On May 27, 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 acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. The company further announced that Georg Pirmin Meyer, M.D., has joined the company as Chief International Officer.

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"With today’s announcement, New Drug Applications for both zidesamtinib and neladalkib in TKI pre-treated populations are now under review with the FDA, and TKI-naïve expansion strategies are underway," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "Our U.S. commercial and medical affairs teams are in place and focused on establishing the strong foundational systems and infrastructure required to effectively deliver on multiple synergistic launches in biomarker-driven NSCLC."

Dr. Porter continued, "Nuvalent’s commitment to patients is global, and we are thrilled to welcome Georg Pirmin as we develop an international strategy with the goal of delivering new medicines beyond the U.S. His proven track record of establishing global operations and strategic partnerships that maximize patient access will be instrumental in realizing the full potential for Patient Impact with our parallel-lead programs."

"Nuvalent presents a unique near-term opportunity to advance multiple potential best-in-class product candidates for patients with cancer, backed by robust clinical experience demonstrating clear global medical need and enthusiasm," said Dr. Meyer. "I am excited to join at this pivotal moment and to partner with the team to realize our shared vision of global leadership in ROS1- and ALK-positive NSCLC."

Neladalkib NDA Accepted for Filing with Priority Review

The U.S. FDA has accepted for filing Nuvalent’s NDA for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated advanced ALK-positive non-small cell lung cancer (NSCLC). The application has been granted Priority Review and assigned a PDUFA target action date of November 27, 2026.

The submission 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. These data, along with preliminary data for TKI-naïve patients, will be shared during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.

Georg Pirmin Meyer, M.D. Joins as Chief International Officer

In this newly created role, Dr. Meyer will be responsible for spearheading Nuvalent’s international expansion strategy and establishing the company’s presence in key markets outside the U.S.

Dr. Meyer brings extensive expertise in global commercial strategy, market access, product launches, and business development across major international markets. Most recently, he served as Senior Vice President and General Manager, International at Blueprint Medicines, where he held full P&L accountability for international operations. In this role, Dr. Meyer led the European market preparation and successful launches of Ayvakit (avapritinib) across three indications, while building and scaling a cross-functional team spanning nine European countries. Prior to Blueprint Medicines, Dr. Meyer served as General Manager, Germany at Vertex Pharmaceuticals, where he held full P&L responsibility for the German market, scaled commercial operations for four marketed orphan disease products, and drove uncompromising market access strategies including HTA submissions and complex price negotiations. Earlier in his career, he held progressive global commercial operational roles at Amgen and Sanofi, establishing a strong foundation in biopharmaceutical commercialization. Dr. Meyer received his M.D. from the University of Freiburg, Germany and the University of Innsbruck, Austria.

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.

Based on data in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ALKOVE-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. 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.

About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib 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/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC.

(Press release, Nuvalent, MAY 27, 2026, View Source;and-alk-positive-nsclc-302782393.html [SID1234666114])

On May 27, 2026 Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, and ImmuXell Biotech, a Shanghai-based clinical-stage cell therapy company, reported their strategic partnership which began in December 2025. The milestone: the first patient has been dosed in an investigator initiated trial (IIT) using ImmuXell’s TCR-T cell therapy manufactured on Ori’s IRO platform.

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The IIT is aiming to evaluate ImmuXell’s TCR-T therapy in patients with solid tumors harboring KRAS G12V mutations, including those with colorectal cancer, pancreatic cancer, and lung cancer — all among the deadliest and most treatment-resistant cancers. This is a proof point that the IRO platform can take a therapy from process development to patient dosing with the speed, quality, and consistency that GMP manufacturing demands.

From platform installation to first patient dosed in four months, the Ori and ImmuXell teams working together have rapidly adapted and optimized ImmuXell’s proprietary manufacturing process on IRO, demonstrating the platform’s flexibility without sacrificing safety, efficacy or quality. The partnership includes IRO platform deployment at ImmuXell’s Shanghai facilities, with full scientific and technical support from Ori. The two companies plan to progress the current IIT and file an IND application in China to conduct a Phase 1 clinical trial later in 2026.

Jason C. Foster, CEO, Ori Biotech, said:

"This is the milestone we’ve been building toward for the last 7 years — IRO manufacturing a therapy for a patient who desperately needs it. Our platform was designed to eliminate the tradeoffs that have held back cell therapy: speed vs. quality, scale vs. cost, R&D vs. GMP. This partnership with ImmuXell demonstrates that IRO can deliver on all of them, in one of the world’s most important emerging biopharma markets, in the most intractable cancers, quickly and efficiently. We’re proud to be the manufacturing backbone for ImmuXell’s clinical ambitions, and we see this as the first step in a long and impactful collaboration."

Dr. HongMing Hu, Founder, ImmuXell Biotech, said:

"When you’re developing therapies for cancers with no good treatment options, speed to patients is everything. IRO let us move faster than we thought possible — adapting to our unique process, hitting our CQAs, and outperforming the flask and bag based manufacturing approach we had been using for years in just a few short months. Ori is the kind of partner that makes the impossible feel achievable. We look forward to bringing our TCR-T therapy to more patients in China this year and working together with Ori on our ex-vivo cell therapy pipeline."

This partnership marks Ori’s first collaboration in Asia Pacific and underscores the company’s rapid global momentum. IRO now counts 18 partners worldwide — including the recently announced partnership with AdAlta and Cell Therapies Pty in Australia as well as longstanding US partners Charles River Laboratories, CTMC, ElevateBio, and Kincell Bio, as well as other leading CDMOs and two Tier 1 pharma companies. Since its commercial launch in December 2024, IRO has been adopted across R&D, PD and now clinical settings. Ori expects the first INDs for IRO-manufactured products to be filed in late 2026.

(Press release, ImmuXell Biotech, MAY 27, 2026, View Source [SID1234666130])

On May 27, 2026 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company, reported the closing of an oversubscribed CHF 26 million (EUR 28.4 million) Series B extension, bringing the Series B total raised to CHF 105 million (approximately EUR 115 million). The financing was led by existing investors Kurma Growth Opportunities Fund, Angelini Ventures, together with EIB co-investment facility Aurea, Wellington Partners and Neva SGR (Intesa Sanpaolo Group), with participation from DeepTech & Climate Fonds (DTCF), Bayern Kapital, Vives Partners, NRW.BANK, and additional existing investors.

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„Emerging data from our Phase 1/2 diagnostics studies continue to generate strong momentum for NUCLIDIUM’S true radiotheranostics approach. We will build on our programs‘ best-in-class potential by initiating Phase 1/2a therapeutic studies for NU-101 and NU-201 later this year, demonstrating our direct conversion strategy from diagnosis to treatment. The Series B extension and support from our world-class investors further validate our strategy to advance next-generation copper-based radiotheranostics and unlock the full potential of the theranostic modality," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM .

Proceeds from the Series B extension will accelerate and expand the clinical development of NUCLIDIUM’S lead theranostic programs, NU101 in metastatic castration resistant prostate cancer (mCRPC) and NU201 in metastatic breast cancer (mBC), into advanced clinical trials. The financing will also support the continued buildout of its worldwide production and manufacturing network for diagnostics and therapeutics and expand novel target development for its preclinical programs to bring radiotheranostics to novel solid tumor indications.

„Radiopharmaceuticals are one of the most compelling growth opportunities in oncology today. NUCLIDIUM has established clear differentiation with its copper-based radiotheranostic approach, demonstrating clinical superiority to competing radioligands and ease-of-use that supports seamless integration into hospital workflow. We are proud to support NUCLIDIUM through this new phase of growth as it advances its pipeline toward additional clinical proof-of-concept data," said Regina Hodits, PhD, Managing Director at Angelini Ventures , Daniel Parera, MD, Partner at Kurma Partners and Mario Costantini, CEO and General Manager at Neva SGR (Intesa Sanpaolo Group) for all participating investors.

The Series B financing transaction was advised by VISCHER AG as legal counsel.

(Press release, NUCLIDIUM, MAY 27, 2026, View Source [SID1234666099])

On May 27, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that following review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), the company has received CDE endorsement to conduct the pivotal Phase III CLINCH-3 study of ATG-022, a Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The study is expected to be initiated in China first and is planned as a multi-regional clinical trial (MRCT).

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"Receiving CDE endorsement to conduct the pivotal Phase III CLINCH-3 study represents a defining milestone for Antengene." said Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene. "This achievement underscores Antengene’s fully integrated R&D capabilities, from the design and discovery of novel molecules to clinical translation and registrational development. The Breakthrough Therapy Designation previously granted by CDE provided an important basis for our regulatory discussions on this pivotal study and enabled efficient feedback from CDE. We are highly encouraged by the potential of ATG-022 to address the significant unmet medical needs of patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma, and we look forward to working closely with investigators to advance this important study."

The CLINCH-3 study will be led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator’s choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. As a pivotal registrational study, CLINCH-3 is intended to support a future marketing approval application for ATG-022 as monotherapy for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The primary endpoints of the study are progression-free survival as assessed by independent review committee (PFS by IRC) and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety, and other measures. The initiation of this pivotal study is supported by encouraging results from the Phase I/II CLINCH study, which showed that ATG-022, as monotherapy, demonstrated a differentiated efficacy and safety profile in patients with advanced gastric or gastroesophageal junction adenocarcinoma. As of December 25, 2025, among patients whose tumors had CLDN18.2 expression of IHC 2+ >20%, ATG-022 achieved ORRs of 46.7% and 40.0% at 1.8 mg/kg and 2.4 mg/kg, respectively, with corresponding DCRs of 86.7% and 90.0%. Median PFS (mPFS) was 6.97 months and 5.09 months, respectively, while median OS (mOS) was not yet reached in the 1.8 mg/kg cohort and was 14.72 months in the 2.4 mg/kg cohort. In the 1.8 mg/kg cohort, the incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was 19.4%, highlighting a highly differentiated safety profile for an ADC. Together with its robust antitumor activity, encouraging survival outcomes and favorable tolerability, these data position ATG-022 as a potential best-in-disease therapy for gastric cancer or gastroesophageal junction adenocarcinoma.

"Advanced gastric and gastroesophageal junction adenocarcinoma remains one of the most difficult solid tumors to treat, and the challenge is particularly acute in the 3L setting, where current options, including chemotherapy, anti-angiogenic agents and immunotherapy, provide limited efficacy, low objective response rates and insufficient survival benefit," said Professor Lin Shen of Peking University Cancer Hospital, principal investigator of the CLINCH-3 study. "ATG-022 has shown a compelling clinical profile as monotherapy at 1.8 mg/kg, with strong anti-tumor activity, meaningful survival benefit and a favorable safety profile. The CDE endorsement to conduct this pivotal Phase III study represents an important step toward potentially transforming the treatment landscape for patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. I am pleased to lead CLINCH-3 and look forward to working with Antengene to bring this promising therapy to more patients."

Antengene will continue to advance a comprehensive clinical development strategy for ATG-022 across multiple settings, including its pivotal monotherapy study in advanced gastric or gastroesophageal junction adenocarcinoma, ongoing combination studies with anti-PD-1 therapy and chemotherapy in the 1L gastric cancer setting, and further exploration in other CLDN18.2+ solid tumors, including tumor types beyond the digestive system where encouraging efficacy signals with confirmed tumor responses, have been observed. Through this strategy, the company aims to maximize the clinical potential of ATG-022 and bring innovative, impactful therapies to patients in China and around the world.

(Press release, Antengene, MAY 27, 2026, View Source [SID1234666115])

On May 27, 2026 Palleon Pharmaceuticals, the first company to translate glycan editing science into clinical-stage therapeutics for immune modulation, reported the first patient has been dosed in a Phase 1 clinical trial of E-688/HLX316, a first-in-class B7-H3-targeted sialidase. The study is being conducted in China by strategic collaborator Shanghai Henlius Biotech in patients with tumors prone to B7-H3 overexpression and hypersialylation, with an initial focus on platinum-resistant ovarian cancer.

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This milestone marks the clinical translation of a fundamentally new mechanism — glycan editing for immune modulation — grounded in the pioneering glycobiology research of Nobel laureate Carolyn Bertozzi. Tumor hypersialylation, the upregulation of sialic acid-containing glycans on the surface of cancer cells, can suppress anti-tumor immunity by activating sialic acid-dependent immune regulatory pathways. This axis of immune evasion is present across many solid tumors and correlates with poor clinical outcomes in dozens of published studies.

"E-688/HLX316 is designed to enzymatically remove sialic acid from tumor cell surfaces at the site of B7-H3 overexpression, unmasking tumors to the immune system in a durable, mechanistically distinct way. This first-in-human trial is a critical step toward validating glycan editing for immune modulation as a new therapeutic paradigm across hypersialylated solid tumors," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "The protocol includes a planned expansion into platinum-resistant ovarian cancer, where high B7-H3 expression and hypersialylation provide a compelling biological rationale for this approach."

About E-688/HLX316

E-688/HLX316 is generated from Palleon’s EAGLE (Enzyme-Antibody Glycan-Editing) platform and combines a human sialidase enzyme with a targeting arm directed at B7-H3, a tumor antigen broadly overexpressed across solid tumors and associated with aggressive disease biology and poor prognosis. By enzymatically removing sialic acid from tumor cell surfaces, E-688/HLX316 restores immune recognition through glycan-binding receptor pathways, disrupts the immunosuppressive tumor microenvironment, and is designed to generate durable anti-tumor immune responses — activating both innate and adaptive immunity through a mechanism distinct from existing checkpoint therapies.

In preclinical studies, E-688/HLX316 demonstrated tumor surface desialylation lasting more than seven days in vivo and showed improved anti-tumor activity relative to anti-PD-1 monotherapy in humanized tumor models.

Phase 1 Trial Design

The Phase 1 first-in-human trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary anti-tumor activity of E-688/HLX316 monotherapy, comprising a Phase 1a dose escalation in B7-H3+ advanced solid tumors and Phase 1b dose expansion in platinum-resistant ovarian cancer. Palleon and Henlius intend to expand the program into additional solid tumor indications characterized by high B7-H3 expression and hypersialylation.

(Press release, Palleon Pharmaceuticals, MAY 27, 2026, View Source [SID1234666131])