On April 9, 2026 GenFleet Therapeutics reported that oral KRAS G12D (ON/OFF) inhibitor GFH375 has been granted with the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation of China’s National Medical Products Administration. The designation is intended for GFH375 monotherapy treating patients with KRAS G12D-mutant metastatic pancreatic cancer who have received at least one prior systemic therapy, representing China’s first BTD inclusion of KRAS G12D inhibitor monotherapy for pancreatic cancer. Earlier this year, GFH375 became the first KRAS G12D inhibitor granted with China’s BTD for non-small cell lung cancer. GenFleet’s partner Verastem Oncology started overseas development of GFH375 (known as VS-7375 outside of China) last year, and VS-7375 was granted with US FDA’s Fast Track Designation for the treatment of KRAS G12D-mutant pancreatic ductal adenocarcinoma across all lines of therapy.

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GFH375 entered the world’s first phase III registrational study of a KRAS G12D inhibitor monotherapy (GFH375X1301) in 2025. This is also the world’s first registrational study of an oral KRAS G12D inhibitor, being conducted in approximately 40 clinical sites in China. GFH375 received clinical trial approval in China for a phase I/II trial in June 2024; the monotherapy data from treating solid tumors, pancreatic ductal adenocarcinoma and non-small cell lung cancer were selected as late-breaking abstracts and oral presentations at the ASCO (Free ASCO Whitepaper), WCLC and ESMO (Free ESMO Whitepaper) annul meetings consecutively in 2025. Multiple monotherapy and combination trials of GFH375/VS-7375 are currently underway in all lines of setting in China (by GenFleet) and globally (by Verastem).

"We are delighted that the product has received multiple regulatory designations globally, vindicating the promising efficacy of GFH375 in various cancer types. In the clinical development of GFH375, we are deeply impressed with the urgent need for innovative targeted therapies among patients with pancreatic cancer and KRAS G12D mutations. GenFleet looks forward to the continued progress of GFH375’s clinical programs to bring new treatment options. We expect to disclose updated data from GFH375 trials across various indications at academic conferences this year."stated Yu Wang, M.D., Ph.D.Chief Medical Officer of GenFleet.

Pancreatic cancer is among the most aggressive malignancies due to its rapid progression, high tumor heterogeneity and complex tumor microenvironment, with a 5-year survival rate below 10%. RAS mutations occur in up to 90% of pancreatic cancer cases (with a KRAS G12D mutation ratio of approximately 40%). Patients with KRAS G12D mutations have significantly shorter overall survival and relapse-free survival compared to those with wild-type KRAS or other KRAS mutant subtypes. GenFleet’s pipeline features top-tier selective and Pan RAS inhibitors, together with a bispecific antibody for cancer cachexia, which are poised to establish a novel targeted matrix for pancreatic cancer. The Company’s collaborative project, "Research on the Pathogenesis of Pancreatic Cancer and a New Paradigm for Precise Clinical Diagnosis and Treatment", was successfully awarded a National Science and Technology Major Project in 2025.

About GFH375/VS-7375

GFH375 is an orally active, potent, highly selective small-molecule KRAS G12D (ON/OFF) inhibitor designed to target the GTP/GDP exchange, thereby disrupting the activation of downstream pathways and effectively inhibiting tumor cell proliferation. Preclinical studies demonstrated dose-dependent inhibition in models bearing KRAS G12D mutation; GFH375 also demonstrated low off-target risk in kinase selectivity and safety target assays.

GenFleet entered into a discovery and development collaboration with Verastem Oncology (Nasdaq: VSTM) to advance three novel oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase I trial. Verastem selected GFH375/VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, as its lead program from the collaboration, in December 2023 and the license for GFH375 that was exercised in January 2025 is the first one from this collaboration. The licenses would give Verastem development and commercialization rights outside of China while GenFleet would retain rights inside of China.

(Press release, GenFleet Therapeutics, APR 9, 2026, http://www.genfleet.com/en/press_release-106 [SID1234666091])

On April 9, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), the global leader in relapsed/refractory AL Amyloidosis, reported that it will participate and host institutional investor meetings at the Jefferies Global Healthcare Conference being held June 2-4, 2026 in New York, NY.

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The Company will be available for one-on-one meetings during the conference. Interested investors should contact their Jefferies representative to request meetings. A link to access the replay, when available, will be posted to the Immix website on the Presentation & Events page under the Investors section.

(Press release, Immix Biopharma, APR 9, 2026, View Source [SID1234664269])

On April 9, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px1, (Pixclara2, Floretyrosine F 18 or 18F-FET), an investigational PET3 agent for the imaging of glioma (brain cancer), and has assigned a PDUFA4 goal date of September 11, 2026.

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The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients5. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines – including NCCN Guidelines6 – and TLX101-Px has been granted Orphan Drug7 and Fast Track8 designations by the FDA.

"There remains a critical unmet need in improving our ability to image residual glioma after treatment," said Thomas Hope, MD, Vice Chair, Department of Radiology and Biomedical Imaging, University of California, San Francisco (UCSF). "We have worked with Telix for the last three years to help leverage our clinical data to help make FET-PET9 available to patients in the United States."

Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, added, "Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care. PET imaging with 18F-FET is an important tool in clinical practice worldwide, and the FDA’s acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States."

Kevin Richardson, CEO, Telix Precision Medicine, added, "The FDA’s acceptance of our NDA resubmission is an important milestone for Telix. We appreciate the FDA’s constructive engagement and look forward to working closely with the Agency to urgently obtain approval and then bring this product to market for the benefit of patients."

Telix’s FY 2026 financial guidance does not include any revenue contribution from TLX101-Px.

About TLX101-Px

TLX101-Px is a PET imaging candidate, which has been granted Fast Track and Orphan Drug designations by the FDA for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for Telix’s LAT1-targeting therapy candidate TLX101-Tx (iodofalan 131I), currently under investigation in the pivotal IPAX-BrIGHT trial in patients with recurrent glioblastoma10. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.

About gliomas

Gliomas are diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) cancer that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors11. In the U.S., there are approximately 24,000 new glioma cases diagnosed annually12. Glioblastoma (GBM) is a high-grade glioma and the most common and aggressive form of primary brain cancer. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients13, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, APR 9, 2026, View Source [SID1234664285])

On April 9, 2026 Aveta Biomics, together with researchers from the VA Greater Los Angeles Healthcare System (VAGLAHS), reported new Phase 2A subpopulation data for APG-157 in head and neck squamous cell carcinoma (HNSCC) from patients at one of the clinical trial sites, which will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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HNSCC is a disease with limited durable treatment options, driven by multiple biological mechanisms, including persistent HPV16 infection in a growing subset of patients and chronic NF-κB-mediated immune suppression across the broader population. APG-157, an oral immunotherapy, is designed to address these drivers simultaneously.

The new analysis reveals distinct yet complementary effects across patient subpopulations. In HPV-positive patients, APG-157 reduces HPV16 expression in both tumor tissue and saliva, supporting antiviral activity. Across the broader population, treatment is associated with activation of systemic immune responses, including expansion of B and T cells.

These preliminary translational findings contain TWO CLINICALLY SIGNIFICANT observations that, to our knowledge, no therapy in HNSCC has previously reported. First, it showed a reduction in HPV viral load, addressing the root viral driver of disease in HPV-positive patients. Second, activation of gigaxonin and its downstream modulation of Snail and E-cadherin, pointing to a novel mechanism for reducing metastatic potential. While the confirmation in larger studies is the next step, these findings point to mechanisms of real clinical significance.

"The multiple mechanisms of action of APG-157 demonstrate strong potential, particularly in head and neck cancers that respond poorly to currently available chemotherapy and immunotherapy agents," said Dr. Marilene Wang, Professor of Head and Neck Surgery at the David Geffen School of Medicine at UCLA and lead investigator.

"APG-157 appears to activate gigaxonin, a novel regulator linked to NF-κB degradation, and modulates EMT markers with decreased Snail and increased E-cadherin, consistent with a less invasive, lower-metastatic-risk phenotype," added Dr. Eri S. Srivatsan, professor of surgery and senior Author at the David Geffen School of Medicine at UCLA and VAGLAHS.

These findings build on data previously presented at ASCO (Free ASCO Whitepaper) 2025 and ESMO (Free ESMO Whitepaper) 2025, adding further mechanistic depth to the emerging clinical profile.
The implications of these early observations may extend beyond HNSCC. HPV16 is a key driver of multiple anogenital cancers globally, and NF-κB activation is a hallmark across many solid tumors.

"These early findings of reduced HPV viral load may extend to other HPV-driven cancers, including cervical cancer. The observed shift toward a less invasive phenotype also suggests broader potential across solid tumors where reducing metastatic risk remains a key unmet need," said Dr. Selda Samakoglu, Chief Medical Officer of Aveta Biomics.

PRESENTATION DETAILS
• Title: Downregulation of HPV 16 and NF-κB and upregulation of gigaxonin and immune markers in APG-157 treated head and neck cancer: A phase 2A clinical investigation
• Presenter: Dr. Saroj Basak, Research Scientist, VAGLAHS
• Session: Biomarkers Predictive of Therapeutic Benefit
• Date: April 21, 2026
• Time: 9:00 AM – 12:00 PM
• Location: Section 42

(Press release, Aveta Biomics, APR 9, 2026, View Source [SID1234664535])

On April 9, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage biotechnology company, reported preliminary select operational results for the fiscal quarter ending March 31, 2026. ImmunityBio reported preliminary net product revenue of approximately $44.2 million during the three-month period ending March 31, 2026, with net product revenue growth in every quarter since ANKTIVA’s commercial launch, including a 168% increase over Q1 2025. This builds on full-year 2025 net product revenue of $113 million, a 700% increase over full-year 2024. Q1 2026 net product revenue also represents a 15% sequential increase over the $38.3 million earned during Q4 2025.

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ANKTIVA is now approved or authorized across five regulatory jurisdictions, representing approximately 34 countries. Additionally, the pivotal BCG-naïve CIS trial (QUILT-2.005) is fully enrolled, with the IDMC confirming no additional enrollment is required. A supplemental BLA submission is on track for 2026.

The Company ended the quarter with an estimated $380.9 million in cash, cash equivalents and marketable securities as of March 31, 2026.

"ANKTIVA’s continued momentum reflects growing physician adoption and disciplined commercial execution," said Richard Adcock, President and CEO of ImmunityBio. "Following strong growth in 2025, we are focused on scaling in the U.S. and expanding across an increasing number of global markets."

"The sustained momentum of ANKTIVA reflects its growing commercial adoption in the BCG-unresponsive NMIBC CIS setting and feedback from treating urologists has been consistently positive," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "Across our clinical programs, we are seeing strong enrollment and growing investigator participation, supporting advancement of our broader pipeline. Full enrollment of our pivotal BCG-naïve CIS with or without papillary disease trial, with IDMC confirmation of adequate statistical power further strengthen the expanding body of clinical evidence supporting ANKTIVA in the NMIBC bladder cancer setting. With our BCG-unresponsive NMIBC with papillary-only disease supplemental BLA now filed and our commitment to our pipeline development across multiple solid and liquid tumor types, we remain focused on advancing new treatment options for patients with bladder cancer and other indications."

These amounts reflect the Company’s preliminary estimates based solely upon information available to it as of the date of this press release, and the amounts reported are not a comprehensive statement of its operating results or financial position as of March 31, 2026. Any actual amounts that the Company reports in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026 will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its operating results and financial position for the fiscal quarter ended March 31, 2026 are finalized. As a result, these preliminary estimates may differ materially from the actual results that will be reflected in the Company’s consolidated financial statements for the fiscal quarter ended March 31, 2026 when they are completed and publicly disclosed in its Quarterly Report on Form 10-Q.

(Press release, ImmunityBio, APR 9, 2026, View Source [SID1234664270])