DNLI Tops on Q2 Earnings, Expects Decree on Hunter Syndrome Drug in '26
Denali Therapeutics posts narrower-than-expected Q2 loss. The company advances multiple rare disease therapies toward potential approvals.
Catalyst Pharmaceutics to Report Q2 Earnings: What's in the Cards?
CPRX gears up to report Q2 results as Firdapse sales rise, Agamree grows, and Fycompa faces a post-patent dip.
Amgen Gears Up to Report Q2 Earnings: Will the Beat Streak Continue?
AMGN eyes another earnings beat as strong drug volumes offset pricing pressure and biosimilar headwinds.
Tenvie Therapeutics Promotes Tony Estrada, PhD, to Chief Executive Officer
SOUTH SAN FRANCISCO, Calif., July 23, 2025 ( GLOBE NEWSWIRE ) -- Tenvie Therapeutics, a biotechnology company committed to engineering small molecules that transform the treatment of neurological diseases, today announced the appointment of Tony Estrada, Ph.D., as President and Chief Executive ...
Royalty Pharma Appoints Carole Ho and Elizabeth Weatherman to the Company's Board of Directors
NEW YORK, July 17, 2025 ( GLOBE NEWSWIRE ) -- Royalty Pharma plc ( Nasdaq: RPRX ) today announced the appointment of Carole Ho and Elizabeth ( Bess ) Weatherman to its Board of Directors, effective immediately. Carole Ho is Chief Medical Officer and Head of Development at Denali Therapeutics, a ...
Royalty Pharma Appoints Carole Ho and Elizabeth Weatherman to the Company's Board of Directors - Royalty Pharma ( NASDAQ:RPRX )
Strengthens Board of Directors with appointment of two new independent members, increasing independent representation to greater than 90% Underscores Royalty Pharma's commitment to enhanced corporate governance following acquisition of its external manager
DNLI's BLA for Hunter Syndrome Drug Gets FDA's Priority Review
Denali's lead drug for Hunter syndrome wins FDA Priority Review, marking a key step toward commercial-stage status.
Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application ( BLA ) for Tividenofusp Alfa for Hunter Syndrome ( MPS II ) - Denali Therapeutics ( NASDAQ:DNLI )
FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approval Tividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brain Tividenofusp alfa leads company's broader TransportVehicle™-enabled pipeline
Why Is Denali Therapeutics ( DNLI ) Up 0.7% Since Last Earnings Report?
Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Denali Q1 Loss Wider Than Expected, Hunter Syndrome Drug in Focus
DNLI reports a wider-than-expected loss for the first quarter of 2025. Denali submits a BLA for tividenofusp alfa under the FDA???s accelerated approval pathway based on data from the phase I/II study in participants with Hunter syndrome.
5 Drug/Biotech Stocks Likely to Outperform Q1 Earnings Estimates
Let us look at some drug/biotech stocks, NVO, PCRX, RARE, ACAD and DNLI, which are poised to beat on first-quarter 2025 earnings.
Viatris Q1 Earnings Release: What's in Store for the Stock?
VTRS' Q1 results are likely to gain from new product launches in all major geographies.
Can Amgen Keep the Beat Streak Alive This Earnings Season?
Volume growth of AMGN's key drugs like Evenity, Repatha and Kyprolis is expected to have been partially offset by biosimilar/generic competition for mature drugs.
DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up
Denali stock up as it begins rolling BLA submission with the FDA for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome.
What Happened To Denali Therapeutics Stock Wednesday? - Denali Therapeutics ( NASDAQ:DNLI )
Denali initiates its biologics license application ( BLA ) application for the accelerated approval of Tividenofusp Alfa. Denali announces that it expects the BLA application to be completed by mid-May. Feel unsure about the market's next move?
Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome ( MPS II ) and Positive Ongoing Interactions with FDA on DNL126 Through START Program - Denali Therapeutics ( NASDAQ:DNLI )
Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026 Alignment through recent interactions with CDER on path to accelerated approval and conversion to full approval for tividenofusp alfa
Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome ( MPS II ) and Positive Ongoing Interactions with FDA on DNL126 Through START Program
SOUTH SAN FRANCISCO, Calif., April 02, 2025 ( GLOBE NEWSWIRE ) -- Denali Therapeutics Inc. ( NASDAQ: DNLI ) , today announced that the company's initiation of a rolling submission of a biologics license application ( BLA ) for accelerated approval of tividenofusp alfa for the treatment of Hunter ...
Why You Shouldn't Bet Against Denali ( DNLI ) Stock
Denali (DNLI) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.
Denali Therapeutics Ends ALS Trial Extension, Analyst Stays Optimistic Despite Trial Setback - Denali Therapeutics ( NASDAQ:DNLI )
Denali's ALS drug DNL343 failed to show efficacy in slowing disease progression. Analyst lowers Denali's fair value estimate from $32 to $30 per share. Get 5 stock picks identified before their biggest breakouts, identified by the same system that spotted Insmed, Sprouts, and Uber before their ...
Denali Q4 Earnings Beat Estimates, Hunter Syndrome Drug in Focus
DNLI reports a narrower-than-expected loss for the fourth quarter of 2024. Denali remains on track to submit a BLA for tividenofusp alfa for the treatment of MPS II (Hunter syndrome).
DNLI Reports Upbeat Longer-Term Data From Hunter Syndrome Study
Denali announces encouraging additional longer-term data from the phase I/II Hunter Syndrome study of its investigational therapy, tividenofusp alfa.
Amgen Set to Report Q4 Earnings: Is a Beat in the Cards?
Volume growth of AMGN's key drugs like Prolia, Repatha and Evenity is expected to have been partially offset by biosimilar/generic competition for mature drugs.
Denali Gains 26.6% in a Year: How Should You Play the Stock?
DNLI has had a good run in the past year on positive pipeline updates. A potential approval of its Hunter Syndrome drug should be a boost. However, recent pipeline setbacks warrant caution.
Why Is Denali Therapeutics Stock Trading Higher On Wednesday? - Denali Therapeutics ( NASDAQ:DNLI )
Denali Therapeutics Inc DNLI CEO Ryan Watts presented at the J.P. Morgan Healthcare Conference.
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome.
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome ( MPS II )
Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated ...
Denali's ALS Study Fails to Meet Primary and Secondary Endpoints
DNLI's DNL343 fails to achieve the primary and secondary endpoints, as observed from an analysis of Regimen G of the phase II/III HEALEY ALS platform trial.
Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected - Denali Therapeutics ( NASDAQ:DNLI )
On Monday, Denali Therapeutics Inc. DNLI revealed topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for amyotrophic lateral sclerosis. Compared to placebo, the study did not meet the primary endpoint of efficacy in slowing disease progression.
Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial - Denali Therapeutics ( NASDAQ:DNLI )
Primary endpoint of overall function ( ALSFRS-R ) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24 weeks
Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial
SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 ( GLOBE NEWSWIRE ) -- Denali Therapeutics Inc. ( NASDAQ: DNLI ) today announced topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis ( ...
Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic - Denali Therapeutics ( NASDAQ:DNLI )
William Blair has initiated coverage on Denali Therapeutics Inc DNLI, a company focused on developing drugs for neurodegenerative diseases. The analyst highlights that Denali is developing a specialized transport vehicle ( TV ) platform to enhance the delivery of treatments across the blood-brain ...
This Denali Therapeutics Analyst Begins Coverage On A Bullish Note; Here Are Top Initiations For Friday - Denali Therapeutics ( NASDAQ:DNLI ) , Elevation Oncology ( NASDAQ:ELEV )
Top Wall Street analysts initiated coverage on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page. William Blair analyst Andy Hsieh initiated coverage on Elevation Oncology, Inc.
Why Is Denali Therapeutics ( DNLI ) Down 21.2% Since Last Earnings Report?
Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Denali Starts Dosing in Phase II Parkinson's Disease Study
DNLI begins dosing in the phase IIa study on BIIB122 in approximately 50 participants with Parkinson's disease and LRRK2 pathogenic mutations confirmed by genetic testing.
Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson's Disease - Denali Therapeutics ( NASDAQ:DNLI )
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 ( GLOBE NEWSWIRE ) -- Denali Therapeutics Inc. DNLI today announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug leucine-rich repeat kinase 2 ( LRRK2 ) inhibitor BIIB122 ( DNL151 ) in participants with ...
Denali Q3 Earnings Miss Estimates, Pipeline Progress Encouraging
DNLI reports a wider-than-expected loss in the third quarter of 2024. Nonetheless, the pipeline progress has been encouraging.
Analysts Estimate Arcus Biosciences, Inc. ( RCUS ) to Report a Decline in Earnings: What to Look Out for
Arcus Biosciences (RCUS) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Denali Therapeutics Inc. ( DNLI ) May Report Negative Earnings: Know the Trend Ahead of Q3 Release
Denali Therapeutics (DNLI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Denali Therapeutics Stock Is Sliding After The Bell: Here's Why - Denali Therapeutics ( NASDAQ:DNLI )
Denali Therapeutics Inc DNLI shares are moving lower in Thursday's after-hours session after the company announced that its Phase 2 study of oditrasertib was discontinued.
Inozyme Pharma Announces Appointment of Biopharmaceutical Commercial Leader Erik Harris to its Board of Directors - Inozyme Pharma ( NASDAQ:INZY )
BOSTON, Oct. 07, 2024 ( GLOBE NEWSWIRE ) -- Inozyme Pharma, Inc. INZY ( "the Company" or "Inozyme" ) , a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced the appointment of Erik Harris ...
Inozyme Pharma Announces Appointment of Biopharmaceutical Commercial Leader Erik Harris to its Board of Directors
BOSTON, Oct. 07, 2024 ( GLOBE NEWSWIRE ) -- Inozyme Pharma, Inc. ( Nasdaq: INZY ) ( "the Company" or "Inozyme" ) , a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced the appointment of ...
Strength Seen in Voyager Therapeutics ( VYGR ) : Can Its 17.5% Jump Turn into More Strength?
Voyager Therapeutics (VYGR) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
Strength Seen in Denali Therapeutics ( DNLI ) : Can Its 10.1% Jump Turn into More Strength?
Denali Therapeutics (DNLI) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.
Why Is Kymera Therapeutics ( KYMR ) Up 10.9% Since Last Earnings Report?
Kymera Therapeutics (KYMR) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Myriad ( MYGN ) Down 4.8% Since Last Earnings Report: Can It Rebound?
Myriad (MYGN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug
DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS II and its subsequent conversion to full approval.
Why Is BioMarin ( BMRN ) Up 5.4% Since Last Earnings Report?
BioMarin (BMRN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Denali Therapeutics Announces Successful Meeting with the FDA and Plans to File for Accelerated Approval of Tividenofusp Alfa ( DNL310 ) for the Treatment of MPS II ( Hunter Syndrome )
SOUTH SAN FRANCISCO, Calif., Sept. 03, 2024 ( GLOBE NEWSWIRE ) -- Denali Therapeutics Inc. ( Nasdaq: DNLI ) today announced the outcome of a recent successful meeting with the Center for Drug Evaluation and Research ( CDER ) division of the U.S.
Denali Therapeutics Announces Publication in Science Translational Medicine Demonstrating the Potential of the Oligonucleotide Transport Vehicle Platform to Achieve Broad Biodistribution of Antisense Oligonucleotides in the CNS and Muscle Following Intravenous Administration
SOUTH SAN FRANCISCO, Calif., Aug. 14, 2024 ( GLOBE NEWSWIRE ) -- Denali Therapeutics Inc. ( Nasdaq: DNLI ) , a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier ( BBB ) for the treatment of neurodegenerative and lysosomal ...
Wall Street Analysts Believe Denali Therapeutics ( DNLI ) Could Rally 79.62%: Here's is How to Trade
The consensus price target hints at a 79.6% upside potential for Denali Therapeutics (DNLI). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
