BioNTech Rises on Lung Cancer Data While Cullinan Falls as Sector Sees Broad Monday Premarket Gains

Healthcare stocks broadly rose in Monday premarket trading, with BioNTech leading the sector after presenting positive lung cancer pipeline data at the IASLC 2026 World Conference on Lung Cancer in Seoul, running September 12 to 15. BioNTech highlighted late-stage momentum and first global clinical data for its pumitamig and elfetabart drozuntecan novel combination at the conference, sending shares higher.

Cullinan Oncology (CGEM) moved in the opposite direction, falling roughly 6.3% in premarket trading after data showed its zipalertinib combined with chemotherapy produced a statistically significant and clinically meaningful improvement in progression-free survival in lung cancer patients. Investors appeared to view the data as placing the drug in an increasingly competitive field rather than as a clear catalyst, even though the results met a pre-planned threshold for trial unblinding.

The FDA delivered two separate decisions affecting the sector on Monday. The agency granted Regenerative Medicine Advanced Therapy designation to Tenaya Therapeutics for TN-401, its gene therapy targeting arrhythmogenic right ventricular cardiomyopathy caused by PKP2 gene mutations, a move that accelerates its path toward regulatory alignment on pivotal studies. The FDA also approved a reduced patient monitoring period for Amgen's lung cancer drug, easing a practical burden on clinicians using the treatment. Separately, Bionano highlighted new studies supporting the utility of optical genome mapping in blood cancers, and Cardinal Health reaffirmed broad-based growth momentum at the Morgan Stanley conference.