1. Homepage
  2. Equities
  3. Sweden
  4. Nasdaq Stockholm
  5. Ascelia Pharma AB (publ)
  6. News
  7. Summary
    ACE   SE0010573113

ASCELIA PHARMA AB (PUBL)

(ACE)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

Ascelia Pharma receives FDA acceptance of IND application for Oncoral clinical trial

12/16/2021 | 03:40am EDT

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for the upcoming global Phase 2 clinical study in gastric cancer with the daily oral chemotherapy candidate drug Oncoral.

“We are very happy that the FDA has accepted our IND application to start our Phase 2 study with Oncoral in the US, which is an important step forward for Ascelia Pharma. We believe this daily oral tablet formulation of irinotecan has the potential to provide both better efficacy and improved safety to patients suffering from this very aggressive cancer form where there is a large unmet medical need”, said Carl Bjartmar, Chief Medical Officer of Ascelia Pharma.

In this combination study, Ascelia Pharma’s irinotecan chemotherapy tablet Oncoral (ASC-201) will be evaluated in combination with Taiho Oncology’s LONSURF® (trifluridine and tipiracil) film-coated tablets for oral use. The all-oral combination of Oncoral and LONSURF is investigational at this time and not approved for use in gastric cancer or any other disease.

Following an initial dose-finding part, the Phase 2 study will be a randomized controlled multicenter study of Oncoral added to LONSURF compared to LONSURF alone. The primary endpoint will be progression-free survival, with secondary endpoints including response rate, overall survival, pharmacokinetics, safety, and tolerability.

The study will include approximately 100 patients with metastatic gastric cancer and first patient visit is planned for H1 2022. The initial portion of the planned global study will be conducted at hospitals in Europe, whereas the subsequent randomized part will also include US sites.

© Modular Finance, source Nordic Press Releases

All news about ASCELIA PHARMA AB (PUBL)
05/11TRANSCRIPT : Ascelia Pharma AB, Q1 2022 Earnings Call, May 11, 2022
CI
05/11QUARTERLY REPORT Q1 2022 : Strong Orviglance support from healthcare professionals
AQ
05/11Ascelia Pharma AB Reports Earnings Results for the First Quarter Ended March 31, 2022
CI
05/10Ascelia Pharma's Food Effect Study shows that Orviglance image enhancement of the liver..
AQ
05/10Ascelia Pharma's Food Effect Study Shows Orviglance Image Enhancement of the Liver Is N..
CI
05/05Bulletin from the Annual General Meeting in Ascelia Pharma AB on 5 May 2022
AQ
05/05Ascelia Pharma AB Announces Resignation of Bo Jesper Hansen as Board Member
CI
04/11Ascelia Pharma publishes Annual Report for 2021
AQ
04/05Notice of annual general meeting in ascelia pharma ab
AQ
04/01CFO Kristian Borbos to leave Ascelia Pharma
AQ
More news
Financials
Sales 2022 - - -
Net income 2022 -155 M -15,8 M -15,8 M
Net cash 2022 104 M 10,6 M 10,6 M
P/E ratio 2022 -4,48x
Yield 2022 -
Capitalization 678 M 69,3 M 69,3 M
EV / Sales 2022 -
EV / Sales 2023 -
Nbr of Employees 21
Free-Float 83,7%
Chart ASCELIA PHARMA AB (PUBL)
Duration : Period :
Ascelia Pharma AB (publ) Technical Analysis Chart | ACE | SE0010573113 | MarketScreener
Technical analysis trends ASCELIA PHARMA AB (PUBL)
Short TermMid-TermLong Term
TrendsBearishBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 1
Last Close Price 20,15 SEK
Average target price 61,50 SEK
Spread / Average Target 205%
EPS Revisions
Managers and Directors
Magnus Olafsson Corfitzen Chief Executive Officer
Kristian Borbos Chief Financial Officer
Peter James Arthur Benson Chairman
Carl Bjartmar Chief Medical Officer
Bo Jesper Hansen Independent Director
Sector and Competitors
1st jan.Capi. (M$)
ASCELIA PHARMA AB (PUBL)-31.99%70
MODERNA, INC.-45.81%54 740
LONZA GROUP AG-27.15%42 618
IQVIA HOLDINGS INC.-27.91%38 497
SEAGEN INC.-9.87%25 649
ICON PUBLIC LIMITED COMPANY-29.74%17 688