Genmab Announces Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2025

On October 14, 2025 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,672 million in the third quarter of 2025. Net trade sales were USD 2,088 million in the U.S. and USD 1,584 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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(Press release, Genmab, OCT 14, 2025, View Source [SID1234656638])

Corcept Submits Marketing Authorization Application to European Medicines Agency for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

On October 14, 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 it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

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Corcept’s MAA submission 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, the type, frequency and severity of adverse events in the combination arms were comparable to those in the nab-paclitaxel monotherapy arms. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it.

The U.S. Food and Drug Administration (FDA) is reviewing Corcept’s application to market relacorilant in the United States to treat patients with platinum-resistant ovarian cancer. The FDA’s Prescription Drug User Fee Act (PDUFA) target action date is July 11, 2026.

"Our MAA submission brings us a step closer to our goal of delivering relacorilant to patients with platinum-resistant ovarian cancer," said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. "Better treatment options are urgently needed. 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, and a PDUFA date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer.

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.

(Press release, Corcept Therapeutics, OCT 14, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-submits-marketing-authorization-application-european [SID1234656635])

Circle Pharma Announces Upcoming Poster Presentation Highlighting the Anti-tumor Potential of Cyclin D1 RxL Inhibition at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 14, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported an upcoming poster presentation highlighting the preclinical anti-tumor potential of cyclin D1 RxL inhibition at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held from October 22 – 26, 2025, in Boston, MA.

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Details of the presentation are as follows:

Title: First-in-class Oral Macrocyclic Cyclin D1-selective Inhibitors Demonstrate Anti-Tumor Activity in Cyclin D1-dependent Tumors

Session: Poster Session A

Date & Time: Thursday, October 23, 12:30-4:00 p.m. ET

About Circle Pharma’s Oral Cyclin D1 RxL Inhibitor Program

Cyclin D1 is overexpressed in certain solid tumors and hematologic malignancies. In these cancers, the cyclin D1/CDK4 complex drives cell proliferation by binding to the tumor suppressor retinoblastoma protein (Rb) and promoting its phosphorylation and inactivation. Using its MXMO platform, Circle Pharma has developed oral macrocyclic inhibitors that potently and selectively disrupt the cyclin D1-Rb interaction, demonstrating robust anti-tumor activity in cyclin D1-driven cancers.

(Press release, Circle Pharma, OCT 14, 2025, View Source [SID1234656633])

Candel Therapeutics Enters into $130 Million Term Loan Facility with Trinity Capital Inc.

On October 14, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that it has entered into a five-year, $130 million term loan facility with Trinity Capital Inc. (Nasdaq: TRIN) ("Trinity Capital").

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The loan facility consists of four tranches, with the first tranche of $50 million drawn upon closing of the agreement. The second and third tranches totaling $50 million in the aggregate are available to be drawn subject to the achievement of certain regulatory, clinical and operational milestones, subject to certain conditions precedent described in the agreement, and the fourth tranche of $30 million is available at the lender’s discretion. Interest is payable on the outstanding principal amount at a fixed or floating rate at the Company’s option, initially 10.25% per annum. The loan facility has a five-year term with an interest-only period of 36 months, which is extendable for an additional 12 months upon achievement of a certain commercial milestone. The loan facility contains customary representations, warranties, covenants, and events of default.

"This strategic financing, combined with our cash and cash equivalents of $87.2 million, as of September 30, 2025, significantly strengthens our balance sheet, positioning the Company for the initiation of a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2’26, and supporting the Company through its potential launch in early localized prostate cancer and into commercialization," commented Charles Schoch, CFO of Candel Therapeutics. "This transaction and use of proceeds reflects our disciplined capital allocation approach."

"We believe Candel’s strong clinical data and innovative approach positions them well to make a real impact for patients facing prostate cancer and NSCLC – conditions with large commercial opportunities and a continued unmet need," said Rob Lake, Senior Managing Director of Life Sciences at Trinity Capital. "Our investment underscores Trinity’s commitment to provide flexible capital solutions to innovative life sciences companies that are working on bringing important therapies to patients and providers worldwide."

Paul Peter Tak, M.D., Ph.D., FMedSci, highlighted, "In parallel to this transaction, the Company has also made further portfolio prioritization decisions, and will seek externally funded partnerships for the clinical development of CAN-2409 in pancreatic ductal adenocarcinoma (PDAC). While we have compelling phase 2a data, successfully conducted enabling work for a phase 2b/3 clinical trial in this indication, had a positive Scientific Advisory Board meeting, and were awarded Orphan Designation by the EMA, we decided to completely focus our resources and capital for CAN-2409 on early localized prostate cancer and NSCLC, reinforcing our commitment to advancing breakthrough therapies for patients in two of the largest oncology indications, while delivering sustainable value to shareholders. Furthermore, based on the positive interim data for multiple injections of CAN-3110 in recurrent glioblastoma, from the ongoing phase 1b clinical trial that is funded by the Break Through Cancer foundation, we will conduct enabling work for the design of a small randomized controlled phase 2 clinical trial in this indication, which is within the current budget."

Proceeds from this facility will be used (i) with respect to the first tranche, solely to refinance that certain Loan and Security Agreement, dated as of February 24, 2022, by and between First-Citizens Bank & Trust Company (as successor to Silicon Valley Bank) and the Company, on the closing date and as working capital and to fund its general corporate purposes, initiation of a pivotal phase 3 clinical trial of CAN-2409 in NSCLC, while preparing for expected submission of a Biologics License Application for CAN-2409 in prostate cancer in the fourth quarter of 2026, and (ii) with respect to any subsequent tranche of loans, solely as working capital and to fund its general corporate purposes, completion of critical launch readiness, medical affairs and pre-commercialization activities, funding for potential commercial launch, upon the potential approval from the U.S. Food and Drug Administration (FDA), as well as ongoing costs from the potential phase 3 clinical trial for NSCLC.

Jefferies LLC acted as the Company’s exclusive financial advisor on this transaction.

(Press release, Candel Therapeutics, OCT 14, 2025, View Source [SID1234656632])

Results of Operations and Financial Condition

On October 14, 2025 Biogen Inc. (Biogen) reported that its GAAP and non-GAAP results for the third quarter of 2025 will include acquired in-process research and development, upfront and milestone expense of approximately $2 million on a pre-tax basis (Press release, Biogen, OCT 14, 2025, View Source [SID1234656631]). The estimated charge is expected to impact GAAP and non-GAAP net income per diluted share for the third quarter 2025 by approximately ($0.01) per share.

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During the first quarter of 2025 we began presenting acquired in-process research and development, upfront and milestone expense as a separate line item in our condensed consolidated statements of income. Acquired in-process research and development, upfront and milestone expense includes costs incurred in connection with collaboration and license agreements such as upfront and milestone payments and, when applicable, premiums on equity securities and asset acquisitions of acquired in-process research and development. Biogen does not forecast such acquired in-process research and development, upfront and milestone expense due to the uncertainty of the future occurrence, magnitude and timing of these transactions in any given period.

Results for the quarter ended September 30, 2025, have not been finalized and are subject to our financial statement closing procedures. There can be no assurance that our final results will not differ from the preliminary unaudited estimates described herein.