Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. Australia
  4. Australian Stock Exchange
  5. Mayne Pharma Group Limited
  6. News
  7. Summary
    MYX   AU000000MYX0

MAYNE PHARMA GROUP LIMITED

(MYX)
  Report
SummaryChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

MAYNE PHARMA : PROVIDES FDA UPDATE ON GENERIC NUVARINGO

10/07/2021 | 06:56am EST

Adelaide Australia: Mayne Pharma Group Limited (ASX: MYX) has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to its abbreviated new drug application (ANDA) for a generic version of NUVARINGO. Mayne Pharma is working closely with its development partner, Mithra Pharmaceuticals, SA (Mithra) and the FDA to address the questions raised in the CRL. Following submission of the response to the CRL, Mayne Pharma will receive a new target action date from the FDA.

Mayne Pharma's CEO Scott Richards said, 'We are now one step closer to approval and are confident that we can address the few remaining outstanding questions raised by the FDA in a timely manner. Pleasingly, the FDA had no questions around Mithra's facility, the drug product manufacturing process, drug substance or bioequivalence. The market opportunity continues to be attractive with two independent generics approved and an addressable market of US$670m1

Contact:

Lisa Pendlebury

VP

Investor Relations & Communications

T: +61 419 548 434

E: lisa.pendlebury@maynepharma.com

About Mayne Pharma

Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercialising novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. Mayne Pharma also provides contract development and manufacturing services to clients worldwide.

Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems. These technologies have been successfully commercialised in numerous products that continue to be marketed around the world. Mayne Pharma has two facilities based in Salisbury, Australia and Greenville, NC, US with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and poorly soluble compounds.

(C) 2021 Electronic News Publishing, source ENP Newswire

Stocks mentioned in the article
ChangeLast1st jan.
MAYNE PHARMA GROUP LIMITED 5.88% 0.27 End-of-day quote.-21.74%
MITHRA PHARMACEUTICALS S.A. 0.72% 21 Real-time Quote.5.84%
All news about MAYNE PHARMA GROUP LIMITED
12/06MAYNE PHARMA : Change of Director's Interest Notice
PU
12/03MAYNE PHARMA : Notification regarding unquoted securities - MYX
PU
11/30Mayne pharma and mithra announce tga approval of nextstellis oral contraceptive
AQ
11/30MAYNE PHARMA : Notification of cessation of securities - MYX
PU
11/29Mayne Pharma Secures Australian Regulatory Approval for Oral Contraceptive
MT
11/28MAYNE PHARMA : 29/11/2021áTGA approval of novel oral contraceptive NEXTSTELLIS
PU
11/28Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA Announces Therapeutic Goods A..
CI
11/22MAYNE PHARMA : 23/11/2021 2021 AGM CEO's Speech
PU
11/22MAYNE PHARMA : 23/11/2021 2021 AGM Chairman's Address
PU
11/22MAYNE PHARMA : 2021 Mayne Pharma AGM Speeches
PU
More news
Financials
Sales 2022 461 M 330 M 330 M
Net income 2022 -26,7 M -19,1 M -19,1 M
Net Debt 2022 260 M 186 M 186 M
P/E ratio 2022 -14,0x
Yield 2022 -
Capitalization 477 M 342 M 341 M
EV / Sales 2022 1,60x
EV / Sales 2023 1,33x
Nbr of Employees 967
Free-Float 77,2%
Chart MAYNE PHARMA GROUP LIMITED
Duration : Period :
Mayne Pharma Group Limited Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends MAYNE PHARMA GROUP LIMITED
Short TermMid-TermLong Term
TrendsBearishBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 5
Last Close Price 0,27 AUD
Average target price 0,48 AUD
Spread / Average Target 78,0%
EPS Revisions
Managers and Directors
Scott Richards Chief Executive Officer, MD & Executive Director
Peter Paltoglou Chief Financial Officer
Frank C. Condella Chairman
Gerard G. Nahum Chief Medical Officer
Keith Moore Vice President-Research & Development