We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Denali Enters Into a $275M Funding Deal With Royalty Pharma
Read MoreHide Full Article
Key Takeaways
Denali struck a $275M funding deal with Royalty Pharma tied to tividenofusp alfa.
RPRX will pay up to $275M for royalty rights contingent on U.S. and EU approvals.
Tividenofusp alfa's BLA review now targets April 5, 2026, after a major amendment submission.
Denali Therapeutics Inc. (DNLI - Free Report) has announced a funding agreement with Royalty Pharma plc (RPRX - Free Report) for $275 million. The stock gained 5.84% following the announcement.
The deal centers on future net sales of Denali’s lead drug candidate, tividenofusp alfa, an investigational TransportVehicle-enabled enzyme replacement therapy designed to treat mucopolysaccharidosis type II (MPS II), commonly known as Hunter syndrome.
The funding agreement with RPRX provides a significant influx of capital as Denali approaches a crucial regulatory event.
Please note that the biologics license application (BLA) seeking accelerated approval for tividenofusp alfa is currently under review in the United States, with a target action date set for April 5, 2026.
Shares of DNLI have lost 1.3% year to date against the industry’s 20% growth.
Image Source: Zacks Investment Research
More on DNLI’s Funding Agreement With RPRX
The transaction is contingent on various closing conditions, including accelerated approval of tividenofusp alfa by the FDA.
Upon closing, Royalty Pharma will make an initial payment of $200 million.
Royalty Pharma is also required to make an additional payment of $75 million once DNLI obtains European Medicines Agency approval of tividenofusp alfa by Dec. 31, 2029.
In lieu of the above-mentioned payments, 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.
More on DNLI’s Hunter Syndrome Drug
Denali earlier suffered a setback when the FDA extended its review timeline of the BLA seeking accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome.
Consequently, the target action date got extended to April 5 from Jan. 5, 2026.
The BLA was extended after DNLI submitted updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process. DNLI stated that the response was not related to efficacy, safety or biomarkers.
The FDA classified the submission as a major amendment to the BLA, leading to the extension of the target action date.
Nevertheless, the regulatory body did not ask for additional data.
Denali believes that the updated information submitted in the amendment does not affect the clinical pharmacology or benefit-risk conclusions of the BLA.
The FDA had previously granted tividenofusp alfa Breakthrough Therapy, Fast Track, Orphan Drug and Rare Pediatric Disease designations.
If approved, tividenofusp alfa may become the first Hunter syndrome therapy designed to address cognitive and physical manifestations of the disorder.
As of Sept. 30, 2025, cash, cash equivalents and marketable securities amounted to approximately $872.9 million.
DNLI’s Other Candidates
Denali is also developing other candidates in partnership with Takeda (TAK - Free Report) and Biogen (BIIB - Free Report) .
Denali and partner Takeda have collaborated to develop DNL593, an investigational therapeutic designed to deliver progranulin across the blood-brain barrier for the treatment of granulin (GRN) mutation-associated frontotemporal dementia (FTD-GRN). A phase I/II study is ongoing.
Denali and Biogen continue co-development of BIIB122. Biogen is leading the global phase IIb LUMA study, evaluating BIIB122's impact on disease progression in early-stage PD. In May 2025, Biogen announced that the LUMA study was fully enrolled, with a readout expected in 2026.
Meanwhile, Denali is conducting the phase IIa BEACON study, specifically enrolling participants with LRRK2-associated PD to assess how LRRK2 inhibition may impact this disease.
Image: Bigstock
Denali Enters Into a $275M Funding Deal With Royalty Pharma
Key Takeaways
Denali Therapeutics Inc. (DNLI - Free Report) has announced a funding agreement with Royalty Pharma plc (RPRX - Free Report) for $275 million. The stock gained 5.84% following the announcement.
The deal centers on future net sales of Denali’s lead drug candidate, tividenofusp alfa, an investigational TransportVehicle-enabled enzyme replacement therapy designed to treat mucopolysaccharidosis type II (MPS II), commonly known as Hunter syndrome.
The funding agreement with RPRX provides a significant influx of capital as Denali approaches a crucial regulatory event.
Please note that the biologics license application (BLA) seeking accelerated approval for tividenofusp alfa is currently under review in the United States, with a target action date set for April 5, 2026.
Shares of DNLI have lost 1.3% year to date against the industry’s 20% growth.
Image Source: Zacks Investment Research
More on DNLI’s Funding Agreement With RPRX
The transaction is contingent on various closing conditions, including accelerated approval of tividenofusp alfa by the FDA.
Upon closing, Royalty Pharma will make an initial payment of $200 million.
Royalty Pharma is also required to make an additional payment of $75 million once DNLI obtains European Medicines Agency approval of tividenofusp alfa by Dec. 31, 2029.
In lieu of the above-mentioned payments, 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.
More on DNLI’s Hunter Syndrome Drug
Denali earlier suffered a setback when the FDA extended its review timeline of the BLA seeking accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome.
Consequently, the target action date got extended to April 5 from Jan. 5, 2026.
The BLA was extended after DNLI submitted updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process. DNLI stated that the response was not related to efficacy, safety or biomarkers.
The FDA classified the submission as a major amendment to the BLA, leading to the extension of the target action date.
Nevertheless, the regulatory body did not ask for additional data.
Denali believes that the updated information submitted in the amendment does not affect the clinical pharmacology or benefit-risk conclusions of the BLA.
The FDA had previously granted tividenofusp alfa Breakthrough Therapy, Fast Track, Orphan Drug and Rare Pediatric Disease designations.
If approved, tividenofusp alfa may become the first Hunter syndrome therapy designed to address cognitive and physical manifestations of the disorder.
As of Sept. 30, 2025, cash, cash equivalents and marketable securities amounted to approximately $872.9 million.
DNLI’s Other Candidates
Denali is also developing other candidates in partnership with Takeda (TAK - Free Report) and Biogen (BIIB - Free Report) .
Denali and partner Takeda have collaborated to develop DNL593, an investigational therapeutic designed to deliver progranulin across the blood-brain barrier for the treatment of granulin (GRN) mutation-associated frontotemporal dementia (FTD-GRN). A phase I/II study is ongoing.
Denali and Biogen continue co-development of BIIB122. Biogen is leading the global phase IIb LUMA study, evaluating BIIB122's impact on disease progression in early-stage PD. In May 2025, Biogen announced that the LUMA study was fully enrolled, with a readout expected in 2026.
Meanwhile, Denali is conducting the phase IIa BEACON study, specifically enrolling participants with LRRK2-associated PD to assess how LRRK2 inhibition may impact this disease.
DNLI’s Zacks Rank
Denali currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.