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    4503   JP3942400007

ASTELLAS PHARMA INC.

(4503)
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Chromocell and Astellas Announce FDA Fast Track Designation and First Subject Dosing with Lead Candidate CC8464/ASP1807 for the Management of Neuropathic Pain Associated with iSFN

10/12/2016 | 09:00pm EDT

Chromocell Corporation and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program of the drug candidate CC8464/ASP1807, for the management of neuropathic pain associated with idiopathic small fiber neuropathy (iSFN). In 2015, Chromocell and Astellas entered into a license and collaboration agreement for the development and commercialization of CC8464/ASP1807 for the management of neuropathic and other pain indications. Chromocell submitted the IND for CC8464/ASP1807 in July, 2016, and recently dosed the first subject in a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the oral formulation of CC8464/ASP1807. The FDA's Fast Track program is intended to help ensure that therapies intended for serious or life threatening conditions that address unmet medical needs are approved and available to patients as soon as it can be concluded that the therapies' benefits justify their risks. Features of Fast Track designation include actions that expedite development and review including frequent interactions with the FDA Division responsible for review.


ę S&P Capital IQ 2016
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Financials
Sales 2022 1 325 B 12 037 M 12 037 M
Net income 2022 194 B 1 767 M 1 767 M
Net cash 2022 478 B 4 339 M 4 339 M
P/E ratio 2022 17,6x
Yield 2022 2,68%
Capitalization 3 453 B 31 513 M 31 372 M
EV / Sales 2022 2,25x
EV / Sales 2023 1,89x
Nbr of Employees 15 455
Free-Float 98,9%
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Astellas Pharma Inc. Technical Analysis Chart | 4503 | JP3942400007 | MarketScreener
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Mean consensus BUY
Number of Analysts 13
Last Close Price 1 863,50 JPY
Average target price 2 451,54 JPY
Spread / Average Target 31,6%
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Managers and Directors
Kenji Yasukawa President, CEO & Representative Director
Naoki Okamura CFO, Representative Director & Vice President
Yoshihiko Hatanaka Chairman
Yoshitsugu Shitaka Chief Scientific Officer
Fumiaki Sakurai Head-Business Administration & Compliance
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