Cecluity was able to have a monumental day the other day on Tuesday, July 14, 2026, as it was able to receive FDA approval of REVTORPYK [gedatolisib] for the treatment of patients with 2nd-line wild-type PIK3CA hormone receptor positive [HR+]/Human Epidermal Growth Factor Receptor 2 negative [HER2-] locally advanced or metastatic breast cancer [ABC]. Such approval was given as 2nd-line therapy for these wild-type [non-mutant] breast cancer [BC] patients because they had to have progressed on or after treatment with at least one line of endocrine therapy in this advanced setting.

Typically, FDA approvals happen all the time, but what makes this one highly special is that it is the first and only FDA-approved therapy that targets all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2. What does this mean? Well, the goal of this drug is to target the entire PAM pathway, which consists of PI3K/AKT/mTOR. There are breast cancers that, for instance, target PI3K types, but before this approval, none that went after the entire pathway had been approved.

What I will state is that the market opportunity for this company is definitely in play. That’s because, first and foremost, it is going after such patients with HR+/HER2- disease, which is found in up to 70% of all BC cases. Secondly, as I mentioned above, this approval consists of wild-type PIK3CA patients. This means they don’t have to have the mutation for either the triplet [REVTORPYK + palbociclib + fulvestrant] or doublet [REVTORPYK + fulvestrant] in order to help these patients. With that said, patients who took the triplet and doublet were able to reduce their risk of disease progression or death by 76% and 67%, respectively.

The FDA approval of REVTORPYK for these 2nd-line wild-type HR+/HER2- ABC patients was given based on the positive data that was achieved in the phase 3 VIKTORIA-1 study that the company had ran. The downside is that the launch is expected to come about a later time. It was mentioned that Celcuity would start to commercialize this drug starting in late Q3 of 2026, which in essence is a delayed launch. The reason why it is important to mention the phase 3 VIKTORIA-1 study is because the company had another cohort as a part of it.

This would be a cohort that specifically only recruited 2nd-line PIK3CA-mutant HR+/HER2- ABC patients. A total of 350 patients were randomized to either the REVTORPYK triplet, alpelisib + fulvestrant, or the REVTORPYK doublet. The final outcome was that the REVTORPYK triplet reduced the risk of disease progression or death by 50% [median progression-free survival or mPFS]. Then, the doublet was able to achieve an mPFS of 49%.

I bring this data up because this is what will allow the company to file a supplemental New Drug Application [sNDA] of REVTORPYK to expand the label to include the targeting of PIK3CA-mutant HR+/HER2- ABC patients. Such a filing is expected to happen in Q3 of 2026 as well. Not only that, but the company is already making moves to expand towards 1st-line patients [treatment-naive]. Having said that, it is in the process of evaluating two separate patient cohorts in the 1st-line setting in the phase 3 VIKTORIA-2 study.

This isn’t the only expansion move that it has left to work with. It is also expected to submit VIKTORIA-1 data to other global health authorities so that it can receive marketing approval in several other territories for gedatolisib [REVTORPYK] for the treatment of patients with 2nd-line wild-type PIK3CA HR+/HER2- ABC. It ended Q1 of 2026 with $387.1 million in cash, and it believes that this is going to be enough to fund its operations through 2027.