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Sanofi completes acquisition of DR-0201 Paris

Key Takeaway: Sanofi has completed its acquisition of DR-0201 from Dren Bio, now designated as SAR448501. This bispecific myeloid cell engager is aimed at treating B-cell mediated autoimmune diseases by inducing deep B-cell depletion. Sanofi's acquisition is expected to strengthen its immunology portfolio, particularly in addressing unmet needs in conditions like lupus. The deal involves an upfront payment of $600 million and potential future milestone payments of $1.3 billion.
Price reaction · baseline $51.98 (2025-05-23 close) · hit after-hours · clean, no other SNY news in the window
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Market Sentiment Analysis

POSITIVE FACTORS

  • Sanofi's acquisition of DR-0201 enhances its immunology pipeline.
  • The acquired drug has shown robust B-cell depletion in studies.
  • The potential to reset the immune system offers hope for autoimmune disease patients.

CONCERNS & RISKS

  • The acquisition involves significant upfront and potential future payments.
  • There are inherent risks in clinical development and regulatory approvals.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+11%
120-day peak, hindsight
Typical move
1.8%
average across 15 past catalysts
Lead asset
teplizumab/mL
Phase 2 · Diabetes Mellitus, Type 1

Full Press Release Details

Sanofi completes acquisition of DR-0201
Paris, May 27, 2025. Sanofi announces the completion of its acquisition of DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., a private clinical-stage biopharmaceutical company. The acquisition bolsters Sanofi s
ambition to become the foremost immunology company and broadens the company s leading immunology pipeline.
DR-0201, now named SAR448501, has shown robust B-cell depletion in pre-clinical and early clinical studies. The potential first-in-class targeted bispecific myeloid cell engager targets and engages
specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis.
Recent pre-clinical and early clinical study data in autoimmune diseases suggest that deep B- cell depletion has the potential to reset the adaptive immune system, leading to
sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.
Sanofi acquired DR-0201 through the acquisition of the Dren Bio affiliate Dren 0201, Inc. for an upfront payment of
$600 million and potential future payments totaling $1.3 billion upon achievements of certain development and launch milestones. Dren Bio will continue to operate independently to advance its pipeline of antibody therapeutics that
selectively deplete pathogenic cells and other disease-causing agents.
an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into
the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
| +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 |
+33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
Aliz Kaisserian | +33 6 47 04 12 11 |
| +1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | +1 781 249 1766 |
+33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Ch telet | +33 6 80 80 89 90 |
84 00 90 72 | yun.li3@sanofi.com
Jeff Macfarland, EVP, Finance | ir@drenbio.com
Sanofi forward-looking statements
This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements
are generally identified by the words expects , anticipates , believes , intends , estimates , plans and similar expressions. Although Sanofi s management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the
availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi s ability to
benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and
other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with
the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofi s annual report on Form 20-F
for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Frequently Asked Questions

What is DR-0201 now called?

DR-0201 is now named SAR448501 after Sanofi's acquisition.

What are the benefits of SAR448501?

SAR448501 shows strong B-cell depletion and may reset the adaptive immune system.

How much did Sanofi pay for DR-0201?

Sanofi paid $600 million upfront, with potential future payments of $1.3 billion.

What will Dren Bio do after the acquisition?

Dren Bio will continue operating independently to advance its pipeline.

What is Sanofi's goal with this acquisition?

Sanofi aims to become the leading immunology company by expanding its pipeline.

Last updated: May 27, 2025