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])

On April 7, 2026 Florida Cancer Specialists & Research Institute, LLC (FCS) reported key findings from stage 1 of the PRESERVE-003 Phase 3 clinical trial conducted with participation have shown that gotistobart, a novel CTLA-4 checkpoint-targeting immunotherapy, may offer improved effectiveness with fewer side effects in patients with metastatic non-small cell lung cancer (NSCLC). The global PRSERVE-003 trial is a multi-year, groundbreaking study evaluating gotistobart against the chemotherapy drug docetaxel in people with squamous NSCLC (sqNSCLC) whose disease has worsened after standard immunotherapy and chemotherapy.

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Gustavo A. Fonseca, MD, FACP, FCS director of research and clinical trials, said, "Lung cancer remains the leading cause of cancer deaths worldwide and treatment options have historically been limited. FCS clinical research is contributing to discoveries that are revolutionizing the treatment of these and other advanced cancers."

Patients with metastatic NSCLC were randomized into stage 1 of the study conducted from June 2023 to September 2024 in study centers in the U.S., Australia, China, Korea and the UK. Stage 1 aimed "to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel."

The trial has moved forward into its pivotal later stage where the findings will be confirmed in a larger population of patients with sqNSCLC. The authors note: "The primary endpoint of PRESERVE-003 is overall survival (OS), and secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and safety."

FCS provides ongoing access to more than 180 clinical trials within 29 FCS clinics statewide and early-phase Drug Development Units (DDUs) located in Sarasota and Central Florida. Research conducted at FCS is made possible in partnership with Sarah Cannon Research Institute, one of the world’s leading oncology research organizations conducting community-based clinical trials.

View the abstract: Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial

(Press release, Florida Cancer Specialists & Research Institute, APR 7, 2026, View Source;research-institute-phase-3-trial-demonstrates-initial-clinical-benefit-of-novel-immunotherapy-for-advanced-non-small-cell-lung-cancer-302735982.html [SID1234664215])

On April 7, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported the initiation of the dose expansion phase in their clinical study evaluating spevatamig in combination with chemotherapy for the treatment of biliary tract cancer (BTC), following dose-limiting toxicity (DLT) clearance at two dose levels.

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Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple oncology indications, including a Phase 2 study evaluating the efficacy of spevatamig in combination with chemotherapy in first-line pancreatic ductal adenocarcinoma (PDAC) patients. As of March 2026, more than 160 patients globally have been dosed with spevatamig collectively in monotherapy and combination therapy settings. Three posters on spevatamig will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego. Presentation details can be found here: Phanes Therapeutics to present three clinical posters at AACR (Free AACR Whitepaper) 2026

(Press release, Phanes Therapeutics, APR 7, 2026, View Source [SID1234664214])