On October 2, 2026 Abogen Biosciences ("Abogen" or the "Group"), a clinical-stage biotechnology group pioneering RNA innovation, reported that it has entered into a licensing and option agreement with Novartis to advance RNA-encoded therapeutics. The agreement includes an exclusive worldwide license to Abogen’s lead asset, ABO2203, as well as options to exclusively license other potential programs leveraging Abogen’s proprietary RNA platform.

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ABO2203 is a novel mRNA-encoded CD19xCD3 T-cell engager with the potential to transform the treatment landscape for patients with autoimmune diseases. The program is designed to reset B cells by utilizing mRNA to direct the endogenous production of T-cell engagers in vivo. This approach offers a highly differentiated mechanism for B-cell depletion, potentially providing distinct advantages over traditional recombinant T-cell engagers.

Under the agreement, Novartis will also have the exclusive option to license a number of next-generation therapeutic assets developed on Abogen’s RNA platform.

"This agreement marks an important milestone for Abogen, underscoring the broad potential of our RNA platform to expand beyond prophylactic vaccines," said Bo Ying, Chief Executive Officer of Abogen. "ABO2203 is the first mRNA-encoded T-cell engager to enter clinical evaluation for autoimmune diseases, reflecting our commitment to delivering differentiated, accessible and scalable therapies for patients with B-cell-mediated disorders. We are thrilled to be able to accelerate ABO2203 and unlock new therapeutic targets through this agreement with Novartis."

"Achieving effective and durable immune reset remains an important goal across a number of autoimmune diseases," said Fiona Marshall, President of Biomedical Research at Novartis. "mRNA-encoded T-cell engagers represent an innovative approach that could complement existing therapeutic modalities by enabling in vivo production of these molecules. We look forward to further developing the potential of ABO2203 and additional possible applications of Abogen’s RNA platform."

Under the terms of the proposed agreement, Abogen will receive an upfront payment of USD 575 million and, if all options on all programs are exercised, Abogen is eligible to receive up to approximately USD 7.2 billion in potential milestone payments, subject to the achievement of agreed development, regulatory and commercial milestones. In addition, Abogen may be eligible to receive potential royalties on future product sales. The transaction is subject to customary closing conditions, including required regulatory clearances.

(Press release, Abogen Biosciences, OCT 2, 2026, View Source [SID1234671225])

On October 2, 2026 AstraZeneca and Daiichi Sankyo reported to have entered into a clinical collaboration agreement with Summit Therapeutics Inc. to evaluate Datroway (datopotamab deruxtecan) in combination with ivonescimab across multiple tumour types including lung and breast cancers. The companies intend to begin with a Phase III trial in 1st-line triple-negative breast cancer (TNBC).

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Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Central to our strategy to transform cancer outcomes is harnessing the power of immunotherapy and antibody drug conjugate combinations to drive deeper, more durable responses. We believe the combination of Datroway and ivonescimab has the potential to make a meaningful difference in multiple tumour types including lung and breast cancers."

Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics, said: "We believe this collaboration with Daiichi Sankyo and AstraZeneca reflects increasing conviction in ivonescimab’s potential as a foundational next-generation immunotherapy and advances our ambition for ivonescimab to become the global PD-1 / VEGF partner of choice for novel combinations. Beginning with a Phase III study in first-line triple negative breast cancer, this collaboration represents an important expansion of Summit’s global development program into breast cancer and a path for additional solid tumour settings."

John Tsai, Global Head, R&D, Daiichi Sankyo, said: "At Daiichi Sankyo, we are focused on maximising the potential of our DXd antibody drug conjugate portfolio through innovative combinations and strategic collaborations that support the continued advancement of our pipeline. We are encouraged by the opportunity to explore ivonescimab in combination with Datroway to potentially deliver clinically meaningful benefit to patients."

Under the terms of this agreement, each company will contribute their respective medicine for the planned combination trials which will be sponsored by AstraZeneca or Daiichi Sankyo. AstraZeneca, Daiichi Sankyo and Summit will each contribute to trial costs and each company will retain development and commercial rights to their respective medicines.

AstraZeneca also recently announced an equity investment which will help in part to support clinical collaborations evaluating combinations with ivonescimab including this agreement for Datroway, AstraZeneca’s separate agreement with Summit for combinations with sonesitatug vedotin (Sone-Ve), and planned future clinical collaborations intended to evaluate combinations with other AstraZeneca cancer medicines, including additional ADCs.

Ivonescimab is a novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is approved to treat certain patients with non-small cell lung cancer (NSCLC) in China, and a Biologics License Application (BLA) seeking approval in EGFR-mutated NSCLC is under review by the US Food and Drug Administration (FDA). Ivonescimab is currently being studied in Phase III clinical trials in NSCLC, small cell lung cancer, biliary tract cancer, bladder cancer, TNBC, head and neck squamous cell carcinoma, colorectal cancer, and pancreatic cancer.

Notes

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 30 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial.

Datroway is also approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is approved in the US and several other countries for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, one Phase III trial and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

(Press release, AstraZeneca, OCT 2, 2026, View Source [SID1234671224])

On October 1, 2026, Regeneron Pharmaceuticals, Inc., a New York corporation ("Regeneron" or the "Company"), Sanofi Biotechnology SAS, a société par actions simplifée organized under the laws of France ("Sanofi Biotechnology"), and Sanofi, a société anonyme organized under the laws of France ("Sanofi Parent" and, with Sanofi Biotechnology, "Sanofi"), reported to have entered into the Sixth Amendment to the Amended and Restated License and Collaboration Agreement (the "Sixth Amendment"), which amends the Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended), by and between the Company, Sanofi Biotechnology (as successor in interest to Aventis Pharmaceuticals Inc.), and Sanofi Parent (the "Antibody LCA"). Pursuant to the Sixth Amendment, the parties have agreed to co-develop and co-commercialize four new long-acting, Regeneron-invented antibodies: (i) an antibody targeting interleukin-13 ("IL-13"), (ii) an antibody targeting interleukin-4 ("IL-4"), (iii) an antibody targeting IL-4 receptor alpha (IL-4Rα), and (iv) a bispecific antibody targeting IL-4xIL-13 (each, a "New Licensed Product" and, collectively, the "New Licensed Products"). Regeneron will also have the option, on an asset-by-asset basis after completion of certain ongoing clinical trials, to include in the collaboration Sanofi’s Phase 2/3 asset lunsekimig, an investigational bispecific Nanobody VHH therapy targeting thymic stromal lymphopoietin (TSLP) and IL-13, and another Sanofi early development product. In the event Regeneron exercises this option for any such product, it will reimburse Sanofi for certain development costs related to such product.

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Pursuant to the Sixth Amendment, Sanofi will make an upfront payment to Regeneron of $1.0 billion. In addition, the Sixth Amendment provides that Regeneron will be entitled to receive up to an additional $7.0 billion of payments in the aggregate upon the achievement of certain development, regulatory, and commercial milestones with respect to the New Licensed Products. Global profits realized on the sale of New Licensed Products will be shared equally between Regeneron and Sanofi, as calculated under the Antibody LCA.

Pursuant to the Sixth Amendment, the parties have agreed on an initial global development plan for the IL-13 asset and are to agree on an initial global development plan for each of the other New Licensed Products. All development costs incurred with respect to all licensed products under the Antibody LCA, including the New Licensed Products, will be shared equally by the parties. In addition, development costs in excess of a budget cap for all New Licensed Products will be the responsibility of Regeneron, subject to certain rights to recoup such excess costs in future years. Regeneron will be the lead development party and the lead regulatory party prior to the filing of an application for marketing approval for each New Licensed Product. Regeneron will remain the lead regulatory party for applications for marketing approval and further commercialization in the United States, and Sanofi will be the lead regulatory party for applications for marketing approval and further commercialization outside the United States. Sanofi will be the lead party with respect to the commercialization of the New Licensed Products.

The foregoing description of the Sixth Amendment is qualified in its entirety by reference to the full text of the Sixth Amendment, a copy of which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Quarterly Report on Form 10-Q to be filed by the Company for the quarterly period ended September 30, 2026.

(Filing, Regeneron, OCT 1, 2026, View Source [SID1234673219])

On October 1, 2026 Moleculin presented its corporate presentation.

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(Presentation, Moleculin, OCT 1, 2026, View Source [SID1234673178])

On October 1, 2026 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a biotechnology company pioneering a new class of medicines that treat serious diseases, reported that, following a review of clinical data from the Phase 1 dose escalation trial of FHD-909 (LY4050784), Foghorn and Lilly have decided not to advance the program into the clinical development expansion phase. The Collaboration also will not be advancing the Selective SMARCA2 degrader program, and the companies do not anticipate further collaboration activities. As a result, Foghorn is prioritizing resources toward its proprietary portfolio programs with the greatest potential to address significant patient needs and create long-term value.

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"While we are disappointed with the clinical results, we and Lilly developed a drug in FHD-909 that selectively hits the SMARCA2 target with a favorable safety profile at exposures that exceeded our preclinical targets. Unfortunately, the biology of the SMARCA2/4 synthetic lethality relationship has not translated into the level of efficacy required to further advance the program," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics. "We built Foghorn based on a demonstrated capability in designing drugs for challenging molecular targets, and we have leveraged this capability to build a proprietary pipeline. Today, we are committed to focusing our financial and developmental resources to advance these programs toward the clinic."

"Foghorn is reducing its workforce by approximately 40% and further aligning its operating structure resulting in cash to fund Foghorn’s priority programs into the second half of 2029. These proprietary programs include our EP300 degrader program, our novel, oral immunology and inflammation program, our CBP degrader program, and our induced proximity platform.

Mr. Gottschalk continued, "I would like to thank our partner Lilly for their support, as well as the patients, caregivers, investigators, study site staff, and all others who participated in and contributed to the FHD-909 clinical trial."

About FHD-909
FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system.

(Press release, Foghorn Therapeutics, OCT 1, 2026, View Source [SID1234671238])