On May 11, 2026 Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has approved BIZENGRI (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This marks the first targeted therapy approved specifically for NRG1+ cholangiocarcinoma, a molecularly defined cancer with a profound unmet need. The approval was expedited by PTx’s receipt of a Commissioner’s National Priority Voucher (CNPV). BIZENGRI previously received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for NRG1+ cholangiocarcinoma, reflecting the unmet need in this patient population.

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"Today’s FDA approval of BIZENGRI for NRG1 fusion-positive cholangiocarcinoma is a historic milestone for patients who have had no approved targeted therapy. We thank the patients, their families, and the investigators for their participation in the eNRGy trial. The results demonstrate meaningful tumor responses, durable benefit, and a favorable tolerability profile—and we are grateful that the FDA’s Commissioner’s National Priority Voucher pilot program greatly reduced the review time, helping bring this treatment to patients more quickly. We look forward to working with the oncology community to ensure appropriate patients can access BIZENGRI without delay."

— Pritesh J. Gandhi, Chief Development Officer, Partner Therapeutics

FDA APPROVAL FOR NRG1+ CHOLANGIOCARCINOMA

The FDA approved BIZENGRI based on safety and efficacy data from the eNRGy trial, a multicenter, open-label, multi-cohort Phase 2 clinical trial in adults with advanced solid tumors harboring NRG1 gene fusions. A total of 22 patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma were enrolled, with 19 evaluable for efficacy.

The major efficacy outcome measures were confirmed overall response rate (ORR), which is the percentage of patients in a clinical trial whose cancer shrinks or disappears after treatment, and duration of response (DOR). The ORR was 36.8% with a DOR range of 2.8 to 12.9 months.

The most common adverse reactions (≥20%), excluding laboratory findings, were fatigue, diarrhea, musculoskeletal pain, abdominal pain, nausea, cough, dyspnea, and decreased appetite.

"NRG1 fusion–positive cholangiocarcinoma represents a rare but clinically important subset of disease with limited therapeutic options and poor outcomes. In the eNRGy study, zenocutuzumab demonstrated a clinically meaningful overall response rate, and the drug was well tolerated with a favorable safety profile. Less than 1% of patients discontinued treatment due to a drug related adverse event, supporting its role as a targeted treatment option in this setting. These data further highlight the essential role of comprehensive molecular testing, particularly tissue-based RNA-based sequencing, to reliably detect gene fusions such as NRG1 and ensure patients are appropriately identified for targeted therapy."

— James Cleary, MD, PhD, Director of Clinical Research, Division of Gastrointestinal Oncology at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School

BIZENGRI was first approved under accelerated approval in 2024 in advanced, unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma for patients harboring an NRG1 gene fusion on or after systemic therapy. Additionally, zenocutuzumab is included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for non-small cell lung cancer, pancreatic adenocarcinoma, and cholangiocarcinoma.

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

About NRG1+ Cholangiocarcinoma

Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with an all-stage 5-year overall survival of less than 15%. NRG1 gene fusions occur in fewer than 1% of cholangiocarcinoma cases. NRG1 fusions typically occur in patients who are otherwise driver negative, leaving affected patients, many of whom are younger adults, without approved targeted therapy. Standard cytotoxic regimens carry substantial toxicity, and second-line options such as FOLFOX produce objective responses in only approximately 5% of patients.

About NRG1 Gene Fusions
NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS
BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.*

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.*

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions
BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis
BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.

In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.

Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction
BIZENGRI can cause left ventricular dysfunction.

Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.

In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.

Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity
Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS

NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC
Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).

In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transferase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).

NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma
Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.

In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transferase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

NRG1 Gene Fusion Positive Advanced, Unresectable or Metastatic Cholangiocarcinoma
Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive cholangiocarcinoma who received BIZENGRI (n=22).

In patients with NRG1 gene fusion positive cholangiocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased magnesium (59%), increased alanine aminotransferase (50%), fatigue (46%), decreased platelets (46%), decreased hemoglobin (41%), increased aspartate aminotransferase (41%), increased alkaline phosphatase (41%), decreased phosphate (41%), diarrhea (41%), abdominal pain (36%), musculoskeletal pain (36%), increased gamma-glutamyl transferase (36%), increased bilirubin (32%), decreased potassium (32%), decreased sodium (32%), nausea (27%), cough (27%), increased activated partial thromboplastin time (aPTT) (27%), dyspnea (23%), decreased appetite (23%), and decreased albumin (23%).

(Press release, Partner Therapeutics, MAY 11, 2026, View Source [SID1234665458])

On May 11, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs"; Stock Code: 9887.HK) reported its R&D Symposium in Shanghai. Under the theme "Leads Innovation, Future Forward", the event comprehensively presented the Company’s strategic elevation from "multi-platform synergy" to "multi-mechanism integration". Leads Biolabs highlighted its innovation ecosystem propelled by four proprietary technology platforms—IO 2.0, TCE, ADC, and the world-first TDC—alongside milestone advancements in core clinical pipelines, a preclinical pipeline matrix with global first-in-class potential, and forward-looking development roadmaps.

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Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, said: "Focusing on the prevailing unmet clinical needs and core challenges in immuno-oncology (IO), Leads Biolabs has established a differentiated layout by deeply integrating three frontier technologies: IO 2.0, TCE, and ADC. We have constructed a clinical pipeline matrix characterized by multi-mechanism fusion. By adhering to a phased development strategy encompassing single-agent validation, platform iteration, and combination expansion, we aim to systematically surmount clinical barriers such as ‘cold tumors’, immune resistance, and poor response. The year 2027 is poised to witness the launch of the Company’s first commercial product, marking its official transition into the inaugural year of commercialization. Propelled by our robust technology platforms, we aim to advance 20+ novel molecules into clinical trials, progress 4 to 8 assets into late-stage development, and achieve commercialization for 3 products by 2030. These milestones will drive us steadily toward our ultimate vision: ‘Transforming cancer into a manageable chronic disease’."

Clinical Breakthroughs & Value Realization: From Clinical-Stage Biotech to Integrated Biopharma

Since its inception, Leads Biolabs has remained committed to an "asymmetric competition" strategy, taking unaddressed clinical gaps left by PD-(L)1 inhibitors as its strategic cornerstone. By proactively anchoring its research in IO 2.0, the Company has pioneered the synergistic mechanism of "immune checkpoint inhibition plus co-stimulatory signal activation". This approach has successfully propelled LBL-024—a potential global first-in-class (FIC) PD-L1/4-1BB bispecific antibody—to the BLA (Biologics License Application) submission stage.

LBL-024: A Potential IO 2.0 Pan-Tumor Backbone Therapy with Survival Benefit. Utilizing the unique 2:2 molecular structure design of the X-body platform, LBL-024 releases PD-L1-mediated immunosuppression while conditionally activating the 4-1BB co-stimulatory pathway, achieving the synergistic effect of "releasing the brakes and stepping on the accelerator". Clinical studies have confirmed that LBL-024 not only overcomes the global technical challenge of the 4-1BB target, where no drugs have been marketed due to uncontrollable hepatotoxicity, but also demonstrates breakthrough efficacy across multiple cancer types and "cold tumors":

Safety: With over 600 patients enrolled, liver enzyme abnormalities in LBL-024 monotherapy or combination with chemotherapy occurred only in the early stages. No cumulative hepatotoxicity was observed with long-term treatment, and the overall safety profile is similar to that of PD-(L)1 monoclonal antibodies. Dose escalation up to 25.0 mg/kg did not reach the maximum tolerated dose (MTD), and no dose-limiting toxicities (DLTs) were observed.
Pan-cancer Efficacy: LBL-024 has demonstrated global first- or best-in-class potential in registrational or Phase II clinical studies for extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancer (BTC).
Cold Tumor Efficacy: LBL-024 is poised to become the first approved drug for EP-NEC, a typical cold tumor. In first-line SCLC combined with chemotherapy, the objective response rate (ORR) reached 88.1%, significantly superior to the approximately 60% of standard of care (SoC). It is also effective in PD-L1 low-expression NSCLC, achieving an efficacy breakthrough in populations difficult to cover with PD-1 monoclonal antibodies.
Durable Response: In late-line EP-NEC, the median overall survival (mOS) reached 11.9 months, doubling that of existing regimens. A clear survival benefit trend was also observed in first-line patients, offering the potential for long-term functional cure.
LBL-024 adopts a clear and progressive development strategy: advancing from late-line to first-line, from monotherapy to combination therapy, and from orphan diseases to major indications. Currently, LBL-024 covers 13 solid tumor indications, with one pivotal registrational study and eight proof-of-concept (PoC) studies underway.

LBL-024 is set to reach a series of intensive milestones in the second half of 2026. Regarding data readouts, data from a large patient cohort for first-line NSCLC will be presented at the World Conference on Lung Cancer (WCLC) in September. In October, the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting will feature the pivotal single-arm registrational clinical trial data for late-line EP-NEC, alongside the latest clinical results for first-line EP-NEC, SCLC, and BTC. On the commercialization front, LBL-024 has garnered Breakthrough Therapy Designation (BTD) from the CDE, as well as Fast Track Designation (FTD) and Orphan Drug Designation (ODD) from the U.S. FDA, and ODD from the European Union. The Company expects to submit the BLA for LBL-024 to the CDE in Q3 2026. The approval of LBL-024 will signify a pivotal milestone in the Company’s transition from a clinical-stage Biotech to an integrated Biopharma.

Platform-Driven, Innovation from the Source: An In-house R&D System Integrating High-Efficiency Multi-functional Platforms and Technical Capabilities

The future of oncology treatment lies in synergy, with combinations such as IO + ADC and TCE + ADC emerging as essential expansion pathways under this prevailing trend. Leads Biolabs is dedicated to expanding the reach of immunotherapy through the deep integration of its platforms. Currently, the Company has established four core technology platforms:

X-body (4-1BB Engager) Platform (IO 2.0): This platform utilizes advanced antibody engineering to create differentiated bispecific antibodies with a 2:2 molecular architecture, successfully addressing the hepatotoxicity and narrow therapeutic window typically associated with 4-1BB agonists.
LeadsBody (CD3 T-cell Engager) Platform (TCE): Designed to enhance efficacy and overcome treatment resistance, the next-generation LeadsBody platform has been clinically validated in hematologic malignancies by the potential best-in-class (BIC) LBL-034 (GPRC5D/CD3 bispecific antibody). For solid tumors, the platform is advancing in three strategic directions: multi-TAA (Tumor-Associated Antigen) targeting, co-stimulatory trispecific TCE, and TCE-ADC.
TOPiKinectics Platform in the ADC Field: The differentiated TOPiKinectics platform possesses full-chain, in-house design capabilities, including payload release within the tumor microenvironment (TME). It enables targeted tumor killing while minimizing off-target toxicity, thereby resolving industry pain points such as the narrow therapeutic window and frequent resistance associated with traditional ADC treatments. Furthermore, it offers advantages such as synergistic anti-tumor effects between ADC and IO.

World-First TDC Platform ImBiTDC (TCE-ADC): Leveraging proprietary antibody platforms and the TOPiKinectics platform, this technology deeply integrates TCE modules targeting tumor-specific antigens with ADC technology. This pioneers a completely new therapeutic track designed to address challenges such as overlapping toxicities and patient compliance issues associated with separate administration in traditional combination regimens. The TDC platform offers two key advantages: broad-spectrum efficacy and optimized safety. Unconstrained by the single mechanisms of either ADC or TCE, it is adaptable to diverse tumor scenarios with varying T-cell infiltration levels, T-cell functional states, and antigen expression abundance. It can efficiently kill high-antigen, high-payload-sensitive tumors, while also covering low-antigen, immunosuppressive patient populations through bystander effects and T-cell redirection. This significantly expands the eligible patient population and substantially reduces the risk of CRS, enhancing efficacy while simultaneously improving safety.

Through the progressive synergy of its technology platforms and the deep integration of multiple mechanisms, Leads Biolabs is constructing an innovative R&D ecosystem characterized by the cross-empowerment of multiple targets, molecule types, and technological routes. This ecosystem aims to lead the next generation of immuno-oncology, ensuring more cancer patients benefit from the continuous evolution of immunotherapy.

(Press release, Nanjing Leads Biolabs, MAY 11, 2026, View Source [SID1234665457])

On May 11, 2026 Ranok Therapeutics, a clinical-stage biotechnology company developing innovative therapies, reported the publication of preliminary clinical results from its Phase 1a study of RNK08954 in the peer-reviewed journal Cancer Discovery. RNK08954 is a proprietary, highly selective, oral small-molecule inhibitor targeting KRAS G12D mutation in patients with advanced solid tumors.

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The study evaluated the safety, tolerability, and clinical activity of RNK08954 in patients harboring KRAS G12D mutation across multiple sites in China. The study enrolled patients with advanced solid tumors, primarily focusing on safety and the determination of the Recommended Dose for Expansion. A total of 36 patients were evaluable for clinical activity. The overall objective response rate (ORR) was 28%, with a disease control rate (DCR) of 86%. Notably, patients with non-small cell lung cancer (NSCLC) achieved an ORR of 58.33% and a DCR of 100%. RNK08954 was generally well tolerated, with treatment-related adverse events consisting predominantly of Grade 1-2 gastrointestinal adverse events and decreased appetite. No dose-limiting toxicities were observed during the dose-escalation phase. [1]

"I am grateful that the editors of Cancer Discovery selected our study for publication," said Professor Song Zhengbo, Director of Phase I Clinical Trial Unit at Zhejiang Cancer Hospital, and the study’s Principal Investigator. "RNK08954 represents a critical step in advancing KRAS G12D-targeted therapy from concept to clinical validation. These findings not only accelerate the clinical translation of precision oncology but also lay a solid data foundation for subsequent pivotal clinical studies."

"The publication of these data underscores the potential for RNK08954 to provide a meaningful option for KRAS G12D-mutant cancers," commented Dr. Iman Elhariry, Chief Medical Officer at Ranok Therapeutics and co-author of the article. "Seeing a 58.33% objective response rate in the NSCLC cohort is particularly encouraging as it validates our approach of targeting the Switch II pocket with high selectivity. Based on these strong signals of clinical activity and the clean safety profile, we have already initiated our Phase 1b expansion study to further explore the drug’s potential as a monotherapy and in combination regimens across NSCLC, pancreatic and other indications."

Dr. Weiwen, Founder and CEO of Ranok Therapeutics, added: "The significant progress in KRAS inhibitors has been made possible by over a decade of accumulated knowledge in structural biology and medicinal chemistry. These clinical research achievements will inspire our team to further explore the clinical potential of RNK08954, fully unlocking its value for patients who currently lack effective targeted therapies."

About RNK08954 and KRAS G12D

KRAS G12D is one of the most prevalent oncogenic drivers in solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC). For decades, this mutation was considered "undruggable". RNK08954 is designed to bind directly to the Switch II pocket of the KRAS G12D protein in its active and inactive states, effectively blocking downstream signaling pathways that drive tumor growth.

(Press release, Ranok Therapeutics, MAY 11, 2026, View Source [SID1234665456])

On May 11, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported financial results and business highlights for the first quarter ended March 31, 2026.

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"We continue to build momentum toward delivering a new class of radiopharmaceuticals targeting tumor types with large patient populations, leveraging our differentiated miniprotein radioconjugate platform and patient-first end-to-end supply chain," said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. "Last week, we announced the initiation of our Phase 1b clinical trial of AKY-2519 in patients with mCRPC. This is the first of two trials in our clinical development strategy designed to expand the breadth of tumors studied and augment speed to data, with preliminary data from the mCRPC trial anticipated in 2027. We plan to initiate a second Phase 1b basket trial of AKY-2519 in additional solid tumors in the second half of this year. We also look forward to presenting our first AKY-2519 clinical imaging and dosimetry data for AKY-2519 at ASCO (Free ASCO Whitepaper), which informed our clinical development strategy."

Dr. Roden continued, "AKY-2519 marks the second program we have advanced from our proprietary miniprotein radioconjugate platform to the clinic in the last twelve months. In parallel, we continue to enroll patients in our ongoing Phase 1b trial of AKY-1189 targeting Nectin-4 expressing tumors, with preliminary data expected in the first quarter of 2027. We remain focused on generating clinical data intended to support advancement of both programs and maximizing the potential clinical benefit for patients."

Q1 and recent business highlights

AKY-1189 highlights

AKY-1189 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver actinium-225 (225Ac) to Nectin-4 expressing tumors.

Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies.
Enrolling patients in the ongoing Phase 1b clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.
Expect to report preliminary data from the Phase 1b trial in the first quarter of 2027.

AKY-2519 highlights

AKY-2519 is a novel, clinical-stage miniprotein radioconjugate designed to selectively deliver 225Ac to B7-H3 expressing tumors, including prostate, lung, and other solid tumors.

Received FDA clearance for the Company’s Investigational New Drug (IND) applications to proceed to a Phase 1b clinical trial with AKY-25191.
Announced two-trial clinical development strategy for AKY-2519, which was informed by insights from the Company’s clinical advisory boards and reflects the distinct treatment patterns and clinical needs of patients with mCRPC compared to other solid tumor patients. This strategy is designed to enable the broad evaluation of AKY-2519 in multiple patient segments while efficiently generating indication-relevant data.
Initiated Phase 1b, multicenter, open label clinical trial of AKY-2519 in PLUVICTO-naïve and PLUVICTO-experienced patients with mCRPC.
Plan to initiate a Phase 1b basket trial in patients with lung, colorectal, and other B7-H3 expressing solid tumors in the second half of 2026. The protocol for this trial has been finalized and is currently under regulatory review.
Announced clinical imaging and dosimetry data for AKY-2519 has been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 29 – June 2, 2026, in Chicago. The data facilitate initial understanding of AKY-2519 biodistribution and predicted absorbed doses in tumors and normal tissues in patients with B7-H3 expressing solid tumors.
1 IND applications were cleared for [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use.

General corporate highlights

Appointed industry veteran Glenn Gormley, MD, PhD as an independent director to the Company’s Board of Directors (Board) and as co-chair of the Board’s newly established Science and Technology Committee.
In January 2026, completed an initial public offering of 20,297,500 shares of common stock, including the exercise in full by the underwriters of their option to purchase an additional 2,647,500 shares of common stock, at $18.00 per share, resulting in gross proceeds of approximately $365.4 million, before deducting underwriting discounts and commissions and other offering expenses.

Anticipated pipeline and corporate milestones for the next 12 months

AKY-1189: Expect preliminary data from the ongoing Phase 1b clinical trial in the first quarter of 2027.
AKY-2519:
Will present clinical imaging and dosimetry data of AKY-2519 in patients with mCRPC and various solid tumors at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting.
Expect to commence Phase 1b basket trial in lung, colorectal, and other solid tumor cancers in the second half of 2026.
Expect preliminary data from the Phase 1b mCRPC clinical trial in 2027.
Early pipeline: Two programs are tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate: In-house Good Manufacturing Practices (GMP) facility expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.

First quarter 2026 financial results

Cash position: Cash, cash equivalents and marketable securities were $538.5 million as of March 31, 2026, compared to $226.8 million as of December 31, 2025. The increase of $311.7 million primarily reflects net proceeds from the Company’s initial public offering in January 2026, primarily offset by cash used in operations. The Company’s cash, cash equivalents and marketable securities as of March 31, 2026 are expected to fund its operations into 2029.
Collaboration revenue: Collaboration revenue was $3.2 million for the quarter ended March 31, 2026, compared to $1.4 million for the comparable prior year period. The increase of $1.8 million was attributable to continued advancement of the Company’s research collaboration with Eli Lilly and Company, with revenue recognized over time using the cost incurred input method.
R&D expenses: Research and development expenses were $20.0 million for the quarter ended March 31, 2026, compared to $15.9 million for the comparable prior year period. The increase of $4.1 million was primarily driven by Phase 1b clinical trial expenses for AKY-1189, which initiated in the second quarter of 2025, increased expenses with advancing AKY-2519 through IND-enabling studies, and increased employee-related costs (including stock-based compensation) associated with increased hiring to support the advancing clinical pipeline.
G&A expenses: General and administrative expenses were $5.9 million for the quarter ended March 31, 2026, compared to $3.7 million for the comparable prior year period. The increase of $2.2 million was primarily due to higher employee-related costs (including stock-based compensation) related to increased hiring to support the Company’s growth, and increased expenses associated with operating as a public company.
Net loss: Net loss was $18.3 million for the quarter ended March 31, 2026, compared to $15.0 million for the comparable prior year period. The increase in net loss of $3.3 million was primarily driven by increased operating expenses.

About Aktis’ miniprotein radioconjugate platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, MAY 11, 2026, View Source [SID1234665455])

On May 11, 2026 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported its financial results for the first quarter ended March 31, 2026, and provided a business update.

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"Across our portfolio, we continue to execute with focus and discipline, with all of our key clinical programs progressing on track toward important upcoming milestones, while maintaining a disciplined approach to managing our cash burn," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "The recent 52-week data from the Phase II COVALENT-112 clinical trial in type 1 diabetes further support targeting menin as a novel approach across both type 1 and type 2 diabetes, which offers a paradigm shift and differs materially from existing therapeutic approaches. We are building on these findings with plans to initiate an investigator-sponsored Phase II clinical trial in collaboration with leading academic institutions specializing in T1D. We believe this collaboration, alongside the continued advancement of our type 2 diabetes and obesity programs, positions Biomea to deliver meaningful data across multiple indications in 2026."

Recent Corporate Highlights:

Icovamenib
Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes

Chronic toxicology studies in two species were successfully completed for icovamenib, providing nonclinical support for chronic clinical dosing beyond the 12-week duration used to date; findings demonstrated a favorable safety profile consistent with previously reported preclinical and clinical data.
With more than 400 subjects dosed to date, icovamenib was generally well tolerated and demonstrated a favorable safety profile throughout the observation periods.
Two Phase II clinical trials evaluating icovamenib in T2D have been initiated and enrollment is ongoing:
COVALENT-211, a Phase II, randomized, double-blind, placebo-controlled trial in patients with insulin-deficient T2D not achieving glycemic targets despite standard of care therapy.
COVALENT-212, a Phase II, randomized, double-blind, placebo-controlled trial in patients with T2D not achieving glycemic targets while on a GLP-1 RA-based therapy.
Both trials include a 26-week primary endpoint, with topline data anticipated in the fourth quarter of 2026.
Topline data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in T1D patients were reported from the 52-week follow-up:
A 52% increase from baseline in mean C-peptide AUC at Week 12, after completion of the dosing period, in patients diagnosed within 0-3 years (n=5) receiving icovamenib 200 mg, with a dose response observed vs 100 mg (n=6). Persistence observed through Week 52, with mean C-peptide AUC largely preserved in the 200 mg group (~7% decline from baseline).
Preservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9).
Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52.
Comprehensive dataset to be presented at the American Diabetes Association’s (ADA) Scientific Sessions (abstract is preliminary until time of presentation; full release scheduled for June 5, 2026 at 6:30 pm CDT).
Planning a Phase II trial in recently diagnosed T1D patients (≤ 3 years since diagnosis), in collaboration with four U.S. academic centers, to evaluate extended dosing (6–12 months) of icovamenib 200 mg and assess potential combination with an immunosuppressive agent; trial initiation expected in the second half of the year at leading centers including the Barbara Davis Center for Diabetes, Joslin Diabetes Center, University of Texas Health Science Center at San Antonio Diabetes Division, and the University of Miami Diabetes Research Institute.

BMF-650
Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity

GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing.
Initial 28-day clinical weight reduction data from the Phase I GLP-131 clinical trial is anticipated in the second quarter of 2026.

First Quarter 2026 Financial Results

Cash, Cash Equivalents, and Restricted Cash: As of March 31, 2026, the Company had cash, cash equivalents and restricted cash of $45.1 million.

Net Loss: The Company reported a net loss attributable to common stockholders of $12.4 million for the three months ended March 31, 2026, which included $1.6 million of stock-based compensation, compared to a net loss of $29.3 million for the same period in 2025, which included $3.2 million of stock-based compensation.
Research and Development ("R&D") Expenses: R&D expenses were $9.1 million for the three months ended March 31, 2026, compared to $22.9 million for the same period in 2025. The decrease of approximately $13.8 million was primarily driven by a decrease of $7.6 million in external costs primarily driven by a decrease of $3.8 million related to clinical activities, a decrease of $1.9 million related to preclinical and exploratory programs, and a decrease of $1.9 million in other external costs related to consultants, advisors and other professional services to support our clinical trials. Personnel-related expenses decreased by $4.5 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $1.7 million due to a decrease in rent and facilities-related costs.

General and Administrative ("G&A") Expenses: G&A expenses were $3.7 million for the three months ended March 31, 2026 compared to $6.8 million for the same period in 2025. The decrease of $3.2 million was primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $1.1 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.2 million.

(Press release, Biomea Fusion, MAY 11, 2026, View Source [SID1234665452])