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Biotech catalyst, news and analysis PDUFA tracker

Merlintrader Trading Pub
Biotech catalyst, news and analysis PDUFA tracker
AI transparency: articles and reports are produced with the help of artificial intelligence and checked through a process that does not constitute specialist validation. They may contain errors: verify relevant information with independent sources. Read the full disclaimer.
Oct 27, 2026, 4:05 PM ET
Corcept Therapeutics will report third quarter financial results and provide a corporate update on November 3, 2026, with a conference call at 5:00 p.m. Eastern Time that day.
Nasdaq: $CORTLifyorli commercial launchRelacorilant / Cushing’sRegulatory and execution risk
CORT Stock Hub: Corcept Therapeutics News, Lifyorli and Relacorilant
Lifyorli’s oncology launch and the Cushing’s application are separate businesses and regulatory tests. The next results call is November 3; the relacorilant FDA target action date remains December 17. Q2 revenue was $256.1M. The October 30 regular-session close was $81.12 (-5.62% versus October 29).
Full research report · PDF
Corcept Therapeutics ($CORT), research as of October 27, 2026
17 pages covering Lifyorli commercial launch, BELLA and ROSELLA evidence, cortisol-directed development, dated financial results and the separate regulatory pathways. This is a dated research snapshot; the hub follows later developments. For personal use only: redistribution prohibited.
Next scheduled corporate event
November 3, 2026 · results call at 5:00 p.m. ET
Corcept will report third-quarter results and provide a corporate update. Revenue, launch costs and liquidity can be assessed separately from the regulatory calendar. Primary source
December 17 is the FDA target action date for relacorilant in hypercortisolism, not a promised approval. European Commission timing and MONARCH data remain company windows.
CORT stock at a glance
Close · October 30, 2026
$81.12
Regular session; -5.62% versus $85.9500 on October 29.
Q2 2026 net product revenue
$256.1M
Compared with $194.4M in Q2 2025.
Q2 2026 Lifyorli revenue
$47.6M
Initial U.S. launch quarter; not total product revenue.
Q2 2026 net income
$43.0M
$0.40 basic EPS and $0.36 diluted EPS.
Q2 2026 SG&A
$156.9M
Compared with $103.9M a year earlier; launch spending increased.
Cash + short securities · June 30
$308.2M
$111.0M cash plus $197.2M short-term securities; long-term investments separate.
H1 2026 operating cash flow
+$16.8M
Positive operating cash generation, not a future guarantee.
Common shares · July 22
108.098M
108,098,397 shares in the dated quarterly report.
Where Corcept Therapeutics stands now
Corcept is a commercial cortisol-modulation company. Q2 product revenue reached $256.1M, including $47.6M from the initial Lifyorli launch quarter. The June balance sheet contains $308.2M of cash and short-term securities, distinct from total cash and investments including long-term holdings. Primary source
Lifyorli’s existing oncology approval does not establish approval for Cushing’s or the BELLA combination. BELLA Part A is single-arm and open-label. Comparisons with ROSELLA across trials are contextual, not randomized proof of the incremental bevacizumab benefit. Launch costs, payer access and a separate FDA decision remain material.
The constructive case
An established revenue franchise can fund oncology expansion and development. Lifyorli contributed revenue during its first launch quarter, and several pipeline or regulatory milestones have different sources of evidence.
The cautious case
Higher commercial spending and concentration in the cortisol portfolio can offset growth. A new indication, European authorization and additional combinations each require their own decisions or controlled evidence.
Latest Corcept Therapeutics news
Oct 27, 2026
Third-quarter results and update scheduled for November 3
Corcept scheduled third-quarter results and a corporate update for November 3, followed by a call at 5:00 p.m. ET. A reporting date does not change the separate FDA action date.
Oct 26, 2026
BELLA Part A: Lifyorli with nab-paclitaxel and bevacizumab, median PFS 7.2 months and response rate 59% in platinum-resistant ovarian cancer
Corcept reported positive results from Part A of the Phase 2 BELLA trial, a single-arm, open-label study of Lifyorli (relacorilant) with nab-paclitaxel and bevacizumab in 95 women with platinum-resistant ovarian cancer at about 45 sites. Median progression-free survival by investigator was 7.2 months and the objective response rate 59%; median overall survival had not been reached, and 88% of patients were alive at six months. In the roughly half of patients who had never received bevacizumab, median PFS was 8.1 months, the response rate 66% and six-month survival 91%. The company set these figures against the Phase 3 ROSELLA results (median PFS 5.4 months and response rate 37% for Lifyorli plus nab-paclitaxel; 3.9 months and 30% for nab-paclitaxel alone): that is a cross-trial comparison with a single-arm study, not a randomized result. No new safety signals were identified; the most common adverse events included neutropenia, anemia, nausea, asthenia, nail disorder, peripheral neuropathy, fatigue and leukopenia. Lifyorli is not approved in combination with bevacizumab. Corcept expects the findings to augment Lifyorli’s preferred status in the NCCN Guidelines and will present complete Part A results at a medical conference next year.
Sep 23, 2026
New head of Corcept Endocrinology from October 1
The President of Corcept Endocrinology stepped down effective October 1 and stays on as a consultant. The executive who built the oncology sales force for the Lifyorli launch succeeds him. No change to guidance or to the regulatory calendar was announced.
Sep 18, 2026
Positive CHMP opinion advances Lifyorli toward Europe
The CHMP recommended Lifyorli (relacorilant) with nab-paclitaxel for platinum-resistant ovarian cancer. This is a positive scientific opinion, not a final EU marketing authorization. Corcept expects the European Commission's decision in Q4 2026 ; no exact decision date was announced. The separate U.S. Cushing's application retains its December 17 PDUFA date.
Jul 29, 2026
Second-quarter revenue and Lifyorli launch update
Q2 net product revenue was $256.1M and net income $43.0M, or $0.36 per diluted share. June cash and short-term securities were $308.2M; long-term investments are a separate balance-sheet category.
Jun 17, 2026
Relacorilant application resubmitted for hypercortisolism
The company resubmitted the hypercortisolism NDA after the prior complete response letter and additional analyses. The quarterly report states a December 17, 2026 target action date. Resubmission and a target date are not approval.
CORT stock catalysts: results, relacorilant and European review
- November 3, 2026 · 5:00 p.m. ET — Third-quarter results and corporate-update call. Scheduled company event
- December 17, 2026 — FDA target action date for relacorilant in hypercortisolism. Regulatory target, not approval commitment
- Q4 2026 — Company expectation for a European Commission decision after positive CHMP opinion. Company window
- By year-end 2026 — MONARCH Phase 2b MASH results expected. Company clinical window
Lifyorli launch and the limits of BELLA cross-trial comparisons
Q2 Lifyorli revenue was $47.6M. BELLA Part A subsequently reported investigator-assessed median PFS of 7.2 months and response rate of 59% in a single-arm population of 95 women. Those figures cannot establish a randomized advantage over ROSELLA. The bevacizumab combination is not approved. Primary source
CORT earnings, launch spending and dated liquidity
In DAZALS, 300 mg dazucorilant was associated in exploratory analyses with an 84% reduction in the risk of death at one year and an 87% reduction into year two. Those figures are attention-grabbing, but the randomized Phase 2 study did not meet its primary functional endpoint, ALSFRS-R. Non-serious gastrointestinal distress caused most discontinuations, which is why Corcept is running a dose-titration study before designing the planned pivotal trial.
The signal sits between two extremes, ignoring it and treating it as confirmatory Phase 3 evidence. A credible pivotal design, regulatory alignment, tolerability improvements and replication of survival benefit are all required.
Merlintrader Health Score · $CORT
3.85out of 5
Assessed September 30, 2026. Weighted calculation: 4.0×30% + 4.0×30% + 4.0×20% + 3.5×10% + 3.0×10% = 3.85. This describes financial and operational robustness over twelve to eighteen months, not an investment recommendation.
Red flags
- Regulatory applications in distinct indications require separate decisions.
- BELLA is single-arm, and cross-trial efficacy comparisons have important limitations.
- Commercial spending and reimbursement affect the retained economics of launch growth.
- Cash plus short-term securities and total cash/investments use different categories.
CORT Stock FAQ: Corcept Therapeutics Questions Answered
When is the next CORT stock catalyst?
Corcept’s next scheduled event is its November 3, 2026 earnings call at 5 p.m. ET. The FDA target date for relacorilant in hypercortisolism is December 17, 2026, following resubmission. That application covers a different indication from the existing Lifyorli oncology approval. Confirmed results call. Hypercortisolism resubmission and FDA target.
Is Corcept’s relacorilant FDA approved?
Relacorilant was approved as Lifyorli in March 2026, with sales starting in April; Corcept’s separate hypercortisolism review target is December 17, 2026. Lifyorli plus nab-paclitaxel covers platinum-resistant epithelial ovarian, fallopian-tube or primary-peritoneal cancer after one to three regimens including bevacizumab. The hypercortisolism application received a December 30, 2025 rejection seeking additional efficacy evidence. FDA requested analyses of previously submitted data in April 2026, and Corcept resubmitted on June 17. Approved oncology use and separate endocrine application.
How much cash does Corcept have, and is it profitable?
Corcept held $308.2 million cash and short-term investments at June 30, 2026: $111.0 million cash plus $197.2 million short-term investments. H1 operating cash flow was positive $16.8 million. Q2 revenue was $256.1 million versus $194.4 million; net income was $43.0 million, with EPS $0.40 basic and $0.36 diluted. H1 nevertheless showed an $8.3 million operating loss and $11.2 million net income; selling, general and administrative expense rose to $302.3 million from $194.5 million. Liquidity, cash flow and profitability.
Is CORT stock at risk of dilution?
Corcept reported 108,098,397 common shares on July 22, 2026, with employee equity awards creating potential dilution. Its capital structure should be assessed alongside cash generation and any subsequent issuance or repurchase. An outstanding-share count is not a measure of freely tradable float. Cover share count and equity compensation.
When does Corcept Therapeutics report earnings?
Corcept announced that it will discuss Q3 2026 financial results on November 3, 2026 at 5 p.m. ET. Its October 27 company announcement confirms the call and webcast. It does not provide a separate exact publication time for the release. Company financial-results announcement.
What does Corcept Therapeutics do?
Corcept develops and commercializes medicines that modulate cortisol activity. Korlym treats eligible patients with endogenous Cushing’s syndrome, while Lifyorli contains relacorilant for its approved ovarian-cancer combination use. The company also develops cortisol-modulating candidates and additional indications. Commercial medicines and development programs.
What did Corcept announce about Lifyorli in Europe?
Corcept announced a positive CHMP opinion recommending Lifyorli on September 18, 2026 and expected a European Commission decision in Q4. That announcement records a recommendation, not the Commission’s authorization. EMA’s opinion page provides the regulatory source for the recommendation and subsequent published product information. Dated company announcement. EMA regulatory record.
What securities litigation did Corcept disclose?
Corcept’s June 2026 quarterly filing describes a putative securities class action alleging misleading statements about the relacorilant application during October 31, 2024–December 30, 2025. Lead-plaintiff motions were pending when that filing was issued. The allegations are claims in litigation, rather than judicial findings of wrongdoing. Dated legal-proceedings disclosure.
Primary sources
- October 27, 2026 — Third-quarter results and update scheduled for November 3
- October 26, 2026 — BELLA Part A: Lifyorli with nab-paclitaxel and bevacizumab, median PFS 7.2 months and response rate 59% in platinum-resistant ovarian cancer
- September 23, 2026 — New head of Corcept Endocrinology from October 1
- September 18, 2026 — Positive CHMP opinion advances Lifyorli toward Europe
- July 29, 2026 — Second-quarter revenue and Lifyorli launch update
- June 17, 2026 — Relacorilant application resubmitted for hypercortisolism
Disclaimer. This content is published by Merlintrader for educational and informational purposes only. It is independent educational research. It does not constitute investment advice, an investment recommendation, an offer or a solicitation to buy or sell any security, and it is not a research report within the meaning of applicable United States securities regulation. Nothing here should be read as a recommendation to buy, sell or hold $CORT or any other security.
Figures are taken from public filings with the U.S. Securities and Exchange Commission, company press releases and market-data providers, and are stated with their reference dates. Data can change without notice, and figures published before a results release become outdated the moment that release is issued. Merlintrader makes no representation that the information is complete or current at the time of reading. Readers should verify every figure against the primary source before acting on it.
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