Celcuity Inc. began shipping REVTORPYK (gedatolisib) to U.S. patients on 30 September 2026, the Minneapolis, Minnesota biotech's first commercial product since its 2017 Nasdaq listing. The launch follows FDA's 14 July 2026 approval of the drug for HR-positive, HER2-negative, PIK3CA-wild-type advanced breast cancer — and comes roughly eleven weeks later than the approval date, after FDA required validation data from a second manufacturing site before product could ship.
Gedatolisib's case, in four numbers
Figures from Celcuity's VIKTORIA-1 trial disclosures and its 30 September 2026 SEC filing.
Sixty percent of patients, zero prior options
About 40% of HR-positive, HER2-negative advanced breast cancers carry a PIK3CA mutation — and three targeted drugs already treat that group: Novartis’ Piqray (alpelisib, approved 2019), AstraZeneca’s Truqap (capivasertib, approved 2023, for PIK3CA/AKT1/PTEN-altered disease) and Genentech’s Itovebi (inavolisib, approved 2024). The remaining roughly 60% — patients whose tumors test negative for those mutations — had no PI3K- or AKT-pathway drug of their own until REVTORPYK’s July approval. Celcuity built its first commercial product specifically for that gap.
What a wild-type approval opens
$10.89B → $17.26B
Global metastatic HR-positive, HER2-negative breast cancer treatment market, 2025 to 2030, as forecast by The Business Research Company.
Sources: The Business Research Company, Metastatic HR+/HER2- Breast Cancer Global Market Report
Regulatory News outlook
We expect REVTORPYK's reach into the PIK3CA-wild-type majority — a population with no prior targeted PI3K/AKT-pathway drug — to capture a meaningful share of this market's growth, with further upside if its pending supplemental application for PIK3CA-mutant patients is approved.
How we got here: The Business Research Company's published figures show the metastatic HR+/HER2- breast cancer market growing from $10.89 billion in 2025 to $17.26 billion by 2030; since PIK3CA mutations occur in roughly 40% of these cancers by published estimates, we treat the wild-type segment REVTORPYK currently serves as the majority of that addressable total.
Four drugs, one pathway, different patients
| Product | Mechanism | Required biomarker | Pivotal trial result |
|---|---|---|---|
| REVTORPYK (Celcuity) | Pan-PI3K (α/β/γ/δ) + mTORC1/mTORC2 inhibitor | None — approved for PIK3CA-wild-type disease | VIKTORIA-1: 9.3 vs. 2.0 months PFS (triplet vs. fulvestrant alone) |
| Piqray / alpelisib (Novartis) | PI3Kα-selective inhibitor | PIK3CA mutation required | SOLAR-1: 11.0 vs. 5.7 months PFS |
| Truqap / capivasertib (AstraZeneca) | Pan-AKT (1/2/3) inhibitor | PIK3CA, AKT1 or PTEN alteration required | CAPItello-291: 7.3 vs. 3.1 months PFS (biomarker-positive) |
| Itovebi / inavolisib (Genentech) | PI3Kα-selective inhibitor | PIK3CA mutation required | INAVO120: 15.0 vs. 7.3 months PFS |
From each company’s own FDA-approved labeling and published pivotal-trial results; not a head-to-head clinical comparison. Trial populations and endpoints differ across studies.
What 30 September actually started
FDA's approval on 14 July 2026 made REVTORPYK legal to prescribe; it did not make it available. Celcuity has said it submitted validation data for a second manufacturing site to FDA almost immediately after approval, and could not begin shipping product made at that site until the agency signed off — the gap the company's own guidance described only as a launch expected “late in the third quarter” of 2026. That sign-off landed, and REVTORPYK began reaching pharmacies and infusion centers, on 30 September 2026, the last day of the quarter the company had guided to.
“With the FDA approval of REVTORPYK, positive results from the PIK3CA MT cohort of the pivotal VIKTORIA-1 study, and a preferred Category 1 recommendation in the NCCN Guidelines®, we are well positioned to address a significant unmet need.” Brian Sullivan, Chief Executive Officer, Celcuity — 14 July 2026 approval announcement
Four kinase targets, one pathway
The PI3K/AKT/mTOR signaling pathway is one of the most commonly disrupted in HR-positive breast cancer, and tumors that escape one blocked node in it often reroute through another. Where Piqray, Truqap and Itovebi each block a single point — a specific PI3K isoform, AKT, or both only in mutated tumors — gedatolisib blocks all four class I PI3K isoforms (α, β, γ, δ) and both mTOR complexes (mTORC1 and mTORC2) at once. Celcuity licensed the molecule from Pfizer in April 2021, paying $5 million in cash and $5 million in stock upfront against up to $330 million in milestones plus royalties, after early-phase data suggested the broader blockade could work in tumors the mutation-specific drugs cannot reach.
Three edges of a first-in-class label
No mutation gate
Unlike Piqray, Truqap or Itovebi, REVTORPYK's approval carries no PIK3CA or AKT-pathway mutation requirement, opening the roughly 60% of HR-positive, HER2-negative advanced breast cancer patients who test negative for those mutations and had no targeted PI3K/AKT option before.
A triplet, not just a doublet
VIKTORIA-1 tested gedatolisib alongside fulvestrant alone and alongside fulvestrant plus palbociclib, letting FDA approve the regimen either way. The triplet's 9.3-month median progression-free survival is the trial's strongest result, and the only one of the four drugs' pivotal findings built on a three-drug combination.
A second act already filed
Celcuity has submitted a supplemental application seeking to extend REVTORPYK into the PIK3CA-mutant population too, based on VIKTORIA-1's separate mutant cohort — a second approval that would let the drug compete head-to-head with Piqray and Itovebi rather than only serve the patients they cannot treat.
From a Pfizer shelf to Minneapolis
Gedatolisib's road to a commercial launch
- 2012
Celcuity founded
Founded in Minneapolis, Minnesota, initially developing the CELsignia functional-signaling diagnostic platform.
- 20 September 2017
Nasdaq listing
Celcuity completes its initial public offering, raising approximately $18 million.
- April 2021
Gedatolisib licensed from Pfizer
Celcuity takes a global exclusive license to gedatolisib, paying $5 million cash plus $5 million in stock upfront against up to $330 million in milestones.
- 18 July 2022
FDA Breakthrough Therapy designation
Granted for gedatolisib in combination with fulvestrant and a CDK4/6 inhibitor in HR-positive, HER2-negative advanced breast cancer.
- 20 January 2026
NDA accepted, Priority Review
FDA accepts Celcuity's New Drug Application under its Real-Time Oncology Review program with Priority Review.
- 14 July 2026
FDA approval
REVTORPYK approved with fulvestrant, with or without palbociclib, for PIK3CA-wild-type HR-positive, HER2-negative advanced breast cancer.
- 26 August 2026
Supplemental application filed
Celcuity submits a supplemental application seeking approval in the PIK3CA-mutant population, based on VIKTORIA-1's mutant cohort.
- 30 September 2026
First U.S. shipments
REVTORPYK becomes commercially available, after FDA clears data from a second manufacturing site.
- Ahead
PIK3CA-mutant decision pending
FDA's decision on the supplemental application would extend REVTORPYK to the mutation-positive population Piqray and Itovebi already serve.
What the sNDA decision will decide
Celcuity's own disclosures do not yet give REVTORPYK a public list price, and the company has not named the second manufacturing site whose FDA clearance held up the launch by nearly eleven weeks — both are open questions this article could not independently confirm. What is on the record is narrower and more concrete: a first-in-class drug, for a patient population three approved rivals cannot treat, now shipping, with a second regulatory decision still pending that would decide whether it competes for the other 40% as well.
- Launch: First U.S. commercial shipments of REVTORPYK began 30 September 2026, after FDA cleared data from a second manufacturing site.
- Current label: Approved with fulvestrant, with or without palbociclib, only for PIK3CA-wild-type HR-positive, HER2-negative locally advanced or metastatic breast cancer after endocrine-therapy progression.
- Pending: A supplemental application to extend approval to PIK3CA-mutant patients, based on VIKTORIA-1's mutant cohort, remains under FDA review.
- Not yet public: REVTORPYK's list price and the identity of the second manufacturing site — Celcuity's disclosures do not specify either.
Sources & further reading
- Celcuity Inc., SEC Form 8-K announcing commercial availability of REVTORPYK, 30 September 2026. sec.gov
- Celcuity Inc., SEC Form 8-K announcing FDA approval of REVTORPYK, 14 July 2026. sec.gov
- FDA, REVTORPYK (gedatolisib) prescribing information, NDA 219908. accessdata.fda.gov
- S&P Global Market Intelligence, “Celcuity's REVTORPYK approval fuels blockbuster expectations,” July 2026. spglobal.com
- FiercePharma, “Celcuity keeps cool amid questions about Revtorpyk launch timing.” fiercepharma.com
- ClinicalTrials.gov, VIKTORIA-1 (NCT05501886) study record. clinicaltrials.gov
- BioSpace, coverage of Celcuity's exclusive license agreement with Pfizer for gedatolisib, April 2021. biospace.com
- BioSpace, FDA approval of Novartis' Piqray (alpelisib), May 2019. biospace.com
- FiercePharma, AstraZeneca's Truqap (capivasertib) approval and its biomarker restriction, November 2023. fiercepharma.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did Celcuity actually announce on September 30, 2026?
That REVTORPYK (gedatolisib) is now commercially available in the United States — its first shipments to patients, following FDA approval on July 14, 2026. The launch had been delayed roughly eleven weeks while FDA reviewed validation data for a second manufacturing site.
Who can be prescribed REVTORPYK today?
Adults with HR-positive, HER2-negative, PIK3CA-wild-type locally advanced or metastatic breast cancer who have progressed on at least one line of endocrine therapy, taken with fulvestrant, with or without palbociclib. It is not approved for patients with a PIK3CA mutation.
How is REVTORPYK different from Piqray, Truqap or Itovebi?
Those three drugs all require a PIK3CA or broader AKT-pathway mutation to qualify. REVTORPYK is approved for PIK3CA-wild-type patients instead — roughly 60% of this cancer population — who had no targeted PI3K/AKT-pathway drug available before.
Could REVTORPYK eventually be approved for PIK3CA-mutant patients too?
Celcuity has submitted a supplemental application based on VIKTORIA-1's separate mutant-cohort data, which the company says showed a larger progression-free-survival benefit than alpelisib plus fulvestrant. That application is still under FDA review; this article does not treat it as approved.
