CORCEPT THERAPEUTICS INC
For the period ended Jun 30, 2026. Filed Jul 29, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Jul 29, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-04-30.
0001628280-26-028902
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-07-29.
0001628280-26-050613
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 79 previous paragraphs and 80 current paragraphs.
45 unchanged; 31 reworded; 3 added; 2 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 1 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
Net product revenue was $256.1 million and $421.1 million for the three and six months ended June 30, 2026, respectively, compared to $194.4 million and $351.6 million for the comparable periods in 2025. The increases were driven by higher net product revenue from our Hypercortisolism Products and net product revenue from Lifyorli. Lifyorli’s commercial launch was on April 1, 2026.
Current report
Net product revenue from our Hypercortisolism Products was $208.6 million and $373.5 million for the three and six months ended June 30, 2026, respectively, compared to $194.4 million and $351.6 million for the comparable periods in 2025. Higher sales volume accounted for 76.1 percent of the increase for the three months ended June 30, 2026, with the remaining growth due to a price increase for our Hypercortisolism Products taken in August 2025 and improved payor reimbursement rates for our Hypercortisolism Products at our current specialty pharmacy, partially offset by higher sales volume of our authorized generic version of Korlym, which has a lower price. The increase in net product revenue for the six months ended June 30, 2026 was driven by higher sales volume, partially offset by a 2.1 percent decrease in average price. The decrease in average price was due to higher sales volume of our authorized generic version of Korlym, partially offset by a price increase for our Hypercortisolism Products taken in August 2025 and improved payor reimbursement rates for our Hypercortisolism Products at our current specialty pharmacy.
Current report
Income tax- Income tax expense was $2.9 million for the three months ended June 30, 2026, while income tax benefit was $10.0 million for the six months ended June 30, 2026, compared with income tax benefits of $3.5 million and $14.4 million for the comparable periods in 2025, respectively. The increase in income tax expense during the three months ended June 30, 2026 and decrease in income tax benefit during the six months ended June 30, 2026 were primarily due to a decrease in stock compensation deductions in 2026 as compared to the comparable periods in 2025.
Removed paragraphs (2)
Previous report
Net product revenue was $164.9 million for the three months ended March 31, 2026, compared to $157.2 million for the comparable period in 2025. The increase was driven by a 12.4 percent increase in sales volume, partially offset by a 6.7 percent decrease in average price due to higher sales volume from our authorized generic version of Korlym. The decrease in average price was partially offset by a price increase of our Hypercortisolism Products in August 2025.
Previous report
Income tax benefit– Income tax benefit was $13.0 million for the three months ended March 31, 2026, compared to $10.9 million for the comparable period in 2025. The increase in income tax benefit during the three months ended March 31, 2026 was primarily due to first quarter loss, partially offset by decreased stock compensation deductions, compared to the corresponding period in 2025.
Reworded paragraphs (31)
Previous wording
Our Hypercortisolism Products. We sell Korlym and a generic version of Korlym in the United States (our “Hypercortisolism Products”) using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. From 2017 to 2025, we used an exclusive specialty pharmacy vendor, Optime Care, Inc. (“Optime”) and a specialty distributor to distribute our Hypercortisolism Products and provide logistical support to physicians and patients. In June 2025, we notified Optime that it would cease to be our exclusive specialty pharmacy, and in October 2025, we delivered a notice of termination of our agreement with them, which became effective February 4, 2026. In the fourth quarter of 2025 and in January and February 2026, we transferred all of our specialty pharmacy services to Curant Health Georgia, LLC (“Curant”).
Current wording
Our Hypercortisolism Products. We sell Korlym and our authorized generic version of Korlym in the United States (our “Hypercortisolism Products”) using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. We use an exclusive specialty pharmacy vendor, Curant Health Georgia, LLC (“Curant”) to distribute our Hypercortisolism Products directly to patients and provide patients and physicians with logistical and pharmacy support. From 2017 to 2025, our specialty pharmacy was Optime Care, Inc. We use a specialty distributor to distribute our Hypercortisolism Products to hospital pharmacies and other purchasers.
Previous wording
Because most people who suffer from hypercortisolism are undiagnosed or inadequately treated, we have developed and continue to refine and expand programs to educate physicians and patients about screening for hypercortisolism and the role our Hypercortisolism Products can play in treating patients with the disorder. In 2023 and 2024, we conducted the “CATALYST” study to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes, defined as hemoglobin A1c (“HbA1c” – a measure of glucose control that rises in people with diabetes) of 7.5 percent or higher, despite receiving optimum treatment. Of the 1,057 patients enrolled in the first phase of CATALYST, 23.8 percent were found to have hypercortisolism. These patients were offered the chance to enter CATALYST’s second phase, in which 136 eligible patients were randomized 2:1 to receive either Korlym or placebo for 24 weeks. The primary endpoint of CATALYST’s second phase was a reduction in HbA1c in patients who received Korlym compared to patients who received placebo. CATALYST met this primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant decrease in HbA1c of 1.47 percent, compared to a decrease of 0.15 percent in patients who received placebo (p-value: <0.0001). This phase of the trial also met its secondary endpoints. Patients who received Korlym exhibited significantly greater reductions in body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002) than patients who received placebo. The safety profile of Korlym in CATALYST was manageable and consistent with the medication’s label: No new side effects or adverse events were identified.
Current wording
Because most people who suffer from hypercortisolism are undiagnosed or inadequately treated, we have developed and continue to refine and expand programs to educate physicians and patients about screening for hypercortisolism and the role our Hypercortisolism Products can play in treating patients with the disorder. We also conduct clinical research: In 2023, we initiated our CATALYST study to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes, defined as hemoglobin A1c (“HbA1c” – a measure of glucose control that rises in people with diabetes) of 7.5 percent or higher, despite receiving optimum treatment. Of the 1,057 patients enrolled in the first phase of CATALYST, 23.8 percent were found to have hypercortisolism. These patients were offered the chance to enter CATALYST’s second phase, in which 136 eligible patients were randomized 2:1 to receive either Korlym or placebo for 24 weeks. The primary endpoint of CATALYST’s second phase was a reduction in HbA1c in patients who received Korlym compared to patients who received placebo. CATALYST met this primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant decrease in HbA1c of 1.47 percent, compared to a decrease of 0.15 percent in patients who received placebo (p-value: <0.0001). This phase of the trial also met its secondary endpoints. Patients who received Korlym exhibited significantly greater reductions in body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002) than patients who received placebo. The safety profile of Korlym in CATALYST was manageable and consistent with the medication’s label: No new side effects or adverse events were identified.
Previous wording
To determine the prevalence of hypercortisolism in patients with resistant hypertension, we conducted the MOMENTUM trial in 2025. Resistant hypertension is defined by the American Heart Association as systolic blood pressure greater than 130mm Hg and diastolic blood pressure greater than 80mm Hg despite the use of three or more antihypertensive medications of different classes, including a diuretic. Of the 1,086 patients enrolled in MOMENTUM, 27.3 percent were found to have hypercortisolism. MOMENTUM’s results were presented at the American College of Cardiology Annual Scientific Session in March 2026.
Current wording
To determine the prevalence of hypercortisolism in patients with resistant hypertension, we conducted the MOMENTUM trial in 2025. Resistant hypertension is defined by the American Heart Association as systolic blood pressure greater than 130 mm Hg and diastolic blood pressure greater than 80 mm Hg, despite the use of three or more antihypertensive medications of different classes, including a diuretic. Of the 1,086 patients enrolled in MOMENTUM, 27.3 percent were found to have hypercortisolism. MOMENTUM’s results were presented at the American College of Cardiology Annual Scientific Session in March 2026.
Previous wording
In December 2024, we submitted a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) seeking approval to market relacorilant as a treatment for patients with endogenous hypercortisolism. The NDA was based on positive results from our pivotal GRACE trial, with confirmatory evidence from our Phase 3 GRADIENT trial, our Phase 3 long-term extension study and our Phase 2 study. Patients in these trials exhibited clinically meaningful improvements in a wide range of hypercortisolism signs and symptoms, including hypertension, glucose control, weight and body composition. Relacorilant has been well-tolerated in all of its clinical trials. Notably, patients did not experience some of the serious adverse events that can arise in patients taking Korlym or other currently approved treatments.
Current wording
In December 2024, we submitted a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) seeking approval to market relacorilant as a treatment for patients with endogenous hypercortisolism. The NDA was based on positive results from our pivotal GRACE trial, with confirmatory evidence from our Phase 3 GRADIENT trial, our Phase 3 long-term extension study and our Phase 2 study. Patients in all these trials exhibited clinically meaningful improvements in a wide range of hypercortisolism signs and symptoms, including hypertension, glucose control, weight and body composition. Relacorilant has been well-tolerated in all of its clinical trials. Notably, patients did not experience some of the serious adverse events that can arise in patients taking Korlym or other currently approved treatments.
Previous wording
On December 30, 2025, the FDA issued a Complete Response Letter (“CRL”) declining to approve relacorilant. While the letter acknowledged that our GRACE trial had met its primary endpoint and that our GRADIENT trial had provided confirmatory evidence, the FDA stated that additional evidence of efficacy would be required for approval. We are working with the FDA to determine relacorilant’s optimal path to approval.
Current wording
On December 30, 2025, the FDA issued a Complete Response Letter (“CRL”) declining to approve relacorilant. While the letter acknowledged that our pivotal GRACE trial had met its primary endpoint and that our GRADIENT trial had provided confirmatory evidence, the FDA stated that additional evidence of efficacy would be required for approval. In April 2026, the FDA asked us to conduct additional analyses of the data included in our NDA. Based on the outcome of those analyses, we resubmitted our NDA to the FDA on June 17, 2026. The FDA has assigned a Prescription Drug User Fee Act target date of December 17, 2026 to complete its review.
Previous wording
In the open-label phase, patients experienced clinically meaningful and statistically significant improvements in a wide-array of hypercortisolism signs and symptoms, including hypertension, hyperglycemia, weight, waist circumference, fat and lean body mass, cognition and Cushing’s Quality of Life score. Rapid and sustained improvements in systolic blood pressure (“SBP”) and diastolic blood pressure (“DBP”) were observed in all patients with hypertension, with an improvement in mean SBP of 7.9 mm Hg and mean DBP of 5.4 mm Hg at 22 weeks (p-values: <0.0001). During the open-label phase, 63 percent of patients with hypertension met the study’s response criteria. The improvements were even greater in the patients with hypertension who entered the randomized withdrawal phase, with reductions in SBP of 12.6 mm Hg and DBP of 8.3 mm Hg (p-values: <0.0001). To ensure accuracy, hypertension was measured by 24-hour ambulatory blood pressure monitoring (“ABPM”).
Current wording
In the open-label phase, patients experienced clinically meaningful and statistically significant improvements in a wide array of hypercortisolism signs and symptoms, including hypertension, hyperglycemia, weight, waist circumference, fat and lean body mass, cognition and Cushing’s Quality of Life score. Rapid and sustained improvements in systolic blood pressure (“SBP”) and diastolic blood pressure (“DBP”) were observed in all patients with hypertension, measured by 24-hour ambulatory blood pressure monitoring (“ABPM”), with an improvement in mean SBP of 7.9 mm Hg and mean DBP of 5.4 mm Hg at 22 weeks (p-values: <0.0001). Sixty-three percent of patients with hypertension met the study’s open label response criteria. Hypertension improvements were even greater in patients with hypertension who entered the study’s randomized withdrawal phase, with reductions in SBP of 12.6 mm Hg and DBP of 8.3 mm Hg (p-values: <0.0001).
Previous wording
Glucose metabolism was measured by several diagnostic tests, including the oral glucose tolerance test (glucose area under the curve or AUCglucose), HbA1c and fasting glucose. In the open-label phase, clinically meaningful and statistically significant improvements in glucose metabolism were observed in patients with diabetes or impaired glucose tolerance (i.e., pre-diabetes), with reductions in AUCglucose of 3.3 hmmol/L, HbA1c of 0.3 percent and fasting glucose of 12.4 mg/dL at 22 weeks (p-values: <0.0001, 0.03, 0.03, respectively). During the open-label phase, 50 percent of patients with hyperglycemia met the study’s response criteria. Patients with hyperglycemia who entered the randomized withdrawal phase exhibited more pronounced improvements, with reductions in AUCglucose of 6.2 hmmol/L, HbA1c of 0.7 percent and fasting glucose of 25.2 mg/dL at 22 weeks (p-values: <0.0001, <0.0001, 0.006, respectively).
Current wording
Glucose control in GRACE was measured by several diagnostic tests, including the oral glucose tolerance test (glucose area under the curve or AUCglucose), HbA1c and fasting glucose. In the open-label phase, clinically meaningful and statistically significant improvements in glucose metabolism were observed in patients with diabetes or impaired glucose tolerance (i.e., pre-diabetes), with reductions in AUCglucose of 3.3 hmmol/L, HbA1c of 0.3 percent and fasting glucose of 12.4 mg/dL at 22 weeks (p-values: <0.0001, 0.03, 0.03, respectively). During the open-label phase, 50 percent of patients with hyperglycemia met the study’s response criteria. Patients with hyperglycemia who entered the randomized withdrawal phase exhibited more pronounced improvements, with reductions in AUCglucose of 6.2 hmmol/L, HbA1c of 0.7 percent and fasting glucose of 25.2 mg/dL at 22 weeks (p-values: <0.0001, <0.0001, 0.006, respectively).
Previous wording
Our Phase 3 GRADIENT study enrolled patients with hypercortisolism caused by adrenal adenomas or adrenal hyperplasia. These patients have a more gradual decline than patients with other etiologies of hypercortisolism, although their health outcomes are ultimately poor. GRADIENT enrolled 137 patients with hypercortisolism and either hypertension, hyperglycemia or both. Patients were randomized on a double-blind basis 1:1 to receive either relacorilant or placebo for 22 weeks. The trial’s primary endpoint was the improvement compared to placebo in systolic blood pressure with glycemic control, weight and body composition as secondary endpoints.
Current wording
Our Phase 3 GRADIENT study enrolled patients with hypercortisolism caused by adrenal adenomas or adrenal hyperplasia. These patients have a more gradual decline than patients with other etiologies of hypercortisolism, although their health outcomes are ultimately poor. GRADIENT enrolled 137 patients with hypercortisolism and either hypertension, hyperglycemia or both. Patients were randomized on a double-blind basis 1:1 to receive either relacorilant or placebo for 22 weeks. The trial’s primary endpoint was improvement compared to placebo in systolic blood pressure with glycemic control, weight and body composition as secondary endpoints.
Previous wording
Patients in GRADIENT who received relacorilant exhibited clinically meaningful improvements in a wide array of hypercortisolism’s signs and symptoms, including hypertension, hyperglycemia, weight and body composition, while patients who received placebo did not.
Current wording
Patients in GRADIENT who received relacorilant exhibited clinically meaningful improvements in a wide array of hypercortisolism signs and symptoms, including hypertension, hyperglycemia, weight and body composition, while patients who received placebo did not.
Previous wording
GRADIENT patients with hypertension who received relacorilant experienced a reduction in systolic blood pressure of 6.6 mm Hg (p-value 0.012) compared to baseline. The reduction in patients who received placebo was 2.1 mm Hg (p-value: ns) compared to baseline. The comparison between those who received relacorilant and placebo was not statistically significant. During the study, five patients who received placebo required rescue therapy with anti-hypertension medications, compared to one patient who received relacorilant. To ensure accuracy, hypertension was measured by 24-hour ABPM.
Current wording
GRADIENT patients with hypertension who received relacorilant experienced a reduction in SBP of 6.6 mm Hg (p-value: 0.012) compared to baseline. The reduction in patients who received placebo was 2.1 mm Hg (p-value: ns) compared to baseline. The comparison between those who received relacorilant and placebo was not statistically significant. During the study, five patients who received placebo required rescue therapy with anti-hypertension medications, compared to one patient who received relacorilant. To ensure accuracy, hypertension was measured by 24-hour ABPM.
Previous wording
Relacorilant in Combination with Chemotherapy. In March 2026, the FDA approved Lifyorli (relacorilant) in combination with the chemotherapy medication nab-paclitaxel to treat patients with platinum-resistant ovarian cancer who have received one to three prior systemic treatment regimens including bevacizumab. We use a specialty pharmacy and specialty distributors to distribute Lifyorli and provide logistical support to physicians and patients. Lifyorli was added to National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred regimen in April 2026.
Current wording
Relacorilant in Combination with Chemotherapy. In March 2026, the FDA approved Lifyorli (relacorilant) in combination with the chemotherapy medication nab-paclitaxel to treat patients with platinum-resistant ovarian cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. We sell Lifyorli using sales representatives to call on physicians caring for patients with platinum-resistant ovarian cancer. We also have a field-based force of medical science liaisons. We use specialty pharmacies to dispense Lifyorli directly to patients and provide logistical support to physicians and patients. We also sell Lifyorli to specialty distributors who, in turn, sell Lifyorli to community oncology practices, group purchasing organizations and hospitals. Lifyorli was added to National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred regimen in April 2026. We offer a patient assistance program to provide support to patients to help them overcome financial barriers or coverage denials.
Previous wording
Lifyorli’s FDA approval was based on positive results from our pivotal Phase 3 ROSELLA and Phase 2 trials, in which patients exhibited clinically meaningful improvements in progression free survival (“PFS”) and overall survival (“OS”). In October 2025, we submitted a marketing authorization application (“MAA”) to the EMA seeking approval in the EU.
Current wording
Lifyorli’s FDA approval was based primarily on positive data from our pivotal Phase 3 ROSELLA trial, with our positive Phase 2 trial providing confirmatory evidence. In both trials, patients exhibited clinically meaningful improvements in both progression-free survival (“PFS”) and overall survival (“OS”).
Previous wording
ROSELLA enrolled three hundred eighty-one women with recurrent, platinum-resistant ovarian cancer who were randomized 1:1 to receive either 150 mg of relacorilant intermittently in addition to the chemotherapeutic agent nab-paclitaxel or nab-paclitaxel monotherapy. Patients enrolled in ROSELLA received prior bevacizumab therapy, which is the approved standard of care for patients with platinum-resistant ovarian cancer. Women who have received more than three prior lines of therapy were excluded.
Current wording
ROSELLA enrolled 381 women with recurrent, platinum-resistant ovarian cancer who were randomized 1:1 to receive either 150 mg of relacorilant intermittently in addition to the chemotherapeutic agent nab-paclitaxel or nab-paclitaxel monotherapy. Patients enrolled in ROSELLA received prior bevacizumab therapy, which is the approved standard of care for patients with platinum-resistant ovarian cancer. Women who have received more than three prior lines of therapy were excluded.
Previous wording
In April 2025, we initiated a Phase 2 trial, BELLA, which has three parts. In December 2025, Part A completed enrollment of 95 patients with platinum-resistant ovarian cancer. Part A will evaluate the efficacy and safety of treatment with relacorilant plus nab-paclitaxel and bevacizumab. Part B has a planned enrollment of 90 patients with platinum-sensitive ovarian cancer, whose disease had progressed while receiving treatment with a PARP-inhibitor. Part B will evaluate the efficacy and safety of treatment with relacorilant plus nab-paclitaxel and bevacizumab. Part C has a planned enrollment of 90 patients with endometrial cancer who have received one or two prior lines of therapy. Part C will evaluate the efficacy and safety of treatment with relacorilant plus nab-paclitaxel.
Current wording
In April 2025, we initiated BELLA, an open-label Phase 2 trial with three parts. In each part, the primary endpoint is PFS, with OS being a key secondary endpoint. BELLA Part A is evaluating the efficacy and safety of relacorilant combined with nab-paclitaxel and bevacizumab to treat patients with platinum-resistant ovarian cancer. Enrollment of 95 patients in Part A was completed in December 2025. BELLA Part B is evaluating the efficacy and safety of relacorilant plus nab-paclitaxel and bevacizumab to treat women with platinum-sensitive ovarian cancer whose disease had progressed while receiving treatment with a PARP-inhibitor. BELLA Part C is evaluating the efficacy and safety of relacorilant plus nab-paclitaxel to treat patients with endometrial cancer who have received one or two prior lines of therapy. Planned enrollment of 90 patients in each of Parts B and C is underway. BELLA is being conducted at sites in the United States, Europe and Asia.
Previous wording
In December 2025, we initiated a Phase 2 trial, TRIDENT, with a planned enrollment of 60 patients with pancreatic cancer, who have not received prior therapy for metastatic disease. TRIDENT will evaluate the efficacy and safety of treatment with relacorilant plus nab-paclitaxel and gemcitabine.
Current wording
In December 2025, we initiated an open-label Phase 2 trial, TRIDENT, to evaluate the efficacy and safety of relacorilant combined with nab-paclitaxel and gemcitabine in patients with pancreatic cancer who have not received prior therapy for metastatic disease. The trial’s primary endpoint is PFS, with OS being a key secondary endpoint. TRIDENT’s planned enrollment is 60 patients at sites in the United States, Europe and Asia. The EC has designated relacorilant as an orphan drug for the treatment of patients with pancreatic cancer.
Previous wording
Nenocorilant in Combination with Immunotherapy. Immunotherapy harnesses the body’s immune system to identify and destroy cancer cells. We are testing the ability of our proprietary selective cortisol modulator, nenocorilant, to increase the potency of immunotherapy by reducing cortisol-activated immune suppression. In December 2025, we initiated a Phase 1b trial, SYNERGY, with a planned enrollment of 30 patients with solid tumors to evaluate the efficacy and safety of treatment with nenocorilant plus nivolumab (a PD-1 checkpoint inhibitor).
Current wording
Nenocorilant in Combination with Immunotherapy. Immunotherapy harnesses the body’s immune system to identify and destroy cancer cells. We are testing the ability of our proprietary selective cortisol modulator, nenocorilant, to increase the potency of immunotherapy by reducing cortisol-activated immune suppression. In December 2025, we initiated a Phase 1b trial, SYNERGY. SYNERGY is studying nenocorilant plus nivolumab (a PD-1 checkpoint inhibitor) in patients with solid tumors.
Previous wording
Although DAZALS did not meet its primary endpoint – change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to those who received placebo – a reduction in early death was observed at week 24 of the study (p-value: 0.02). An exploratory analysis at the one-year mark found that this benefit continued: Patients who received 300 mg of dazucorilant from the start of DAZALS had an 84 percent lower risk of death than did patients who received only placebo, with a hazard ratio of 0.16 (p-value: 0.0009). This benefit persisted into the study’s second year. Measured at the two-year mark, the risk of death in patients who received 300 mg of dazucorilant from the start of the study was reduced by 87 percent compared to patients who received only placebo with a hazard ratio of 0.13 (p-value: <0.0001). A similar survival benefit was observed at the one-year mark in patients who received 300 mg of dazucorilant for greater than 24 weeks, either in the treatment period or in the extension phase, compared to patients who received either placebo or 150 mg of dazucorilant for 24 weeks and did not receive dazucorilant in the extension phase with a hazard ratio of 0.36 (p-value: 0.02). This benefit persisted into the study’s second year with a hazard ratio of 0.39 (p-value: 0.02).
Current wording
Although DAZALS did not meet its primary endpoint – change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to those who received placebo – a reduction in early death was observed at the end of the 24-week double-blind treatment period (p-value: 0.02). An exploratory analysis at 52 weeks found that this benefit continued: Patients who received 300 mg of dazucorilant from treatment start had an 84 percent lower risk of death than did patients who received only placebo, with a hazard ratio of 0.16 (p-value: 0.0009). This benefit persisted into the study’s second year. Measured at 104 weeks, the risk of death in patients who received 300 mg of dazucorilant from the start of the study was reduced by 87 percent compared to patients who received only placebo with a hazard ratio of 0.13 (p-value: <0.0001). A similar survival benefit was observed at 52 weeks in patients who received 300 mg of dazucorilant for greater than 24 weeks, either in the treatment period or in the extension phase, compared to patients who received either placebo or 150 mg of dazucorilant for 24 weeks and did not receive dazucorilant in the extension phase with a hazard ratio of 0.36 (p-value: 0.02). This benefit persisted into the study’s second year with a hazard ratio of 0.39 (p-value: 0.02).
Previous wording
Dazucorilant has demonstrated a manageable safety profile, with 92 percent of adverse events being mild to moderate in severity. The frequency of severe and serious adverse events in patients who received dazucorilant was similar to those who received placebo. Mild to moderate, dose-related, transient abdominal pain was the most common adverse effect. The open-label, long-term extension phase of DAZALS, which enrolled 118 patients, is continuing. We are conducting a study in patients with ALS to determine whether dose titration will reduce instances of abdominal pain and allow more patients to benefit from dazucorilant. Following completion of this study, we expect to start a pivotal Phase 3 trial in 2026.
Current wording
Dazucorilant has demonstrated a manageable safety profile, with 92 percent of adverse events being mild to moderate in severity. The frequency of severe and serious adverse events in patients who received dazucorilant was similar to those who received placebo. Mild-to-moderate, dose-related, transient abdominal pain was the most common adverse effect. The open-label, long-term extension phase of DAZALS, which enrolled 118 patients, is continuing. We are conducting a study in patients with ALS to determine whether dose titration will reduce instances of abdominal pain and allow more patients to benefit from dazucorilant.
Previous wording
The IRA also imposes a one percent excise tax on certain share repurchases and introduces a 15 percent corporate alternative minimum tax on adjusted financial statement income. The corporate alternative minimum tax became effective for us on January 1, 2024. We do not expect either of these provisions to significantly affect our condensed consolidated financial statements.
Current wording
The IRA imposes a one percent excise tax on certain share repurchases and a 15 percent corporate alternative minimum tax on adjusted financial statement income. The corporate alternative minimum tax became effective for us on January 1, 2024. We do not expect either of these provisions to significantly affect our condensed consolidated financial statements.
Previous wording
Net Product Revenue – Net product revenue is gross product revenue from sales to our customers less deductions for estimated government rebates and chargebacks, patient co-pay assistance program, discounts provided to our specialty distributor for prompt payment and reserves for expected returns.
Current wording
Product Revenue, Net – Product Revenue, Net, or Net product revenue, is gross product revenue from sales to our customers less deductions for estimated government rebates and chargebacks, patient assistance programs, discounts provided to our specialty pharmacies and distributors for prompt payment and reserves for expected returns.
Previous wording
Cost of sales was $2.9 million for the three months ended March 31, 2026, compared to $2.4 million for the comparable period in 2025. Cost of sales as a percentage of revenue was 1.7 percent and 1.5 percent for the three months ended March 31, 2026 and 2025, respectively. The increase in cost of sales as a percentage of revenue was primarily due to a decrease in the average selling price of our Hypercortisolism Products.
Current wording
Cost of sales was $4.1 million and $6.9 million for the three and six months ended June 30, 2026, respectively, compared to $3.4 million and $5.8 million for the comparable periods in 2025. Cost of sales as a percentage of revenue was 1.6 percent for each of the three and six months ended June 30, 2026, compared to 1.8 percent and 1.7 percent for the comparable periods in 2025, respectively. The decreases in cost of sales as a percentage of revenue were primarily due to lower manufacturing costs for our Hypercortisolism Products. All drug product included in the cost of sales for Lifyorli for the three and six months ended June 30, 2026 was manufactured and its cost recorded as research and development expense prior to regulatory approval.
Previous wording
Research and development expense was $66.3 million for the three months ended March 31, 2026, compared to $60.7 million for the comparable period in 2025. The increase was primarily due to increased expenses related to the advancement of our development programs and employee compensation expenses, partially offset by decreased expenses related to development programs that are nearing completion.
Current wording
Research and development expense was $53.9 million and $120.2 million for the three and six months ended June 30, 2026, respectively, compared to $60.5 million and $121.2 million for the comparable periods in 2025. The decreases were primarily due to decreased expenses related to the development programs that are nearing completion and the decrease in the cost of manufacturing relacorilant that was recorded as research and development expenses prior to receiving regulatory approval, partially offset by increased expenses related to the advancement of our development programs and employee compensation expenses.
Previous wording
Selling, general and administrative expense was $145.4 million for the three months ended March 31, 2026, compared to $90.7 million for the comparable period in 2025. The increase was primarily due to increased sales and marketing activities and employee compensation expenses to support commercialization of our Hypercortisolism Products and Lifyorli.
Current wording
Selling, general and administrative expense was $156.9 million and $302.3 million for the three and six months ended June 30, 2026, respectively, compared to $103.9 million and $194.5 million for the comparable periods in 2025. The increases were primarily due to increased sales and marketing activities and employee compensation expenses to support commercialization of our Hypercortisolism Products and Lifyorli.
Previous wording
Interest and other income– Interest and other income was $4.9 million for the three months ended March 31, 2026, compared to $6.2 million for the comparable period in 2025 and consisted primarily of interest income from marketable securities. The decrease was primary due to lower cash, cash equivalents and marketable securities and market-wide decreases in interest rates.
Current wording
Interest and other income- Interest and other income was $4.6 million and $9.5 million for the three and six months ended June 30, 2026, respectively, compared to $5.0 million and $11.2 million for the comparable periods in 2025 and consisted primarily of interest income from marketable securities. The decreases were due to market-wide decreases in interest rates and lower cash, cash equivalents and marketable securities.
Previous wording
Since 2015, we have relied on revenues from the sale of our Hypercortisolism Products to fund our operations.
Current wording
Since 2015, we have relied on revenues from the sale of our Products to fund our operations.
Previous wording
As of March 31, 2026, we had cash, cash equivalents and marketable securities of $515.4 million, consisting of cash and cash equivalents of $108.7 million and marketable securities of $406.7 million, compared to cash, cash equivalents and marketable securities of $532.4 million, consisting of cash and cash equivalents of $120.5 million and marketable securities of $411.9 million as of December 31, 2025.
Current wording
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $544.6 million, consisting of cash and cash equivalents of $111.0 million and marketable securities of $433.6 million, compared to cash, cash equivalents and marketable securities of $532.4 million, consisting of cash and cash equivalents of $120.5 million and marketable securities of $411.9 million as of December 31, 2025.
Previous wording
Net cash used in operating activities was $16.8 million for the three months ended March 31, 2026, compared to net cash provided by operating activities of $4.8 million for the comparable period in 2025. The change was primarily due to net loss resulting from higher operating expenses to support increased sales and marketing activities.
Current wording
Net cash provided by operating activities was $16.8 million for the six months ended June 30, 2026, compared to $49.1 million for the comparable period in 2025. The decrease was primarily due to lower net income resulting from higher operating expenses to support increased sales and marketing activities.
Previous wording
Net cash provided by investing activities was $4.5 million for the three months ended March 31, 2026, compared to net cash used for $3.2 million for the comparable period in 2025. The change was primarily due to a higher allocation of cash proceeds from maturities of marketable securities towards cash equivalents during the three months ended March 31, 2026.
Current wording
Net cash used in investing activities was $24.7 million for the six months ended June 30, 2026, compared to net cash provided by investing activities of $67.0 million for the comparable period in 2025. The change was primarily due to the allocation of cash towards purchases of marketable securities during the six months ended June 30, 2026. In the comparable period in 2025, we allocated higher cash proceeds from the maturities of marketable securities towards cash equivalents to purchase shares in connection with our stock repurchase program.
Previous wording
Net cash provided by financing activities was $0.8 million for the three months ended March 31, 2026, compared to net cash used in financing activities of $39.8 million for the comparable period in 2025. In the three months ended March 31, 2026, we received $4.0 million from the exercise of stock options and $2.5 million in connection with our ESPP, offset by cash spent to acquire $5.8 million of our common stock in connection with the satisfaction of statutory withholding requirements for net settlement of cashless option exercises and vesting of restricted stock grants. In the comparable period in 2025, we spent $15.8 million to acquire our common stock in connection with the satisfaction of statutory withholding requirements for net settlement of cashless option exercises and vesting of restricted stock grants and $27.4 million in connection with our stock repurchase program to repurchase up to $200 million of our common stock (the “Stock Repurchase Program”), offset by $1.7 million received from the exercise of stock options and $1.7 million received in connection with our ESPP.
Current wording
Net cash used in financing activities was $1.3 million for the six months ended June 30, 2026, compared to $142.7 million for the comparable period in 2025. In the six months ended June 30, 2026, we spent $17.2 million to acquire our common stock in connection with the satisfaction of statutory withholding requirements for net settlement of cashless option exercises and vesting of restricted stock grants, offset by $6.2 million received in connection with our ESPP and $9.7 million net cash received from the exercise of stock options. In the comparable period in 2025, we spent $158.7 million acquiring shares of our common stock, comprised of $130.5 million in connection with our stock repurchase program and $28.2 million to acquire our common stock in connection with the satisfaction of statutory withholding requirements for net settlement of cashless option exercises and vesting of restricted stock grants, offset by $5.0 million received in connection with our ESPP and $11.0 million net cash received from the exercise of stock options.
Previous wording
As of March 31, 2026, we had retained earnings of $611.6 million.
Current wording
As of June 30, 2026, we had retained earnings of $654.6 million.
Previous wording
Our contractual payment obligations and purchase commitments are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. Other than the addition of a commitment to purchase $10.2 million of API, our payment obligations and purchase commitments did not change materially during the three months ended March 31, 2026. See Note 4 to our Unaudited Condensed Consolidated Financial Statements for more information regarding our purchase commitments.
Current wording
Our contractual payment obligations and purchase commitments are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. Other than the addition of a commitment to purchase $10.2 million of API, our payment obligations and purchase commitments did not change materially during the six months ended June 30, 2026. See Note 4 to our Unaudited Condensed Consolidated Financial Statements for more information regarding our purchase commitments.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
In October 2025, we submitted a marketing authorization application (“MAA”) to the EMA seeking approval in the EU, with an EMA decision expected in the fourth quarter of 2026. The EC has designated relacorilant as an orphan drug for the treatment of patients with ovarian cancer.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The EC has designated relacorilant as an orphan drug for the treatment of ovarian and pancreatic cancers.