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Post by wyattdog on Jun 25, 2021 21:55:56 GMT -5
MannKind Plans Late-Stage Afrezza Insulin Powder Trial in Pediatric Patients in Fall
2:52 PM ET, 06/25/2021 - MT Newswires
02:52 PM EDT, 06/25/2021 (MT Newswires) -- MannKind (MNKD) said Friday it plans to start a late-stage trial of its Afrezza inhalation insulin powder drug to improve glycemic control in pediatric patients with diabetes later this year, backed by results from its mid-stage study presented at the American Diabetes Association meeting this week.
"The pharmacokinetics and safety results provide us the rationale to move forward with conducting a phase 3 safety and efficacy study in pediatric patients with diabetes, which we expect to initiate in the fall," said Kevin Kaiserman, vice president of medical affairs and safety at MannKind.
Afrezza inhaled insulin powder is already indicated to improve glycemic control in adult patients with diabetes mellitus.
MannKind shares were over 4% lower in afternoon trading.
Price: 4.53, Change: -0.19, Percent Change: -3.93
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Post by uvula on Jun 25, 2021 22:43:57 GMT -5
Might explain the end of day trading if something leaked.
"Kevin Kaiserman, vice president of medical affairs and safety at MannKind." Is he new? Don't recognize the name.
Update. Googled him. Been there since end of August.
Update 2: it isn't a leak if the news is announced before the stock market closes.
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Post by Clement on Jun 26, 2021 8:37:57 GMT -5
MannKind Plans Late-Stage Afrezza Insulin Powder Trial in Pediatric Patients in Fall 2:52 PM ET, 06/25/2021 - MT Newswires 02:52 PM EDT, 06/25/2021 (MT Newswires) -- MannKind (MNKD) said Friday it plans to start a late-stage trial of its Afrezza inhalation insulin powder drug to improve glycemic control in pediatric patients with diabetes later this year, backed by results from its mid-stage study presented at the American Diabetes Association meeting this week. "The pharmacokinetics and safety results provide us the rationale to move forward with conducting a phase 3 safety and efficacy study in pediatric patients with diabetes, which we expect to initiate in the fall," said Kevin Kaiserman, vice president of medical affairs and safety at MannKind. Afrezza inhaled insulin powder is already indicated to improve glycemic control in adult patients with diabetes mellitus. MannKind shares were over 4% lower in afternoon trading. Price: 4.53, Change: -0.19, Percent Change: -3.93 Price at the close 4.74. Up 0.21 from time of news item (2:52 pm ET). |
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Post by cjm18 on Jun 26, 2021 11:07:08 GMT -5
Price went up not Bc Of this. But preparing the market/public for the real peds trial. Good job mannkind.
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Post by radgray68 on Jun 26, 2021 14:10:20 GMT -5
A full six months on Afrezza with an optional six months option/follow-up period. Can anyone see both parents and children wanting to go BACK to needles? It'd seem primitive I would think. If titration and dosing are improved over trials 170-171(?) we should finally, finally get Al's Mann's Holy S---! Kind of numbers.
Looking at the 20 year chart, back before inadequate dosing, limiting label and a reluctant Sanofi helped ruin Afrezza's reputation, Wall Street once valued Mannkind at $100. In the period after trial results, leading up to approval, we still got up to $50.....TWICE.
I believe that superior pediatric trial results, along with all the other positives happening between now and then, will cause us to explode to the $25 range. At least $10-15.
So does anyone think I'm out of my mind?
"And I still think they're cheap"
- Al Mann
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Post by awesomo on Jun 26, 2021 14:25:27 GMT -5
A full six months on Afrezza with an optional six months option/follow-up period. Can anyone see both parents and children wanting to go BACK to needles? It'd seem primitive I would think. If titration and dosing are improved over trials 170-171(?) we should finally, finally get Al's Mann's Holy S---! Kind of numbers. Looking at the 20 year chart, back before inadequate dosing, limiting label and a reluctant Sanofi helped ruin Afrezza's reputation, Wall Street once valued Mannkind at $100. In the period after trial results, leading up to approval, we still got up to $50.....TWICE. I believe that superior pediatric trial results, along with all the other positives happening between now and then, will cause us to explode to the $25 range. At least $10-15. So does anyone think I'm out of my mind? "And I still think they're cheap" - Al Mann Yes, it hit those highs on pure speculation that Afrezza would become a billion dollar blockbuster drug. 5+ years later that hasn’t even come close to becoming a sniff of reality. Valuation off Afrezza speculation is long over, so no trial is going to cause the share price to skyrocket until it translates to actual revenue. |
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Post by cjm18 on Jun 26, 2021 14:26:57 GMT -5
A full six months on Afrezza with an optional six months option/follow-up period. Can anyone see both parents and children wanting to go BACK to needles? It'd seem primitive I would think. If titration and dosing are improved over trials 170-171(?) we should finally, finally get Al's Mann's Holy S---! Kind of numbers. Looking at the 20 year chart, back before inadequate dosing, limiting label and a reluctant Sanofi helped ruin Afrezza's reputation, Wall Street once valued Mannkind at $100. In the period after trial results, leading up to approval, we still got up to $50.....TWICE. I believe that superior pediatric trial results, along with all the other positives happening between now and then, will cause us to explode to the $25 range. At least $10-15. So does anyone think I'm out of my mind? "And I still think they're cheap" - Al Mann Yes. Market cap was 2.5B (4B for a second) due to Afrezza approval. That’s 10 bucks (16 dollars for a second) today. |
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Post by sellhighdrinklow on Jun 26, 2021 14:46:19 GMT -5
If the trial doesn't include a CGM for all patients, it will be very unfortunate imho
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Post by golfeveryday on Jun 26, 2021 15:42:31 GMT -5
MannKind Plans Late-Stage Afrezza Insulin Powder Trial in Pediatric Patients in Fall 2:52 PM ET, 06/25/2021 - MT Newswires 02:52 PM EDT, 06/25/2021 (MT Newswires) -- MannKind (MNKD) said Friday it plans to start a late-stage trial of its Afrezza inhalation insulin powder drug to improve glycemic control in pediatric patients with diabetes later this year, backed by results from its mid-stage study presented at the American Diabetes Association meeting this week. "The pharmacokinetics and safety results provide us the rationale to move forward with conducting a phase 3 safety and efficacy study in pediatric patients with diabetes, which we expect to initiate in the fall," said Kevin Kaiserman, vice president of medical affairs and safety at MannKind. Afrezza inhaled insulin powder is already indicated to improve glycemic control in adult patients with diabetes mellitus. MannKind shares were over 4% lower in afternoon trading. Price: 4.53, Change: -0.19, Percent Change: -3.93 they have been talking about this Peds trial forever and it is still not starting until the Fall. The big issue before was money. Now they have it. What are they waiting on to start this? Something related to the label maybe? Did they submit for a label update before P3? Waiting on a partner? |
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Post by sportsrancho on Jun 26, 2021 20:55:12 GMT -5
MannKind Plans Late-Stage Afrezza Insulin Powder Trial in Pediatric Patients in Fall 2:52 PM ET, 06/25/2021 - MT Newswires 02:52 PM EDT, 06/25/2021 (MT Newswires) -- MannKind (MNKD) said Friday it plans to start a late-stage trial of its Afrezza inhalation insulin powder drug to improve glycemic control in pediatric patients with diabetes later this year, backed by results from its mid-stage study presented at the American Diabetes Association meeting this week. "The pharmacokinetics and safety results provide us the rationale to move forward with conducting a phase 3 safety and efficacy study in pediatric patients with diabetes, which we expect to initiate in the fall," said Kevin Kaiserman, vice president of medical affairs and safety at MannKind. Afrezza inhaled insulin powder is already indicated to improve glycemic control in adult patients with diabetes mellitus. MannKind shares were over 4% lower in afternoon trading. Price: 4.53, Change: -0.19, Percent Change: -3.93 they have been talking about this Peds trial forever and it is still not starting until the Fall. The big issue before was money. Now they have it. What are they waiting on to start this? Something related to the label maybe? Did they submit for a label update before P3? Waiting on a partner? Or deciding if they want to spend the money? |
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Post by dh4mizzou on Jun 27, 2021 6:12:59 GMT -5
they have been talking about this Peds trial forever and it is still not starting until the Fall. The big issue before was money. Now they have it. What are they waiting on to start this? Something related to the label maybe? Did they submit for a label update before P3? Waiting on a partner? Or deciding if they want to spend the money? I'm interested to hear your reasoning for this comment. |
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Post by prcgorman2 on Jun 27, 2021 8:49:13 GMT -5
MannKind Plans Late-Stage Afrezza Insulin Powder Trial in Pediatric Patients in Fall 2:52 PM ET, 06/25/2021 - MT Newswires 02:52 PM EDT, 06/25/2021 (MT Newswires) -- MannKind (MNKD) said Friday it plans to start a late-stage trial of its Afrezza inhalation insulin powder drug to improve glycemic control in pediatric patients with diabetes later this year, backed by results from its mid-stage study presented at the American Diabetes Association meeting this week. "The pharmacokinetics and safety results provide us the rationale to move forward with conducting a phase 3 safety and efficacy study in pediatric patients with diabetes, which we expect to initiate in the fall," said Kevin Kaiserman, vice president of medical affairs and safety at MannKind. Afrezza inhaled insulin powder is already indicated to improve glycemic control in adult patients with diabetes mellitus. MannKind shares were over 4% lower in afternoon trading. Price: 4.53, Change: -0.19, Percent Change: -3.93 they have been talking about this Peds trial forever and it is still not starting until the Fall. The big issue before was money. Now they have it. What are they waiting on to start this? Something related to the label maybe? Did they submit for a label update before P3? Waiting on a partner? Trials happen in phases and over extended periods of time, and you might recall there was about a year of lockdowns thanks to COVID19. |
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Post by sportsrancho on Jun 27, 2021 8:54:09 GMT -5
Or deciding if they want to spend the money? I'm interested to hear your reasoning for this comment. Could be any of the above but with sales so low like I said in the Vdex thread I have a personal sense of urgency about it. They’re not where they projected they would be as far as revenue. Scripts etc. |
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Post by MnkdWASmyRtrmntPlan on Jun 27, 2021 9:32:33 GMT -5
Exactly, Sports. MC struggled at MNKD in charge of Sales, and even after 3 years as CEO, he has been a failure at getting sales of the potentially revolutionary Afrezza to anything close to an inflection point.
Despite Bill from Vdex shouting the solution to Afrezza's obstacles-to-success in his ear with a megaphone for years now, Afrezza sales have plateaued and flailed all that time.
In fact, he appears to have given up and put it on the shelf, waiting for the only other potential catalyst, Peds ... and that progress is moving a a snail's pace imho.
Sure, we will still get there ... eventually. But, come on already! How can long-term investors not be impatient?!
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Post by hellodolly on Jun 27, 2021 10:36:42 GMT -5
Might explain the end of day trading if something leaked. "Kevin Kaiserman, vice president of medical affairs and safety at MannKind." Is he new? Don't recognize the name. Update. Googled him. Been there since end of August. Update 2: it isn't a leak if the news is announced before the stock market closes. All of the Russell Indexes reconstituted at the close on Friday. The Russell does this once a year. Going up means they added more shares but, it was market mechanics that drove the last minute price increase. |
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