Celcuity Inc. (CELC) Stock Price & How to Invest

Short answer

Celcuity (CELC) is a clinical-stage oncology company whose value rides almost entirely on gedatolisib, its late-stage breast-cancer drug, so a position is effectively a bet on FDA approval and commercial launch rather than on current earnings. It is a binary, pre-revenue biotech, not a business with trailing sales to value.

CELC stock price

As of 2026-07-08, Celcuity Inc. (CELC) last closed at $108.90, up 706.1% over the past year. Over the past 52 weeks it has traded between $13.51 and $144.98.

CELC last close
$108.90
1 day
-5.89%
1 month
+24.56%
1 year
+706.07%
52-week range
$13.51 to $144.98
Last close
2026-07-08

Prices are daily closing prices from Yahoo Finance and may be delayed. For the live quote, check your broker or Celcuity Inc.'s investor relations page. Walnut is informational, not investment advice.

What does Celcuity Inc. (CELC) do?

Celcuity Inc. is a Minneapolis-based clinical-stage biotechnology company focused on targeted therapies for solid tumors. Its lead candidate, gedatolisib, is a pan-PI3K/AKT/mTOR (PAM) inhibitor being developed for HR+/HER2- advanced breast cancer. Unlike single-node inhibitors such as alpelisib, capivasertib, and everolimus, gedatolisib is designed to block the whole pathway at once. In 2026 the pivotal Phase 3 VIKTORIA-1 trial hit its primary endpoint, with gedatolisib combination regimens roughly doubling progression-free survival versus alpelisib plus fulvestrant in the PIK3CA-mutant cohort, results presented at ASCO. The FDA granted Priority Review to the New Drug Application for the PIK3CA wild-type population with a PDUFA goal date of July 17, 2026.

The investment picture is the classic late-stage biotech setup: a large addressable market and strong trial data on one side, and pre-revenue economics with concentrated single-asset risk on the other. Celcuity has essentially no product revenue and funds heavy research spending from cash and a debt facility, so the stock trades on the probability and size of a gedatolisib launch rather than on trailing financials. The near-term FDA decision, the readout of additional cohorts and the VIKTORIA-2 first-line studies, and the company's ability to fund a commercial launch are the variables that matter most. Walnut is not an investment adviser, and a name like this carries outcomes that can swing sharply on single regulatory or clinical events.

What's driving Celcuity Inc. (CELC)?

1. Gedatolisib FDA decision and launch

The July 17, 2026 PDUFA date for the HR+/HER2-/PIK3CA wild-type indication is the single largest catalyst. An approval would convert Celcuity from a pre-revenue developer into a commercial-stage company, while the wider PIK3CA-mutant opportunity from VIKTORIA-1 could follow via a supplemental filing. Execution on manufacturing, pricing, and salesforce build-out then becomes the next test.

2. Differentiated pan-pathway mechanism

Gedatolisib blocks all four class I PI3K isoforms plus mTORC1 and mTORC2, aiming to close the adaptive-resistance loops that single-target drugs can leave open. In VIKTORIA-1 the combinations improved median progression-free survival by roughly 5.5 to 5.7 months versus alpelisib plus fulvestrant. If that profile holds in real-world use, it supports a premium position within the PAM-inhibitor class.

3. Label-expansion pipeline

Beyond the initial indication, the Phase 3 VIKTORIA-2 program is studying gedatolisib in first-line advanced breast cancer, including endocrine-sensitive and endocrine-resistant patients. Additional cohorts and combination regimens broaden the potential eligible population over time. Each readout is a discrete catalyst that can move the shares independent of the base indication.

What are the risks to Celcuity Inc. (CELC)?

Celcuity is a pre-revenue, essentially single-asset company, so a delay or rejection at the PDUFA date, a label narrower than hoped, or disappointing later cohort data could sharply reduce the value the market assigns. It posted a net loss of roughly $52.8 million in the first quarter of 2026 and funds operations from cash plus a debt facility, so additional equity or debt financing (and potential dilution) is a live risk if a launch takes longer or costs more than planned. Even with approval, commercial uptake faces entrenched and newly approved competitors, payer and pricing pressure, and the operational challenge of a first launch. The stock has been volatile and can gap on single events, which is characteristic of clinical-stage biotech rather than a defect specific to this name.

How is Celcuity Inc. (CELC) valued? (approximate, JUNE 2026)

A simple financial snapshot. These are approximations and refresh quarterly; for current figures see Celcuity Inc.'s investor relations page or your broker.

  • Revenue (TTM): ~$0 (pre-revenue, clinical-stage)
  • Market cap: ~$5B
  • Share price (Jun 30, 2026): ~$105
  • Q1 2026 net loss: ~$52.8M
  • Q1 2026 R&D expense: ~$33.1M
  • Cash & short-term investments: ~$205.7M

Because Celcuity has essentially no product sales, standard multiples like price-to-earnings or price-to-sales do not apply, and the market cap reflects the expected value of a gedatolisib approval and launch. Management has said current cash plus debt-facility drawdowns are expected to fund clinical activities through 2026, which places the funding runway alongside the launch timeline as a key watch item. Figures are approximate and as of the periods noted.

Who competes with Celcuity Inc. (CELC)?

Approved PI3K/AKT/mTOR pathway drugs

Alpelisib (Novartis, a PI3K-alpha inhibitor), capivasertib (AstraZeneca, an AKT inhibitor), and everolimus (mTORC1 inhibitor) are already approved with endocrine therapy in HR+/HER2- advanced breast cancer. They are the direct comparators gedatolisib is measured against and the incumbents it would have to displace on launch.

Emerging pathway and resistance-targeting agents

Newer entrants such as inavolisib and other PI3K/AKT-pathway candidates target the same resistance biology in overlapping patient populations. Competition here shapes how much of the market gedatolisib can win and at what price.

Broader HR+/HER2- treatment landscape

CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) and endocrine therapies frame the standard of care that gedatolisib combinations slot into or follow. Sequencing decisions and combination partners determine where gedatolisib fits in the treatment pathway.

How to invest in Celcuity Inc. (CELC)

There are three common ways to get CELC exposure. Buy shares (or fractional shares) directly at any major broker. Hold an ETF that includes it, which spreads the position across many companies. Or build it into a focused thematic basket, so CELC sits alongside other stocks that express the same thesis.

Walnut takes the basket route. Describe a thesis where CELC fits (for example “AI infrastructure” or “dividend-growth large-caps”) and the AI proposes 5 to 6 constituents with target weights. You review the plan and fund it through your own broker when you're ready.

The bottom line on Celcuity Inc. (CELC)

CELC is a single-asset, pre-revenue biotech whose story is the gedatolisib approval and launch, which makes it high-reward and high-risk in equal measure.

More on Celcuity Inc. (CELC)

Whether CELC is worth buying today depends more on your time horizon and what you already hold than on any single call. We walk through valuation, what would have to go right, and the risks in is CELC a buy?, and where the stock could go from here in the CELC stock forecast.

For income investors, whether CELC pays a dividend and how the payout looks is covered in does CELC pay a dividend?

Build a basket around CELC with Walnut

Use Celcuity Inc. as one constituent in a thematic basket Walnut's AI helps you assemble. Describe a thesis you believe in, the AI proposes the holdings and weights, and you approve before any broker order.

FAQ

What does Celcuity do?

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Celcuity is a clinical-stage biotechnology company developing targeted cancer therapies. Its lead drug, gedatolisib, is a pan-PI3K/AKT/mTOR inhibitor being developed for HR+/HER2- advanced breast cancer, and the company also runs diagnostic and functional-testing work supporting its programs.

Does Celcuity make any money yet?

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No. Celcuity is pre-revenue and reported a net loss of roughly $52.8 million in the first quarter of 2026. It funds heavy research spending from cash, short-term investments, and a debt facility rather than from product sales.

What is gedatolisib?

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Gedatolisib is Celcuity's lead drug candidate, an intravenously administered inhibitor that blocks all four class I PI3K isoforms plus mTORC1 and mTORC2. The design aims to suppress the whole pathway at once and reduce the adaptive resistance that single-target drugs can trigger.

What is the FDA PDUFA date for gedatolisib?

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The FDA granted Priority Review to the New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer and set a PDUFA goal date of July 17, 2026. That decision is the company's largest near-term catalyst.

What did the VIKTORIA-1 trial show?

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The pivotal Phase 3 VIKTORIA-1 trial met its primary endpoint. In the PIK3CA-mutant cohort, gedatolisib combination regimens roughly doubled the likelihood of survival without disease progression versus alpelisib plus fulvestrant, improving median progression-free survival by about 5.5 to 5.7 months.

Who competes with gedatolisib?

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Approved pathway drugs including alpelisib, capivasertib, and everolimus are the direct comparators, alongside emerging agents such as inavolisib. In the broader HR+/HER2- setting, gedatolisib combinations sit within a landscape shaped by CDK4/6 inhibitors and endocrine therapies.

Why is CELC considered a high-risk stock?

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Its value rests largely on one asset, gedatolisib, so regulatory or clinical setbacks can move the shares sharply. As a pre-revenue company, it also depends on continued financing, and the stock has shown the volatility typical of clinical-stage biotech.

How much cash does Celcuity have?

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Celcuity reported roughly $205.7 million in cash, cash equivalents, and short-term investments as of the first quarter of 2026. Management has said current cash plus debt-facility drawdowns are expected to fund clinical development activities through 2026.

Walnut is informational, not investment advice. Financial figures on this page are approximations; always verify current numbers with Celcuity Inc.'s investor relations page or your broker before making investment decisions.