Integra LifeSciences Reports Second Quarter 2026 Financial Results

On July 29, 2026 Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2026.

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Second Quarter 2026 Highlights

•Second quarter revenues of $418.8 million increased 0.8% on a reported basis and 0.7% on an organic basis compared to the prior year.

•Second quarter GAAP earnings per diluted share of $0.06, compared to $(6.31) in the prior year.

•Adjusted earnings per diluted share of $0.56, compared to $0.45 in the prior year.

•The Company is updating its reported revenue guidance range to $1.654 billion to $1.695 billion to reflect the impact of a stronger U.S. dollar on foreign exchange rates.

•The Company is reaffirming its 2026 full-year organic revenue growth guidance of 0.8% to 3.3% and adjusted earnings per share guidance of $2.40 to $2.50.

•The Company initiated production at its Braintree manufacturing facility and remains on track for the planned fourth-quarter relaunch of SurgiMend.

"Our second-quarter performance reflects meaningful progress on our most important priorities. We are improving supply reliability, advancing quality, and returning products to market with discipline. The Braintree facility is now producing and ramping to support the planned SurgiMend relaunch later this year," said Stuart Essig, Chairman and CEO of Integra LifeSciences.

"At the same time, we are seeing the benefits of a more aligned commercial organization while we continue to reduce our balance sheet leverage. Supported by our broad portfolio, attractive markets, and focused leadership team, we are strengthening our operating foundation and enhancing our ability to deliver sustainable long-term shareholder value."
Second Quarter 2026 Consolidated Performance
Total reported revenues of $418.8 million increased 0.8% on a reported basis and 0.7% on an organic basis compared to the prior year.
The Company reported GAAP gross margin of 52.5%, compared to 50.4% in the second quarter of 2025. Adjusted gross margin was 61.3%, compared to 60.7% in the prior year.
Adjusted EBITDA for the second quarter of 2026 was $78.4 million, or 18.7% of revenue, compared to $71.2 million, or 17.1% of revenue, in the prior year.
The Company reported GAAP net income of $4.5 million, or $0.06 per diluted share, in the second quarter of 2026, compared to GAAP net loss of $(484.1) million, or $(6.31) per diluted share, in the prior year.

Adjusted net income for the second quarter of 2026 was $43.7 million, or $0.56 per diluted share, compared to $34.4 million, or $0.45 per diluted share, in the prior year.

Second Quarter 2026 Segment Performance
Specialty Surgery (~70% of Revenues)
Total revenues were $309.3 million, representing reported growth of 1.7% and an organic growth of 1.6% compared to the second quarter of 2025.

•Sales in Neuro increased 1.9% on an organic basis primarily driven by growth in Certas Plus, Bactiseal and CUSA.
•Sales in Instruments grew 3.2% on an organic basis.
•ENT sales declined (1.9%) as MicroFrance ENT instrument growth was offset by declines in other products.

Tissue Reconstruction (~30% of Revenues)

Total revenues were $109.5 million, representing reported and organic declines of (1.9)% and (2.0)% respectively compared to the second quarter of 2025. Key drivers for the quarter include:

•Mid-single digit decline in wound reconstruction, driven by strong growth in DuraSorb and the relaunch of PriMatrix, offset by declines in MicroMatrix and Integra Skin. Integra Skin faced a prior year comparison that included the clearance of back orders in the second quarter of 2025.
•Sales in private label grew 4.7%.

Balance Sheet, Cash Flow and Capital Allocation
The Company generated cash flow from operations of $22.8 million in the quarter. Net debt at the end of the quarter was $1.6 billion, and the consolidated total leverage ratio was 4.1x.

As of the end of the quarter, the Company had total liquidity of approximately $496 million, including $274.1 million in cash plus short-term investments and the remainder available under its revolving credit facility.
2026 Revenue and Adjusted Earnings Per Share Guidance

For the third quarter of 2026, the Company expects reported revenues in the range of $410 million to $425 million, representing reported growth of 2.0% to 5.7% and organic growth of 1.9% to 5.7%. The Company expects adjusted EPS in the range of $0.53 to $0.61 per share.

The Company is updating its reported revenue outlook from a range of $1.662 billion to $1.702 billion to a range of $1.654 billion to $1.695 billion to reflect the impact of a stronger U.S. dollar on foreign exchange rates. For the full year 2026, the Company is reaffirming its organic revenue growth guidance of 0.8% to 3.3% and adjusted earnings per share guidance of $2.40 to $2.50. The adjusted EPS outlook reflects updated tariff assumptions, a higher interest rate environment, and potential debt refinancing actions.

The Company’s organic sales growth guidance for the third quarter and full year excludes the impact of acquisitions, divestitures, and foreign currency.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, July 29, 2026, to discuss second quarter 2026 financial results and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra’s management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.

A live webcast will be available on the Investors section of the Company’s website at investor.integralife.com. For those planning to participate on the call, register here to receive dial-in details and an individual pin. While not required, it is recommended to join 10 minutes prior to the event’s start. A webcast replay of the conference call will be available on the Investors section of the company’s website following the call.

(Press release, Integra LifeSciences, JUL 29, 2026, View Source [SID1234669492])

INOVIO Announces Proposed Public Offering

On July 29, 2026 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof), in an underwritten public offering. INOVIO intends to grant the underwriter a 30-day option to purchase additional shares of its common stock and/or accompanying warrants in an amount up to 15% of the shares of its common stock and/or accompanying warrants offered in the public offering under the same terms and conditions. All of the securities in the proposed offering will be sold by INOVIO. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Piper Sandler is acting as sole manager for the offering.

A shelf registration statement relating to the shares of common stock and accompanying warrants offered in the offering described above was filed with the Securities and Exchange Commission ("SEC") on July 2, 2026 and declared effective by the SEC on July 10, 2026. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting: Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Inovio, JUL 29, 2026, View Source [SID1234669491])

ImmunityBio Receives United Arab Emirates (UAE) Marketing Authorization for ANKTIVA® Across BCG-Unresponsive Non-Muscle Invasive Bladder Cancer for CIS and Papillary Disease and Metastatic Non-Small Cell Lung Cancer

On July 29, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage biotechnology company, reported that the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted Marketing Authorization for ANKTIVA (nogapendekin alfa inbakicept) across two indications. The authorization covers ANKTIVA 0.4 mg in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC, and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC. With this action, the UAE becomes the fifth regulatory jurisdiction to authorize ANKTIVA, expanding its global footprint to 34 countries. The UAE has taken the lead in the broadest approval of ANKTIVA to date. The NMIBC authorization is the first anywhere in the world to span carcinoma in situ (CIS) and papillary disease, including patients with papillary-only tumors in the absence of CIS.

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World’s First Approval Spanning the Full Spectrum of BCG-Unresponsive Disease in NMIBC

Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors and BCG-unresponsive NMIBC with papillary tumors. Eligible patients therefore include those with CIS alone, CIS accompanied by papillary tumors, and papillary disease alone without CIS.

BCG-unresponsive NMIBC carries a high risk of progression and, historically, radical cystectomy has been the standard option for patients who fail BCG. An approval that spans CIS and papillary disease addresses a defined unmet need across the disease spectrum by offering an alternative immunotherapy option.

"For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options. This approval by the Emirates Drug Establishment is the first in the world to reach across the entire spectrum of non-muscle invasive bladder cancer from carcinoma in situ with or without papillary tumors, and, for the first time, papillary disease alone. Since the National Cancer Institute ranked IL-15 as the number one priority cytokine for cancer immunotherapy in 2007, we have worked to translate that biology into an immunotherapy that activates the trifecta of natural killer cells, CD8+ killer T cells, and memory T cells to deliver durable responses. That same immunological backbone now extends to lung cancer, where ANKTIVA, by stimulating NK cells which target tumor cells that have lost MHC-I T cell receptors, can restore the immune response in patients whose disease has progressed on checkpoint therapy. This approval in lung cancer patients who failed checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.

Authorization in Checkpoint-Refractory Metastatic Non-Small Cell Lung Cancer

Per the approved UAE Summary of Product Characteristics, ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alterations should have disease progression on approved therapy for those alterations, before receiving ANKTIVA in combination with immune checkpoint inhibitors. In this indication, ANKTIVA is administered as a fixed 1 mg subcutaneous dose once every 21 days for the duration of checkpoint inhibitor therapy.

Checkpoint inhibitor resistance represents a defined unmet need in metastatic NSCLC, with limited options and poor survival after progression. By activating the natural killer and memory T cells that checkpoint inhibitors alone do not reach, ANKTIVA is designed to restore anti-tumor immunity in this setting.

Clinical Evidence Supporting the Approvals

NMIBC Indication: The NMIBC authorization is supported by QUILT-3.032, the multicenter registrational trial of ANKTIVA plus BCG in BCG-unresponsive NMIBC (ClinicalTrials.gov NCT03022825).

Papillary Disease Alone (QUILT-3.032, Cohort B): In the papillary-only cohort (papillary disease without CIS; N=80), the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with a median disease-free survival of 25.3 months, and 83.1% of patients avoided cystectomy at 36 months as shown in the table below.

In the QUILT-3.032 program, most treatment-related adverse events were Grade 1 or 2; Grade 3 treatment-related adverse events occurred in 1% of patients, and no Grade 4 or Grade 5 treatment-related events were reported.

NSCLC Indication: The NSCLC authorization is supported by QUILT-3.055 (ClinicalTrials.gov NCT03228667), a Phase 2 study of ANKTIVA in combination with a checkpoint inhibitor in patients with advanced NSCLC whose disease had progressed on prior checkpoint inhibitor therapy (N=79). Median overall survival was 14.6 months (95% CI: 12.0, 19.5). Among the 77% of patients who achieved an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival was 16.2 months (95% CI: 13.8, 22.0). The table below summarizes these findings.

In QUILT-3.055, the most common NAI-related adverse drug reactions were injection site reaction (86%), chills (46%), fatigue (32%), pyrexia (28%), nausea (16%), injection site erythema and injection site pruritus (15% each), injection site pain (14%), influenza like illness (13%), decreased appetite (10%).

Regulatory Details

The EDE issued Marketing Authorization approval for both presentations with first registration in July 2026 and validity through July 2031. ANKTIVA 0.4 mg (solution for intravesical instillation), indicated for BCG-unresponsive NMIBC, is registered under No. 78609-45860-260486. ANKTIVA 1.2 mg (solution for subcutaneous injection), indicated for metastatic NSCLC, is registered under No. 78609-1572-260487. ImmunityBio, Inc. is the Marketing Authorization Holder, with Modern Pharmaceutical Company serving as the local agent in the United Arab Emirates. The UAE is the fifth regulatory jurisdiction to authorize ANKTIVA, following the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the European Union, and expands the global footprint of ANKTIVA to more than 30 countries.

"With this authorization, the global regulatory footprint for ANKTIVA now includes 34 countries. Securing approvals across two distinct indications, bladder cancer and lung cancer, on the strength of the same data packages we submitted to the FDA, positions us to broaden access across the Gulf region through our partnership with Modern Pharmaceutical Company, in markets where the need for new treatment options is significant," said Richard Adcock, President and Chief Executive Officer of ImmunityBio.

Sources

Chamie K, et al. IL-15 Superagonist NAI (N-803) plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer. NEJM Evidence. 2023;2(1). (CIS cohort complete response rate.)
QUILT-3.032 updated analyses, including the papillary-only (Ta/T1) cohort and extended duration-of-response follow-up, as presented at AUA 2025 and disclosed by ImmunityBio, Inc.
QUILT-3.055 Phase 2 overall survival results in checkpoint-refractory advanced NSCLC, as disclosed by ImmunityBio, Inc. (ClinicalTrials.gov NCT03228667).
gov Identifiers NCT03022825 (QUILT-3.032) and NCT03228667 (QUILT-3.055).
Emirates Drug Establishment, Product Marketing Authorization Approval certificates and approved Summaries of Product Characteristics, Registration Nos. 78609-45860-260486 (NMIBC) and 78609-1572-260487 (NSCLC), first registration 24 July 2026.
Immunotherapy Agent Workshop, July 12, 2007 NCI, View Source
Cancer Immune Evasion Through Loss of MHC Class I Antigen Presentation. Karthik Dhatchinamoorthy, et. al. View Source
About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, JUL 29, 2026, View Source [SID1234669490])

HCW Biologics Inc. Announces Pricing of $1.6 Million Private Placement Offering

On July 29, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics"), (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia, reported the pricing of its $1.6 million private placement offering (the "Offering") with a group of investors, including officers, directors and an existing stockholder of the Company, (each, and "Investor" and collectively, the "Investors’). Pursuant to a securities purchase agreement entered into with the Investors (the "Purchase Agreement"), the Company agreed to issue and sell an aggregate of 618,682 units (the "Units"), with each Unit consisting of (i) one share of the Company’s common stock, par value $0.0001 per share ("Common Stock"), or, in lieu thereof, one pre-funded warrant to purchase one share of Common Stock (a "Pre-Funded Warrant"), and (ii) the right to receive one common stock purchase warrant (a "Common Warrant") to purchase one share of Common Stock upon, and subject to, stockholder approval of the issuance thereof.

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In connection with the Offering, the Company will issue 218,682 shares of Common Stock and 400,000 Pre-Funded Warrants. Subject to stockholder approval, which the Company is obligated to seek pursuant to the terms of the Purchase Agreement, the Investors will also be entitled to receive Common Warrants to purchase up to an aggregate of 618,682 shares of Common Stock.

Hing C. Wong, Ph.D., the Company’s Founder and Chief Executive Officer, Scott Garrett, a member and the Chairman of the Company’s Board of Directors, and Lee Flowers, the Company’s Senior Vice President of Business Development, participated in the Offering on the same terms and conditions as the other Investor. The closing of the Offering is expected to occur on or about July 29, 2026, subject to the satisfaction of customary closing conditions.

The combined purchase price for each Unit consisting of one share of Common Stock and the right to receive one Common Warrant upon, and subject to, stockholder approval of the issuance thereof, was $2.585 per Unit. The combined purchase price for a Pre-Funded Warrant and the right to receive one Common Warrant upon, and subject to, stockholder approval of the issuance thereof, was $2.5849 per Unit. The Pre-Funded Warrants have an exercise price of $0.0001 per share of Common Stock, are exercisable immediately and will not expire until exercised in full. The Common Warrants will have an exercise price of $2.585 per share and will expire on the five and one half (5.5) year anniversary of their issuance. Under Nasdaq Listing Rule 5635(d), the Company is required to obtain stockholder approval before issuing the Common Warrants because the potential issuance of shares upon exercise of the Common Warrants could exceed the thresholds set forth in such rule. Following receipt of stockholder approval, the Company will issue the Common Warrants to the Investors in accordance with the Purchase Agreement.

The Company intends to use the net proceeds from this Offering to continue clinical trials for HCW9302, advance its IND-enabling studies for its T-Cell Engager, HCW11-018b, and its second-generation immune checkpoint inhibitor, HCW11-040, and for general corporate purposes.

On July 29, 2026, the Company also entered into a registration rights agreement with the Investors, pursuant to which the Company agreed to submit to the U.S. Securities and Exchange Commission (the "SEC") a registration statement on Form S-1 within 15 trading days of the closing of the Offering covering the resale of the shares of Common Stock sold in the Offering, the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants and the shares of Common Stock issuable upon exercise of the Common Warrants. The Company also agreed to use commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within 60 days following the closing of the Offering.

The number of shares of Common Stock the Company that may be held by an Investor, including those shares issued at closing and upon the exercise of Pre-Funded Warrants from time to time in the Offering, may not exceed 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such issuances.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, HCW Biologics, JUL 29, 2026, View Source [SID1234669489])

Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update

On July 29, 2026 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, reported its results for the quarter ended June 30, 2026.

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Financial Results

"Our oncology and Cushing’s syndrome businesses delivered strong results in the second quarter.
In our oncology business, over 1,300 patients have now started treatment with Lifyorli following FDA approval in March 2026. Demand for Lifyorli has accelerated each month with physicians responding favorably to Lifyorli’s efficacy and safety profile, oral administration and lack of biomarker requirement.

Our Cushing’s syndrome business, once again, had a record number of new prescriptions written for our medications as physicians increasingly recognize hypercortisolism’s true prevalence and the necessity of appropriate treatment. We expect this trend to continue as the findings from our CATALYST and MOMENTUM studies are fully incorporated into clinical practice.

We anticipate continued strength across our businesses and have increased our 2026 revenue guidance to $1.1 – $1.2 billion," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Corcept’s second quarter 2026 revenue was $256.1 million, compared to $194.4 million in the second quarter of 2025. Korlym and authorized generic product revenue was $208.6 million, compared to $194.4 million in the prior year period. Lifyorli product revenue was $47.6 million in its first quarter of availability.

Second quarter 2026 operating expenses were $214.8 million, compared to $167.8 million in the same period in 2025, due to increased spending to launch Lifyorli and investments in our Cushing’s syndrome business. Net income per common share (diluted) was $0.36 in the second quarter of 2026, compared to $0.29 in the prior year period.
Cash and investments were $544.6 million at June 30, 2026, compared to $515.4 million at March 31, 2026.

Clinical Development

"The FDA’s approval of Lifyorli (relacorilant) in platinum-resistant ovarian cancer is the first step in advancing glucocorticoid receptor antagonism as a treatment for many types of cancer. Our oncology development program aims to establish the broad utility of our medicines to help many more patients. We anticipate that the European Medicines Agency will approve our Marketing Authorization Application of relacorilant in platinum-resistant ovarian cancer later this year. We expect results from our trial of relacorilant with nab-paclitaxel and bevacizumab in patients with platinum-resistant ovarian cancer by the end of this year. Our studies of relacorilant to treat platinum-sensitive ovarian, endometrial, cervical and pancreatic cancers are expected to produce results by the end of next year. Our study of nenocorilant with the PD-1 checkpoint inhibitor nivolumab to treat a variety of solid tumors will also produce results by the end of next year," said Dr. Belanoff.
"We resubmitted our New Drug Application (NDA) for relacorilant in Cushing’s syndrome in June. Relacorilant has the potential to help many patients and it’s important it is available as quickly as possible. We expect a decision on our NDA by December 17, 2026.
In addition, results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH), are expected by the end of this year. We also plan to start a Phase 3 trial of dazucorilant in patients with ALS, with the goal of replicating the significant survival benefit observed in our Phase 2 DAZALS study," added Dr. Belanoff.

Hypercortisolism (Cushing’s Syndrome)

•Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026
•GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in The Lancet Diabetes & Endocrinology (Pivonello et al, February 2026)
•CATALYST and MOMENTUM – New data presented at American Diabetes Association’s (ADA) 86th Scientific Sessions in June
"Our studies have shown that patients with hypercortisolism who receive relacorilant experience clinically and statistically significant improvements in the multiple signs and symptoms of the disease. Importantly, relacorilant delivers these improvements without the off-target effects and serious adverse events associated with currently available treatments," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Relacorilant has the potential to become the new standard of care."
"The need for better treatment for patients with hypercortisolism is urgent. Our CATALYST and MOMENTUM studies demonstrate that hypercortisolism is an underlying driver of disease for many patients with diabetes and hypertension whose health is at risk because their disease isn’t adequately managed with standard-of-care treatments. These findings will lead to increased screening and improved treatment for patients with hypercortisolism," added Dr. Guyer.

Oncology

Relacorilant in Combination with Chemotherapy
•FDA approved Lifyorli (relacorilant) plus nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer in March 2026
•Lifyorli plus nab-paclitaxel added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen in April 2026
•Marketing Authorization Application (MAA) – European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of this year
•ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – Both dual primary endpoints (progression-free and overall survival) met – Results published in The Lancet (Lorusso et al, April 2026)
•BELLA Part A – Enrollment completed in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer – Results expected by the end of this year.

•BELLA Part B – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor – Results expected by the end of next year
•BELLA Part C – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy) – Results expected by the end of next year
•STELLA – Initiated Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy), conducted in collaboration with ARCAGY-GINECO – Results expected by the end of next year
•TRIDENT – Enrollment continues in Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 60 patients with pancreatic cancer – Results expected by the end of next year
Relacorilant in Combination with Androgen Deprivation Therapy
•Prostate cancer – Enrollment continues in randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in 90 patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
Nenocorilant in Combination with Immunotherapy
•SYNERGY – Enrollment continues in Phase 1b dose-finding trial of nenocorilant plus nivolumab in 30 patients with a variety of solid tumors – Results expected by the end of next year
"There is tremendous potential for glucocorticoid receptor antagonism to help treat many types of solid tumors. Our Phase 3 ROSELLA trial demonstrated that adding Lifyorli to nab-paclitaxel chemotherapy reduced the risk of death in patients with platinum-resistant ovarian cancer by 35 percent, without the need for biomarker selection. Our ongoing oncology studies, many of which will produce results by the end of next year, build on these findings by evaluating the role of our medications across a broad range of tumor types and treatment combinations. We will continue to advance and expand our research to realize the substantial opportunity before us," added Dr. Guyer.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

•MONARCH – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 175 patients with biopsy-confirmed or presumed MASH – Results expected by the end of this year
"Data from our Phase 1b study demonstrated that miricorilant rapidly reduced liver fat while improving fibrosis, liver enzymes and other markers of liver health, including key metabolic and lipid measures. We look forward to building on these promising findings in our Phase 2b MONARCH study, with results expected by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)
•DAZALS – Exploratory analyses showed that patients who received dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009) – This benefit persisted into the study’s second year with an 87 percent reduction in risk of death (hazard ratio: 0.13, p-value: < 0.0001)
•Phase 3 trial – Planned to begin early next year
"Patients with ALS often have elevated cortisol levels. Data from our Phase 2 DAZALS study showed that patients treated with dazucorilant exhibited a profound reduction in early mortality, during a period when many patients with ALS still retain significant function and maintain good quality of life," said Dr. Guyer. "Our ongoing dose-titration study’s goal is to improve gastrointestinal tolerability and inform next steps for this program."

Conference Call
We will hold a conference call on July 29, 2026, 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. 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.

(Press release, Corcept Therapeutics, JUL 29, 2026, View Source [SID1234669488])