On September 14, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported its acquisition of Convergent Genomics. The acquisition adds Convergent Genomics’ UroAmp platform, including its proprietary urinary tumor DNA (utDNA) technology, to Veracyte’s product portfolio. To date, UroAmp has been clinically validated in non-muscle invasive bladder cancer (NMIBC), including therapy-response monitoring and post treatment surveillance.

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In the U.S., there are approximately 85,000 patients diagnosed with bladder cancer annually, including about 65,000 with NMIBC. Of the 750,000 patients living with bladder cancer, approximately 600,000 are living with NMIBC.

NMIBC is generally confined to the bladder and may shed only limited tumor DNA into the bloodstream, which can make blood-based detection challenging. Urine, by contrast, comes into direct contact and can provide a highly relevant source of tumor-derived genomic information. UroAmp analyzes this information, creating the potential to help inform treatment decisions and monitor patients throughout their care.

"Bladder cancer care is advancing quickly, yet clinicians and patients still face significant uncertainty at critical decision points," said Marc Stapley, Veracyte’s chief executive officer. "UroAmp brings a differentiated urine-based platform that is especially well suited to non-muscle-invasive disease. Together with our Decipher Bladder and TrueMRD tests, this acquisition strengthens Veracyte’s ability to deliver complementary insights from urine, tissue, and blood to help guide care across the bladder cancer continuum."

UroAmp is supported by a robust and growing body of evidence, including nine peer-reviewed publications and more than 40 posters and abstracts. Veracyte’s initial test will be intended to help determine whether patients who have completed Bacillus Calmette-Guerin (BCG) induction therapy are likely to benefit from maintenance treatment. The company expects to commercialize this test in late 2028, subject to reimbursement timelines. Veracyte also plans to expand its use of the UroAmp platform to additional indications, including intravesical maintenance therapy monitoring and surveillance following treatment with curative intent.

In the RUMBLE study published in The Journal of Urology, a multicenter prospective clinical validation study, patients who were clinically negative following induction BCG treatment but tested positive for utDNA had a 12-month recurrence-free survival rate of 25%, compared with 91% among utDNA-negative patients.1

"This acquisition brings together UroAmp’s differentiated platform and scientific expertise with Veracyte’s evidence-generation capabilities, commercial infrastructure, and established relationships," said Brian Slingerland, chief executive officer, Convergent Genomics. "We believe this combination can help accelerate the development of new tools that give physicians greater confidence in treatment and monitoring decisions and can ultimately improve care for people living with bladder cancer."

The acquisition includes $150 million in upfront cash consideration and up to $30 million in additional cash consideration tied to key milestones related to UroAmp reimbursement efforts. Veracyte contemplated the ongoing operating expenses of Convergent in its previously provided 2026 adjusted EBITDA guidance and is not updating such guidance at this time.

(Press release, Veracyte, SEP 14, 2026, View Source [SID1234670825])

On September 14, 2025 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer reported that, following the formal completion of the Phase 1b clinical study, it has submitted a meeting request and comprehensive briefing package to the U.S. Food and Drug Administration (FDA).

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The submission describes the nonclinical development program and integrated clinical pharmacology data for PH-762 and provides details of the completed Phase 1b study as well as the next planned Phase 2b neoadjuvant clinical study in cutaneous squamous cell carcinoma. The briefing package includes the scientific rationale, study design, and pharmacokinetic strategy intended to support the next stage of clinical development.

"Delivering this comprehensive briefing package to the FDA is a key achievement for the PH-762 program and an important step toward unlocking its clinical potential in cutaneous squamous cell carcinoma," said Robert J. Bitterman, President and CEO of Phio Pharmaceuticals. "We are encouraged by the Phase 1b findings and look forward to working with the FDA as we pursue the next phase of development."

Phio is currently preparing to manufacture clinical supplies for the next planned study, which are expected to be available in the first quarter of 2027. In addition, the dosing phase of the company’s nonclinical toxicology study has been completed. Final activities supporting the next phase of clinical development are expected to be completed during the first quarter of 2027.

(Press release, Phio Pharmaceuticals, SEP 14, 2026, View Source [SID1234670824])

On September 14, 2026 Pasithea Therapeutics Corp. (Nasdaq: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, for the long-term treatment of chronic diseases including neurofibromatosis type 1 (NF1)-associated neurofibromas, reported it will present initial Part A clinical data from its ongoing Phase 1/1b trial of PAS-004 in adults with NF1.

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The data will be presented at the 2026 European Neurofibromatosis Conference, taking place November 12–14, 2026, at the Hyatt Regency Vienna in Vienna, Austria, and will represent the Company’s first public disclosure of clinical data from Part A of the trial.

Details of the Oral Presentation:
Presenter: Rebecca Brown, MD, University of Alabama at Birmingham
Presentation Type: Oral Presentation
Session title: Clinical Session 3: Visible Manifestations in Neurofibromatosis
Session day and time: Friday, 13 November 2026, 08:00-09:30 (CET)
Room: Lecture Hall 1

Details of the Poster Presentation:
Presenter: Tiago Reis Marques, Pasithea Therapeutics Chief Executive Officer
Presentation Type: Poster
Poster Session: Thursday, November 12

The full presentations will be made available in accordance with the conference’s program schedule. The Company plans to issue a follow-up press release with detailed results at the time of presentation.

(Press release, Pasithea Therapeutics, SEP 14, 2026, View Source [SID1234670823])

On September 14, 2026 Cardiff Oncology, Inc. (NASDAQ: CRDF) ("Cardiff") and Nerviano Medical Sciences S.r.l. ("NMS") reported that they have reached a settlement and amended their 2017 Exclusive License Agreement, resolving all outstanding disputes between the two companies related to the global rights for onvansertib, Cardiff’s lead PLK1 inhibitor drug candidate, and establishing an expanded collaborative framework to support onvansertib’s continued clinical development.

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Cardiff and NMS have agreed to a full and mutual release of all claims asserted in the litigation pending in the U.S. District Court for the Southern District of California. Cardiff and NMS plan to jointly request dismissal of all claims with prejudice.

"This Amendment strengthens our long-term rights to onvansertib as a promising treatment for cancer, beginning with first-line RAS-mutated metastatic colorectal cancer," said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. "We are pleased to be entering into this agreement with NMS, which reflects our shared commitment to bringing onvansertib to patients with high unmet need."

"We look forward to working with Cardiff to advance onvansertib into a global Phase 3 study in first-line RAS-mutated metastatic colorectal cancer and to bring this therapy to patients," said Hugues Dolgos, PharmD, Chief Executive Officer of NMS Group S.r.l.

The Parties clarified and expanded on the royalty structure in the License Agreement. The agreement also includes development objectives related to Cardiff’s upcoming Phase 3 program, as well as rights for NMS to appoint a Board observer and join Cardiff’s Scientific Advisory Board.

About Onvansertib

Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated mCRC. In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

(Press release, Nerviano Medical Sciences, SEP 14, 2026, View Source [SID1234670822])

On September 14, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported updated safety and efficacy data from the completed dose-escalation and expansion phases of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center ("UT MD Anderson") evaluating radiotherapy-activated JNJ-1900 (NBTXR3) for patients with inoperable, locoregionally recurrent non-small cell lung cancer ("NSCLC") amenable to re-irradiation ("reRT"). The data were presented by study principal investigator Saumil Gandhi, MD, PhD, at the International Association for the Study of Lung Cancer ("IASLC") 2026 World Conference on Lung Cancer ("WCLC"), taking place September 12–15, 2026 in Seoul, Republic of Korea.

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POSTER P2.260: Re-irradiation (ReRT) with NBTXR3 for Inoperable Locoregionally Recurrent Non-Small Cell Lung Cancer (NSCLC): A Phase I Trial

Saumil N. Gandhi, MD, PhD; Enoch Chang, MD; Aileen B. Chen, MD; Stephen G. Chun, MD; Joe Y. Chang, MD, PhD; Steven H. Lin, MD, PhD; Matthew S. Ning, MD, MPH; David Qian, MD; Julianna K. Bronk, MD, PhD; Rahul A. Sheth, MD; Jianjun Zhang, MD, PhD; Tina Cascone, MD, PhD; Marcelo Vailati Negrao, MD; Anne S. Tsao, MD; George R. Blumenschein, MD; Mehmet Altan, MD; John V. Heymach, MD, PhD; James W. Welsh, MD; Suyu Liu, PhD; Zhongxing Liao, MD; Roberto F. Casal, MD — The University of Texas MD Anderson Cancer Center

Patients who are candidates for re-irradiation are frequently limited to palliative radiation doses because of normal-tissue tolerance, and their recurrent tumors typically harbor the most radiation-resistant cells. Effective strategies to safely deliver radiotherapy doses capable of controlling recurrent tumors remain a significant unmet need in this setting.

"Recurrence within a previously irradiated field is one of the least forgiving problems in thoracic oncology," said Saumil Gandhi, MD, PhD, Department of Thoracic Radiation Oncology, Division of Radiation Oncology at UT MD Anderson. "The normal tissue near the tumor has already received a full course of radiation, so the dose that can delivered safely during a second course is limited. Additionally, the disease that returns is often more radioresistant because it survived radiation the first time. In this study, JNJ-1900 (NBTXR3) was delivered without dose-limiting toxicities, and we observed clinically meaningful local control at a substantially lower re-irradiation dose. These findings warrant evaluation in a randomized trial."

Results from the pooled dose-escalation and expansion phases showed that all 24 patients completed treatment with JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities. Investigators reported no Grade 3 or higher adverse events related to JNJ-1900 (NBTXR3) or to the injection procedure.

Grade 3 radiotherapy-related adverse events occurred in 33% of patients (n=8), and Grade 5 radiotherapy-related adverse events in 8% (n=2). The recommended Phase 2 dose was established at 33% of gross tumor volume.

At a median follow-up of 12 months (data cutoff: August 2026) the one-year locoregional control rate was 79%. One-year local progression-free survival ("LPFS") was 61% (median 13.6 months), and one-year overall survival ("OS") was 70% (median 14.8 months). Investigators concluded that JNJ-1900 (NBTXR3) may permit clinically meaningful local control using a substantially lower re-irradiation dose.

"The Nanobiotix team is encouraged by these full-cohort findings in one of the most difficult settings in lung cancer," said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. "If a physics-based approach can improve local control in tissue that has already failed radiation, and do so at a reduced dose, then the conditions in earlier settings, where full-dose radiotherapy reaches previously untreated tissue, could be even more favorable. We look forward to further evaluation in additional patients enrolled to this study and across indications."

Enrollment in both the dose-escalation and expansion parts of the study is complete per protocol. Following the encouraging findings, additional patient enrollment in this study is planned.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma study sponsored by Nanobiotix in 2018.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations.

In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies being led by Johnson & Johnson include NANORAY-312 (NCT04892173), a global, randomized Phase 3 study in platinum-based chemotherapy-ineligible, locally advanced head and neck squamous cell cancers; LUMIRAY (NCT07219212), a global, phase 1b, open-label study in locally advanced head and neck squamous cell cancers; and CONVERGE (NCT06667908), a phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III non-small cell lung cancer (NSCLC).

(Press release, Nanobiotix, SEP 14, 2026, View Source [SID1234670821])