Celcuity has secured FDA approval for gedatolisib, now branded as Revtorpyk, marking a significant milestone in the treatment of hormone receptor-positive, HER2-negative breast cancer.
The regulator approved Revtorpyk specifically for previously treated patients without mutations in the PIK3CA gene, used in combination with fulvestrant, with or without Pfizer’s (PFE) Ibrance (palbociclib).
Late-stage clinical data underpinned the approval, showing the triple combination reduced the risk of disease progression or death by 76% compared with fulvestrant alone.
Patients receiving the combination remained progression-free for a median of 9.3 months, compared with just 2.0 months for those receiving fulvestrant alone.
Revtorpyk holds a unique regulatory position as the only approved inhibitor of class I PI3K isoforms and mTOR complexes mTORC1 and mTORC2 to receive the FDA’s green light.
The FDA’s review of the application used the Real-Time Oncology Review program, which streamlined data submission prior to filing of the complete clinical application.
News of the approval sent Celcuity’s (CELC) share price surging, closing at $111.05, up from its previous close of $103.79, reflecting strong investor confidence in the drug’s commercial prospects.
Celcuity CEO Brian Sullivan said the company hopes Revtorpyk can grant patients “more time to feel like the disease is under control” so they can maintain “some semblance of a normal life.”
Sullivan confirmed the company already has a sales force and commercial organisation ready to launch, with pricing details still to be announced for Revtorpyk.
“We are committed to making gedatolisib available to as many patients as possible and plan to have a patient assistance program in place,” the CEO said.
Revtorpyk will enter a competitive advanced breast cancer market alongside treatments including AstraZeneca’s (AZN) Truqap, Novartis’ Piqray, and Eli Lilly’s (LLY) Verzenio.
One analyst noted that the competitive landscape raises the commercial bar considerably, observing that “breast and prostate both have options, so the bar is higher.”
Revtorpyk is administered intravenously, requiring patients to regularly travel to an infusion centre for treatment, which presents an additional challenge for long-term patient adherence.
Celcuity is also developing Revtorpyk for patients with PIK3CA mutations, with plans to file a supplemental application to the FDA in the third quarter of 2026.
The drug is additionally being evaluated in the ongoing Phase 3 VIKTORIA-2 clinical trial, incorporating two independent studies across two patient cohorts with HR-positive, HER2-negative locally advanced or metastatic breast cancer who are treatment-naive in the advanced setting.
Revtorpyk is also being tested in a Phase 1/2 trial in prostate cancer, a market that could significantly expand the drug’s addressable patient population if results prove positive.
Analysts are already speculating that a successful commercial launch could make Celcuity an attractive acquisition target for major pharmaceutical companies looking to bolster their oncology pipelines.
“Any company that’s going to have multi-blockbuster revenues before the end of the decade is a strategic target for large pharma,” one analyst told Fierce Pharma, adding that strategic values “could be very, very high.”
“My perception is that investors believe this is a company that belongs in the hands of a large pharma company,” the analyst concluded, underlining the elevated takeover speculation surrounding Celcuity following the landmark approval.