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])

On April 7, 2026 Singlomics Biopharmaceuticals, an innovative clinical-stage biopharmaceutical company focused on the discovery and development of antibody therapeutics for oncology, inflammation, and autoimmune diseases, reported that the first patient has been dosed in its Phase I clinical trial of DXP-106, a potential best-in-class IL-1RAP monoclonal antibody, in China.

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DXP-106 has previously received Investigational New Drug (IND) approvals from both the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). The ongoing first-in-human Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of DXP-106 in patients with advanced solid tumors.

"Dosing of the first patient in our Phase I trial represents a key milestone as we advance DXP-106 into clinical development globally," said Dr. Qian Shi, Chief Executive Officer of Singlomics. "IL-1RAP is a compelling target in oncology and immune-related diseases. DXP-106 is designed to function through both directly killing tumor cells by ADCC, and inhibit MDSCs in tumor microenvironment via inhibition of multiple IL-1 superfamily signaling pathways. It has demonstrated strong anti-tumor activity in preclinical studies. We look forward to generating initial clinical data and exploring potential global partnering opportunities to accelerate development."

DXP-106 is a humanized monoclonal antibody that specifically binds to a differentiated epitope on IL-1RAP domain 2, enabling simultaneous blockade of IL-1, IL-33, and IL-36 signaling pathways. This multi-pathway inhibition approach may provide broader anti-tumor activity and improved therapeutic benefit.

IL-1RAP is broadly expressed across tumor cells, stromal cells, and immune cells within the tumor microenvironment, and plays a central role in tumor progression, immune evasion, and chronic inflammation. Elevated IL-1 pathway signaling has been associated with poor clinical outcomes across multiple cancer types, supporting IL-1RAP as a promising therapeutic target.

Singlomics is advancing a differentiated pipeline of antibody therapeutics leveraging its proprietary single-cell sequencing and AI-enabled antibody engineering platform. The Company is actively seeking global partnerships for selected programs.

About DXP-106: IL-1RAP mAb

DXP-106 is a humanized IL-1RAP monoclonal antibody targeting a unique epitope on domain 2 of IL-1RAP, enabling inhibition of three key IL-1 superfamily signaling pathways. In preclinical in vitro and in vivo tumor models, DXP-106 demonstrated robust anti-tumor activity and favorable developability, supporting its potential as a best-in-class therapeutic.

(Press release, Singlomics Biopharmaceuticals, APR 7, 2026, View Source [SID1234664217])

On April 7, 2026 EQT Life Sciences reported that the LSP 7 fund ("EQT Life Sciences") has exited its minority stake in Tubulis (the "Company"), a Germany-based, clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs), through a sale to Gilead Sciences [Nasdaq: GILD].

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Tubulis’ lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor (TOPO1i) ADC, is currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer (NSCLC). Gilead will also acquire TUB-030, a 5T4 targeted ADC, which has demonstrated promising initial clinical data across various solid tumor types as well as a next-generation ADC platform and a promising early pipeline.

EQT Life Sciences co-led the oversubscribed Series B2 financing in 2024, and since then, has helped Tubulis advance into a clinical-stage oncology player, progress its pipeline, and build a differentiated antibody-drug conjugate platform targeting solid tumors. Working closely with the management team, EQT Life Sciences supported this journey through active board involvement and strategic guidance, helping position Tubulis as a partner of choice in a rapidly growing and highly competitive field.

The transaction represents a strong and strategic outcome for LSP 7 and its co-investors, and reflects EQT Life Sciences’ ambition to back outstanding science early, helping companies scale through critical inflection points into globally relevant businesses. Today’s announcement also underscores the continued demand for innovative oncology platforms that can address significant unmet medical needs.

"From the outset, we believed our conjugation technology platforms could have broad impact across the ADC field, and the initial data from TUB-040 have reinforced that conviction," said Dominik Schumacher, PhD, Chief Executive Officer and Co-founder of Tubulis. "Joining Gilead allows us to build on this foundation within an organization that brings deep scientific expertise, global development capabilities, and the scale needed to translate innovation into medicines for patients worldwide. Through our existing collaboration, Gilead has already seen the potential of our technologies and together, we are well positioned to accelerate the development of our ADC pipeline. I’m deeply grateful to the Tubulis team, our Board of Directors, investors, and partners for their commitment and helping make this milestone possible."

"From day one, it was clear that Tubulis had both the science and the ambition to compete at the very highest level in oncology," said Christoph Broja, Partner at EQT Life Sciences and Board Director at Tubulis." A European-born platform with world-class talent and technology, this is exactly the kind of company EQT Life Sciences was built to back. Today’s announcement is a testament to that conviction, and we are proud to have supported its journey from Munich to the global stage"

Following the close of the transaction, Tubulis will operate as a dedicated ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation, building on its integrated discovery, manufacturing, and clinical capabilities to advance next generation ADCs.

Terms of the Transaction

Under the terms of the sale and purchase agreement, Gilead will acquire all of the outstanding equity of Tubulis for $3.15 billion in upfront cash consideration on a cash-free, debt-free basis, subject to customary adjustments, which is payable at closing, and up to $1.85 billion in contingent milestone payments. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions. The transaction is expected to close in the second quarter of 2026. Gilead plans to finance the transaction with a combination of cash on hand and senior unsecured notes.

Centerview Partners LLC and Allen & Company LLC are acting as financial advisors for Gilead. J.P. Morgan Securities LLC is acting as the exclusive financial advisor for Tubulis. Covington & Burling LLP, Arnold & Porter LLP, and Venable LLP are serving as legal counsel to Gilead. Goodwin Procter LLP and CMS Hasche Sigle are serving as legal counsel to Tubulis.

(Press release, Gilead Sciences, APR 7, 2026, View Source [SID1234664216])