ELI LILLY & (LLY) Company Report

The FDA granted Breakthrough Therapy designation to Eli Lilly’s sofetabart mipitecan for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after prior bevacizumab and mirvetuximab soravtansine treatment.
Phase 1a/b data (March 9, 2025 cutoff) in 58 efficacy-evaluable patients showed an overall response rate of 45% (3% unconfirmed CR, 41% PR) and a disease control rate of 74%.
Initial safety results indicated low rates of interstitial lung disease, peripheral neuropathy, and alopecia, with no significant ocular toxicity reported.
The program has advanced into a Phase 3 trial under the expedited review pathway provided by the designation.

5 days ago

Morningstar

Lilly’s sofetabart mipitecan receives FDA Breakthrough Therapy designation

LLY

FDA granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for treating platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who had prior bevacizumab and mirvetuximab soravtansine.
The designation is based on Phase 1a/b study results showing responses across all folate receptor α expression levels and a favorable tolerability profile.
Lilly has initiated the global Phase 3 FRAmework-01 trial, evaluating the drug as monotherapy in platinum-resistant ovarian cancer and in combination with bevacizumab for platinum-sensitive disease.
Ovarian cancer is the fifth leading cause of cancer death among U.S. women, with around 70% of patients experiencing recurrence after platinum-based chemotherapy and limited options for platinum-resistant cases.

5 days ago

Press Release

Eli Lilly outlines obesity and pipeline strategy at JPMorgan conference

LLY

Product Launch

New Projects/Investments

Eli Lilly expects Q2 approval for oral GLP-1 orforglipron under the FDA’s Priority Review Voucher Program and has resolved prior supply shortages; LillyDirect now serves ~1 million patients.
Medicare Part D will cover obesity treatments at $50 OOP; Medicaid eligibility is expanding, while commercial coverage remains uneven at <60% of employer plans, with new PBM carve-out solutions launching in 2026.
Lilly has launched 24 new molecular entities over the past decade and is ~3.5 years faster than peers from candidate selection to first introduction; late-stage programs include Lp(a) siRNA/oral therapies, four Phase 3 oncology assets, and Alzheimer’s candidates.
The oral GLP-1 strategy targets three use cases—needle aversion, polypharmacy convenience, and emerging-market reach—with maintenance-phase switching studies to orforglipron following parenteral therapies.

Jan 13, 2026, 10:15 PM

Transcript

Lilly outlines obesity portfolio expansion and $55B investment

LLY

New Projects/Investments

Entering a new era in obesity treatment by expanding from a single marketed product to a broad portfolio with global launches and 13 manufacturing sites under construction to improve supply and coverage.
Maintaining a broad pipeline with five late-phase incretin/amylin candidates, six additional clinical-stage programs, and 34 discovery efforts targeting obesity, diabetes, sleep apnea, pain, cardiovascular, renal, and hepatic diseases—aiming to help 1 billion people.
Committing $55 billion to create a sustainable advantage, including 13 new R&D sites globally, and driving 24 NME launches from 2015–2025 with a development timeline 3.5 years faster than industry average.
Focusing 75% of new clinical medicines outside incretins/amylins and advancing indications in elevated lipoprotein(a) (63 M patients), chronic pain (51 M), early Alzheimer’s (20 M), and early breast cancer (3 M).

Jan 13, 2026, 10:15 PM

Presentation

Eli Lilly outlines 2026 obesity and pipeline strategy at J.P. Morgan Healthcare Conference

LLY

Product Launch

New Projects/Investments

Eli Lilly celebrates its 150th anniversary and reports strong momentum in its metabolic franchise, highlighting retatrutide achieving up to 29% weight loss and four additional obesity candidates in phase III.
The company resolved 2024 supply shortages and scaled its LillyDirect platform to serve ~1 million patients monthly, with vials becoming the second-best-selling obesity treatment.
Oral GLP-1 candidate orforglipron has been submitted under the FDA Priority Review Voucher program, with approval anticipated in Q2 2026, ahead of the Medicare Part D obesity benefit expansion.
U.S. access expansion includes Medicare Part D coverage for obesity drugs with $50 out-of-pocket costs and planned Medicaid rollouts, expected to surpass current commercial penetration.
Beyond obesity, the pipeline is diversified with late-stage assets in Lp(a) (lepodisiran, muvalaplin), oncology (four phase III programs), and Alzheimer’s candidates (remternetug, donanemab), supported by accelerated development capabilities.

Jan 13, 2026, 10:15 PM

Transcript

Lilly discusses obesity portfolio expansion and access strategy at JPM Healthcare Conference

LLY

Resolved supply constraints for tirzepatide and scaled LillyDirect to serve about one million people per month, making Lilly vials on LillyDirect the second best-selling obesity drug after Zepbound.
Advanced obesity pipeline with phase 3 data on oral GLP-1 orforglipron and retatrutide, initiated two additional phase 3 programs (eloralintide and brivapotide), plus six phase 1/2 and 34 preclinical programs.
Anticipates US Part D benefit launch enabling obesity coverage with $50 out-of-pocket costs for Medicare, coupled with state-by-state Medicaid expansion.
International presence expanded with launches in over 30 major markets, leveraging self-pay demand and preparing for orforglipron launch to increase global reach.

Jan 13, 2026, 10:15 PM

Transcript

Juvena Therapeutics raises $33.5M Series B

LLY

Convertible Preferred Issuance

New Projects/Investments

$33.5M Series B led by Bison Ventures, with participation from Eli Lilly and Company, Jefferson Life Sciences, Mubadala Capital, and Manta Ray.
Proceeds will advance its AI-enabled regenerative biologics pipeline, including Phase 1 trials of lead asset JUV-161 targeting muscle degeneration.
Entered a $650M+ research collaboration with Eli Lilly, tied to potential milestones, to develop regenerative therapeutics.
Initiated search for a new CEO; co-founder Dr. Hanadie Yousef will transition to Board Director and Executive Advisor.

Jan 12, 2026, 4:00 PM

Press Release

Eli Lilly plans €15B bid for Abivax

LLY

M&A

Takeover Bid

French media report Eli Lilly is preparing a €15 billion bid for biotech Abivax, though neither company has confirmed the offer.
Speculation sent Abivax shares up 22–31% in early trading, following a roughly 1,900% rally over the past year after positive Phase 3 obefazimod results.
Analysts at Kepler Cheuvreux and Oddo BHF view Abivax as a highly attractive M&A target; Kepler suggests a takeover could value the stock at €150–€250 per share due to control premiums and synergies.
Eli Lilly is awaiting guidance from French authorities on foreign investment controls, and a recent partial stake sale by Sofinnova has heightened takeover expectations.

Jan 12, 2026, 8:50 AM

Morningstar

Eli Lilly anchor investment supports Aktis Oncology IPO

LLY

New Projects/Investments

Aktis Oncology raised $318 million in its initial public offering, bolstered by an anchor investment from Eli Lilly.
The collaboration between Eli Lilly and Aktis Oncology is valued at up to $1.2 billion, targeting development of alpha-emitting radiopharmaceuticals for solid tumors.
Aktis’s pipeline includes AKY-1189 (actinium-225–based targeting Nectin-4) and AKY-2519 (targeting B7-H3), following $346 million in prior private financing.
Vida Ventures co-led the Series A, is now Aktis’s second-largest shareholder, and has held board representation through Helen Kim since 2021.

Jan 9, 2026, 5:58 PM

Press Release

Lilly collaborates with Revvity to expand AI drug discovery models

LLY

New Projects/Investments

Revvity, Inc. (NYSE: RVTY) partners with Eli Lilly to make Lilly TuneLab predictive AI/ML models available through the Revvity Signals platform, broadening access to Lilly’s drug discovery tools.
The collaboration builds on Revvity’s Signals Xynthetica offering, establishing a scalable, federated framework to accelerate AI-enabled drug discovery.

Jan 9, 2026, 5:11 PM

Press Release