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CECELC

Celcuity Inc.

$CELC·$4.5B·Biotechnology·Healthcare
$88.44-5.1%YTD-7.3%1Y+62.0%
Mentions · last 7 days
2026-08-21: 17 posts2026-08-22: 2 posts2026-08-23: 2 posts64-18%
Price updated 2d ago·X counts updated 7d ago
CECELC
$CELCCelcuity Inc.
$88.44-5.15%64 posts-18%
AI analysisFundamentalsVoices on X
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AI verdict & sentimentAI analysisGenerated by AI from underlying data

Top X posts

Today's AI verdict on what's driving $CELC, plus how loud the X conversation is and which way it's leaning.

AI analysis

TickerTalks’ read on the fundamentals and what’s driving the move.

Hinges on a big eventCooling offAI verdict · as of 2026-08-29

Catching its breath after a run — could pick back up or fade from here.

Just submitted sNDA for REVTORPYK in HR+/HER2- PIK3CA-mutant breast cancer — commercial launch pending FDA acceptance.

Celcuity discovers cancer sub-types and commercializes diagnostic tests for targeted-therapy patients — its lead therapeutic candidate REVTORPYK (gedatolisib) just crossed a key regulatory milestone with a supplemental NDA submitted for HR+/HER2- PIK3CA-mutant locally advanced breast cancer.

What's actually here:

  • Revenue is functionally zero (pre-commercial) — the last four quarters were essentially zero; consensus FY26 revenue of $40M growing to FY27 $390M and FY28 $720M reflects the REVTORPYK commercial-launch ramp assumed to arrive after FDA acceptance.
  • The economics are burn-heavy — Q1 operating margin against no revenue, FCF -$55M per quarter, and consensus FY26 EPS of -$4.22 widening from FY25; the $4.52B market cap requires the REVTORPYK launch to arrive on schedule.
  • The sNDA is the specific dated catalyst — the FDA submission for REVTORPYK in HR+/HER2- PIK3CA-mutant metastatic breast cancer is the specific event that starts the commercial-clock; FDA acceptance and eventual approval decisions typically take 6-10 months from submission.
  • The tape is digesting the run — position 41% of the 52-week range, 6% below the 50-day, 17% below the 200-day, on 0.62x volume; the day -5.15% shows the +62% 12-month run is drawing profit-taking.

The forward path is that Q3 earnings on Nov 11 with any FDA acceptance commentary or PDUFA date disclosure is the specific data point; the bull case requires acceptance plus a favorable label, while the bear case is any advisory-committee concerns or CRL that delays commercial launch by 12-18 months. Analyst forecasts were slashed after Q2 (per news) so consensus has already been cut, meaning the model may be under-modeling from here.

Agrees with X sentimentThe bullish X read on the sNDA submission for REVTORPYK in HR+/HER2- PIK3CA-mutant metastatic breast cancer is factually grounded on the Aug 26 announcement; Needham's reference to CELC as a multi-node inhibitor for competitive positioning adds sell-side validation.

What to watch: Q3 earnings on Nov 11 — specifically FDA acceptance of the REVTORPYK sNDA and any PDUFA date. Also cash runway and Phase 3 pipeline updates.

On the calendar: 2026-11-11 — Q3 2026 earnings

snda submitted recentcommercial launch pending

X sentiment

What the X crowd is saying right now — descriptive, summarised from the day’s posts.

Bullish sentiment5 posts analyzed · as of 2026-08-30

Celcuity is being framed as executing well following its supplemental NDA submission to the FDA for REVTORPYK (gedatolisib) in HR+/HER2-, PIK3CA-mutant locally advanced or metastatic breast cancer. Posters share a CEO podcast interview on how CELC in-licensed the molecule from Pfizer and became a Geda company. A separate KZIA-focused post cites pre-clinical head-to-head data, but that framing is not itself hostile to CELC.

Read the AI verdict + X sentiment for $CELC

  • One-line verdict on what's driving the move — fundamentals, momentum, both, or an event
  • Next dated catalyst when there is one (earnings, deal closing, activist clock)
  • X crowd read with bullish/bearish call + post volume
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What it does

Plain-English summary of the business — what they sell and how they make money.

Clinical-stage oncology biotech developing molecularly targeted therapies for solid tumors based on cellular pathway analysis.

Industry overviewAI analysisGenerated by AI from underlying data

Where Biotechnology sits in its cycle right now — and what that implies for $CELC.

Biotechnology · Healthcare

GLP-1 oral formulation competition — emerging clinical data from pipeline challengers — is the central bifurcation: platform holders (LLY, NVO) defend on efficacy breadth while precision oncology names decouple entirely. FDA catalyst cadence over the next 60 days sets the near-term tone.

What this means for $CELC

Partial — software subscription economics provide some insulation from macro cycles; AI integration is the growth catalyst for this segment; Celcuity, Inc.

Top industry ETF

$IBBiShares Biotechnology ETF
+12.1%YTD
+51.2%1Y

Fundamentals & catalyst

Profitability, valuation, and the next earnings event — at a glance, with rule-of-thumb signals.

Key ratios

P/E
-24.9How much investors are paying per dollar of profit the company actually earned in the last 12 months. Lower means the stock looks cheaper relative to earnings.~15–25 is typical for the S&P 500; high-growth names trade 30+; hyper-growth or speculative can be 100+ or negative.
ROIC
-49.5%What percentage return the business earns on every dollar of capital (equity + debt) deployed in operations. The cleanest measure of business quality.Above ~15% is high-quality; consistently above 25% suggests a real moat. Below the company's cost of capital is value-destroying.
Op margin
0.0%Operating profit (after sales, marketing, R&D, and overhead but before interest and taxes) as a percentage of revenue. The clearest view of how well the underlying business is run.Mature business above 20% is healthy; software businesses can run 30%+; commodity / retail businesses operate in single digits.
FCF yield
-4.0%Free cash flow (operating cash flow minus capex) divided by the company's market cap. The cash-on-cash return you'd get owning the whole business at today's price.Above ~5% is attractive; below ~2% means you're paying up for growth. Capital-light businesses (software) run higher than capital-heavy ones (utilities).
P/S
0.0Same idea as P/E but per dollar of revenue. Useful for companies that aren't profitable yet, where P/E is meaningless.Under ~2 is cheap; software / SaaS often runs 8–15; well above 20 implies the market is pricing in very high future growth.
ROE
-245%Net income as a percentage of shareholders' equity. Similar to ROIC but counts only the equity side.Above 20% is strong, but can be inflated by leverage — a heavily indebted company can show high ROE with weak underlying ROIC.
Gross margin
0.0%Revenue minus the direct cost of producing what was sold, as a percentage of revenue. The first read on whether the product is structurally profitable.Software / SaaS is typically 70%+; consumer goods 30–50%; commodity / hardware businesses can be under 20%.
D/E
3.7Total debt divided by shareholders' equity. Measures how much the business runs on borrowed money versus owner capital.Under 1 is conservative; 1–2 is typical for mature businesses; over 2 is leveraged and more sensitive to interest rates.

Past earnings

QuarterReportedActualEstimateSurprise
Q2 2026Aug 13, 2026$-1.44$-1.16-24.1%
Q1 2026May 14, 2026$-0.97$-1.04+6.7%
Q4 2025Mar 25, 2026$-0.97$-1.06+8.5%
Q3 2025Nov 12, 2025$-0.92$-1.02+9.8%
Next earningsWed, Nov 11·consensus EPS $-1.50

Quarterly trend

QuarterRevenueYoYGrossOpEPSFCF
Q1 FY26$0———$-0.97$-55.3M
Q4 FY25$0———$-0.96$-36.5M
Q3 FY25$0———$-0.92$-44.9M
Q2 FY25$0———$-1.04$-36.3M

Forward consensus

5-year forecast · up to 7 analysts
FYRevenueRangeEPSRangeAnalysts
FY26$39.9M$22.6M – $57.2M-$4.22-$4.62 – -$4.007
FY27$392.4M$229.2M – $555.5M-$0.50-$68.41 – $42.667
FY28$716.3M$471.2M – $1.2B$3.26$0.27 – $6.666
FY29$1.1B$599.5M – $1.9B$7.42$2.81 – $13.815
FY30$1.6B$850.5M – $2.7B$10.96$4.16 – $20.403

Setup & momentum

Volume, range, and moving-average position — the technical setup driving short-term moves.

Right now

Vol vs 30dToday's traded share volume divided by the average over the prior 30 trading days. ≥3× signals unusual interest; below 1× is quiet.0.6×Today's traded share volume divided by the average over the prior 30 trading days. ≥3× signals unusual interest; below 1× is quiet.
52w rangeWhere the latest close sits between the 52-week low (0%) and high (100%). Above 80% is extended; below 30% is basing or in a downtrend.41%Where the latest close sits between the 52-week low (0%) and high (100%). Above 80% is extended; below 30% is basing or in a downtrend.
vs 50d MALatest close vs the 50-day simple moving average. Positive = short-term trend is up.-6.2%Latest close vs the 50-day simple moving average. Positive = short-term trend is up.
vs 200d MALatest close vs the 200-day simple moving average. Positive = long-term trend is up.-16.6%Latest close vs the 200-day simple moving average. Positive = long-term trend is up.

Float & profile

FloatLow float · 29.9M shFree-float shares — the slice of issued stock actually available to trade. Lower buckets squeeze harder on a catalyst.Traded today2.0% of floatToday's volume as a percent of the free float. Above 5% on a single day is unusually high turnover for the available share count.β0.165-year weekly beta vs the S&P 500. Above 1.5 means the stock typically moves more than the index; below 0.8 moves less.FilingActive offeringA shelf registration (S-3 / S-3ASR / S-1) or prospectus supplement (424B*) was filed in the last 90 days — the company is registered to (or actively) issuing new shares. Dilution risk.

Insider activity

Recent open-market buys and sells by officers and directors — flagged when multiple insiders cluster.

Recent transactions

SellJul 14Baker Bros. Advisors LpFormer 10% owner3.1M sh$317.8MSellMay 4David DalveyDirector25.0K sh$3.5MSellMay 4Richard E BullerDirector9.0K sh$1.3MSellMar 31Richard E BullerDirector3.0K sh$331K
+ 16 other (9 awards · 4 gifts · 3 exempts) in window

See when $CELC insiders are putting their own money in

  • Real-time open-market buys and sells from Form 4 filings
  • Cluster-buy detection when multiple insiders pile in at once
  • 30 / 60 / 180-day windows so you can spot building conviction
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SEC filings

Material 8-K, 13D, S-3, and 424B5 events from the last 180 days — the filings that actually move the price.

Recent material filings

8-KPress release / Reg FDAug 268-K — Item 7.01: Press release / Reg FD · Item 8.01: Other event
AI summary

Celcuity Inc. submitted a supplemental New Drug Application (sNDA) to the FDA for REVTORPYK (gedatolisib), seeking approval to treat HR+/HER2- locally advanced or metastatic breast cancer patients with a PIK3CA mutation after progression on at least one line of endocrine therapy. This is a major regulatory milestone: the sNDA submission puts gedatolisib on a formal FDA review pathway for a substantial breast cancer patient population, potentially unlocking a broad new commercial indication for Celcuity.

SC 13D/AActivist amendmentJul 16SC 13D/A
AI summary

Baker Bros. Advisors LP and related entities (Julian C. Baker, Felix J. Baker, and Baker Bros. Advisors (GP) LLC) filed Amendment No. 2 to their SC 13D on Celcuity Inc. (CELC), disclosing 4,877,963 shares representing 9.99% of the class. Baker Bros. is classified as an investment advisor (IA/PN); no activist intent is stated in the excerpt. Significant position update by a prominent healthcare-focused investment manager at just under the 10% threshold.

8-K/APress release / Reg FD (amended)Jul 158-K/A — Item 7.01: Press release / Reg FD · Item 8.01: Other event
AI summary

Celcuity (CELC) filed Amendment No. 1 to its 8-K originally dated July 15, 2026, to correct a missing slide in Exhibit 99.2 (investor presentation). The underlying event covered by the original filing was the FDA approval of REVTORPYK (gedatolisib) for the treatment of HR+/HER2- locally advanced or metastatic breast cancer in patients without a PIK3CA mutation who had received at least one prior endocrine therapy. No new substantive information was added beyond the corrected exhibit. This amendment ensures the investor presentation is complete.

8-KPress release / Reg FDJul 158-K — Item 7.01: Press release / Reg FD · Item 8.01: Other event
AI summary

Celcuity (CELC) announced on July 14, 2026, that the FDA approved REVTORPYK (gedatolisib) for the treatment of HR+/HER2- locally advanced or metastatic breast cancer in patients without a PIK3CA mutation following at least one prior endocrine-based therapy. The company expects a commercial launch in late Q3 2026 and plans to file a supplemental NDA (sNDA) in Q3 2026 targeting the PIK3CA-mutant breast cancer indication. Gedatolisib is a pan-PI3K/mTOR inhibitor. This approval establishes REVTORPYK in a defined patient population with an unmet need.

8-KAgreement terminatedJun 88-K — Item 1.01: Material agreement · Item 1.02: Agreement terminated · Item 2.03: Material debt obligation · Item 8.01: Other event
AI summary

Celcuity Inc. (CELC) disclosed a material definitive agreement under Item 1.01, reporting a merger or acquisition transaction involving growth company as defined in Rule. The deal is valued at approximately $557.0 million. Details of the transaction terms, consideration structure, and closing conditions are set forth in the full 8-K filing. Definitive merger agreements are among the most material events a public company can disclose, triggering regulatory review and shareholder vote requirements.

424B5Prospectus supplement (offering)Jun 5424B5
AI summary

CELC (CELC) filed a 424B5 prospectus supplement for an offering of senior notes. The offering size is $0 at 0.250 %, due 2032. Proceeds are intended for general corporate purposes, which may include debt repayment, capital expenditures, or working capital. The 424B5 is a prospectus supplement filed under an existing shelf registration, allowing the company to offer securities on an accelerated timeline without a standalone registration statement.

424B5Prospectus supplement (offering)Jun 3424B5
AI summary

CELC (CELC) filed a 424B5 prospectus supplement for an offering of senior notes. The offering size is $400,000,000 at 000 %, due 2032. Proceeds are intended for general corporate purposes, which may include debt repayment, capital expenditures, or working capital. The 424B5 is a prospectus supplement filed under an existing shelf registration, allowing the company to offer securities on an accelerated timeline without a standalone registration statement.

8-KPress release / Reg FDJun 28-K — Item 7.01: Press release / Reg FD · Item 8.01: Other event
AI summary

Celcuity announced detailed Phase 3 VIKTORIA-1 trial efficacy and safety results for the PIK3CA mutant-type cohort on June 2, 2026; press release filed as Exhibit 99.1. Potentially pivotal clinical readout — Phase 3 data in a named mutation cohort is a high-impact catalyst for Celcuity's lead oncology program.

+ 19 other (3 earnings 8-Ks · 3 13Gs · 3 8-Ks · 2 10-Qs) in window

Recent news

Latest headlines from major outlets, sourced and timestamped — context for whatever just moved.

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancerglobenewswire.com·5d agoBrandywine Managers LLC Acquires New Stake in Celcuity, Inc. $CELCdefenseworld.net·6d agoCelcuity: REVTORPYK Is Now A Commercial Storyseekingalpha.com·17d agoCelcuity Analysts Slash Their Forecasts After Q2 Lossbenzinga.com·17d agoCelcuity Inc. (CELC) Q2 2026 Earnings Call Transcriptseekingalpha.com·17d ago

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