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Lisata Therapeutics Enters into Definitive Agreement to be Acquired by Kuva Labs, Inc.

On March 6, 2026 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported that it has entered into a definitive agreement to be acquired by Kuva Labs Inc. ("Kuva"), a privately-held company.

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Details of the Transaction

Under the terms of the merger agreement, Kuva will commence a tender offer to acquire all the issued and outstanding shares of common stock of the Company for $5.00 per share in cash payable at closing plus one contingent value right ("CVR") per share (the "Transaction"). The CVR entitles the holders of record to receive an additional cash payment of $1.00 per share if a New Drug Application or similar registration is filed or formally accepted for review by the FDA or any governmental authority in any jurisdiction with respect to any pharmaceutical product that contains or incorporates the product candidate referred to as of the date of the merger agreement as certepetide for any indication or patient population prior to the earlier of (a) 11:59 p.m. New York City Time on the seventh (7th) anniversary of the closing date, and (b) termination of the CVR agreement. Should the relevant milestone not be met, then no additional consideration will be payable to the holders of the CVRs in relation to such milestone.

The Transaction is subject to customary offer conditions contained in the merger agreement that will be filed with the SEC, including the tender of a majority of the outstanding shares of the Company’s capital stock. The merger agreement does not include a financing condition. The Transaction is expected to close in the second quarter of 2026, subject to satisfaction of the offer conditions. If the tender offer closes, then Kuva would acquire the untendered shares and convertible securities of the Company through a second-step merger for the same consideration.

Following completion of the Transaction, Lisata will become part of Kuva, a privately-held company, and its common stock will be delisted from the Nasdaq Capital Market. Lisata will also apply to deregister its common stock and cease to be a reporting company under the United States Securities Exchange Act of 1934, as amended.

Board of Directors Recommendation

Following a comprehensive strategic review and thorough evaluation conducted with the assistance of its independent legal and financial advisors, the Lisata board of directors has unanimously determined that the definitive agreement and the transactions contemplated thereby are advisable, fair to, and in the best interests of Lisata and its stockholders. The board of directors has duly authorized and approved the execution and delivery of the merger agreement and unanimously recommends that all stockholders accept the offer and tender their shares.

Advisors

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. is serving as legal counsel to Lisata and H.C. Wainwright & Co. acted as financial advisor to Lisata. Goodwin Procter LLP is acting as legal counsel to Kuva.

(Press release, Lisata Therapeutics, MAR 6, 2026, View Source [SID1234664401])

BBOT Announces Publication in Cancer Discovery Highlighting Preclinical Data Demonstrating BBO-11818 is a Potent and Selective panKRAS Inhibitor

On March 6, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported the publication of preclinical data describing the discovery and characterization of BBO-11818, a panKRAS inhibitor targeting KRAS in both the ON and OFF states, with significant therapeutic potential for patients with KRAS mutant cancers. The publication, titled "Discovery of BBO-11818, a Potent and Selective Non-covalent Inhibitor of (ON) and (OFF) KRAS with Activity Against Multiple Oncogenic Mutants" was published in the peer-reviewed journal Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper).

"While advances with current KRASG12C inhibitors have shown promising clinical efficacy, there are currently no approved targeted therapies for most clinically significant KRAS mutants, including KRASG12D and KRASG12V," said Pedro J. Beltran, PhD, Chief Scientific Officer of BBOT. "To address this significant unmet need, we developed BBO-11818 as a potent panKRAS inhibitor with strong binding affinity for KRAS and broad selectivity over HRAS and NRAS, designed to achieve high levels of KRAS inhibition in both the ON and OFF states. BBO-11818 has the potential to be used as a monotherapy treatment, or in combination with standard-of-care therapies, as well as with our RAS:PI3Kα breaker, BBO-10203. These preclinical data underscore the strength of our platform and highlight the promise of BBO-11818 as a foundational therapy that could meaningfully reshape the treatment landscape for KRAS driven tumors."

The preclinical findings in this publication highlight the key properties BBO-11818 and its potential to address critical limitations associated with other compounds targeting mutant KRAS. Unlike several existing inhibitors that primarily target the inactive GDP-bound state, BBO-11818 potently binds and inhibits KRAS in both its ON and OFF states, as demonstrated through structural analysis, surface plasmon resonance, and functional assays. By targeting the active state of KRAS, BBO-11818 may overcome a critical resistance mechanism observed with current KRAS inhibitors, in which tumors upregulate KRAS expression or activate upstream signaling to sustain pathway activation.

Data demonstrate potent activity against multiple clinically relevant KRAS mutants, including KRASG12D, KRASG12V, and KRASG12C, with high selectivity for KRAS, exhibiting >500-fold selectivity over other RAS isoforms. BBO-11818’s activity across a broad range of KRAS mutants is designed to help prevent the emergence of resistance driven by secondary activating KRAS mutations that can limit the efficacy of allele-specific inhibitors. In addition, its high specificity for KRAS may support improved tolerability and greater potential for combination with other therapeutic agents. Monotherapy studies show robust anti-tumor activity across multiple in vitro and in vivo models of KRAS mutant solid tumors, including colorectal, pancreatic, and lung cancers. BBO-11818 also demonstrated strong combination potential with immune checkpoint inhibitors, anti-EGFR antibodies, and BBO-10203, the company’s RAS:PI3Kα breaker compound.

"The discovery and development of BBO-11818 reflect the exceptional collaboration between the BBOT team and our colleagues at Frederick National Lab," said Frank McCormick, PhD, FRS, BBOT Board Director, Advisor to the National Cancer Institute’s RAS Initiative at Frederick National Laboratory for Cancer Research, and Professor of Tumor Biology and Cancer Research at UCSF. "We are incredibly proud of what we’ve accomplished together and are hopeful that our collective efforts will ultimately lead to meaningful improvements in patient outcomes."

BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial (NCT06917079) in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. Initial Phase 1 monotherapy data were announced in January 2026, demonstrating encouraging early anti-tumor activity across dose levels and tumor types, including a confirmed partial response in a patient with pancreatic ductal adenocarcinoma (PDAC) with a 56% tumor reduction. The company plans to provide additional data updates in the second half of 2026 and to study the combination of BBO-11818 with BBO-10203 later in 2026.

The discovery and preclinical characterization of BBO-11818 is the result of a collaborative effort between BBOT, the RAS Initiative at Frederick National Laboratory, and Lawrence Livermore National Laboratory.

About BBO-11818
BBO-11818 is a selective, orally bioavailable non-covalent inhibitor that targets KRAS in both the ON and OFF states, has high selectivity over HRAS and NRAS, and displays strong activity in KRAS mutant preclinical models, including KRASG12D and KRASG12V. In addition, it potently suppresses MAPK signaling and inhibiting cell proliferation in KRAS mutant cell lines. BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

(Press release, BridgeBio Oncology Therapeutics, MAR 6, 2026, View Source [SID1234663342])

Incyte Announces the European Commission Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)

On March 6, 2026 Incyte (Nasdaq:INCY) reported that the European Commission (EC) has approved Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).

"The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades," said Bill Meury, President and Chief Executive Officer, Incyte. "As the first PD-1 immunotherapy approved in Europe in combination with platinum-based chemotherapy in the first-line setting, Zynyz helps expand the standard-of-care options available to clinicians and underscores our commitment to delivering innovative medicines that can have an impact for patients."

The EC decision follows the January 2026 positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This marks the second indication in Europe for Zynyz, which was previously approved by the EC as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

This approval is based on data from the Phase 3 POD1UM-303/InterAACT2 trial (NCT04472429) evaluating Zynyz or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.1

Results from the trial, also published in The Lancet, demonstrated a statistically significant 37% reduction in the risk of progression or death (P=0.0006).1 Patients in the Zynyz and chemotherapy combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in the placebo combination group.1 Clinically meaningful improvement was also demonstrated for all secondary efficacy endpoints, including the key secondary endpoint of overall survival. No new safety signals were identified, and the safety profile was representative of other combinations with PD-1 inhibitors and chemotherapy. Serious adverse reactions occurred in 47% of patients receiving Zynyz in combination with chemotherapy.1 The most frequent serious adverse reactions (≥ 2% of patients) were sepsis, pulmonary embolism, diarrhea and vomiting.1

About Squamous Cell Carcinoma of the Anal Canal (SCAC)

Worldwide, SCAC is the most common type of anal cancer, making up 85% of cases.2 It is a rare disease for which the incidence increases approximately 3% per year, with an estimated prevalence at around 1 or 2 cases per 100,000 people.3,4,5,6 About 90% of cases are associated with human papillomavirus (HPV) infection—the number one risk factor for anal cancer.5 HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it.7,8 Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.9

About POD1UM

The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-303, POD1UM-202 and several other Phase 1, 2 and 3 studies for patients with solid tumors.

For more information about the study, please visit View Source

About Zynyz (retifanlimab)

Zynyz (retifanlimab) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) in the U.S and Japan and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

Zynyz is also indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S., EU, Canada and Switzerland.

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

For more information, see the Zynyz SmPC.

(Press release, Incyte, MAR 6, 2026, View Source [SID1234663341])

Foresee Pharmaceuticals Welcomes Positive CHMP Opinion Recommending Approval of CAMCEVI 21mg, 3-month strength in the European Union for Advanced Prostate Cancer

On March 6, 2026 Foresee Pharmaceuticals (6576.TWO), ("Foresee") reported that it has received notification from its licensing partner, Accord Healthcare, that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending granting an extension of the marketing authorization for CAMCEVI to include a new 21 mg, 3-month ready-to-use strength of the long-acting injectable formulation for the treatment of advanced prostate cancer.

This CHMP positive opinion is a regulatory milestone for patients living with advanced prostate cancer and the healthcare providers who treat them. CAMCEVI 21 mg is a ready-to-use subcutaneous leuprolide injection that eliminates the complex, multi-step mixing procedures required by traditional therapies. By offering a convenient 3-month dosing interval, CAMCEVI 21 mg complements CAMCEVI 42 mg by providing more options for stakeholders, streamlining the administration process for clinical staff, and also enhancing patient comfort and treatment compliance.

The European Commission (EC), which has the authority to approve medicine for the European Union, will now review the CHMP recommendation. A final decision regarding marketing authorization is expected in the second quarter of 2026.

Under the partnership framework, CAMCEVI is exclusively licensed to Accord Healthcare for commercialization across the European market. The anticipated approval of the CAMCEVI 21 mg 3-month strength will build upon the commercialization of the CAMCEVI 42 mg (6-month formulation), which officially launched in Europe in 2025.

(Press release, Foresee Pharmaceuticals, MAR 6, 2026, View Source [SID1234663340])

CARsgen Therapeutics Announces 2025 Annual Results

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.

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])