CORCEPT THERAPEUTICS INC

Previous wording

We are a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. We have been selling and distributing Korlym in the United States for the treatment of patients suffering from hypercortisolism (also known as “Cushing’s syndrome”) since 2012. In June 2024, we made an authorized generic version of Korlym available. In March 2026, the FDA approved Lifyorli™ (relacorilant) in combination with the chemotherapy medication nab-paclitaxel as a treatment for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. In April 2026, we began selling and distributing Lifyorli in the United States. Our portfolio of proprietary selective cortisol modulators consists of five structurally distinct series totaling more than 1,000 compounds.

Current wording

We are a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. We have been selling Korlym in the United States for the treatment of patients suffering from hypercortisolism (also known as “Cushing’s syndrome”) since 2012. In June 2024, we made an authorized generic version of Korlym available. In March 2026, the United States Food and Drug Administration (“FDA”) approved Lifyorli® (relacorilant) in combination with the chemotherapy medication nab-paclitaxel as a treatment for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Since April 2026, we have been selling Lifyorli in the United States. Our portfolio of proprietary selective cortisol modulators consists of five structurally distinct series totaling more than 1,000 compounds.

Previous 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.

Current wording

Our Hypercortisolism Products. We sell Korlym and our authorized generic version of Korlym (our “Hypercortisolism Products”) in the United States 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 a 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. 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.

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 consistent with the medication’s label: No new side effects or adverse events were identified. The findings from the CATALYST study were referenced in the March 2026 update of the American Association of Clinical Endocrinology (AACE) Consensus Statement Algorithm for Management of Adults with Type 2 Diabetes and the October 2026 update of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) consensus report, Management of Type 2 Diabetes, 2026.

Previous wording

CATALYST’s results were published in Diabetes Care (Buse et al., April 2025 (first phase) and DeFronzo et al., June 2025 (second phase)), the peer-reviewed journal of the American Diabetes Association.

Current wording

CATALYST’s results were published in Diabetes Care (Buse et al., April 2025 (prevalence phase) and DeFronzo et al., June 2025 (treatment phase)), the peer-reviewed journal of the American Diabetes Association.

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 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.

Current wording

In 2025, we conducted the MOMENTUM trial to determine the prevalence of hypercortisolism in patients with resistant hypertension. 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 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.

Current wording

In December 2024, we submitted a New Drug Application (“NDA”) to the 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, excess body weight and body composition. Relacorilant has been well-tolerated in all its clinical trials. Notably, patients have not experienced 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 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.

Current wording

On December 30, 2025, the FDA issued a Complete Response Letter (“CRL”) declining to approve relacorilant. While the letter acknowledged that the pivotal GRACE trial met its primary endpoint and that the GRADIENT trial had provided confirmatory evidence, the FDA stated that additional evidence of efficacy would be required for approval. Rather than requiring additional evidence, however, at the customary post-CRL meeting held in April 2026, the FDA asked for additional analyses of the data already submitted as part of our NDA – specifically, a global statistical test (“GST”) of relacorilant’s effect on three of the most common and serious symptoms of Cushing’s syndrome – hypertension, hyperglycemia and excess body weight. When applied to data from a clinical trial, a GST helps determine whether the medication being studied contributed to changes in any of a set of identified measures. This statistical technique is well-suited for analyzing clinical results in patients with rare diseases, such as Cushing’s syndrome, that have a wide array of symptoms, the manifestation of which vary from patient to patient. Based on the positive outcome of the requested analyses, we resubmitted our NDA to the FDA on June 17, 2026. The Prescription Drug User Fee Act target date for the FDA to complete its review is December 17, 2026.

Previous wording

The GRACE trial had two parts. The first, open-label phase enrolled 152 patients with any etiology of hypercortisolism. Each patient received relacorilant for 22 weeks. Patients who exhibited pre-specified improvements in either hypertension, hyperglycemia or both symptoms were eligible to proceed to GRACE’s second, double-blind, randomized withdrawal phase, in which half of the patients continued to receive relacorilant and half received placebo for 12 weeks. GRACE’s primary endpoint was the number of patients in the relacorilant group who lost blood pressure control compared to the number of patients in the placebo group who lost blood pressure control.

Current wording

Our pivotal GRACE trial had two parts. The first, open-label phase enrolled 152 patients with any etiology of hypercortisolism. Each patient received relacorilant for 22 weeks. Patients who exhibited pre-specified improvements in either hypertension, hyperglycemia or both symptoms were eligible to proceed to GRACE’s second, double-blind, randomized withdrawal phase, in which half of the patients continued to receive relacorilant and half received placebo for 12 weeks. GRACE’s primary endpoint was the number of patients in the relacorilant group who lost blood pressure control compared to the number of patients in the placebo group who lost blood pressure control.

Previous 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.

Current wording

GRADIENT patients with hypertension who received relacorilant experienced a reduction in SBP, measured by 24-hour ABPM, 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.

Previous wording

Cortisol activity at the GR reduces the efficacy of certain anti-cancer therapies and there is substantial evidence that antagonizing cortisol at a solid tumor’s glucocorticoid receptors may help those therapies achieve their intended effect. In some cancers, cortisol retards cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers. Many types of solid tumors express the GR and are potential targets for cortisol modulation therapy, among them ovarian, endometrial, cervical, pancreatic and prostate cancers.

Current wording

Cortisol activity at the GR reduces the efficacy of certain anti-cancer therapies and there is substantial evidence that antagonizing cortisol at a solid tumor’s glucocorticoid receptors may help those therapies achieve their intended effect. Cortisol suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers. In some cancers, cortisol retards cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Many types of solid tumors are potential targets for cortisol modulation therapy, among them ovarian, endometrial, cervical, pancreatic and prostate cancers.

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, 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.

Current wording

Lifyorli 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 ensure that no patients are denied access to Lifyorli for financial reasons.

Previous wording

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.

Current wording

In October 2025, we submitted a marketing authorization application (“MAA”) to the EMA seeking approval in the EU. In September 2026, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended that the EC approve relacorilant combined with nab-paclitaxel to treat patients with platinum-resistant ovarian cancer. The EC will review the CHMP’s opinion and issue a final decision regarding approval in the fourth quarter of 2026. The EC has designated relacorilant as an orphan drug for the treatment of patients with ovarian cancer.

Previous 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”).

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”). The primary analysis from ROSELLA was published in The Lancet (Olawaiye et al., June 2025). ROSELLA’s final results were published in The Lancet (Lorusso et al., April 2026).

Previous wording

We have initiated trials to evaluate the potential for relacorilant to treat patients with other types of solid tumors and in combination with other anti-cancer agents.

Current wording

We have initiated trials to evaluate the potential for Lifyorli to treat patients with other types of solid tumors, at different stages of treatment, and in combination with other anti-cancer agents. BELLA is an open-label Phase 2 trial with three parts. In each part, the primary endpoint is PFS, with OS being a key secondary endpoint. In October 2026, we announced results of our primary analysis of data from Part A of BELLA. In Part A, 95 patients with platinum-resistant ovarian cancer treated with Lifyorli plus nab-paclitaxel and bevacizumab demonstrated clinically meaningful median PFS of 7.2 months and objective response rate (“ORR”) of 59 percent. Although median OS had not yet been reached at the time of the primary analysis, 88% of patients were alive at 6 months. Clinical benefit was most pronounced among patients earliest in their course of treatment in the platinum-resistant setting, including those who had not received bevacizumab previously. In bevacizumab-naïve patients, median PFS was 8.1 months, ORR was 66 percent and 91 percent of patients were alive at 6 months. The safety profile of Lifyorli plus nab-paclitaxel and bevacizumab was consistent with the known profiles of each individual agent, with no new safety signals identified.

Previous 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.

Current wording

BELLA Part B is evaluating the efficacy and safety of Lifyorli plus nab-paclitaxel and bevacizumab with planned enrollment of 90 women with platinum-sensitive ovarian cancer whose disease had progressed while receiving treatment with a PARP-inhibitor. Enrollment of patients in Part B is nearing completion. BELLA Part C is evaluating the efficacy and safety of Lifyorli plus nab-paclitaxel to treat 92 patients with endometrial cancer who have received one or two prior lines of therapy. Enrollment of patients in Part C is complete. All parts of BELLA are being conducted at sites in the United States, Europe and Asia.

Previous 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.

Current wording

In December 2025, we initiated an open-label Phase 2 trial, TRIDENT, to evaluate the efficacy and safety of Lifyorli 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

We are also collaborating with the Paris-based academic research cooperative ARCAGY-GINECO to conduct a Phase 2 trial, STELLA, evaluating the efficacy and safety of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer who have already received one or two prior lines of therapy.

Current wording

We are also collaborating with the Paris-based academic research cooperative ARCAGY-GINECO to conduct a Phase 2 trial, STELLA, evaluating the efficacy and safety of Lifyorli plus nab-paclitaxel in 50 patients with cervical cancer who have already received one or two prior lines of therapy.

Previous wording

Relacorilant in Combination with Androgen Deprivation Therapy. Androgen deprivation is the standard treatment for prostate cancer because androgens stimulate prostate tumor growth. One reason prostate cancer tumors eventually escape androgen deprivation therapy is they evolve to grow in response to cortisol activity. Combining a cortisol modulator with an androgen modulator may block this escape route. Our collaborators at the University of Chicago have initiated a randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, pre-prostatectomy. Patents we have licensed from the University of Chicago cover the use of relacorilant combined with anticancer agents, including enzalutamide, to treat patients with this disease.

Current wording

Relacorilant in Combination with Androgen Deprivation Therapy. Androgen deprivation is the standard treatment for prostate cancer because androgens stimulate prostate tumor growth. One reason prostate cancer tumors eventually escape androgen deprivation therapy is that they evolve to grow in response to cortisol activity. Combining a cortisol modulator with an androgen modulator may block this escape route. Our collaborators at the University of Chicago have initiated a randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, pre-prostatectomy. Patents we have licensed from the University of Chicago cover the use of relacorilant combined with anticancer agents, including enzalutamide, to treat patients with this disease.

Previous wording

Liver Disease. Metabolic dysfunction-associated steatohepatitis (“MASH”) is an advanced form of metabolic dysfunction-associated fatty liver disease that afflicts millions of patients and is a leading cause of liver-related mortality. Our Phase 1b trial of the selective cortisol modulator miricorilant as a potential treatment for MASH identified a dosing regimen that was well-tolerated and reduced liver fat, improved liver health and key metabolic and lipid measures. In October 2023, we initiated a randomized, double-blind, placebo-controlled, Phase 2b trial, MONARCH, of miricorilant in patients with MASH. MONARCH has two patient cohorts: Cohort A enrolled 82 patients with biopsy-confirmed MASH, randomized 2:1 to receive either 100 mg of miricorilant twice weekly or placebo for 48 weeks. The primary endpoint for Cohort A is reduction in liver fat; MASH resolution and fibrosis improvement are key secondary endpoints. Cohort B enrolled 93 patients with presumed MASH, randomized 2:1 to receive either (i) 100 mg of miricorilant twice weekly for 6 weeks, then 200 mg of miricorilant twice weekly for 18 weeks or (ii) placebo for 24 weeks. The primary endpoint of Cohort B is reduction in liver fat. Enrollment in both cohorts is complete.

Current wording

Liver Disease. Metabolic dysfunction-associated steatohepatitis (“MASH”) is an advanced form of metabolic dysfunction-associated fatty liver disease that afflicts millions of patients and is a leading cause of liver-related mortality. We are studying our selective cortisol modulator miricorilant as a potential treatment for MASH. In October 2023, we initiated a randomized, double-blind, placebo-controlled, Phase 2b trial, MONARCH. MONARCH enrolled two patient cohorts: Cohort A enrolled 82 patients with biopsy-confirmed MASH, randomized 2:1 to receive either 100 mg of miricorilant twice weekly or placebo for 48 weeks. Cohort B enrolled 93 patients with presumed MASH, randomized 2:1 to receive either (i) 100 mg of miricorilant twice weekly for 6 weeks, then 200 mg of miricorilant twice weekly for 18 weeks or (ii) placebo for 24 weeks. The primary endpoint for both Cohort A and B was reduction in liver fat compared to placebo; fibrosis improvement and MASH resolution were key secondary endpoints for Cohort A.

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.

Current wording

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

Please see the risk factor under Item 1A of this Quarterly Report on Form 10-Q, “New laws, government regulations, or changes to existing laws and regulations could make it difficult or impossible for us to obtain acceptable prices or adequate insurance coverage and reimbursement for our Products, which would adversely affect our results of operations and financial position.”

Current wording

Please see the risk factor under Part II, Item 1A of this Quarterly Report on Form 10-Q, “New laws, government regulations, or changes to existing laws and regulations could make it difficult or impossible for us to obtain acceptable prices or adequate insurance coverage and reimbursement for our Products, which would adversely affect our financial results.”

Previous 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.

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 distributors for prompt payment, distribution and administrative fees, voucher assistance and reserves for expected returns.

Previous wording

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 wording

Net product revenue was $340.5 million and $761.5 million for the three and nine months ended September 30, 2026, respectively, compared to $207.6 million and $559.3 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.

Previous wording

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 wording

Net product revenue from our Hypercortisolism Products was $249.1 million and $622.6 million for the three and nine months ended September 30, 2026, respectively, compared to $207.6 million and $559.3 million for the comparable periods in 2025. Higher sales volume accounted for 75.2 percent and 97.2 percent of the increases for the three and nine months ended September 30, 2026, respectively, 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.

Previous 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.

Current wording

Cost of sales was $4.6 million and $11.6 million for the three and nine months ended September 30, 2026, respectively, compared to $4.6 million and $10.4 million for the comparable periods in 2025. Cost of sales as a percentage of revenue was 1.4 percent and 1.5 percent for the three and nine months ended September 30, 2026, respectively, compared to 2.2 percent and 1.9 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 and a $0.7 million reduction of scrapped inventory. All costs to manufacture Lifyorli prior to regulatory approval were recorded as research and development expense. Cost of sales for Lifyorli for the three and nine months ended September 30, 2026 included tableting, packaging, personnel, overhead, stability testing and distribution costs of Lifyorli that were incurred after regulatory approval.

Previous 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.

Current wording

Research and development expense was $56.7 million and $176.9 million for the three and nine months ended September 30, 2026, respectively, compared to $68.8 million and $190.1 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 Lifyorli 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

It is difficult to predict the timing and cost of development activities, which are subject to many uncertainties and risks, including inconclusive or negative results, slow patient enrollment, adverse side effects and difficulties in the formulation or manufacture of study drugs and lack of drug-candidate efficacy. In addition, clinical development is subject to government oversight and regulations that may change without notice. We expect our research and development expense to be higher in 2026 than in 2025 as our clinical programs advance and we initiate new clinical trials. Research and development spending in future years will depend on the outcome of our pre-clinical and clinical trials and our development plans.

Current wording

It is difficult to predict the timing and cost of development activities, which are subject to many uncertainties and risks, including inconclusive or negative results, slow patient enrollment, adverse side effects and difficulties in the formulation or manufacture of study drugs and lack of drug-candidate efficacy. In addition, clinical development is subject to government oversight and regulations that may change without notice. We expect our research and development expense in 2026 to be approximately the same as in 2025, as we advance our clinical programs and initiate new clinical trials, offset by decreased expenses due to clinical programs that are nearing completion and as the cost of manufacturing Lifyorli after regulatory approval is no longer recorded as research and development expenses.

Previous 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.

Current wording

Selling, general and administrative expense was $164.4 million and $466.7 million for the three and nine months ended September 30, 2026, respectively, compared to $124.0 million and $318.5 million for the comparable periods in 2025. The increases were primarily due to increased employee compensation expenses and sales and marketing activities to support commercialization of our Hypercortisolism Products and Lifyorli and increased legal expenses.

Previous 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.

Current wording

Interest and other income- Interest and other income was $5.6 million and $15.1 million for the three and nine months ended September 30, 2026, respectively, compared to $5.0 million and $16.2 million for the comparable periods in 2025 and consisted primarily of interest income from marketable securities. The increase in interest and other income for the three months ended September 30, 2026 was due to higher cash, cash equivalents and marketable securities, partially offset by market-wide decreases in interest rates. The decrease in interest and other income for the nine months ended September 30, 2026 was primarily due to market-wide decreases in interest rates.

Previous wording

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.

Current wording

Income tax benefit- Income tax benefit was $6.5 million and $16.5 million for the three and nine months ended September 30, 2026, respectively, compared to income tax benefits of $4.4 million and $18.8 million for the comparable periods in 2025, respectively. The increase in income tax benefit during the three months ended September 30, 2026 was primarily due to an increase in stock compensation deductions as compared to the comparable period in 2025. The decrease in income tax benefit during the nine months ended September 30, 2026 was primarily due to an increase in pre-tax income in 2026 as compared to the comparable period in 2025.

Previous 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.

Current wording

As of September 30, 2026, we had cash, cash equivalents and marketable securities of $662.3 million, consisting of cash and cash equivalents of $98.7 million and marketable securities of $563.6 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 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.

Current wording

Net cash provided by operating activities was $159.7 million for the nine months ended September 30, 2026, compared to $103.5 million for the comparable period in 2025. The increase was primarily due to higher revenue.

Previous 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.

Current wording

Net cash used in investing activities was $156.7 million for the nine months ended September 30, 2026, compared to net cash provided by investing activities of $81.6 million for the comparable period in 2025. The change was primarily due to the allocation of cash towards purchases of marketable securities during the nine months ended September 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 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.

Current wording

Net cash used in financing activities was $25.2 million for the nine months ended September 30, 2026, compared to $189.2 million for the comparable period in 2025. In the nine months ended September 30, 2026, we spent $60.9 million acquiring shares of our common stock, comprised of $55.2 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 and $5.7 million in connection with our stock repurchase program, offset by $26.7 million net cash received from the exercise of stock options and $9.1 million received in connection with our ESPP. In the comparable period in 2025, we spent $209.3 million acquiring shares of our common stock, comprised of $172.9 million in connection with our stock repurchase program and $36.4 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 $13.0 million net cash received from the exercise of stock options and $7.2 million received in connection with our ESPP.

Previous wording

As of June 30, 2026, we had retained earnings of $654.6 million.

Current wording

As of September 30, 2026, we had retained earnings of $781.4 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 six months ended June 30, 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 commitments to purchase $34.0 million of API, our payment obligations and purchase commitments did not change materially during the nine months ended September 30, 2026. See Note 4 to our Unaudited Condensed Consolidated Financial Statements for more information regarding our purchase commitments.