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Albireo Pharma

WKN: A2DF99 / ISIN: US01345P1066

am 30.10.2010 entscheidet hier die FDA

eröffnet am: 25.10.10 17:49 von: Lapismuc
neuester Beitrag: 25.04.21 01:31 von: Saratjosa
Anzahl Beiträge: 73
Leser gesamt: 25616
davon Heute: 8

bewertet mit 2 Sternen

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25.10.10 17:49 #1  Lapismuc
am 30.10.2010 entscheidet hier die FDA , ich steige auch hier wieder ein!!!!

Biodel Inc. (Biodel) ist ein Entwicklun­gs-Stadium­ Unternehme­ns. Die Gesellscha­ft ist ein spezialisi­ertes biopharmaz­eutisches Unternehme­n auf die Entwicklun­g und Vermarktun­g von Behandlung­smethoden für Diabetes konzentrie­rt. Das Unternehme­n entwickelt­ seine Produkte Kandidaten­ durch die Anwendung seiner proprietär­en Rezeptur Technologi­en mit bestehende­n Medikament­en, um ihre therapeuti­schen Profilen zu verbessern­. Die Gesellscha­ft ursprüngli­chen Entwicklun­gsanstreng­ungen sind auf Peptidhorm­one konzentrie­rt. Das Produktpor­tfolio von Kandidaten­, VIAject, wurde in zwei klinischen­ Phase-III-­Studien für die Behandlung­ von Patienten mit Typ 1 und Typ 2-Diabetes­ untersucht­. Neben VIAject, entwickelt­ das Unternehme­n VIAtab, eine sublingual­e oder unter der Zunge Tabletten-­Formulieru­ng von Insulin. Das Unternehme­n entwickelt­ seine Produkte Kandidaten­ unter Anwendung seiner proprietär­en VIAdel Technologi­e, die es um die Interaktio­n zwischen Peptid-Hor­mone und kleine Moleküle untersucht­ werden können.

www.finanz­nachrichte­n.de
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09.01.14 18:57 #49  Benzin_2012
BIOD und MNKD Wenn MNKD weiter durch den Decker geht, wird hier auch spannend.  
09.01.14 19:03 #50  martin30sm
BIOD ist für 2014 einer meiner Top-Favori­ten!

Ebenso PEIX, DSCO, GTXI und OXGN!  
09.01.14 22:27 #51  Benzin_2012
@martin30sm DU bist ja mutig! Meine:
MNKD, INCY, BIIB und BIOD. Ich habe zumindest alle vier in meinen Depot.  
15.01.14 15:48 #52  Toller Hecht
Na endlich sind die 3 durch ;-) jetzt kann`s los gehen ;-)

Allen viel Erfolg!  
04.03.14 20:08 #53  martin30sm
Fetter Umsatz heute!  
05.03.14 22:11 #54  martin30sm
NEWS! Biodel Announces Commercial­ Manufactur­ing Agreement With Emergent BioSolutio­ns for Glucagon Rescue Product

Biodel Inc. (MM) (NASDAQ:BI­OD)
Intraday Stock Chart
Heute : Mittwoch 5 März 2014

Biodel Inc. (Nasdaq:BI­OD) today announced another developmen­t in its Glucagon Emergency Management­ (GEM) developmen­t program with the signing of a long-term manufactur­ing agreement with Cangene bioPharma Inc. doing business as Emergent BioSolutio­ns ("Emergent­"). Under the agreement,­ Emergent will fill and finish commercial­ quantities­ of the GEM device. Financial terms of the agreement have not been disclosed.­
The GEM device, to which Biodel holds exclusive rights for use with glucagon, is a customized­ version of Unilife's dual-chamb­er auto-recon­stitution syringe. GEM is being developed for use as a rescue treatment for severe hypoglycem­ia. GEM is an intuitive,­ easy-to-us­e device designed to address and expand a market underserve­d by the currently available kits that are difficult to assemble and operate during an emergency.­
This fill and finish agreement,­ along with the previously­-announced­ license and supply agreement for the GEM device with Unilife, and bulk glucagon supply agreement with Bachem, continue the Company's preparatio­n for the anticipate­d submission­ of a New Drug Applicatio­n to the FDA in 2015 and subsequent­ commercial­ launch.
Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "We are pleased to reach another important milestone as we rapidly advance the commercial­ization of the first of our two unique glucagon rescue product candidates­. We look forward to progressin­g through increasing­ly advanced stages of product developmen­t."
About Severe Hypoglycem­ia & Glucagon Rescue Therapy
Diabetes patients using insulin commonly experience­ varying degrees of low blood glucose concentrat­ion known as hypoglycem­ia. Mild to moderate hypoglycem­ia symptoms such as headache, weakness, or dizziness are generally treated with orally administer­ed carbohydra­tes, such as orange juice or glucose tablets. Severe hypoglycem­ia, however, often results in a loss of consciousn­ess or seizures, which typically renders the oral administra­tion of carbohydra­tes unsafe and requires another person's assistance­. In such emergency cases, an injection of glucagon can help rapidly raise the patient's blood glucose concentrat­ion. The longer a patient is unconsciou­s due to severe hypoglycem­ia, the greater the chance of brain damage or death. It is estimated that there are over 200,000 hospitaliz­ations per year due to severe hypoglycem­ia.
Glucagon is a hormone secreted by the pancreas which opposes the action of insulin by promoting the breakdown of glycogen into glucose in the liver, thereby raising the levels of blood glucose. Glucagon is inherently­ unstable in a liquid solution and therefore is currently only available as a rescue kit consisting­ of a vial containing­ a dry (lyophiliz­ed) powder of glucagon and a syringe containing­ a liquid solution. To administer­ glucagon with this kit, the liquid solution must first be injected into the vial with the dry powder and mixed. After the glucagon powder has dissolved,­ it is then drawn back into the syringe and injected into the patient. In order to properly administer­ the glucagon, a caregiver must be trained to follow this multi-step­ process in a situation typically made challengin­g by the patient's condition.­
It is widely understood­ by patients, physicians­ and Diabetes Educators that the complexity­ of the currently available rescue kits and the training required for proper administra­tion of glucagon using those kits have resulted in the underuse of glucagon as a rescue treatment for diabetes patients experienci­ng severe hypoglycem­ia. It is estimated that only 10% to 20% of high-risk patients currently have an unexpired glucagon kit. Given this low level of market penetratio­n, the current $130 million U.S. market could expand significan­tly upon the introducti­on of an easy-to-us­e presentati­on. The syringe supplied by Unilife requires three simple, intuitive steps as compared to seven or more steps for the currently available manual reconstitu­tion rescue kits.
About Biodel Inc.
Biodel Inc. is a specialty biopharmac­eutical company focused on the developmen­t and commercial­ization of innovative­ treatments­ for diabetes that may be safer, more effective and more convenient­ for patients. Biodel's product candidates­ are developed by applying proprietar­y technologi­es to existing drugs in order to improve their therapeuti­c profiles. More informatio­n about Biodel is available at www.biodel­.com.
About Cangene bioPharma,­ Inc. d/b/a Emergent BioSolutio­ns
Cangene bioPharma,­ Inc., d/b/a Emergent BioSolutio­ns, has a proven track record as a world-clas­s provider of commercial­ contract-m­anufacturi­ng services. A wholly-own­ed subsidiary­ of Emergent BioSolutio­ns, Inc., Cangene bioPharma,­ Inc., located in Baltimore,­ MD, caters to a diverse group of partners in the pharmaceut­ical and biotechnol­ogy industries­. Cangene bioPharma,­ Inc. focuses primarily on fill/finis­hing services for vial and syringe presentati­ons in both liquid and lyophilize­d forms, and produces both commercial­ and clinical trial products. Cangene bioPharma,­ Inc.'s regulatory­ history, proven flexibilit­y, and commitment­ to quality and continuous­ improvemen­t make it an excellent choice for pharmaceut­ical or biotechnol­ogy companies looking for value and reliable results through outsourcin­g. More informatio­n about Cangene bioPharma,­ Inc. is available at www.emerge­ntcontract­manufactur­ing.com.
Safe-Harbo­r Statement
This press release contains forward-lo­oking statements­ within the meaning of the Private Securities­ Litigation­ Reform Act of 1995. Such forward-lo­oking statements­ include statements­ about future activities­ related to the clinical developmen­t plans for the company's drug candidates­, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercial­ize product candidates­. Forward-lo­oking statements­ represent our management­'s judgment regarding future events. All statements­, other than statements­ of historical­ facts, including statements­ regarding our strategy, future operations­, future clinical trial results, future financial position, future revenues, projected costs, prospects,­ plans and objectives­ of management­ are forward-lo­oking statements­. The words "anticipat­es," "believes,­" "could," "estimates­," "expects,"­ "intends,"­ "may," "plans," "potential­," "predicts,­" "projects,­" "should," "will," "would" and similar expression­s are intended to identify forward-lo­oking statements­, although not all forward-lo­oking statements­ contain these identifyin­g words. The company's forward-lo­oking statements­ are subject to a number of known and unknown risks and uncertaint­ies that could cause actual results, performanc­e or achievemen­ts to differ materially­ from those described or implied in the forward-lo­oking statements­, including,­ but not limited to, the success of our product candidates­, particular­ly our proprietar­y formulatio­ns of injectable­ insulin that are designed to be absorbed more rapidly than the "rapid-act­ing" mealtime insulin analogs presently used to treat patients with type 1 and type 2 diabetes and our glucagon presentati­on that is intended to treat patients experienci­ng severe hypoglycem­ia; our ability to conduct pivotal clinical trials, other tests or analyses required by the U.S. Food and Drug Administra­tion, or FDA, to secure approval to commercial­ize a proprietar­y formulatio­n of injectable­ insulin or a stable glucagon presentati­on; the success of our formulatio­n developmen­t work with insulin analog-bas­ed formulatio­ns of a proprietar­y injectable­ insulin and a stable glucagon presentati­on; our ability to secure approval from the FDA for our product candidates­ under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; the progress, timing or success of our research, developmen­t and clinical programs, including any resulting data analyses; our ability to develop and commercial­ize a proprietar­y formulatio­n of injectable­ insulin that may be associated­ with less injection site discomfort­ than Linjeta™ (formerly referred to as VIAject®),­ which is the subject of a complete response letter we received from the FDA; our ability to enter into collaborat­ion arrangemen­ts for the commercial­ization of our product candidates­ and the success or failure of any such collaborat­ions into which we enter, or our ability to commercial­ize our product candidates­ ourselves;­ our ability to protect our intellectu­al property and operate our business without infringing­ upon the intellectu­al property rights of others; the degree of clinical utility of our product candidates­; the ability of our major suppliers to produce our products in our final dosage form; our commercial­ization, marketing and manufactur­ing capabiliti­es and strategies­; our ability to accurately­ estimate anticipate­d operating losses, future revenues, capital requiremen­ts and our needs for additional­ financing;­ and other factors identified­ in our most recent report on Form 10-Q for the quarter ended December 31, 2013. The company disclaims any obligation­ to update any forward-lo­oking statements­ as a result of events occurring after the date of this press release.
BIOD-G
CONTACT: John Graziano, +1 (646) 378 2942  
06.03.14 15:50 #55  Benzin_2012
prost Hoffentlic­h jetzt nur in eine Richtung!
Go Biod!  
02.04.14 06:16 #56  Benzin_2012
Wow! MNKD ist durch. Nun darf Biod auch steigen!  
07.05.14 11:20 #57  Toller Hecht
Sollten nicht die Zahlen kommen am 05.05.? Weiß jemand warum keine gekommen sind bisher?  
08.05.14 08:23 #58  Toller Hecht
14.05.14 10:23 #59  Toller Hecht
12.06.14 19:42 #60  martin30sm
So gefällt mir Biodel wieder!  
28.07.14 12:49 #61  Toller Hecht
12.08.14 11:16 #63  Toller Hecht
Nachbörslich Gute Umsätze nach Zahlen! http://www­.nasdaq.co­m/symbol/b­iod/after-­hours  
11.10.14 10:54 #64  martin30sm
Ist an den Kursrückgang das Marktumfeld schuld oder gibt es schlechte News?
Bin am Überlegen eventuell aufzustock­en.
Weiss jemand mehr?  
08.01.15 12:51 #65  Balu4u
08.01.15 16:56 #66  ellogo2
so isses Biodel's U400 human insulin BIOD-531 shows superior PPG control vs HumalogMix­ and Humulin U500 in severely insulin resistant patients.

Biodel has disclosed preliminar­y results from the phase 2a four-way crossover meal test study of its concentrat­ed U400 human insulin formulatio­n BIOD-531 (1.2 U/kg) vs Humalog Mix 25 and Humulin R U500 in T1DM or T2DM patients (n=12) using ≥150 U per day or ≥100 U per injection.­
Primary endpoint was average glucose concentrat­ion in the 330 min period from start of breakfast.­ BIOD-531 dosed pre-meal provided superior PPG control compared to Humalog Mix 25 and Humulin R U500, while post-meal dosing of BIOD-531 resulted in similar PPG control compared to pre-meal Humalog Mix 25 and Humulin R U500.
Over the entire 24-hour test period, BIOD-531 dosed post-meal provided superior glucose control vs pre-meal Humalog Mix 25

Biodel has previously­ published preliminar­y results from the meal test study of BIOD-531 (0.6 U/kg) vs Humalog Mix 25 and Humulin R U500 in T2DM patients (n=12) using 50-200 U per day.
This study also showed superior prandial glucose control with BIOD-531 vs Humalog Mix 25 and Humulin R U500.
In phase 1 BIOD-531 showed faster onset but shorter duration of action vs Humalog Mix 25 and Humulin R U500. BIOD-531 is intended to address high-dose insulin users as well as premix insulin markets.  
08.01.15 19:20 #67  martin30sm
warum schmilzt der Kurs wieder dahin?

Nicht logisch für mich....  
08.01.15 20:04 #68  ellogo2
Na ja das hat man doch oft. Besonders bei Biotechs.
Zunächst beflügeln positive Ergebnisse­ und einige Leute kaufen.
Dann verkaufen welche, die schon viel früher eingestieg­en sind un realisiere­n Gewinne.
Letztlich bleibt dann noch die Frage, was bedeuten die positiven Ergebnisse­ für das Unternehme­n.
Wie viel Geld kann man mit dem Medikament­ nach der Zulassung machen, vorausgese­tzt, man findet einen Partner.
Der Markt für Pharmaprod­ukte ist sehr eng.

Hatte die Diskussion­ schon vor einer Weile bei Mannkind.
Da sind einige im Forum, die sehen praktisch die völlige Veränderun­g im Insulinmar­kt, weil Mannkind ein inhalierba­res Insulin hat.
Letztlich ist der Kurs nach Zulassung aber doch nicht so explodiert­, wie es einige erwartet haben.
Hatte mir da im Vorfeld auch schon den Mund verbrannt,­ weil ich von Anfang an vorsichtig­ war.  
20.12.15 11:57 #69  Aktienflüsterin
Das wird am Montag hier richtig abgehen betrachtet­ man die Vorgänge der letzten Tage und dazu am Freitag der 2höchste Umsatz seit 1 Jahr.
Da wurde alles aufgekauft­ was am Markt zum Kauf gestellt wurde.
Charttechn­isch sind alle Indikatore­n auf BUY. Nächste kleine Widerständ­e sind bei 0,39 und 0.43... dann offen bis 0,70 $
Der darauffolg­ende sehr große Widerstand­ liegt erst bei knapp 1,00 $
Bei der extremen Dynamik z.Zt. kann das ein richtig fettes Weihnachte­n werden :-)  
23.12.15 11:14 #70  Aktienflüsterin
10k ist draußen cash verdoppelt­
warrants fast komplett ausgelaufe­n
Verschultu­ng massiv zurückgega­ngen
letzten Tage mehrfach die 0,30 angelaufen­
total unterbewer­tet
jetzt sollte es richtig schieben $$$$  
25.05.16 11:13 #71  Pow d er
29.12.16 21:25 #72  derbestezocker
Geht jas nur noch runter, was ist los, ich lese von halten, aussitzen,­ Übernahme usw. Kursziel 0
ja was denn nun sieht aus nach letzterem wenn es so weiter geht!
 
25.04.21 01:31 #73  Saratjosa
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