STOCK TITAN

Royalty Pharma and Denali Therapeutics Announce $275 Million Royalty Funding Agreement

Rhea-AI Impact
(High)
Rhea-AI Sentiment
(Neutral)
Tags

Royalty Pharma (Nasdaq: RPRX) agreed to provide $275 million in synthetic royalty funding to Denali Therapeutics (Nasdaq: DNLI) tied to future net sales of tividenofusp alfa for MPS II (Hunter syndrome).

Royalty Pharma will pay $200 million at closing and an additional $75 million upon EMA approval by Dec 31, 2029. In return, Royalty Pharma receives a 9.25% royalty on worldwide net sales, capped at a 3.0x multiple (or 2.5x if reached by Q1 2039). The transaction requires U.S. FDA accelerated approval (PDUFA date Apr 5, 2026).

Loading...
Loading translation...

Positive

  • $275M upfront/contingent funding for Denali
  • 9.25% royalty provides predictable monetization
  • $200M initial cash at closing strengthens liquidity
  • Contingent $75M on EMA approval extends funding runway

Negative

  • Funding contingent on FDA accelerated approval (PDUFA Apr 5, 2026)
  • Royalty capped at 3.0x (or 2.5x by Q1 2039) limits long-term upside
  • Additional $75M payment depends on EMA approval by Dec 31, 2029

News Market Reaction

-1.10%
1 alert
-1.10% News Effect
-$254M Valuation Impact
$22.86B Market Cap
1K Volume

On the day this news was published, RPRX declined 1.10%, reflecting a mild negative market reaction. This price movement removed approximately $254M from the company's valuation, bringing the market cap to $22.86B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Royalty funding size: $275 million Initial payment: $200 million Milestone payment: $75 million +5 more
8 metrics
Royalty funding size $275 million Total synthetic royalty funding tied to tividenofusp alfa sales
Initial payment $200 million Payment by Royalty Pharma at closing of the transaction
Milestone payment $75 million Additional payment upon EMA approval by Dec 31, 2029
Royalty rate 9.25% Royalty on worldwide net sales of tividenofusp alfa
Royalty cap multiple 3.0x Maximum multiple on Royalty Pharma’s invested capital
Early cap multiple 2.5x Reduced cap if reached by Q1 2039
PDUFA date April 5, 2026 Target action date for FDA review of tividenofusp alfa BLA
EMA deadline December 31, 2029 Deadline for EMA approval to trigger $75M payment

Market Reality Check

Price: $45.19 Vol: Volume 4,089,828 vs 20-da...
normal vol
$45.19 Last Close
Volume Volume 4,089,828 vs 20-day average 4,268,849 (relative volume 0.96x). normal
Technical Price $38.81 is trading above the 200-day MA of $35.30 and 5.9% below the 52-week high of $41.24.

Peers on Argus

Peers show mixed moves: GMAB +1.97%, INSM +2.63%, INCY +, SMMT +0.78%, while BNT...

Peers show mixed moves: GMAB +1.97%, INSM +2.63%, INCY +, SMMT +0.78%, while BNTX is -0.36%, suggesting stock-specific factors for RPRX.

Historical Context

5 past events · Latest: Dec 04 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 04 Royalty funding deal Positive -1.1% $275M synthetic royalty funding agreement tied to tividenofusp alfa.
Nov 26 Investor conferences Neutral +0.8% Participation in two early-December healthcare investor conferences.
Nov 05 Q3 2025 earnings Positive +6.8% Q3 growth, higher Portfolio Receipts, and raised full‑year guidance.
Nov 04 Royalty acquisition Positive +1.4% $310M purchase of 1% AMVUTTRA royalty through March 2035.
Oct 17 Dividend declaration Positive +1.8% Declared Q4 2025 dividend of $0.22 per Class A share.
Pattern Detected

Recent fundamentally positive events (earnings beat/guidance raise, acquisitions, dividend) generally coincided with positive price reactions, while the Denali royalty agreement saw a mild negative move, indicating occasional divergence on new deal announcements.

Recent Company History

Over the last few months, Royalty Pharma reported strong Q3 2025 results with Portfolio Receipts of $814M (up 11%) and raised full‑year guidance to $3.20B–$3.25B, which was followed by a 6.82% gain. The company continued capital deployment, acquiring an AMVUTTRA royalty for $310M and announcing a $0.22 Q4 2025 dividend, both associated with positive stock reactions. The new $275M synthetic royalty deal with Denali fits this strategy, though its initial -1.1% move diverged from the usual positive response to capital allocation news.

Market Pulse Summary

This announcement adds a new revenue-linked asset to Royalty Pharma’s portfolio via a $275M syntheti...
Analysis

This announcement adds a new revenue-linked asset to Royalty Pharma’s portfolio via a $275M synthetic royalty tied to tividenofusp alfa, contingent on regulatory approvals. It follows recent capital deployment, including the AMVUTTRA royalty purchase and strong Q3 2025 Portfolio Receipts growth. Investors may track progress toward the April 5, 2026 PDUFA date, subsequent EMA decisions, and how this commitment fits alongside leverage, cash generation, and future deal capacity.

Key Terms

biologics license application, accelerated approval, u.s. food and drug administration, prescription drug user fee act (pdufa), +2 more
6 terms
biologics license application regulatory
"A Biologics License Application (BLA) for accelerated approval..."
A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.
accelerated approval regulatory
"BLA for accelerated approval of tividenofusp alfa is under review..."
Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.
u.s. food and drug administration regulatory
"under review by the U.S. Food and Drug Administration (FDA)..."
The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.
prescription drug user fee act (pdufa) regulatory
"with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026."
The Prescription Drug User Fee Act (PDUFA) is a law that allows drug companies to pay fees to the government to help speed up the review process for new medicines. This funding aims to ensure that important drugs reach patients faster, which can influence a company's ability to bring products to market efficiently. For investors, PDUFA-related decisions can impact drug approval timelines and company performance.
enzyme replacement therapy medical
"lead investigational ... enzyme replacement therapy for the treatment of MPS II..."
Enzyme replacement therapy is a medical treatment that involves providing patients with artificial versions of natural enzymes their bodies are missing or not producing enough of. This approach can help manage certain health conditions by restoring essential functions, similar to replacing a faulty part in a machine to keep it running smoothly. For investors, advancements or approvals in this therapy can signal progress in biotech innovation and potential market growth.
blood-brain barrier medical
"Denali’s technology platform delivers therapeutics across the blood-brain barrier..."
A protective barrier of tightly packed cells and supporting tissue that controls what substances in the blood can enter the brain, acting like a security checkpoint that keeps out most pathogens and many drugs while allowing essential nutrients through. For investors, the barrier matters because whether a therapy can cross or safely bypass it often determines clinical success, regulatory approval and commercial potential for treatments of brain disorders.

AI-generated analysis. Not financial advice.

NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Denali Therapeutics, Inc. (Nasdaq: DNLI) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa.

Tividenofusp alfa is Denali’s lead investigational TransportVehicleTM-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026.

“We are delighted to partner with Denali and acquire a royalty on tividenofusp alfa, an innovative therapy that addresses a significant unmet need in the cognitive and physical manifestations of Hunter syndrome,” said Pablo Legorreta, Chief Executive Officer and Chairman of the Board of Royalty Pharma. “Denali’s technology platform delivers therapeutics across the blood-brain barrier and is a promising new approach to brain diseases. We are thrilled to establish a relationship with Denali and believe tividenofusp alfa is a potential practice-changing therapy that could transform the lives of patients with Hunter syndrome.”

“We are pleased to partner with Royalty Pharma, whose investment recognizes the value and potential of tividenofusp alfa for the Hunter community and supports our ability more broadly to realize the promise of the TransportVehicle platform,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “With these additional funds, we are well positioned to advance our development programs as we prepare for the launch of tividenofusp alfa, unlocking broad opportunities across serious diseases.”

Transaction Terms

The transaction is subject to various closing conditions, including Denali achieving U.S. FDA accelerated approval of tividenofusp alfa. At the closing, Royalty Pharma will make an initial payment of $200 million and Royalty Pharma will be obligated to make an additional payment of $75 million upon achieving European Medicines Agency (EMA) approval of tividenofusp alfa by December 31, 2029. In exchange, Royalty Pharma will receive a 9.25% royalty on worldwide net sales of tividenofusp alfa from Denali. The royalty payments to Royalty Pharma will cease upon reaching a multiple of 3.0x, or 2.5x if achieved by the first quarter of 2039.

Advisors

Gibson Dunn acted as legal advisor to Denali. Goodwin Procter and Maiwald acted as legal advisors to Royalty Pharma.

About Royalty Pharma

Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta and Alyftrek, GSK’s Trelegy, Roche’s Evrysdi, Johnson & Johnson’s Tremfya, Biogen’s Tysabri and Spinraza, Servier’s Voranigo, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Pfizer’s Nurtec ODT, and Gilead’s Trodelvy, and 18 development-stage product candidates.

About Denali Therapeutics

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using its proprietary TransportVehicleTM platform. With a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform the lives of people living with neurodegenerative, lysosomal storage and other serious diseases. For more information, please visit www.denalitherapeutics.com.

Royalty Pharma Forward-Looking Statements

The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this document unless stated otherwise, and neither the delivery of this document at any time, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof. This document contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of Royalty Pharma’s strategies, financing plans, growth opportunities, market growth, and plans for capital deployment. In some cases, you can identify such forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “target,” “forecast,” “guidance,” “goal,” “predicts,” “project,” “potential” or “continue,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of Royalty Pharma’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, and other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of Royalty Pharma’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this document are made only as of the date hereof. Royalty Pharma does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law. For further information, please reference Royalty Pharma’s reports and documents filed with the U.S. Securities and Exchange Commission (“SEC”) by visiting EDGAR on the SEC’s website at www.sec.gov.

Denali Therapeutics Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, plans, timelines and expectations related to tividenofusp alfa and Denali’s TransportVehicle platform; expectations regarding the collaboration with Royalty Pharma, including financial aspects of the royalty financing agreement; the potential benefits and results of the royalty financing agreement; expectations regarding achieving accelerated approval from the FDA; and plans to conduct development and commercialization activities.

Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of the agreement with Royalty Pharma; the impact of adverse economic conditions, tariffs, and inflation on Denali’s business and operations; Denali’s transition to a late-stage clinical drug development company; Denali’s and its partners’ ability to complete the development and, if approved, commercialization of its product candidates; Denali’s reliance on third parties for the manufacture and supply of its product candidates; Denali’s dependence on successful development of its blood-brain barrier platform technology; Denali’s and its partners’ ability to conduct or complete clinical trials on expected timelines; the risk of significant adverse events, toxicities, or other undesirable side effects; the uncertainty that product candidates will receive regulatory approval necessary to be commercialized; developments relating to Denali’s competitors and its industry, including competing product candidates and therapies; Denali’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Denali’s strategic plans for its business, product candidates and blood-brain barrier platform technology; Denali’s ability to obtain additional capital to finance its operations, as needed; Denali’s ability to accurately forecast future financial results in the current environment; general economic and market conditions; and other risks and uncertainties, including those described in Denali’s most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on February 27, 2025 and November 6, 2025, and Denali’s future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Denali as of the date hereof. Denali disclaims any obligation to update any forward-looking statements, except as required by law.

Royalty Pharma Investor Relations and Communications

+1 (212) 883-6637
ir@royaltypharma.com

Denali Investor Contact

Laura Hansen, Ph.D.
hansen@dnli.com

Denali Media Contact

Erin Patton
epatton@dnli.com


FAQ

What did Royalty Pharma (RPRX) agree to pay Denali (DNLI) for tividenofusp alfa?

Royalty Pharma agreed to provide $275 million in funding: $200M at closing and $75M upon EMA approval by Dec 31, 2029.

What royalty rate will Royalty Pharma (RPRX) receive on tividenofusp alfa sales?

Royalty Pharma will receive a 9.25% royalty on worldwide net sales of tividenofusp alfa.

What are the approval conditions tied to the RPRX–DNLI transaction and key dates?

The transaction requires U.S. FDA accelerated approval (PDUFA target date Apr 5, 2026) and a contingent EMA approval by Dec 31, 2029 for the additional payment.

How long do royalty payments to Royalty Pharma (RPRX) last for tividenofusp alfa?

Royalties cease upon reaching a 3.0x multiple of payments, or 2.5x if that multiple is achieved by Q1 2039.

How will the initial $200M payment affect Denali Therapeutics' (DNLI) near-term finances?

The $200M initial payment provides immediate liquidity to advance launch preparedness and development programs as stated by management.

Does the RPRX funding dilute Denali (DNLI) shareholders?

This agreement is a synthetic royalty funding structure tied to future sales and does not describe an equity issuance in the disclosed terms.
Royalty Pharma Plc

NASDAQ:RPRX

RPRX Rankings

RPRX Latest News

RPRX Latest SEC Filings

RPRX Stock Data

19.36B
405.07M
Biotechnology
Pharmaceutical Preparations
Link
United States
NEW YORK