On September 10, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer diagnostics, reported the launch of the Cancerguard test, a new multi-cancer early detection (MCED) blood test that is now available as a laboratory-developed test (LDT) in the United States (Press release, Exact Sciences, SEP 10, 2025, View Source [SID1234655919]). Cancerguard is the first MCED test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.

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Nearly 70 percent of annual cancer cases and deaths in the U.S. occur in cancers with no recommended screening.1,2,3 The Cancerguard test can help address the unmet need by complementing existing routine screening and extending the reach of early detection. With a simple blood draw, the Cancerguard test can detect signals from cancer types responsible for more than 80 percent of annual U.S. cancer diagnoses, including some with the highest mortality rates, such as pancreatic, ovarian, liver, esophageal, lung, and stomach cancers.1,4 Overall, the Cancerguard test can detect more than 50 cancer types and subtypes.5

The Cancerguard test delivered 68 percent sensitivity across six of the deadliest cancers and 64 percent overall sensitivity across a broader range of cancers, excluding breast and prostate, in test-development studies. It also found more than a third of stage I or II cancers, demonstrating its ability to detect disease when it’s most treatable.1,2,4* Additionally, the test achieved high specificity of 97.4 percent, helping to minimize false positives and avoid unnecessary procedures.4 Modeling shows that over a 10-year period, use of Exact Sciences’ MCED technology alongside current screening methods could reduce stage IV cancer diagnoses by 42 percent and lower overall cancer-related mortality by 18 percent.6 Together, these findings underscore the Cancerguard test’s potential to meaningfully improve outcomes and elevate the standard of cancer detection.

The Cancerguard test will be delivered through Exact Sciences’ expansive commercial and operational infrastructure, including a national sales force that engages primary care physicians, oncologists, and leading health systems. To support patient access, Exact Sciences has entered into an agreement with Quest Diagnostics to enable blood collection at the company’s approximately 7,000 patient access sites across the U.S., including through its patient service centers and in-office phlebotomists in provider offices, as well as mobile phlebotomy services for at-home collections.

"Cancerguard builds on the legacy of Cologuard, which has delivered more than 20 million test results and transformed colorectal cancer screening," said Kevin Conroy, chairman and CEO of Exact Sciences. "Backed by strong science and developed to screen for many of the deadliest cancers, the Cancerguard test represents the next bold step in our mission to detect cancer earlier. With deep, trusted relationships across the health care system, Exact Sciences has the reach, credibility, and commitment to bring earlier answers to more people. This is the moment where we begin to change the course of cancer forever and give people power over their futures."

The Cancerguard test is the culmination of nearly a decade of development and is backed by rigorous science in partnership with top academic institutions. The test is supported by data from robust test-development studies, such as DETECT-A and ASCEND 2, involving more than 20,000 participants, including the first-ever prospective interventional MCED trial.7,8,9 To further validate clinical utility and support broad adoption, Exact Sciences is actively enrolling up to 25,000 participants in the Falcon registry, a real-world evidence study conducted under a U.S. FDA-reviewed Investigational Device Exemption (IDE).10 This comprehensive body of evidence is designed to inform future regulatory submissions, support payer discussions on coverage and reimbursement, and guide efforts to include the Cancerguard test in clinical guidelines.

"The Cancerguard test offers a critical early warning that cancer may be present and helps inform an imaging-guided pathway to diagnosis, giving people the chance to act when it matters most," said Dr. Tom Beer, chief medical officer for multi-cancer early detection at Exact Sciences. "As adoption grows, we’ll look back and ask how we ever settled for screening for only a few cancers while letting the majority go undetected. Like the smartphone redefined communication, Cancerguard has the power to redefine cancer detection and the future of early intervention."

Exact Sciences delivers the Cancerguard test with comprehensive support for both patients and clinicians. The test integrates seamlessly into existing workflows and electronic medical records (EMRs) and is backed by industry-leading care navigation support, including dedicated support for patients with positive results. The Cancerguard test is recommended for individuals aged 50-84 with no known cancer diagnosis in the past three years and can be considered annually. It is priced at $689 and may be eligible for flexible spending and health savings account use, with payment plans available. Additional financial support includes a patient imaging assistance program** to help reduce the impact of non-covered imaging costs for eligible patients. The Cancerguard test is currently available for providers to order at www.exactsciences.com/cancerguard, with broader consumer telehealth access beginning in October 2025 at www.cancerguard.com.

On September 10, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported the publication of a peer-reviewed article in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Alligator Bioscience, SEP 10, 2025, View Source [SID1234655916]). The paper presents preclinical data on ATOR-4066, a bispecific antibody targeting CD40 and CEACAM5 developed using Alligator’s proprietary Neo-X-Prime platform and RUBY format.

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The study, titled "ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, induces strong myeloid and T cell dependent tumor immunity and synergizes with PD-1 blockade", highlights the potential of ATOR-4066 to overcome key resistance mechanisms in the tumor microenvironment. The data demonstrates that ATOR-4066 induces localized activation of myeloid cells and T cells within the tumor, while sparing healthy peripheral tissues, resulting in potent antitumor immunity.

Key findings from the publication include:

Tumor-localized activation: ATOR-4066 selectively activated CD40 in human tumor samples.
Potential to outperform other tumor targeting therapies: ATOR-4066 mediates strong anti-tumor activity also in tumors with heterogenous CEACAM5 expression.
Turning the tumor hot: Mechanistic analyses shows that ATOR-4066 efficiently activates the immune system in the tumor resulting in tumor rejection.
Synergy with checkpoint blockade: ATOR-4066 demonstrated synergistic activity with anti-PD-1 treatment.
"Publication of these data in Cancer Immunology Research underscores the potential of our Neo-X-Prime platform and RUBY format to generate bispecific antibodies capable of reshaping the tumor microenvironment and driving durable immune responses," said Søren Bregenholt, CEO of Alligator Bioscience. "As a follow-on to mitazalimab, ATOR-4066 represents a promising new therapeutic strategy for CEACAM5-expressing tumors and provides further evidence of Alligator’s strength in developing tumor-targeted CD40 agonists."

On September 10, 2025 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 that the U.S. Food and Drug Administration (FDA) has accepted Corcept’s New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, SEP 10, 2025, https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0 [SID1234655914]). The FDA has assigned a PDUFA date of July 11, 2026 for the application.

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Corcept’s NDA is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, relacorilant conferred its benefit without increasing the safety burden of the patients who received it. The type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms.

"The FDA’s acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease," said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. "Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated."

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

On September 9, 2025 Celcuity Inc. ("Celcuity"), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC ("Innovatus") and Oxford Finance LLC ("Oxford") (Press release, Celcuity, SEP 9, 2025, View Source [SID1234655918]). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. At the closing of the Amendment, the initial funding under the amended credit facility was in a principal amount of $30 million, bringing the total term loan outstanding to $130 million.

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Highlights of the amended credit facility include:

● Increased Capital Availability: Adds $170 million in new committed capital, including an additional $50 million for a total of $100 million available upon U.S. Food and Drug Administration ("FDA") approval of gedatolisib in second-line wild-type advanced breast cancer ("ABC") patients post-CDK4/6 inhibitor therapy, and $120 million upon achievement of certain commercial revenue milestones. An additional up to $150 million is also available at the mutual discretion of Celcuity and its lenders.
● Improved Structure and Financial Flexibility: Extends the interest-only period by 14 months, with an additional seven-month extension available upon FDA approval. The maturity date of the facility was also extended by six months.

The amendment significantly enhances Celcuity’s financial flexibility and access to capital following the positive topline data from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 Phase 3 clinical study. The upsized facility strengthens Celcuity’s ability to manage its capital structure efficiently while providing additional funding to support the rolling submission to FDA of its New Drug Application ("NDA") via FDA’s RTOR program, commercial launch preparations for gedatolisib, and other strategic initiatives.

On September 9, 2025 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Actuate Therapeutics, SEP 9, 2025, View Source [SID1234655915]). The Company also expects to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of shares of its common stock offered in the public offering at the public offering price per share, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company intends to use the net proceeds from the proposed offering for working capital and general corporate purposes.

Lucid Capital Markets is acting as sole book-running manager for the offering.

The common stock described above is being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-289988), including a base prospectus, previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement describing the terms of the offering will be filed with the SEC. The offering will be made only by means of the prospectus supplement and the accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. Copies of the preliminary prospectus supplement, and accompanying base prospectus relating to this offering, may be obtained from Lucid Capital Markets, LLC, 570 Lexington Avenue, 40th Floor, New York, NY 10022.

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