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Denali to Sell Priority Review Voucher for $195M Cash Boost
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Key Takeaways
DNLI signed a definitive agreement to sell its Rare Pediatric Disease PRV for $195M in gross proceeds.
The PRV was awarded after FDA accelerated approval of Avlayah for Hunter syndrome in March 2026.
DNLI said the non-dilutive funding will help advance its clinical portfolio in key disease areas.
Denali Therapeutics Inc. (DNLI - Free Report) announced that it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (“PRV”).
The sale will generate gross proceeds of $195 million.
The PRV was granted to DNLI following the FDA accelerated approval of Avlayah (tividenofusp alfa-eknm) in March 2026 for the treatment of Hunter syndrome (mucopolysaccharidosis type II, or MPS II).
The transaction provides a significant non-dilutive capital infusion, strengthening the company’s balance sheet without requiring an equity raise. The added financial flexibility will help advance Denali’s broad TransportVehicle-enabled clinical portfolio for lysosomal storage disorders and neurodegenerative diseases.
The PRV sale remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
Shares of DNLI have gained 41.2% year to date against the industry’s 1.7% decline.
Image Source: Zacks Investment Research
More on DNLI’s Avlayah
Avlayah is the first FDA-approved therapy based on an emerging of biotherapeutics designed to cross the blood-brain barrier using transferrin receptor (TfR)-mediated transport technology.
The approval for Avlayah has significantly boosted DNLI’s growth prospects.
Denali's clinical-stage portfolio includes DNL126 for Sanfilippo syndrome type A (MPS IIIA), DNL593 for GRN-related frontotemporal dementia, DNL952 for Pompe disease and DNL628 for Alzheimer's disease.
Denali is also advancing several early-stage pipeline candidates, including DNL921 for Alzheimer's disease, DNL111 for Parkinson’s and Gaucher diseases, DNL622 for Hurler syndrome (MPS I), and DNL422 (OTV) for Parkinson’s disease.
Denali has also collaborated with other pharma and biotech giants like Sanofi (SNY - Free Report) , Biogen (BIIB - Free Report) and Takeda (TAK - Free Report) to develop other candidates.
Last month, Denali and partner Biogen announced disappointing top-line results from a mid-stage study evaluating BIIB122 (DNL151) in individuals with early-stage Parkinson’s disease.
The study did not meet its primary or secondary endpoints.
Consequently, Biogen and Denali have discontinued the development of BIIB122 in idiopathic Parkinson’s disease.
Nonetheless, Denali will continue independently advancing the phase IIa BEACON study on evaluating the small molecule inhibitor in patients carrying pathogenic LRRK2 variants.
Partner Sanofi is developing eclitasertib for moderate to severe ulcerative colitis.
In April 2026, Denali announced that partner Takeda decided to terminate their collaboration for DNL593 (PTV:PGRN) in frontotemporal dementia associated with GRN mutations (FTD-GRN).
The termination, effective 60 days after notice, returns full rights to the program to Denali. Per DNLI, Takeda’s decision was based on strategic priorities and not on any efficacy or safety issues.
The company’s sound cash position is a positive and underscores its ability to fund ongoing programs.
View the Zacks #1 Rank List
Image: Bigstock
Denali to Sell Priority Review Voucher for $195M Cash Boost
Key Takeaways
Denali Therapeutics Inc. (DNLI - Free Report) announced that it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (“PRV”).
The sale will generate gross proceeds of $195 million.
The PRV was granted to DNLI following the FDA accelerated approval of Avlayah (tividenofusp alfa-eknm) in March 2026 for the treatment of Hunter syndrome (mucopolysaccharidosis type II, or MPS II).
The transaction provides a significant non-dilutive capital infusion, strengthening the company’s balance sheet without requiring an equity raise. The added financial flexibility will help advance Denali’s broad TransportVehicle-enabled clinical portfolio for lysosomal storage disorders and neurodegenerative diseases.
The PRV sale remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
Shares of DNLI have gained 41.2% year to date against the industry’s 1.7% decline.
Image Source: Zacks Investment Research
More on DNLI’s Avlayah
Avlayah is the first FDA-approved therapy based on an emerging of biotherapeutics designed to cross the blood-brain barrier using transferrin receptor (TfR)-mediated transport technology.
The approval for Avlayah has significantly boosted DNLI’s growth prospects.
Denali's clinical-stage portfolio includes DNL126 for Sanfilippo syndrome type A (MPS IIIA), DNL593 for GRN-related frontotemporal dementia, DNL952 for Pompe disease and DNL628 for Alzheimer's disease.
Denali is also advancing several early-stage pipeline candidates, including DNL921 for Alzheimer's disease, DNL111 for Parkinson’s and Gaucher diseases, DNL622 for Hurler syndrome (MPS I), and DNL422 (OTV) for Parkinson’s disease.
Denali has also collaborated with other pharma and biotech giants like Sanofi (SNY - Free Report) , Biogen (BIIB - Free Report) and Takeda (TAK - Free Report) to develop other candidates.
Last month, Denali and partner Biogen announced disappointing top-line results from a mid-stage study evaluating BIIB122 (DNL151) in individuals with early-stage Parkinson’s disease.
The study did not meet its primary or secondary endpoints.
Consequently, Biogen and Denali have discontinued the development of BIIB122 in idiopathic Parkinson’s disease.
Nonetheless, Denali will continue independently advancing the phase IIa BEACON study on evaluating the small molecule inhibitor in patients carrying pathogenic LRRK2 variants.
Partner Sanofi is developing eclitasertib for moderate to severe ulcerative colitis.
In April 2026, Denali announced that partner Takeda decided to terminate their collaboration for DNL593 (PTV:PGRN) in frontotemporal dementia associated with GRN mutations (FTD-GRN).
The termination, effective 60 days after notice, returns full rights to the program to Denali. Per DNLI, Takeda’s decision was based on strategic priorities and not on any efficacy or safety issues.
The company’s sound cash position is a positive and underscores its ability to fund ongoing programs.
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.