Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
Gilead jumps into in vivo CAR T cell space
After acquiring Kite Pharma in 2017 for $11.9 billion to enter the CAR T cell therapy market, Gilead Sciences announced they will now acquire Interius BioTherapeutics (under Kite) for $350 million to advance their pipeline into the in vivo CAR T cell arena. Using Interius’ in vivo platform, CAR T cells can be developed within the patient’s body, rather than the expensive and time-consuming process of extracting T cells and engineering them to become CAR T cells in a lab. In the press release, Executive Vice President of Kite Cindy Perettie said, “By combining Interius’s teams and their novel platform with Kite’s deep expertise and footprint in cell therapy research, development and manufacturing, we aim to advance best-in-class in vivo therapies to bring them to patients more efficiently.” – Allison Whitten
Breakthrough brings lab-grown eggs a step closer to reality
Infertility affects more than one in six adults worldwide, and many cases trace back to errors in meiosis, the specialized cell division that creates egg and sperm cells. Replicating meiosis outside the human body has long been a major challenge, but researchers at the Wyss Institute at Harvard University and Harvard Medical School have now developed the first in vitro method to induce meiosis in human stem cells. By introducing a specific gene cocktail and chemical cues into induced pluripotent stem cells, the team observed live human cells initiating meiosis in a culture dish, a milestone published in Science Advances. Although the cells have not yet completed the full process, this breakthrough marks a significant step toward the future creation of functional gametes in the lab. Near-term applications could include drug testing and contraceptive development, while longer-term goals focus on addressing infertility by generating healthy eggs and sperm for patients who cannot produce them naturally. – Bree Foster
Modernization act could redefine patient access to clinical trials
Rural and low-income cancer patients are about 30 percent less likely to enroll in clinical trials, not due to lack of interest, but because of costs like travel, lodging, and lost wages. To address these barriers, more than 100 patient advocacy and health care professional organizations have endorsed the Clinical Trial Modernization Act, a bipartisan bill introduced in May 2025. Building on legislation passed in 2022, the bill would allow sponsors to cover both medical and non-medical costs such as copays, travel, lodging, childcare, and digital health technology needed for remote participation — without jeopardizing patients’ eligibility for safety-net programs. It also empowers the US Department of Health and Human Services to fund community outreach and education to improve enrollment among underrepresented groups, including rural residents, older adults, racial and ethnic minorities, and people with limited incomes. With 80 percent of trials failing to meet enrollment timelines, supporters argue that the act could expand patient access, increase diversity, and accelerate innovation in oncology and other life-threatening diseases. – Bree Foster
Psychedelic drug from Reunion Neuroscience shows positive results
On Monday, Reunion Neuroscience announced that RE104, their prodrug designed to mimic a shorter experience with psilocybin or LSD, successfully met the primary endpoint in women with postpartum depression. The Phase 2 RECONNECT trial findings showed a significant reduction in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS). Reunion noted that the drug was generally well-tolerated, and the amount of metabolites found in breastmilk were low enough that patients could likely return to breastfeeding soon after treatment. The company plans to continue on to a Phase 3 trial in 2026. “Findings from the RECONNECT trial are promising and underscore RE104’s potential as a single subcutaneous injection therapy that addresses limitations of current treatments by delivering symptom relief quickly and safely following a single dose of therapy, with minimal disruption to caregiving responsibilities and a lack of sedation,” said Anita H. Clayton, a psychiatrist at the University of Virginia School of Medicine, and lead investigator in the RECONNECT trial, in a press release. – Allison Whitten
FDA clears first RNA-targeted therapy for hereditary angioedema
This week, the FDA approved Ionis Pharmaceuticals’ Dawnzera (donidalorsen) as the first and only RNA-targeted prophylactic treatment for hereditary angioedema (HAE) in patients 12 and older. The subcutaneous therapy, given every four or eight weeks, targets plasma prekallikrein to prevent swelling attacks associated with the rare genetic disorder, which affects about 7,000 people in the US. Approval was based on the Phase 3 OASIS-HAE study, where Dawnzera cut monthly HAE attack rates by up to 87 percent and reduced moderate-to-severe episodes by about 90 percent. In a switch cohort, patients moving from other prophylactic therapies experienced a 62 percent drop in attacks, with most preferring Dawnzera for its convenience and disease control. Ionis said Dawnzera will be available in the US within days. – Andrea Corona
Study links nerve injury to immunotherapy resistance
An international team led by Moffit Cancer Center has discovered that cancer-induced nerve injury can drive resistance to anti-PD-1 (programmed cell death protein 1) immunotherapy, according to findings published in Nature. The researchers showed that when tumor cells infiltrate and damage surrounding nerves, they degrade the protective myelin sheath, triggering the release of inflammatory signals such as IL-6 (interleukin-6) and type 1 interferons. Using patient samples and preclinical models across several cancer types, the team found resistance could be reversed by removing pain-transmitting nerves, blocking neuronal injury signals, or pairing anti-PD-1 therapy with IL-6 inhibitors. The findings could open new avenues for drug discovery by identifying neuronal injury signaling pathways, such as IL-6, as potential therapeutic targets to enhance the effectiveness of existing immunotherapies. – Andrea Corona
