North Carolina Life Sciences News: Fortrea’s $45 Million Acquisition, United Therapeutics FDA Approval & More

The FDA approved the combination of Pfizer's talazoparib (Talzenna) and Astellas Pharma/Pfizer's enzalutamide (Xtandi) for earlier treatment of metastatic prostate cancer with HRR gene mutations. The approval, based on the TALAPRO-3 trial, expands the use of the combination to include patients who have not yet undergone androgen pathway modulation. The trial showed a 52% reduction in risk for radiographic PFS or death compared to placebo plus enzalutamide.

Pfizer announced that its Elrexfio treatment reduced the risk of disease progression or death in a Phase 3 trial for adults with multiple myeloma, earlier than its current U.S. indication. The study, involving 523 patients, met its primary endpoint, with over 75% of patients alive without disease progression. Pfizer plans to submit findings to health authorities.

Regeneron presented Phase III data for Libtayo (cemiplimab) in skin cancer, showing a 37% reduction in death risk. Pfizer's STARBOARD trial showed Keytruda triplet therapy improved outcomes in melanoma. Both studies were discussed at ESMO 2026.

Pfizer's elranatamab (Elrexfio) met the primary endpoint of progression-free survival in a phase 3 trial for relapsed/refractory multiple myeloma, showing a 68% 18-month PFS rate. The study compared elranatamab to standard regimens, with safety data consistent with prior findings. Pfizer plans to submit the data to global health authorities. Elranatamab was previously approved for a different patient population in 2023.

Pfizer (PFE) reported positive Phase 3 trial results for ELREXFIO in relapsed or refractory multiple myeloma, meeting its primary endpoint of progression-free survival. The study showed significant risk reduction compared to existing treatments. Pfizer also announced FDA approval for Talzenna in combination with Xtandi for metastatic hormone-sensitive prostate cancer with HRR gene mutations. PFE stock is down slightly in pre-market trading.

Pfizer's ELREXFIO met primary endpoint in Phase 3 trial for multiple myeloma, showing 68% 18-month PFS. The study involved 523 patients. No new safety concerns were found. Pfizer plans regulatory submissions and future data presentations. PFE shares were down 0.34% in pre-market trading.