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AMGN

Amgen

$164.06

1.41 (0.87%)

, CHRS

Coherus Biosciences

$20.65

-2.05 (-9.03%)

15:20
06/12/17
06/12
15:20
06/12/17
15:20

Amgen price target raised to $161 on Neulasta biosimilar delay at Leerink

Leerink analyst Geoffrey Porges noted that Coherus Biosciences (CHRS) received a complete response letter from the FDA for its biosimilar to Amgen's (AMGN) Neulasta, which he views as likely delaying its launch by at least a year. However, the "windfall" is offset by the Supreme Court decision that "effectively eliminates" the 6-month delay for biosimilars associated with notification, Porges tells investors. Based on his forecast for a six-month delay in the timing of a Neulasta biosimilar launch in the U.S., to the second quarter of 2018 from the fourth quarter of 2017, Porges increased his 2018 Amgen revenue forecast by $500M and raised his price target to $161 from $159, though he keeps a Market Perform rating on the stock.

AMGN

Amgen

$164.06

1.41 (0.87%)

CHRS

Coherus Biosciences

$20.65

-2.05 (-9.03%)

  • 12

    Jun

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    Jun

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    Jun

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    Jul

  • 14

    Aug

AMGN Amgen
$164.06

1.41 (0.87%)

05/22/17
ADAM
05/22/17
NO CHANGE
Target $85
ADAM
Buy
CV events 'may kill' Amgen's romosozumab development, says Canaccord
Canaccord analyst John Newman said Amgen (AMGN) and partner UCB's report of a higher rate of cardiovascular Serious Adverse Events for romosozumab in the Phase 3 ARCH study in osteoporosis suggests a much lower chance of FDA approval for the drug and may "kill" romosozumab's development. He notes that Merck's (MRK) cathepsin-K inhibitor was previously discontinued due to increased risk of atrial fibrillation and stroke. In addition to the safety signals, Newman points out that romosozumab was worse than Radius' (RDUS) Tymlos for non-vertebral fracture and for vertebral fracture, suggesting Radius' drug also has much better efficacy, said the analyst, who keeps a Buy rating and $85 price target on Radius Health shares, which are up $4.47, or 12.8%, to $39.40 in pre-market trading.
05/22/17
LEER
05/22/17
NO CHANGE
Target $159
LEER
Market Perform
Leerink sees only 50/50 chance of Amgen's Evenity hitting market
After Amgen (AMGN) and UCB reported an "imbalance of positively adjudicated serious cardiovascular adverse events" in its Phase 3 study of Evenity, Leerink analyst Geoffrey Porges believes the product now has only a 50/50 probability of coming to market at all. The analyst lowered his price target for Amgen shares to $159 from $160 and keeps a Market Perform rating on the name. Radius Health (RDUS), which has a drug that would compete with Evenity, is trading up 16% to $40.58 in the premarket.
05/22/17
FBCO
05/22/17
NO CHANGE
Target $177
FBCO
Neutral
Amgen romosozumab U.S. approval in July 'off the table,' says Credit Suisse
After Amgen (AMGN) and UCB (UCBJY) announced that the Evenity "ARCH" study met both primary endpoints but that there was also a newly observed cardiovascular safety signal in the trial, Credit Suisse analyst Alethia Young said any potential U.S. approval by the drug's July 19 PDUFA date is "off the table" and it is unclear as of now what U.S. approval timelines may be. She reduced her probability of success for romosozumab to 80% from 100% and lowered her price target on Amgen to $177 from $178. Young keeps a Neutral rating on Amgen shares.
05/22/17
JPMS
05/22/17
NO CHANGE
Target $74
JPMS
Overweight
Amgen data a 'clear positive' for Radius Health, says JPMorgan
JPMorgan analyst Jessica Fye believes the imbalance in observed cardiovascular serious adverse events reported by Amgen (AMGN) and UCB over the weekend for Evenity is a "clear positive" for Radius Health (RDUS). The FDA will now add results from the Phase 3 ARCH study to the regulatory review, and as a result Amgen does not expect U.S. approval for Evenity in 2017, Fye tells investors in a research note. The update is a "clear positive" for Radius Health, who has Tymlos already approved with a clean clinical safety profile, the analyst contends. She continues to believe Tymlos is well positioned for a successful launch into the large market opportunity of postmenopausal women with osteoporosis at high risk of fracture. Fye has an Overweight rating on Radius with a $74 price target. The stock in premarket trading is up 13%, or $4.62, to $39.55.
CHRS Coherus Biosciences
$20.65

-2.05 (-9.03%)

06/12/17
SBSH
06/12/17
NO CHANGE
Target $33
SBSH
Buy
Coherus price target lowered to $33 after complete response letter at Citi
Citi analyst Mohit Bansal, in an intraday follow up note on Coherus Biosciences, lowered his price target on the stock to $33 from $38, stating that the CRL for its Neulasta biosimilar creates uncertainty and delays the product's potential launch by about one year. The analyst, who noted that a positive Supreme Court decision today eliminates a 180 day notice after approval and could expedite launch for the drug by six months, keeps a Buy rating on Coherus shares.
06/12/17
JPMS
06/12/17
NO CHANGE
JPMS
Overweight
Coherus shares can hit $30-plus on 2018 approval, says JPMorgan
JPMorgan analyst Chris Schott said that while today's news from Coherus Biosciences of a complete response letter on CHS-1701 is "clearly disappointing," the letter appears "very much addressable." The FDA is requesting reanalysis of a subset of samples using a more sensitive immunogenicity assay, which likely will result in a one year delay in approval, Schott told investors earlier in a research note. He notes the FDA did not request additional clinical studies. Schott continues to believe CHRS-1701 will be one of the first approved biosimilar versions of Neulasta. He views today's selloff in Coherus shares as an overreaction and keeps an Overweight rating on the name. The analyst sees upside to $30 per share assuming CHS-1701 gets approved in 2018. Coherus in afternoon trading is down 27% to $14.98.
06/12/17
COWN
06/12/17
NO CHANGE
Target $45
COWN
Outperform
Coherus Biosciences CHS-1701 CRL 'appears resolvable', says Cowen
Cowen analyst Ken Cacciatore said Coherus Biosciences' CHS-1701 CRL "appears resolvable," with a delay most likely being a year. There does not seem to be any specific issue with 1701, but the FDA would like further analysis with a more refined assay to ensure the highest quality possible, the analyst wrote. Cacciatore rates Coherus a Buy with a $45 price target.
06/12/17
BMOC
06/12/17
NO CHANGE
Target $43
BMOC
Outperform
Coherus Biosciences weakness a buying opportunity, says BMO Capital
BMO Capital analyst Ian Somaiya said CHS-1701 CRL is disappointing but the issues raised are addressable, and expects a timely resolution and re-submission. The analyst lowered Coherus Biosciences' price target to $43 from $54, assuming a one-year delay in the US and reduced probability of an on-time European approval, but said to use weakness as a buying opportunity and maintains an Outperform rating.

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SECO

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RBS

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