Genmab — Juni 2020
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BioNTech collaboration adds DKK50/share to our Fair Value
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H.C. Wainwright reiterates Buy on Genmab, says ofatumumab delay not impactful Genmab's (GMAB) partner Novartis (NVS) announced yesterday that the Prescription Drug User Fee Act approval decision date on ofatumumab for treatment of relapsing-remitting multiple sclerosis had been pushed back three months to September 20, H.C. Wainwright analyst Raghuram Selvaraju tells investors in a research note
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Since the analyst always assumed that royalty-based revenues from ofatumumab sales in the U.S. would only begin accruing to Genmab starting in early 2021, he does not view the delay as impactful and is not making any changes to forecasts. Selvaraju, who notes that Novartis continues to expect ofatumumab approval for the MS indication in Europe during Q2 of 2021, reiterates a Buy rating on Genmab with a $34 price target.
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GOLDMAN SACHS belässt NOVARTIS AG auf 'Buy'
Die US-Investmentbank Goldman Sachs hat die Novartis-Aktie angesichts einer erweiterten US-Prüfung des Multiple-Sklerose-Medikaments Ofatumumab auf der "Conviction Buy List" mit einem Kursziel von 110 Franken belassen. Eine Verzögerung um drei Monate habe wohl keine bedeutende Auswirkungen auf den Kapitalwert des Pharmakonzerns, schrieb Analyst Keyur Parekh in einer am Mittwoch vorliegenden Studie. -
Kursen på ADS følger 100%. $29,14 = 1936.
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Et finanshus skriver: There is no reason in the press release that support the delay although there are usually two: either the agency is crowded by filings and cannot respect timelines due to the covid-19 crisis or Novartis has added new data in the course of the review and the agency is asking for more time to review the new data.
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We have no sign of a busy FDA that would ask for more time, that would affect other filings too, which has not been the case as much as we are aware. So, we would think that maybe more data has been either voluntarily submitted (unlikely) or required by the FDA before making a final decision.
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Der har længe været historier om FDAs problemer. For eksempel: https://medcitynews.com/2020/03/biopharma-companies-face-regulatory-deal-delays-due-to-covid-19/
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