Orphazyme: Tumbles as key drug candidate fails to win FDA support

Strategic Partners A/S

18/06/2021 08:11

** Copenhagen-listed shares of Orphazyme  ORPHA.CO  plummet
75% after the U.S. Food & Drug Administration did not support
the biotech company's application for approval of arimoclomol, a
genetic disorder drug candidate  urn:newsml:reuters.com:*:nL2N2O00CG
    ** Instead, FDA issued a Complete Response Letter requesting
additional qualitative and quantitative evidence for the drug's
effectiveness
    ** The decision triggered downward revision of Orphazyme's
2021 outlook as the company said it needs to reduce costs
substantially
    ** "The situation is hopeless," Nordnet's analyst Per Hansen
says, adding it was expected FDA would approve arimoclomol,
which did not happened and now Orphazyme has no money and no
documentable projects  
    ** It's "game over for 'meme speculation'", he comments
referring to the stock's recent price frenzy
    ** Oprhazyme shares became a 'meme stock' recently,
seesawing significantly and being up 91% Thursday in U.S. trade
in anticipation of the FDA decision  urn:newsml:reuters.com:*:nL3N2NY3OL
    ** The stock is on track for its worst day ever with today's
losses wiping off DKK 2.6 bln ($416.15 mln) from the company's
market cap        
    


($1 = 6.2478 Danish crowns)

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