ATNX

Tirbanibulin ointment

Actinic keratosis

Stage (next event)

Expected Date

PDUFA

December 30, 2020

Catalyst Info & Data Links

TITLE: Tirbanibulin ointment used for Actinic keratosis - PDUFA



WHAT IS THE CATALYST EVENT?


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • December 2020


PRIOR DATA/EVENTS 


PRESS RELEASE

Mechanism of Action

MECHANISM OF ACTION / RATIONALE

  • The Src Kinase inhibition platform refers to novel small molecule compounds that have differentiated mechanisms of actions (MOAs) including: (1) the inhibition of the activity of Src Kinase and (2) the inhibition of tubulin polymerization. We believe the combination of the two mechanisms of action provides a broader range of anticancer activity compared to either mechanism of action alone. Our three key clinical product candidates in this platform are tirbanibulin (formerly KX2-391 or KX-01) ointment for actinic keratosis, pre-cancerous lesions and psoriasis; tirbanibulin oral for solid and liquid tumors, and KX2-361 (formerly KX-02) oral for glioblastoma multiforme (GBM) (source). 


COMPETITORS

  • Ameluz® (aminolevulinic acid hydrochloride) - Biofrontera

MARKET

  • >50MM affected; constitutes 14-29% of dermatologist visits (in US)

  • 10-15% progress to cancer if left untreated

  • Source (slide 27)

Updated by MV

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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