CORCEPT THERAPEUTICS INC
For the period ended Mar 31, 2026. Filed Apr 30, 2026.
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Mar 31, 2026 · Filed Apr 30, 2026
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ITEM 1. LEGAL PROCEEDINGS
Purported Securities Class Action
On February 20, 2026, a purported securities class action complaint was filed in the United States District Court for the Northern District of California by the Allegheny County Employees’ Retirement System (Allegheny County Employees’ Retirement System v. Corcept Therapeutics Incorporated, et al., Case No. 3:26-cv-1525) (the “Securities Action”). The complaint names Corcept and certain of its executive officers as defendants asserting violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 and alleges, among other things, that the defendants made or are responsible for making false and materially misleading statements and omissions regarding our NDA for relacorilant as a treatment for patients with hypercortisolism. The complaint asserts a putative class period from October 31, 2024, to December 30, 2025 and seeks damages, attorneys’ fees and costs and unspecified relief. On April 21, 2026, three groups of purported Corcept stockholders and their counsel each filed motions for appointment as lead plaintiff and lead counsel. We will vigorously defend ourselves against this lawsuit.
Teva Patent Litigation
In February 2018, we received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. (“Teva”) had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking authorization to manufacture and sell a generic version of Korlym prior to the expiration of patents related to Korlym that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). In March 2018, we filed a lawsuit in the United States District Court for the District of New Jersey (“D.N.J.”) against Teva for infringement of our patents. In August 2020, Teva received final approval from the FDA for its ANDA in accordance with the Hatch-Waxman Act. And, in November 2020, the Patent Trial and Appeal Board (“PTAB”) issued a decision upholding the validity of U.S. Patent No. 10,195,214 (the “’214 patent”) in its entirety, which decision the Court of Appeals for the Federal Circuit upheld.
Trial was held in September 2023, before Judge Renee Marie Bumb in the D.N.J. regarding infringement of the ’214 patent and U.S. Patent No. 10,842,800 (the “’800 patent”). On December 29, 2023, Judge Bumb ruled that Teva’s proposed generic product would not infringe either of these patents. Teva launched its generic product in January 2024. We appealed the District Court’s ruling to the United States Court of Appeals for the Federal Circuit, which heard oral argument in the matter on July 7, 2025. On February 19, 2026, the appellate court affirmed the District Court’s ruling, finding no infringement of either the ’214 or the ’800 patent. On April 22, 2026, we filed a petition for rehearingen banc to the United States Court of Appeals for the Federal Circuit asking all active judges of the circuit to review the decision of the three-judge panel.
We will continue to vigorously enforce our intellectual property rights relating to Korlym.
Antitrust Litigation
On June 13, 2024, Teva filed a complaint in the Northern District of California, captioned Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc., et al. (N.D. Cal.), Case No. 5:24-cv-03567 (the “Teva Antitrust Litigation”). This lawsuit names, as defendants, Corcept and Optime Care, Inc. (“Optime”), the specialty pharmacy that previously served as our exclusive specialty pharmacy services vendor dispensing Korlym and the authorized generic version of Korlym and performing related pharmacy and patient support services. The lawsuit alleges, among other things, that Corcept and Optime violated federal and state laws related to antitrust and unfair business practices. On September 12, 2025, the District Court granted in part and denied in part defendants’ motion to dismiss the lawsuit, thereby dismissing some of Teva’s claims and theories. Teva subsequently filed a Second Amended Complaint (“SAC”) reasserting some of its state law claims, and, later, a Third Amended Complaint (“TAC”) adding claims related to Corcept’s agreement with the new specialty pharmacy vendor to which we transferred specialty pharmacy services in 2025. Corcept and Optime have filed motions to dismiss portions of Teva’s SAC and TAC. The District Court held a hearing on these motions on February 18, 2026. We cannot predict the outcome of these motions or when the Court will issue its opinion. Trial for this matter is scheduled for March 2027.
On February 10, 2025, several named plaintiffs filed a complaint against Corcept in the Alameda County Superior Court for the State of California, captioned, Aetna Inc., Health Care Service Corporation, Humana Inc. and Molina Healthcare Inc. vs. Corcept Therapeutics, Inc., Case No. 25CV110493 (the “Aetna Litigation”). This lawsuit names Corcept as the sole defendant and includes allegations substantially similar to those made in the Teva Antitrust Litigation. On March 17, 2025, Corcept filed a cross-complaint against the plaintiffs in the Aetna Litigation and a notice to remove this lawsuit from state court to federal court. On September 18, 2025, the United States District Court for the Northern District of California granted the plaintiffs’ motion to remand this case back to the state court. We have petitioned the Court to dismiss this case or, in the alternative, stay the proceedings pending the resolution of the Teva Antitrust Litigation.
Other Litigation
On April 10, 2026, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California by Mark LeRiger, captioned LeRiger v. Belanoff et al., Case No. 3:26-cv-03106 (N.D. Cal.). This complaint names as defendants several of our executive officers, all current members of our board of directors and one former director. Corcept is named as a nominal defendant. Based on the same statements at issue in the Securities Action, the complaint asserts claims for violations of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder, breach of fiduciary duty, unjust enrichment, waste of corporate assets, and disgorgement of insider trading profits. The complaint seeks unspecified monetary relief and various forms of equitable relief, including disgorgement. We intend to seek a stay of this lawsuit pending resolution of any motion to dismiss the Securities Action.
November 2021 Records Subpoena
In November 2021, we received a records subpoena from the United States Attorney’s Office for the District of New Jersey (the “NJ USAO”) pursuant to Section 248 of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) seeking certain information relating to Korlym. The NJ USAO has informed us that it does not currently consider us a defendant but rather an entity whose conduct is within the scope of the government’s investigation regarding matters referenced in the subpoena.
In addition to the above-described matters, we are involved from time-to-time in other legal proceedings arising in the ordinary course of our business. Although the outcome of any such matters and the amount, if any, of our liability with respect to them cannot be predicted with certainty, we do not believe that they will have a material adverse effect on our business, results of operations or financial position.
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