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    CLIN   GB00B89J2419

CLINIGEN GROUP PLC

(CLIN)
  Report
Delayed Quote. Delayed London Stock Exchange - 01/25 06:31:00 am
900.5 GBX   +0.28%
01/20Clinigen Group plc Issues Open Letter to the Shareholders
CI
01/20Form 8.3 - - (CGWL)
AQ
01/19Form 8.3 - Octopus Investments - Clinigen Group plc
AQ
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SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector news

Clinigen Erwinaze License Application Rejected by FDA in Current Form

12/01/2021 | 04:34am EST

By Joe Hoppe

Clinigen Group PLC said Wednesday that the U.S. Food and Drug Administration has issued a complete response letter to its partner Porton Biopharma Ltd., rejecting its leukemia treatment license application in its current form.

The pharmaceutical services and products company said Porton is in the process of reviewing the letter and will provide it updates as soon as discussions with the FDA have been completed.

The company signed a global licensing and distribution agreement with Porton in April 2020 to commercialize and distribute Erwinaze, an acute lymphoblastic leukemia treatment designed for patients who have developed hypersensitivity to E. coli-derived treatments. Clinigen supplies Erwinaze to more than 30 licensed and unlicensed markets outside the U.S.

Given that the company has recently negotiated more favorable terms with Porton, cost-savings linked to the delayed rollout of Erwinaze in the U.S. and its strong pipeline, Clinigen maintained its fiscal 2022 guidance for earnings growth of 5% to 10%, and continues to expect strong growth thereafter.

At 0903 GMT, shares were down 47.0 pence, or 7.9%, at 550.5 pence.

Write to Joe Hoppe at joseph.hoppe@wsj.com

(END) Dow Jones Newswires

12-01-21 0434ET

All news about CLINIGEN GROUP PLC
01/20Clinigen Group plc Issues Open Letter to the Shareholders
CI
01/20Form 8.3 - - (CGWL)
AQ
01/19Form 8.3 - Octopus Investments - Clinigen Group plc
AQ
01/19Form 8.3 - - (CGWL)
AQ
01/19HSBC Bank Plc - Form 8.5 (EPT/RI) - Clinigen Group PLC
AQ
01/18Clinigen Postpones Court, General Meetings following Increased Takeover Offer
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01/17GLOBAL MARKETS LIVE : Credit Suisse, Unilever, Pfizer, Volkswagen, Triton...
01/17UK's Clinigen agrees to sweetened $1.8 billion Triton take-private deal
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01/17Clinigen Receives Sweetened $1.8 Billion Takeover Bid From Triton
MT
01/17Clinigen Group plc Communicates with the Shareholders
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More news
Analyst Recommendations on CLINIGEN GROUP PLC
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Financials
Sales 2022 550 M 742 M 742 M
Net income 2022 39,0 M 52,6 M 52,6 M
Net Debt 2022 295 M 398 M 398 M
P/E ratio 2022 29,9x
Yield 2022 0,93%
Capitalization 1 198 M 1 612 M 1 614 M
EV / Sales 2022 2,71x
EV / Sales 2023 2,35x
Nbr of Employees 1 069
Free-Float 83,8%
Chart CLINIGEN GROUP PLC
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Clinigen Group plc Technical Analysis Chart | CLIN | GB00B89J2419 | MarketScreener
Technical analysis trends CLINIGEN GROUP PLC
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Income Statement Evolution
Consensus
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Mean consensus BUY
Number of Analysts 9
Last Close Price 898,00 GBX
Average target price 808,85 GBX
Spread / Average Target -9,93%
EPS Revisions
Managers and Directors
Shaun Edward Chilton Chief Executive Officer & Executive Director
Richard Paling Chief Financial Officer & Financial Controller
Elmar J. Schnee Independent Non-Executive Chairman
Ivo Timmermans Chief Medical Officer
Samuel Gordon Herbert Chief Operating Officer
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