On March 2, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided an overview of recent developments.

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"2025 was a tremendously successful and transformative year for UroGen, highlighted by the FDA approval and commercial launch of ZUSDURI, the first and only approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer," said Liz Barrett, President and Chief Executive Officer of UroGen. "2026 is a pivotal year for the ZUSDURI launch, and we are encouraged by the early post-J Code trajectory. As expected, we are seeing an acceleration across key launch indicators, including physician uptake and adoption. We believe ZUSDURI is well positioned to address a significant unmet need and represents a greater than $1 billion peak sales opportunity."

Ms. Barrett continued, "We are advancing our pipeline with meaningful momentum across our next-generation clinical programs, UGN-103 and UGN-104. The UTOPIA trial evaluating UGN-103 demonstrated compelling complete response results consistent with the ENVISION trial, and we remain on-track to submit an NDA in the second half of 2026. We also plan to explore label expansion opportunities for UGN-103, including in high-grade NMIBC settings and as an adjuvant to TURBT in IR-NMIBC patients. Following the refinancing of our term loan agreement with Pharmakon, we have further strengthened our balance sheet, and believe we are well-positioned to execute on our long-term growth strategy and build upon our leadership in uro-oncology."

Q4 2025 and Recent Business Highlights:

ZUSDURI (mitomycin) for intravesical solution:

Commercial launch is progressing as expected for ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. ZUSDURI was approved by the U.S. Food and Drug Administration (FDA) on June 12, 2025. The Company’s expanded field team is scaled and actively supporting the ZUSDURI launch.
On January 1, 2026, the permanent Healthcare Common Procedure Coding System Level II J Code (J9282) became effective, building buy-and-bill reimbursement confidence across hospital and community urology practices, removing a key barrier and supporting broader uptake.
ZUSDURI achieved net product sales of $15.8 million in 2025. As of December 31, 2025, UroGen reports:
838 activated sites of care
102 unique ZUSDURI prescribers
32 repeat ZUSDURI prescribers
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):

Generated net product sales of $94.0 million in the year ended December 31, 2025, compared to $90.4 million reported in 2024 (which included CREATES Act sales of $0.2 million in 2025 and $3.0 million in 2024). Underlying demand revenue grew by 7% year-over-year.
Next-generation novel mitomycin-based formulation for urothelial cancers

UroGen announced robust results from its ongoing Phase 3 UTOPIA trial evaluating UGN-103 (mitomycin) for intravesical solution in recurrent LG-IR-NMIBC. UGN-103 demonstrated a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%). For more information on the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.
The FDA has agreed with the regulatory plan to submit a New Drug Application (NDA) based on the data from the Phase 3 UTOPIA trial to support potential approval of UGN-103 for recurrent LG-IR-NMIBC. UroGen plans to submit the NDA in the second half of 2026 with potential FDA approval in 2027.
UGN-103 is a next generation product designed to offer improvements over ZUSDURI, including a shorter manufacturing process and simplified reconstitution procedure. It combines UroGen’s RTGel technology with a novel mitomycin formulation licensed from medac GmbH. UroGen plans to continue evaluating lifecycle management and pipeline expansion opportunities, including potential applications in high-grade NMIBC settings and adjuvant use of UGN-103 in IR-NMIBC patients.
The Phase 3 clinical trial to explore the safety and efficacy of UGN-104 is ongoing and is expected to be fully enrolled by the end of 2026. UGN-104 is a next generation product for LG-UTUC. For more information on the UGN-104 Phase 3 trial, refer to View Source
UGN-501 (investigational next-gen oncolytic virus) for use in high-grade non-muscle invasive bladder cancer (HG-NMIBC)

UGN-501 is a potent and fast-replicating investigational next generation oncolytic virus therapy being developed as a locally administered cancer treatment. Investigational New Drug-enabling studies are currently ongoing, with the goal of submitting an IND and initiating a Phase 1 trial by the end of 2026. UroGen intends to evaluate several modes of administration, including delivery using its proprietary RTGel technology. The initial focus will be bladder cancer, and UroGen also intends to explore UGN-501’s potential in a broader range of cancers beyond the genitourinary system.
Expanded Debt Facility with Pharmakon Advisors

On February 26, 2026, UroGen entered into an amended and restated loan agreement with Pharmakon Advisors for two additional tranches of senior secured term loans. The first tranche of $200 million was funded at closing to refinance the existing $125 million loan facility and provide additional non-dilutive capital. A second tranche of $50 million may be drawn at the Company’s option no later than June 30, 2027, subject to customary conditions. All outstanding loans with Pharmakon Advisors will accrue interest at a fixed rate of 8.25% and be repaid in four equal quarterly payments commencing in the first quarter of 2030. All outstanding loans with Pharmakon Advisors can be prepaid in whole at UroGen’s discretion at any time, subject to prepayment premiums, make-whole amounts, as applicable, and fees.
Full Year 2025 Financial Results

Revenue: Total revenue was $109.8 million for the full year ended December 31, 2025, compared to $90.4 million for the full year ended December 31, 2024. The 21% year-over-year increase was primarily driven by the commercial launch of ZUSDURI in 2025 and JELMYTO revenue growth.

R&D Expenses: Research and development (R&D) expenses were $67.1 million for the full year ended December 31, 2025, including non-cash shared-based compensation expense of $2.3 million. This compares to $57.1 million, including non-cash shared-based compensation expense of $2.2 million, for the full year ended December 31, 2024. The increase in R&D expenses was primarily driven by higher ZUSDURI manufacturing costs, which are recognized as R&D expenses prior to receiving FDA approval, costs associated with the Phase 3 trials for UGN-103 and UGN-104, and the acquisition of UGN-501, partially offset by lower clinical trial costs and regulatory expenses in connection with ZUSDURI.

SG&A Expenses: Selling, general and administrative (SG&A) expenses were $155.1 million for the full year ended December 31, 2025, including non-cash shared-based compensation expense of $9.6 million. This compares to $121.2 million, including non-cash shared-based compensation expense of $10.9 million, for the full year ended December 31, 2024. The increase in SG&A expenses was primarily driven by ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval in 2025, as well as an increase in overall commercial operation costs.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $18.5 million and $23.4 million for the years ended December 31, 2025 and 2024, respectively. The decrease was driven primarily by changes in underlying assumptions for remeasuring the effective interest rate.

Interest Expense on Long-term Debt: Interest expense related to the prior $125 million term loan facility with funds managed by Pharmakon Advisors was $15.3 million and $12.5 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily attributed to the interest expense on the $25 million third tranche of the loan that was funded in September 2024.

Net Loss: UroGen reported a net loss of $153.5 million or ($3.19) per basic and diluted share for the year ended December 31, 2025, compared with a net loss of $126.9 million or ($2.96) per basic and diluted share for the year ended December 31, 2024.

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2025, cash, cash equivalents and marketable securities totaled $120.5 million.

2026 JELMYTO Sales and Company Operating Expense Guidance: Guidance for full-year 2026 net product sales for JELMYTO are expected to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over the $94 million of JELMYTO sales reported in 2025. The Company is not providing full-year 2026 sales guidance for ZUSDURI at this time, as the product remains in the early stages of its commercial launch. Full-year 2026 operating expenses are expected to be in the range of $240 million to $250 million, including non-cash share-based compensation expense of $20 million to $24 million.

For further details on the Company’s financials, refer to our Annual Report on Form 10-K, being filed with the SEC today.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.urogen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

(Press release, UroGen Pharma, MAR 2, 2026, View Source [SID1234663185])

On March 2, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the fourth quarter and full-year ended December 31, 2025 and highlighted recent corporate progress.

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"At TYRA, we are following the science," said Todd Harris, Ph.D., CEO of TYRA. "The strength of the genetic and biological validation behind FGFR3 gives us conviction to concentrate our resources and strategy around indications where this target plays a central role. Through our "dabogratinib 3×3" strategy, we are deliberately deploying capital toward high unmet needs – low grade upper tract urothelial carcinoma (LG-UTUC), intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and achondroplasia (ACH) – where selective FGFR3 inhibition has the potential to make a meaningful impact for patients, while creating significant potential long-term value."

"Oral dabogratinib reflects years of deliberate molecular optimization to achieve highly selective FGFR3 inhibition with a profile designed to balance potency, safety and convenience," said Doug Warner, MD, Chief Medical Officer of TYRA. "The clinical data generated to date – with more than 100 participants dosed – reinforces our confidence in its potential efficacy and tolerability and supports once-daily (QD) dosing across our targeted indications. We believe this target profile positions oral dabogratinib to deliver meaningful benefit for patients, and we look forward to expanding our clinical database this year."

Fourth Quarter and Recent Corporate Highlights

Dabogratinib 3×3 Strategy

TYRA is focused on executing our "dabogratinib 3×3" strategy: developing the first orally available, FGFR3 selective inhibitor in 3 future potentially pivotal clinical studies to support regulatory submissions with the aim to commercialize in 3 potential blockbuster indications: LG-UTUC, IR NMIBC and ACH.

"In Q4 2025, we prioritized our portfolio to maximize potential return on invested capital," commented Alan Fuhrman, Chief Financial Officer of TYRA. "Exiting metastatic bladder cancer allows us to focus financial and operational resources on the three core indications within our "dabogratinib 3×3" strategy that we believe offer the most compelling risk-adjusted opportunities."

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Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses in participants with LG-UTUC, a rare cancer where approximately 85% of tumors are driven by FGFR3. Study startup is ongoing, and the first patient is anticipated to be dosed in 2026.

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Phase 2 IR NMIBC Study – SURF302. SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses in participants with FGFR3-altered low-grade IR NMIBC. TYRA opened additional US and international trial sites in Q4 2025, and the Company expects to report initial three-month complete response data by the end of 1H 2026.

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Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with achondroplasia. The study is enrolling a safety sentinel cohort of at least 3 participants per dose level in children ages 5 to 10, and TYRA has successfully cleared two of the four dose levels with no safety events to report. The Company remains on track and is expected to report interim results from the safety sentinel cohort – which will include 6-month average height velocity data and safety results – in 2H 2026.
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Phase 1/2 mUC Study – SURF301. At ASCO (Free ASCO Whitepaper) GU 2026, TYRA presented a poster detailing the response, safety, pharmacokinetics/pharmacodynamics and circulating tumor DNA data from the SURF301 mUC study. These translational data were leveraged to select doses that have the potential to achieve the target product profiles for efficacy and safety in the SURF303, SURF302 and BEACH301 studies. TYRA is planning to publish final Phase 1 results from SURF301 in a future scientific publication. The SURF301 study is no longer recruiting patients.

Corporate

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Strengthened Leadership Team. In Q4 2025, TYRA announced the appointments of Bhavesh Ashar as Chief Operating Officer, and Heather Faulds as Chief Regulatory Officer. Together, Mr. Ashar and Ms. Faulds will be essential in advancing oral dabogratinib through potentially global Phase 2 studies in skeletal dysplasia and urothelial cancers, and preparing for future potential pivotal studies.

SNÅP Platform and Pipeline

•
TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.

Fourth Quarter and Full-Year 2025 Financial Results

•
Cash, Cash Equivalents and Short-Term Investments. As of December 31, 2025, TYRA had cash, cash equivalents and marketable securities of $256.0 million. TYRA’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2027.
•
Research and Development (R&D) Expenses. R&D expenses for the three months ended December 31, 2025 were $28.2 million compared to $22.2 million for the same period in 2024, and $102.9 million for the full year 2025 compared to $80.1 million for the same period in 2024. The increases were primarily associated with development activities for oral dabogratinib, reflecting ongoing BEACH301 and SURF302 clinical trials and start-up costs for SURF303, as well as development expenditures for SURF431.
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General and Administrative (G&A) Expenses. G&A expenses for the three months ended December 31, 2025 were $8.3 million compared to $7.6 million for the same period in 2024, and $29.8 million for the full year 2025 compared to $24.1 million for the same period in 2024. The increases were primarily driven by higher compensation and other personnel costs driven by headcount growth.
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Net Loss. Fourth quarter net loss was $33.8 million compared to $25.6 million for the same period in 2024, and $119.9 million for the full year 2025 compared to $86.5 million for the same period in 2024.

Upcoming Clinical Milestones:

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SURF303: dose first patient with LG-UTUC – 2026
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SURF302: initial three-month complete response data – end of 1H 2026
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BEACH301: initial results from safety sentinel cohort – 2H 2026

About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3 selective inhibitor to enter clinical development and it has been studied in more than 100 patients to date across multiple clinical studies. To date, oral dabogratinib has demonstrated very positive target engagement with FGFR3, favorable anti-tumor effects and safety results in oncology, and an optimized QD dosing regimen.

Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

Please visit the Patients page of our website for more information on our clinical trials.

(Press release, Tyra Biosciences, MAR 2, 2026, View Source [SID1234663184])

On March 2, 2026 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that members from the Replimune management team will present and host investor meetings at the following two conferences:

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Leerink Partners 2026 Global Healthcare Conference
Date: Monday, March 9, 2026
Fireside Chat Time: 2:20 pm EDT

Jefferies 2026 Biotech on the Beach Summit
Date: Tuesday, March 10, 2026
1×1 Meetings

Live webcasts of the fireside chat will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.

(Press release, Replimune, MAR 2, 2026, View Source [SID1234663183])

On March 2, 2026 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported the achievement of a clinical milestone under its license agreement with TG Therapeutics, Inc. (Nasdaq: TGTX). The milestone payment for azercabtagene zapreleucel (azer-cel) was triggered by progress of a Phase 1 clinical trial of azer-cel in progressive forms of multiple sclerosis (MS). As a result of this milestone event, Precision will receive $7.5 million in proceeds, inclusive of $5.25 million cash and $2.25 million for the purchase of 201,504 shares of Precision common stock by TG Therapeutics at $11.17 per share, pursuant to the terms of the companies’ license agreement. Existing cash and cash equivalents, inclusive of the azer-cel milestone proceeds, continued fiscal and operating discipline, and availability of the ATM facility, are expected to provide sufficient cash runway through 2028.

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"We are pleased with TG Therapeutics’ continued advancement of azer-cel in progressive multiple sclerosis and with the achievement of this clinical milestone," said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. "Their clinical progress reflects the potential of azer-cel in autoimmune diseases such as multiple sclerosis and underscores the value of our strategic partnering approach. Importantly, it also highlights the additive value of our partnered programs as we enter a catalyst-rich 2026, with multiple potential data and development milestones complementing progress across our wholly-owned in vivo gene editing pipeline."

In January 2024, Precision BioSciences announced a licensing deal, granting TG Therapeutics exclusive worldwide rights to develop and commercialize azer-cel in autoimmune diseases and other non-oncology indications. Under the agreement, Precision received upfront and potential near-term economics and remains eligible for additional development, regulatory, and commercial milestone payments, as well as royalties on net sales. Precision is eligible to receive up to $288 million in additional milestone payments as well as high-single-digit to low-double-digit royalties on net sales.

(Press release, Precision Biosciences, MAR 2, 2026, View Source [SID1234663182])

On March 2, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that clinical data will be presented in seven oral and poster sessions at the 52nd Annual Meeting of the EBMT from March 22-25 in Madrid.

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The encore presentations will include data on the company’s pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematologic malignancies, including Orca-T and Orca-Q.

"Our participation at this year’s meeting of the EBMT provides an important opportunity to engage directly with the global transplant community as we continue our shared efforts to advance the field of allogeneic stem cell transplant," said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. "As we progress toward the potential FDA approval of Orca-T, the strength and consistency of our data reinforce our commitment to delivering a new therapy for patients with blood cancer. We look forward to being in Madrid to connect with clinicians and partners from around the world and to participate in scientific exchange focused on improving patient outcomes."

The EBMT abstracts are now available at www.ebmt.org/annual-meeting-2026. Details of the Orca Bio presentations follow:

Oral Session: OS14 | Graft Manipulation and Conditioning

Title: Orca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT plus Tac/MTX for GVHD Prevention in a Randomized Phase 3 Clinical Trial (Precision-T)

Date and Time: Wednesday, March 25 at 08:30 AM – 08:39 AM CET

Location: N107

Oral Session: OS14 | Graft Manipulation and Conditioning

Title: Clinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison

Date and Time: Wednesday, March 25 at 08:39 AM – 08:48 AM CET

Location: N107

Oral Session: OS12 | Acute GVHD – Clinical

Title: Cost-Effectiveness of Orca-T vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States

Date and Time: Tuesday, March 24 at 2:39 PM – 2:48 PM CET

Location: N101-102

Poster Session: A

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients

Presentation ID: A038

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy

Presentation ID: A145

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors

Presentation ID: A043

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison

Presentation ID: A085

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

About Orca-Q
Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

(Press release, Orca Bio, MAR 2, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-clinical-data-on-its-pipeline-of-high-precision-cell-therapies-at-the-52nd-annual-meeting-of-the-ebmt [SID1234663181])