Lovastatin

JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE ® (tocilizumab-bavi) injection, for intravenous use, a biosimilar to ACTEMRA (tocilizumab). The approval expands TOFIDENCE indications to include treatment of: (1) adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) and (2) hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). “The approval of these new indications for TOFIDENCE is a vital step forward in expanding access to treatment options that address critical needs, including for patients facing CRS, a serious side effect of CAR-T therapies,” said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon. 1,2 “In the US, biosimilar adoption may help reduce the affordability burden of high-cost brand biologics on the health care system. 3 By expanding the use of TOFIDENCE, we continue to advance our biosimilars portfolio and our commitment to broadening access to high-quality treatment options for patients in need.” 1,3 TOFIDENCE, the first approved tocilizumab biosimilar entrant in the US market, was launched in May 2024 and is also indicated in appropriate patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. 4,5 See full indications below. TOFIDENCE injection is available in the following presentations: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20mL (20 mg/mL), in single-dose vials for further dilution prior to intravenous infusion. Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TOFIDENCE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. See additional safety information below. Organon acquired the regulatory and commercial rights to TOFIDENCE in the US in 2025. Bio-Thera Solutions Ltd., the product developer, maintains manufacturing rights for TOFIDENCE for the US market. 5 About TOFIDENCE ® (tocilizumab-bavi) TOFIDENCE is an interleukin-6 (IL-6) receptor antagonist indicated for: Rheumatoid Arthritis (RA): TOFIDENCE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA): TOFIDENCE is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Polyarticular Juvenile Idiopathic Arthritis (PJIA): TOFIDENCE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older. Systemic Juvenile Idiopathic Arthritis (SJIA): TOFIDENCE is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older. Cytokine Release Syndrome (CRS): TOFIDENCE is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older. Coronavirus Disease 2019 (COVID-19) : TOFIDENCE is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). SELECTED SAFETY INFORMATION RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products, including TOFIDENCE, are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before TOFIDENCE use and during therapy. Treatment for latent infection should be initiated prior to TOFIDENCE use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral, and other infections due to opportunistic pathogens. Do not administer TOFIDENCE in patients with an active infection, including localized infections. The risks and benefits of treatment with TOFIDENCE should be carefully considered prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TOFIDENCE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Hold TOFIDENCE if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with TOFIDENCE should undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor the patient. COVID-19 In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with TOFIDENCE. Tuberculosis Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating TOFIDENCE. Consider anti-tuberculosis therapy prior to initiation of TOFIDENCE in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Closely monitor patients for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before initiating TOFIDENCE. Viral Reactivation Viral reactivation has been reported with immunosuppressive biologic therapies and cases of herpes zoster exacerbation were observed in clinical studies with tocilizumab. CONTRAINDICATIONS TOFIDENCE is contraindicated in patients with known hypersensitivity to tocilizumab products. WARNINGS AND PRECAUTIONS GASTROINTESTINAL PERFORATIONS Use TOFIDENCE with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with fever, new onset abdominal symptoms, and change in bowel habits for early identification of gastrointestinal perforation . HEPATOTOXICITY Serious cases of hepatic injury have been observed in patients taking intravenous tocilizumab products. Some of these cases have resulted in liver transplant or death. For rheumatoid arthritis (RA) and giant cell arteritis (GCA) patients, obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) before initiating TOFIDENCE routinely. It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with elevated transaminases ALT or AST greater than 1.5 x upper limit of normal (ULN). In patients who develop elevated ALT or AST greater than 5 x ULN, discontinue TOFIDENCE. It is not recommended to initiate TOFIDENCE treatment in COVID-19 patients with elevated ALT or AST above 10 x ULN. Monitor ALT and AST during treatment. Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. If the patient is found to have abnormal liver tests, TOFIDENCE treatment should be interrupted and investigation done to establish the probable cause. TOFIDENCE should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests. A similar pattern of liver enzyme elevation is noted with tocilizumab products treatment in the polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA) populations. Monitor liver test panel at the time of the second administration and thereafter every 4 to 8 weeks for PJIA and every 2 to 4 weeks for SJIA. CHANGES IN LABORATORY PARAMETERS Patients with RA, GCA, and COVID-19: Neutropenia Treatment with tocilizumab products was associated with a higher incidence of neutropenia. It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with a low neutrophil count, ie, absolute neutrophil count (ANC) less than 2000 per mm 3 . In patients who develop an ANC less than 500 per mm 3 , treatment is not recommended. It is not recommended to initiate TOFIDENCE treatment in COVID-19 patients with an ANC less than 1000 per mm 3 . Neutrophils should be monitored. Monitor neutrophils 4 to 8 weeks after start of therapy and every 3 months thereafter. Thrombocytopenia Treatment with tocilizumab products was associated with a reduction in platelet counts. It is not recommended to initiate TOFIDENCE treatment in RA and GCA patients with a platelet count below 100,000 per mm 3 . In patients who develop a platelet count less than 50,000 per mm 3 , treatment is not recommended. Monitor platelets 4 to 8 weeks after start of therapy and every 3 months thereafter. In COVID-19 patients with a platelet count less than 50,000 per mm 3 , treatment is not recommended. Elevated Liver Enzymes Refer to Hepatotoxicity. (See above.) Lipid Abnormalities Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol . Assess lipid parameters approximately 4 to 8 weeks following initiation of TOFIDENCE therapy. Patients with Polyarticular and Systemic Juvenile Idiopathic Arthritis: A similar pattern of liver enzyme elevation, low neutrophil count, low platelet count, and lipid elevations is noted with tocilizumab products treatment in the PJIA and SJIA populations. Monitor neutrophils, platelets, ALT, and AST at the time of the second administration and thereafter every 4 to 8 weeks for PJIA and every 2 to 4 weeks for SJIA. Monitor lipids as above for approved adult indications . IMMUNOSUPPRESSION TOFIDENCE is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies. HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab products and anaphylactic events with a fatal outcome have been reported with intravenous infusion of tocilizumab products. Reactions that required treatment discontinuation included generalized erythema, rash, and urticaria. TOFIDENCE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. If a hypersensitivity reaction occurs, immediately discontinue TOFIDENCE; treat promptly, and monitor until signs and symptoms resolve. DEMYELINATING DISORDERS Prescribers should exercise caution in considering the use of TOFIDENCE in patients with preexisting or recent onset demyelinating disorders. ACTIVE HEPATIC DISEASE AND HEPATIC IMPAIRMENT Treatment with TOFIDENCE is not recommended in patients with active hepatic disease or hepatic impairment . VACCINATIONS Avoid use of live vaccines concurrently with TOFIDENCE as clinical safety has not been established. No data are available on the effectiveness of vaccination in patients receiving tocilizumab products. Because interleukin-6 (IL-6) inhibition may interfere with the normal immune response to new antigens, it is recommended that all patients, particularly pediatric or elderly patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating TOFIDENCE therapy. ADVERSE REACTIONS The most common adverse reactions (incidence of at least 5%) associated with tocilizumab-IV were upper respiratory tract infection, nasopharyngitis, headache, hypertension, and increased ALT. DRUG INTERACTIONS Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates. Exercise caution when coadministering TOFIDENCE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, eg, oral contraceptives, lovastatin, atorvastatin, etc. USE IN SPECIFIC POPULATIONS Pregnancy The available data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on the animal data, there may be a potential risk to the fetus. Lactation No information is available on the presence of tocilizumab products in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Discontinue the drug or nursing, taking into consideration the importance of the drug to the mother. Before prescribing TOFIDENCE, please read the Prescribing Information , including the Boxed Warning about serious infections. The Medication Guide also is available. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at and follow us on LinkedIn , Instagram , X , YouTube , TikTok and Facebook . Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations regarding the anticipated impact and potential benefits to Organon of the expanded indications for TOFIDENCE. Forward-looking statements may be identified by words such as “will,” “may,” “continue,” “commitment to broadening,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other SEC filings, available at the SEC’s Internet site ( ). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. ACTEMRA is a trademark registered in the US by Chugai Seiyaku Kabushiki Kaisha; Organon is not associated with this trademark owner. References Overview for health care professionals. US Food and Drug Administration. Updated August 1, 2024. Accessed February 23, 2026. Cytokine release syndrome. Cleveland Clinic. Updated July 14, 2025. Accessed May 27, 2026. Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability . IQVIA Institute for Human Data Science. January 31, 2023. Accessed February 5, 2026. FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis. US Food and Drug Administration; September 29, 2023. Organon acquires TOFIDENCE™ (tocilizumab-bavi), a commercialized biosimilar to ACTEMRA ® (tocilizumab) injection, for intravenous infusion in the U.S. Press release. Organon; April 1, 2025. © 2026 Organon group of companies. All rights reserved. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. Contacts Media Contacts: Janine Colavita (732) 861-3806 Karissa Peer (614) 314-8094 Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129

New data from CATALYST and MOMENTUM trials presented at American Diabetes Association’s (ADA) 86 th Scientific Sessions In the CATALYST trial, patients with hypercortisolism treated with Korlym exhibited clinically and statistically significant improvements in hemoglobin A1c (HbA1c) and clinically meaningful reductions in body weight, body mass index and waist circumference, with numerically greater benefit in those taking GLP-1 receptor agonists or tirzepatide Late-breaking data from the MOMENTUM trial confirm high prevalence of endogenous hypercortisolism in patients with type 2 diabetes and resistant hypertension REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), 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, today announced the presentation of new data from its CATALYST and MOMENTUM trials at the American Diabetes Association’s 86 th Scientific Sessions. The presentations underscore the critical role of hypercortisolism in difficult-to-control type 2 diabetes and resistant hypertension, and the potential of cortisol modulation treatment. The CATALYST trial screened 1,057 patients with difficult-to-control type 2 diabetes (HbA1c of 7.5 – 11.5 percent despite receiving multiple glucose-lowering medications) and found that 24 percent had hypercortisolism (cortisol levels of greater than 1.8 μg/dL in the 1 mg dexamethasone suppression test (DST)). In CATALYST’s treatment phase, 136 of the patients who had been found to have hypercortisolism were randomized 2:1 to receive either Korlym or placebo for 24 weeks. Patients who received Korlym exhibited a clinically meaningful and statistically significant reduction in HbA1c (1.3 percent, p-value: 10 percent) were hypokalemia, fatigue, nausea, vomiting, headache, peripheral edema, diarrhea and dizziness. The data presented at ADA described treatment outcomes in the 71 patients in CATALYST who were taking GLP-1 receptor agonists or the GLP-1/GIP agonist tirzepatide. In this group, patients who received Korlym exhibited numerically greater benefit than the overall study population with reductions in HbA1c (1.7 percent), body weight (6.1 kg), body mass index (2.0 kg/m 2 ) and waist circumference (6.5 cm), compared to patients who received placebo (all nominal p-values less than 0.04). “These new CATALYST data demonstrate the potential of cortisol modulation to improve critical metabolic parameters, even for patients who have poorly controlled type 2 diabetes despite treatment with powerful GLP-1 or GLP-1/GIP receptor agonists, such as semaglutide or tirzepatide. Excess cortisol disrupts the incretin system, impairs beta cell function, and induces insulin and incretin resistance, potentially limiting the effectiveness of these otherwise potent therapies. Screening for hypercortisolism and considering cortisol-directed treatment is a key part of managing type 2 diabetes in patients not responding to standard-of-care treatments,” said Lance Sloan, M.D., President, Texas Institute for Kidney and Endocrine Disorders. At ADA, Corcept also presented late-breaking data from its MOMENTUM trial, which screened 1,086 patients with resistant hypertension (as defined by the American Heart Association’s criteria ) and found that 27.3 percent of them had hypercortisolism . The prevalence of hypercortisolism was even higher in patients who had hemoglobin A1c (HbA1c) of 7.5 percent or higher and were taking 3 or more blood pressure medicines: 36.6 percent in CATALYST and 32.6 percent in MOMENTUM. “Data consistently show that hypercortisolism is an underlying driver of treatment resistant cardiometabolic disease, including in patients receiving best-in-class therapies like GLP-1s,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Data from CATALYST demonstrate that treatment with a cortisol modulator, such as Korlym, can be synergistic with GLP-1s or tirzepatide to help patients better control type 2 diabetes. It is our hope that this new research will lead to increased screening for hypercortisolism and improved treatment.” About CATALYST CATALYST is the largest and most rigorous trial ever conducted to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and assess the effect of treating patients found to have hypercortisolism with a cortisol modulator. The initial prevalence phase of the trial screened 1,057 patients with difficult-to-control type 2 diabetes (i.e., patients with HbA1c greater than 7.5 percent despite receiving multiple glucose-lowering medications, including best-in-class therapies such as GLP-1 and GLP-1/GIP agonists) at 36 sites in the United States. Based on results from a standard 1-mg dexamethasone suppression test, 24 percent of the patients screened were found to have hypercortisolism and were eligible to enter the trial’s treatment phase, where they were randomized, 2:1, to receive either Korlym or placebo for 24 weeks. One hundred thirty-six patients enrolled in the treatment phase. About MOMENTUM MOMENTUM was the largest trial ever conducted to assess the prevalence of hypercortisolism in patients with resistant hypertension. A total of 1,086 patients were screened at 50 sites in the United States. All patients had resistant hypertension as defined by the American Heart Association’s criteria (systolic blood pressure greater or equal to 130 mmHg despite taking 3 or more blood-pressure lowering medications, including a diuretic, or taking 4 or more blood-pressure lowering medications). Using a simple, standardized 1-mg dexamethasone suppression test (DST), 27 percent of these patients were found to have hypercortisolism. About Hypercortisolism Hypercortisolism, also known as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be fatal if not treated effectively. Cardiovascular events are the most common cause of death among patients with hypercortisolism. Recent research shows that endogenous hypercortisolism is more prevalent than previously believed. INDICATION KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Limitations of use: KORLYM should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing’s syndrome. IMPORTANT SAFETY INFORMATION BOXED WARNING: TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential. CONTRAINDICATIONS Pregnancy; patients taking simvastatin or lovastatin and CYP3A substrates with narrow therapeutic ranges; patients receiving systemic corticosteroids for lifesaving purposes; women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma; patients with known hypersensitivity to mifepristone or to any of the product components. WARNINGS AND PRECAUTIONS Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency. See full Prescribing Information for further management instructions. Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. Measure serum potassium 1-2 weeks after starting or increasing the Korlym dose, and periodically thereafter. Mifepristone-induced hypokalemia should be treated with potassium supplementation based on severity. If hypokalemia persists despite potassium supplementation, consider adding mineralocorticoid antagonists. Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if the patient also has a hemorrhagic disorder or is on anticoagulant therapy. Women who experience vaginal bleeding during treatment should be referred to a gynecologist for further evaluation. QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval. Exacerbation/Deterioration of Conditions Treated with Corticosteroids: For medical conditions in which chronic corticosteroid therapy is lifesaving, Korlym is contraindicated. Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Use only when necessary and do not exceed a Korlym dose of 900 mg per day. The labeling contains warnings and precautions for Pneumocystis jiroveci Infection and potential effects of hypercortisolemia . See full Prescribing Information for further management instructions. ADVERSE REACTIONS Most common adverse reactions in Cushing’s syndrome (≥20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, and endometrial hypertrophy. DRUG INTERACTIONS Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Use only when necessary, and do not exceed a Korlym dose of 900 mg. CYP3A inducers: Do not use Korlym with CYP3A inducers. Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym. Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz. Hormonal contraceptives: Do not use with Korlym. DOSAGE AND ADMINISTRATION Obtain a negative pregnancy test prior to initiating treatment with Korlym in females of reproductive potential, or if treatment is interrupted for more than 14 days. Administer once daily orally with a meal. The recommended starting dose is 300 mg once daily. Renal impairment: Do not exceed 600 mg once daily. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment. Based on clinical response and tolerability, the dose may be increased in 300-mg increments to a maximum of 1200 mg once daily. Do not exceed 20 mg/kg per day. Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 900 mg per day if clinically indicated. When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: for patients receiving a daily dose of 600 mg, reduce dose to 300 mg. For patients receiving a daily dose of 900 mg, reduce dose to 600 mg. For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor. USE IN SPECIFIC POPULATIONS Lactation: Mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym ® , the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com . Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements. In this press release, forward-looking statements include statements concerning: the potential for cortisol modulation treatment to improve critical metabolic parameters, even for patients with poorly controlled type 2 diabetes despite treatment with powerful GLP-1 or GLP-1/GIP receptor agonists; and our hope that the findings from the CATALYST and MOMENTUM trials will lead to increased screening for hypercortisolism and improved treatment. A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release. Contacts Investor inquiries: ir@corcept.com Media inquiries: communications@corcept.com