On October 1, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the publication of a peer-reviewed case series in Case Reports in Oncology from researchers at Hackensack Meridian Health’s Jersey Shore University Medical Center.

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The publication describes two patients with locally advanced pancreatic cancer (LAPC), whose tumors were not surgically removable due to significant complex blood vessel involvement despite receiving extensive prior treatment. Both patients underwent chemotherapy utilizing TAMP-mediated local intra-arterial gemcitabine delivery enabled by RenovoCath. Notably, both patients demonstrated tumor treatment response with reductions in CA 19-9, a marker used to monitor disease activity in pancreatic cancers, and favorable changes on imaging, including resolution of vascular narrowing, without major procedural complications.

"Locally advanced pancreatic cancer remains one of the most difficult cancers to treat, and patients have limited options when standard systemic therapies, like intravenous chemotherapy, are no longer effective," said Gregory Tiesi, MD, FACS, FSSO, Chief of Surgical Oncology for the Southern Region and Medical Director of Hepatobiliary Surgery at Hackensack Meridian Health Jersey Shore University Medical Center, and lead author of the case series. "This case illustrates that gemcitabine can potentially be safely delivered at the local level via the TAMP platform in patients with complex vascular anatomy and adds to the peer-reviewed evidence supporting further utilization and evaluation of RenovoCath." Hackensack Meridian Health Jersey Shore University Medical Center has been using the TAMP Platform with the RenovoCath device in its oncology program for over a year.

"Independent, peer-reviewed publications such as this case series provide important clinical evidence supporting the potential of our novel, targeted drug-delivery approach," said Ramtin Agah, MD, RenovoRx’s Chief Medical Officer, Executive Chairman, and Founder. "These findings strengthen the scientific rationale for our drug-delivery platform and support our broader mission to bring meaningful new options to patients with difficult-to-treat tumors, especially as promising pancreatic treatments emerge that could be delivered via TAMP enabled by RenovoCath."

Publication Details
Title: Trans-Arterial Micro Perfusion in Locally Advanced Pancreatic Cancer: A Case Series and Review of Evidence
Journal: Case Reports in Oncology
Lead Author: Gregory Tiesi, MD, FACS, FSSO
Institution: Hackensack Meridian Health Jersey Shore University Medical Center

(Press release, Renovorx, OCT 1, 2026, View Source [SID1234671237])

On October 1, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, reported a new installment of its CEO Corner series featuring President and Chief Executive Officer Sanjeev Luther. The discussion highlights the recent appointment of Robert J. Spiegel, M.D., FACP, to the Company’s Board of Directors and how his deep oncology, clinical development and regulatory experience strengthens Ernexa as it sharpens its oncology focus and advances lead program ERNA-101 toward the clinic.

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Dr. Spiegel brings decades of experience spanning oncology, clinical development, regulatory strategy and pharmaceutical leadership, including more than 25 years at Schering-Plough Research Institute, where he ultimately served as Chief Medical Officer.

"We believe Ernexa is entering one of the most important periods in our evolution, and Dr. Spiegels’s addition to the Board comes at a highly relevant time," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "His experience aligns directly with where we are headed as we move ERNA-101 toward the clinic. With meaningful development milestones ahead and a broader opportunity across difficult-to-treat solid tumors, we believe we are building a strong foundation for Ernexa’s next stage of growth."

ERNA-101 is initially being developed for platinum-resistant ovarian cancer and is designed to leverage the tumor-homing properties of iMSCs to deliver immune-enhancing cytokines directly into the tumor microenvironment. The program is also designed to address immunologically "cold" tumors, supporting potential expansion into additional difficult-to-treat solid tumors.

Ernexa has completed IND-enabling preclinical studies for ERNA-101, clinical-grade manufacturing is underway, and the Company is targeting an IND submission in the fourth quarter of 2026, followed by initiation of a first-in-human study in the first quarter of 2027.

The CEO Corner also highlights encouraging preclinical findings supporting ERNA-101. In an ovarian cancer model, ERNA-101 in combination with anti-PD-1 demonstrated complete tumor clearance and 100% survival, further supporting the scientific rationale for the program as Ernexa prepares for clinical development.

Dr. Spiegel’s experience across first-in-human, proof-of-concept and registration-stage development is particularly relevant as Ernexa approaches clinical evaluation.

"ERNA-101 represents a compelling approach to addressing some of the persistent challenges in ovarian cancer," said Dr. Spiegel. "I am encouraged by the progress Ernexa has made as ERNA-101 approaches clinical development and look forward to contributing my experience as the Company advances this program and its broader oncology strategy." His appointment further strengthens Ernexa’s oncology, regulatory and clinical development expertise as the Company approaches key milestones."

Beyond ERNA-101, Ernexa is advancing next-generation oncology assets, including ERNA-102 and ERNA-103, as it works to build a differentiated portfolio of engineered iMSC therapies across solid tumors.

As Ernexa advances its oncology strategy, hope and accessibility remain central to the Company’s vision. Its allogeneic, off-the-shelf approach is designed with scalability in mind, with the goal of expanding accessibility while bringing meaningful new options and renewed hope to patients facing difficult-to-treat cancers.

The CEO Corner concludes with Mr. Luther outlining Ernexa’s priorities: advancing ERNA-101 into the clinic, generating human data and building a differentiated oncology company around the broader potential of its synthetic iMSC platform.

The Ernexa CEO Corner is now accessible on the Company’s website and social media channels. Access it here.

(Press release, Ernexa Therapeutics, OCT 1, 2026, View Source [SID1234671236])

On October 1, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the first results for the investigational ubamatamab in patients with low-grade serous ovarian cancer (LGSOC). The data are from an ongoing Phase 1/2 trial in recurrent platinum-resistant high- or low-grade serous ovarian cancer that were presented in a late-breaking plenary oral session at the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting. Ubamatamab is a MUC16xCD3 bispecific antibody designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation. Based on these preliminary trial results, Regeneron has been enrolling a single-arm, potentially registrational LGSOC trial and will be discussing the data with the U.S. Food and Drug Administration (FDA) in the coming months. Regeneron is also planning to initiate a confirmatory, randomized, controlled Phase 3 trial to support the use of ubamatamab in LGSOC.

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LGSOC is a biologically distinct variant from the more common high-grade serous ovarian cancer (HGSOC), comprising up to 10% of serous ovarian cancer, with typically uniformly high MUC16 expression and limited treatment options. The disease often affects younger women and is characterized by slower-growing tumors than those seen in HGSOC, but frequently recurs and is less responsive to conventional chemotherapy with few treatment options. LGSOC has a median overall survival of approximately seven years from initial diagnosis, compared to approximately four years for HGSOC. In recurrent advanced LGSOC, historical trial data have shown that objective response rates (ORRs) generally remain below 15% with chemotherapy and endocrine therapy, while the only approved therapy has an ORR of 44% in biomarker-selected patient populations (representing about 30% of the overall LGSOC population).

"The high rate of durable responses observed thus far with ubamatamab in low-grade serous ovarian cancer, without requiring biomarker selection, are highly encouraging and reinforce our excitement about MUC16 as a new therapeutic target in this difficult-to-treat disease," said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. "This initial clinical evidence highlights the potential of our bispecific approach to bring a differentiated and first-in-class treatment option to patients in need. We are pleased with the safety profile of the drug as well, and are eager to build on these findings through our ongoing trial and planned confirmatory Phase 3 trial."

Data presented at IGCS focused on the LGSOC subset of 19 patients who had received a median of four prior lines of therapy and were dosed with intravenous ubamatamab ranging from 3 to 800 mg weekly or every three weeks. Ubamatamab was given either as monotherapy or in combination with Libtayo (cemiplimab).

Included in the presentation were 11 patients treated with 800 mg of ubamatamab monotherapy, eight treated weekly and three treated every three weeks. Results at the 800 mg doses showed a:

73% ORR (95% Confidence Interval [CI]: 39.0 to 94.0), with all responses being partial responses
9-month median duration of response (95% CI: 6.9 to not estimable [NE]), per Kaplan-Meier estimate
11-month median progression-free survival (95% CI: 3.0 to NE), per Kaplan-Meier estimate
Safety was assessed across all 19 patients in the LGSOC subset. Treatment-emergent adverse events (TEAEs) occurred in 100% of participants (n=19). Cytokine release syndrome occurred in 90% of participants (n=17), all of which were Grade 1 or 2. Serious TEAEs grade 3 or higher occurred in 21% (n=4) of participants and treatment-related adverse events (TRAEs) occurred in 74% of participants (n=14). Grade 3 or higher TRAEs included neutropenia (21%; n=4), anemia (11%; n=2), increased alanine aminotransferase (11%; n=2), increased aspartate aminotransferase (11%; n=2), abdominal pain (5%; n=1) and ileus (5%; n=1). Most adverse events occurred during the step-up dosing period. One participant discontinued treatment due to a stroke considered unrelated to ubamatamab treatment; no TEAEs resulted in death.

The potential uses of ubamatamab described above are investigational, and its safety and efficacy have not been evaluated by any regulatory authority.

About the Trial
The ongoing, open-label, Phase 1/2 trial is evaluating ubamatamab alone and in combination with Libtayo in adult patients with recurrent platinum-resistant ovarian cancer and other recurrent MUC16-expressing cancers.

The Phase 1 portion of the trial is primarily assessing safety, tolerability, dose-limiting toxicities and pharmacokinetics of ubamatamab, with efficacy evaluated as a secondary endpoint through measures such as ORR, duration of response and progression-free survival. The Phase 2 portion is evaluating the anti-tumor activity of ubamatamab, primarily through ORR, while continuing to assess safety and tolerability.

A prospective, dedicated, potentially registrational cohort in the Phase 2 portion of this trial is evaluating ubamatamab 800 mg monotherapy every three weeks in up to 100 patients with recurrent LGSOC and is currently enrolling. If you are interested in learning more about this trial, please contact us ([email protected], +1 844 734 6643), or visit our clinical trial website.

About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic cancers and remains a leading cause of cancer-related mortality among women. It arises from the uncontrolled growth of abnormal cells in the ovary and is frequently diagnosed at an advanced stage, when disease has spread beyond the ovary. In 2026, an estimated 21,010 new cases of ovarian cancer were expected to be diagnosed in the U.S., and approximately 12,450 women were expected to die from the disease. Despite advances in treatment, ovarian cancer remains a significant unmet medical need, with many patients ultimately experiencing disease recurrence and progression.

LGSOC is a distinct form of ovarian cancer that occurs in younger women and comprises up to 10% of new epithelial ovarian cancer cases. While LGSOC tumor cells tend to grow and divide more slowly than those seen in high-grade serous ovarian cancer, the disease frequently recurs and is less responsive to conventional chemotherapy. LGSOC has a median overall survival of approximately seven years from initial diagnosis, compared to approximately four years for HGSOC. Although endocrine therapy and targeted therapies are used in selected patients, treatment options remain limited for many people with recurrent disease.

(Press release, Regeneron, OCT 1, 2026, View Source [SID1234671235])

On October 1, 2026 Trethera Corporation ("Trethera"), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for TRE-515 in combination with KRAS inhibitors for the treatment of G12C mutation-positive non-small cell lung cancer (NSCLC) previously treated with an anti-PD-(L)1 antibody and platinum-based chemotherapy.

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Lung cancer remains the leading cause of cancer-related mortality worldwide, with more than 2.5 million new cases and 1.8 million deaths globally. NSCLC accounts for approximately 80% of lung cancer deaths. While KRAS inhibitors (KRASi) have created a major advance for patients whose tumors harbor KRAS G12C mutations, response rates remain limited and many responding patients later experience relapse.

"Fast Track designation in lung cancer represents an important milestone for TRE-515 and further validates our strategy of combining dCK inhibition with targeted cancer therapies," said Dr. Ken Schultz, Trethera Chairman and CEO. "KRAS G12C inhibitors have transformed the NSCLC treatment landscape, but resistance and incomplete responses remain major challenges. We believe TRE-515 has the potential to address a key metabolic escape pathway used by cancer cells and improve outcomes for patients with this devastating disease."

TRE-515 inhibits deoxycytidine kinase (dCK), the key enzyme in the nucleoside salvage pathway, which can become activated and essential for abnormal cell growth in cancer. TRE-515 has demonstrated favorable safety and antitumor activity in an ongoing first-in-human trial. Trethera’s approach is based on the observation that KRASi-treated tumors may increase reliance on the salvage pathway as a metabolic support system under therapeutic stress. In preclinical studies, specialized PET imaging showed persistent dCK activity following KRASi treatment, while subsequent TRE-515 treatment completely blocked tumor dCK activity, providing a visual demonstration of the biological rationale for the drug combination (Figure 1).

"For decades, oncology has focused heavily on targeting oncogenic signaling pathways, including KRAS," said Dr. Owen Witte, UCLA Professor and Trethera co-founder. "The next frontier is understanding how cancer cells adapt metabolically to survive those therapies. If successful, TRE-515 could represent a first-in-class approach by targeting the nucleoside salvage pathway, a key metabolic support system that tumors may use under therapeutic stress."

The FDA Fast Track decision builds on Trethera’s $2.7 million NIH grant awarded in 2025 to evaluate TRE-515 with KRASi therapies and marks the second FDA Fast Track designation, following its prior designation in metastatic castration-resistant prostate cancer. Fast Track status is intended to facilitate development and expedite review for drugs addressing serious conditions with unmet medical need, including potential eligibility for more frequent FDA communication, Accelerated Approval, and Priority Review if relevant criteria are met.

"For patients with advanced NSCLC, the central challenge is not only achieving an initial response but also making that response more durable," said Dr. Evan Abt, UCLA Assistant Professor and co-investigator for the preclinical studies. "This Fast Track designation underscores the importance of rapidly evaluating innovative, rational combination strategies that may extend the benefit of KRAS-targeted therapies to more patients."

(Press release, Trethera, OCT 1, 2026, View Source [SID1234671234])

On October 1, 2026 ADARx Pharmaceuticals, Inc. (ADARx) (Nasdaq: ADRX), a late-stage clinical biotechnology company developing next-generation siRNA therapeutics, reported that, in connection with its upsized initial public offering of its common stock, the underwriters have fully exercised their option to purchase an additional 3,937,500 shares of ADARx’s common stock at a price to the public of $17.00 per share. The issuance of the additional shares closed on October 1, 2026, bringing the total number of shares sold in the initial public offering to 30,187,500 shares and the aggregate gross proceeds to ADARx from the offering, before deducting underwriting discounts and commissions and offering expenses payable by ADARx, to approximately $513.2 million.

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J.P. Morgan, Morgan Stanley, TD Cowen and UBS Investment Bank acted as lead book-running managers for the offering. LifeSci Capital acted as a book-running manager for the offering.

Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on September 24, 2026. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering was made only by means of a prospectus forming part of the registration statements relating to these securities. Copies of the final prospectus relating to the initial public offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected] and [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at 1-866-718-1649, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or UBS Securities LLC, Attention: Equity Syndicate, 11 Madison Avenue, New York, NY 10010 or by email at [email protected].

Including the purchase by AbbVie of 5,255,542 shares of ADARx’s common stock at a price of $17.00 per share in a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the Securities Act), the aggregate gross proceeds to ADARx from the initial public offering and the concurrent private placement, before deducting underwriting discounts and commissions, placement agent fees and other offering and private placement expenses payable by ADARx, were approximately $602.5 million.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy these securities, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, ADARx Pharmaceuticals, OCT 1, 2026, View Source [SID1234671233])