Log in
Forgot password ?
Become a member for free
Sign up
Sign up
Dynamic quotes 

MarketScreener Homepage  >  Equities  >  Nyse  >  Allergan plc    AGN   IE00BY9D5467

My previous session
Most popular
Delayed Quote. Delayed  - 08/20 10:00:26 pm
190.75 USD   +2.77%
08/16ALLERGAN PLC : Ex-dividend day for
08/14ALLERGAN : Appoints Neurobiology Expert Michael E. Greenberg, PhD to..
08/14BIOCENTURY - MA : FDA, Allergan
News SummaryMost relevantAll newsofficial PublicationsSector newsTweets

Evolus investors frown as FDA declines to approve Botox rival

share with twitter share with LinkedIn share with facebook
share via e-mail
05/16/2018 | 05:07pm CEST
A view shows the U.S. Food and Drug Administration (FDA) logo at its headquarters in Silver Spring

(Reuters) - U.S. health regulators on Wednesday declined to approve Evolus Inc's rival product to Allergan Plc's Botox, citing deficiencies related to the chemistry and manufacturing of its potential treatment for frown lines, sending its shares down as much as 35 percent.

The deficiencies cited by the U.S. Food and Drug Administration were "manageable", according to Chief Executive Officer David Moatazedi, who joined the company earlier this month after serving as U.S. head of Allergan's medical aesthetics business.

"They are all questions we have considered and contemplated prior to the response from the FDA," Moatazedi said on a call with analysts, but refused to specify the exact questions asked by the FDA.

The company said it was committed to getting its DWP-450, which is being developed to treat glabellar lines or frown lines in adult patients, to the market by spring 2019.

Evolus expects to respond to the FDA with a complete submission within 90 days.

The deficiencies cited by the FDA were isolated to items related to chemistry, manufacturing, and controls processes, and none related to clinical or non-clinical matters, the company said.

The deficiencies were communicated in a so-called complete response letter related to Evolus' marketing application for DWP-450, a Botox-like treatment.

Allergan's Botox is the market leader for treatment of wrinkles and frown lines, but the threat of looming competition for the blockbuster treatment has put some pressure on the drugmaker.

Revance Therapeutics in February teamed up with Mylan NV to develop a biosimilar to Botox.

A likely delay for Evolus' treatment sent Allergan's shares up 2.1 percent in morning trading.

The FDA's decision on DWP-450 was widely anticipated by analysts, after the agency had issued a "form 483", which outlined violations at the company's facility following inspections in 2017.

Also on Wednesday, the company said that its partner Daewoong Pharmaceutical Co received a favorable inspection report of its manufacturing facility, which makes DWP-450.

Shares of Evolus, which went public about three months ago, were down 31 percent at $10.18 in morning trading.

(Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber)

By Manas Mishra

Stocks mentioned in the article
ChangeLast1st jan.
ALLERGAN PLC 2.77% 190.75 Delayed Quote.13.46%
EVOLUS INC 2.13% 20.17 Delayed Quote.0.00%
MYLAN NV 0.68% 38.41 Delayed Quote.-9.22%
REVANCE THERAPEUTICS INC 1.34% 26.55 Delayed Quote.-26.71%
share with twitter share with LinkedIn share with facebook
share via e-mail
Latest news on ALLERGAN PLC
08/16ALLERGAN : Appoints Neurobiology Expert Michael E. Greenberg, PhD to its Board o..
08/16ALLERGAN : Trademark Application for "PROJECT MOONWALKER" Filed
08/16ALLERGAN : Trademark Application for "MOONWALKER" Filed
08/16ALLERGAN : An Application for the Trademark "WHEN SKINCARE WORKS, YOU KNOW IT'S ..
08/16ALLERGAN : Trademark Application for "REGI" Filed by Allergan
08/16ALLERGAN : Reports from Allergan Describe Recent Advances in Dermatologic Surger..
08/16ALLERGAN : and Editas Medicine Announce Exercise of Options to Jointly Develop C..
08/16ALLERGAN PLC : Ex-dividend day for
08/14ALLERGAN : Appoints Neurobiology Expert Michael E. Greenberg, PhD to its Board o..
More news
News from SeekingAlpha
08/20Big Pharma in the green in early trade 
08/17Entasis Therapeutics files for $86.25M initial public offering 
08/17Ironwood Pharmaceuticals' Proposed Separation Should Offer A Favorable Outcom.. 
08/16White House proposing cuts in opioid production 
08/16FDA OKs Sun Pharma's Cequa for dry eye disease 
Financials ($)
Sales 2018 15 535 M
EBIT 2018 7 412 M
Net income 2018 -1 106 M
Debt 2018 23 084 M
Yield 2018 1,49%
P/E ratio 2018 -
P/E ratio 2019
EV / Sales 2018 5,54x
EV / Sales 2019 5,31x
Capitalization 63 001 M
Duration : Period :
Allergan plc Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends ALLERGAN PLC
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 23
Average target price 208 $
Spread / Average Target 12%
EPS Revisions
Brenton L. Saunders Chairman, President & Chief Executive Officer
Wayne R. Swanton Executive Vice President-Global Operations
Matthew M. Walsh Chief Financial Officer & Executive Vice President
C. David Nicholson Chief Research & Development Officer
Paul M. Bisaro Director
Sector and Competitors
1st jan.Capitalization (M$)
ALLERGAN PLC13.46%63 001
JOHNSON & JOHNSON-3.76%360 750
PFIZER16.21%246 736
NOVARTIS0.10%211 093
ROCHE HOLDING LTD.-2.66%208 211
MERCK AND COMPANY22.73%183 667