Loading page
Research idea · below 8/10
Cogent Biosciences, Inc.
Cogent Biosciences is a clinical-stage biotechnology company built around a single lead asset, bezuclastinib, an orally administered, selective inhibitor of the KIT D816V mutation and related exon 17 KIT mutations.
Expected time 1 year is when we expect the main question to be answered. Full holding time 12-24 months is the longest the idea may stay open if the facts still support it.
Research only. At 7/10, this idea stays in research but does not appear with our strongest ideas. It returns there if our belief reaches 8/10.
Reviewed Sep 2, 2026
Cogent is a drug company with one experimental medicine, bezuclastinib, and no product on the market yet. The pill blocks a faulty gene that drives certain cancers and a rare blood-cell disease. It doesn't earn money today — it lost about $96 million in the three months to June 2026 — but it holds roughly $866 million in cash, enough to run into late 2028. The big deal is that U.S. regulators are reviewing it for three separate uses at once, with two yes-or-no decisions due November 30 and December 30, 2026, and the trial results behind them are strong. The one thing that has to go right: the FDA has to say yes, and then doctors have to actually switch patients to it from Sanofi's established drug, Ayvakit. The one thing that could go wrong: a rejection or a slow launch would wipe out most of the value, because the shares already cost about $5.75 billion for a company with no sales. It also keeps selling new stock, which shrinks each owner's share.
Price estimates are hidden here. We keep checking them for the record, but at 7/10 this is research only. Estimates return if our belief reaches 8/10.
Loading company facts
Loading reported-quarter evidence
Checked through Aug 28, 2026
Each source says whether it supports the idea, challenges it, or adds background. A quick no-change check may update the review date without replacing these sources.
Cogent said bezuclastinib remained on track for potential GIST approval on November 30, 2026 and NonAdvSM approval on December 30, 2026, with AdvSM NDA submitted and pro forma cash sufficient into late 2028.
Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results (cogentbiosciences.gcs-web.com)Cogent's FDA-acceptance release says the GIST NDA received Priority Review with a November 30, 2026 PDUFA date, no planned advisory committee, no identified review issues, and PEAK mPFS of 16.5 versus 9.2 months.
Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GISTChecks are shown newest first. Repeated copies are folded together on screen, while every saved record remains unchanged.
We previously believed Cogent needed bezuclastinib to stay on track for late-2026 FDA decisions in GIST and systemic mastocytosis. Current searches checked company updates, CRL, review-delay, safety, competitive and financing categories; no cutoff-eligible material change was found after the Aug. 30 review. The GIST PDUFA outcome and label quality remain the next decisive items.
Prior view was that Cogent's bezuclastinib value unlock depends on late-2026 FDA decisions, led by the GIST PDUFA. Searches for a CRL, review delay, safety issue, or cash-runway deterioration found no material post-review change; the multi-indication approval window remains the unresolved catalyst.
1 check left
Checked Cogent releases, CRL, review-delay, safety, competitive and financing categories; no cutoff-eligible material change was found.
Whether FDA approves the GIST application on November 30 and whether labels support uptake against established therapy.
Hidden while our belief stays below 8/10.
Rich valuation and momentum: shares are up ~340% year-over-year near the 52-week high ($10.72-$43.73), so much of the systemic-mastocytosis opportunity may already be priced, limiting upside and raising drawdown risk on any disappointment
The FDA issues a Complete Response Letter (rather than approval) for bezuclastinib in GIST at the November 30, 2026 PDUFA date, breaking the multi-indication expansion thesis.
Kept as the original record. These do not replace the current sources above.
Three checks come from TickerYou's research review. The app calculates the other three from dated prices, events, and sources. Each check keeps its published weight on every idea; the app never changes a weight to make an idea look better.
How strongly the research engine believes the thesis is right, judged 1-10. This pass judged it 7 out of 10.
Whether the price being paid helps or hurts, judged 1-10: 10 means you are paid to take the risk, 1 means the thesis must be right and the multiple must expand. This pass judged it 4 out of 10.
How contained the damage is if the thesis is wrong, judged 1-10: 10 means a real floor of assets or cash, 1 means a permanent loss. This pass judged it 4 out of 10.
The clearest catalyst still ahead opens in 79 days, on a single dated day.
Price is +2.4% over the last 63 trading sessions — moving with the thesis for this long view.
2 dated claim receipts average 10 out of 10 from explicit source tiers 1, 1; roles: 2 support, 0 challenge, 0 context. Roles establish claim linkage; only the stored tiers set reliability.
This confidence score of 63 out of 100 is the weighted average of the 6 ready checks above, on their 0-10 scales, adjusted to 100.
We previously believed Cogent's late-2026 bezuclastinib setup depended on GIST and systemic-mastocytosis reviews staying on track. Reopened company sources confirm the GIST Nov. 30 PDUFA, NonAdvSM Dec. 30 PDUFA, AdvSM NDA submission, PEAK efficacy baseline, and runway into late 2028; no CRL or delay was found. The target record is repaired without moving conviction; approval labels and uptake against Ayvakit remain unresolved.
Prior belief was that Cogent needed bezuclastinib's GIST and systemic mastocytosis review paths to remain active into late-2026 PDUFA dates. Since the last review, current searches found no cutoff-eligible CRL, advisory-committee reversal, or delay; the Aug. 10 update and May 28 acceptance release confirm the regulatory baseline. The view is confirmed, with FDA approval and competitive label strength still unresolved.
Previously we believed Cogent needed the bezuclastinib regulatory tracks to remain active, especially the Nov. 30 GIST PDUFA. I found no eligible post-Aug. 24 CRL or delay; the Aug. 10 company update says GIST and NonAdvSM remain on track for possible 2026 approvals and AdvSM was submitted, while the May 28 FDA-acceptance release confirms GIST Priority Review, the Nov. 30 PDUFA, no planned advisory committee, and no identified review issues. The thesis is confirmed but still binary.
We previously believed Cogent's long thesis depended on bezuclastinib staying on track for a late-2026 multi-indication approval sequence, with a GIST CRL at the Nov. 30 PDUFA as the invalidation event. This review found no cutoff-eligible post-review CRL, regulatory delay, or label setback. The opened Cogent Q2 update still shows GIST and NonAdvSM PDUFA dates, AdvSM NDA submission, pivotal efficacy summaries, and cash runway into late 2028. The unresolved issue is whether FDA approvals and final labels preserve the multi-indication commercial case.
We previously believed Cogent’s thesis was a three-review bezuclastinib regulatory setup, with the GIST PDUFA on Nov. 30 as the invalidation gate. This run found no opened source reporting a GIST CRL, label setback or safety surprise. Cogent’s latest primary update still says the GIST and NonAdvSM PDUFAs are on track, AdvSM NDA has been submitted, cash funds operations into late 2028, and the PEAK/APEX data remain the regulatory basis. The unresolved issue is FDA action on the first GIST decision.
Aug 10, 2026 Q2 update reaffirmed all three regulatory clocks: bezuclastinib GIST PDUFA Nov 30, 2026 (Priority Review, no review issues), non-advanced SM PDUFA Dec 30, 2026, AdvSM NDA submitted June 30; pro-forma cash $865.9M funds into late 2028. No CRL or label setback, so the multi-indication thesis and invalidation trigger are unchanged. Conviction held.
All three NDA/PDUFA tracks confirmed on schedule since the idea opened August 11. GIST (bezuclastinib + sunitinib): PDUFA November 30 — Priority Review, no advisory committee planned, no review issues identified. Non-advanced SM: PDUFA December 30 — no advisory committee, no review issues. Advanced SM: NDA submitted June 30, PDUFA December 30. No new safety signals, label concerns, or competitive approvals in any of the three indications found. Stock down 4.9% since rec on no fundamental news. The three-approval-in-one-quarter thesis remains intact; the 340% YTD run leaves limited valuation buffer for any disappointment. Invalidation trigger (CRL for bezuclastinib in GIST at the November 30 PDUFA) has not triggered.
Both key NDA reviews are proceeding without issue: GIST (November 30 PDUFA, Priority Review, Breakthrough Therapy Designation, no advisory committee, no review issues identified) and non-advanced SM (December 30 PDUFA, no advisory committee, no review issues). The AdvSM NDA submitted June 30 is on file and under review. Pro-forma cash of $865.9M is confirmed, funding operations into late 2028. No new competition signal from Sanofi or Blueprint's Ayvakit and no label or safety development has emerged. Three-indication approval thesis is intact.
Q2 2026 results (reported Aug 10, 2026) confirmed $865.9M pro-forma cash, funded into late 2028. GIST NDA carries Priority Review with PDUFA Nov 30, 2026 and no review issues identified. NonAdvSM PDUFA Dec 30, 2026. AdvSM NDA submitted June 30, 2026—all three indications in FDA review as expected. Invalidation trigger (GIST CRL) has not fired. Three-indication regulatory calendar intact.
Q2 2026 results (Aug 10, 2026): both PDUFA dates confirmed on track — GIST Nov 30 (Priority Review, no advisory committee, no review issues), NonAdvSM Dec 30 (no review issues). AdvSM NDA submitted June 30, 2026 with strong efficacy: 65% ORR per mIWG criteria and 81% per PPR in 68 evaluable APEX patients, with 57% achieving CR/CRh/PR as best response. Pro-forma cash confirmed at $865.9M, funded into late 2028 through all three potential approvals and early commercial launch. Invalidation trigger (GIST CRL) has NOT fired. Three-indication thesis intact.
Q2 2026 results released Aug 10, 2026. All three PDUFA dates intact: GIST Nov 30, 2026 (Priority Review; FDA communicated no advisory committee and no review issues identified), NonAdvSM Dec 30, 2026 (NDA accepted), AdvSM NDA submitted June 30, 2026. Cash $865.9M pro-forma, funded into late 2028 through potential approvals and early commercialization. No CRL or safety signals found. Multi-indication approval run in a single quarter remains the thesis.
Q2 2026 results (Aug 10): cash $792.3M, pro-forma $865.9M after ATM proceeds, funded into late 2028 through approvals and early commercial launch — balance sheet stronger than thesis assumed. Crucially, a third NDA was submitted to FDA on June 30, 2026 for bezuclastinib in advanced SM (AdvSM). Both prior NDA acceptances are clean: GIST PDUFA Nov 30 (no advisory committee, no review issues identified); non-advanced SM PDUFA Dec 30. Three potential approvals from a single asset in one quarter — a scenario the thesis did not fully price. Conviction raised.
Opened by the biotech hunt.
Each quarter is named by the fiscal quarter the company itself reported — the label its release used and its consensus estimate was quoted against — and by the month that quarter ended, taken from the filer's own XBRL period boundaries. A fiscal year need not follow the calendar, so Apple's Q2 runs January to March; naming the quarter end keeps that true in both calendars, and no quarter number is ever inferred from a date. Quarterly financials beside this card names the same quarter the same way. TickerYou takes the figures from the release and its filing; every word, sign and percentage is calculated by the app from those stored numbers. A post-release reaction appears only with the stored first-close measurement stamp; otherwise the card says the window is not established and computes no divergence. EPS here is on the basis consensus quotes — adjusted for most US names — so it can legitimately differ from the GAAP figure in Quarterly financials. Rows marked [backfilled] were confirmed from archived coverage after the fact — a lower evidence tier than live capture, and labelled so.
Q2 FY2026 · Jun 2026: EPS beat the stored consensus estimate. The first stamped post-release close moved down 2.0%.
A surprise shows how the release differed from expectations, not whether the business is good or the thesis is right. The price reaction shows repricing, not its cause.
Watch whether the next comparable release confirms the result; one beat or market move does not establish a durable trend.
Quarter ended Jun 30, 2026 · Reported Aug 10, 2026 · post-release reaction · muted · 1.4× typical
Quarter ended Mar 31, 2026 · Reported May 5, 2026 · stock move after results · not shown
[backfilled] Pre-revenue quarter; net loss widened to $97.4M from $72.0M a year ago, driven by R&D ramp ($75.4M) and higher G&A ($28.2M) ahead of bezuclastinib commercialisation; $866M cash runway extends to 2028, two bezuclastinib NDAs under FDA review with a PDUFA date of Dec 30, 2026 for NonAdvSM.
Quarter ended Dec 31, 2025 · Reported Feb 17, 2026 · stock move after results · not shown
[backfilled] Q4 2025 net loss widened to $102.5M (from $67.9M in Q4 2024) as R&D spending accelerated ahead of three planned bezuclastinib NDA submissions; the company remains pre-revenue and ended the year with $900.8M cash guiding operations into 2028, while the quarter's EPS miss broke a three-quarter streak of outperformance.
Quarter ended Sep 30, 2025 · Reported Nov 3, 2025 · stock move after results · not shown
[backfilled] COGT posted a Q3 2025 net loss of $80.9M with no product revenue; cash and securities of $390.9M extend runway into 2027, and the company flagged imminent top-line PEAK (bezuclastinib + sunitinib in GIST) and APEX (AdvSM) readouts as well as an NDA filing for NonAdvSM on track for year-end 2025.
Quarter ended Jun 30, 2025 · Reported Aug 5, 2025 · stock move after results · not shown
Computed from SEC filings — never model output. Each quarter is named by the fiscal quarter the company itself reported and the month that quarter ended, through the same resolver the Earnings card beside this one uses; where no release established a fiscal label, the quarter is named by its end alone rather than by a quarter number guessed from the date. EPS is GAAP diluted, as filed, so it can legitimately differ from the adjusted figure in the Earnings card (consensus is quoted adjusted). Y/Y compares the same fiscal quarter a year earlier; a comparison that cannot be made honestly is an em-dash that says why.
Jun 2026: the filing establishes the quarter, but comparable year-ago growth and margin are not established.
Comparing the same fiscal quarter a year earlier controls for seasonality. Revenue direction and margin direction together show whether sales are translating into profit, but one quarter is evidence—not a complete thesis.
Watch for the next filing that supplies a same-quarter comparison rather than substituting an older period.
No product revenue (pre-commercial); net loss of $96.4M reflected a surge in G&A to $31.8M (from $13.4M a year ago) driven by commercial readiness build-out, with R&D at $70.8M supporting three NDA submissions in H1 2026; pro forma cash of $865.9M funds operations into late 2028, bracketing dual PDUFA dates for bezuclastinib in GIST (Nov 30) and NonAdvSM (Dec 30).
[backfilled] Pre-revenue clinical biotech; Q2 2025 net loss widened to $96.4M driven by $62.2M R&D spend on the PEAK (GIST) and APEX (AdvSM) pivotal trials; company raised $230M in a July 2025 upsized public offering and reported positive SUMMIT top-line data for bezuclastinib in NonAdvanced SM just ahead of the print.
Quarter ended Mar 31, 2025 · Reported May 6, 2025 · stock move after results · not shown
[backfilled] Pre-revenue quarter; $72.0M net loss on $74.9M operating expenses as COGT funded the SUMMIT, APEX, and PEAK bezuclastinib trials, ended with $245.7M cash, and guided to top-line data readouts from all three programs by year-end 2025.
| (USD) |
|---|
| Jun 2026 |
|---|
| vs last year |
|---|
| Revenue | — | — |
| Profit after costs | $-96.41 M | — |
| Profit per share | -0.52 | — |
| Profit margin | — | — |
† derived: the fiscal year minus its three reported quarters — no 10-K reports a Q4 figure directly. For EPS this assumes per-share figures add across the year.
| Quarter | Revenue | Y/Y | Net income | Margin |
|---|---|---|---|---|
| Mar 2026 | — | — | $-97.35 M | — |
| Dec 2025 | — | — | $-102.49 M † | — |
| Sep 2025 | — | — | $-80.93 M | — |
| Jun 2025 | — | — | $-73.53 M | — |
| Mar 2025 | — | — | $-71.99 M | — |
| Dec 2024 | — | — | $-67.93 M † | — |
| Sep 2024 | — | — | $-70.63 M | — |
| Jun 2024 | — | — | $-58.95 M | — |
1M
3M
6M
1Y