On March 16, 2026 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported two "trial in progress" presentations at the 2026 European Association of Urology congress (EAU) in London, UK. These trials investigate different stages of the diagnostic pathway, addressing data gaps to improve individual patient care and outcomes.

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The EAU annual meeting is one of the largest international meetings in the global urology calendar, showcasing the latest and most relevant clinical and scientific advancements in this area of patient care.

Photocure participated with its Hexvix product, designed for better detection and resection of bladder tumors. As in past sessions and as a service to non-attending urologists, Photocure will make 2026 EAU bladder cancer session highlights available to healthcare professionals after the event, by means of video interviews with the presenters of these sessions at the Photocure booth. This successful initiative is once again supported by two of the leading names in Bladder Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University Paris, France and Prof. P. Gontero, Division of Urology, University of Studies of Torino, Italy.

In addition to this educational activity, the EAU scientific program prominently featured Photocure’s Hexvix product and/or the blue light cystoscopy procedure in which it is used. In particular, two notable bladder cancer "trial in progress" presentations from Monday, March 16, 2026 were:

A0648: VI-RADS & PDD-TURBT to avoid Second-look and Resection (Re-TURBT) in Non-Muscle Invasive Bladder Cancers: The CUT-less Randomized Clinical Trial

F. Del Giudice, Rome (IT)

The CUT-less trial investigates whether second-look TURB can be safely omitted by combining preoperative staging accuracy of Magnetic Resonance Imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) with enhanced cystoscopy using blue-light-TURB

The primary endpoint of this randomized, single-center, non-inferiority trial is short-term bladder cancer recurrence. Patients eligible for second-look resection who are randomized to BL-TURB and demonstrate a very-low to low likelihood of muscle-invasive disease on MRI will omit the second-look resection, whereas patients randomized to WL-TURB will undergo the standard second-look resection. Over 3 years, 327 patients with intermediate- or high-risk NMIBCs* who are candidates for second-look TURBT will be enrolled. Results will also include building a health economic lifetime model, looking at cost-utility per quality-adjusted life year gained using 2-year clinical outcomes.

The CUT-less trial aims to generate evidence supporting a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway across the European Union and potentially worldwide.

ClinicalTrial.gov identifier (ID): NCT05962541 Read more: View Source

A0649: Trial in progress: Evaluation of urinary minimal residual disease and outcomes in high-risk non-muscle invasive bladder cancer surveilled with blue light compared to white light cystoscopy

A.K. Smith, Bethesda (US)

Urinary comprehensive genomic profiling offers a non-invasive method to assess the presence or extent of bladder cancer. The urinary biomarker UroAmp (Convergent Genomics) detects minimal residual disease (MRD). By enhancing tumor margin visualization, Blue Light Cystoscopy (BLC) may improve TURBT (transurethral resection of bladder tumors) completeness. This randomized controlled trial (RCT) enrolls high-risk NMIBC patients receiving either standard of care white light or Blue Light Cystoscopy. UroAmp will be used to evaluate completeness of resection for each modality.

The study will enroll 200 subjects undergoing TURBT for suspected high risk NMIBC randomized 1:1 to WLC or BLC-enhanced cohorts. Urinary MRD analyses will be conducted at all major decision points during treatment. The primary endpoint is the post-TURBT difference in MRD scores between the BLC and WLC arms. Secondary clinical outcomes include recurrence-free survival at 12 and 24 months.

Clinical Trial Registry number is NCT06525571. Read more: View Source

"Photocure’s support for these trials underscores our commitment to the transformation toward more personalized, data-driven care in uro-oncology, enabling better clinical outcomes and supporting the shift toward precision medicine. Minimally invasive procedures are on the rise and these trials address data gaps in the care pathway and in the impact of complete TURBTs using BLC to reduce tumor burden on clinical outcomes for high-risk patients. At Photocure, we strongly believe that the clinical utility of different precision diagnostic techniques can be optimized by using them in combination and in sequence throughout the patient pathway to inform physician decision-making and provide value for patients and healthcare. The same is true for their use in clinical trials," said Anders Neijber, Chief Medical Officer of Photocure.

During the EAU Congress on March 13, 2026, Photocure, in collaboration with medac, hosted a well-attended scientific event titled "Optimising Care in Bladder Cancer." The session was moderated by Mr. John McGrath (Consultant Urological Surgeon North Bristol Trust). The program brought together leading clinicians to discuss current challenges and advances in bladder cancer management, with a focus on improving patient pathways, in particular outcomes for women. This collaboration between Photocure and medac reflects a shared commitment to advancing evidence-based practice and supporting healthcare professionals in delivering high-quality, patient-centered bladder cancer care.

(Press release, PhotoCure, MAR 16, 2026, View Source [SID1234663581])

On March 16, 2026 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a leader in the field of masked, conditionally activated biologics, reported that it has commenced an underwritten public offering of $250.0 million of shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants. In addition, CytomX expects to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock and pre-funded warrants are to be offered by CytomX.

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CytomX expects to use the net proceeds from this offering for the continued development of Varseta-M and other pipeline programs. CytomX expects to use any remaining net proceeds from this offering for capital expenditures, working capital and other general corporate purposes.

Jefferies, Piper Sandler, Cantor and Barclays are acting as joint bookrunning managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on March 16, 2026, and automatically became effective upon filing. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, for free from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, or by telephone at (800) 747-3924, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected].

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

(Press release, CytomX Therapeutics, MAR 16, 2026, View Source [SID1234663564])

On March 16, 2026 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported the addition of a platinum resistance AI signature to the growing portfolio of Caris AI Insights. This new signature is designed to predict early platinum resistance in patients with high-grade serous ovarian cancer (HGSOC) and provides clinicians with unprecedented molecular insight into how long a patient may benefit from first-line platinum-based chemotherapy.

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Caris Life Sciences continues to advance precision oncology by integrating multimodal real-world datasets available with its proprietary CodeAI platform, enabling the creation of Caris AI Insights, an engine that utilizes Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS) and clinical data to generate deeper biological understanding and more actionable insights for clinicians and researchers.

By harnessing AI across its comprehensive real-world database, Caris is building next-generation multimodal models that accelerate biomarker discovery, enhance therapeutic decision-making and support the development of more personalized cancer treatments.

HGSOC is the most common and aggressive type of ovarian cancer and is often diagnosed at an advanced stage, creating urgency in treatment planning. Platinum resistance, defined as disease progression or recurrence within six months of finishing first-line platinum-based chemotherapy, is estimated to affect 20-30% of patients with advanced HGSOC. For clinicians, understanding a patient’s likelihood of chemotherapy resistance can guide the creation of a patient-specific treatment plan.

The ovarian platinum resistance signature is particularly relevant in light of the recent FDA approval of a combination therapy for patients with platinum-resistant disease. The FDA approved a new combination treatment that opens the door to another option for patients whose cancer has stopped responding to initial platinum-based chemotherapy. The approval underscores the importance of identifying resistance earlier in the treatment course so clinicians can make more informed decisions about subsequent therapy.

"The ability to anticipate which patients are likely to develop early platinum resistance has the potential to significantly improve how we approach ovarian cancer care," said David Spetzler, MS, PhD, MBA, Caris President. "Platinum-based chemotherapy works well for many patients, but when it doesn’t, patients need to be able to quickly move on to other therapeutic options."

By identifying complex molecular features associated with platinum resistance, this signature generates a risk score and a "platinum sensitive" or "platinum resistant" prediction that estimates the likelihood of early transition to the next line of treatment using features from the Caris industry-leading Whole Exome and Whole Transcriptome tissue platform. Also, clinicians receive supporting Kaplan-Meier curves to help contextualize the risk and assist with treatment planning. The Caris AI Insights for ovarian cancer is available now, by request, through the Caris Molecular Tumor Board Report when ordering Caris’ tissue-based test, MI Cancer Seek.

Caris received FDA approval in November 2024 for MI Cancer Seek, a tissue-based assay that is the first and only simultaneous WES and WTS-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.

(Press release, Caris Life Sciences, MAR 16, 2026, View Source [SID1234663582])

On March 16, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported positive Phase 1 expansion data for its EpCAM PROBODY ADC, varsetatug masetecan (Varseta-M) in late-line metastatic CRC. The preliminary data are as of a January 16, 2026 data cutoff from the ongoing CTMX-2051-101 Phase 1 study.

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"These latest Phase 1 data reinforce the potential of Varseta-M to meaningfully improve the standard of care in late-line colorectal cancer. We are now planning interactions with the FDA to discuss the initial registrational path for bringing this highly innovative, first-in-class ADC to the market in late-line CRC," said Sean McCarthy, D. Phil, chief executive officer and chairman of CytomX.

McCarthy added, "Our ultimate vision is to reach a broad CRC patient population with Varseta-M, including in earlier lines of treatment, as well as to expand into additional EpCAM-expressing cancers. We aim to aggressively advance this novel therapy towards late-stage development for the benefit of patients as we set our sights on building CytomX into a commercial-stage company."

"Patients with late-stage metastatic CRC face a poor prognosis and have very limited treatment options. These exciting clinical data demonstrate that Varseta-M can drive consistent and durable responses with a manageable tolerability profile in patients with heavily pretreated CRC, supporting its promise as a potential new treatment option for advanced CRC," said Dr. Kimmie Ng, Associate Chief of the Division of Gastrointestinal Oncology at Dana-Farber Cancer Institute.

Varsetatug Masetecan Phase 1 Expansion Data Summary in Advanced, Late-line Colorectal Cancer

The CTMX-2051-101 study was initiated in April 2024 with dose escalation proceeding through seven dose levels ranging from 2.4 mg/kg to 12 mg/kg. As of the data cutoff of January 16th 2026, a total of 93 patients with late-line metastatic CRC had been enrolled in the study. 60 patients were enrolled across the Phase 1 expansion dose range of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg of which 56 were efficacy evaluable as of the data cutoff.
Starting in October 2025, the expansion doses of 8.6 mg/kg and 10 mg/kg were prioritized for dose optimization utilizing optimized adverse event management guidelines and adjusted ideal body weight (AIBW) dosing. 20 patients had been enrolled in expanded dose optimization as of the January 16th data cutoff towards an enrollment goal of 40 patients.

Patient Characteristics:

Patients enrolled in the study had previously received a median of 3 prior lines of therapy in the metastatic setting and 96% of patients had previously been treated with irinotecan. 76% of patients had liver metastases and 71% had KRAS mutations.
Patients were not preselected based on EpCAM expression levels. All patients with evaluable tumor biopsies had high EpCAM levels as measured by immunohistochemistry.1

Efficacy:

As of the data cutoff, 56 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W. Median duration of follow-up across the efficacy-evaluable patient population was approximately 8 months. Efficacy data across the Phase 1 Expansion doses are summarized below in Table 1.

Table 1. Varseta-M Efficacy Summary by Phase 1 Expansion Dose

7.2 mg/kg 8.6 mg/kg 10 mg/kg
Confirmed
Overall Response Rate (ORR)2 6% (1/17) 20% (4/20) 32% (6/19)
Median Progression Free Survival (PFS) 5.5 mo.
(95% CI: 2.5, NE) 6.8 mo.
(95% CI: 2.8, NE) 7.1 mo.
(95% CI: 3.9, NE)
Disease Control Rate (DCR) 88% (15/17) 90% (18/20) 84% (16/19)

At the 8.6 mg/kg dose, the confirmed response rate was 20% with an estimated median PFS of 6.8 months and at the 10 mg/kg dose, the confirmed response rate was 32% with an estimated median PFS of 7.1 months.
The disease control rate was 88% (49/56) across the expansion doses of 7.2 – 10 mg/kg.
The doses of 8.6 mg/kg and 10 mg/kg have been prioritized for further evaluation with the goal of selecting a dose or doses for a registrational study.
Dose optimization at 8.6 mg/kg and 10 mg/kg utilizing AIBW dosing and updated prophylaxis for adverse event management is ongoing.
At the doses of 11 mg/kg Q3W and 12 mg/kg Q3W, which were not expanded for further evaluation, the overall response rate was 30% (3/10).

Safety:

As of the data cutoff, 93 patients were evaluable for safety including 80 patients across the expansion dose range of 7.2 mg/kg to 10 mg/kg. Varseta-M’s safety profile was generally consistent with data presented in Phase 1 dose escalation. Most treatment related adverse events were Grade 1 or Grade 2 in severity.

No interstitial lung disease, febrile neutropenia or pancreatitis were observed.
The most common treatment-related adverse event (TRAE) was diarrhea which was generally manageable and reversible.
In Phase 1 dose expansions starting in Q2 2025, prophylactic strategies for diarrhea management were investigated. In dose optimization starting in Q4 2025, an updated prophylaxis regimen of anti-motility medication (loperamide or diphenoxylate/atropine) plus budesonide was implemented.3
In the 20 patients receiving the updated prophylactic regimen in dose optimization at doses of 8.6 mg/kg and 10 mg/kg, Grade 3 diarrhea was 10%.4,5
Overall, as of the January 16th 2026 data cutoff, in the 80 patients treated at expansion and optimization doses ranging between 7.2 mg/kg to 10 mg/kg, the most common treatment-related adverse events (TRAEs) were diarrhea (68 pts, 19 Gr 3), nausea (44 pts, 4 Gr 3), vomiting (29 pts, 3 Gr 3), fatigue (32 pts, 2 Gr 3), hypokalemia (21 pts, 13 Gr 3+), and anemia (13 pts, 6 Gr 3). Serious treatment related adverse events (SAEs) in > 1 patient included diarrhea (4), vomiting (3), hypokalemia (3), dehydration (3), acute kidney injury (2), and colitis (2).
As previously reported on August 13, 2025, there was one treatment-related grade 5 acute kidney injury (AKI) in a patient treated at the 7.2 mg/kg dose. The patient had a complex medical history including having a solitary kidney, and the AKI was determined to be secondary to Grade 3 nausea and Grade 2 diarrhea. No other Grade 5 TRAEs have been reported as of the January 16th 2026 data cutoff.
At the 11 mg/kg and 12 mg/kg doses, there were no dose limiting toxicities in dose escalation. The most common TRAEs across the patients in the 11 mg/kg dose (n=8) and 12 mg/kg dose (n=3) were diarrhea (9 pts, 6 GR 3), nausea, (8 pts, 0 Gr 3), and vomiting (8 pts, 1 Gr 3). Patients treated at the 11 and 12 mg/kg doses did not receive the optimized prophylactic regimen or adjusted ideal body weight dosing.

Varsetatug Masetecan Next Steps:

Additional efficacy and safety data from the Phase 1 study are expected to be presented at one or more medical meetings in 2026.
The Company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
A Phase 1 Varseta-M combination study with bevacizumab in CRC has been initiated and a Phase 1b/2 study in combination with bevacizumab and chemotherapy is expected to start by the end of 2026.
Initiation of Phase 1 expansion cohort(s) in additional EpCAM-expressing indications is planned for 2H 2026.

(Press release, CytomX Therapeutics, MAR 16, 2026, View Source [SID1234663565])

On March 16, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported two peer-reviewed publications highlighting the clinical utility of Signatera, its personalized, tumor-informed circulating tumor DNA (ctDNA) assay, in anal squamous cell carcinoma (ASCC) and locally advanced rectal cancer (LARC).A recently published study evaluated 84 patients with ASCC to assess whether serial Signatera testing may offer a dynamic, treatment-responsive biomarker to further stratify recurrence risk and inform surveillance and treatment. Key findings include:

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Signatera-status was strongly correlated with clinical outcomes. Patients who were Signatera-negative at baseline or cleared ctDNA during chemoradiotherapy (CRT) had favorable outcomes, including 100% one-year overall survival and progression-free survival, and 0% one-year local regional failure. Patients who remained ctDNA-positive after CRT had poorer outcomes (63% OS, 44% PFS, 39% locoregional failure at one year).
In 100% of recurrent cases, Signatera-positivity preceded clinical and/or radiographic recurrence highlighting ctDNA’s potential as an early indicator of relapse.
LARC: publication in Cancers

Another recent study evaluated 220 patients with LARC treated with neoadjuvant therapy (NAT) followed by non-operative management (NOM) (n=72) or surgery (n=148). The study examined how Signatera status after NAT may inform patient selection for organ-preserving NOM versus surgery and guide intensified surveillance strategies. Key findings include:

Signatera identified post-NAT patients at high risk of relapse requiring surgical intervention. Signatera-positive NOM patients were at 4.6x higher risk of regrowth requiring surgery (HR 4.62; p=0.003), even among those with a complete or near-complete clinical response.
Post-operative Signatera negativity was associated with excellent clinical outcomes. Signatera-negative patients (HR:15, p=0.001) experienced a relapse rate of 11.5% compared to 88.0% among Signatera-positive patients (p<0.0001).
"Together, these publications address key questions about monitoring treatment response and recurrence risk in anal and rectal cancers," said Alexey Aleshin, M.D., MBA, corporate chief medical officer and general manager of oncology at Natera. "By providing earlier insight into molecular residual disease, Signatera can support more individualized surveillance and treatment decisions."

(Press release, Natera, MAR 16, 2026, View Source [SID1234663583])