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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])

On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Increased Survival in Nude Mice Inoculated with MCF7 Breast Cancer (BC) in the Mammary Fat-Pad Achieved via a Single Injection of a Lipid-like Hydrogel Emulsion Containing a New Molecular Entity (NME) and N-ally Noroxymorphone (NaN) Compared to Tamoxifen (TAM) and Abemaciclib (ABE)", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025.

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In a head-to-head comparison with standard-of-care therapies Tamoxifen and Abemaciclib (i.e., Verzenio), a single intratumoral injection of Zeta-BC-007 significantly outperformed both agents. Mice treated with Zeta-BC-007 containing NME + NaN + ABE showed a 66% reduction in tumor volume and complete absence of tumor activity by day 60, while all mice in the TAM and ABE groups succumbed to disease.

"Zeta-BC-007 represents a significant leap forward in intratumoral cancer therapy. By combining a novel molecular entity with synergistic therapeutics in a lipid-based hydrogel, we’ve demonstrated not only superior tumoricidal activity but also extended survival in preclinical models. These results reinforce our commitment to developing localized, non-systemic treatments that challenge the limitations of conventional cancer care."

— Bryan S. Margulies, PhD, Co-founder and CSO, Zetagen Therapeutics

"These results mark a pivotal moment in our journey to redefine primary breast cancer treatment," said Joe C. Loy, CEO of Zetagen Therapeutics. "the ability of Zeta-BC-007 to deliver potent tumoricidal effects through a single localized injection — without systemic toxicity — represents a new frontier in oncology. We believe this platform has the potential to transform how solid tumors are treated."

Presentation Details:

Abstract Number: 3638
Presentation Number: PSA-06-30
Presentation Title: Increased Survival in Nude Mice Inoculated with MCF7 Breast Cancer (BC) in the Mammary Fat-Pad Achieved via a Single Injection of a Lipid-like Hydrogel Emulsion Containing a New Molecular Entity (NME) and N-ally Noroxymorphone (NaN) Compared to Tamoxifen (TAM) and Abemaciclib (ABE)
Poster Presentation: Thursday, December 11, 2025, 5:00-6:30pm CST
About ZetaPrime (Zeta-PBC-007)
ZetaPrime is a neo-adjuvant treatment for primary HR+ breast cancer, engineered for a locoregional administration following diagnosis. Utilizing a proprietary hydrogel-like lipid carrier, the novel formulation enables controlled release of multiple small molecules — with one being our novel molecular entity coupled with any other fat-soluble drugs; including other companies CDK4 or CDK4/6 protein inhibitors or any anticancer therapeutic. Designed for solubility within adipose tissue, ZetaPrime is a paradigm-shifting intratumoral approach to adjuvant therapy that targets primary breast cancer, aiming to mitigate off-target effects, reduce necessity for lumpectomies and mastectomies, postpone radiation exposure, and enhance patient survival.

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659380])

On November 4, 2025 Radiant Biotherapeutics, a biotechnology company committed to advancing a breakthrough antibody approach, the Multabody, for a broad range of therapeutic areas, including cancer and infectious diseases, reported new data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting demonstrating its lead oncology candidate, RBT-101, exhibited robust, durable and complete tumor regression while avoiding liver toxicity, in a MC38 colorectal mouse tumor model.

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Radiant’s proprietary Multabody technology uniquely harnesses natural mechanisms to effectively engage multiple disease targets with unmatched strength, precise tunability, and exceptional breadth. 4-1BB is a clinically validated immune checkpoint target that elicits potent anti-tumor immunity and enhanced T cell responses but has eluded safe and effective therapeutic targeting by traditional 4-1BB agonists due to systemic and Fc-mediated liver toxicity. Radiant has leveraged its Multabody platform to develop RBT-101, a multivalent 4-1BB agonist that does not rely on traditional antibody methods to enhance potency, binding strength or durability.

Key Highlights from SITC (Free SITC Whitepaper) 2025 Poster Presentation:

RBT-101 achieved sustained complete tumor regression in MC38 colorectal mouse tumor model
RBT-101 demonstrated long-lived anti-tumor immunological memory; no detectable tumor growth was observed in mice that were re-challenged with MC38 tumor cells after previous successful treatment
RBT-101 demonstrated no signs of liver toxicity, in contrast to benchmark 4-1BB agonist urelumab
"Our data to be presented at SITC (Free SITC Whitepaper) demonstrates that RBT-101 achieves what first-generation 4-1BB agonists could not – delivering robust anti-tumor activity without liver toxicity," said Jo Hulme, Ph.D., CSO of Radiant. "This validates our Multabody platform’s potential to address a broad range of therapeutic targets while avoiding the inherent limitations of conventional antibody-based approaches, as RBT-101 drove potent, tunable and safe agonism of 4-1BB that more closely mimicked natural ligand biology. We look forward to the continued development of Multabodies as promising therapeutics in oncology and other disease areas."

The poster, titled "Multabodies: A next-generation approach for cancer immunotherapy and 4-1BB agonist therapy," will be presented onsite on Friday, November 7, 2025, and will also be available on the SITC (Free SITC Whitepaper) virtual meeting platform beginning November 7 at 9 a.m. ET.

(Press release, Radiant Biotherapeutics, NOV 4, 2025, View Source [SID1234659398])