Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
Genmab’s head and neck bispecific cancer drug reduced death by 50 percent
Genmab’s $8 billion acquisition of Merus last year appears to be paying off already. Through that deal, the company gained Merus’ bispecific antibody drug, petosemtamab, that treats head and neck cancer. Phase 3 results announced on Wednesday of this week demonstrated that petosemtamab, in combination with Merck’s Keytruda, decreased the risk of death by 50 percent compared to Keytruda alone in patients with PD-L1 positive head and neck squamous cell carcinoma (HNSCC). The announcement sent Genmab’s stock soaring up nearly 30 percent, and follows two other recent successes from Genmab, with positive results announced earlier this month for epcoritamab in lymphoma and rinatabart sesutecan in ovarian cancer released last week. “These topline Phase 3 results represent a defining milestone for Genmab and further strengthen our conviction in petosemtamab as a potential first-in-class treatment option for patients with this difficult-to-treat cancer,” said Jan van de Winkel, CEO of Genmab, in the press release. – Allison Whitten
Glioblastoma hijacks brain circuits to fuel tumor growth
Glioblastoma can manipulate nearby brain cells to create conditions that help tumors grow, according to a study published in Neuron. Researchers at Baylor College of Medicine found that the cancer disrupts the activity of inhibitory neurons, which normally act as a brake on electrical activity in the brain. The tumors also produce a protein called diazepam binding inhibitor (DBI), which increases neuronal activity and tumor growth. In animal models, activating inhibitory neurons near tumors slowed their growth, while blocking their activity accelerated it. The team also found that two FDA-approved anti-epileptic drugs, lorazepam and valproic acid, which enhance signaling by the inhibitory neurotransmitter GABA, reduced tumor cell proliferation in the models. The findings suggest that restoring the brain’s ability to regulate neuronal activity could offer a complementary approach to treating glioblastoma, an aggressive brain cancer with limited treatment options. However, further research is needed to determine whether these drugs can slow tumor progression in patients. – Bree Foster
FDA lays out one-license path for individualized gene editing
Personalized gene editing just got a clearer regulatory roadmap. On October 27, 2026, the FDA released draft guidance showing how sponsors can fit patient-specific genome editing therapies for rare genetic diseases under a single Biologics License Application (BLA). The big idea is an “Individualized Feature Space,” essentially a set of guardrails defining how much a product can change from patient to patient and still stay within one BLA. Once a therapy is approved, sponsors can add new variants that fit inside those guardrails by leaning on the original clinical data plus in vitro evidence of safety and activity for each new version. The guidance also touches on manufacturing, testing for unintended genetic changes, and naming, and labeling. For developers, that puts assay and manufacturing teams front and center as programs grow. Want to weigh in? Comments are open for 30 days after Federal Register publication under docket FDA-2026-D-11783. The Centers for Medicare & Medicaid Services is also widening its Cell and Gene Therapy Access Model beyond sickle cell disease, with a call for manufacturer applications expected in the coming months. – Andrea Corona
Flagship combines three of its companies to launch Etcelera
On Thursday, Flagship Pioneering announced the creation of the AI-powered drug discovery company Etcelera, which is a merger of three of Flagship’s current startups: Cellarity, Etiome, and Empress Therapeutics. In the press release, Flagship stated the purpose is “to pioneer causal intelligence in human biology: the ability to determine what truly drives disease and predict how a medicine will act in patients before it reaches the clinic.” The company also emphasized the strengths that each of the three companies brings to the new merger: whole cell analysis from Cellarity, temporal disease-stage intelligence from Etiome, and industrialized multi-omics technology from Empress. Flagship hopes that with its own in-house AI tools to support Etcelera, the new company will excel among a slew of massive AI investments in pharma. “Etcelera will allow us to predict the clinical outcome before running the experiment. Our vision is to build a compounding AI system that becomes a definitive source of novel medicines that are more likely to succeed in clinical development than any prior technology,” said Alec Reynolds, Chairman of Etcelera and Senior Partner, Flagship Pioneering, in the press release. – Allison Whitten
Divarasib raises the bar for KRAS-targeted lung cancer treatment
Roche’s KRAS G12C inhibitor divarasib has outperformed two approved drugs in a Phase 3 trial of previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), improving progression-free and overall survival. In the KRASCENDO 1 trial, which enrolled 338 patients with KRAS G12C-mutated tumors, divarasib extended median progression-free survival to 9.8 months, compared with 5.7 months with sotorasib or adagrasib, reducing the risk of disease progression or death by 42 percent. Median overall survival was also longer with divarasib, at 17.7 months versus 12 months, corresponding to a 44 percent reduction in the risk of death. Divarasib also improved the objective response rate by 25.8 percent relative to the control group. The treatment had lower rates of grade 3–4 treatment-related adverse events than the approved inhibitors, including less severe liver toxicity, although severe diarrhea was more common. The results, presented at the ESMO Congress 2026, suggest divarasib could offer a more effective treatment option for patients whose cancer has progressed after initial therapy. A separate trial, KRASCENDO 2, is evaluating divarasib in combination with pembrolizumab against pembrolizumab plus chemotherapy as a first-line treatment for advanced KRAS G12C-mutated NSCLC. – Bree Foster
Aspen Neuroscience raises $140.6 million in Parkinson’s IPO
Another biotech is heading to the Nasdaq. Aspen Neuroscience priced its initial public offering at $15 per share, the low end of its $15 to $17 range, raising about $140.6 million in gross proceeds. Shares start trading today under the ticker ASPE, and the deal is expected to close November 2, 2026. The San Diego company is developing sasineprocel, a one-time autologous cell therapy for Parkinson’s disease that turns a patient’s own skin cells into induced pluripotent stem cells (iPSCs) and then into dopamine-producing neuron precursors for transplant. The therapy is currently in a Phase 1/2a trial for mid-stage to moderately advanced Parkinson’s disease, holds Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, and is slated to begin dosing in a Phase 3 trial in the second half of 2027. For the cell therapy field, it’s a notable test of investor appetite for personalized, patient-derived therapies, which come with roughly four-month manufacturing timelines per patient. – Andrea Corona
