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Orca Bio Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Orca-Q® for the Treatment of High-Risk Hematologic Malignancies

On April 28, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy for the treatment of high-risk hematologic malignancies.

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"The FDA’s RMAT designation for Orca-Q recognizes the significant unmet need for patients with serious hematologic malignancies and validates the promising clinical findings from our ongoing Phase 1 study," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "As this is our second cell therapy candidate to receive RMAT status, we have experienced firsthand how this program can support accelerated development and enhanced communication with the FDA. With our newly expanded Phase 1 study continuing to enroll patients and additional data expected later this year, we remain focused on advancing our high-precision approach to deliver an important new treatment to patients with blood cancer."

The RMAT application included data from the ongoing Phase 1 clinical trial (NCT03802695) evaluating Orca-Q for the treatment of hematologic malignancies across six treatment cohorts, including in patients with haploidentical donors, and in patients receiving non-myeloablative or reduced intensity conditioning. Clinical findings demonstrated durability and encouraging outcomes across key metrics, including overall survival, acute and chronic graft versus host disease (GVHD) and non-relapse mortality. Enrollment is ongoing, with new data expected to be presented at upcoming scientific congresses. Additional details can be found on www.ClinicalTrials.gov.

RMAT designation is a specialized FDA program created to accelerate the development and review of promising new therapies, including cell therapies, intended to treat serious or life-threatening conditions. To qualify, a therapy must demonstrate preliminary clinical evidence suggesting the potential to address unmet medical needs. This designation provides important opportunities during the drug development process, including increased FDA guidance and eligibility for priority and rolling reviews, as well as accelerated approval pathways. By streamlining these regulatory milestones, the program aims to bring transformative innovations to patients more quickly.

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, APR 28, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-u-s-fda-regenerative-medicine-advanced-therapy-rmat-designation-granted-to-orca-q-for-the-treatment-of-high-risk-hematologic-malignancies [SID1234664861])

OPKO Health Reports First Quarter 2026 Business Highlights and Financial Results

On April 28, 2026 OPKO Health, Inc. (NASDAQ: OPK) (OPKO) reported business highlights and financial results for the three months ended March 31, 2026.

Highlights from the first quarter of 2026 and recent weeks included the following:

Initiated and completed first dose cohort of MDX2301 Phase 1 clinical trial for the prevention of COVID-19. MDX2301 is a tetravalent bispecific antibody that neutralizes all known variants of SARS-CoV-2 and also has the potential to delay resistance by emerging variants. The Phase 1 clinical trial (NCT07445971) is evaluating the safety, pharmacokinetics and tolerability of MDX2301 administered via different routes in healthy volunteers and in immune impaired adults at high risk for severe COVID-19. By combining multiple antibody binding domains in a single molecule, MDX2301 is designed to provide high potency and greater breadth compared with conventional monoclonal antibodies. This trial is being funded by the Biomedical Advanced Research and Development Authority (BARDA).

Initiated MDX2003 Phase 1 clinical trial in relapsed or refractory B-cell lymphoma. MDX2003 (CD19xCD20xCD3xCD28) is a novel tetraspecific T-cell engager-expander designed to optimize sustained T-cell function and address the two most common and validated targets in lymphomas and leukemias. The MDX2003 Phase 1 study (NCT07249905) is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MDX2003 in adults with various types of B-cell lymphoma. The study includes dose-escalation and dose-expansion phases. B-cell lymphoma, a form of non-Hodgkin lymphoma arising from B lymphocytes, represents the most common lymphoma subtype, accounting for approximately 85% of cases.

ModeX to present data on multispecific antibody targeted in vivo CAR T cell programs at the American Society of Gene + Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting with plans to enter Phase 1 studies later this year. Built on its multispecific technology, ModeX recently developed an in vivo CAR-T and gene delivery platform that it believes is highly differentiated compared with ex vivo and other in vivo CAR-T approaches. Using antibody-targeted lipid nanoparticles, this platform can deliver genes encoding chimeric antigen receptors (CARs) directly to specific immune cell subsets that generate functional CAR-T cells in vivo.

Presented two posters highlighting MDX2003 and MDX2004 at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2026. In March, an abstract titled "MDX2003, a First-in-Class CD19xCD20xCD3xCD28 Tetraspecific T-Cell Engager with Potent Preclinical Activity against B Cell Malignancies and Promise in Autoimmunity" was presented at the European Society for Medical Oncology’s (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2026 in Paris. An abstract titled "A phase 1/2a, multicenter, first-in-human, open-label clinical trial evaluating monotherapy with MDX2004, a trispecific antibody-fusion protein in patients with advanced tumors" was also presented at the Congress.

Expanded partnership with Entera Bio to advance first-in-class oral long-acting PTH tablet for patients with hypoparathyroidism. This third program under the collaboration combines OPKO’s proprietary long-acting PTH variants with Entera’s proprietary N-Tab technology. Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2026. OPKO and Entera Bio each hold a 50% ownership interest in the long-acting PTH hypoparathyroidism program and each is responsible for 50% of the program’s development costs.

First Quarter Financial Results

Consolidated: Consolidated total revenues for the first quarter of 2026 were $124.2 million compared with $149.9 million for the 2025 period, with the decrease principally resulting from the sale of certain BioReference assets in 2025. Operating loss for the first quarter of 2026 improved to $51.0 million compared with operating loss of $67.2 million for the 2025 quarter. Net loss for the first quarter of 2026 was $54.8 million, or $0.07 per share, compared with net loss of $67.6 million, or $0.10 per share, for the 2025 quarter. The prior year results included a $3.9 million realized gain from the sale of shares of GeneDx Holdings Corp.

Pharmaceuticals: Revenue from products in the first quarter of 2026 was $38.0 million compared with $34.8 million in the first quarter of 2025, driven by higher sales volumes from OPKO’s Spanish operations and by a positive net foreign exchange impact of $2.4 million. Revenue from Rayaldee remained consistent at $6.3 million in the first quarter of both 2026 and 2025. Revenue from the transfer of intellectual property and other rose to $14.0 million, up from $12.3 million in 2025. This was highlighted by an increase in gross profit share payments for NGENLA, which totaled $6.4 million compared with $4.5 million in the 2025 quarter. The increase was partially offset by a decrease in revenue recognized under the BARDA contract, which totaled $4.1 million in the first quarter of 2026 compared with $7.0 million for the same period in 2025. Total costs and expenses were $81.7 million in the first quarter of 2026 compared with $81.9 million in the prior-year period. Operating loss narrowed by 15% to $29.7 million in the first quarter of 2026, which included $18.3 million in depreciation and amortization expense, compared with operating loss of $34.8 million in the first quarter of 2025, which included $17.8 million of depreciation and amortization expense.

Diagnostics: Revenue from services in the first quarter of 2026 was $72.2 million compared with $102.8 million in the prior-year period, which included $25.9 million of revenue related to the oncology assets sold to Labcorp in September 2025. The remaining decrease was principally a result of lower clinical test reimbursement rates as a result of exiting certain higher priced, but lower or negative gross margin test offerings, as well as a slight decrease in overall testing volumes. Total costs and expenses were $85.1 million in the first quarter of 2026 compared with $126.8 million in the first quarter of 2025, which included $31.3 million of costs and expenses related to oncology assets that were sold to Labcorp. Operating loss narrowed by more than 45% to $13.0 million in the first quarter of 2026, which included $3.9 million of depreciation and amortization expense, compared with operating loss of $23.9 million in the 2025 period, which included $5.7 million of depreciation and amortization expense.

Cash, cash equivalents, marketable securities and restricted cash: Cash, cash equivalents, marketable securities and restricted cash were $341.9 million as of March 31, 2026. As of March 31, 2026, approximately $92.0 million of OPKO’s common stock had been repurchased under the program since its authorization in July 2025, including $4.8 million in the first quarter of 2026. Approximately $108.0 million remained authorized and available for future repurchases.

Financial Guidance

The table below contains financial guidance for the 2026 second quarter and the unchanged full year financial guidance (in millions):

For the three months ended
June 30, 2026 For the year ended
December 31, 2026
Low High Low High
Revenue:
Services revenue $ 72 $ 76 $ 300 $ 312
Product revenue 38 42 160 170
IP and other revenue 15 19 70 80
Total revenue 127 132 530 560

Included in revenue
Pfizer gross profit share 6 8 34 37
BARDA 5 7 18 22

Total costs and expenses 180 190 725 750
R&D included in costs and expenses 32 38 125 135

Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss first quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until March 5, 2026, by dialing 855-669-9658 (U.S.) or 412-317-0088 (International) and providing the passcode 2140261. A webcast replay will be available beginning approximately one hour after the completion of the live conference call.

(Press release, Opko Health, APR 28, 2026, View Source [SID1234664860])

Incyte Reports First Quarter 2026 Financial Results and Provides Business Updates

On April 28, 2026 Incyte (Nasdaq:INCY) reported financial results for the first quarter of 2026 and provided a business update.

"Our first quarter represented a strong start to 2026, driven by 20% year-over-year net sales growth and strong commercial execution," said Bill Meury, Chief Executive Officer, Incyte. "At the same time, we are making significant progress toward building a more durable, growth oriented portfolio with four anticipated product approvals and launches over the next 12 months, positive registrational data for povorcitinib in vitiligo and a late stage pipeline that now includes 10 Phase 3 studies underway, including the initiation of a pivotal trial of our G12D inhibitor in first line pancreatic ductal adenocarcinoma."

First Quarter 2026 Results
•Total revenue: Total revenue was $1.27 billion, an increase of 21% compared to the first quarter of 2025, primarily driven by an increase in total net sales.
•Total net sales: Total net sales for the first quarter of 2026 were $1.10 billion, an increase of 20% compared to the first quarter of 2025. The increase was primarily related to demand for Jakafi (ruxolitinib) across all indications, Opzelura (ruxolitinib) cream in atopic dermatitis (AD) and vitiligo, Niktimvo (axatilimab-csfr) in chronic graft versus host disease (GVHD), Monjuvi (tafasitamab-cxix) in follicular lymphoma (FL) and Zynyz (retifanlimab-dlwr) in squamous cell carcinoma of the anal canal (SCAC).
•Cost of sales: GAAP and non-GAAP cost of sales were $104.5 million and $98.3 million, an increase of 43% and 47%, respectively, compared to the prior year period.
•Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were $515.9 million and $476.7 million, an increase of 18% and 19%, respectively, compared to the prior year period.
•Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were $328.1 million and $304.1 million, an increase of 1% for both, respectively, compared to the prior year period.
•Cash, cash equivalents and marketable securities position: As of March 31, 2026 and December 31, 2025, cash, cash equivalents and marketable securities totaled $4.0 billion and $3.6 billion, respectively.

Key Business Updates
Hematology

Monjuvi/Minjuvi (tafasitamab)
•Data from the pivotal Phase 3 frontMIND trial evaluating tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) for the treatment of patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
◦Abstract Title: frontMIND: Phase 3 study of tafasitamab (Tafa) plus lenalidomide (Len) and R-CHOP for patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
◦Abstract Number: 7000
◦Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
◦Date and Time: May 30, 2026, 3:00-6:00 p.m. CDT

Niktimvo
•Data from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are anticipated in the second half of 2026.

INCA033989 (mutCALR)
•The Company is on track to initiate a Phase 3 registrational study evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) who are resistant or intolerant to at least one prior cytoreductive therapy in mid-2026 following a successful end-of-phase meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026.
•Updated data from the ongoing Phase 1 trial in second-line ET and myelofibrosis (MF) patients are anticipated in mid-2026. Data from the cohort evaluating INCA033989 and INCA033989 in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026.
•A Phase 1 study evaluating the pharmacokinetics, safety and tolerability of INCA033989 as a subcutaneous (SC) administration in healthy adult participants was initiated and completed. The Company plans to initiate a Phase 1 study evaluating INCA033989 as a SC administration in mutCALR positive patients mid-year 2026.

INCB160058 (JAK2V617F)
•In the first quarter of 2026, the Company initiated dosing of the amorphous solid dispersion (ASD) formulation of INCB160058 in the Phase 1 trial. Data from the Phase 1 trial evaluating INCB160058 in patients with myeloproliferative neoplasms (MPNs) with a JAK2V617F mutation are anticipated in the second half of 2026.

Jakafi XR (ruxolitinib)
•The Company expects a regulatory decision in the U.S. and potential commercial launch in mid-2026.
Oncology
Zynyz
•In March, the Company announced that the European Commission (EC) approved Zynyz in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent SCAC. This marks the second indication in Europe for Zynyz, which was previously approved by the EC for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

INCB161734 (KRASG12D)
•The Company initiated a Phase 3 study (DAWN-303) evaluating INCB161734 as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in combination with standard-of-care chemotherapy (mFOLFIRINOX or GEMNabP) versus chemotherapy alone in the first quarter of 2026.
•Additional data from the ongoing Phase 1 trial evaluating INCB161734 in combination with standard-of-care chemotherapy as a first-line treatment in patients with metastatic PDAC are anticipated in the second half of 2026.

INCA33890 (TGFβR2xPD-1)
•The Phase 3 study evaluating INCA33890 in combination with standard-of-care chemotherapy and bevacizumab as a first-line treatment in patients with microsatellite stable colorectal cancer (MSS CRC) is ongoing.
•Additional data from the ongoing Phase 1 study evaluating INCA33890 in combination with bevacizumab and/or chemotherapy in patients with solid tumors is expected in the second half of 2026.
Inflammation and Autoimmunity (IAI)
Opzelura
▪The Company expects a regulatory decision in the second half of 2026 following the submission of a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the EU.
▪Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026.
Povorcitinib
▪Today the Company announced positive results from the Phase 3 program evaluating povorcitinib (30mg) in adult patients with nonsegmental vitiligo. In both Phase 3 studies (STOP-V1 and STOP-V2), povorcitinib achieved the primary endpoint of >75% reduction in Facial Vitiligo Area Scoring Index (F-VASI75) from baseline at Week 52.
•In STOP-V1, 18.9% of povorcitinib-treated patients achieved a >75% reduction in F-VASI75 compared to 6.8% of placebo-treated patients at Week 52 (p<0.001). In STOP-V2, 18.9% of povorcitinib-treated patients achieved a >75% reduction in F-VASI75 compared to 3.1% of placebo-treated patients at Week 52 (p<0.001). Across both studies, statistically significant and clinically meaningful differences were also observed in key secondary endpoint measures, including T-VASI50 at Week 52. The overall safety and tolerability profile of povorcitinib through 52 weeks is consistent with prior studies, with no new safety signals observed. We expect to share additional data from the Phase 3 program in the second half of 2026.

•The positive results from the Phase 3 STOP-V1 and STOP-V2 studies will support regulatory applications for povorcitinib in nonsegmental vitiligo planned for the first half of 2027.
▪The New Drug Application (NDA) submission for povorcitinib as a treatment for patients with moderate to severe HS was accepted by the FDA in the first quarter of 2026. The Company anticipates potential approval and launches in late-2026 in the EU and the first quarter of 2027 in the U.S.
▪In March, 54-week data from the Phase 3 clinical studies (STOP-HS1 and STOP-HS2) evaluating povorcitinib in patients with moderate to severe HS were presented during the late-breaking research session at the 2026 American Academy of Dermatology (AAD) Annual Meeting.
•In the studies, treatment with povorcitinib resulted in clinically meaningful and durable efficacy responses through Week 54. Across both STOP HS1 and STOP HS2, up to 71% of patients achieved HiSCR50, with improvements also observed at higher stringency thresholds, including up to 57% achieving HiSCR75 and up to 29% achieving HiSCR100. These responses were accompanied by consistent resolution across all three key types of inflammatory lesions including inflammatory nodules, abscesses and draining tunnels, as well as meaningful improvements in skin pain, fatigue and quality of life. The overall safety profile of povorcitinib through 54 weeks was consistent with previously reported data, and both doses were well tolerated.

▪Data from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026.
▪Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026.

Corporate Updates

▪Today the Company announced the appointment of Suketu (Suky) Upadhyay to Chief Financial Officer, effective May 4, 2026. Mr. Upadhyay most recently served as Executive Vice President and Chief Financial Officer of Zimmer Biomet. Prior to joining Zimmer Biomet, Mr. Upadhyay served as Senior Vice President of Global Financial Operations at Bristol Myers Squibb, where he was responsible for strategic and operational initiatives across BMS’s supply chain, commercial operations, R&D and business development.

▪In March, the Company announced the appointments of Pablo J. Cagnoni, M.D. to President, Incyte and Global Head of Research and Development, Steven Stein, M.D. to Executive Vice President, Chief Medical Officer and Head of Late-State Development and Mohamed Issa, Pharm.D. to Executive Vice President and Head of U.S. Commercial.

2026 First Quarter Financial Results
The financial measures presented in this press release for the three months ended March 31, 2026 and 2025 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP

(Press release, Incyte, APR 28, 2026, View Source [SID1234664859])

GILEAD SCIENCES COMPLETES ACQUISITION OF ARCELLX AHEAD OF POTENTIAL COMMERCIAL LAUNCH OF ANITO-CEL

On April 28, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported the successful completion of its previously announced acquisition of Arcellx, Inc. (Nasdaq: ACLX). Under the terms of the transaction, Gilead acquired Arcellx for $115 per share in cash, plus one non-transferable contingent value right (CVR) of $5 per share, representing a total implied equity value of approximately $7.8 billion at the time of closing.

The acquisition builds on Kite, a Gilead Company, and Arcellx’s successful collaboration and provides Gilead with full control of anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for multiple myeloma. By consolidating ownership of anito-cel and eliminating future profit-share, milestone and royalty obligations, Gilead is positioned to accelerate development, streamline decision-making and maximize the long-term potential of the program.

"With the Arcellx acquisition, our focus turns to executing with speed and discipline as we prepare to bring anito-cel to patients," said Cindy Perettie, Executive Vice President and Global Head of Kite. "I want to thank the Arcellx team for their scientific leadership, close collaboration to date and deep expertise they bring as we advance anito-cel. With this acquisition, anito-cel and the differentiated D-Domain BCMA binder will advance within Kite, combining this science with our global manufacturing, regulatory and commercial capabilities to unlock the full value of this potentially transformative therapy for people living with multiple myeloma."

On April 28, 2026, Gilead successfully completed its tender offer for all outstanding shares of common stock of Arcellx and accepted for payment all shares validly tendered and not validly withdrawn as of the expiration time of the tender offer, which shares represented, together with shares already owned by Gilead, approximately 77.2% of Arcellx’s outstanding shares. Following completion of the offer, Gilead completed the acquisition of Arcellx through a merger of Gilead’s wholly owned subsidiary with and into Arcellx, in which shares of Arcellx common stock were cancelled and converted into the right to receive the same $115 per share in cash and one CVR of $5 per share as shares tendered in the offer.

The CVR is payable upon achievement of cumulative global net sales of anito-cel of at least $6.0 billion from launch through the end of 2029.

As a result of the completion of the merger, Arcellx has become a wholly owned subsidiary of Gilead and the common stock of Arcellx will be delisted from the Nasdaq Global Select Market.

This transaction is expected to be accounted for as an asset acquisition and reduce Gilead’s GAAP and non-GAAP 2026 diluted EPS by approximately $5.57 – $5.67. Excluding the impact of acquired in-process research and development expenses, Gilead expects the transaction to be modestly dilutive to earnings per share in 2026 and 2027, and accretive in 2028 and thereafter, subject to FDA approval of anito-cel.

About Anito-cel

Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes a novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

(Press release, Gilead Sciences, APR 28, 2026, View Source [SID1234664856])

Genprex Collaborators to Present Positive Preclinical Data on Diabetes Gene Therapy for Type 2 Diabetes at the 2026 American Society of Gene and Cell Therapy Annual Meeting

On April 28, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators will present positive preclinical data on the Company’s diabetes gene therapy drug candidate at the upcoming 2026 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place May 11-15, 2026 in Boston, Mass. The collaborators will present preclinical data demonstrating that the diabetes gene therapy (Pdx1/MafA gene therapy, PM or GPX-002) can reverse hyperglycemia in Type 2 diabetic (T2D) mouse models.

"Our collaborators’ preclinical data to be presented at ASGCT (Free ASGCT Whitepaper) 2026 demonstrate the ability of our diabetes gene therapy to reverse hyperglycemia in T2D models, representing a significant advancement toward a novel therapeutic paradigm for T2D patients," said Ryan Confer, President and Chief Executive Officer at Genprex. "The compelling evidence from the preclinical studies, which achieved complete rescue of HFD-induced hyperglycemia at four weeks post-treatment via direct intrapancreatic infusion, suggests the technical translatability of our diabetes gene therapy approach to human application, potentially through endoscopic retrograde cholangiopancreatography, offering a potentially promising avenue for long-term glycemic control in T2D."

The featured Genprex-supported abstract and poster at the 2026 ASGCT (Free ASGCT Whitepaper) Annual Meeting:

Title: "Pancreatic Delivery of AAV-Pdx1/MafA Reverses Hyperglycemia in a Preclinical Model of Type 2 Diabetes"
Abstract ID: 2419
Topic: Gene-Based Therapies in Pre-Clinical Models of Genetic Disease
Poster Presentation Date: Wednesday, May 13, 2026
Poster Presentation Time: 5-6:30 p.m. ET

In this study, eight-week-old male C57BL/6 mice were maintained on a regular diet (RD) or high fat diet (HFD) for 24 weeks. HFD mice then either remained unoperated or underwent intrapancreatic infusion of adeno-associated virus (AAV-8) encoding Pdx1 and MafA (PM) cassettes under the CMV promoter (global–islet cell targeting) or the rat insulin promoter (RIP) (β-cell–specific targeting) or received a control virus. The diet remained unchanged after surgery. At two and/or four weeks after surgery, researchers performed intraperitoneal glucose tolerance testing (IPGTT), insulin tolerance testing (ITT), glucose-stimulated insulin secretion (GSIS), calculated HOMA-IR and assessed glucagon secretion. Mice were then euthanized for pancreatic histology, quantification of β- and α-cell mass, electron microscopy (EM), and islets were isolated for ex-vivo glucose-stimulated insulin secretion (GSIS) and single-cell RNA sequencing. The results at four weeks showed major improvements in the control of diabetes.

At four weeks after surgery, ex-vivo GSIS showed that islets isolated from HFD+CMV-PM-GFP treated mice had insulin secretion similar to islets from RD mice, and both groups had increased insulin secretion compared to islets from the control HFD groups, indicating improved β-cell function with PM treatment.

Similarly, and importantly, treatment of HFD mice with RIP-PM-GFP, which selectively targets β-cells, reversed hyperglycemia and improved ex-vivo GSIS. In addition, EM imaging showed that PM treatment in HFD mice increased the number of total and mature insulin granules and decreased the number of immature insulin granules compared with HFD controls. Furthermore, transcriptomic pseudotime analysis demonstrated a shift in β-cells from an immature state toward a more mature state after PM treatment.

PM gene therapy reverses hyperglycemia, likely in large part by specifically enhancing β-cell function and maturation. This approach is technically translatable to humans using endoscopic retrograde cholangiopancreatography to deliver PM gene therapy to the pancreas.

(Press release, Genprex, APR 28, 2026, View Source [SID1234664855])