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CECELC

Celcuity Inc.

$CELC·$4.5B·Biotechnology·Healthcare
$89.06+0.7%YTD-7.3%1Y+66.2%
Mentions · last 7 days
2026-08-22: 2 posts2026-08-23: 2 posts64-18%
Price updated 9h ago·X counts updated 8d ago
CECELC
$CELCCelcuity Inc.
$89.06+0.70%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 eventWinding up for a moveAI verdict · as of 2026-08-31

Trading in a tight range and building pressure — a move looks likely soon, but the direction isn't clear yet.

Celcuity — REVTORPYK (gedatolisib) sNDA just submitted for HR+/HER2-, PIK3CA-mutant breast cancer, and the equity coils around $88.

Celcuity Inc. is a clinical-stage precision-oncology company developing gedatolisib — a pan-PI3K/mTOR inhibitor licensed from Pfizer — for HR+/HER2- breast cancer subsets. The equity is down 7% YTD but up 62% T12M as the FDA submission Aug 26 landed as a specific regulatory catalyst.

  • Revenue is functionally zero: quarterly EPS ran -$0.92 to -$1.04, with FY26 consensus at -$1.50 EPS — the business is pre-commercial and trades entirely on gedatolisib's regulatory pathway plus potential commercialization ramp.
  • The Aug 26 sNDA submission is the specific catalyst: Celcuity submitted a supplemental New Drug Application (sNDA) for REVTORPYK (gedatolisib) seeking approval to treat HR+/HER2-, PIK3CA-mutant locally advanced or metastatic breast cancer — that's the specific dated regulatory event opening the FDA-review clock toward an approval decision.
  • The Pfizer in-license story is the strategic anchor: CELC in-licensed gedatolisib from Pfizer and became a specific pan-PI3K/mTOR platform company — that's the differentiated positioning versus Novartis's alpelisib and Piqray franchise, and supports the 'REVTORPYK is now a commercial story' framing.
  • Insider tape shows large A-Awards to executives (Sullivan 200K, Laing 30K, Hahne 26K on Aug 18) — those are the executive-comp alignment reset the sNDA submission requires, not selling signals; combined with Brandywine Managers's fresh stake, the ownership base is anchoring into the FDA-review window.

The path if the FDA review lands cleanly is a specific FDA priority-review designation plus positive advisory-committee scheduling — the tape breaks the coil upward toward the $100+ area as commercialization becomes real. What breaks the setup is an FDA Refuse-to-File or a specific competitive PI3K inhibitor readout undermining gedatolisib's positioning; that's when a stock at 41% of the 52-week range extends downward as the commercial-story-becomes-a-clinical-story reverses.

Agrees with X sentimentThe bullish X take — Celcuity 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, and a CEO podcast interview on how CELC in-licensed the molecule from Pfizer and became a Geda company — captures the coiled catalyst-play setup exactly.

What to watch: The FDA sNDA review process — priority-review designation plus positive advisory-committee scheduling breaks the coil upward toward $100+; an FDA Refuse-to-File or a competitive PI3K readout undermining gedatolisib is what extends the drop.

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

X sentiment

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

Bullish sentiment5 posts analyzed · as of 2026-08-31

Chatter is thin but bullish, centered on Celcuity's submission of a supplemental NDA to the FDA for REVTORPYK (gedatolisib) in HR+/HER2-, PIK3CA-mutant metastatic breast cancer. Traders reference a podcast with the CEO recapping how the molecule was in-licensed from Pfizer. Rival small-cap Kazia is publicly claiming better preclinical data versus gedatolisib, adding some competitive noise but drawing no substantive pushback on the filing itself.

Read the AI verdict + X sentiment for $CELC

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  • 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
+48.9%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.0.8×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.42%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.-5.5%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.-16.0%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 today2.6% 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·6d agoBrandywine Managers LLC Acquires New Stake in Celcuity, Inc. $CELCdefenseworld.net·7d agoCelcuity: REVTORPYK Is Now A Commercial Storyseekingalpha.com·18d agoCelcuity Analysts Slash Their Forecasts After Q2 Lossbenzinga.com·18d agoCelcuity Inc. (CELC) Q2 2026 Earnings Call Transcriptseekingalpha.com·18d ago

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