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MANNKIND - 2013 endlich zum Überflieger?

Beiträge: 1.921
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MannKind 4,19 $ +0,72% Perf. seit Threadbeginn:   -66,61%
 
MANNKIND - 2013 endlich zum Überflieger? Oki-Wan 2.0
Oki-Wan 2.0:

MANNKIND - 2013 endlich zum Überflieger?

17
14.02.13 23:07
#1
Alle Anzeichen sprechen dafür, dass MannKind 2013 mit den erwarteten Phase III-Ergebnissen für Afrezza den Durchbruch schafft und das langersehnte FDA-Approval bekommt.
Für MannKind wäre es der Meilenstein schlechthin und durch die daraus erwirtschafteten Revenues würden auch die restlichen Pipelines einen riesigen Schub erfahren.
Soviel steht fest: es wird ein heisser Sommer und die kommenden Monate dürfte MannKind stark zulegen, wie es auch bei anderen Biotech-Schmieden kurz vor Phase III-Resultaten oft der Fall ist.
Zur weiteren Lektüre empfehle ich einen Blick hierauf:
1.
www.fool.com/investing/general/2013/02/13/...-to-watch-in.aspx
2.
finance.yahoo.com/q?s=MNKD
3.
www.nasdaq.com/symbol/mnkd/real-time#.UR1fXqVk6-h
und 4.
www.mannkindcorp.com

Beste Grüsse,
Oki-Wan 2.0

P.S.: Dies ist nur eine Anregung zur eigenen Recherche und keine Handelsempfehlung!
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MANNKIND - 2013 endlich zum Überflieger? Magnetfeldfredy
Magnetfeldfre.:

Mannkind und Afrezza

 
20.02.20 17:07
Top Daten zu Afrezza:

MannKind Presents Novel Scientific Data at 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020)
[GlobeNewswire]
GlobeNewswire•February 20, 2020

WESTLAKE VILLAGE, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD) today announced the presentation of results from multiple clinical studies of Afrezza® (insulin human) Inhalation Powder and MannKind’s BluHale® technology system. These data are being presented in both oral and poster presentations during the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020) in Madrid Spain, February 20-22, 2020.

“We are very pleased to have the opportunity to highlight these positive results during this year’s ATTD,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “These presentations highlight original studies of Afrezza in individuals with both type 1 and type 2 diabetes, and include initial studies of Afrezza in pediatric patients. In addition to the results of clinical studies, we are pleased to disclose novel data on the use of BluHale, our Bluetooth-enabled technology for real-time profiling of inhalation effort and other parameters associated with the use of our inhaler. Collectively, these data further expand our understanding of the unique clinical profile of Afrezza, and highlight the potential use of Afrezza in children and adolescents, as well as advancing the opportunity to create connected technology for our drug delivery system.”

Highlights of the original scientific disclosures:

   Preliminary data from an independent, investigator initiated study of Afrezza on the background of closed loop pump insulin delivery by means of an “artificial pancreas” system showed that pulmonary dosing allows for titration to higher unit doses in individuals with type 1 diabetes (presented by Alfonso Galderisi MD, PhD from Yale University).
   Clinical use of Afrezza in adults with uncontrolled type 2 diabetes on two or more glucose lowering therapies resulted in a significant (1.6%) drop in A1c levels and a significant increase in time in range (presented by Dr. Philip Levin MD, Endocrinology, MODEL Clinical Research).
   Pharmacokinetics (and pharmacodynamics) of Technosphere insulin in children and adolescents ages 8-17 with type 1 diabetes showed that the ultra rapid rise in insulin concentrations corresponded with early post-prandial glucose control within the first hour post-dose, similar to what has been observed in adult patients.
   Two poster presentations highlighting the use of MannKind’s unique Bluetooth enabled technology for enhanced instruction on use of the Afrezza inhaler and as a tool to provide connected dose information on top of continuous glucose monitoring data.

Dr. Phillip Levin, Principal Investigator from MODEL Clinical Research in Baltimore, MD and lead author on the study of uncontrolled type 2 diabetes patients, noted that “the addition and rapid titration of Afrezza in patients with type 2 diabetes not currently at goal using two or more glucose lowering therapies, resulted in a 1.6% reduction in A1C and significantly increased time in range as measured by CGM. Our study provides additional clarity on both dose requirements and the clinical impact of adding ultra rapid-acting Afrezza therapy in uncontrolled type 2 diabetes.”

In addition to the original scientific disclosure presented at this year’s ATTD meeting, Dr. Kendall will participate as faculty in the “Ultra-rapid Insulin Analogues” session on Saturday, February 22, during which he will provide a current perspective on the clinical use of Afrezza, including evidence that ultra rapid-acting Afrezza can be safely and effectively titrated in fixed dose increments and that speed of insulin action may supersede dose precision for achieving post-prandial glucose control.

The full title of each of the presentations, presenting author, and the date and time of each disclosure are provided below.
ORAL PRESENTATION HIGHLIGHTS
 
Title:   Technosphere® Insulin Provides Better Early Postprandial Glucose Control Than Subcutaneous Rapid-Acting Analogue
(ATTD 2020 - Saturday February 22, 2020; 8:50 – 9:00 a.m. – Berlin Room)
 
Presenter: David Kendall, MD, MannKind Corporation
 
ELECTRONIC POSTER PRESENTATION HIGHLIGHTS
 
Title: Patient Trainer Experience with BluHale® V1.0 for Proper Technosphere® Insulin Administration
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
 
Presenter: Nadia Zaveri, PharmD, MannKind Corporation
 
 
Title: Safety and Pharmacokinetics of Technosphere® Insulin in Pediatric Patients
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
 
Presenter: David Kendall, MD, MannKind Corporation
 
 
Title: Insights to Improve Use of Technosphere® Insulin Provided By BluHale®, a Digital Diabetes Tool
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
 
Presenter: Benoit Adamo, MannKind Corporation
 
 
Title: Effective Treatment of Patients with Uncontrolled Type 2 Diabetes On Multiple Diabetes Medications By Adding Mealtime Ultra-rapid Technosphere® Insulin
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
 
Presenter: Philip Levin, MD, Endocrinology, MODEL Clinical Research
 
 
Title: Afrezza® Pre-meal Bolus Reduces Early Glycemic Excursion During Hybrid Closed Loop Treatment
(ATTD 2020 – Saturday, February 22, 2020; 8:30 a.m.)
 
Presenter: Alfonso Galderisi, MD, PhD, Yale University

About ATTD Annual Meeting
The ATTD is a scientific program that brings leading international experts together to discuss breakthroughs in diabetes treatments, technological innovations and showcase the latest developments in new insulin analogues, delivery systems, pumps, glucose sensors, closed-loop systems and much more.

About Afrezza®
Available by prescription, Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.

About MannKind
MannKind Corporation (MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
MANNKIND - 2013 endlich zum Überflieger? Vassago
Vassago:

MNKD 1,35$ (-11%)

 
26.02.20 11:16

Zahlen für Q4/19

  • Umsatz 16 Mio. $
  • Verlust 14 Mio. $

Zahlen für 2019

  • Umsatz 63 Mio. $
  • Verlust 52 Mio. $
  • Cash 50 Mio. $
  • negatives Eigenkapital 191 Mio. $
  • MK 279 Mio. $

investors.mannkindcorp.com/news-releases/...rter-and-full-year

MANNKIND - 2013 endlich zum Überflieger? moggemeis
moggemeis:

Interessanter Artikel

 
10.03.20 16:20
seekingalpha.com/article/...ary-on-your-portfolio-portfolio-1

MANNKIND - 2013 endlich zum Überflieger? Vassago
Vassago:

MNKD 1.04$ (+23%)

 
17.03.20 16:57

Mannkind refokussiert seine Pipeline

investors.mannkindcorp.com/news-releases/...-covid-19-pandemic

MANNKIND - 2013 endlich zum Überflieger? moggemeis
moggemeis:

@Vassago

 
28.03.20 13:11
Interessanter Artikel.
Dennoch erscheint mir die Aktivität bei Mannkind eher als verzweifelte Suche nach einer neuen Story und somit neuen Geldquellen.
Seit Jahren hat der Laden nicht wirklich etwas geliefert, was berechtigt hoffen liese.
MANNKIND - 2013 endlich zum Überflieger? Vassago
Vassago:

MNKD 1.94$ (neues 52 WH)

 
18.06.20 16:32

www.fool.com/investing/2020/06/17/...soaring-again-today.aspx


Zahlen für Q1/20

  • Umsatz 16 Mio. $
  • Verlust 9 Mio. $
  • Cash 39 Mio. $
  • negatives Eigenkapital 198 Mio. $
  • MK 413 Mio. $

investors.mannkindcorp.com/news-releases/...quarter-financial

MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Was ist da los? Gibts News?

 
23.06.20 16:33
MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Toller Anstieg seit ein paar Tagen

 
23.06.20 16:34
MANNKIND - 2013 endlich zum Überflieger? Vassago
Vassago:

MNKD 1.63$ (-12%)

 
06.08.20 16:28

Zahlen für Q2/20

  • Umsatz 15 Mio. $
  • Verlust 10 Mio. $
  • Cash 63 Mio. $
  • negatives Eigenkapital 180 Mio. $
  • MK 347 Mio. $

investors.mannkindcorp.com/news-releases/...quarter-financial

MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Kurs will nach oben, warte auf den Ausbruch....

 
22.09.20 13:34
MANNKIND - 2013 endlich zum Überflieger? sensigo2
sensigo2:

MNKD

 
29.09.20 14:49
alles sitzt in Wartestellung, hab mal eine kleine anfangs Posi. mir ins Depot gelegt.
ich vertraue meiner Glaskugel.
s2
MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Wann kommen wieder News oder Zahlen?

 
14.10.20 13:38
MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Am 04.11. gibts wieder Zahlen....

 
02.11.20 14:03
MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Zahlen

 
05.11.20 07:47
Nov. 4, 2020 10:45 PM ET  | About: MannKind Corporation (MNKD)
Q3: 11-04-20 Earnings Summary
Press Release
EPS of $-0.05 beats by $0.00 Revenue of $15.35M (5.19% Y/Y) misses by $-0.21M
Subscribers Only
Earning Call Audio
MannKind Corporation (NASDAQ:MNKD) Q3 2020 Results Conference Call November 4, 2020 5:00 AM ET

Company Participants

Michael Castagna - CEO

Steven Binder - CFO

Conference Call Participants

Brandon Folkes - Cantor Fitzgerald

Thomas Smith - SVB Leerink

Robert Hazlett - BTIG

Steven Lichtman - Oppenheimer and Company

Operator

Good day, everyone. And welcome to the MannKind Corporation Third Quarter 2020 Earnings Call. As a reminder, this call is being recorded on November 4, 2020, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until November 18, 2020.

This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which could cause actual results to differ materially from these stated expectations. For further information on the Company’s risk factors, please see their 10-Q report filed with the Securities and Exchange Commission this afternoon, the earnings release and the slides prepared for this presentation.

Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Steven Binder.

I would now like to turn the conference over to Mr. Castagna. Please go ahead, sir.

Michael Castagna

Thanks. And thank you and thank you everyone for dialing in on what appears to be a hectic election -- post-election day here.

So, as we get into the agenda, we’re going to go through our Q3 highlights, the financial review of Steve and Q4 expectations and then a Q&A.

I just want to remind people about our mission, which is really to give people control of their health and the freedom to live life, and we call it, life more humann.

Our technology really helps provide quick relief of patients’ symptoms, such as high sugar, pulmonary hypertension, and migraine, almost at the onset of action and being able to correct that with the quick inhalation using our platform. We’re very excited to continue to expand our technology into other assets as we continue to move R&D forward.

I’d also like to announce recent new addition to our team, Dr. Kevin Kaiserman, who now will be our Head of Medical Affairs and Safety. And new week, we expect to also announce a new head of regulatory. Kevin has 25 years of pediatric endocrinology experience, which we felt was very valuable, given our direction to move further into pediatrics in 2021. He is well-respected as a thought leader. He had private practice here in California and was trained at Children’s Hospital of LA. He’ll be leading our medical affairs, expanded field medical team, our safety and our pediatrics program.

Let me talk about a few of the Q3 highlights. Afrezza third quarter net revenue of $7.3 million with 27% ahead of Q3 of 2019. In the U.S., our total prescription grew 8% and sequentially 3% in quarter two. The market was down 3% over -- year-over-year for rapid-acting analogs, and 2% quarter-over-quarter respectively. So, we’re outpacing the market shrinkage and we’re continuing to grow year-over-year, despite the headwinds that COVID-19 presents.

Access is continuing to open up for our field reps reaching customers in the field. Obviously, certain areas of the country are more difficult than others, but our team has done a very decent job given the difficult circumstances they face.

Our U.S. September year-to-date net revenue is $22.1 million or 31% versus 2019 and our trend is starting to pick up nicely in Q4, as we hope to see scripts [ph] up this Friday.

Our United Therapeutics collaboration with TreT remains on track to complete the critical NDA components here in Q4. And we recently received a $1.2 million purchase order for clinical supplies as we get to Q4 in 2021 and beyond.

Our cash at the end of the quarter was $52.7 million and we used $13.5 million in operating activities. We also reduced our debt by $2.6 million in October by prepaying our December promissory note and at schedule.


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MANNKIND - 2013 endlich zum Überflieger? Vassago
Vassago:

MNKD 2.07$

 
05.11.20 10:42

Zahlen für Q3/20

  • Umsatz 15 Mio. $
    • davon 7 Mio. $ Produktumsätze
    • und 8 Mio. $ Kollaboration /Services
  • Verlust 11 Mio. $
  • Cash 53 Mio. $
  • negatives Eigenkapital 186 Mio. $
  • MK 474 Mio. $

Die hohe Bewertung wird mir wohl weiterhin ein Rätsel bleiben. Hohe Schulden, Verluste, Verwässerung und ein langsames Umsatzwachstum.

investors.mannkindcorp.com/news-releases/...quarter-financial


MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Kurs entwickelt sich sehr gut....

 
12.11.20 09:43
Squeeze?
MANNKIND - 2013 endlich zum Überflieger? Vassago
Vassago:

MNKD 3.10$ (neues 52 WH)

 
12.11.20 16:45
Erstaunlich, so ganz ohne News.
MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Muss echt sagen, MNKD hat sich trotz

 
13.11.20 07:17
Gewinnmitnahmen gestern sehr wacker gehalten.

Bin gespannt was da noch möglich ist.
MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Nach der Seitwärtsbewegung sollte jetzt

 
17.11.20 14:29
wieder was gehen....
MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Raus damit mit 40% Plus. Danke!

 
16.12.20 20:38
MANNKIND - 2013 endlich zum Überflieger? Kap Hoorn
Kap Hoorn:

@ ARIVA :

 
05.01.21 06:36
WARUM (?) bekommt Ihr das nicht langsam mal in den Griff mit diesen Schmuddelseiten ?
Wollt Ihr nicht o. könnt Ihr nicht ???
Das nimmt langsam ein Ausmaß an was nicht mehr akzeptabel ist !!!
Ausserdem schadet es der Reputation von ARIVA auf das Äußerste, aber dies werden Sie ja hoffentlich selbst wissen …
MfG K.H.
MANNKIND - 2013 endlich zum Überflieger? sensigo2
sensigo2:

Martin

 
04.02.21 08:11
schlecht gelaufen, hier wird es bald zwei oder sogar dreistellig.
s2
MANNKIND - 2013 endlich zum Überflieger? martin30sm
martin30sm:

Sensigo2: ja bin leider zu früh raus...

 
04.02.21 08:25
...man kann nicht immer alles haben ;-)

MANNKIND - 2013 endlich zum Überflieger? Magnetfeldfredy
Magnetfeldfre.:

Mannkind

 
28.04.21 17:00
Jetzt hat UTHR die Zulassung für DPI Tyvaso eingereicht mit der Mannkind Technosphere Technologie, revenues zwischen 50-100 Millionen jährlich winken.
Jetzt scheint die Cooperation mit RLS erste Früchte zu tragen, die Technosphere Technologie ermöglicht medizinisches Cannabinoik megaschnell und megakonzentriert medizinisch hochwirksam an den Mann/die Frau zu bringen, das kann schnell zweistellig werden:


Receptor Life Sciences Announces Poster Presentations at the Respiratory Drug Delivery 2021 Conference
April 27, 2021 08:00 AM Eastern Daylight Time

SEATTLE--(BUSINESS WIRE)--Receptor Life Sciences (RLS) today announced the acceptance of two posters for presentation at the Respiratory Drug Delivery (RDD 2021) conference. The posters report Cannabidiol (CBD) pharmacokinetics in healthy volunteers following inhalation of RLS103, an investigational inhaled dry powder CBD. RLS103 is being developed for the treatment of acute panic attack in panic disorder and performance anxiety in social anxiety disorder (SAD).

   “An Indirect Pharmacokinetic Comparison of Cannabidiol Formulations: Dry Power Inhaled (DPI) vs Vaporization”
   Tweet this

This pharmacokinetic study demonstrated that RLS103 facilitates immediate CBD delivery to the bloodstream with peak concentrations at 3.8 minutes that are 71-fold greater than oral CBD on a dose-adjusted basis. The overall systemic exposure, adjusted for dose, was 9-fold greater than that following oral administration because inhalation delivery bypasses hepatic first-pass metabolism. RLS103 delivered CBD with an efficiency 7-fold greater than a vaporizer.

“No immediate-acting treatments for these conditions are currently available, so an inhaled CBD, like RLS103, with an ultra-rapid onset, has the potential to address this need in both disorders,” said Andrea Leone-Bay, PhD, Founder and Chief Scientific Officer of Receptor Life Sciences. RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation.

RDD 2021 is the premier international conference for scientists and drug developers focused on pulmonary and nasal drug delivery. This year, RDD is a virtual conference and Receptor’s poster presentations can be viewed online by conference participants between April 27 and June 20.

   “Using Inhalation to Bypass First-Pass Metabolism as a Means of Improving Cannabidiol Bioavailability,” Kelly S. Kraft, Orrin Devinsky, Lorraine Rusch, Melanie Fein, and Andrea Leone-Bay; and
   “An Indirect Pharmacokinetic Comparison of Cannabidiol Formulations: Dry Power Inhaled (DPI) vs Vaporization,” Andrea Leone-Bay, Orrin Devinsky, Lorraine Rusch, Melanie Fein, and Kelly S. Kraft.

Panic disorder affects about 5.4 million adults in the United States, according to the National Institute of Mental Health. Social Anxiety Disorder affects about 15 million adults in the U.S. and is the second-most commonly diagnosed anxiety disorder (adaa.org/understanding-anxiety/social-anxiety-disorder).

About Receptor Life Sciences

Receptor Life Sciences is a pharmaceutical company that applies FDA-approved drug delivery technologies to develop innovative therapies to address central nervous system disorders that have few safe and effective treatments. Receptor Life Sciences uses these technologies to produce inhaled and oral cannabinoid products that hold the potential to provide precision, consistency, reliability, and convenience. For more information about Receptor Life Sciences, its patented product candidates and its progress toward FDA approval see www.receptorlife.com.  
MANNKIND - 2013 endlich zum Überflieger? Vassago

MNKD 2.92$ (-20%)

 

FDA verlängert die Frist um den Arzneimittelantrag (NDA) für Tyvaso DPI zu prüfen

  • von Februar auf Mai 2022

seekingalpha.com/news/...xtends-deadline-to-review-tyvaso-dpi


Seite: Übersicht ... 75 76 77 1 2 3 4 ...

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