On March 6, 2026 Lantheus Holdings, Inc. ("Lantheus") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has approved PYLARIFY TruVu (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent. PYLARIFY TruVu is indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

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"The FDA approval of PYLARIFY TruVu demonstrates Lantheus’ continued commitment to advancing innovation that directly expands patient access to high-quality diagnostic tools," said Mary Anne Heino, Executive Chairperson and CEO, Lantheus. "The availability of PYLARIFY TruVu addresses a key need identified by clinicians – greater access to our market-leading formulation."

PYLARIFY TruVu was submitted for FDA approval via the 505(b)(2) regulatory pathway, allowing for review based upon previously submitted data from two PYLARIFY pivotal studies: OSPREY and CONDOR. The new formulation has the same diagnostic properties and is expected to offer similar safety and effectiveness as PYLARIFY.

Additionally, PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution. These improvements are expected to increase batch sizes, enabling manufacturing sites with high‑energy cyclotrons to reach more patients and serve broader geographic markets. Overall, PYLARIFY TruVu has the potential to enhance supply flexibility and improve operating leverage for the network of PMFs that will manufacture and distribute the product.

"As we continue to innovate and expand our portfolio, ensuring a reliable and uninterrupted supply for our customers remains our top priority," said Dorothy Barr, Senior Vice President, Manufacturing and Technical Operations. "The PYLARIFY TruVu formulation is designed to enhance manufacturing efficiency, strengthen supply chain dependability and ultimately improve the healthcare system’s ability to deliver timely, accurate imaging for people with prostate cancer."

PYLARIFY TruVu is expected to be commercially available in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, allowing customers to transition from PYLARIFY to the new formulation with minimal disruption.

"As a community dedicated to improving the lives of people facing prostate cancer, we’ve seen firsthand how advanced PSMA PET diagnostic tools like PYLARIFY have truly been game changers, providing real-time, highly accurate information that can meaningfully shape treatment decisions," said Gina B. Carithers, President and CEO, Prostate Cancer Foundation. "With prostate cancer incidence expected to rise in the years ahead, it’s encouraging to see companies like Lantheus putting patients first and introducing innovations that help ensure timely, precise imaging while keeping pace with growing demand. Access to accurate diagnostics, especially when metastatic or recurrent disease is suspected, can profoundly impact both quality of life and long-term outcomes for people living with prostate cancer."

More than 760,000 people with prostate cancer have received PSMA PET scans with PYLARIFY since the FDA granted approval in May 2021 based on findings from the OSPREY and CONDOR studies.

PYLARIFY Pivotal Data Summary
The safety and efficacy of PYLARIFY and PYLARIFY TruVu were established based on the PYLARIFY pivotal trials, OSPREY and CONDOR. OSPREY was a phase 2/3 clinical trial of 385 patients. In Cohort A, 252 men with high-risk prostate cancer had evaluable histopathology for determining the diagnostic performance of PYLARIFY in identifying pelvic nodal metastases. OSPREY Cohort A assessed sensitivity, specificity, PPV, and NPV in pelvic lymph nodes and the prostate gland for PSMA-targeted PET with PYLARIFY. The median sensitivity, specificity, PPV and NPV were 38% (26, 51), 96% (94, 99), 77% (62, 92) and 83% (78, 88). Results showed that a PSMA-targeted PET scan with PYLARIFY significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV in men at risk for metastatic prostate cancer prior to initial therapy. Compared to standard imaging, PYLARIFY PET/CT delivered: Significantly higher specificity (97.9% vs 65.1%), nearly three times the PPV (86.7% vs 28.3%) and similar sensitivity to standard imaging (40.3% vs 42.6%).1

CONDOR was a robust, multicenter, phase 3 trial of 208 patients with suspected recurrent or metastatic prostate cancer with negative or equivocal results using standard imaging. The study design assessed correct localization rate (CLR), a metric of diagnostic performance measuring PPV at the patient level enhanced with anatomic lesion matching in patients with biochemically recurrent (BCR) prostate cancer.
CONDOR found that a PSMA-targeted PET scan with PYLARIFY in men with biochemical recurrent prostate cancer achieved the primary endpoint of correct localization rate (CLR): 85%-87% across all 3 readers (lower bound of 95% CI: 78%-80%).2

The safety of PYLARIFY was evaluated in 593 clinical patients who were exposed to a single dose of PYLARIFY and was generally well tolerated. The most common adverse reactions reported in ≤ 2% of patients were headache, dysgeusia and fatigue. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction.3

About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the U.S. An estimated 1 in 8 men will be diagnosed in their lifetime. The incidence rate for prostate cancer has been increasing since 2014 at a rate of 3% per year overall. For 2026, estimates suggest nearly 334,000 new cases and more than 36,000 deaths. Prostate cancer can be a serious disease and is the second-leading cause of cancer death in men (behind lung cancer), but most men diagnosed with prostate cancer do not die from it. In fact, more than 3.5 million men in the U.S. consider themselves prostate cancer survivors.4

PYLARIFY TruVu (piflufolastat F 18) Injection
PYLARIFY TruVu (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.1,2

PYLARIFY TruVu was developed to build on the success of PYLARIFY, the number one utilized PSMA PET imaging agent in the U.S. which has been used in over 760,000 scans across 48 states, Puerto Rico and Washington, D.C.5

INDICATION
PYLARIFY (piflufolastat F 18) and PYLARIFY TRUVU (piflufolastat F 18) Injection are indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY and PYLARIFY TRUVU imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY and PYLARIFY TRUVU for imaging biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY and PYLARIFY TRUVU for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY and PYLARIFY TRUVU uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly those with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
PYLARIFY and PYLARIFY TRUVU, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

DRUG INTERACTIONS
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY and PYLARIFY TRUVU in prostate cancer. The effect of these therapies on performance of PYLARIFY and PYLARIFY TRUVU PET has not been established.

To report suspected adverse reactions for PYLARIFY or PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see the full Prescribing Information for PYLARIFY and PYLARIFY TRUVU.

(Press release, Lantheus, MAR 6, 2026, View Source [SID1234663333])

On March 6, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported financial results for the full year ended December 31, 2025, and provided a corporate update.

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"2025 was an important and productive year for PMV Pharma as we reported positive Phase 2 interim data from the registrational PYNNACLE clinical trial and made significant progress in enrolling the study," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We look forward to submitting an NDA in the first quarter of 2027 for rezatapopt in platinum-resistant/refractory ovarian cancer."

PYNNACLE Phase 2 Monotherapy Update:

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Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational, Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors.

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PMV Pharma anticipates submitting a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027.

Full Year 2025 and Recent Corporate Highlights:

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On March 2, 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to rezatapopt for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The FDA provides ODD status to drugs intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Benefits of the designation may include exemption from certain FDA fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved.

•
Phase 1 results from the ongoing Phase 1/2 PYNNACLE study were published in the New England Journal of Medicine, "Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors." The manuscript highlighted that rezatapopt demonstrated antitumor activity in heavily pretreated patients across multiple solid tumor types which provided proof-of-concept for p53 reactivation. Clinical activity and biomarker data were consistent with selective binding to the Y220C pocket and restoration of wild-type p53 tumor suppressor function.

•
Updated data from the ongoing PYNNACLE Phase 2 trial were presented as an oral presentation at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) based on a September 4, 2025 data cut-off.

o
34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6 months.

o
46% ORR observed among 48 evaluable patients in ovarian cancer cohort with a median duration of response of 8.0 months.

o
Treatment-related adverse events (TRAEs) were mostly Grade 1-2 with the most frequent TRAEs observed (>15%) being nausea, fatigue, blood creatinine increased, and alanine aminotransferase (ALT) increased.

•
Natural history study results were also presented at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) where TP53 Y220C–mutant advanced solid tumors were associated with poor outcomes reinforcing the significant unmet medical need addressed by rezatapopt.

•
New findings from the rezatapopt PYNNACLE Phase 2 trial in ovarian cancer were presented at the 2026 European Society of Gynecologic Oncology Congress, demonstrating robust and consistent ORRs across key ovarian cancer subgroups.

o
The ORR subgroup data included those with platinum-resistant, platinum-refractory disease, prior systemic therapies and folate receptor alpha status, that provide further evidence of the broad efficacy of rezatapopt within ovarian cancer patients.

o
After the September 4, 2025 data cut-off, among the 48 evaluable patients in the ovarian cancer cohort, a 50% ORR was observed with 23 confirmed responses and one unconfirmed partial response.
Fiscal Year 2025 Financial Results

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As of December 31, 2025, PMV Pharma had $112.9 million in cash, cash equivalents, and marketable securities, compared to $183.3 million at December 31, 2024. Net cash used in operations was $73.6 million for the year ended December 31, 2025, compared to $51.3 million for the year ended December 31, 2024.

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Net loss for the year ended December 31, 2025, was $77.7 million compared to $58.7 million for the year ended December 31, 2024.

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Research and development (R&D) expenses were $69.9 million for the year ended December 31, 2025, compared to $58.5 million for the year ended December 31, 2024. The increase in R&D expenses was primarily related to clinical expenses for advancing rezatapopt, the Company’s lead product candidate.

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General and administrative (G&A) expenses were $16.3 million for the year ended December 31, 2025, compared to $26.9 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due to lower facility-related and personnel costs following the relocation of the Company’s lab and office space and staff reductions in the prior year.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors, conducted across approximately 70 sites.

For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, MAR 6, 2026, View Source [SID1234663334])

On March 6, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported that it has closed a $20 million non-convertible debt financing with Streeterville Capital.

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The transaction is structured as a note purchase agreement pursuant to which the Company issued two non-convertible promissory notes: (i) a promissory note in the original principal amount of $10,930,000 and (ii) a secured promissory note in the original principal amount of $10,000,000, together providing approximately $20 million in net proceeds to the Company.

The financing is expected to extend the Company’s cash runway into the summer of 2028. The Company intends to use the proceeds primarily to support key initiatives designed to accelerate the advance of stenoparib toward pivotal development, FDA approval and commercialization.

Additional information regarding the transaction is included in the Company’s Form 8-K filed with the Securities and Exchange Commission on March 6, 2026.

"This financing demonstrates the confidence which Streeterville has in Allarity and the capital received positions us to complete Phase 2 enrollment, prepare for our FDA meeting, advance our companion diagnostic strategy, and prepare for pivotal development of stenoparib in advanced ovarian cancer," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "The financing also supports broader strategic initiatives, including further advancement of our DRP companion diagnostic platform and potential exploratory development in additional WNT-driven tumor types. We view stenoparib as a novel, highly differentiated therapeutic candidate, and this non-convertible financing provides the resources necessary to propel its continued advancement, while reflecting confidence in the strength of our clinical progress and regulatory strategy."

Stenoparib has demonstrated durable clinical benefit in heavily pre-treated ovarian cancer patients, including previously reported extended overall survival. Notably, certain patients have remained on therapy for more than 30 months, highlighting the long-term therapeutic potential of stenoparib in this population. The open-label Phase 2 trial will generate the critical clinical data to inform future regulatory engagement and pivotal trial development.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, MAR 6, 2026, View Source [SID1234663337])

On March 6, 2026 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.1

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"The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. DARZALEX FASPRO, incorporating the ENHANZE technology, continues to set new standards in multiple myeloma treatment and outcomes," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme

The approval is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy. TECVAYLI in combination with DARZALEX FASPRO demonstrated statistically significant improvements in PFS and OS in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM. Results show an 83% reduction in the risk of disease progression or death compared to standard regimens (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001).2 The three-year PFS rate was 83%,2 underscoring a durable benefit.

For more information on this approval, please view Johnson & Johnson’s press release issued on March 5, 2026.

(Press release, Halozyme, MAR 6, 2026, View Source;FDA-Approves-TECVAYLI-in-Combination-with-DARZALEX-FASPRO-for-RelapsedRefractory-Multiple-Myeloma/default.aspx [SID1234663338])

On March 6, 2026 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported its 2025 Annual Results.

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Business Highlights

Cash and cash equivalents were around RMB1,123 million as of December 31, 2025. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,000 million. The net loss for the year ended December 31, 2025 was RMB103 million, representing a decrease of approximately 87% compared to the year ended December 31, 2024. In light of operational factors such as the changes in operating cash flow, we expect to have adequate cash into the 2030.
During 2025, CARsgen has received a total of 218 confirmed orders of zevor-cel from its commercialization partner Huadong Medicine. In December 2025, zevor-cel has been included in China’s Commercial Health Insurance Innovative Drug Catalogue (2025).
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) and granted Priority Review for satri-cel. The results of satri-cel confirmatory Phase II trial in China have been simultaneously published in The Lancet and at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.
Multiple allogeneic CAR-T products are in development, covering treatment areas such as hematologic malignancies, solid tumors, and autoimmune diseases.
CARsgen independently developed the lentiviral-based CARvivo platform for creating in vivo CAR T-cell products.
CARsgen entered into strategic cooperation agreements with a key platform enterprise in Jinshan District, Shanghai to establish an advanced commercial manufacturing base for CAR T-cell products.
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "2025 is a pivotal year for CARsgen Therapeutics. As we enter the phase of substantial value realization in commercialization, zevor-cel has demonstrated an excellent market performance. Meanwhile, satri-cel, the world’s first CAR-T candidate for solid tumors that has entered the NDA review process, is expected to be approved in the first half of 2026 and initiate commercialization. With its strong clinical value and broad market potential, it is poised to become the company’s next core growth driver. In 2025, the company has shifted its focus to the field of allogeneic CAR-T cell therapies. We believe that off-the-shelf cell therapies capable of large-scale production are crucial for serving a broad patient population and opening a new chapter for the industry. Leveraging our proprietary THANK-uCAR and THANK-u Plus platforms, we are advancing multiple allogeneic CAR-T candidates, with encouraging preliminary clinical data demonstrating promising efficacy and a favorable safety profile. Additionally, we are also advancing in vivo CAR T-cell therapies based on our proprietary CARvivo platform. Looking ahead, we will continue to unite our efforts, move forward with determination, and execute our strategic plans with rigorous precision, bringing renewed hope to patients worldwide."

Financial Highlights

CARsgen’s revenue was around RMB125.7 million for the year ended December 31, 2025 mainly from zevor-cel, autologous BCMA CAR T-cell product in which the primary revenue of zevor-cel was calculated on the basis of ex-works price, rather than on the basis of end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. CARsgen’s gross profit was around RMB80 million for the year ended December 31, 2025. In the commercialization stage, we are demonstrating a strong cost competitive advantage, which is mainly due to self-manufacture for plasmids and vectors with stable output and high yield per batch. Our net loss was around RMB103 million for the year ended December 31, 2025, representing a decrease of around RMB695 million from around RMB798 million for the year ended December 31, 2024.

Cash and cash equivalents were around RMB1,123 million as of December 31, 2025, representing a decrease of around RMB356 million from around RMB1,479 million as of December 31, 2024. The decrease was mainly due to research and development expenses, administrative expenses and investment of capital expenditure. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,000 million. In light of operational factors such as the changes in operating cash flow, we expect to have adequate cash into the 2030.

Zevor-cel demonstrates rapids sales growth

Zevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA) approved by the NMPA of China for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent).

CARsgen entered into a collaboration agreement with Huadong Medicine (000963.SZ) for the commercialization of zevor-cel in mainland China. In terms of commercialization, Huadong Medicine has established a dedicated, professional, and comprehensive commercial team to promote the use of zevor-cel and has been utilizing China’s multi-layered insurance system to improve patient accessibility. During 2025, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities and we have received a total of 218 confirmed orders from Huadong Medicine. In December, 2025, zevor-cel was included in China’s Commercial Health Insurance Innovative Drug Catalogue (2025). We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage.

The updated long-term follow-up results of Phase I clinical trial of CT053 have been published in Blood Advances. The updated data of Phase II clinical trial, involving 102 patients with a median follow-up of 20 months, were published in Experimental Hematology & Oncology. Zevor-cel demonstrates manageable safety profile while eliciting deep and durable responses in R/R MM patients.

CARsgen entered into a collaboration with Dispatch Bio, to conduct a Phase I trial in China, planned to begin in 2026. The trial will evaluate DISP-11, an investigational therapy leveraging Dispatch’s first-in class Flare platform – including DV-10, the company’s novel tumor-specific virus – and zevor-cel, in patients suffering from solid tumors.

Satri-cel is about to be commercialized in China

Satricabtagene autoleucel (satri-cel, R&D code: CT041) is an autologous humanized CAR T-cell product against Claudin18.2. In China, satri-cel was granted Breakthrough Therapy Designation (BTD) in March 2025 and Priority Review in May 2025 by the CDE. In June 2025, the CDE of NMPA of China has accepted the NDA for satri-cel for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Satri-cel is the first CAR T-cell therapy for the treatment of solid tumors that has advanced to NDA stage worldwide. It is expected to be approved and start commercialization in the first half of 2026.

The results of satri-cel confirmatory Phase II trial (NCT04581473) in China have been published in The Lancet and were orally presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Satri-cel demonstrated significant progression-free survival (PFS) improvement and a clinically meaningful overall survival (OS) benefit with a manageable safety profile, compared to standard therapy.

The research results of the Phase Ib registrational clinical trial of satri-cel for PC adjuvant therapy in China (NCT05911217) has been presented as a poster session at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2025. The trial represents the world’s first proof-of-concept (POC) study exploring CAR T-cell therapy for the adjuvant treatment of solid tumors.

In addition, an investigator-initiated trial (IIT) for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (NCT06857786), and an IIT for satri-cel as a sequential therapy following first-line treatment in patients with advanced G/GEJA (NCT07179484) have been conducted in China.

Multiple allogeneic CAR-T product candidates in development

CARsgen has been advancing differentiated allogeneic CAR T-cell products utilizing the CARsgen’s proprietary THANK-uCAR and THANK-u Plus platform. THANK-u Plus platform, as an enhanced version of THANK-uCAR, was developed to address the potential impact of NKG2A expression levels on therapeutic efficacy of the allogeneic CAR T-cells.

CT0596 is a BCMA-targeting allogeneic CAR T-cell product candidate deploying our THANK-u Plus technology. The IITs are ongoing in China to evaluate the safety and efficacy of CT0596 for the treatment of R/R MM and PCL. Two IND applications for R/R MM and primary plasma cell leukemia (pPCL) separately were submitted to the NMPA in December 2025 and have been accepted. Phase Ib registration trials in China are planned to be initiated in 2026. Preliminary results of an IIT have been presented at the 67th ASH (Free ASH Whitepaper) in December 2025.

CT1190B (KJ-C2219) is an allogeneic CAR T-cell product candidate targeting CD19/CD20 deploying our THANK-u Plus technology, for hematologic malignancies and autoimmune diseases. The IITs have been initiated for R/R B-NHL, and for systemic lupus erythematosus (SLE) and systemic sclerosis (SSc), separately. It is expected to obtain IND approval from the NMPA for B-cell malignancies in 2026. Phase Ib registration study is planned to be initiated in 2026 in China.

In addition, multiple products against different targets are currently under development: KJ-C2320 against CD38 for acute myeloid leukemia (AML); KJ-C2526 against NKG2DL for AML, other malignancies and senescence; CT1390B against CLL1 for AML; KJ-C2527 against Claudin18.2 for gastric cancer.

On February 25, 2025, CARsgen has entered into the agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership), to jointly invest in UCARsgen Biotech Limited.

In vivo CAR-T product candidates in development

Apart from CAR T-cell products manufactured via in vitro gene editing, CARsgen is also developing in vivo CAR T-cell products. CARsgen’s proprietary lentiviral-based CARvivo platform demonstrates excellent T cell transduction and targeting specificity. KJ-C2529 is an in vivo CAR T-cell product candidate against CD19/CD20 deploying our CARvivo platform for the treatment of B-cell lymphoma. An IIT is expected to be initiated in 2026 for the treatment of R/R B-NHL.

Expand CAR-T commercial manufacturing base

CARsgen is actively preparing for capacity expansion, enhancing the manufacturing capabilities for CAR T-cell therapies that meet international standards to support the commercialization of multiple products and strengthen its global competitiveness. On February 12, 2026, CARsgen, through its indirectly wholly-owned subsidiary CARsgen Diagnostics Co., Ltd., signed strategic cooperation agreements with Shanghai Jingong Enterprise Development Co., Ltd., which is a key platform enterprise in the Bay Area High-Tech Zone of Jinshan District, Shanghai. With a total investment amount not exceeding RMB370 million, CARsgen will establish an advanced commercial manufacturing base for CAR T-cell products in Jinshan District, Shanghai. No significant upfront capital expenditure is required from CARsgen, effectively preserving valuable cash flow for core research and development as well as market expansion. In addition, the repurchase mechanism ensures CARsgen can fully acquire asset control after long-term operation, maintaining production stability and enhancing the flexibility of asset layout.

(Press release, Carsgen Therapeutics, MAR 6, 2026, View Source [SID1234663339])