IONS) through ownership of its most advanced-stage programs. The analyst cites the unfolding "breakthrough" in the approval of a new class of antisense drugs which "directly block protein synthesis in cells by binding to RNA". Messer adds that Akcea is positioned for near-term commercial opportunity for its Tegsedi and Waylivra programs.
09/24/18
PIPR
09/24/18
NO CHANGE
Target $50
PIPR
Neutral
Ionis platelet issue now appears removed, says Piper Jaffray
The most important takeaway from Ionis Pharmaceuticals' APO(a)-LRx results this morning is that there appears to be no platelet issue associated with the LICA technology, Piper Jaffray analyst Tyler Van Buren tells investors in a research note titled "These LICA Results Are A Big Deal - Platelet Issue Now Appears Removed." As it relates to Tegsedi specifically, the analyst says that while the product's subcutaneous dosing provides a clear competitive advantage to Alnylam's (ALNY) Onpattro infusion regimen, many view it as being offset by the need for bi-weekly platelet monitoring. However, Van Buren now believes that the need for platelet monitoring is definitively removed with Ionis' LICA technology. He believes this morning's results provide significant long-term validation for Ionis' LICA technology platform. The analyst keeps a Neutral rating on Ionis Pharmaceuticals with a $50 price target.
10/03/18
MSCO
10/03/18
NO CHANGE
Target $45
MSCO
Equal Weight
Ionis most likely gets Tegsedi approval with black box, says Morgan Stanley
Morgan Stanley analyst David Lebowitz laid out three potential scenarios for the upcoming FDA approval decision about Ionis Pharmaceuticals' Tegsedi, which is scheduled to come on or before October 6. If the FDA were to issue a complete response letter, or CRL, and prevent on-time launch, Lebowitz sees greater than 20% downside for the shares, though he puts the probability of this occurring at 40%. If Tegsedi is approved with a black box safety warning, which he sees as the most likely scenario with odds he pegs at 45%, Lebowitz sees the stock trading up or down about 5%. If Tegsedi is approved with a "clean" label it would lead to a steeper ramp in revenue and Lebowitz sees 20% or more upside to the stock in this scenario, though he puts the odds at just 15%. He maintains an Equal Weight rating on Ionis shares ahead of the PDUFA with a $45 price target.

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