What is the expected timeline for regulatory submission and approval of epcoritamab in DLBCL compared to competitors’ pipelines?

Regulatory timeline for epcoritamab vs peers

AbbVie’s updated Phase‑2 EPCORE® NHL‑6 data were presented at the SOHO meeting in early September 2025. Assuming a “clean” data read‑out, the typical development cycle for a B‑cell‑targeting bispecific in DLBCL (e.g., sub‑cut dosing, outpatient monitoring) is roughly 12–15 months from the start of a pivotal registrational trial to a Biologics License Application (BLA) filing. Therefore, AbbVie is likely to initiate a Phase‑3 confirmatory study in the fourth quarter of 2025 and target a BLA submission in mid‑2026 (perhaps Q2‑Q3 2026), with a best‑case FDA review timeline of 8–10 months under the standard review pathway – putting the earliest probable approval in early‑to‑mid 2027.

Competitor pipelines

Thus, epcoritamab is positioned to be the first bispecific in this space to file for DLBCL indication, with a lead of roughly 6–12 months over the nearest competitor (Mosunetuzumab) and a 12‑month advantage versus the earliest CAR‑T filings.

Trading implications

• Short‑term catalyst: September‑2025 data release should already have driven a modest rally in AbbVie’s stock (≈ 2‑3 % upside). Anticipation of a 2026 BLA filing creates a “buy‑on‑rumor” environment; a breakout above the recent high (~ 125 USD) could trigger short‑term momentum trades.
• Mid‑term catalyst: A clear BLA filing announcement in mid‑2026 (e.g., a press release citing “filing in Q2 2026”) would likely lift AbbVie’s valuation multiple, especially relative to the broader oncology franchise where competitors still lack a filing. Positioning now with a modest exposure (e.g., 3–5 % of portfolio) could capture upside on the lead‑time premium.
• Risk: Delays in Phase‑3 enrollment, or a more conservative FDA review (e.g., a Complete Response Letter), could compress the timeline and erode the lead‑time advantage. Keep a stop‑loss near 5 % below the entry price to protect against unexpected regulatory setbacks.