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ABNX — Abionyx Pharma SA News Story

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Abionyx jumps after FDA's orphan drug designation for its treatment of LCAT deficiency

** Shares in Abionyx  ABNX.PA  jump 23% after the
biopharmaceutical group received FDA orphan drug designation
(ODD) for its treatment of LCAT deficiency, a disorder that
primarily affects the eyes and kidneys
    ** The group said on Tuesday the designation, which targets 
drugs intended to treat a rare disease, had been granted to its
CER-001 treatment following to positive results in two
compassionate use cases  urn:newsml:reuters.com:*:nASM0005I6
    ** Data demonstrated for first time that a high-density
lipoprotein (HDL) therapy can reduce lipid deposits in the
kidney, slow the decline of kidney function, beneficially
remodel lipoproteins, and improve visual impairment due to
corneal lipid deposits, Abionyx said
    ** ODD designation qualifies sponsors for incentives such as
tax credits for qualified clinical trials, exemption from user
fees, and a potential for seven years of market exclusivity
after approval, the group said
    ** "Our scenario of marketing authorisation and
commercialisation of CER-001 in the LCAT indication, estimated
for 2024, could be too conservative," says Midcap Partners 
    ** The stock is down 9% year-to-date
    



 (Reporting by Diana Mandiá)
 ((diana.mandiaalvarez@thomsonreuters.com))

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