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 Dren Bio, a privately held, clinical-stage biotechnology company developing first-in-class myeloid cell engager therapeutics, reported that it has entered into a strategic collaboration with Sanofi (NASDAQ: SNY) for the discovery and development of a next-generation B-cell depleting therapy for the treatment of various autoimmune diseases.

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The new agreement builds on the existing relationship between the two companies, following Sanofi’s acquisition earlier this year of Dren Bio’s DR-0201 program for deep B-cell depletion. DR-0201, now known as SAR448501, is currently being evaluated in two ongoing phase 1 studies and has shown robust B-cell depletion, with the potential to induce sustained treatment-free remission in patients with autoimmune diseases.

"Our newly expanded strategic alliance with Dren Bio reflects Sanofi’s deep commitment to developing best-in-class therapies with the potential to achieve remission in patients with immune-mediated diseases," said Alyssa Johnsen, Global Therapeutic Head, Immunology and Oncology Development at Sanofi. "By combining Dren Bio’s unique scientific approach with Sanofi’s development expertise, we aim to accelerate the development of innovative therapies for patients in need."

Amit Mehta, Ph.D., Chief Operating Officer and Chief Business Officer of Dren Bio, added, "Sanofi has been a valued partner in unlocking the full potential of deep B-cell depletion through the acquisition of DR-0201, and we’re thrilled to expand our collaboration by further leveraging the capabilities of our Targeted Myeloid Engager and Phagocytosis platform. The U.S. profit/loss share option allows us to partner with a global commercial leader and represents an important milestone in our growth into a fully integrated biopharmaceutical company."

Under the terms of the agreement, Dren Bio will receive an upfront payment of $100 million and is eligible to receive up to $1.7 billion in development, regulatory, and commercial milestone payments. The companies will collaborate on discovery and preclinical development activities leveraging Dren Bio’s proprietary platform. Following development candidate selection, Sanofi will assume subsequent responsibility for development, manufacturing, regulatory, and commercialization efforts. Dren Bio has the option to enter into a U.S. profit/loss sharing arrangement with Sanofi. If exercised, Dren Bio will co-fund 40% of ongoing global development costs in exchange for U.S. co-promotion rights and a 50/50 share of U.S. profits and losses. Dren Bio will also remain eligible to receive milestones and tiered royalties on net sales outside the United States.

(Press release, Dren Bio, DEC 15, 2025, View Source [SID1234661447])

On December 15, 2025 Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, reported that Jake Becraft, PhD, Co-founder and Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 10:30 AM PT.

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"2025 was a transformative year as we moved programmable mRNA from promise to proof, delivering clinical results that have the potential to redefine what’s possible in oncology," said Dr. Becraft. "Strand is programming conditional therapeutic protein expression into the mRNA itself, enabling it to sense its environment and activate selectively within the target. We’re entering 2026 with clinical momentum and a platform that positions us at the forefront of the next generation of genetic medicine."

In 2025, Strand achieved multiple expansive milestones and validation with significant progress across clinical development, pipeline expansion, and corporate growth:

Clinical validation: Presented first-in-human Phase 1 data for STX-001 at the ASCO (Free ASCO Whitepaper) Annual Meeting, demonstrating response rates in late-stage cancer patients who had exhausted other treatment options
Capital to scale: Closed a $153 million Series B financing led by Kinnevik with participation from Regeneron Ventures, ICONIQ, Amgen Ventures, Eli Lilly, and other leading pharma investors
Pipeline acceleration: Unveiled preclinical data for STX-003 at the AACR (Free AACR Whitepaper) Annual Meeting, advanced ongoing solid tumor trials, progressed multiple programs to support 2026 clinical entry for STX-003, and expanded into in vivo CAR-T therapy
Board and leadership expansion: Appointed Jeb Keiper to Strand’s Board of Directors; Jason J. Luke, MD, FACP, as Chief Medical Officer; Prashant Nambiar, DVM, PhD, MBA, as Chief Scientific Officer; and Ethan Cash as Senior Vice President of Portfolio Management and Program Development

(Press release, Strand Therapeutics, DEC 15, 2025, View Source [SID1234661448])

On December 15, 2025 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported key accomplishments from 2025 and provided an overview of strategic priorities and anticipated milestones for 2026. The Company also announced its attendance at the 44th Annual J.P. Morgan Healthcare Conference, with a presentation scheduled for Thursday, January 15 at 10:30 a.m. PT (1:30 p.m. ET).

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"PharmaEssentia delivered a year of substantial progress in 2025, driven by the strong performance of BESREMi and preparation for continued growth supported by exceptional commercial execution and important pending product milestones," said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. "BESREMi has become a key growth engine for our company with the potential to transform treatment across multiple patient populations living with serious myeloproliferative neoplasms (MPNs). In 2025, we saw strong performance in polycythemia vera (PV) and are well positioned for further acceleration. With our injection pen submitted to the FDA and a supplemental BLA under review for the essential thrombocythemia (ET) indication, we are preparing for meaningful opportunities to expand adoption and patient reach. Alongside these anticipated 2026 catalysts, we continue to advance our pipeline, including the ongoing Phase 3 study evaluating BESREMi in pre-fibrotic/early primary myelofibrosis (Early PMF), and preparing to move additional earlier-stage programs into the clinic."

2025 Major Accomplishments

Commercial Performance of BESREMi

Delivered strong commercial growth of BESREMi in PV, with substantial year-over-year revenue growth (Q3 2025 revenue of $127.8 million, representing 44% YoY growth)
Strengthened commercial and medical affairs readiness for anticipated 2026 product launches
Regulatory & Clinical Progress

Submitted the BESREMi injection pen presentation to the FDA for review
Submitted supplemental BLA seeking BESREMi label expansion for ET based on positive head-to-head Phase 3 results
Continued global enrollment in the Phase 3 trial in Early PMF
Earlier Stage Program Progress

Advanced six high value programs to the IND-enabling stage:
PEG-IL-2 and P11838 for immunology and inflammation indications
PD-1–IL-2 immunocytokine for solid tumors
Dual-targeting LILRB1/2 monoclonal antibody for solid tumors
Novel ADC candidate for solid tumors
KRAS and NY-ESO TCR-T cell therapies for solid tumors
2026 Anticipated Milestones

BESREMi

U.S. launch of BESREMi Pen expected (H1 2026)
Potential FDA approval and commercial launch of ET indication (H2 2026)
Completion of enrollment in the global Early PMF Phase 3 clinical trial (H1 2026)
Pipeline & Portfolio Growth

File IND submissions for multiple earlier-stage pipeline programs
Share initial clinical results from multiple earlier-stage programs

(Press release, PharmaEssentia, DEC 15, 2025, View Source [SID1234661449])

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])