ELI LILLY & (LLY) Company Report

Double-digit share jump on renewed takeover speculation after reports Eli Lilly met French Treasury on Dec. 10 to discuss a proposal under FDI rules
Official addition to the Nasdaq Biotechnology Index likely triggered mechanical buying by index-tracking funds
Positive Phase 3 results for obefazimod in ulcerative colitis and analyst target upgrades (Guggenheim to $175, Piper Sandler at $142, Citizens to $131) underpin enthusiasm
Application filed to offer up to USD 400 million in American Depositary Shares in the U.S. market
Prior volatility includes a 500% one-session rally and over 1,300% YTD gain, with estimated cash reserves of ~€500 million

14 hours ago

Morningstar

Lilly reports positive Phase 3 results for orforglipron in weight maintenance trial

LLY

In the Phase 3 ATTAIN-MAINTAIN trial, participants switching to orforglipron maintained weight loss after 52 weeks with an average weight difference of 0.9 kg (from Wegovy) and 5.0 kg (from Zepbound) versus placebo.
Orforglipron met all primary and key secondary endpoints for weight maintenance as an adjunct to diet and exercise in adults with obesity or overweight.
The safety profile of orforglipron was consistent with prior Phase 3 studies, with mainly mild-to-moderate gastrointestinal adverse events and no hepatic safety signal.
Lilly has submitted a new drug application to the FDA for orforglipron in obesity treatment and received a Commissioner's National Priority Voucher.

5 days ago

Press Release

Recludix Pharma receives FDA clearance for REX-8756 IND

LLY

New Projects/Investments

The FDA cleared the IND application for REX-8756, an oral STAT6 inhibitor, enabling entry into Phase 1 clinical trials.
REX-8756 demonstrated complete pathway inhibition and potent efficacy in preclinical asthma, lung inflammation and dermatitis models, comparable to anti-IL-4/IL-13 antibody controls.
Recludix has a strategic development and commercialization partnership with Sanofi, with an option to share U.S. profits and losses 50:50.
A Phase 1 study in healthy volunteers is expected to begin shortly.

7 days ago

Press Release

Lilly updates efficacy data for Inluriyo in advanced ER+, HER2- breast cancer

LLY

In monotherapy for ESR1-mutated patients, imlunestrant achieved a 38% reduction in risk of progression (median PFS 5.5 vs 3.8 months; HR=0.62) and an 11.4-month OS improvement (34.5 vs 23.1 months; HR=0.60).
The imlunestrant plus abemaciclib combination nearly doubled PFS to 10.9 vs 5.5 months (HR=0.59) and delayed chemotherapy initiation by >1 year (27.8 vs 15.5 months).
Safety across inluriyo-based regimens remained consistent with no new signals on additional follow-up.
Lilly has submitted the combination data for U.S. regulatory review in ESR1-mutated metastatic breast cancer.

Dec 12, 2025, 4:45 PM

Press Release

Lilly reports retatrutide Phase 3 obesity trial results

LLY

New Projects/Investments

In the 68-week TRIUMPH-4 Phase 3 trial, retatrutide achieved up to 28.7% average body weight reduction (71.2 lbs) at the 12 mg dose versus –2.1% with placebo.
Retatrutide delivered up to a 75.8% reduction in WOMAC pain scores (4.5-point decrease) and significant improvements in physical function compared to placebo.
Safety profile aligned with incretin therapies; most common adverse events at 12 mg included nausea (43.2%), diarrhea (33.1%) and constipation (25.0%).
Seven additional Phase 3 retatrutide trials in obesity and type 2 diabetes are expected to complete in 2026, expanding its clinical evaluation.

Dec 11, 2025, 11:45 AM

Press Release

Lilly completes tender offer for Adverum Biotechnologies

LLY

M&A

Lilly’s subsidiary Flying Tigers Acquisition Corp. tender offer expired on December 8, 2025, offering $3.56 per share plus one CVR per share for up to $8.91 in contingent payments.
16,493,335 shares (approximately 64% of outstanding) were validly tendered and accepted, satisfying all offer conditions.
The acquisition is expected to be consummated on December 9, 2025 under the Merger Agreement dated October 24, 2025.
The deal expands Lilly’s gene therapy portfolio in age-related vision loss and brings Adverum’s team and platform into Lilly.

Dec 9, 2025, 1:28 PM

Press Release

Eli Lilly reports Phase 3 Jaypirca trial results in treatment-naive CLL/SLL

LLY

Eli Lilly’s Phase 3 BRUIN CLL-313 trial of Jaypirca (pirtobrutinib) versus bendamustine + rituximab in treatment-naïve CLL/SLL demonstrated an 80% reduction in risk of progression or death (HR 0.20; p < 0.0001) at a median follow-up of 28.1 months (data cutoff July 11, 2025).
The study enrolled 282 previously untreated CLL/SLL patients without del(17p) randomized 1:1 to continuous pirtobrutinib monotherapy or BR—marking the first prospective, randomized Phase 3 of a non-covalent BTK inhibitor in this front-line setting.
Safety profile favored Jaypirca: 40.0% of patients on pirtobrutinib experienced Grade ≥3 treatment-emergent adverse events versus 67.4% with BR, with fewer dose reductions (3.6% vs 31.1%) and discontinuations (4.3% vs 15.2%).
Overall survival showed a favorable trend for Jaypirca (HR 0.257; p = 0.0261) despite 52.9% of BR patients crossing over; OS data remain immature.
Lilly has begun submitting BRUIN CLL-313 data to regulatory authorities aiming to expand Jaypirca’s label into earlier lines of therapy next year.

Dec 9, 2025, 12:30 PM

Press Release

Eli Lilly’s Jaypirca meets primary endpoint in Phase 3 head-to-head trial versus Imbruvica

LLY

Jaypirca achieved non-inferiority on overall response rate: 87.0% vs. 78.5% for ibrutinib in the intent-to-treat population (nominal p = 0.0035).
Progression-free survival trending favorably, with a 43% risk reduction in the ITT population (HR = 0.569) and 76% in treatment-naïve patients (HR = 0.239).
Safety profile showed fewer key adverse events versus ibrutinib, including atrial fibrillation/flutter (2.4% vs. 13.5%) and hypertension (10.6% vs. 15.1%), plus lower dose reductions (7.9% vs. 18.2%) and discontinuations (9.4% vs. 10.8%).
Phase 3 BRUIN CLL-314 enrolled 662 patients (331 per arm; ITT: 225 treatment-naïve, 437 relapsed/refractory); results to be published in the Journal of Clinical Oncology and presented at ASH 2025.

Dec 7, 2025, 9:30 PM

Press Release

Eli Lilly Gains Full FDA Approval for Jaypirca in CLL/SLL Treatment

LLY

FDA grants full traditional approval to Jaypirca for relapsed/refractory CLL/SLL after covalent BTK inhibitor, upgrading from accelerated approval in December 2023.
Phase 3 BRUIN-CLL-321 trial demonstrated median progression-free survival of 11.2 months versus 8.7 months for comparators.
Jaypirca, the only non-covalent BTK inhibitor approved for this indication, is available in 50 mg and 100 mg tablet formulations.
Eli Lilly’s stock price was $1,039.16, down 0.67%, following the FDA announcement.

Dec 3, 2025, 8:18 PM

Morningstar

Eli Lilly’s Jaypirca receives expanded FDA approval for CLL/SLL

LLY

Product Launch

U.S. FDA granted traditional approval for Jaypirca (pirtobrutinib) in adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor, converting its December 2023 accelerated approval to a full approval.
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor, offering continuity in BTK pathway targeting after covalent BTK inhibitor therapy.
The label expansion allows physicians to use Jaypirca earlier in the treatment course immediately following covalent BTK inhibitor failure.
Approval is supported by the BRUIN CLL-321 Phase 3 trial, which randomized 238 patients 1:1 to Jaypirca versus investigator’s choice (idelalisib + rituximab or bendamustine + rituximab) with progression-free survival as the primary endpoint.

Dec 3, 2025, 5:59 PM

Press Release

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ELI LILLY & (LLY)

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