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Great news for Lou Gehrig sufferers: First results should be available in a little over 6 months although with a fast track designation, the FDA may allow swifter approvals. Fast Track is like a gold star, quicker approval, no other available medicines, and great hope for successful results. The check for $ 40 million will be cut for the 2nd quarter.
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Denali Therapeutics reached a 52 Week low at 23.08
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Denali Therapeutics reached a 52 Week low at 22.27
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Denali Therapeutics reached a 52 Week low at 26.22
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Denali Therapeutics reached a 52 Week low at 27.50
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Denali Therapeutics reached a 52 Week low at 27.79
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Denali Therapeutics reached a 52 Week low at 24.32
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Denali Therapeutics reached a 52 Week low at 28.47
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More good news for patients: The Phase 1/2 trial is more for safety and dosage since there is no treatment for FTD and it is always fatal within a short period of time. Researchers keep up the good work!
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Understanding the recent announcement from Denali...everything is working fine. Receiving payments from various companies for studies being done and all old products and new products are advancing. On Hunter's disease they have gone from 5 patients to 12 and the BBB drugs are working well. This board is more worried about finances: Remember they have about $1.4 Billion in cash and are receiving payments for studies in the present quarter. That is almost $ 13. per share in cash. They will probably show a profit of $ 400 Million for the year and thus about $ 4. per share or 17 times earnings. The future is probably not $ 100. per share, try a multiple of $ 1,000. Wait for more information on January 12th!
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Rapid response was observed in most patients (n=12) by Week 7, which is consistent with the crossing of the blood-brain barrier (BBB) and activity in tissues of the CNS.
Furthermore, the observed decline in urine and serum heparan sulfate was consistent with improved peripheral activity with DNL310.
Exploratory clinical data suggest improved clinical symptoms and function for all five patients enrolled in Cohort A.
Data showed clinical improvement in overall MPS II symptoms, cognitive abilities, behavior, and physical abilities.
The safety profile of DNL310 remained consistent with the standard of care enzyme replacement therapy.
DNL310 was generally well tolerated, with the most common treatment-emergent adverse events being infusion-related reactions.
Infusion reactions occurred in 12 of 17 (71%) patients, and the majority had mild or moderate reactions.
Denali is accelerating efforts to initiate a pivotal Phase 2/3 study in 1H 2022.
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ALS study with DNL343 is over the initial 28 day period which began on 8/11/21. Since there has been no mention of it failing or any toxic results, then the study with active participants is continuing. Although this study is supposed to take a year and a half, due to the extremely deadly disease progression, any positive news would show within a very short time, maybe within in a month of initial dosing. Hold on for the initial results! The results may already be apparent.
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News like today's fast track designation for Hunter Syndrome only furthers my conviction in DNLI. I love the fact Denali is still fairly under the radar and doesn't trade on the whims of most day traders. I own all my shares (decent sized position) in the mid-high teens and as strange as it sounds, am considering adding a bit to my position up here in the low-$60's. I've long said Denali is this generations Genentech and will one day reach a $100B+ valuation and possibly significantly higher. Good luck DNLI longs!
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Nice Run! I do notice that these new highs are on low volume...absence of sellers rather than an absence of buyers. I'm glad that shareholders are taking a long term approach to allow the company to do their important research and development of their pipeline without the hype of Wall Street day traders!
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DNLI continually making new all-time highs and yet, still an under the radar stock. The potential for this company is immense. Roche v2.0!
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Exciting news about Hunter's...3 months of results to be discussed. Only a small amount of patients have Hunter's, around 500, in the USA, but the BBB transport system can be applied to other neurodegenerative diseases. Thanks for the great work!
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Surprising to see DNLI drop by 7%+ with the broad market up huge today. Unconcerned as a long shareholder, but strange to see nonetheless.
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What people should know about ALS is that the life expectancy is only 2 to 5 years, so a clinical study with positive results will be apparent before the termination of this study. As such, positive news will result in an almost 100% chance of medical acceptance and the reversible effects of DNL343 on the neurons will be quickly established and it will be available to patients immediately.
Fast Track is like a gold star, quicker approval, no other available medicines, and great hope for successful results.
The check for $ 40 million will be cut for the 2nd quarter.
Researchers keep up the good work!
On Hunter's disease they have gone from 5 patients to 12 and the BBB drugs are working well.
This board is more worried about finances: Remember they have about $1.4 Billion in cash and are receiving payments for studies in the present quarter. That is almost $ 13. per share in cash.
They will probably show a profit of $ 400 Million for the year and thus about $ 4. per share or 17 times earnings.
The future is probably not $ 100. per share, try a multiple of $ 1,000.
Wait for more information on January 12th!
Furthermore, the observed decline in urine and serum heparan sulfate was consistent with improved peripheral activity with DNL310.
Exploratory clinical data suggest improved clinical symptoms and function for all five patients enrolled in Cohort A.
Data showed clinical improvement in overall MPS II symptoms, cognitive abilities, behavior, and physical abilities.
The safety profile of DNL310 remained consistent with the standard of care enzyme replacement therapy.
DNL310 was generally well tolerated, with the most common treatment-emergent adverse events being infusion-related reactions.
Infusion reactions occurred in 12 of 17 (71%) patients, and the majority had mild or moderate reactions.
Denali is accelerating efforts to initiate a pivotal Phase 2/3 study in 1H 2022.
Since there has been no mention of it failing or any toxic results, then the study with active participants is continuing.
Although this study is supposed to take a year and a half, due to the extremely deadly disease progression, any positive news would show within a very short time, maybe within in a month of initial dosing.
Hold on for the initial results!
The results may already be apparent.
Thanks for the great work!
As such, positive news will result in an almost 100% chance of medical acceptance and the reversible effects of DNL343 on the neurons will be quickly established and it will be available to patients immediately.