Hematogenix's MM MRD Assay Underpins FDA Accelerated Approval of Bristol Myers Squibb's ZENBEXUS™, the First Approved CELMoD Therapy for Multiple Myeloma

Bristol-Myers Squibb (BMY) will invest $2.3B in a Houston plant, part of a $40B U.S. investment. Eli Lilly (LLY) won UK approval for its weight-loss drug, Foundayo. BMY's investment aims to boost domestic manufacturing, while LLY expands internationally. Both companies face challenges, including patent expirations for BMY and market competition for LLY. Hedge funds show mixed interest in both stocks.

China's IIT system faces scrutiny after undisclosed gene therapy deaths. AstraZeneca and Daiichi Sankyo's Enhertu showed promise in lung cancer trials. Tanabe Pharma to receive $435M for global rights to dermatology drug. Sandoz partners with Shanghai Henlius for biosimilars. Other biotech news includes CAR-T trial deaths, SK's settlement, and Hengrui's profit squeeze.

Moderna and Merck shares surged after positive Phase 3 trial results for an mRNA cancer vaccine, boosting other biotech and oncology stocks. BioNTech and Novavax also rose, while Bristol-Myers Squibb and Regeneron gained. Barclays estimates the combo could generate $3B in melanoma revenue by 2035, potentially impacting competitors.

The FDA granted accelerated approval to iberdomide (Zenbexus) for adults with relapsed or refractory multiple myeloma after at least one prior therapy, introducing the first CELMoD class drug in myeloma. The approval is based on the EXCALIBER-RRMM trial, where 41% vs 21% achieved MRD-negative complete response at 16 months. Iberdomide is combined with daratumumab (Darzalex Faspro) and dexamethasone.

Bristol Myers Squibb (BMY) said the FDA granted accelerated approval for ZENBEXUS (iberdomide) with daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma after at least one prior therapy. Based on Phase 3 EXCALIBER-RRMM (n=207 vs 213), MRD-negative CR was 41% vs 21% at 16 months. Confirmatory trials required.

The FDA approved iberdomide (Zenbexus, Bristol Myers Squibb) as the first cereblon E3 ligase modulation therapy for relapsed or refractory multiple myeloma, in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro) and dexamethasone. In the phase 3 EXCALIBER-RRMM trial, MRD-negative complete response at any time was 41% vs 21% in the comparator arm.