On April 9, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, reported the selection of 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2) as the optimal monotherapy dose of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC) based on the prespecified interim data analysis from DENALI Part 2a. This dose will be carried forward in the ongoing potentially pivotal DENALI Phase 2 clinical trial as well as the confirmatory ASPENOVA Phase 3 clinical trial.

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"Selecting the pivotal monotherapy dose for azenosertib is a key inflection point that supports our registration-intended path. Beyond executing on DENALI and ASPENOVA, we are initiating launch preparedness by adding commercial capabilities to our organization, scaling manufacturing capacity, and advancing companion diagnostic development," said Julie Eastland, Chief Executive Officer of Zentalis. "Importantly, the therapeutic profile of the selected dose from the DENALI Part 2a interim analysis provides us confidence to further pursue expansion of the clinical pipeline for azenosertib into first-line maintenance, or platinum sensitive, ovarian cancer and explore combinations in new tumor types."

"The emerging DENALI Part 2a data from the planned interim analysis provide a favorable benefit-risk profile at the 400mg QD 5:2 dose over 300mg QD 5:2. A meaningful, differentiated response rate with the selected dose and comparable safety profiles across both dose groups were observed in this interim analysis," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "While DENALI is an ongoing trial, we are encouraged by the interim Part 2a data and continued momentum of the clinical study. As an oral monotherapy, azenosertib may offer Cyclin E1-positive PROC patients an efficacious, convenient alternative to current standard-of-care intravenous chemotherapy, if approved."

DENALI Part 2a Interim Analysis

A comprehensive review of the interim data from DENALI Part 2a informed the selection of the 400mg QD 5:2 dose over 300mg QD 5:2. A prespecified interim analysis showed:

A meaningful and clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 dose
Comparable safety profiles across the two dose groups and observed improvements in several key measures, such as a discontinuation rate due to adverse events at approximately half of the rate reported in DENALI Part 1b and no treatment-related deaths.

Consistent with the seamless design of the registration-intended DENALI Part 2 trial, data from Part 2a will be included in the ongoing, full Part 2 dataset after the trial is completed, rather than reported separately. This approach is intended to preserve the integrity of the overall pivotal dataset and support the potential accelerated approval pathway.

DENALI Part 2 Trial Design Updated to Address Evolving PROC Landscape

The treatment landscape in PROC is evolving. The DENALI Part 2 study has been expanded to maintain alignment between the study population and available approved treatment options.

A new DENALI cohort that broadens inclusion to patients previously treated with a taxane-containing regimen for PROC, called Part 2c, intends to further align the study with the evolving treatment landscape. Enrollment in Part 2c is planned to initiate in Q2 2026.

Together, all three DENALI Part 2 cohorts are designed to support a potential accelerated approval pathway in the Cyclin E1 biomarker selected patient population, subject to regulatory review. Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 and provide a topline readout by year-end 2026.

About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.

Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.

Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff.

Part 2, in total, is designed to support accelerated approval, pending study outcome and discussions with the FDA. The study design consists of the following parts:

Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
Part 2b: Enrollment expansion at the selected dose up to approximately 100 patients, including patients at the 400mg QD 5:2 dose in Part 2a. This cohort is currently enrolling.
Part 2c: Broadening study population to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. Enrollment is expected to initiate in this cohort in Q2 2026.

For physician and patient information about the DENALI trial, please visit www.denalitrial.com.

About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The trial will enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator’s choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The trial design was aligned with the U.S. FDA to meet requirements for the accelerated approval pathway and potential conversion to full approval. ASPENOVA is expected to initiate in Q2 2026.

(Press release, Zentalis Pharmaceuticals, APR 9, 2026, View Source [SID1234664293])

On April 9, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science reported that it has entered into a new collaboration agreement with Roche (SIX: RO, ROP; OTCQX: RHHBY) to advance research in the emerging degrader-antibody conjugate (DAC) modality. Working together, C4T and Roche will combine antibody-drug conjugation (ADC) and targeted protein degradation (TPD) to develop a new way to treat cancers that leverages both the specificity and catalytic efficiency of degraders with the delivery capabilities of ADCs.

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"For the past decade, C4T and Roche have worked together to drive research in targeted protein degradation and to establish this modality as a new way to treat cancer," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "Our new collaboration leverages C4T’s ability to design highly catalytic and selective degraders, as well as degrader payloads for DACs, alongside Roche’s extensive experience developing ADCs with specific binding. Together, these capabilities build a powerful new modality that can offer transformative medicines for patients."
"Roche has been a believer in targeted protein degradation and its potential for differentiation early on, when partnering with C4T for the first time in 2016," said Boris Zaïtra, head of corporate business development, Roche. "Our relationship with C4 Therapeutics is built on a decade of trust and shared scientific ambition. We are pleased to enter into our third collaboration, expanding our long-standing partnership to pioneer the emerging modality of degrader-antibody conjugates (DACs)."

Under the joint research plan, C4T and Roche will collaborate on two programs to develop DACs against undisclosed oncology targets exclusive to the collaboration. C4T will use its proprietary TORPEDO platform to design degrader payload candidates. Roche will select and design the antibody as well as conjugate the antibody to the degrader payload. Roche will be responsible for advancing DAC candidates through preclinical and clinical development as well as commercialization.

C4T will receive a $20 million upfront payment for the two programs. Should Roche exercise its option for a third target, C4T will receive an additional payment. Across the collaboration, C4T will receive near-term discovery milestone payments. C4T is eligible to receive over $1 billion in discovery, regulatory and commercial milestone payments. In addition, C4T is entitled to tiered royalties on future sales, subject to reductions under certain circumstances as described in the collaboration agreement.

About Degrader-Antibody Conjugates (DACs)

ADCs over the last 15 years have made important contributions to cancer therapy, but their clinical utility has historically been challenged by a limited therapeutic margin. Degrader-based ADCs, or degrader-antibody conjugates (DACs), represent a potential step-change in this modality. By utilizing degrader payloads that target specific cellular dependencies, DACs offer a superior therapeutic index. These small-molecule degraders are characterized by a catalytic mechanism of action—a feature unique to this approach—rendering them exceptionally well suited for targeted antibody delivery.

(Press release, C4 Therapeutics, APR 9, 2026, View Source [SID1234664262])

On April 9, 2026 Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee", SSE: 603087) reported the signing of an exclusive licensing agreement with JW Pharmaceutical, a leading pharmaceutical company in South Korea. Under the agreement, the two parties will collaborate on the clinical development, regulatory filing, and commercialization in South Korea of Bofanglutide Injection, a bi-weekly (once every two weeks) Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) independently discovered and developed by Gan & Lee.

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Under the terms of the agreement, JW Pharmaceutical will be granted the exclusive rights to develop and commercialize Bofanglutide Injection in South Korea. Gan & Lee Pharmaceuticals will receive a one-time, non-refundable upfront payment of USD 5 million. Additionally, Gan & Lee is eligible to receive milestone payments totaling USD 76.1 million, contingent upon research and development progress, regulatory approvals, and commercialization achievements. Following the product’s commercial launch, Gan & Lee will also receive tiered royalties based on net sales. The total potential transaction value reaches up to USD 81.1 million (excluding royalties).

This collaboration marks the third overseas out-licensing deal for Gan & Lee’s Bofanglutide Injection, following previous partnerships in Latin America and India. According to data from Grand View Research, the GLP-1RA market in the Asia-Pacific region reached USD 5.47 billion in 2025 and is projected to grow to USD 16.95 billion by 2033, representing a compound annual growth rate (CAGR) of 14% [1], making it one of the fastest-growing regions globally. Currently, the treatment penetration rate of GLP-1 drugs remains extremely low, indicating massive growth potential. As a mature market in the Asia-Pacific region, South Korea’s GLP-1RA market size reached USD 526 million in 2025 and is expected to increase to USD 1.6 billion by 2033 [2]. With its high acceptance of innovative drugs and strong patient purchasing power, the South Korean market has become a strategic foothold for multinational pharmaceutical companies entering East Asia. This collaboration marks another key step in the rapid global expansion of Gan & Lee’s differentiated bi–weekly GLP–1RA, Bofanglutide.

Steady Progress in Global Phase III Clinical Trials; Bi-weekly Dosing Regimen Significantly Enhances Patient Compliance

Currently, as the world’s first bi-weekly GLP-1RA to enter Phase III clinical research, Bofanglutide has advanced into the critical Phase III stage of its global development for three proposed indications: obesity/overweight, type 2 diabetes mellitus (T2DM), and obstructive sleep apnea (OSA). Existing clinical data demonstrate that Bofanglutide can effectively reduce body weight and blood glucose levels while comprehensively improving other metabolic parameters, yielding overall metabolic benefits. Its safety and tolerability profiles are consistent with other GLP-1RA class therapies. The bi-weekly dosing regimen further reduces the annual number of injections by 50% compared to mainstream once-weekly GLP-1RAs. This is anticipated to substantially boost patient adherence, offering a more convenient treatment option for the long-term, effective management of metabolic diseases.

As the global burden of metabolic diseases continues to rise, GLP-1 therapies are encountering tremendous market opportunities. South Korea, as one of the world’s key pharmaceutical markets, exhibits a robust demand for innovative diabetes and weight-loss therapies. This collaboration will effectively address the clinical and commercial needs of the South Korean market for highly efficacious and convenient treatment regimens.

"This partnership with JW Pharmaceutical marks another pivotal step in the globalization strategy for Bofanglutide," stated Dr. Zhi Li, Chief Business Officer of Gan & Lee Pharmaceuticals. "GLP-1 therapies are reshaping the global treatment landscape for metabolic diseases. The convenience of Bofanglutide’s bi-weekly dosing and its compelling clinical benefits will help address the unmet medical needs of South Korean patients. With over 80 years of experience, JW brings deep development and commercial expertise in metabolic diseases—a key factor in our decision to partner with JW."

Young-sub Shin, CEO of JW Pharmaceutical, commented: "This agreement represents a significant milestone in expanding our product portfolio within the rapidly growing therapeutic area of metabolic diseases, particularly diabetes and obesity. JW Pharmaceutical will leverage its established expertise in clinical development and regulatory execution, remaining committed to advancing the development and commercialization of Gan & Lee’s Bofanglutide in South Korea, thereby bringing innovative treatment options to South Korean patients."

About Bofanglutide

Bofanglutide Injection (GZR18), independently developed by Gan & Lee Pharmaceuticals, is a bi-weekly administered GLP-1RA designed for the treatment of obesity/overweight, type 2 diabetes mellitus (T2DM), and other metabolic diseases. Clinical research data indicates that Bofanglutide can effectively reduce body weight and lower blood glucose levels, while comprehensively improving other metabolic parameters. With safety and tolerability profiles consistent with the GLP-1RA class of drugs, it is poised to potentially become the world’s first commercially available bi-weekly GLP-1RA. Currently, the global development of Bofanglutide Injection has entered the Phase III clinical research stage.

(Press release, Gan and Lee Pharmaceuticals, APR 9, 2026, View Source;lee-pharmaceuticals-signs-exclusive-license-agreement-with-jw-pharmaceutical-the-leading-south-korean-pharma-to-advance-the-global-commercialization-of-the-innovative-glp-1-receptor-agonist-bofanglutide-302738066.html [SID1234664278])

On April 9, 2026 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported that it will share new data at the Society of Gynecologic Oncology (SGO) Annual Meeting, including two oral presentations and two posters.

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"Having four abstracts accepted at the prestigious SGO annual meeting underscores the importance of the data we are sharing and our commitment to the cancer care continuum," said Dale Muzzey, PhD, Chief Scientific Officer, Myriad Genetics. "We are particularly pleased to be presenting the latest Precise MRD data, showing that Precise MRD testing after adjuvant therapy for ovarian cancer was significantly prognostic of recurrence during the monitoring period. Importantly, recurrence risk tracked with the quantitative ctDNA fraction detected by Precise MRD, with elevated risk observed even at ctDNA levels detectable only by an ultrasensitive assay."

The remaining three presentations use data from the Myriad Collaborative Research Registry (MCRR), one of the largest pan-cancer registries accessible for research use, including de-identified data for more than 1.3 million participants. The studies demonstrate Myriad’s commitment to externally driven research that addresses diverse questions with immediate clinical implications:

Germline pathogenic and likely pathogenic variant prevalence is associated with age and ancestry in patients diagnosed with ovarian cancer before age 40;
Ovarian cancer diagnosis varies by Lynch syndrome gene, informing counseling and risk-reducing surgery recommendations;
Universal hereditary cancer screening identifies more individuals at high risk for endometrial cancer compared to age-based screening.

These studies will be presented at the Society of Gynecologic Oncology Annual Meeting on April 10-13 at the Puerto Rico Convention Center in San Juan. Myriad will exhibit at booth #523. For more information, visit: View Source

Myriad Genetics Presentations
Precise MRD
Evaluation of the Relationship of Molecular Residual Disease Testing to Ovarian Cancer Recurrence
Poster Board Number: 1590
Sun., April 12 at 12:00-1:00 pm AST
Presenter: John Nakayama, MD, Allegheny Health Network

MCRR
Prevalence of germline pathogenic variants in patients with endometrial cancer diagnosed before and after 65 years old within a laboratory-based research registry
Rapid Fire Oral I: Genetics Prevention and Surgery
Sat., April 11 – 3:05-3:08 pm AST
Presenter: Kieran Seay, MD, University of Pittsburgh Medical Center

Broad landscape of genetic variants and ancestry associated with ovarian cancer before age forty
Poster Board Number: 1450
Sun., April 12 – 4:00-4:45 pm AST
Presenter: Eliya K. Shachar, MD, University of California, Los Angeles

Age at ovarian cancer diagnosis varies by lynch syndrome gene: a genetic testing laboratory registry study
Focused Forum X: Genetics – Keeping up with the Genes
Mon., April 13 – 9:30-10:30 am AST
Presenter: Ying L. Liu, MD, MPH, Memorial Sloan Kettering Cancer Center

(Press release, Myriad Genetics, APR 9, 2026, View Source [SID1234664294])

On April 9, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO, and that she will continue as a member of the Board. The Company also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff’s commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.

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"I am honored to step into the role of Chief Executive Officer at this important time for Cardiff. We have made meaningful progress advancing onvansertib in first-line RAS-mutant metastatic colorectal cancer and remain focused on delivering clinical data to support our registrational program," said Mani Mohindru, PhD, President and Chief Executive Officer. "Building the right team to advance this promising asset is central to our strategy and to ultimately delivering a potential new therapy to patients in need."

Dr. Mohindru continued, "We are excited to welcome Josh and Ajay to our team. Josh is a highly accomplished financial leader with a strong track record of executing complex financings and building trusted relationships across the investment community. Ajay brings deep clinical development and operational expertise, with a proven ability to advance programs from early research through late-stage development. Together, their complementary experience strengthens our ability to execute our strategic priorities."

Josh Muntner

Mr. Muntner brings deep expertise in capital markets strategy, financial operations and supporting clinical-stage organizations through key inflection points. He is a seasoned biopharma finance executive with more than 25 years of experience spanning investment banking and corporate leadership roles, including as CFO of both private and publicly traded biotechnology companies. Previously, Mr. Muntner served as Chief Financial Officer of Imvax, Inc., where he led all finance functions, including raising $86 million in a convertible financing. Prior to that, he served as Chief Financial Officer of Mesoblast Ltd., a Nasdaq- and ASX-listed biotechnology company, where he completed multiple cross-border equity and debt financings totaling approximately $300 million and helped expand the company’s U.S. investor base. Earlier in his career, Mr. Muntner held senior roles in investment banking, completing more than 90 transactions and raising over $9 billion in equity and debt financing for life sciences companies. Mr. Muntner serves as a member of the Board Directors at Devonian Health Group Inc., a biopharmaceutical company developing immunomodulatory treatments for inflammatory diseases.

Mr. Muntner holds an MBA from the UCLA Anderson School of Management and a BFA from Carnegie Mellon University.

Ajay Aggarwal, MD, MBA

Dr. Aggarwal is a board-certified Pulmonary, Critical Care and Sleep Medicine physician with more than 15 years of experience in the pharmaceutical industry, spanning respiratory, immunology and oncology drug development. Most recently, he served as Senior Vice President and Head of Clinical Development at Aclaris Therapeutics, where he led clinical strategy and execution across multiple programs.

Prior to Aclaris, Dr. Aggarwal served as Chief Medical Officer of CereXis, Inc., a company advancing therapies for rare neurology and oncology indications. He has also held clinical leadership roles at Insmed, Inc. and AstraZeneca PLC, where he successfully advanced several compounds from preclinical stages into late-stage clinical development.

Earlier in his career, he held academic leadership roles, including Chief of Medicine at a VA Hospital, and has authored numerous peer-reviewed publications. He is a Fellow of the American College of Chest Physicians.

Dr. Aggarwal received his MBA from the Kellogg School of Management at Northwestern University and his medical degree from the All India Institute of Medical Sciences.

Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

In connection with Mr. Muntner joining Cardiff Oncology, the Company’s Board of Directors approved the grant of non-qualified stock options to purchase 486,650 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock option was granted as an inducement material to Mr. Muntner becoming an employee of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The option was granted as of April 6, 2026, and has an exercise price of $1.58 per share, the closing price on the grant date. The option vests over four years with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36 months, subject to Mr. Muntner’s continued employment with Cardiff Oncology on such vesting dates.

(Press release, Cardiff Oncology, APR 9, 2026, View Source [SID1234664263])