On February 24, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported that it has concluded enrollment in the GOBLET study, having generated the necessary clinical and translational data to inform its next phase of development. With sufficient cash on hand to execute near-term milestones, the Company will now focus its efforts and resources on registrational and registration-enabling studies in squamous cell anal cancer ("SCAC") and metastatic colorectal cancer ("CRC").

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"GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, Chief Executive Officer of Oncolytics. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution."

The promising efficacy signal observed in GOBLET Cohort 4 has defined a clear registrational path for pelareorep-based therapy in second-line and later SCAC, a setting in which available therapies offer only limited benefit. The Company is planning to move quickly to pursue regulatory approval through a U.S.-based study to ensure the enrollment of patients representative of the current standard of care.

Oncolytics expects to meet with the U.S. Food and Drug Administration ("FDA") in mid-April. The objective of this meeting is to align on the design of a single-arm SCAC registrational study. Based on the observed efficacy signal in GOBLET Cohort 4, the Company believes a clinical trial of well under 100 subjects will be sufficient to secure FDA approval in this rare cancer indication.

Given its strategic focus on SCAC and CRC, and the desire to deploy capital efficiently, Oncolytics has elected to stop further enrollment in the GOBLET Cohort 5 metastatic pancreatic ductal adenocarcinoma ("PDAC") cohorts at approximately 20 patients per arm. The Company believes the available data are sufficient to inform its future PDAC strategy while limiting additional spend on this indication at this time.

Current enrollment in GOBLET Cohort 5 allows responses to therapy, including overall survival, to be analyzed. The Company will continue to follow Cohort 5 patients currently on study, monitor their responses, and plan to report results once the data reach maturity.

"The GOBLET study has provided invaluable insights into the efficacy and safety of pelareorep in gastrointestinal cancers," said Thomas Heineman, MD, Chief Medical Officer of Oncolytics. "These data have provided crucial support for our platform approach in GI cancers. They have, in fact, allowed us to identify a clear and efficient path forward as we move into registration-focused development of pelareorep in GI cancers."

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

(Press release, Oncolytics Biotech, FEB 24, 2026, View Source [SID1234662922])

On February 24, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH) reported a significant expansion of its CLEER-001 Phase 2a clinical trial with the addition of Regis Clinical Research as a new enrolling site. Located in Miami, Florida, Regis joins the growing CLEER-001 investigational site network as surging patient demand outpaces capacity at existing sites — a direct reflection of the compelling early clinical results HT-001 has produced and the desperate unmet need it addresses.

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For the estimated 200,000 Americans who begin EGFR Inhibitor cancer therapy each year, the skin toxicities that accompany treatment are not a minor inconvenience. They are severe, often disfiguring rashes, lesions, and unrelenting itch that force up to one-third of patients to reduce or discontinue the chemotherapy keeping them alive. Today, those patients have no FDA-approved treatment option. HT-001 is designed to change that — and the data so far suggests it can.

Positive Signal

The interim CLEER-001 data is generating physician and patient interest that drives enrollment expansions like today’s announcement:

100% of open-label cohort patients achieved the primary efficacy endpoint — an ARIGA rash severity score of ≤1 — by week six
Zero patients required dose reduction or discontinuation of their life-saving EGFRi cancer therapy while on HT-001
Over 65% of patients reported meaningful reductions in pain and itching
Zero dose-limiting toxicities observed across the entire trial to date
At the American Academy of Dermatology Annual Meeting, a case study demonstrated complete lesion and symptom resolution after just one week of twice-daily application in a metastatic breast cancer patient
For a patient population that currently has no targeted treatment, results like these represent a potential paradigm shift in how oncologists can manage one of the most common and quality-of-life-destroying side effects in all of cancer care.

A New Site, A New Market, A Growing Network

Regis Clinical Research brings IRB-approved, FDA-compliant research infrastructure and a new South Florida patient population to the CLEER-001 network. For Hoth, it means faster enrollment, a faster path to a complete data set, and a faster road to the regulatory milestones that matter.

"The addition of Regis Clinical Research is a direct response to the acceleration we are seeing in enrollment demand," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "The data speaks for itself. Patients and oncologists are taking notice — and we are building the infrastructure to meet that demand and deliver the full clinical readout this program deserves."

Patients and referring physicians may visit regisclinical.com or call +1 (305) 546-3952 to learn more about participation in the CLEER-001 trial.

(Press release, Hoth Therapeutics, FEB 24, 2026, View Source [SID1234662945])

On February 24, 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 and year ended December 31, 2025.

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Financial Results

"In 2025, our Cushing’s syndrome business experienced a surge in demand due to growing recognition among physicians of hypercortisolism’s true prevalence and the necessity of appropriate treatment. We had a record number of new prescriptions written for our medications and a record number of new prescribers in 2025, which translated to a 37 percent increase in the number of tablets sold compared to the prior year. We should have achieved higher growth but were not able to fully meet demand because of capacity constraints at our previous specialty pharmacy vendor. There were also operational disruptions in the fourth quarter as we transitioned our business to our new specialty pharmacy. This transition is now fully complete and February is on track to be a record month for the number of new patients that have started treatment with our medications. We expect that our Cushing’s syndrome business will expand for many years," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Corcept’s fourth quarter 2025 revenue was $202.1 million, compared to $181.9 million in the fourth quarter of 2024. Revenue for the full year was $761.4 million, compared to $675.0 million in 2024.

Net income was $24.3 million in the fourth quarter, or $0.20 diluted net income per common share, compared to net income of $30.7 million, or $0.26 diluted net income per common share, in the fourth quarter of 2024. For the full year, net income was $99.7 million, or $0.82 diluted net income per common share, compared to net income of $141.2 million, or $1.23 diluted net income per common share, in 2024.

Cash and investments were $532.4 million at December 31, 2025, compared to $603.2 million at December 31, 2024. In 2025, Corcept paid $245.9 million to purchase its common stock, pursuant to the company’s stock repurchase program, net exercise of employee stock options and net vesting of restricted stock grants.

Clinical Development

"We are engaged with the FDA to determine the best path forward for our New Drug Application (NDA) for relacorilant in Cushing’s syndrome and are confident that the ultimate outcome will be approval," said Dr. Belanoff. "Our NDA for relacorilant in platinum-resistant ovarian cancer, which is now bolstered by the final overall survival results from our ROSELLA study, has a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026.

In addition, our ongoing clinical studies will soon produce important data. Results from MOMENTUM, our trial evaluating the prevalence of hypercortisolism in patients with resistant hypertension, will be featured in an oral presentation at the American College of Cardiology (ACC) meeting in March. Results from our BELLA trial in patients with advanced ovarian cancer will be available by the end of this year, as will results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH). By the end of next year, we expect results from our studies in platinum-sensitive ovarian, endometrial, cervical and pancreatic cancers."

"We are also planning to start a Phase 3 trial of dazucorilant in patients with ALS, which will seek to replicate the benefit patients exhibited in our DAZALS trial, by the middle of this year," added Dr. Belanoff.

Hypercortisolism (Cushing’s Syndrome)

New Drug Application – Engaged with FDA to determine best path forward to approval following Complete Response Letter for relacorilant in patients with Cushing’s syndrome
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)
MOMENTUM – Enrollment completed in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension; results will be presented at ACC meeting in March
"Relacorilant has the potential to become the new standard of care for patients with Cushing’s syndrome. In its Phase 2 and Phase 3 studies, patients treated with relacorilant showed clinically meaningful and statistically significant improvements in hypertension and a wide range of Cushing’s syndrome’s other signs and symptoms. Importantly, these benefits were observed without off-target effects and toxicities such as drug-induced hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency and QT prolongation. These adverse events can have serious health consequences and are associated with currently available treatments. We are working with the FDA to bring relacorilant to patients as soon as possible," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

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 this year
ROSELLA – Both dual primary endpoints (progression-free and overall survival) met, without the need for biomarker selection and without increased safety burden – Complete results will be presented at the Society of Gynecology Oncology (SGO) meeting in April
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 underway 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
BELLA Part C – Enrollment underway 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)
STELLA – 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
TRIDENT – Enrollment underway in Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 50 patients with pancreatic cancer
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 underway in Phase 1b dose-finding trial of nenocorilant plus nivolumab in 30 patients with a variety of solid tumors
"Results from our pivotal Phase 3 ROSELLA study demonstrate a 35 percent reduction in the risk of death in patients with platinum-resistant ovarian cancer (PROC). These results – without the need for biomarker selection, without increased safety burden and with oral administration – highlight relacorilant’s potential to become the new standard of care in PROC. Our applications are under review with regulatory authorities in both the United States and Europe, and we are working with urgency to bring this medication to patients with this highly challenging form of ovarian cancer," said Dr. Guyer.

"Our ROSELLA results, as well as other pre-clinical and clinical oncology data, highlight the potential of glucocorticoid receptor antagonism to benefit patients across a wide variety of solid tumor types beyond PROC. We are currently studying relacorilant in other solid tumors, including platinum-sensitive ovarian, endometrial, cervical, pancreatic and prostate cancers, and we will continue to broaden our research to help as many patients as possible," 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
"In our Phase 1b study, miricorilant was well-tolerated and very rapidly reduced liver fat while improving fibrosis, liver enzymes and other markers of liver health, as well as 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)
Phase 3 trial – Planned to begin by the middle of this year
"Elevated cortisol activity is linked to ALS. In our Phase 2 DAZALS study, patients who received dazucorilant experienced a profound reduction in early mortality – a period when many patients with ALS retain significant function and quality of life," said Dr. Guyer. "We are currently conducting a dose titration study, with the goal of improving gastrointestinal tolerability, to inform the direction of our Phase 3 program."

Conference Call

We will hold a conference call on February 24, 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, FEB 24, 2026, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2025 [SID1234662904])

On February 24, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that Mark A. Goldsmith, M.D., Ph.D., the company’s chief executive officer and chairman, will participate in a fireside chat as part of the TD Cowen 46th Annual Health Care Conference on Tuesday, March 3 at 9:50 a.m. ET.

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To listen to a live webcast of this event, or access an archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, FEB 24, 2026, View Source [SID1234662923])

On February 24, 2026 AtomVie Global Radiopharma (AtomVie), a global leading radiopharmaceutical CDMO, reported that it has supplied the successful dosing of the first patient in Radiopharm Theranostics’ First-in-Human Phase 1/2a clinical study of 177Lu‑BetaBart (RV‑01) by providing GMP manufacturing and distribution services for the radiotherapeutic drug product, after successfully developing and qualifying the radiolabeling process and analytical methods using a phase-appropriate approach that expedited IND filing.

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The Phase 1/2a clinical study is designed as a dose-escalation and expansion trial evaluating the safety, biodistribution, radiation dosimetry, and preliminary anti-tumor activity of 177Lu‑BetaBart, while also determining the recommended dose for future studies. 177Lu-BetaBart (RV‑01) is a 177Lutetium‑conjugated monoclonal antibody engineered to target the 4Ig isoform of B7‑H3, an immune checkpoint molecule overexpressed across multiple solid tumor types.

"Enabling the first patient dose of 177Lu-BetaBart reflects what matters most to us, ensuring that high‑quality radiopharmaceuticals are manufactured, released, and delivered on time so patients can access innovative therapies without delay," said Bruno Paquin, Chief Executive Officer of AtomVie. "Our team is deeply focused on operational excellence and reliability, supporting our partners from early clinical development through global supply."

"Dosing the first patient in the Phase 1/2a clinical study of 177Lu‑BetaBart represents an important milestone for Radiopharm Theranostics," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We appreciate AtomVie’s manufacturing expertise and commitment to quality as we advance BetaBart for patients with aggressive and difficult‑to‑treat solid tumors."

About BetaBart (RV-01)

RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and The University of Texas MD Anderson Cancer Center. 177Lu-BetaBart is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with BetaBart have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent.

About the Phase 1/2a Clinical Trial

The FIH Phase 1/2a study (NCT07189871) is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of 177Lu-Betabart . The study aims to enroll 61 eligible participants who have a documented history of histopathologically confirmed castrate resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma.

(Press release, Radiopharm Theranostics, FEB 24, 2026, View Source [SID1234662946])