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CHRS

Coherus Biosciences

$20.65

-2.05 (-9.03%)

06:39
06/12/17
06/12
06:39
06/12/17
06:39

Coherus Biosciences receives CRL from FDA for BLA for CHS-1701

Coherus BioSciences announced that the U.S. FDA has issued a complete response letter for its biologics license application for CHS-1701, a pegfilgrastim biosimilar candidate, under the 351(k) pathway. The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors. Coherus will work with the FDA to address the information requests.

CHRS Coherus Biosciences
$20.65

-2.05 (-9.03%)

05/17/17
MAXM
05/17/17
NO CHANGE
Target $44
MAXM
Buy
Coherus could beat Humira competitors to market by 4 years, says Maxim
Maxim analyst Jason McCarthy said the invalidation of AbbVie's (ABBV) dosing patent for Humira is a "major victory" for Coherus Biosciences (CHRS) that has reduced its risk profile. The last IP hurdle to launching a Humira biosimilar is formulation, where Coherus has the advantage, said McCarthy, who believes the company could be first to market with a biosimilar by late 2018, which would be four years or more ahead of its competition. He raised his price target on Coherus shares to $44 from $43 and keeps a Buy rating on the stock, which is up $1.95, or 8.8%, to $24 in pre-market trading.
05/17/17
SBSH
05/17/17
NO CHANGE
Target $38
SBSH
Buy
Citi sees up to $8/share upside for Coherus on patent win
Citi analyst Mohit Bansal sees $4 to $8 per share upside for Coherus Biosciences (CHRS) after the Patent Trial and Appeal Board ruled in favor of the company's petitions for Inter Partes Review of AbbVie's (ABBV) '135 Patent. The stock in premarket trading is up 9%, or $1.95, to $24.00. The win makes a Humira biosimilar launch from Coherus more realistic, Bansal tells investors in a research note. Further, he believes the news makes an anti-TNF franchise partnership for Coherus with big bio-pharma more likely. He thinks a deal could be announced in the second half of 2017. Bansal keeps a Buy rating on Coherus with a $38 price target.
05/15/17
MAXM
05/15/17
NO CHANGE
Target $43
MAXM
Buy
Maxim sees probability of Humira patent ruling favoring Coherus
Maxim analyst Jason McCarthy said if Amgen's (AMGN) '135 patent for Humira is invalidated on May 17, Coherus Biosciences (CHRS) could potentially launch CHS-1420, its proposed biosimilar of adalimumab, in 2018, four years before others competing to launch a Humira biosimilar. He believes the probability favors Coherus, citing the fact that the company's focus on developing biosimilars is based on IP first. Coherus will need to raise capital again, but the outcome of the Humira patent decision and the upcoming approval decision for Neulasta on June 9 will determine at what valuation, said McCarthy, who has a Buy rating and $43 price target on Coherus shares.
05/05/17
05/05/17
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Snap (SNAP) initiated with a Buy at Cleveland Research. 2. Versartis (VSAR) initiated with an Overweight at Cantor. 3. Alder Biopharmaceuticals (ALDR) initiated with a Sell at UBS. 4. Playa Hotels & Resorts (PLYA) initiated with a Neutral at Citi. 5. Coherus Biosciences (CHRS) initiated with an Outperform at BMO Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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CI

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BTU

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CRMT

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GUID

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