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Post by mnholdem on Jun 25, 2018 7:17:29 GMT -5
20%-25% reduction WITHOUT REGARD to adherence to the dosing protocol. That is impressive.
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Post by mnholdem on Jun 25, 2018 3:43:36 GMT -5
Apparently MannKind released the PR exclusively to GlobeNewsWire. Reprints of the GNW report started showing up yesterday at other online news sites, such as Bloombergs.
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Post by mnholdem on Jun 24, 2018 16:43:05 GMT -5
Discussing government, administration or its departments' and agencies' policies and actions, if related to the drug industry or Wall Street, is fine. Same with congressional actions along the same vein. However, let's leave political ideologies off our discussion board, please.  |
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Post by mnholdem on Jun 15, 2018 10:33:34 GMT -5
I asked CEO Castagna about a refrigeration study via email back in July-2017:
Good Morning!
Have you considered sponsoring a post-market trial that would provide data confirming that Afrezza cartridges may be stored at room temperature? The impact of that label change would be pretty significant. As a PharmaD you can appreciate the likelihood that pharmacies may welcome not having to refrigerate Afrezza packs, not to mention the reduced costs of shipping. I emailed this recommendation to Matt and Ray last year shortly after Afrezza commercialization was returned by Sanofi-Aventis.
I know we’re shooting for that “ultra-fast acting” label, but not having to refrigerate Afrezza cartridges would be yet another benefit to consumers.
I’m looking forward the team speaking at 2Q17 earnings call. Good luck!
This was Mike's response:
If we felt that would drive growth we would have done it by now. It's the least of our issues and therefore we are spending our capital in other places bc that process below is 24+ months either way before you would be able to pull it off.
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So there you have it. The MannKind team is focusing on areas that will drive growth. Combined with the cost and duration ("24+ months) of conducting a study and obtaining approval to upgrade the label, the CEO believes there are higher priorities for capital spending.
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Post by mnholdem on Jun 15, 2018 8:28:36 GMT -5
Excerpt:
The company spent $2.9 billion getting Afrezza to market, and MannKind didn’t operate like a well-run pharmaceutical company, Castagna said. “We have to get the information out there. We’re already well on our way and Wall Street will catch up.” |
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Post by mnholdem on Jun 14, 2018 7:54:17 GMT -5
The $2 "reiteration" on the June 13 article does seem to be a misprint because Oren's last target call on MNKD was published only a month ago (May 10):
"...while H.C. Wainwright analyst Oren Livnat sticks tight with the bulls, he dials down his target expectations. The company’s innovative asset Afrezza, a rapid-acting, inhaled mealtime insulin for Type 1 and Type 2 diabetes is experiencing a more sluggish-to-take-off ramp than Livnat anticipated.
"On back of the quarterly earnings show, the analyst reiterates a Buy rating on MNKD stock while dialing the price target from $7 to $5, which implies a 184% upside from current levels. "
Source: www.smarteranalyst.com/analyst-insights/h-c-wainwright-sticks-bulls-mannkind-mnkd-lowers-price-target-sluggish-afrezza-adoption/
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Post by mnholdem on Jun 14, 2018 6:40:32 GMT -5
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Post by mnholdem on Jun 13, 2018 16:10:10 GMT -5
The article (which I posted excerpts of in Articles) states that the PAH drug is not yet factored into that price target. |
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Post by mnholdem on Jun 13, 2018 16:01:08 GMT -5
MannKind (MNKD) Phase 1 Data Hints at ‘Transformational’ PAH Drug, Cheers H.C. Wainwright
H.C. Wainwright's Oren Livnat sees compelling potential for MNKD's dry powder inhalation PAH drug to grab substantial share or "grow the market." Julie Lamb, Senior Editor-June 13, 2018, 3:41 PM ET Excerpt:
H.C. Wainwright analyst Oren Livnat is out with an upbeat research note on MannKind (NASDAQ:MNKD) and its prospective pulmonary arterial hypertension (PAH) innovation, Technosphere treprostinil. Last Thursday, the biotech player released positive Phase 1 data of its dry powder inhalation designed for PAH and with impressive timing- “months ahead of schedule.” Livnat cheers this as a key indication that MNKD”s inhalation asset delivery platforms pose prospectively vastly “more value” when weighed up against “just” Afrezza inhalable insulin.
Therefore, the analyst reiterates a Buy rating on MNKD stock with a $2 price target, which implies a 5% upside from current levels.
Though Livnat is not factoring in the PAH asset so far in his expectations, he nonetheless sees a powerhouse drug that could become “transformational.” Consider that United Therapeutics’ PAH treprostinil franchise circles beyond $1.1 billion in sales this year translating to more than $500 million for parenteral Remodulin, $375 million for inhalable Tyvaso, as well as $240 million for oral Orenitram. Source: www.smarteranalyst.com/analyst-insights/biotech-stocks/mannkind-mnkd-phase-1-data-hints-transformational-pah-drug-cheers-h-c-wainwright/
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Post by mnholdem on Jun 13, 2018 11:38:20 GMT -5
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Post by mnholdem on Jun 12, 2018 16:02:54 GMT -5
I've been browsing the funds listed at WhaleWisdom, particularly PUT holdings. Many have been reducing their PUTS by around 50% since previous filings, FWIW.
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Post by mnholdem on Jun 12, 2018 7:31:36 GMT -5
CEO Michael Castagna recently spoke about how TreT has medical properties which can position MannKind to take a significant percentage of the PAH treatment market. If you are a MNKD shareholder, you may be interested in the current Medicare pricing for the current PAH Standard of Care (Tyvaso). Even though this report is from Nov-2016, you can bet that PAH drug prices (like most drugs) are not getting cheaper:
5 Most Expensive Medicare Drugs -- and Which Companies Are Getting Rich from Them
Excerpt:
3. Tyvaso
Another pulmonary arterial hypertension treatment, Tyvaso, came in right behind Remodulin on Medicare's list of costly drugs. Medicare spent $107,489 per patient for Tyvaso in 2015.
Like Remodulin, Tyvaso is sold by United Therapeutics. Tyvaso, an inhaled solution for PAH, received U.S. regulatory approval in 2009. United Therapeutics made $470.1 million in net sales for the drug last year -- roughly 32% of the company's total revenue.
Source: www.fool.com/investing/2016/11/20/5-most-expensive-medicare-drugs-and-which-companie.aspx
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Post by mnholdem on Jun 11, 2018 8:25:46 GMT -5
ClinicalTrials.gov Identifier: NCT02527265
Recruitment Status: Recruiting
First Posted: August 18, 2015
Last Update Posted: May 16, 2018
Study Design
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Single-arm, Multiple-dose Safety, Titration, and Pharmacokinetic Trial of Afrezza® in Pediatric Patients Ages 4 to 17 Years With Type 1 Diabetes Mellitus
Actual Study Start Date: September 28, 2017
Estimated Primary Completion Date: July 2020
Estimated Study Completion Date: January 2021
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This study design was posted in 2015 when MannKind had a different CEO and Chief Medical Officer working with the FDA. With Michael Castagna PharmD promoted to CEO in May-2017, followed by the hiring of David Kendall MD as the company's new CMO, the trial design and estimated completion dates may have changed.
Even though the ClinicalTrials.gov site for this trial was last updated May-2018, MannKind may not have revised the estimated completion dates on this filing, even though the graphics presented at the ASM indicate that the trial may be completed way ahead of schedule.
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Post by mnholdem on Jun 7, 2018 15:18:27 GMT -5
Perhaps but it's still encouraging to see the largest shareholders adding to their positions, even if on behalf of their clients.
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Post by mnholdem on Jun 7, 2018 13:48:07 GMT -5
| Name | Shares | Change | MNKD Shares Held | | Sabby Management LLC | 7,801,908 | 7,801,908 | 6.19% | | D. E. Shaw & Co LP | 4,988,205 | 963,649 | 3.96% | | Vanguard Group Inc | 4,589,397 | 132,878 | 3.64% | | Fidelity Management & Research Company | 1,801,400 | 0 | 1.43 | | BlackRock Inc | 1,764,375 | -54,874 | 1.40% | | BlackRock Institutional Trust Company NA | 1,721,153 | 5,591 | 1.37% | | Deerfield Management Co | 1,482,601 | 1,482,601 | 1.18% | | Goldman, Sachs & Co. | 1,467,025 | 1,077,238 | 1.16% | | Scopia Management Inc | 1,129,453 | 1,129,453 | 0.90% | | Millennium Management LLC | 1,039,696 | 878,432 | 0.83% | Top 10 Institutions Totals
| 33,692,916
| 12,586,688
| 26.73%
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Comments:
Sabby & Scopia are new among Top 10 Institutional Investors Goldman, Sach & Co increased holdings by 376% Deerfield position confirms that they did not hold onto previous shares issued last year in lieu of interest payments
Top 10 Institutional Investors, accounting for 26.73% of MNKD shares, have increased their positions by 22.6%
Reports filed May-2018 (sources: WhaleWisdom, Morningstar)
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