On December 15, 2025 XOMA Royalty Corporation ("XOMA Royalty") (NASDAQ: XOMA), the biotech royalty aggregator, reported it has entered into an agreement to acquire Generation Bio Co. ("Generation Bio") (NASDAQ: GBIO) for a cash price of $4.2913 per share at the closing of the merger. Generation Bio stockholders also will receive one non-transferable contingent value right ("CVR") per share that entitles holders to receive potential payments of a pro rata portion of:

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100% of the amount by which net cash at closing, as finally determined pursuant to the CVR agreement, exceeds $29 million;
either 90% or 100% of any savings realized by XOMA Royalty on the Company’s Cambridge office lease obligations, subject to the timing of resolution of the lease obligations;
a share of any proceeds from Generation Bio’s existing license agreement with Moderna, which includes potential development and commercial milestones and royalties on commercial sales, calculated on a sliding scale delivering up to 90% of such payments to CVR holders; and
a share of payments from any out license or sale of the Generation Bio ctLNP delivery platform, calculated on a sliding scale delivering up to 70% of such payments to CVR holders
following the closing.

Following a thorough review process conducted with the assistance of its legal and financial advisors, Generation Bio’s board of directors has determined that the acquisition by XOMA Royalty is in the best interests of all Generation Bio stockholders and has unanimously approved the Merger Agreement.

Terms
Pursuant and subject to the terms of the Merger Agreement, a wholly owned subsidiary of XOMA Royalty will commence a tender offer (the "Offer") within 15 business days, to acquire all outstanding shares of Generation Bio common stock. Closing of the Offer is subject to certain conditions, including the tender of Generation Bio common stock representing at least a majority of the total number of outstanding shares and other customary closing conditions. Immediately following the closing of the tender offer, Generation Bio will merge with a subsidiary of XOMA Royalty, and all remaining shares not tendered in the offer, other than appraisal shares, will be converted into the right to receive the same cash and CVR consideration per share as is provided in the tender offer.

Generation Bio stockholders in possession of approximately 15% of Generation Bio common stock have signed support agreements under which such stockholders agreed to tender their shares in the Offer and support the merger. The acquisition is expected to close in February 2026.

Advisors
XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP. TD Cowen served as financial advisor, and Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel, to Generation Bio.

(Press release, Xoma, DEC 15, 2025, View Source [SID1234661433])

On December 15, 2025 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported positive in vivo results, indicating that opaganib combined with venetoclax reduces Chronic Lymphocytic Leukemia (CLL) cells by half compared to controls, and further demonstrates opaganib’s potential as an add-on therapy to venetoclax in venetoclax-resistant CLL.

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"Understanding mechanisms of resistance to targeted therapies such as the BCL-2 inhibitor venetoclax is essential to improve current treatment strategies and may provide key insights to personalize treatment for chronic lymphocytic leukemia (CLL) patients" said Romina Gamberale, PhD, Independent Researcher at CONICET from the Institute of Experimental Medicine (IMEX, CONICET-National Academy of Medicine) in Buenos Aires, Argentina, who led the study. "Our previous ex vivo work has shown that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant CLL cells and that inhibiting SPHK2 may reduce T-cell-induced resistance and resensitize previously resistant cells. The results of this in vivo study in mice indicate that adding opaganib, a potent SPHK2 inhibitor, to venetoclax reduced CLL cell counts by 50% compared to controls, showing that opaganib may have a significant role to play in mitigating BCL-2 inhibitor resistance."

Dr. Mark Levitt, Chief Scientific Officer at RedHill said: "Venetoclax is a key CLL therapy and finding ways to maintain its effectiveness, and to reduce the potential for resistance-related treatment failure, could represent a breakthrough in the ability to treat CLL patients. This promising data supports the hypothesis that opaganib, as a potent inhibitor of SPHK2, provides a potential route to maintaining venetoclax effects in treating CLL. Opaganib has shown potential as add-on therapy in several preclinical oncology models and is currently undergoing a Phase 2 clinical trial in combination with darolutamide in advanced prostate cancer. This new data now adds CLL to the list of potential cancer indications where opaganib has shown potential to bring additive therapeutic value."

Opaganib has a safety and tolerability profile shown in more than 470 clinical trials / expanded access participants. It targets multiple oncology, virology, inflammation, medical countermeasures, diabetes and obesity indications, with several U.S. government partnerships, including BARDA funding, in place.

Approved by the FDA in 2016, venetoclax (Venclexta and Venclyxto, Abbvie / Genentech), is a first-in-class BCL-2 inhibitor that has become a mainstay of CLL therapy, achieving sales of approximately $2.5 billion in 2024. Venetoclax works by blocking a protein called BCL-2, which is often overproduced in certain cancer cells and prevents the process of apoptosis (programmed cell death) – helping to keep the cancer cells alive and growing. By binding to, and inhibiting, the BCL-2 protein, venetoclax enables the cancer cells to undergo apoptosis and die.

About Chronic Lymphocytic Leukemia (CLL)

CLL is a slow-growing blood and bone marrow cancer that affects a type of white blood cell called lymphocytes. It is the most common type of leukemia in adults and has a highly variable clinical course. It is generally not considered to be curable.

About Opaganib (ABC294640)

Opaganib is a first-in-class, proprietary investigational host-directed and potentially broad-acting orally administered drug with anticancer, anti-inflammatory and antiviral activity. Opaganib is targeted at multiple potential oncology, radioprotection, viral, inflammatory, and gastrointestinal indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, Ebola and other viruses as part of pandemic preparedness. Opaganib has also shown positive preclinical results in renal fibrosis.

Opaganib has received orphan-drug designations from the FDA in cholangiocarcinoma and neuroblastoma. It is currently undergoing a Phase 2 clinical trial in combination with darolutamide in advanced prostate cancer and has previously undergone studies in advanced cholangiocarcinoma (Phase 2a). Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Several U.S. government medical countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications, including GI-ARS, Ebola virus disease and others. Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. government Department of Health & Human Services’ National Institutes of Health, and the Administration for Strategic Preparedness and Response’s (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA).

Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.

Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms.

(Press release, RedHill Biopharma, DEC 15, 2025, View Source [SID1234661428])

On December 15, 2025 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported the publication of the Precision-T Phase 3 study results of its lead investigational allogeneic T-cell immunotherapy, Orca-T, in Blood, a journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The study compared Orca-T to a conventional allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). These results were first presented on April 2, 2025, at the 51st Annual Meeting of The EBMT in Florence, Italy, and further analyses were presented at the 67th ASH (Free ASH Whitepaper) Annual Meeting on December 6, 2025.

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In the randomized Precision-T study, Orca-T plus single-agent tacrolimus (TAC) demonstrated a significant improvement in the primary endpoint of survival free from moderate-to-severe chronic graft versus host disease (cGFS) compared to alloHSCT plus tacrolimus/methotrexate (TAC/MTX). The rate for patients who received Orca-T was 78% (95% CI: 65%, 87%) compared to 38.4% (95% CI: 26%, 51%) for patients who received an alloHSCT (HR 0.26; p<0.00001), an improvement driven by a reduction in moderate-to-severe chronic graft versus host disease (cGvHD) and fewer patient deaths.

"Today, treating patients with serious blood cancers using conventional allogeneic stem cell transplants often forces a difficult risk–benefit trade-off, as clinicians work to cure the disease while avoiding life-threatening complications like GvHD," said lead author Everett Meyer, M.D., Ph.D., hematologist and associate professor of medicine in Blood and Marrow Transplantation and Cellular Therapy at Stanford Medicine. "The Precision-T results showed that Orca-T can meaningfully shift that balance, delivering improved GvHD-free survival alongside less toxicity, including fewer serious infections and lower non-relapse mortality. Orca-T has the potential to become an important new therapy for patients and a valuable new option for the providers who care for them."

In the study, all patients (n=187) with a median age of 43.6 years (range 19-65 years) were randomized 1:1 to Orca-T plus TAC or alloHSCT plus TAC/MTX. Patients across both groups received myeloablative conditioning and used a related or unrelated matched donor. Patients had a median follow-up time of 11.4 months (range 0.2-24.3 months) across both arms. Additional results from the Precision-T study at one year include:

A secondary endpoint of cumulative incidence of moderate-to-severe cGvHD was 12.6% (95% CI: 5%, 23%) and 44.0% (95% CI: 31%, 56%) in the Orca-T and alloHSCT arms, respectively (HR 0.19; p<0.00002).
The overall survival (OS), another secondary endpoint, was 93.7% (95% CI: 86%, 97%) in the Orca-T arm and 83.2% (95% CI: 73%, 90%) in the alloHSCT arm (HR 0.49; p=0.11823).
A secondary endpoint of GvHD and relapse-free survival (GRFS) was 63.1% and 30.9% with Orca-T and alloHSCT (p<0.001 in a post hoc analysis), respectively.
The cumulative incidence of non-relapse mortality (NRM) was 3.4% (95% CI: 0.9%, 8.8%) for Orca-T versus 13.2% (95% CI: 6.8%, 21.6%) for alloHSCT (HR 0.27 [95% CI: 0.08, 0.93]; p=0.03 in a post hoc analysis).

Additional safety findings were consistent with previous studies. The cumulative incidence for grade III or IV acute GvHD at day +180 was reduced with Orca-T with 6.2% (95% CI: 2.3, 12.9) versus 16.5% (95% CI: 9.4, 25.3) with alloHSCT (HR 0.37 [95% CI: 0.13, 1.02]; p=0.044 in a post hoc analysis). Grade 3+ infections were less common with Orca-T, with a one-year estimated incidence of 8.4% (95% CI: 3.6%, 16%) for Orca-T and 16.1% (95% CI: 9.2%, 25%) for alloHSCT.

An exploratory endpoint evaluated health-related quality of life (HRQoL) and hospitalization patterns and found Orca-T delivered marked improvements over conventional alloHSCT. In the data presented at ASH (Free ASH Whitepaper) 2025, patients receiving Orca-T experienced faster recovery to, and higher improvement above, baseline HRQoL, fewer ICU stays, lower likelihood of rehospitalization and higher rehospitalization-free survival, suggesting better early post-treatment recovery and a lower burden of GvHD symptoms.

Rehospitalizations due to adverse events occurred less frequently among Orca-T recipients (27.3% [24] vs. 45.7% [43]), with fewer total hospitalization days per patient (30.6 vs. 40.8). Rehospitalization-free survival at 18 months was also significantly improved with Orca-T, reaching 66.4% (95% CI: 54.0, 76.2) compared to 33.8% (95% CI: 18.5, 49.9) for conventional alloHSCT (p=0.0096 in a post hoc analysis; HR 0.53 [0.32, 0.86]).

"As the first Treg-based immunotherapy to show improved outcomes for patients with acute leukemias and myelodysplastic syndrome compared with a conventional transplant, Orca-T has the potential to become a new standard of care," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "The Phase 3 results published in Blood underscore our ability to potentially redefine how blood cancers are treated today. We look forward to continuing to work closely with the FDA on the review of our application with the goal of making Orca-T available to patients who need it."

The safety and efficacy of Orca-T have not been determined by any regulatory authority. Orca-T is currently being evaluated under Priority Review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

About Precision-T
Precision-T (NCT05316701) is a randomized, open-label multi-center study that evaluated the safety, efficacy and tolerability of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT). Orca Bio received guidance from the U.S. Food and Drug Administration on the design of Precision-T, which evaluated Orca-T in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). There are 19 leading treatment centers participating in the trial, which enrolled 187 patients across the U.S.

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.

(Press release, Orca Bio, DEC 15, 2025, https://orcabio.com/orca-bio-announces-positive-results-from-the-pivotal-phase-3-study-of-investigational-orca-t-compared-to-allogeneic-stem-cell-transplant-for-the-treatment-of-hematologic-malignancies-2/?utm_source=rss&utm_medium=rss&utm_campaign=orca-bio-announces-positive-results-from-the-pivotal-phase-3-study-of-investigational-orca-t-compared-to-allogeneic-stem-cell-transplant-for-the-treatment-of-hematologic-malignancies-2 [SID1234661426])

(Press release, Orca Bio, DEC 15, 2025, https://orcabio.com/orca-bio-announces-positive-results-from-the-pivotal-phase-3-study-of-investigational-orca-t-compared-to-allogeneic-stem-cell-transplant-for-the-treatment-of-hematologic-malignancies-2/?utm_source=rss&utm_medium=rss&utm_campaign=orca-bio-announces-positive-results-from-the-pivotal-phase-3-study-of-investigational-orca-t-compared-to-allogeneic-stem-cell-transplant-for-the-treatment-of-hematologic-malignancies-2 [SID1234661426])

On December 15, 2025 Link Cell Therapies ("Link"), an oncology cell therapy company, reported its official launch from stealth with a $60 million Series A financing that was led by Johnson & Johnson, through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc. , with participation from founding investors Samsara BioCapital and Sheatree Capital, as well as Wing Venture Capital and other new strategic and financial investors.

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Link’s proprietary logic-gating technologies allow for safe targeting of multiple antigens that are co-expressed on cancer cells but do not overlap or only minimally overlap in their normal healthy tissue expression. This platform enables the creation of next-generation CAR-T therapeutics for solid and liquid cancers built upon an entirely new landscape of "clean" target pairs.

"We recognized that for most cancer types, particularly solid tumors, the promise of CAR-T therapies is limited by a dearth of cancer-specific targets and abundant expression of most solid tumor targets in normal vital tissue," said Co-Founder Robbie Majzner, MD of the Dana-Farber Cancer Institute and Harvard Medical School. "Link is advancing a technology that we developed while at Stanford University that allows for logic-gated CAR-T cell control. The Link-based CAR activates and kills target cells only when a combination of antigens is co-localized on the tumor, thereby bypassing normal tissues that express only one of those targets. We believe this approach will enable potent CAR-T therapies to attack a wide range of tumors while sparing healthy tissue."

The Series A financing, which follows a 2022 Seed Round led by Samsara and Sheatree, adds a number of strong financial and strategic investors to the syndicate, including JJDC, Inc, Bristol Myers Squibb, Kyowa Kirin, Wing Venture Capital, and Sherpa Healthcare Partners.

"It has been a pleasure to support Link Cell Therapies since its founding," said Abraham Bassan, Member of the Link Board of Directors and Partner at Samsara BioCapital. "The team at Link has advanced a unique technology that could enable the development of multiple, impactful treatments for patients with cancer. I have been impressed with the team’s achievements and the progress on Link’s lead program and pipeline."

Link’s Progress and Development Status

Link’s lead program, LNK001 for the treatment of renal cell carcinoma ("RCC"), is on track for an Investigational New Drug (IND) application and initiation of dosing in a Phase I clinical trial in 2026. LNK001 targets two antigens that are uniquely and highly co-expressed in most RCC tumors. LNK001 is designed to enable tumor-specific efficacy while avoiding on-target, off-tumor toxicity that has limited prior experimental therapies targeting each individual antigen.

Link’s second program being developed for colorectal cancer will target Development Candidate selection in 2026 and initiation of human clinical studies in 2027. The company has multiple additional CAR-T programs in earlier development in solid and liquid cancers that will be developed internally or through partnerships.

(Press release, Link Cell Therapies, DEC 15, 2025, View Source [SID1234661425])

On December 15, 2025 Ipsen (Euronext: IPN; ADR: IPSEY) reported it has completed the acquisition of ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies.

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(Press release, Ipsen, DEC 15, 2025, View Source [SID1234661424])