On August 12, 2026 Senhwa Biosciences, Inc. (TPEx: 6492) reported a significant research advance involving its investigational drug Pidnarulex (CX-5461). A multinational research team comprising investigators from Poland, Slovakia, France and Senhwa Biosciences in Taiwan found that, under specific cell-based experimental conditions, controlled light activation increased the cancer-cell-killing activity of CX-5461 by up to 96-fold and induced immunogenic cell death (ICD). The findings, published in the peer-reviewed journal Nucleic Acids Research, reveal that CX-5461 may have potential applications in photodynamic therapy and photoimmunotherapy in addition to its established research profile involving G-quadruplex (G4) targeting and DNA-damage-related mechanisms. The study opens a potential new development path for this clinical-stage asset.

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Turning Photosensitivity into a Controlled Therapeutic Mechanism
Photosensitivity observed during the clinical development of CX-5461 has generally been viewed as a drug characteristic requiring risk management. In the new study, researchers reframed this property as a potentially controllable and spatially targeted therapeutic mechanism. By applying light of an appropriate wavelength to the tumor area, CX-5461 may be activated at the intended site, increasing local tumor-cell killing while limiting activity in non-illuminated tissue.

This light-switch concept could extend CX-5461 from a systemically administered anticancer agent into a photosensitizer with temporal and spatial control. The approach may warrant further investigation in tumors that are accessible to external light, endoscopy or fiber-optic delivery, including selected skin, oral and esophageal tumors.

Light Activation Triggers Tumor-Cell Killing and Immunogenic Cell Death
The study further showed that light-activated CX-5461 not only directly damaged cancer cells but also induced ICD. When cancer cells die through an immunogenic process, they release or expose danger-associated signals, including cell-surface calreticulin, extracellular ATP and high-mobility group box 1 (HMGB1). These signals can help dendritic cells recognize and take up tumor antigens, potentially initiating a T-cell-mediated antitumor immune response.

The therapeutic objective may therefore extend beyond destroying an illuminated local tumor. By making antigens from dying cancer cells more visible to the immune system, the treatment could provide a biological basis for using localized therapy to stimulate a broader antitumor immune response.

Preclinical Findings Support an In Situ Cancer Vaccine Concept
In preclinical mouse studies, animals whose tumors regressed after treatment with CX-5461 and light exposure showed suppressed tumor growth when subsequently challenged with the same cancer cells. The observation suggests that treatment may establish tumor-specific immune memory and supports further investigation of an in situ cancer vaccine concept. Under this approach, the patient’s own tumor could serve as the source of tumor antigens, allowing an immune response to be initiated at the treatment site without the need to manufacture an external vaccine in advance.

If validated through additional studies, this mechanism could also be explored in combination with immune checkpoint inhibitors targeting PD-1 or PD-L1, with the goal of broadening or prolonging antitumor immune activity. These findings are preclinical and require confirmation in additional animal studies and human clinical trials.

Expanding the Potential Value of an Existing Clinical-Stage Asset
In drug development, a molecule can gain a second life when its existing properties and mechanisms are understood in a new way. CX-5461 has already generated a body of development data across chemistry, manufacturing and controls, toxicology, pharmacology and human clinical safety. The new research reframes photosensitivity as a potentially useful therapeutic mechanism and extends the molecule’s research potential beyond G4 targeting and DNA-damage response into photodynamic therapy, photoimmunotherapy and immune-combination strategies.

Compared with developing an entirely new molecule from the outset, identifying a new mechanism and potential indications for an existing clinical-stage asset may support development continuity and broaden its potential product lifecycle, subject to successful preclinical, regulatory and clinical evaluation.

Next Steps
Senhwa views these findings as an important starting point for repositioning the value of CX-5461. Based on further validation, the Company plans to evaluate suitable tumor types, dosing and illumination conditions, light-delivery technologies and potential combination strategies. Senhwa will also seek multinational academic and industry collaborations to support the clinical translation of this photoimmunotherapy approach.

Additional preclinical and regulatory work will be required before clinical development can proceed. The safety and efficacy of CX-5461 as a photodynamic or photoimmunotherapy treatment have not been established in human clinical trials, and CX-5461 has not been approved for commercial use in these applications.

(Press release, Senhwa Biosciences, AUG 12, 2026, View Source [SID1234670026])

On August 12, 2026 Cypherpunk Technologies Inc., (Nasdaq: CYPH) ("Cypherpunk"), reported financial results for the second quarter ended June 30, 2026.

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"In the second quarter, Cypherpunk built upon the momentum established earlier this year through the disciplined execution of our Zcash digital asset treasury strategy, increasing our treasury holdings to 323,394.38 ZEC, and welcoming Dev Ojha, founder of Valar Group, as an Advisor," said Douglas E. Onsi, President and CEO of Cypherpunk Technologies. "Our Leap Therapeutics subsidiary reached alignment with the FDA on a proposed Phase 3 trial in a DKK1-high, second-line, metastatic colorectal cancer population, with objective response rate as the primary endpoint to support accelerated approval and overall survival to support full approval in the United States and registration globally. We are conducting a strategic process to determine the best path to advance sirexatamab, whether as an independently financed spin-out company or with a partner who shares our commitment to cancer patients."

"In an increasingly AI-driven economy, the demand for true privacy is moving from a technical preference to a civilizational necessity. Our execution in the second quarter reinforces Cypherpunk’s conviction in Zcash as a foundational monetary asset. By growing our ZEC treasury, expanding our world-class advisory team, and continuing to back core infrastructure developers like ZODL, we are systematically positioning Cypherpunk to capture the long-term value of digital privacy adoption," said Will McEvoy, Chief Investment Officer of Cypherpunk.

Cypherpunk Highlights:

· Zcash treasury holdings increased to 323,394.38 ZEC

o As of August 11, 2026, Cypherpunk held a total of 323,394.38 ZEC at an average purchase price of $341.83, representing approximately 1.92% of the total circulating supply of the Zcash network.

o ZEC is a digital currency that can be transmitted over a peer-to-peer payment system. Zcash uses a cryptographic method called "zero-knowledge proofs" to allow users to engage in financial transactions while maintaining greater privacy.

· Dev Ojha Appointed as an Advisor

o Cypherpunk appointed Dev Ojha, the founder of Valar Group, a leading development and research team focused on the Zcash Network, as an Advisor. Valar Group has taken a significant role in developing Zakura, a high-performance full node software designed for massive scalability of Zcash, and on the Ironwood shielded pool. Dev also serves as an official ZIP Editor for Zcash protocol standards. Cypherpunk’s Advisory Team also includes: Arjun Khemani, Zcash key opinion leader; Josh Swihart, CEO of ZODL; Jeff Tiller, Chief of Staff of Gemini; and Zooko Wilcox, Founder of Zcash and Chief Product Officer at Shielded Labs.

Leap Therapeutics Subsidiary Highlights:

· Publication of randomized Phase 2 DeFianCe study in Clinical Cancer Research

o Leap Therapeutics announced the publication of results from the randomized Phase 2 DeFianCe (NCT05480306) study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in Clinical Cancer Research. The publication, "Sirexatamab in Combination with Bevacizumab and Chemotherapy as Second-Line Therapy for Advanced Colorectal Adenocarcinoma: the Phase II DeFianCe Trial," reported the complete efficacy, safety, and biomarker analyses from the study and details the statistical basis for the DKK1 biomarker finding.

o The peer-reviewed analyses establish that, while the prespecified primary endpoint was not met in the intent-to-treat population, the benefit of sirexatamab increases as a patient’s baseline plasma DKK1 level rises — a relationship confirmed by independent statistical approaches and reinforced by the observation that high DKK1 predicts poorer outcomes on standard of care alone. Together, these findings define DKK1-high metastatic colorectal cancer (mCRC) as a biologically distinct population with high unmet need.

· Reached FDA alignment on registrational Phase 3 trial in DKK1-high colorectal cancer

o Leap Therapeutics held a Type C meeting with the FDA to discuss the DeFianCe results and proposed registrational path for sirexatamab in DKK1-high, second-line mCRC. Leap presented its proposed Phase 3 trial design, and the FDA provided feedback supporting key elements of that design, including the use of a DKK1 biomarker-selected patient population and a dual-endpoint structure intended to support both accelerated and full approval.

o Leap Therapeutics reached alignment with the FDA on a randomized, controlled Phase 3 trial evaluating sirexatamab in combination with investigator’s-choice fluoropyrimidine-based chemotherapy (FOLFIRI or mFOLFOX6) plus bevacizumab, compared with chemotherapy and bevacizumab alone. Approximately 270 patients with mCRC whose disease has progressed following one prior line of systemic therapy prospectively identified as DKK1-high using a baseline plasma DKK1 assay cut point are expected to be enrolled and randomized 1:1. Potential accelerated approval in the United States could be determined by objective response rate (ORR) in an initial group of approximately 160 patients, and overall survival (OS) will be evaluated in the full study population intended to support a filing for full approval in the United States and to support registration in markets outside the United States.

o A blood-based companion diagnostic would be developed in parallel to identify DKK1-high patients in routine clinical practice.

· Sirexatamab received Fast Track designation from FDA

o In May 2026, the FDA granted Fast Track designation to sirexatamab in combination with fluoropyrimidine plus oxaliplatin- or irinotecan-based chemotherapy and bevacizumab, for the treatment of patients with DKK1-high mCRC whose disease has progressed following one prior systemic therapy.

o The Fast Track program is intended to facilitate the development and expedite the review of drug candidates and vaccines that treat serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from frequent communication with the FDA, in addition to a rolling submission of the marketing application.

· Business update

o Leap Therapeutics has initiated a strategic process to identify the best path forward for sirexatamab and to secure the resources required to advance the program into Phase 3 development. The process is expected to consider a range of alternatives, which may include financing the program as an independent entity, or a strategic transaction with a pharmaceutical or biotechnology company, including a partnership, license, collaboration, sale, or other business combination.

o There can be no assurance that the strategic process will result in any transaction or financing, or that any transaction or financing that is completed will be on terms favorable to the Company or its stockholders. The Company has not set a timetable for the conclusion of the process and does not intend to disclose developments unless and until it determines that further disclosure is appropriate or required.

Selected Second Quarter 2026 Financial Results

Net income was $39.4 million, or $0.18 per diluted share, for the second quarter of 2026, compared to a net loss of $16.6 million for the second quarter of 2025. The change was primarily due to a $46.0 million unrealized gain on the fair value of the Company’s ZEC treasury holdings during the second quarter of 2026, which are marked to market at the end of each period. During the second quarter of 2026, the price of ZEC increased from $243.35 to $400.09.

Research and development expenses were $0.2 million for the three months ended June 30, 2026, compared to $10.5 million for the same period in 2025. The decrease was primarily due to a decrease in clinical trial and manufacturing expenses due to the completion of the clinical trials, together with a decrease in payroll and related expenses associated with the 2025 reduction in force.

General and administrative expenses were $4.5 million for the three months ended June 30, 2026, compared to $1.8 million for the same period in 2025. The increase of $2.7 million for the three months ended June 30, 2026 was primarily due to a $1.7 million increase in stock-based compensation related to restricted stock units granted to general and administrative employees and directors in the fourth quarter of 2025, a $0.8 million increase in payroll and related expenses, and a $0.2 million increase in professional fees.

During the three months ended June 30, 2026, the Company recorded a $46.0 million unrealized gain on the change in fair value of the Company’s ZEC treasury holdings as the price of ZEC increased during the second quarter of 2026 from $243.35 to $400.09.

Cash and cash equivalents totaled $7.6 million on June 30, 2026, and ZEC treasury holdings, categorized as digital asset receivable, totaled $129.4 million based on the ZEC price of $400.09 on June 30, 2026.

(Press release, Cypherpunk Technologies, AUG 12, 2026, View Source [SID1234670005])

On August 12, 2026 NMPA reported to have granted approval to Geneseeq’s PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for VELMARTO (Eratrectinib), a next‑generation highly selective TRK inhibitor independently developed by Vcare PharmaTech. The approval provides critical support for the precise identification and clinical medication of patients with NTRK fusion‑positive solid tumors.

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As the original companion diagnostic for Eratrectinib, PanTRKare addresses key testing challenges including the pan‑tumor distribution, low incidence and complex fusion patterns of NTRK1/2/3 fusions, enabling accurate detection of NTRK fusion variants across diverse cancer types. Following clinical accuracy validation, bridging study results demonstrated that patients tested positive by PanTRKare achieved objective response rates highly consistent with those observed in the drug’s clinical trials, in both treatment‑naïve and pre‑treated populations. This further validates the assay’s stability and consistency for companion diagnostic applications.

Eratrectinib marks Nanjing’s first innovative drug approval this year. Through innovative cyclic structural optimization, it delivers more potent and highly selective inhibition of TRK kinases, overcoming structural limitations and drug‑resistance drawbacks of first‑generation agents at the molecular‑mechanism level. The pivotal VC004‑101 clinical trial has comprehensively verified Eratrectinib’s clinical efficacy and long‑term patient benefits. Study data revealed an overall ORR of 68.5% for Eratrectinib. Among patients with follow‑up exceeding six months, the ORR rose further to 89.7%, representing clinically meaningful improvement superior to first‑generation TRK inhibitors.

In terms of long‑term therapeutic benefit, Eratrectinib exhibited favorable PFS and DOR, with a 2‑year PFS rate of 75.7% and a 2‑year DOR rate of 85.5%. These findings confirm its capacity to deliver durable disease control and sustained remission for patients. It also demonstrates prominent advantages in long‑term survival outcomes by effectively prolonging overall survival; the median OS reached 40.7 months, bringing substantial long‑term survival benefits to patients.

Both Vcare PharmaTech and Geneseeq are enterprises located in the Life Science & Health Industry Office of Nanjing Jiangbei New Area, with a solid long‑term collaborative foundation. Eratrectinib gained marketing approval in June this year, and merely two months later, PanTRKare obtained approval for its companion diagnostic use. This completes a key link in the diagnosis‑treatment workflow for NTRK‑fusion solid tumors, creating favorable conditions for post‑launch patient identification, clinical implementation and market adoption, and enabling eligible NTRK‑positive patients to access Eratrectinib targeted therapy at an earlier time point. Such expedited dual approvals fully illustrate the synergistic value brought by the strong partnership between the two parties. It also underscores the industrial ecosystem strengths of Life Science & Health Industry Office of Nanjing Jiangbei New Area in connecting upstream‑downstream industrial chains and empowering collaborative innovation among resident enterprises.

(Press release, Jiangsu Vcare PharmaTech, AUG 12, 2026, View Source [SID1234670027])

On August 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported second quarter 2026 financial results and provided a corporate update.

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"In only its second full quarter of launch, KOMZIFTI established early leadership in relapsed or refractory NPM1-mutant AML, achieving a majority share of new patient starts in the menin inhibitor class," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Increasing physician preference for KOMZIFTI, combined with outstanding commercial execution and encouraging frontline data, establish a strong foundation for ziftomenib as a potential market leader throughout the AML treatment continuum. In parallel, darlifarnib is emerging as a differentiated precision combination platform across multiple targeted therapies in major solid tumor indications. Together, these programs position Kura to build long-term value while advancing innovative therapies for patients with significant unmet need."

Recent Developments

KOMZIFTI Commercial Launch

Commercial highlights for the quarter included:

·
$9.1 million in net product revenue, a 57% increase from 1Q 2026

·
Approximately 115 new patient starts (NPS), a 35% increase from 1Q 2026

·
More than 250 total prescriptions (TRx) in 2Q 2026, including repeat prescriptions, a 59% increase from 1Q 2026

·
In its second full quarter on the market, KOMZIFTI achieved a majority share of new patient starts in the R/R NPM1-m AML menin inhibitor class

New patient starts are a key indicator of physician preference, future prescription growth, and overall market leadership. Additional indicators of KOMZIFTI’s commercial momentum included broader adoption across academic and community treatment centers, increasing repeat prescribing, and physician-directed use of KOMZIFTI in combination with established standards of care.

Advancing Ziftomenib Across the Broader AML Treatment Landscape

•
EHA 2026

Long-term KOMET-007 data demonstrated high and durable clinical activity with 600 mg ziftomenib plus intensive chemotherapy (7+3) in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML, including:

o
CRc rates of 96% and 90%, respectively
o
12-month OS rates of 94% and 71%, respectively
o
Deep MRD negativity, no new safety signals, and median overall survival not reached in either molecular subgroup

•
Blood Publication (June 2026)

Updated KOMET-007 results demonstrated deep and durable responses with 600 mg ziftomenib plus venetoclax and azacitidine in R/R NPM1-m AML. Venetoclax-naïve patients achieved an 87% ORR and 70% CRc rate, with 75% of composite complete responders achieving central MRD negativity. Median duration of CRc was 9.2 months. Median OS in these patients was not reached after 10.7 months of follow-up. The regimen was generally well tolerated, with low rates of differentiation syndrome and QTc prolongation.

Together, these results support the potential of ziftomenib in combination with standard-of-care regimens, increasing confidence in the ongoing KOMET-017 frontline program.

•
Registrational and Combination Programs

o
Site activation and patient enrollment across KOMET-017 frontline registrational studies for intensive and non-intensive chemotherapy eligible patients ongoing
o
Enrollment in KOMET-008 evaluating ziftomenib plus gilteritinib in patients with R/R FLT3-ITD/NPM1 co-mutated AML continues
o
Enrollment in the KOMET-007 cohort evaluating ziftomenib plus quizartinib and intensive chemotherapy in patients with newly diagnosed FLT3/NPM1 co-mutated AML ongoing

Advancing Darlifarnib as a Precision Combination Platform Across Solid Tumors

•
KRAS G12C-mutated Solid Tumors (ASCO 2026)

First-in-human Phase 1 FIT-001 data evaluating darlifarnib plus adagrasib provided clinical proof of mechanism, including tumor shrinkage in 77% of response-evaluable patients and confirmed ORRs of:

o
67% in pancreatic cancer
o
50% in non-small cell lung cancer
o
29% in KRAS inhibitor-naïve colorectal cancer

•
Cabozantinib-naïve Clear Cell Renal Cell Carcinoma (KCRS 2026)

Updated Phase 1 FIT-001 results demonstrated encouraging and durable clinical activity with darlifarnib plus cabozantinib, with ORRs of up to 50% across dose levels and an mPFS of 13 months.

•
Cabozantinib-exposed Clear Cell Renal Cell Carcinoma (IKCS 2026)

Phase 1 FIT-001 data demonstrated darlifarnib’s potential to overcome resistance to VEGFR-targeted therapy. Despite prior cabozantinib exposure, patients on the combination of darlifarnib plus cabozantinib, across multiple dose levels of each, achieved a:

o
44% ORR
o
94% disease control rate (DCR)
o
Tumor shrinkage in 75% of patients

Collectively, these data continue to support darlifarnib’s potential as a precision combination platform capable of enhancing multiple targeted therapy classes while creating opportunities for future development opportunities, potential strategic collaborations and multiple registrational paths.

•
FIT-001 Phase 1b Dose Expansion
Enrollment continues in the global, randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib versus cabozantinib alone to establish the recommended Phase 3 dose in patients with cabozantinib-naïve ccRCC.

Anticipated Milestones: Commercial and Development Priorities

Kura expects multiple commercial and clinical catalysts over the next 12 to 18 months.

KOMZIFTI 2026 Commercial Execution

•
Expand physician adoption across academic and community treatment centers
•
Increase repeat prescribing and broaden physician adoption
•
Deliver sustained quarter-over-quarter growth
•
Strengthen leadership within R/R NPM1-m AML menin inhibitor market

Building on Emerging Leadership Across the AML Treatment Continuum

Kura’s strategy is to build on KOMZIFTI’s early commercial success by moving ziftomenib into earlier lines of therapy, combining it with multiple standards of care and expanding its use across genetically defined AML populations.

Key near-term milestones include anticipated presentation of:

•
Updated long-term KOMET-007 Phase 1b data evaluating ziftomenib with venetoclax and azacitidine in newly diagnosed, intensive chemotherapy-ineligible NPM1-m AML patients, including durability, survival, and MRD outcomes – 2H 2026
•
Initial data from the KOMET-007 Phase 1b study evaluating ziftomenib with 7+3 intensive chemotherapy and quizartinib in patients with newly diagnosed NPM1-m/ FLT3-ITD AML– 2H 2026
•
Initial KOMET-008 data evaluating ziftomenib with gilteritinib in patients with R/R NPM1-m/FLT3-m AML, including activity in patients previously treated with FLT3 inhibitors– 2H 2026
•
An exploratory analysis from the KOMET-001 study evaluating ziftomenib monotherapy activity in molecularly defined, MEIS1-associated AML subtypes beyond NPM1-m and KMT2A-r disease – 2H 2026

Ziftomenib and Menin Inhibition – Expansion Beyond AML

•
Continue enrollment of KOMET-015 study evaluating ziftomenib plus imatinib in patients with gastrointestinal stromal tumors
•
Progress preclinical development of next-generation menin inhibitor for use in other solid tumors

KO-7246 (Next-Generation Menin Inhibitor)

•
Advance KO-7246, a next-generation menin inhibitor specifically designed for use in diabetes and cardiometabolic disease, into IND-enabling studies

•
Present additional scientific data characterizing menin inhibitors in preclinical models of diabetes

Darlifarnib – Precision Combination Platform in Solid Tumors

•
Complete enrollment in the randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib in cabozantinib-naïve ccRCC in 1H 2027 and report initial clinical data in 2H 2027
•
Initiate a platform study of darlifarnib plus daraxonrasib in patients with KRAS-mutant 2L+ PDAC in 1H 2027
•
Advance darlifarnib as a precision combination platform across additional targeted therapy classes

Second Quarter 2026 Financial Results

•
Net product revenue: $9.1 million, compared to none for 2Q 2025
•
Collaboration revenue: $11.8 million, compared to $15.3 million for 2Q 2025
•
R&D expenses: $61.9 million, compared to $62.8 million for 2Q 2025
•
SG&A expenses: $31.8 million, compared to $25.2 million for 2Q 2025
•
Net loss: $68.3 million, compared to $66.1 million for 2Q 2025. Net loss includes $8.2 million in non-cash, share-based compensation expense compared to $6.9 million for the same period in 2025.
As of June 30, 2026, Kura had $519.0 million in cash, cash equivalents and short-term investments, compared to $667.2 million as of December 31, 2025.

Combined with $180 million in anticipated collaboration payments from Kyowa Kirin, the Company believes its current cash resources will be sufficient to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 trial, anticipated in 2028.

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 12, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available on the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, AUG 12, 2026, View Source [SID1234670006])

On August 12, 2026 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) reported that the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of zipalertinib and platinum-based chemotherapy compared with chemotherapy alone in the first-line treatment of adult patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations, met its primary endpoint of progression-free survival (PFS) at a planned interim analysis.

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In this analysis, the study demonstrated a statistically significant and clinically meaningful improvement in PFS in the zipalertinib containing arm. Observed safety for the zipalertinib containing arm was manageable. Based on these data, the Independent Data Monitoring Committee recommended unblinding the study. The trial will continue to monitor efficacy and safety.

Full results from REZILIENT3 will be submitted for presentation at an upcoming international medical conference. Based on these results, pending discussions with the U.S. Food and Drug Administration (FDA), Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics plan to pursue U.S. regulatory approval for this combination regimen in the first-line setting.

"The positive topline results from the planned interim analysis of REZILIENT3 further support the potential of zipalertinib to meet the high unmet medical need in patients with NSCLC harboring EGFR exon 20 insertion mutations," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We look forward to pursuing regulatory approval of zipalertinib in combination with chemotherapy in the first-line treatment setting with the goal of providing a new treatment option for this group of patients."

"Zipalertinib is a compound created through Taiho Pharmaceutical’s proprietary drug discovery technology," said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. "Achieving positive results in this Phase 3 trial in the first-line setting represents an important milestone for this program. We will continue to work closely with Taiho Oncology and Cullinan Therapeutics to bring zipalertinib in combination with chemotherapy to patients as soon as possible."

"Meeting the primary endpoint early at a planned interim analysis marks an important milestone for the REZILIENT3 study and supports the potential role of zipalertinib in the first-line treatment setting," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "These topline results give us confidence in the potential for zipalertinib to offer a first-line treatment option for patients with NSCLC with EGFR exon 20 insertion mutations."

About the REZILIENT3 Trial

This multicenter, randomized, controlled, open-label global trial enrolled 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. The primary objective of this trial is to assess progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm.

About Zipalertinib

Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,1 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Taiho, AUG 12, 2026, View Source [SID1234670028])