Lilly's sofetabart mipitecan receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer

Rhea-AI Summary

Eli Lilly (NYSE: LLY) announced that the U.S. FDA granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) on January 20, 2026 for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received prior bevacizumab and mirvetuximab soravtansine, if eligible.

Sofetabart mipitecan is an FRα antibody-drug conjugate using proprietary linker technology and an exatecan payload. The designation was based on encouraging preliminary Phase 1a/b results showing responses across all FRα expression levels, activity in patients who progressed after mirvetuximab soravtansine, and a tolerability profile with low rates of interstitial lung disease, peripheral neuropathy, and alopecia. Lilly has initiated the global Phase 3 FRAmework-01 trial (NCT07213804).

Positive

• FDA Breakthrough Therapy designation granted on Jan 20, 2026
• Phase 1a/b showed responses across all FRα expression levels
• Activity observed in patients progressed on prior mirvetuximab soravtansine
• Advanced into global Phase 3 FRAmework-01 study (NCT07213804)
• Preliminary tolerability: low rates of ILD, neuropathy, alopecia

Negative

• Regulatory advantage based on preliminary Phase 1 data, not confirmatory evidence
• Indicated population requires prior bevacizumab and mirvetuximab soravtansine, limiting eligible patients
• Phase 3 results and final approval timeline remain uncertain

News Market Reaction

+0.28%

1 alert

+0.28% News Effect

On the day this news was published, LLY gained 0.28%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Development phase: Phase 1a/b and Phase 3 Trial identifier: NCT07213804 Expression coverage: All FRα levels +5 more

8 metrics

Development phase Phase 1a/b and Phase 3 Preliminary Phase 1a/b data underpinning Phase 3 FRAmework-01 trial

Trial identifier NCT07213804 FRAmework-01 global Phase 3 study of sofetabart mipitecan

Expression coverage All FRα levels Responses reported across all folate receptor alpha expression levels

Toxicity profile Low ILD, neuropathy, alopecia Phase 1 data indicated promising tolerability and no significant ocular toxicity

Current price $1,038.40 Price before news, <b>-8.43%</b> vs 52-week high

52-week range $623.78 – $1,133.95 LLY trading well above 52-week low, below recent high

Market cap $929,387,477,269 Pre-news equity value for Eli Lilly and Company

Relative volume 1.39x Volume 3,827,476 vs 20-day average 2,752,392 before this announcement

Market Reality Check

Price: $1058.18 Vol: Volume 3,827,476 vs 20-da...

normal vol

$1058.18 Last Close

Volume Volume 3,827,476 vs 20-day average 2,752,392 (relative volume 1.39) ahead of this news. normal

Technical Price 1,038.40 trading above 200-day MA at 839.70, roughly 8.4% below 52-week high 1,133.95.

Peers on Argus

LLY was up 0.53% while key peers were mixed: ABBV -0.58%, JNJ -0.17%, AZN -0.05%...

LLY was up 0.53% while key peers were mixed: ABBV -0.58%, JNJ -0.17%, AZN -0.05%, NVS +0.39%, NVO +4.04%. The lack of a uniform move suggests this Breakthrough Therapy designation was more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Jan 09 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 09	Partner IPO news	Neutral	-2.0%	Vida Ventures highlighted Aktis IPO and Lilly-linked collaboration value.
Jan 08	Clinical data update	Positive	-2.1%	Phase 3b TOGETHER-PsA trial showed superior efficacy for Taltz plus Zepbound.
Jan 07	M&A transaction	Positive	-2.1%	Lilly agreed to acquire Ventyx Biosciences in a <b>$1.2B</b> all-cash deal.
Dec 18	Clinical trial success	Positive	+1.4%	Orforglipron Phase 3 trial met primary and key secondary endpoints.
Dec 16	Conference participation	Neutral	-0.7%	Planned participation in the J.P. Morgan Healthcare Conference.

Pattern Detected

Recent price reactions show mixed behavior: some positive clinical updates aligned with gains, while other positive R&D and deal news coincided with declines.

Recent Company History

Over the past months, LLY has reported several notable developments. A Phase 3 trial of oral orforglipron met all endpoints and was followed by a +1.45% move. In contrast, positive psoriatic arthritis Phase 3b data and a $1.2 billion Ventyx acquisition each coincided with -2.07% reactions. Conference participation and partner-related news had relatively modest impacts. Against this backdrop, the FDA Breakthrough Therapy designation for sofetabart mipitecan adds another significant clinical milestone to Lilly’s pipeline narrative.

Market Pulse Summary

This announcement highlights the FDA Breakthrough Therapy designation for sofetabart mipitecan in pl...

Analysis

This announcement highlights the FDA Breakthrough Therapy designation for sofetabart mipitecan in platinum-resistant ovarian cancer, backed by Phase 1 data and advancement into the global Phase 3 FRAmework-01 trial (NCT07213804). Within Lilly’s recent flow of positive trial readouts and acquisitions, it adds another late-stage oncology asset targeting a high unmet need. Investors may monitor future efficacy and safety readouts, regulatory interactions, and any updates on study enrollment or expansion across folate receptor alpha expression levels.

Key Terms

breakthrough therapy designation, platinum-resistant, antibody-drug conjugate, folate receptor alpha, +4 more

8 terms

breakthrough therapy designation regulatory

"FDA has granted Breakthrough Therapy designation to sofetabart mipitecan..."

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

platinum-resistant medical

"for the treatment of adult patients with platinum-resistant epithelial ovarian..."

Platinum-resistant describes a cancer that no longer responds to chemotherapy drugs containing platinum, such as cisplatin or carboplatin. Like a key that no longer fits a lock, these tumors stop shrinking after treatment, which matters to investors because it narrows standard therapy options, drives demand for novel drugs or combination regimens, affects clinical trial design and endpoints, and can change a treatment’s potential market size and regulatory path.

antibody-drug conjugate medical

"Sofetabart mipitecan is a novel folate receptor alpha (FRα) antibody-drug conjugate..."

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

folate receptor alpha medical

"a novel folate receptor alpha (FRα) antibody-drug conjugate (ADC)..."

Folate receptor alpha is a protein on the surface of some cells that acts like a lock for folate, a vitamin cells need; certain cancers present many more of these “locks” than healthy tissue. Because it can serve as a clear marker of disease and a focused entry point for drugs or imaging agents, it matters to investors — therapies or diagnostics that target this receptor can affect clinical trial success, regulatory approval, and commercial value.

interstitial lung disease medical

"low rates of interstitial lung disease, peripheral neuropathy, and alopecia..."

A group of lung conditions that cause inflammation and scarring of the thin tissue between the air sacs, which makes it harder for oxygen to pass into the blood; imagine the lungs’ fine filters becoming stiff and less effective. Investors care because reports of interstitial lung disease can affect a drug’s safety profile, trigger regulatory warnings or label changes, and shift demand for treatments or create liability risks that influence a company’s valuation.

peripheral neuropathy medical

"low rates of interstitial lung disease, peripheral neuropathy, and alopecia..."

A condition where nerves outside the brain and spinal cord are damaged, causing numbness, tingling, pain or weakness—like faulty wiring that sends mixed or dropped signals between the brain and parts of the body. Investors watch it because it drives demand for drugs, medical devices and diagnostics, shapes clinical trial results and regulatory decisions, and can influence healthcare costs, company revenues and legal risk in related industries.

monotherapy medical

"a global trial investigating the treatment as a monotherapy in patients with..."

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

clinicaltrials.gov regulatory

"Phase 3 FRAmework-01 study (NCT07213804), a global trial investigating..."

clinicaltrials.gov is a publicly accessible U.S. government database that lists details, timelines and status updates for medical studies testing drugs, devices or procedures. For investors it acts like a public calendar and scoreboard—showing when trials start, are delayed, or report results—so it helps gauge a company’s development progress, regulatory risk and potential value impact before official earnings or approvals are announced.

AI-generated analysis. Not financial advice.

INDIANAPOLIS, Jan. 20, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sofetabart mipitecan (LY4170156) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible. Sofetabart mipitecan is a novel folate receptor alpha (FRα) antibody-drug conjugate (ADC) that uses proprietary linker technology and an exatecan payload. 

Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

"Platinum-resistant ovarian cancer remains one of the most challenging settings in gynecologic oncology, with limited treatment options and poor outcomes for patients," said Bhavana Pothuri, M.D., professor of Obstetrics/Gynecology and Medicine at NYU Grossman School of Medicine, NYU Langone Health and director of Clinical Trials Office at the Perlmutter Cancer Center. "The Breakthrough Therapy designation and preliminary clinical data for sofetabart mipitecan across all levels of FRα expression are encouraging and point to its potential as a meaningful treatment option for patients."

"We are pleased the FDA has granted Breakthrough Therapy designation for sofetabart mipitecan, reflecting the significant unmet need in platinum-resistant ovarian cancer and the promising initial results shown in our Phase 1 study," said Jacob Van Naarden, executive vice president, and president of Lilly Oncology and head of corporate business development. "Building on compelling results generated to date, we've initiated our Phase 3 FRAmework-01 trial with the goal of bringing a potential therapeutic option to patients with advanced ovarian cancer, across all levels of folate receptor expression."

The FDA Breakthrough Therapy designation is based on encouraging preliminary results from the Phase 1a/b study. Lilly presented initial Phase 1 results at the 2025 ASCO Annual Meeting in June and updated data at the 2025 ESMO Congress in October, showing responses at all dose levels and across all FRα expression levels, including in patients who progressed on prior mirvetuximab soravtansine. These initial data also indicate a promising tolerability profile with low rates of interstitial lung disease, peripheral neuropathy, and alopecia, and no significant ocular toxicity.

Sofetabart mipitecan recently advanced into the Phase 3 FRAmework-01 study (NCT07213804), a global trial investigating the treatment as a monotherapy in patients with platinum resistant ovarian cancer (PROC), and in combination with bevacizumab in patients with platinum-sensitive ovarian cancer (PSOC). Lilly is conducting the FRAmework-01 study in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT)

About Ovarian Cancer
Ovarian cancer is the fifth leading cause of cancer death among women in the United States. While most patients initially respond to platinum-based chemotherapy, approximately 70% will experience recurrence, leading to progressively shorter remission periods with each subsequent treatment. When cancer recurs during or within six months of platinum therapy, known as platinum-resistant disease, patients face limited treatment options. 

About Sofetabart Mipitecan
Sofetabart mipitecan (LY4170156) is composed of an Fc-silent, folate receptor alpha (FRα) specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink™). Sofetabart mipitecan was designed to target FRα across all expression levels with improved therapeutic index. FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth.^1,2 FRα is overexpressed in many solid tumors such as ovarian, non-small cell lung, and colorectal cancers.^1,3,4 Sofetabart mipitecan is currently being studied in patients with ovarian cancer as well as other FRα-expressing solid tumors, NCT06400472 and NCT07213804.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about sofetabart mipitecan as a potential treatment for people with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received prior bevacizumab and mirvetuximab soravtansine, if eligible, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that any of these therapies will prove to be a safe and effective treatment or receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Refer to:	Michelle Webb; michelle.webb@lilly.com; 463-206-4463 (Media)
	Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)

¹ Bax, Heather J et al. "Folate receptor alpha in ovarian cancer tissue and patient serum is associated with disease burden and treatment outcomes." British journal of cancer vol. 128,2 (2023): 342-353. doi:10.1038/s41416-022-02031-x Bax HJ, et al. Br J Cancer. 2023;128(2):342-353.
² Scaranti, Mariana et al. "Exploiting the folate receptor α in oncology." Nature reviews. Clinical oncology vol. 17,6 (2020): 349-359. doi:10.1038/s41571-020-0339-5.
³ Kalli, Kimberly R et al. "Folate receptor alpha as a tumor target in epithelial ovarian cancer." Gynecologic oncology vol. 108,3 (2008): 619-26. doi:10.1016/j.ygyno.2007.11.020.
⁴ Viricel W, et al. Cancer Res. 2023;83(suppl 7):1544.

 

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SOURCE Eli Lilly and Company

FAQ

What did Eli Lilly announce about sofetabart mipitecan (LY4170156) on January 20, 2026?

The FDA granted Breakthrough Therapy designation for sofetabart mipitecan for certain platinum-resistant ovarian cancers.

Why did the FDA grant Breakthrough Therapy designation to sofetabart mipitecan (LLY)?

The designation was based on encouraging preliminary Phase 1a/b results showing responses across FRα levels and a promising tolerability profile.

What is the current clinical status of sofetabart mipitecan (LLY)?

Sofetabart mipitecan has advanced into the global Phase 3 FRAmework-01 trial (NCT07213804).

Which patients are eligible under the Breakthrough designation for sofetabart mipitecan (LLY)?

Adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received prior bevacizumab and mirvetuximab soravtansine, if eligible.

What safety signals were reported for sofetabart mipitecan in Phase 1 results?

Initial data indicated low rates of interstitial lung disease, peripheral neuropathy, and alopecia, and no significant ocular toxicity.

Does Breakthrough Therapy designation mean sofetabart mipitecan is approved (LLY)?

No; Breakthrough Therapy designation expedites development and review but does not equal FDA approval.