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Cogent Biosciences, Inc.

COGT
Richly ValuedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$30.08
▼ -0.06 · -0.2%

Financials

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52W LOW $13.7852W HIGH $43.73
Volume
3.64 M
Value Traded
66.66 M
Short % Float
11.63%
-3.03%Week
-12%1 Month
-22.61%3 Month
-17.29%6 Month
+281.66%5 Year
-30.49%All Time

Cash Data

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  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
5.22 B
EPS (TTM)
-2.17
P/E Ratio
-
Ent. Value
4.65 B
Total Shares
173.59 M
Float Shares
155.83 M
Insiders
10.22%
Institutions
103.26%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA Date
bezuclastinib combination
Gastrointestinal Stromal Tumors (GIST) in patients who previously received imatinib
Breakthrough
PDUFASmall MoleculesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

COGT Catalyst Timeline

Dated clinical, regulatory and corporate events for Cogent Biosciences, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Cogent Biosciences, Inc.

385Total events
11Upcoming
75Tier-1 (high impact)
2018 to 2028Coverage

Upcoming catalysts 2

T1PDUFA Date
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BezuclastinibFiled
T1Topline Readout
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BezuclastinibFiled

Event history 50

▲FDA Filing AcceptedBezuclastinibFiledRegulatory Filing
FDA accepts NDA for bezuclastinib in AdvSM
Advanced Systemic Mastocytosis (AdvSM)source ↗
▲AdCom CancelledBezuclastinibFiledAdvisory Committee
FDA communicated no plan to hold an advisory committee for bezuclastinib AdvSM NDA
Advanced Systemic Mastocytosis (AdvSM)source ↗
●Grant / FundingCorporate
Inducement equity awards granted to nine new employees
●Quarterly UpdateCorporate
Reported Q2 2026 financial results
●ATM ProgramCorporate
ATM facility gross proceeds of $73.6 million
▼ATM ProgramCorporate
Raised $73.6 million gross proceeds from ATM facility after quarter end
●NDA SubmissionBezuclastinibFiledRegulatory Filing
NDA submitted to FDA for AdvSM
▼Equity OfferingCorporate
Inducement equity awards to two new employees
◆Poster PresentationCGT1145Presentation
Poster presentation on preclinical characterization of CGT1145 at EHA 2026
JAK2 V617F mutant-selective inhibitorsource ↗
◆Poster PresentationBezuclastinibFiledPresentation
Poster presentation on pathobiology results from APEX trial at EHA 2026
Advanced Systemic Mastocytosissource ↗
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Past FDA Catalysts and PDUFA Decisions

How COGT actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-06-30Bezuclastinib NDA Submission NDA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C49 / 100
Pipeline Score
$575M
Pipeline Value
Richly Valued
Valuation Signal
4
Drugs Scored
0.1x
rNPV / MCap
Top 19%
Small Cap
(rank 126 of 658)
Percentile Rank
Cogent Biosciences, Inc. carries a moderate pipeline score (49/100), with $885M risk-adjusted pipeline value, led by Bezuclastinib in Gastrointestinal Stromal Tumors (Phase 2).
Showing 1 of 4 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Bezuclastinib Small moleculeNCT05208047Advanced Gastrointestinal Stromal TumorsPhase 3 RECRUITING 482Jan 1, 2030
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Clinical Trial Results

Readouts, endpoints and source filings for every COGT program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
bezuclastinib
BreakthroughPriority
advanced systemic mastocytosis2026-06-1265% objective response rate; 81% ORR per PPR criteria; 91% of patients achieving ≥50% reduction in variant allele frequency; 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates; 12-month PFS rate of 79%; 12-month OS rate of 87%Read MoreCogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) CongressRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Morris ArleneDirectorOption 41,927 41,927 held$5.64 08/27/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
Fairmount Funds Management LLC 14.1 % (-7.8 %) 212.98 M 5.50 M
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Shares held by hedge funds each quarter, and who bought or sold.

COGT Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
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Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How COGT ranks across every disease it competes in

Competitive Position is a premium feature
See how COGT ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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COGT News

COGT
Sep 15, 2026
COGTFDA Updates

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

Cogent Biosciences announced that the FDA has accepted its New Drug Application for bezuclastinib, aimed at treating Advanced Systemic Mastocytosis (AdvSM). The acceptance is backed by positive results from the APEX trial, which showed a 65% overall response rate. The PDUFA target action date is set for June 29, 2027, with no advisory committee planned.

Read more →
COGT
Aug 10, 2026
COGTFDA Updates

Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results

Cogent Biosciences reported positive developments including the potential FDA approval of bezuclastinib for GIST and NonAdvSM patients by the end of 2026. The company has successfully onboarded a skilled customer-facing team and maintains a robust cash position to support operations. However, it also reported a significant net loss and rising R&D expenses.

Read more →
COGT
Jun 30, 2026
COGTFDA Updates

Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)

Cogent Biosciences has submitted a New Drug Application for bezuclastinib to the FDA for treating Advanced Systemic Mastocytosis. The submission is based on positive results from the APEX pivotal trial, which demonstrated a 65% objective response rate and a well-tolerated safety profile. The company is optimistic about achieving FDA approval by Q4 2026.

Read more →
COGT
Jun 12, 2026
COGTConferences/Events

Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress

Cogent Biosciences presented promising preclinical data for its JAK2 V617F inhibitor, CGT1145, at the 2026 EHA Congress. The drug exhibits high selectivity and oral bioavailability, potentially addressing key disease drivers in myeloproliferative neoplasms. The company aims to submit an Investigational New Drug application in 2026.

Read more →
COGT
Jun 12, 2026
COGTPhases

Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress

Cogent Biosciences presented updated results from the APEX trial of bezuclastinib for advanced systemic mastocytosis at the 2026 EHA Congress. The trial demonstrated a 65% objective response rate and significant reductions in mast cell burden. The drug also showed a favorable safety profile. An NDA submission is planned for June 2026.

Read more →
COGT
May 30, 2026
COGTPhases

Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

Cogent Biosciences announced promising results from the PEAK Phase 3 trial, demonstrating that the bezuclastinib and sunitinib combination significantly improves progression-free survival in GIST patients compared to sunitinib alone. The combination therapy was well tolerated, with no new risks identified. The FDA has granted Priority Review for this treatment, with a PDUFA date set for November 30, 2026.

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COGT
May 28, 2026
COGTFDA Updates

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

Cogent Biosciences has announced the FDA's acceptance of its New Drug Application for bezuclastinib in combination with sunitinib for treating GIST patients. The application has been granted Priority Review, with a target action date set for November 30, 2026. The combination therapy demonstrated a significant improvement in median progression-free survival compared to sunitinib alone, marking a potential breakthrough in treatment options.

Read more →
COGT
May 27, 2026
COGTConferences/Events

Cogent Biosciences Announces Participation in the 2026 Jefferies Global Healthcare Conference

Cogent Biosciences, Inc. will participate in the Jefferies Global Healthcare Conference on June 3, 2026. The event will feature a live webcast accessible via the company's website. Additionally, Cogent announced inducement equity awards for new employees, reflecting its commitment to growth and innovation in precision therapies for genetically defined diseases.

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COGT
May 12, 2026
COGTConferences/Events

Cogent Biosciences Announces Multiple Presentations at the European Hematology Association (EHA) 2026 Congress

Cogent Biosciences has announced two key presentations at the upcoming European Hematology Association Congress 2026. The company will present pivotal data from its APEX trial on bezuclastinib, a therapy for Advanced Systemic Mastocytosis, showcasing its findings in two oral sessions. Additionally, preclinical data from their selective JAK2 V617F program will be highlighted in a poster presentation. These presentations represent a significant platform for Cogent to share its advancements in targeted therapies at an esteemed international venue.

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COGT
May 5, 2026
COGTGeneral

Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results

Cogent Biosciences has reported significant business highlights and financial results for Q1 2026, including plans for dual launches of their drug bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors. The company has a strong financial position, ending the quarter with $866.4 million in cash, which is expected to fund operations into 2028. The upcoming ASCO annual meeting will feature pivotal data from the Phase 3 PEAK trial, potentially setting the stage for multiple drug launches. However, the company recorded a larger net loss this quarter compared to the previous year, alongside increased R&D expenses.

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COGT
Apr 21, 2026
COGTPhases

Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

Cogent Biosciences announced that results from its Phase 3 PEAK trial will be presented at the 2026 ASCO Annual Meeting. The trial demonstrated positive outcomes for bezuclastinib combined with sunitinib in GIST patients previously treated with imatinib. The company is also set to initiate a Phase 2 trial for first-line GIST patients with exon 9 mutations.

Read more →
COGT
Apr 17, 2026
COGTConferences/Events

Cogent Biosciences Announces Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026

Cogent Biosciences announced the presentation of preclinical data on its KRAS and ErbB2 pipeline programs at the AACR Annual Meeting 2026. The data highlights CGT1263's selectivity and potential to reduce skin toxicity, while CGT4255 shows promise in combination with HER2 ADCs for resistant patients. The company is preparing for the potential launch of bezuclastinib later this year.

Read more →
COGT
Apr 1, 2026
COGTFDA Updates
▼ -8.4%on this news

Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)

Cogent Biosciences has submitted a New Drug Application for bezuclastinib to the FDA for treating gastrointestinal stromal tumors (GIST) in patients previously treated with imatinib. The submission is based on positive results from the Phase 3 PEAK trial, which showed a significant increase in progression-free survival and response rates compared to existing treatments. The company aims to present full trial results at a major medical meeting in 2026.

Read more →
COGT
Mar 16, 2026
COGTFDA Updates

Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)

Cogent Biosciences has announced the FDA's acceptance of its New Drug Application for bezuclastinib, targeting patients with NonAdvanced Systemic Mastocytosis. The FDA set a target action date of December 30, 2026, and plans to avoid an advisory committee meeting. Clinical trial results indicated significant improvements across primary and secondary endpoints, showcasing bezuclastinib's efficacy and safety profile. The company is also on track to submit additional NDA applications for bezuclastinib in related indications in the near future.

Read more →
COGT
Mar 2, 2026
COGTConferences/Events

Cogent Biosciences Highlights Additional Data with Six Bezuclastinib Posters from SUMMIT Trial at 2026 AAAAI Annual Meeting

Cogent Biosciences presented additional data from the SUMMIT trial at the AAAAI Annual Meeting, highlighting the efficacy of bezuclastinib in treating NonAdvanced Systemic Mastocytosis. The results showed significant improvements across primary and secondary endpoints, reinforcing the drug's potential as a preferred treatment option. The findings also indicated benefits in bone mineral density, suggesting disease modification.

Read more →
COGT
Feb 17, 2026
COGTGeneral

Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results

Cogent Biosciences reported strong business highlights and financial results for 2025, showcasing momentum with three successful pivotal trials. The company is advancing its lead product, bezuclastinib, with multiple NDA submissions planned for 2026. Despite a net loss of $102.5 million in Q4 2025, Cogent maintains a robust cash position of $900.8 million.

Read more →
COGT
Feb 10, 2026
COGTConferences/Events

Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting

Cogent Biosciences announced that it will present multiple posters at the 2026 AAAAI Annual Meeting, focusing on bezuclastinib results from the SUMMIT trial in patients with NonAdvanced Systemic Mastocytosis. The company has submitted a New Drug Application for bezuclastinib based on positive clinical data and previously received Breakthrough Therapy Designation. The presentations will take place on February 28, 2026.

Read more →
COGT
Jan 27, 2026
COGTFDA Updates

Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)

Cogent Biosciences has received Breakthrough Therapy Designation from the FDA for bezuclastinib combined with sunitinib for treating imatinib-resistant GIST. The designation is based on promising results from the PEAK trial, showing a 50% reduction in disease progression risk. Cogent plans to submit its NDA by April 2026 and present full trial results at a major medical meeting.

Read more →
COGT
Jan 26, 2026
COGTFDA Updates

Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)

Cogent Biosciences has received Breakthrough Therapy Designation from the FDA for its drug bezuclastinib in combination with sunitinib for treating gastrointestinal stromal tumors (GIST) in patients resistant to imatinib. The designation is based on promising results from the PEAK trial, showing a 50% reduction in disease progression risk. The company plans to submit its New Drug Application by April 2026 and present full trial results at a major medical meeting.

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About Cogent Biosciences, Inc.

Waltham, MA 258 employees cogentbio.com
Headquarters180 THIRD AVENUE, WALTHAM, MA
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