December 30, 2020
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Catalyst Info & Data Links
TITLE: Tirbanibulin ointment used for Actinic keratosis - PDUFA
WHAT IS THE CATALYST EVENT?
Note: FDA currently not planning on holding an advisory committee to discuss application (see slide 29)
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
05-07-2020 Regulatory filings for tirbanibulin ointment for actinic keratosis submitted to both FDA and EMA
03-09-2020 FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis
Ameluz® (aminolevulinic acid hydrochloride) - Biofrontera
>50MM affected; constitutes 14-29% of dermatologist visits (in US)
10-15% progress to cancer if left untreated
Source (slide 27)
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).
Updated by HC
ATNX, Tirbanibulin, Actinic keratosis, PDUFA
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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