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    ONCO   SE0009414576

ONCOPEPTIDES AB (PUBL)

(ONCO)
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Oncopeptides Withdraws Pepaxto? in US, Scale Down Organization and Focus on R&D

10/22/2021 | 09:37am EST

Oncopeptides AB (publ) announced that the company has decided to withdraw Pepaxto? (INN melphalan flufenamide) from the market in the US, following the phase 3 OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the US Food and Drug Administration, FDA. Pepaxto was granted accelerated approval on February 26th 2021. During dialogue with FDA it has become evident that the FDA does not consider that the phase 3 OCEAN study meets the criteria of a confirmatory study. Oncopeptides believes that the OCEAN data are scientifically meaningful and that the findings warrant further evaluation. As a consequence Oncopeptides will immediately refocus the company and return to being a Sweden based R&D company, dedicated to further develop proprietary Peptide Drug Conjugate (PDC) platform including the next generation of drug candidates including OPD5 and OPDC3. The organization will be scaled down to increase cash runway and focus on building a platform for longer term development and growth. The commercial business units in the US and Europe will be closed down and the Stockholm based organization will be significantly reduced. The application to the European Medicines Agency, EMA, for a potential Conditional Marketing Authorization of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma, remains pending. The company expects to receive a CHMP opinion in second quarter, 2022. Oncopeptides will work together with the FDA to continue to make the drug available for patients currently treated with Pepaxto.


© S&P Capital IQ 2021
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Financials
Sales 2021 156 M 17,2 M 17,2 M
Net income 2021 -1 302 M -143 M -143 M
Net cash 2021 187 M 20,6 M 20,6 M
P/E ratio 2021 -0,56x
Yield 2021 -
Capitalization 755 M 83,6 M 83,1 M
EV / Sales 2021 3,64x
EV / Sales 2022 2,03x
Nbr of Employees 321
Free-Float 89,9%
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Mean consensus HOLD
Number of Analysts 5
Last Close Price 10,03 SEK
Average target price 25,23 SEK
Spread / Average Target 152%
EPS Revisions
Managers and Directors
Stig Anders Jakob Lindberg Chief Executive & Scientific Officer
Annika Muskantor Chief Financial Officer
Per Wold-Olsen Chairman
Fredrik Lehmann Head-Research, Chemistry, Manufacturing & Control
Klaas Bakker Chief Medical Officer & Executive Vice President
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