Laidlaw & Co Reiterates Buy Rating on Kazia Therapeutics (KZIA)

This afternoon, one of KZIA’s competitors, CELC, reported that the FDA has approved Revtorpyk (gedatolisib) in combination with fulvestrant, with or without palbociclib, for treating HR+/HER2- locally advanced or metastatic breast cancer without PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy. Our takeaway is the major readthrough from Revtorpyk   approval is since the MOA of paxalisib also targets PI3K and mTOR, this potentially could further de-risk paxalisib clinical development, especially in HR+/HER2- BC. Since TNBC is the initial indication target for paxalisib, Revtorpyk approval will likely have very limited impact on paxalisib’s near-term commercial opportunity. Revtorpyk’s approval as a second-plus line therapy is based on robust gedatolisib combination in HR+/HER2- breast cancer Phase III (VIKTORIA-1) trial results. Revtorpyk is dosed at 180mg delivered via IV once weekly on days 1, 8, and 15 of a 28-day cycle with fulvestrant + palbociclib. CELC plans to launch Revtorpyk in late 3Q26, and also seek approval for Revtorpyk in PIK3CA mutated patients. As a reminder, the ongoing paxalisib in TNBC Phase I study size has increased to 36 from the initial 12 with updates expected later in 2026, which could include potential reporting at the SABCS meeting (12/8-12/2026). Besides TNBC, HR+/HER2- and BRACm BC patients are also being explored in the current study. The approval of Revtorpyk is overall positive for KZIA since the major readthrough is it should bode well for the potential of paxalisib development since both share a general MOA by targeting PI3K and mTOR. This could be particularly true as paxalisib also is exploring the opportunity of HR+/HER2- BC besides TNBC. Revtorpyk is the third approved PI3K-based HR+/HER2 breast cancer treatment. We are reiterating our Buy rating and $25 target price.  

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