Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
Galapagos will discontinue cell therapy unit
On Tuesday, Galapagos announced plans to wind down their cell therapy business, effectively shuttering seven out of its 10 indications currently in the pipeline. The decision follows their earlier plans to sell the unit, with Henry Gosebruch, CEO of Galapagos, saying in Tuesday’s statement, “Following a limited number of non-binding offers, ultimately no viable proposals were received with terms or financing that would reasonably support the business’ future.” Ultimately, the news comes after several setbacks for the company over the last few years, including the FDA’s rejection of its rheumatoid arthritis drug in partnership with Gilead Sciences, and the late-stage failure of the same drug in Crohn’s disease in 2023. The company also stated that the decision is anticipated to cut around 365 positions globally. – Allison Whitten
Takeda strikes multibillion dollar deal to expand its oncology pipeline
Takeda has announced a $1.2 billion upfront deal with Innovent Biologics to gain rights to two late-stage cancer candidates, IBI363 and IBI343, with potential milestone payments of $10.2 billion. The agreement positions the drugs as potential growth drivers as Takeda prepares for patent expirations on its blockbuster inflammatory bowel disease therapy, Entyvio. IBI363 is designed to boost antitumor immunity by blocking PD-1, an immune checkpoint that tumors use to evade detection, while selectively activating IL-2 signaling to expand cancer-fighting T cells. The drug is in Phase 2 trials for non-small cell lung and colorectal cancers and is expected to enter a global Phase 3 study soon. IBI343, an antibody-drug conjugate (ADC) targeting the Claudin 18.2 protein commonly found in gastric and pancreatic cancers, is in late-stage testing for gastric cancer and has shown promise in pancreatic cancer. Under the deal, Takeda and Innovent will co-develop globally and co-commercialize IBI363 in the US, lead commercialization outside of China, and gain exclusive rights to IBI343 outside Greater China, while also securing an option on IBI3001, an early-stage bispecific ADC. – Bree Foster
Sanofi’s first-in-class drug delivers Phase 2 win in rare lung disease
Sanofi’s investigational therapy, efdoralprin alfa, has delivered a Phase 2 win in patients with alpha-1 antitrypsin deficiency (AATD) emphysema, a rare inherited disorder caused by a lack of the AAT protein. AATD increases the risk of lung and liver disease, with symptoms often appearing between ages 25 and 50, including shortness of breath, wheezing, fatigue, and recurring respiratory infections. The therapy consists of a fusion protein that combines a lab-made version of AAT with an Fc fragment to prolong its activity in the body, allowing less frequent dosing. In the ElevAATe study, efdoralprin alfa administered every three or four weeks significantly increased functional AAT levels and met key secondary endpoints, while offering a less frequent dosing schedule than the current weekly standard. The drug was well tolerated, with a safety profile similar to the standard-of-care plasma therapy, Zemaira. Sanofi, which acquired efdoralprin alfa from Inhibrx in 2024 for $1.7 billion, plans to discuss the results with regulators to determine next steps toward potential approval, positioning the therapy as a first-in-class restorative option for patients with AATD. – Bree Foster
Promising results for AI-discovered cancer drug from Iambic
New results released by Iambic Therapeutics on Monday showed that their artificial intelligence (AI)-designed oncology drug, IAM1363, led to anti-tumor activity in patients with a variety of HER2 (human epidermal growth factor receptor 2) cancers along with positive safety and tolerability data. The drug is a brain-penetrant small molecule tyrosine kinase inhibitor (TKI). Specifically, the release states that the Phase 1/1b trial showed that 28 percent of patients with measurable systemic disease showed partial responses and 33 percent with measurable intracranial tumors showed partial responses. The company also noted the speed of the drug’s progress so far, writing in the statement, “The data further validate Iambic's AI platform and clinical execution, with the novel molecule advancing from program start to clinical trial initiation in just two years, and initial proof of concept clinical data now reported just over a year later.” – Allison Whitten
AI virtual scientists show promise in automating complex research tasks
Engineers at Duke University have created an “agentic system” of large language models designed to function as an autonomous research team capable of solving complex inverse design problems. The system, published in ACS Photonics on October 18, coordinates multiple AI agents — each handling specific scientific tasks such as data organization, coding, model verification, and optimization — under the guidance of a central “manager” model. Tested on metamaterial design problems, the AI agents completed work comparable to that of trained PhD students, achieving near-human performance in its best trials. Researchers say this “artificial scientist” concept could accelerate progress in fields that depend on computational modeling, potentially transforming how scientific research is conducted. The framework could be especially beneficial to areas of drug discovery that require screening through thousands of drug compounds, genes, proteins, or even the design of new drugs for a specific target. — Andrea Corona
Alkermes to acquire Avadel for $2.1B, expanding into sleep medicine
Alkermes will acquire Avadel Pharmaceuticals for up to $2.1 billion in cash, adding the once-nightly narcolepsy therapy Lumryz (sodium oxybate) to their portfolio and accelerating its entry into the sleep medicine market. The all-cash deal, approved by both boards and expected to close in early 2026, values Avadel at a 38 percent premium and includes a $1.50 per share contingent value tied to the FDA’s approval of Lumryz for idiopathic hypersomnia last year. Avadel has rapidly grown since Lumryz’s 2023 launch, with more than 3,000 patients on the therapy and projected 2025 revenues of up to $275 million. The acquisition strengthens Alkermes’ commercial base and supports the development of its orexin-2 receptor agonist pipeline, positioning the company to compete with Jazz Pharmaceuticals in the $3 billion oxybate market. — Andrea Corona
