On April 7, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for SIM0505 for the treatment of platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload.

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"Securing Fast Track designation for SIM0505 validates the urgent, unmet need for new treatments for platinum resistant ovarian cancer and enables us to work more closely with FDA to accelerate development. We believe this designation will help to streamline and de-risk development through proactive and ongoing engagement with FDA," said Michael Richman, President and CEO of NextCure. "We are committed to bringing SIM0505 to patients as quickly as possible and we plan to initiate dose optimization in ovarian cancer patients in the second quarter of 2026. In addition, we look forward to presenting Phase 1 data on the program at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference."

About Fast Track Designation

Fast Track Designation is an FDA process designed to facilitate the development of new therapies to treat serious conditions and fulfill an unmet medical need. Drug candidates that receive Fast Track Designation are eligible for more frequent meetings and written interactions with the FDA, rolling review and priority review.

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

(Press release, NextCure, APR 7, 2026, View Source [SID1234664222])

On April 7, 2026 CatalYm reported that the first patient has been dosed in the GDFATHER-HCC-01 trial (NCT07219459). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab in combination with chemoimmunotherapy as a second-line (2L) treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The Phase 2b trial targets patients who have progressed following 1L treatment with an anti-PD-(L)1-based therapy.

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The trial will assess a treatment strategy combining visugromab with the PD-1 inhibitor nivolumab and the multi-target tyrosine kinase inhibitor (TKI) lenvatinib. The study consists of an open-label safety run-in to confirm the recommended dose for expansion, followed by a randomized, double-blind phase evaluating visugromab plus nivolumab plus lenvatinib versus double placebo plus lenvatinib.

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), an immunosuppressive cytokine exploited by tumor cells to promote immune evasion and resistance to anti-PD-(L)1 therapies. By neutralizing GDF-15, visugromab aims to restore anti-tumor immune responses to improve outcomes in a setting where 5-year overall survival remains as low as 18%.1 In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab demonstrated encouraging anti-tumor activity when combined with an anti-PD-1 antibody in advanced-stage, anti-PD-(L)1 relapsed/refractory HCC patients, demonstrating deep and durable responses, with a median duration of response of 21.4 months and a favorable safety profile.

"HCC is the third leading cause of cancer-related deaths globally and continues to present immense clinical challenges, especially in patients who progress on immunotherapy," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "This new trial is designed to combine the immune-restoring properties of visugromab with a checkpoint inhibitor and the standard of care tyrosine kinase inhibitor. With this approach we aim to improve clinical outcomes for HCC patients with limited treatment options."

"Expanding into HCC represents a pivotal step in our strategy to bring visugromab to additional high-need tumor types," said Scott Clarke, Chief Executive Officer at CatalYm. "Visugromab’s dual potential to restore immune sensitivity and address cancer cachexia, which affects nearly one in four patients with HCC at diagnosis, underpins our approach in this study. By combining our antibody with proven standards of care, we aim to shift the treatment paradigm and ultimately improve survival and quality of life for patients who have few options today."

The GDFATHER-HCC-01 trial is a global, randomized, blinded Phase 2b study enrolling approximately 104 participants across 40 sites in North America, Europe and Asia-Pacific. It consists of two parts:

Part 1: An open-label safety run-in assessing the combination of visugromab with nivolumab and lenvatinib to determine the Recommended Dose for Expansion (RDE).
Part 2: A randomized and double-blind evaluation of the triple combination versus double placebo plus lenvatinib.
The primary endpoint is progression-free survival (PFS) assessed by local investigators. Key secondary endpoints include overall survival (OS), independently assessed PFS, and objective response rate (ORR). The study will also explore visugromab’s potential to mitigate cancer cachexia using the Functional Assessment of the Anorexia and Cachexia Therapy questionnaire (FAACT-ACS), as muscle wasting and weight loss are common in HCC and known to negatively affect treatment tolerance and clinical outcomes.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. The five-year survival rate for HCC is only 18%, second lowest among common cancers1. While checkpoint inhibitors have become a first-line standard of care, most patients with advanced-stage HCC ultimately experience disease progression or relapse. Treatment options in the second-line setting remain limited, underscoring the urgent need for more effective and well-tolerated therapies.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, APR 7, 2026, View Source [SID1234664221])

On April 7, 2026 enGene Therapeutics Inc. (formerly, enGene Holdings Inc.) (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that it will change its corporate name to "enGene Therapeutics Inc." effective April 8, 2026. The Company elected to change its corporate name to reflect the near-term transition to a commercial organization with the potential approval of detalimogene voraplasmid in 2027. enGene’s ongoing LEGEND trial is investigating detalimogene across several cohorts of high-risk non-muscle invasive bladder cancer (NMIBC), including a pivotal cohort in BCG-unresponsive NMIBC with carcinoma in situ (CIS).

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"We’re entering an important next phase for enGene as we prepare for potential approval of detalimogene in 2027," said Ron Cooper, President and Chief Executive Officer, enGene. "Our new name reflects our progress — and the opportunity to bring detalimogene to patients and the practices that care for them, where more options are still needed."

The Company’s common shares (the "Common Shares") will continue to trade on the Nasdaq Capital Market (the "Nasdaq") under the symbol "ENGN", and the Company’s listed common share purchase warrants (the "Warrants") will continue to trade on the Nasdaq under the symbol "ENGNW".

The corporate name change does not affect the rights of security holders, and no further action is required by security holders with respect to the change. As of the effective date, the CUSIP numbers and ISINs of the Common Shares and Warrants will change. The new CUSIP number for the Common Shares is 29286X101 and the new ISIN number is CA29286X1015. The new CUSIP number for the Warrants is 29286X119 and the new ISIN number is CA29286X1197.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on our healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Detalimogene has also been selected to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.

(Press release, enGene, APR 7, 2026, View Source [SID1234664220])

On April 7, 2026 Natera, Inc. (NASDAQ: NTRA) a global leader in cell-free DNA and precision medicine, reported that 20 abstracts, including two oral presentations, featuring data generated using its technologies will be presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22 in San Diego, CA.

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These presentations, developed in collaboration with leading academic and clinical partners, span multiple tumor types and applications, including artificial intelligence, digital pathology, molecular residual disease (MRD) and real-world evidence (RWE).

"These presentations reflect both the scale of our platform and the pace of innovation we’re driving across oncology," said Alexey Aleshin, M.D., corporate chief medical officer and general manager, oncology and early cancer detection at Natera. "From AI-enabled genomic insights to real-world evidence supporting ctDNA-guided treatment decisions, this body of work demonstrates how we are continuing to innovate within and beyond MRD to deliver more precise, data-driven approaches across cancer care."

Key highlights

Artificial Intelligence

Natera’s oral presentation, A large-scale, multi-target deep learning model for virtual genomic profiling in colorectal cancer, describes a digital pathology deep learning model trained on molecular and histopathology data from more than 45,000 colorectal cancer patients in a first-of-its-kind analysis. The model predicts risk of recurrence, hundreds of genomic alterations and key guideline biomarkers directly from routine H&E images, with an industry-leading area under the receiver operating curve (AUROC) of 0.98 for MSI-status and 0.93 for BRAF V600E status. This highlights the potential to transform routine pathology slides into a scalable, AI-enabled genomic profiling platform, expanding access to high-value molecular data, reducing tissue constraints and accelerating time to treatment decisions.
An additional poster in breast cancer, A machine learning approach to classify breast cancer receptor subtype using genomic features, analyzed data from nearly 20,000 patients. The study concluded that a machine learning model using tumor DNA can accurately classify breast cancer into its major subtypes, including high precision of 93.5% and recall of 91.1% for identifying HR+/HER2- disease.
ctDNA Decision-Making

A second oral presentation, Circulating tumor DNA (ctDNA) clearance dynamics in microsatellite instability-high metastatic (MSI-H) colorectal cancer (CRC) treated with immune checkpoint inhibitors (ICI), includes a real-world analysis of 465 patients with MSI-H metastatic CRC treated with ICI. The data shows that ~40% of patients had early ctDNA clearance on ICI. Signatera negativity at the first post-ICI timepoint was predictive of overall survival (OS), with 3-year OS of 96%. Moreover, MRD dynamics were strongly associated with improved OS with 65% of Signatera-positive patients achieving clearance anytime on or post-ICI.
Platform Expansion

A poster on Natera’s methylation-based, tissue-free MRD platform entitled, Quantification of circulating tumor DNA (ctDNA) in patients using cancer-specific, methylation-based, tissue-free tests for the detection of molecular residual disease (MRD), shows that quantitative ctDNA levels strongly correlate with Signatera quantitative levels across colorectal, breast, lung and bladder cancers. LatitudeTM, Natera’s tissue-free MRD assay, launched in CRC in 2025 and is expected to launch commercially in additional histologies with quantitative features later this year.
A poster in early cancer detection, Performance of a blood-based screening test for the early detection of advanced precancerous lesions, summarizes previously announced PROCEED trial data that showed strong performance of Natera’s blood-based screening assay for detecting advanced precancerous lesions. The study demonstrated sensitivity of 22.5% (CI: 15.4%-32.4%) and specificity of 91.5% (CI: 88.2%-93.9%)​​ and encompassed all histologic subtypes, including serrated polyps.

(Press release, Natera, APR 7, 2026, View Source [SID1234664219])

On April 7, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the submission to the U.S. Food and Drug Administration (FDA) of the Company’s NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC.

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"The advancement of neladalkib from first clinical trial initiation to NDA submission in less than four years represents a remarkable pace in oncology drug development, underscoring the vigor and urgency our team brought to this program and our deep commitment to the ALK-positive NSCLC community," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "We would like to extend our sincere gratitude to the patients, families and investigators who have made this progress possible, and are committed to working closely with the FDA throughout the NDA review process toward our goal of bringing neladalkib to patients as quickly as possible."

The application is based on data in TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial. In this population, neladalkib demonstrated encouraging overall activity, including intracranial responses, the ability to address key drivers of disease progression, and a generally well-tolerated safety profile consistent with its ALK-selective, TRK-sparing design. The company plans to share detailed results at a future medical meeting.

Neladalkib has received breakthrough therapy designation from the FDA for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About Neladalkib

Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

About the ALKOVE-1 Phase 1/2 Clinical Trial

The ALKOVE-1 trial (NCT05384626) is a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ALK-positive NSCLC patients who previously received at least one ALK TKI, or patients with other ALK-positive solid tumors who had been previously treated or for whom no satisfactory standard of care exists. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of neladalkib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The global, single arm, open label Phase 2 portion is designed with registrational intent for TKI pre-treated patients with advanced ALK-positive NSCLC. Global enrollment in ALKOVE-1 remains ongoing for adult and adolescent patients with ALK-positive solid tumors outside of NSCLC, and adolescent patients with ALK-positive NSCLC.

(Press release, Nuvalent, APR 7, 2026, View Source [SID1234664218])