On November 4, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the company has entered into an agreement to receive funds managed by Blackstone Life Sciences ("Blackstone") for the development of sacituzumab tirumotecan (sac-TMT), an investigational antibody-drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), a protein found on the surface of various cancer cells. Merck is currently evaluating sac-TMT in 15 global Phase 3 clinical trials spanning six tumor types, including breast, endometrial and lung cancers.

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"This agreement positions Merck to harness the potential of sac-TMT, a promising ADC candidate targeting TROP2, while we continue to advance our broad and expansive pipeline," said Caroline Litchfield, chief financial officer, Merck. "We are making important investments to drive patient impact and revenue growth, and to sustain our business for the future while remaining disciplined towards maintaining an appropriate financial profile."

Under the terms of the agreement, Blackstone will pay Merck $700 million (which is non-refundable, subject to termination provisions provided for in the agreement) to fund a portion of the development costs for sac-TMT expected to be incurred throughout 2026. In return, Blackstone is eligible to receive low-to-mid single-digit royalties on net sales of sac-TMT across all approved indications in Merck’s marketing territories contingent upon receipt of regulatory approval in the U.S. for first-line treatment of triple-negative-breast cancer based on findings of the TroFuse-011 clinical trial.

"Sac-TMT is an innovative asset that has the potential to improve patient care across many forms of cancer," said Dr. Nicholas Galakatos, global head, Blackstone Life Sciences. "We are excited to be collaborating with Merck to realize the full value of this high priority product and contribute to our partner’s revenue growth by leveraging our scale capital and expertise."

Sac-TMT is being developed as part of an exclusive license and collaboration agreement with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a holding subsidiary of Sichuan Kelun Pharmaceutical Co, Ltd. ("Kelun-Biotech"), which is unchanged by this agreement with Blackstone. Merck will retain decision-making authority and control over the development, manufacturing, and commercialization of sac-TMT; Blackstone will not receive any rights to sac-TMT.

About sacituzumab tirumotecan (sac-TMT)

Sac-TMT is an investigational ADC that consists of three components: 1) a TROP2-targeting monoclonal antibody, sacituzumab, 2) a cytotoxic payload from the topoisomerase 1 inhibitor class, and 3) a novel, irreversible but hydrolyzable linker, which joins the monoclonal antibody and the cytotoxic payload leveraging proprietary linker conjugation technology. The average drug-to-antibody ratio of sac-TMT is 7.4. TROP2 is highly expressed in a variety of epithelial-derived tumors and can promote tumor cell proliferation, invasion and metastasis. TROP2 ADCs specifically target TROP2-expressing tumor cells to deliver cytotoxic effects and have shown encouraging anti-tumor activity in clinical studies.

Sac-TMT was developed by Kelun-Biotech. Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macau and Taiwan).

(Press release, Merck & Co, NOV 4, 2025, View Source [SID1234659363])

On November 4, 2025 Vivesto AB, an oncology-focused development company, reported that positive results were obtained from preclinical studies in an animal model of Acute Myeloid Leukemia (AML), in which Cantrixil was combined with drugs used in standard of care treatments. Vivesto also announced that a new international patent application covering the treatment of hematological cancer with Cantrixil in combination with other treatments has been filed, with the potential to significantly strengthen the IP position.

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The drug candidate Cantrixil has been evaluated in vivo in combination with other anti-cancer drugs in an animal model involving difficult to treat human AML cancer. The results demonstrate clear positive effects of Cantrixil alone and even stronger effects when Cantrixil was combined with other anti-cancer drugs. These positive results confirm previous preclinical in vitro and in vivo efficacy data that have shown strong effects of Cantrixil alone and synergistic effects when combined with standard of care treatments, and support continued development of Cantrixil in hematological cancer, especially in AML.

"Hematological cancer is one of Vivesto’s priority focus areas, and we are pleased to report successful results from yet another preclinical study supporting further development of the Cantrixil program. The next steps involve further pre-clinical studies ahead of moving the program into clinical development," said Erik Kinnman, CEO of Vivesto. "Vivesto also filed a new international patent application for the treatment of hematological cancer with Cantrixil that may further increase the value of the program."

Vivesto is continuing the planning of activities needed to bring Cantrixil into clinical trials, and in parallel will investigate opportunities to partner the project to optimize the development program.

(Press release, Vivesto, NOV 4, 2025, View Source [SID1234659379])

On November 4, 2025 iLeukon Therapeutics, Inc., a San Diego-based clinical-stage biotechnology company developing next-generation mRNA-based immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application and a phase II protocol evaluating ILKN421H in combination with pembrolizumab for first line and post-IO treatment of patients with advanced NSCLC.

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ILKN421H is a novel LNP-formulated mRNA therapy encoding a non-alpha HSA–IL-2v fusion protein for the treatment of cancer. Administered intravenously every three weeks, ILKN421H achieves efficient and preferential mRNA expression in lymphoid organs with an extended half-life of IL-2v approximately 20 hours. Its non-alpha IL-2v design selectively expands stem-like CD8 T and NK cells, while the mRNA platform overcomes cytokine-sink limitations seen with protein-based IL-2 therapies—offering the potential for greater efficacy with reduced systemic toxicity.

In a first-in-human, open-label Phase I study (NCT05978102), ILKN421H demonstrated antitumor activity and a favorable safety profile, with no cases of vascular-leak syndrome or hypotension. In this trial evaluating ILKN421H as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, ILKN421H was well tolerated, with no dose-limiting toxicities and no maximum tolerated dose reached among the 45 enrolled patients. Combination therapy with pembrolizumab, in first-line NSCLC, achieved a confirmed objective response rate (ORR) of 80% (n=16/20) regardless of PD-L1 expression, with median progression-free survival (PFS) not yet reached and projected to exceed 12 months. The summary of this Phase I study was selected as an oral presentation at the upcoming SITC (Free SITC Whitepaper) Annual Meeting, and the results will be presented on November 8, 2025.

"Next-generation IL-2 agents have been a major focus of the immuno-oncology field for the past decade," said Haining Huang, Chief Executive Officer of iLeukon Therapeutics. "ILKN421H expands cytotoxic lymphocytes—CD8 T cells and NK cells—by up to five- and twenty-five-folds respectively, the first IL-2 based treatment that achieved this level of immune promotion safely. We believe ILKN421H can enhance the efficacy of checkpoint inhibitors, such as pembrolizumab, and may also support future modalities including TIL and in vivo CAR-T therapies. With FDA clearance to proceed to phase II, we look forward to advancing ILKN421H globally to meet the significant unmet needs and to improve the outcomes for patients with NSCLC and potentially other types of cancers in the future."

(Press release, iLeukon Therapeutics, NOV 4, 2025, View Source [SID1234659397])

On November 4, 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 its results for the quarter ended September 30, 2025.

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Financial Results

"The third quarter marked another period of robust growth in our hypercortisolism business. Once again, we had a record number of new prescriptions written for Korlym and continued to add to our base of prescribers. Growing recognition among physicians of hypercortisolism’s true prevalence and the necessity of appropriate treatment is driving higher rates of screening and diagnosis. Our financial results don’t fully reflect this surge in demand, given capacity constraints at our previous specialty pharmacy vendor. We have modified our 2025 revenue guidance to $800 – $850 million. We added a new specialty pharmacy on October 1st and will add others in the coming months. We are confident that these additions will allow us to meet the increasing demand that we now see every month," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Corcept’s third quarter 2025 revenue was $207.6 million, compared to $182.5 million in the third quarter of 2024. Third quarter 2025 operating expenses were $197.4 million, compared to $135.9 million in the same period last year, due to increased spending to prepare for the launches of relacorilant to treat patients with hypercortisolism and platinum-resistant ovarian cancer. Net income per common share (diluted) was $0.16 in the third quarter of 2025, compared to $0.41 in the third quarter of 2024.

Cash and investments were $524.2 million at September 30, 2025, compared to $515.0 million at June 30, 2025. The balance at September 30, 2025 reflects the acquisition of $50.6 million of common stock in the third quarter pursuant to the company’s stock repurchase program as well as shares acquired upon the exercise of employee stock options and the vesting of restricted stock grants.

Clinical Development

"We are approaching important clinical development milestones," said Dr. Belanoff. "Our New Drug Application (NDA) for relacorilant in hypercortisolism has a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025. The PDUFA date for our NDA for relacorilant in platinum-resistant ovarian cancer is July 11, 2026. We believe both deadlines will be met.

"In addition, our clinical studies will soon produce important data. We expect results from MOMENTUM, our trial evaluating the prevalence of hypercortisolism in patients with resistant hypertension, and final overall survival results from our pivotal ROSELLA trial by early next year. Results from our BELLA trial in patients with advanced ovarian cancer should be available by the end of next year, as will results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH)."

"We are also about to start important new studies," added Dr. Belanoff. "These include a Phase 3 trial of dazucorilant in patients with ALS, which will seek to replicate the benefit patients exhibited in our DAZALS trial. In addition, we will initiate Phase 2 trials of relacorilant in combination with chemotherapy and a Phase 1b trial of nenocorilant in combination with immunotherapy in patients with a broad range of solid tumors."

Hypercortisolism (Cushing’s Syndrome)

FDA review of our relacorilant NDA continues, with a December 30, 2025 PDUFA date
MOMENTUM – Enrollment continues in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension; results expected by early next year
CATALYST Part 1 – Prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – Results published in Diabetes Care (Buse et al, April 2025)
CATALYST Part 2 – Randomized, double-blind, placebo-controlled study of Korlym in 136 patients with hypercortisolism and difficult-to-control type 2 diabetes – Results presented at the American Diabetes Association’s 85th Scientific Sessions; published in Diabetes Care (DeFronzo et al, June 2025)
"Relacorilant has the potential to become the new standard of care for patients with hypercortisolism. In its Phase 2 and Phase 3 studies, patients treated with relacorilant showed clinically meaningful and statistically significant improvements in a wide range of hypercortisolism’s signs and symptoms, without off-target effects and toxicities associated with currently available treatments," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

"Our CATALYST study showed that there are significantly more patients with hypercortisolism than previously assumed and that treatment with a cortisol modulator is highly effective in improving their signs and symptoms. We expect that CATALYST’s findings, along with results from our MOMENTUM study examining the prevalence of hypercortisolism in patients with resistant hypertension, will lead to more screening and treatment of patients with hypercortisolism," added Dr. Guyer.

Oncology

Relacorilant in Combination with Chemotherapy

New Drug Application – FDA reviewing NDA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, with a July 11, 2026 PDUFA date
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 next year
ROSELLA – Primary endpoint met in pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – Results presented at the ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) and ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) 2025 annual meetings and published in The Lancet (Olawaiye et al, June 2025) – Final overall survival results expected by early next year
BELLA Part A – Enrollment nearly complete in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-resistant ovarian cancer – Results expected by the end of next year
BELLA Part B – 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 to begin in coming weeks
BELLA Part C – Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy) to begin in coming weeks
Cervical cancer – Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy) to begin in coming weeks, conducted in collaboration with ARCAGY-GINECO, an academic clinical research group specializing in gynecologic cancers
Pancreatic cancer – Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 50 patients with pancreatic cancer to begin in coming weeks
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

Solid tumors – Phase 1b dose-finding trial of nenocorilant, our proprietary selective glucocorticoid receptor antagonist, plus nivolumab in 30 patients with a variety of solid tumors to begin in coming weeks – nenocorilant’s first study in patients
"We are seeking approval of relacorilant in patients with platinum-resistant ovarian cancer (PROC) in both the United States and Europe based on positive data from our Phase 2 and pivotal Phase 3 ROSELLA trials. These trials’ groundbreaking results, in which relacorilant improved progression-free and overall survival in patients with a highly challenging form of ovarian cancer without increasing the safety burden of the patients who took it, highlight relacorilant’s potential to become the new standard care in PROC," said Dr. Guyer.

"All of our pre-clinical and clinical oncology data point to the potential of glucocorticoid receptor antagonism to benefit patients across a wide variety of solid tumors, beyond PROC," he added. "That is why in the next few weeks, we will start Phase 2 trials in additional gynecologic tumors, including patients with platinum-sensitive ovarian (an earlier stage of ovarian cancer), endometrial and cervical cancers, as well as a Phase 2 study in patients with first-line pancreatic cancer. These National Comprehensive Cancer Network guideline-enabling studies should proceed quickly and will inform our longer-term clinical development priorities," added Dr. Guyer. "We are also excited to advance a new proprietary glucocorticoid receptor antagonist, nenocorilant, in a Phase 1b dose-finding study combining nenocorilant with the PD-1 checkpoint inhibitor nivolumab to see if reducing cortisol-driven immune suppression can enhance immunotherapy."

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed or presumed MASH – Results expected by the end of next year
"In our Phase 1b study, miricorilant was well-tolerated and very rapidly reduced liver fat while improving liver enzymes and other markers of liver health, as well as key metabolic and lipid measures. We look forward to building on these promising results in our Phase 2b MONARCH study. With enrollment completed, we will have topline results by the end of next 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) – Results presented at European Network to Cure ALS (ENCALS) 2025 annual meeting
Phase 3 trial – Expected to begin by the middle of next year
"ALS is a devastating disease linked to elevated cortisol activity. In our DAZALS study, patients who received dazucorilant experienced a profound reduction in early mortality – a time during which many patients with ALS retain significant function and quality of life," said Dr. Guyer. "We aim to replicate these findings in a Phase 3 trial and are working with regulatory authorities and leading ALS clinicians to finalize our study design."

Conference Call

We will hold a conference call on November 4, 2025, 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, NOV 4, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-third-quarter-financial-results-4 [SID1234659348])

On November 4, 2025 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the third quarter 2025 and provided an update on recent business progress.

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "Our activity in the third quarter focused on advancing the clinical work required to support our ambitious Phase 1b program for NXP900, which recently commenced." Mr. Bentsur continued, "Our goal for the Phase 1b program is to showcase NXP900’s therapeutic potential, both as a single agent and in combination with certain market-leading therapies with the aim of reversing acquired resistance to these drugs. With the Phase 1b monotherapy component already underway, and the expected upcoming initiation of the combination component, we continue to make strides towards achieving this goal." Mr. Bentsur added, "To support and inform the Phase 1b program, we completed the NXP900 Phase 1a dose escalation study and the drug-drug interaction study in healthy volunteers and are pleased with NXP900’s emerging clinical profile, especially with the deep pharmacodynamic response observed at clinically relevant doses." Mr. Bentsur concluded, "We believe that our cash position and focus on efficient operations will enable us to achieve the key milestones and potential value inflection points for the NXP900 Phase 1b program."

Third Quarter 2025 Financial Results

Cash and cash equivalents were $35.4 million as of September 30, 2025, compared to $18.5 million as of December 31, 2024. The increase of $16.9 million in the cash balance as of the end of the third quarter of 2025 is a result primarily of our public offering in February 2025 and the utilization of our At-the-Market facility, partially offset by the operating expenses for the first nine months of 2025.

The Company’s net loss was $7.5 million for the three months ended September 30, 2025, compared to $4.2 million for the three months ended September 30, 2024, an increase in net loss of $3.4 million. The increase in net loss in the third quarter of 2025 was primarily due to a one-time $2.0 million milestone achievement expense for NXP900 and $0.7 million related to the clinical drug-drug interaction study. The three months ended September 30, 2025 also includes $1.5 million of non-cash stock-based compensation.

Research and development expenses, including non-cash stock-based compensation, were $5.8 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, an increase of $3.0 million.

General and administrative expenses, including non-cash stock-based compensation, were $2.0 million for the three months ended September 30, 2025, compared to $1.5 million for the three months ended September 30, 2024, an increase of $0.5 million.

Interest income was $0.3 million for the three months ended September 30, 2025, compared to $0.2 million for the three months ended September 30, 2024.

(Press release, Nuvectis Pharma, NOV 4, 2025, View Source [SID1234659364])