TheTechno Optimist.

KLN-1010Eli Lilly—Kelonia presents first-in-human Phase 1 data for KLN-1010 in vivo CAR-T at ASH 2025: 100% MRD-negative response in early cohort, no high-grade CRS or ICANSEli Lilly—Eli Lilly acquires Orna Therapeutics for up to $2.4 billion to advance in vivo CAR-T cell therapiesKLN-1010Eli Lilly—Kelonia presents Phase 1 ASCO 2026 data: durable MRD-negative responses, manageable safety in multiple myelomaAK-OTOF (Akouos)Eli Lilly—AK-OTOF at COSM 2026: 8 of 10 children on the higher dose gained hearing, with no therapy-related adverse eventsRetatrutideEli Lilly—Lilly to present TRIUMPH-2 at EASD 2026: retatrutide gave large weight loss and A1C cuts in obesity with type 2 diabetesVERVE-102 (PCSK9 base editor)Eli Lilly—NEJM publishes Heart-2 Phase 1 results: VERVE-102 lowered LDL by 62% on average at the top dose, lasting at least a yearOrforglipron (Foundayo)Eli Lilly—FDA approves Foundayo (orforglipron), an oral GLP-1 pill for obesity, under a national priority voucherTirzepatide (Mounjaro / Zepbound)Eli Lilly—FDA approves Mounjaro to reduce heart attack, stroke and cardiovascular death risk in adults with type 2 diabetesRetatrutideEli Lilly—Retatrutide TRIUMPH-1: 28.3% mean weight loss at 80 weeks on 12 mg vs 2.2% on placeboEloralintideEli Lilly—Eli Lilly advances eloralintide (amylin agonist) to phase 3 trials for obesity as monotherapy and add-on to incretin drugsEli Lilly—Eli Lilly's market capitalization passes $1 trillionKLN-1010Eli Lilly—Eli Lilly to acquire Kelonia Therapeutics in deal worth up to $7 billion, with $3.25 billion upfront payment, closing expected H2 2026RetatrutideEli Lilly—Lilly sues six companies selling unauthorised retatrutide, which is not yet approvedOrforglipron (Foundayo)Eli Lilly—UK authorises orforglipron for weight management and type 2 diabetesOrforglipron (Foundayo)Eli Lilly—Lilly to present ACHIEVE-4, its largest and longest Foundayo study in type 2 diabetes, at EASD 2026

AK-OTOF (Akouos)

by Eli LillyUS

Restore natural hearing to people born deaf from OTOF mutations, about 200,000 worldwide, with a single injection into the inner ear instead of a lifelong cochlear implant.

PilotStage 3 of 5

AK-OTOF-101 recruiting, now registered as Phase 3 with 48 planned patients; results due ~2028.

Updated 11 May 2026Checked 11 Oct0 updates this week

Milestones

Next · Expanded trial enrolling, registered as Phase 3
  1. Lilly agrees to buy Akouos for up to $610M18 Oct 2022Complete.
  2. AK-OTOF-101 trial starts15 Sep 2023Complete.
  3. First child, aged 11, hears within 30 daysJan 2024Complete.
  4. COSM 2026: 8 of 10 higher-dose children improveMay 2026Complete.
  5. Expanded trial enrolling, registered as Phase 3NowCurrent milestone.
  6. Primary completion (estimated)Target Oct 2028Not yet reached.

Most important updates

Upcoming

  1. Oct 2028Primary completion (estimated)in about 103 weeks (next)
Primer