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Ractigen Therapeutics Announces China NMPA IND Approval for Phase II Clinical Trial of saRNA Therapy RAG-01 in Non-Muscle Invasive Bladder Cancer

On March 19, 2026 Ractigen Therapeutics, a pioneering clinical-stage biotechnology company developing innovative small activating RNA (saRNA) therapeutics, reported that China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved its Investigational New Drug (IND) application to initiate a Phase II clinical trial of RAG-01 for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

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This significant milestone makes RAG-01 the second saRNA therapeutic to receive IND approval in China, both of which were developed by Ractigen. This approval not only solidifies Ractigen’s global leadership in saRNA technology but also serves as a critical clinical validator for the company’s broader RNA activation (RNAa) platform and its LiCOTM delivery technology.

RAG-01 is a novel saRNA therapeutic designed to upregulate p21, a key regulator of cell cycle arrest and cellular senescence, to inhibit the abnormal proliferation of bladder cancer cells. This innovative saRNA therapeutic aims to treat NMIBC by increasing p21 mRNA and protein levels.

The progression of RAG-01 into Phase II clinical development follows highly encouraging Phase I data from Australia, which demonstrated clear target engagement (p21 protein upregulation), a favorable safety profile, and promising complete response (CR) signals.

"We are very pleased to receive IND approval from the China NMPA CDE for the Phase II trial of RAG-01," said Dr. Long-Cheng Li, Founder and CEO of Ractigen Therapeutics. "This approval is an important validation of both the RAG-01 program and the broader potential of saRNA therapeutics. RAG-01 reflects our innovation strategy of activating endogenous disease-relevant genes that have long been considered difficult to drug. We believe this differentiated mechanism, together with local bladder delivery, may offer a meaningful new treatment option for patients with NMIBC. We look forward to working closely with investigators and regulatory authorities to advance this program."

The Phase II study is a randomized, controlled, multi-center trial designed to evaluate the efficacy and safety of RAG-01 as monotherapy and in combination with chemotherapy in patients with intermediate- and high-risk NMIBC. The China study builds on encouraging preliminary data from the ongoing Phase I clinical trial in Australia, where RAG-01 has demonstrated favorable safety, clear target engagement, and anti-tumor activity.

About RAG-01

RAG-01 is a pioneering saRNA therapeutic candidate designed to activate the tumor suppressor gene p21 via RNA activation (RNAa). The product is administered through intravesical instillation using Ractigen’s proprietary LiCO delivery technology. In the Phase I clinical trial conducted in Australia, RAG-01 has shown encouraging preliminary safety, target engagement, and efficacy data. In 2024, RAG-01 received IND clearance from the U.S. Food and Drug Administration (FDA) and was granted Fast Track designation.

About NMIBC

Non-muscle invasive bladder cancer (NMIBC) is a common malignancy confined to the lining of the bladder. The standard first-line treatment is transurethral resection of the bladder tumor (TURBT) followed by intravesical BCG or chemotherapy. However, a significant proportion of patients experience treatment failure or multiple recurrences, highlighting the need for new and effective treatment options.

About RNAa

RNA activation is a clinically validated platform technology developed by Dr. Long-Cheng Li and his team. It utilizes saRNAs to target gene regulatory domains, activating gene expression and restoring therapeutic protein levels. This innovative technology holds vast potential for developing therapeutic drugs across various diseases, particularly where traditional methods fall short.

(Press release, Ractigen, MAR 19, 2026, View Source [SID1234663766])

Inhibrx Reports Fourth Quarter and Fiscal Year 2025 Financial Results

On March 19, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") reported financial results for the fourth quarter and fiscal year 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. (the "Acquirer") and the Former Parent’s concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials.

Upcoming Milestones

ozekibart (INBRX-109)
We expect to submit the Biologics License Application ("BLA") for ozekibart for the treatment of unresectable or metastatic conventional chondrosarcoma to the U.S. Food and Drug Administration ("FDA") early in the second quarter of 2026;
We plan to announce progression-free survival ("PFS") data for the Phase 1/2 colorectal cancer expansion cohort in the second quarter of 2026; and
We plan to meet with the FDA to discuss accelerated approval for Ewing Sarcoma and fourth line colorectal cancer in the second half of 2026.
INBRX-106
We plan to announce interim objective response rate ("ORR") data from the randomized Phase 2/3 trial in head and neck squamous cell carcinoma ("HNSCC") in combination with KEYTRUDA (pembrolizumab) in the second quarter of 2026; and
We plan to announce PFS data from the randomized Phase 2/3 trial in HNSCC in combination with pembrolizumab in the fourth quarter of 2026 at the European Society for Medical Oncology ("ESMO") 2026 Congress.
Financial Results

Cash and Cash Equivalents. As of December 31, 2025, Inhibrx had cash and cash equivalents of $124.2 million. On March 18, 2026, the Company entered into the First Amendment to the Loan and Security Agreement with Oxford Finance, LLC and received gross proceeds of $75.0 million.

R&D Expense

Research and development expenses were $25.3 million during the fourth quarter of 2025 as compared to $33.4 million during the fourth quarter of 2024. This decrease during the fourth quarter of 2025 was primarily due to a decrease in expense related to lower clinical trial costs in our ozekibart registration-enabling trial for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment ahead of our data readout in October 2025, as well as a decrease in contract manufacturing expenses;
Research and development expenses were $113.0 million during the fiscal year 2025 as compared to $203.7 million during the fiscal year 2024. This decrease during the fiscal year 2025 was primarily due to the following factors:
a decrease in clinical trial expense primarily related to lower clinical trial costs in our ozekibart registration-enabling trial for the treatment of unresectable or metastatic conventional chondrosarcoma as discussed above;
a decrease in contract manufacturing expense primarily attributable to decreased expenses incurred at our contract development and manufacturing organizations for our ozekibart program and INBRX-106 program, as well as decreased expenses following the 101 Transaction; and
increased personnel-related expense during the fiscal year 2024 related to the recognition of $25.9 million upon the acceleration of outstanding options in connection with the closing of the 101 Transaction.
G&A Expense

General and administrative expenses were $5.6 million during the fourth quarter of 2025, compared to $16.7 million during the fourth quarter of 2024. This decrease during the fourth quarter of 2025 was primarily due to an increase in legal services incurred in the prior period in connection with legal proceedings, which have since concluded, finding the Company not liable for damages.
General and administrative expenses were $23.3 million during the fiscal year 2025, compared to $127.9 million during the fiscal year 2024. This decrease during the fiscal year 2025 was primarily due to the following factors:
one-time expenses incurred during the fiscal year 2024 related to the 101 Transaction, including $68.1 million of legal, advisory, and consulting services, and the recognition of $15.2 million in stock option expense upon the acceleration of outstanding options in connection with the closing of the 101 Transaction; and
increased expense during the fiscal year 2024 related to legal services incurred in connection with the Company’s legal proceedings as discussed above.
Other Income (Expense)

Other expense was $1.9 million during the fourth quarter of 2025, compared to other income of $2.1 million during the fourth quarter of 2024. Other expense in the current period consisted of $3.2 million of interest expense on the Company’s $100.0 million outstanding debt balance, offset in part by other income. Other income during each period consisted of interest income earned on the Company’s sweep and money market account balances. During the fourth quarter of 2024, the Company did not incur any interest expense following the extinguishment of all outstanding debt in connection with the 101 Transaction.
Other expense was $5.0 million during the fiscal year 2025, compared to other income of $2.0 billion during the fiscal year 2024. Other expense in the current period consisted of $12.2 million of interest expense on the Company’s $100.0 million outstanding debt balance, offset in part by other income. Other income during each period consisted of interest earned on the Company’s sweep and money market account balances. During the fiscal year ended 2024, as noted above, other income also included the gain recorded in connection with the completion of the 101 Transaction. This gain consisted of (i) the consideration paid by the Acquirer for all outstanding common stock, warrants, and stock options, (ii) the extinguishment of the Company’s outstanding debt which was assumed by the Acquirer, (iii) assets and liabilities related to the Inhibrx 101 Business, which were assumed by the Acquirer, and (iv) transaction costs paid for by the Acquirer.
Net Income (Loss)

Net loss was $32.8 million during the fourth quarter of 2025, or $2.11 per share, basic and diluted, compared to a net loss of $47.9 million during the fourth quarter of 2024, or $3.09 per share, basic and diluted.
Net loss was $140.1 million during the fiscal year 2025, or $9.04 per share, basic and diluted, compared to a net income of $1.7 billion during the fiscal year 2024, or earnings per share $114.01 basic and $112.62 diluted.

(Press release, Inhibrx, MAR 19, 2026, View Source [SID1234663765])

D3 Bio to Showcase Its Innovative KRAS Pipeline at AACR 2026, Including an Oral Presentation at Clinical Plenary Session

On March 19, 2026 D3 Bio Inc, a global clinical-stage biotechnology company focused on developing transformative oncology therapeutics, reported that five abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, one of the most impactful oncology conferences in the world, taking place April 17–22 in San Diego, California. Notably, two of the five abstracts have been selected for oral presentations at the Clinical Trials Plenary Session and the Clinical Trials Mini-Symposium, respectively. These presentations will highlight data from D3’s robust and comprehensive pipeline targeting KRAS-driven cancers.

Details of the oral presentations are as follows:

Safety and efficacy of Elisrasib (D3S-001), a next generation GDP-bound KRAS G12C inhibitor, as monotherapy in advanced non-small cell lung cancer (NSCLC) previously treated with or without a KRAS G12C inhibitor: Results from a phase 1/2 study
Session Title: Clinical Trials Plenary 1: New Frontiers in Precision Oncology
Date & Time: Sunday, April 19, 2026, 1:00 PM – 3:00 PM
Presentation Number: CT020
This will be presented as an oral presentation in a Clinical Trials Plenary Session.
Safety and efficacy of Elisrasib (D3S-001), a next generation GDP-bound KRAS G12C inhibitor, as monotherapy or combination therapy with cetuximab in previously treated metastatic CRC and PDAC: Results from a phase 1/2 study
Session Title: Advances in Precision Oncology
Date & Time: Tuesday, April 21, 2026, 2:30 PM – 4:30 PM
Presentation Number: CT303
This will be presented as an oral presentation in a Clinical Trials Mini-Symposium session.
Details of the poster presentations are as follows:

First in human phase 1 study of D3S-002, a purposely designed ERK1/2 inhibitor, in advanced solid tumors with MAPK pathway mutations
Session Title: First-in-Human Phase I Clinical Trials
Date & Time: Monday, April 20, 2026, 9:00 AM – 12:00 PM
Location: Poster Section 50
Poster Board Number: 20
Abstract Presentation Number: CT060
First-in-human clinical pharmacokinetic prediction of D3S-003, an orally bioavailable dual-state KRAS G12D inhibitor
Session Category: Experimental and Molecular Therapeutics
Session Title: Quantitative Pharmacology and Translational Modeling
Date & Time: Monday, April 20, 2026, 9:00 AM – 12:00 PM
Location: Poster Section 17
Poster Board Number: 19
Abstract Presentation Number: 1831
D3S-003, an orally bioavailable potent and selective dual-state inhibitor targeting both GDP- and GTP-bound KRAS G12D
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 2
Date & Time: Tuesday, April 21, 2026, 9:00 AM – 12:00 PM
Location: Poster Section 17
Poster Board Number: 12
Abstract Presentation Number: 4569
"We are excited to present new clinical and preclinical data at this year’s AACR (Free AACR Whitepaper) Annual Meeting" said George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. "These presentations will showcase our comprehensive KRAS pipeline, including Elisrasib (D3S-001), our next-generation KRAS G12C inhibitor, D3S-002, a selective ERK1/2 inhibitor designed with a unique profile for combination strategies to enhance clinical efficacy and overcome resistance to KRAS G12C inhibitors; and D3S-003, our differentiated KRAS G12D inhibitor addressing large unmet medical needs in pancreatic and colo-rectal cancers. These data highlight D3 Bio’s strong scientific progress and commitment to advancing transformative therapies for patients with KRAS-driven cancers. We look forward to engaging with the global scientific community and sharing our progress at AACR (Free AACR Whitepaper) and ultimately bringing new treatment options to patients."

About Elisrasib (D3S-001)

Elisrasib is a nextgeneration KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP-bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib‑ is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

Key publications:

Cancer Discovery (2024) 14(9):1675–1698
Nature Medicine (2025) 31(8):2768–2777
About D3S‑002

D3S‑002 is a selective ERK1/2 inhibitor strategically designed for combination approaches, providing vertical MAPK‑pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.

Key publication:

Cancer Res 1 April 2023; 83 (7_Supplement): 5501.
About D3S‑003

D3S‑003 is a differentiated KRAS G12D inhibitor targeting both OFF and ON conformations to address one of the most common KRAS mutations. The program aims to broaden D3 Bio’s multi‑allele KRAS franchise and deliver new solutions to the heterogeneous and evolving landscape of KRAS‑driven cancers.

(Press release, D3 Bio, MAR 19, 2026, View Source [SID1234663764])

GI Innovation Announces First Clinical Supply Agreement to Explore Combination Therapy for Prostate Cancer

On March 19, 2026 GI Innovation reported that it has entered into a clinical supply agreement with Johnson & Johnson to evaluate a combination therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) in a phase 1b clinical trial.

This trial aims to evaluate the combination of GI Innovation’s immuno-oncology agent GI-102 with pasritamig (KLK2-CD3), a first-in-class bispecific T-cell engager. This trial will explore the therapeutic potential of the combination regimen in patients with mCRPC, a disease area with limited treatment options.

Under the terms of the clinical supply agreement, Johnson & Johnson will provide pasritamig to GI Innovation, who will be the sponsor of the Phase 1b clinical trial. The study will be conducted in both Korea and the United States. Dr. Mark Stein of Columbia University Irving Medical Center will serve as the global coordinating investigator. In Korea, leading tertiary hospitals including Asan Medical Center and Severance Hospital will participate in the study.

Dr. Myoung-ho Jang, CEO of GI Innovation, stated, "This agreement represents a meaningful step toward validating the potential of GI-102 in combination with next-generation modalities such as T cell engagers together with Johnson & Johnson. As combination strategies become increasingly important in the field of immuno-oncology, clinical collaborations with global partners will serve as an important opportunity to further strengthen the technological credibility of our platform".

(Press release, GI Innovation, MAR 19, 2026, View Source [SID1234663763])

Plus Therapeutics to Present New Analysis at ISPOR Showing CNSide® May Reduce Leptomeningeal Metastases Healthcare Costs by 40%

On March 19, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported the presentation of a new health economics study evaluating the economic impact of earlier detection and therapeutic management of LM using the CNSide cerebrospinal fluid (CSF) assay. The cost-of-care analysis suggests that earlier LM diagnosis and therapeutic management enabled by CNSide may reduce overall LM-related healthcare costs by approximately 40%, primarily through earlier therapeutic intervention, improved treatment precision, and reduced hospitalizations. The findings support the potential clinical and economic value of CNSide as the Company advances commercialization of the assay in the United States.

The data will be presented at the ISPOR 2026 Annual Meeting, the leading global scientific conference focused on health economics and outcomes research (HEOR), bringing together researchers, healthcare decision-makers, and payer stakeholders. The meeting will take place May 17-20, 2026, in Philadelphia, PA.

"CNSide’s ability to detect and monitor tumor cells in cerebrospinal fluid provides clinicians with actionable information earlier in the disease course," said Russ Havranek, EVP, Commercial and Corporate Strategy of Plus Therapeutics. "Health economics data demonstrating potential cost savings and improved outcomes are increasingly important to payers and health systems evaluating adoption of advanced diagnostics."

Presentation Highlights
The poster, titled, "Economic Impact of Earlier Detection and Therapeutic Management of Leptomeningeal Metastases Using CNSide: A Cost-of-Care Analysis," co-authored by CNSide Diagnostics and Harvard T.H. Chan School of Public Health, will highlight the following:

Late-stage LM diagnosis is associated with substantial healthcare costs, including median inpatient admissions of ~$20,000 (Interquartile range (IQR) $10,000-$30,000)
Total LM-related costs may exceed $100,000 per month, driven by repeated imaging, LM-directed therapies, and palliative care
Earlier detection and treatment optimization enabled by CNSide may reduce overall LM-related healthcare costs by ~40% (33%-47%)
Potential savings are driven by earlier therapeutic intervention, improved treatment precision, reduced adverse events and hospitalizations, and gains in quality-adjusted life years (QALYs)
The analysis also highlights the challenges of quantifying LM costs due to claims bundling with primary cancer treatment
The analysis utilized published literature, real-world data, and healthcare claims databases to estimate direct and indirect costs associated with late-stage LM diagnosis. Additional information on ISPOR 2026 and the presentation abstract can be found here.

About Leptomeningeal metastases
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, MAR 19, 2026, View Source [SID1234663760])