On April 8, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to REYOBIQ (rhenium Re186 obisbemeda) for the treatment of pediatric malignant gliomas.

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Pediatric malignant gliomas are rare, aggressive brain tumors with limited treatment options and poor outcomes, where current standards of care—including surgery and radiation—often fail to prevent recurrence.

Notably, the FDA granted orphan designation for malignant glioma more broadly than originally requested, encompassing pediatric ependymoma.

"Receiving orphan drug designation for REYOBIQ in pediatric malignant gliomas, including the broader scope for progressive pediatric ependymoma, is an important milestone and further validates our approach to delivering targeted radiotherapy directly to CNS tumors," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "We believe REYOBIQ’s ability to deliver high-dose radiation precisely to tumor sites while minimizing exposure to healthy brain tissue has the potential to meaningfully improve outcomes in this underserved patient population. This orphan designation reinforces the potential applicability of REYOBIQ across a wider range of CNS tumor indications and our continued advancement of REYOBIQ across multiple CNS cancer indications."

Orphan Drug Designation is granted by the FDA to investigational therapies intended to treat rare diseases affecting fewer than 200,000 people in the United States. The designation provides several potential benefits, including seven years of market exclusivity upon approval, tax credits for qualified clinical trial expenses, and exemptions from certain regulatory fees.

The ODD for pediatric malignant gliomas builds on recent regulatory and clinical progress for REYOBIQ, including completion of a Type B meeting with the FDA supporting development plans in leptomeningeal metastases (LM), encouraging clinical data from the ReSPECT-LM trial, and ongoing advancement of Phase 1 and Phase 2 studies. In addition, the Company has received FDA clearance of its Investigational New Drug (IND) application to evaluate REYOBIQ in pediatric patients with high-grade glioma and ependymoma.

About Pediatric Malignant Gliomas

Pediatric malignant gliomas are high-grade brain tumors that form from glial cells in the central nervous system that tend to grow quickly in children. Pediatric high grade gliomas (HGG), including ependymoma, are rare (approximately 3.3 cases per 100,000 persons) but aggressive brain tumors with limited treatment options and poor prognosis, particularly in recurrent settings. Standard treatments, including surgical resection and external beam radiation therapy, often fail to prevent recurrence, with 5-year survival rates as low as 22% for HGG, depending on tumor grade and resection extent.

About Leptomeningeal Metastases

LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About REYOBIQ (rhenium Re186 obisbemeda)

REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, APR 8, 2026, View Source [SID1234664236])

On April 8, 2026 Autolus presented its corporate presentation.

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(Presentation, Autolus, APR 8, 2026, View Source [SID1234664235])

On April 7, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported it has entered into a definitive agreement to acquire Tubulis GmbH, a private Germany-based, clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs), building on Gilead’s oncology pipeline, focused on addressing areas of high unmet need.

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The acquisition significantly expands Gilead’s ADC capabilities by adding next-generation assets and platforms designed to more selectively deliver diverse payloads to tumors and maximize patient benefit. Tubulis’ lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor (TOPO1i) ADC, is currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer (NSCLC). Gilead will also acquire TUB-030, a 5T4 targeted ADC, which has demonstrated promising initial clinical data across various solid tumor types. Tubulis’ programs and platforms have broad potential across multiple tumor types, complementing Gilead’s existing development and commercialization expertise in oncology.

"The agreement to acquire Tubulis is a significant milestone in Gilead’s progress in oncology. The company brings a clinical-stage candidate that is a potential new treatment for ovarian cancer, as well as a next-generation ADC platform and a promising early pipeline," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Today’s agreement follows a two-year collaboration with Tubulis, which has given us strong conviction in their programs and research capabilities. Bringing this potential into Gilead would further expand what is already the strongest and most diverse pipeline in our company’s history."

"From the outset, we believed our conjugation technology platforms could have broad impact across the ADC field and the initial data from TUB-040 have reinforced that conviction," said Dominik Schumacher, PhD, Chief Executive Officer and Co-founder of Tubulis. "Joining Gilead allows us to build on this foundation within an organization that brings deep scientific expertise, global development capabilities, and the scale needed to translate innovation into medicines for patients worldwide. Through our existing collaboration, Gilead has already seen the potential of our technologies and together, we are well positioned to accelerate the development of our ADC pipeline. I’m deeply grateful to the Tubulis team, our Board of Directors, investors, and partners for their commitment and helping make this milestone possible."

Following the close of the transaction, Tubulis will operate as a dedicated ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation, building on its integrated discovery, manufacturing and clinical capabilities to advance next generation ADCs.

Terms of the Transaction

Under the terms of the sale and purchase agreement, Gilead will acquire all of the outstanding equity of Tubulis for $3.15 billion in upfront cash consideration on a cash-free, debt-free basis, subject to customary adjustments, which is payable at closing, and up to $1.85 billion in contingent milestone payments. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions. The transaction is expected to close in the second quarter of 2026. Gilead plans to finance the transaction with a combination of cash on hand and senior unsecured notes.

Centerview Partners LLC and Allen & Company LLC are acting as financial advisors for Gilead. J.P. Morgan Securities LLC is acting as the exclusive financial advisor for Tubulis. Covington & Burling LLP, Arnold & Porter LLP, and Venable LLP are serving as legal counsel to Gilead. Goodwin Procter LLP and CMS Hasche Sigle are serving as legal counsel to Tubulis.

(Press release, Gilead Sciences, APR 7, 2026, View Source [SID1234668980])

On April 8, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that members of its senior management team will present and participate in the 25th Annual Needham Virtual Healthcare Conference on Tuesday, April 14, 2026, at 11:00 am Eastern Time.

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A live webcast of the presentation can be accessed through the Investors section of the Company’s website at www.lyell.com. A replay of the webcast will be available on the Company’s website following the presentation date.

(Press release, Lyell Immunopharma, APR 7, 2026, View Source [SID1234664238])

On April 7, 2026 BioOra Limited ("BioOra"), a commercial-stage cell therapy company advancing CAR-T therapies for cancer patients, and Octane Biotech Inc., an Octane Medical Group Company ("Octane"), reported the signing of a Letter of Intent (LOI) to collaborate on the co-development and deployment of advanced cell therapies using the Cocoon automated cell therapy manufacturing platform.

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The collaboration builds upon the existing partnership through which BioOra’s CD19-targeted CAR-T therapy (Atla-Cel) is produced by Octane’s Cocoon Platform for patients with relapsed or refractory B-cell lymphoma in New Zealand as part of the registration trial (ENABLE-2). Under the agreement, BioOra and Octane will work together to expand manufacturing capacity to support BioOra’s regional growth, beginning with Australia and extending to additional international markets.

Octane is advancing the Cocoon Platform to enable efficient, decentralized scaling of cell therapy manufacturing. In parallel, BioOra is constructing a bespoke cell therapy manufacturing facility in Christchurch New Zealand, the BioOra Health & Technology Centre, designed to concurrently operate Cocoon systems to meet growing regional demand for CAR-T and other advanced cell therapies. By leveraging the automated and integrated design of the Cocoon Platform, the collaboration is expected to improve operational efficiency, increase manufacturing throughput, and reduce vein-to-vein time, supporting a new model for delivering personalized cell therapies.

"BioOra has demonstrated that manufacturing using the Cocoon Platform can support the commercial delivery of CAR-T therapy in New Zealand," said John Robson, Chief Executive Officer of BioOra. "Our new Christchurch facility is designed to scale this model using multiple Cocoon systems. Partnering with Octane allows us to expand into Australia and beyond while improving efficiency and increasing patient access."

"Octane was founded to unlock the full potential of cell therapy production," said Timothy Smith, CEO and co-founder of Octane. "BioOra is setting the standard for how this model can be deployed at scale. By combining Cocoon-enabled automation with BioOra’s leading clinical and manufacturing infrastructure, we are building a more efficient, scalable paradigm that has the potential to redefine access to cell therapies globally."

The collaboration is also expected to expand international patient access through therapy delivery in New Zealand, and potentially in Australia, where BioOra is establishing partnerships to deliver CAR-T therapies to the large number of patients who do not have access in their home countries.

As part of the collaboration, BioOra and Octane intend to develop closed, integrated, end-to-end manufacturing solutions spanning cell collection, automated processing, and final product release for BioOra cell therapy products. These innovations are designed to simplify manufacturing workflows, further improving the accessibility and practicality of CAR-T therapy.

"CAR-T therapies have demonstrated extraordinary potential to cure otherwise lethal cancers, but scaling access has been limited by manufacturing complexity," said Laurence Cooper, MD, PhD, CAR-T pioneer, and Board Member of BioOra. "Aligning automation with advanced therapeutics through the Cocoon Platform can dramatically expand access. This collaboration fits directly with BioOra’s vision of becoming the first commercial CAR-T company in the Southern Hemisphere, bringing these transformative therapies to far more patients."

The collaboration will focus on:

Scaling BioOra’s CAR-T manufacturing operations in New Zealand using the Cocoon Platform
Expanding manufacturing into Australia and North America to support regional patient access
Developing additional cell therapy programs for deployment on the Cocoon Platform
Co-developing production efficiencies to further automate CAR-T manufacturing solutions
The companies expect to formalize additional development and commercialization agreements following the execution of definitive collaboration agreements.

(Press release, BioOra, APR 7, 2026, View Source [SID1234664229])