Mifepristone

Since April, Congress has tackled a two-year Medicare telehealth policy extension, comprehensive health data privacy legislation, cybersecurity controls and a roadmap for healthcare AI. The 118th Congress and the Biden administration were hard at work in the last quarter to push their health technology policy priorities forward before their terms come to an end this December. Since April, Congress has tackled a two-year Medicare telehealth policy extension, comprehensive health data privacy legislation, cybersecurity controls and a road map for healthcare AI. Congress has not passed any major health technology legislation yet in 2024, which leaves health program extenders to be hammered out after the August recess—or, more likely, during the lame duck session post-election. The executive agencies have pushed out a trove of proposed and final regulations in the last four months. The Department of Health and Human Services (HHS) finalized changes to the Health Insurance Portability and Accountability Act's Health Breach Notification Rule, the Affordable Care Act's Section 1557 nondiscrimination rule and the Office of the National Coordinator for Health IT's (ONC's) information blocking rule. HHS also overhauled its technology office and opened a short hiring window for a chief technology officer, a chief data officer and a chief AI officer to head up initiatives in the department. The Supreme Court ended its 2024 term with decisions that majorly impact healthcare. Namely, it overturned the Chevron doctrine, allowed emergency abortions to continue in Idaho and kept abortion medication mifepristone on the market.  What to read:ONC reorganization could bump fundingHealthcare lobbyists spent millions in Q2CONGRESSIn May, Senate Majority Leader Chuck Schumer, D-New York, released the Senate’s artificial intelligence framework, which spanned sectors. The main takeaways for healthcare were for Congress to appropriate funds for AI and for congressional healthcare committees to consider AI policy frameworks.Competing telehealth bills emerged from two House healthcare committees. Both pieces of legislation would extend Medicare telehealth flexibilities for two years, through December 2026. The House Ways and Means Committee has forwarded its bill, while the House Energy and Commerce Committee canceled a full committee vote on the bill minutes before the markup began in late June.The E&C innovation subcommittee successfully passed Chairwoman Cathy McMorris-Rodgers’ American Privacy Rights Act. The health data privacy legislation was supposed to be marked up with the telehealth extension bill, but the markup was canceled. The Senate passed the fiscal year 2025 Labor/HHS appropriations bill. The House failed to vote on the legislation before it took its recess in early August.W&M passed its bill that would allow for Medicare coverage of FDA-designated breakthrough devices. The bill passed E&C last year. The Centers for Medicare & Medicaid Services (CMS) also released the final version of the Transitional Coverage for Emerging Technologies (TCET) rule, which addresses the same issue but to some does not go far enough to pay for medical devices. Medical device manufacturing advocates pressed Congress to move forward with the bill.The Healthcare Cybersecurity Act was introduced by Sens. Jacky Rosen, D-Nevada, Todd Young, R-Indiana, and Angus King, I-Maine. It was referred to the Committee on Homeland Security and Governmental Affairs.AGENCIESCMS released the FY2025 Physician Fee Schedule, which contained a new proposed billing framework for digital therapeutics and permanent audio-only telehealth coverage.ONC is now called the Office of the Assistant Secretary for Technology Policy (ASTP). The office announced its reorganization, and additional leading tech policy roles, in late July.ONC finalized its information blocking rule. ASTP/ONC released the proposed HTI-2 rule.FDA announced the first sitting members of its Digital Health Advisory Committee.Micky Tripathi, Ph.D., (ONC) and Troy Tazbaz (FDA) resigned from the board of health AI trade group, the Coalition for Health AI.The Office of Management and Budget released its biannual schedule of regulatory actions. The schedule noted that the highly anticipated Drug Enforcement Administration rule on telehealth prescribing of controlled substances will come out in September.HHS’ Office for Civil Rights (OCR) finalized the Section 1557 nondiscrimination rule which had implications for telehealth and AI. OCR also finalized updates to HIPAA's privacy protections for reproductive health information.A federal judge in Texas vacated HHS policy against hospital web trackers.The Federal Trade Commission finalized changes to the Health Breach Notification Rule. Special edition: SCOTUSThe Supreme Court made major decisions this summer that impact healthcare.SCOTUS overruled a 1984 case that established what has been known as the Chevron doctrine in Loper Bright Enterprises v. Raimondo. The decision will scale back how much leeway healthcare agencies have to interpret laws passed by Congress. The Supreme Court allowed for emergency abortions to continue in Idaho when it dismissed the cases Moyle v. United States and Idaho v. United States. Idaho’s abortion ban continues to be blocked because it conflicts with the Emergency Medical Treatment and Labor Act (EMTALA) of 1986. It also threw out the case Food and Drug Administration v. Alliance for Hippocratic Medicine which challenged the approval of mifepristone, a drug used for medication abortion, keeping the drug on the market for now.  

MENLO PARK, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- 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 reported its results for the quarter ended June 30, 2024. Financial Results Revenue of $163.8 million, a 39 percent increase over the same period in 2023Increase in 2024 revenue guidance to $640 – $670 million, from $620 – $650 millionNet income per common share of $0.32 (diluted), compared to $0.25 in second quarter 2023Cash and investments of $492.5 million as of June 30, 2024 “Once again, we had a record number of new Korlym® prescribers and a record number of patients receiving Korlym this quarter. Physicians are increasingly aware that hypercortisolism is much more prevalent than was previously assumed, so they are screening more patients for the disorder,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “From the launch of Korlym, we implemented a unique system of patient and physician support and have invested in multiple refinements over the past 12 years. Hypercortisolism is a complicated disease and the expertise we have developed is critical to the life-changing impact for patients who receive Korlym treatment.” Corcept’s second quarter 2024 revenue was $163.8 million, compared to $117.7 million in the second quarter of 2023. Second quarter operating expenses were $128.2 million, compared to $88.1 million in the second quarter of 2023, due to increased spending on clinical trials and sales and marketing activities and to support the expansion of our commercial and clinical development teams. Net income was $35.5 million in the second quarter of 2024 compared to $27.5 million in the same period last year. Cash and investments were $492.5 million at June 30, 2024 compared to $451.0 million at March 31, 2024. The company increased its 2024 revenue guidance to $640 – $670 million. Clinical Development “During the second quarter we presented the results from our GRACE and CATALYST trials. GRACE’s positive results are a welcome development for patients with hypercortisolism and constitute a significant step toward our new drug application for relacorilant, which we expect to submit in the fourth quarter. In addition, the results from the prevalence phase of our CATALYST study establish that hypercortisolism is a driving biological force in patients with diabetes refractory to treatment. We expect data from the treatment phase of the CATALYST study, as well as our other late-stage studies, GRADIENT, ROSELLA and DAZALS, by the end of this year,” added Dr. Belanoff. Cushing’s Syndrome GRACE – Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism – primary endpoint achieved in randomized withdrawal phase; open-label phase demonstrated clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognitive impairment and quality of lifeRelacorilant New Drug Application (NDA) – NDA submission for Cushing’s syndrome expected in the fourth quarter GRADIENT – Phase 3 trial of relacorilant in 137 patients with Cushing’s syndrome caused by adrenal adenomas – enrollment completed; results expected in the fourth quarterCATALYST – Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – in the first 1,055 patients enrolled, 24% were found to have hypercortisolism; 136 patients with hypercortisolism entered a randomized, double-blind, placebo-controlled study of Korlym – treatment phase results expected in the fourth quarter “Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing’s syndrome. Patients in GRACE’s open-label phase experienced significant improvements across a broad range of clinically meaningful endpoints, without significant safety burden. In the randomized withdrawal phase, GRACE met its primary endpoint and demonstrated that patients who remained on relacorilant maintained these improvements while those who received placebo saw a significant worsening in their signs and symptoms of hypercortisolism,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Our Phase 4 CATALYST trial is the largest and most rigorous study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. The prevalence results from CATALYST confirm there are considerably more patients with Cushing's syndrome than was previously assumed. CATALYST is poised to become the landmark study that guides physicians toward expanded screening for hypercortisolism and will result in better health outcomes for many patients who are struggling today,” said Dr. Guyer. Oncology ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – enrollment completed; results expected in the fourth quarterOpen-label, Phase 1b trial of relacorilant plus pembrolizumab in 14 patients with advanced adrenal cancer with cortisol excess – improvement in Cushing’s syndrome signs and symptoms observed; no change in tumor progression Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago – enrollment continues “Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer. If our pivotal ROSELLA trial replicates the positive results from our large, controlled, Phase 2 study, it will constitute a major medical advance. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year,” said Dr. Guyer. Amyotrophic Lateral Sclerosis (ALS) DAZALS – Randomized, double-blind, placebo-controlled, Phase 2 trial of dazucorilant in 249 patients with ALS – enrollment completed; results expected in the fourth quarter “Dazucorilant showed great promise in an animal model of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We expect data by the end of this year and are hopeful that the trial results will create a much-needed advance for patients with ALS,” said Dr. Guyer. Metabolic Dysfunction-Associated Steatohepatitis (MASH) MONARCH – Randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant with a cohort of patients with biopsy-confirmed MASH and a second cohort of patients with presumed MASH based on non-invasive diagnostic tests – enrollment continues “In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures, and was well-tolerated. We look forward to building on these promising results in our MONARCH study,” said Dr. Guyer. “Miricorilant has the potential to greatly benefit the millions of patients with MASH.” Conference Call We will hold a conference call on July 29, 2024, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com. About Corcept Therapeutics For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, 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 that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and generate sufficient revenue to fund our activities; the availability of competing treatments for hypercortisolism, including the potential for rapid uptake or discounted pricing of generic versions of Korlym; our ability to obtain acceptable prices and adequate insurance coverage and reimbursement for Korlym; risks related to the development of Korlym, relacorilant, dazucorilant, miricorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; the timing, cost and outcome of legal disputes and investigations; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website. In this press release, forward-looking statements include those concerning: favorable trends in medical practice, our continued revenue growth and 2024 revenue guidance, which may be adversely affected by changing technology, government pricing regulations and increased uptake or price reductions in competing medications, including generic versions of Korlym; the rates of screening and treatment for hypercortisolism; cortisol modulation’s potential to treat serious diseases; development of relacorilant as a treatment for Cushing’s syndrome and ovarian, adrenal and prostate cancer; the design, timing and expectations regarding our GRACE and GRADIENT trials; the timing and disposition of relacorilant’s NDA in Cushing’s syndrome, including any additional requirements, revisions or delays imposed by the FDA in course of its review; the design, timing and expectations regarding our CATALYST trial; the design, timing and expectations of our ROSELLA trial and the potential for relacorilant plus nab-paclitaxel to become a standard of care; the design, timing and expectations of our DAZALS trial of dazucorilant in patients with ALS; the design, timing and expectations of our MONARCH trial in patients with MASH; and the accrual and attributes of clinical data, as well as the timing of regulatory submissions with respect to, all of our development activities. We disclaim any intention or duty to update forward-looking statements made in this press release. CORCEPT THERAPEUTICS INCORPORATEDCONDENSED CONSOLIDATED BALANCE SHEETS(In thousands) June 30, 2024 December 31, 2023(1) (Unaudited) Assets Cash and investments$492,471 $425,397Trade receivables, net of allowances 53,837 41,123Insurance recovery receivable related to Melucci litigation — 14,000Inventory 16,801 15,974Operating lease right-of-use asset 5,684 120Deferred tax assets, net 111,848 90,605Other assets 33,914 34,298Total assets$714,555 $621,517Liabilities and Stockholders’ Equity Accounts payable$19,484 $17,396Accrued settlement related to Melucci litigation — 14,000Operating lease liabilities 5,669 151Other liabilities 93,159 83,265Stockholders’ equity 596,243 506,705Total liabilities and stockholders’ equity$714,555 $621,517 (1)Derived from audited financial statements at that date CORCEPT THERAPEUTICS INCORPORATEDCONDENSED CONSOLIDATED STATEMENTS OF INCOME(In thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Revenues Product revenue, net$163,796 $117,715 $310,604 $223,369 Operating expenses Cost of sales 2,524 1,574 5,059 2,960 Research and development 58,745 43,277 117,251 84,128 Selling, general and administrative 66,935 43,281 123,203 91,845 Total operating expenses 128,204 88,132 245,513 178,933 Income from operations 35,592 29,583 65,091 44,436 Interest and other income 6,004 3,347 11,498 6,928 Income before income taxes 41,596 32,930 76,589 51,364 Income tax expense (6,108) (5,402) (13,339) (7,957)Net income$35,488 $27,528 $63,250 $43,407 Net income attributable to common stockholders$35,120 $27,356 $62,640 $43,173 Basic net income per common share$0.34 $0.27 $0.61 $0.41 Diluted net income per common share$0.32 $0.25 $0.57 $0.38 Weighted-average shares outstanding used in computing net income per common share Basic 103,118 101,964 102,954 104,908 Diluted 111,244 109,590 110,550 112,492 CONTACT:Investor inquiries:ir@corcept.comMedia inquiries:communications@corcept.com www.corcept.com