FDA Accepts Roche's Fenebrutinib Filing for Both Relapsing and Primary Progressive MS
RHHBY sits 31% above its 52-week low of $39.78.
Summary
The FDA accepted Roche's NDA for fenebrutinib under priority review, covering both relapsing and primary progressive multiple sclerosis. This is the first BTK inhibitor to reach this stage in both MS forms. Phase III data showed significant relapse reductions (51.1% and 58.5% vs teriflunomide) and non-inferiority to Ocrevus in PPMS. If approved, fenebrutinib would be the first high-efficacy oral therapy for both RMS and PPMS, expanding Roche's MS franchise beyond Ocrevus. Priority review suggests a decision within six months, a key near-term catalyst.
At the time of this announcement, RHHBY was trading at $52.25 on OTC in the Life Sciences sector, with a market capitalization of approximately $341.4B. The 52-week trading range was $39.78 to $60.85. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.