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Zacks News
Amgen Gears Up to Report Q2 Earnings: Will the Beat Streak Continue?
by Zacks Equity Research
AMGN eyes another earnings beat as strong drug volumes offset pricing pressure and biosimilar headwinds.
DNLI's BLA for Hunter Syndrome Drug Gets FDA's Priority Review
by Zacks Equity Research
Denali's lead drug for Hunter syndrome wins FDA Priority Review, marking a key step toward commercial-stage status.
Why Is Denali Therapeutics (DNLI) Up 0.7% Since Last Earnings Report?
by Zacks Equity Research
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
by Zacks Equity Research
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
by Ahan Chakraborty
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?
by Zacks Equity Research
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?
by Zacks Equity Research
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
by Zacks Equity Research
Denali stock up as it begins rolling BLA submission with the FDA for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome.
Why You Shouldn't Bet Against Denali (DNLI) Stock
by Zacks Equity Research
Denali (DNLI) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.
Denali Q4 Earnings Beat Estimates, Hunter Syndrome Drug in Focus
by Zacks Equity Research
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
by Zacks Equity Research
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?
by Zacks Equity Research
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?
by Zacks Equity Research
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.
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
by Zacks Equity Research
Denali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome.
Denali's ALS Study Fails to Meet Primary and Secondary Endpoints
by Zacks Equity Research
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.
Why Is Denali Therapeutics (DNLI) Down 21.2% Since Last Earnings Report?
by Zacks Equity Research
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
by Zacks Equity Research
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 Q3 Earnings Miss Estimates, Pipeline Progress Encouraging
by Zacks Equity Research
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
by Zacks Equity Research
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
by Zacks Equity Research
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.
Strength Seen in Voyager Therapeutics (VYGR): Can Its 17.5% Jump Turn into More Strength?
by Zacks Equity Research
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?
by Zacks Equity Research
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?
by Zacks Equity Research
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?
by Zacks Equity Research
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
by Zacks Equity Research
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.