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25.01.13 22:55
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19504 Postings, 4449 Tage berliner-nobodySehr gute long Investment Chance

 

BARDA Invites Soligenix to Submit Contract Proposal for  Development of OrbeShield(TM) in GI ARS


PRINCETON, N.J.,  Jan. 7, 2013 /PRNewswire via COMTEX/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix  or the Company), a development stage biopharmaceutical company, announced today  that pursuant to review of the Company's white paper on development of  OrbeShield(TM) as a countermeasure for the gastrointestinal effects of acute  radiation syndrome (GI ARS), the Biomedical Advanced Research and Development  Authority (BARDA), Division of Chemical, Biological, Radiological and Nuclear  (CBRN) Medical Countermeasures has informed the Company that after careful  analysis and consideration, it is inviting Soligenix to submit a full proposal  for a potential multi-year, multi-million dollar contract to develop  OrbeShield(TM) from its current level of technical readiness to FDA approval.

Soligenix submitted its white paper entitled "OrbeShield(TM), oral  beclomethasone 17,21-dipropionate (BDP), a candidate broad spectrum therapeutic  countermeasure for GI ARS," to BARDA in response to a Broad Agency Announcement  (BARDA-BAA-12-100-SOL-00011) for advanced research and development of medical  countermeasures for chemical, biological, radiological and nuclear threats.  BARDA is interested in the advanced development and eventual licensure/approval  of effective medical countermeasures that mitigate, treat, affect, delay, or  interrupt the progression of injuries resulting from an acute exposure to  radiation from a radiological/nuclear accident or attack, particularly injuries  associated with ARS.

In a canine model of GI ARS, OrbeShield(TM) demonstrated a statistically  significant survival advantage in animals that received OrbeShield(TM) therapy  up to 24 hours following exposure to lethal doses of total body irradiation  (TBI) when compared with placebo control animals (p=0.04). Median survival post  TBI exposure in the control group was 8 days, compared to 87 days in the  OrbeShield(TM) treated group. A subsequent study to replicate and expand upon  the observations made in the canine model is being initiated and, like the  previous study, is supported by a recent National Institute of Allergy and  Infectious Diseases (NIAID) Small Business Innovation Research (SBIR) grant  award.

"We are very excited by BARDA's invitation to submit a full proposal for  development of OrbeShield(TM) as a medical countermeasure against GI ARS,"  stated Christopher J Schaber, PhD, President & Chief Executive Officer of  Soligenix. "Although there are no guarantees, we believe that we are  well-positioned to receive BARDA support for this indication and that the full  proposal will allow us to further demonstrate the growing body of compelling  scientific evidence supporting OrbeShield(TM)'s potential as a countermeasure  for GI ARS. We intend to submit our proposal to BARDA in February 2013 and look  forward to their response. Meanwhile, we continue to develop OrbeShield(TM)  pursuant to our recent $600,000 SBIR grant supporting further GI ARS canine  studies."

The invitation to submit a proposal is non-binding and the selection of  Soligenix's white paper for submission of a full proposal is not a guarantee of  a BARDA contract. A contract award will require a favorable technical and  scientific review by BARDA followed by negotiation of fair and reasonable  contract terms.

About GI ARS

ARS occurs after toxic radiation exposure and involves several organ systems,  notably the bone marrow the GI tract and later the lungs. In the event of a  nuclear disaster or terrorist detonation of a nuclear bomb, casualties exposed  to >2 Gy are at high risk for development of clinically significant ARS.  Exposure to high doses of radiation exceeding 10-12 Gy causes acute GI injury  which can result in death in 5-15 days. The GI tract is highly sensitive due to  the requirement for incessant proliferation of crypt stem cells and production  of mucosal epithelium. The extent of injury to the bone marrow and the GI tract  are the principal determinants of survival after exposure to TBI. Although the  hematopoietic syndrome can be rescued by bone marrow transplantation or growth  factor administration, there is no established treatment or preventive measure  for the GI damage that occurs after high-dose radiation. Therefore, there is an  urgent need to develop specific medical countermeasures against the lethal  pathophysiological manifestations of radiation-induced GI injury.

About OrbeShield(TM)

OrbeShield(TM) is formulated for oral administration in GI ARS patients as a  single product consisting of two tablets; one tablet releases BDP in the  proximal portions of the GI tract and the other tablet releases BDP in the  distal portions of the GI tract. BDP has been marketed in the United States and  worldwide since the early 1970s as the active pharmaceutical ingredient in  inhalation products for the treatment of patients with allergic rhinitis and  asthma. Oral BDP may also have application in treating other GI disorders  characterized by severe inflammation such as Crohn's disease and radiation  enteritis.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing  products to treat serious gastrointestinal diseases where there remains an unmet  medical need, as well as developing several biodefense vaccines and  therapeutics. Soligenix is developing proprietary formulations of oral BDP  (beclomethasone 17.21-dipropionate) for the prevention/treatment of  gastrointestinal disorders characterized by severe inflammation, including  pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and  chronic Graft-versus-Host disease (orBec�), as well as SGX942 for the treatment  of oral mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures  pursuant to the Biomedical Advanced Research and Development Authority (BARDA)  Strategic Plan of 2011-2016 for inclusion in the US government's Strategic  National Stockpile. Soligenix's lead biodefense products in development are a  recombinant subunit vaccine called RiVax(TM), which is designed to protect  against the lethal effects of exposure to ricin toxin and VeloThrax(TM), a  vaccine against anthrax exposure. RiVax(TM) has been shown to be well tolerated  and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both  RiVax(TM) and VeloThrax(TM) are currently the subject of a $9.4 million National  Institute of Allergy and Infectious Diseases (NIAID) grant supporting  development of Soligenix's new vaccine heat stabilization technology known as  ThermoVax(TM). Soligenix is also developing OrbeShield(TM) for the treatment of  gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small  Business Innovation Research (SBIR) grant. OrbeShield(TM) has previously  demonstrated statistically significant preclinical survival results in two  separate canine GI ARS studies funded by the NIH.

For further information regarding Soligenix, Inc., please visit the Company's  website at www.soligenix.com.

This press release contains forward-looking statements that reflect  Soligenix, Inc.'s current expectations about its future results, performance,  prospects and opportunities. Statements that are not historical facts, such as  "anticipates," "believes," "intends," or similar expressions, are  forward-looking statements. These statements are subject to a number of risks,  uncertainties and other factors that could cause actual events or results in  future periods to differ materially from what is expressed in, or implied by,  these statements. Soligenix cannot assure you that it will be able to  successfully develop or commercialize products based on its technology,  particularly in light of the significant uncertainty inherent in developing  vaccines against bioterror threats, manufacturing and conducting preclinical and  clinical trials of vaccines, and obtaining regulatory approvals, that product  development and commercialization efforts will not be reduced or discontinued  due to difficulties or delays in clinical trials or due to lack of progress or  positive results from research and development efforts, that it will be able to  successfully obtain any further grants and awards, maintain its existing grants  which are subject to performance, enter into any biodefense procurement  contracts with the US Government or other countries, or that the US Congress may  not pass any legislation that would provide additional funding for the Project  BioShield program. These and other risk factors are described from time to time  in filings with the Securities and Exchange Commission, including, but not  limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law,  Soligenix assumes no obligation to update or revise any forward-looking  statements as a result of new information or future events.

SOURCE Soligenix, Inc.

 

 

www.prnewswire.com  Copyright (C) 2013 PR Newswire. All rights reserved

-0-

 

KEYWORD:          New Jersey INDUSTRY KEYWORD: HEA                   MTC                   PHA SUBJECT CODE:     CON

 

 

Also das ist meine erste Thread Eröffung :)

mit der News oben begann mein interesse, erst scheute ich mich daran zu glauben, aber nun bin ich investiert!  Ich sehe nach dem kontinuierlichen Kursanstieg gute Chancen.

Es ist kein Zock!!

Pusherblätter gibt es stand heute kaum, der Wert, ist gänzlich ruhig.

Aktienanzahl stand heute Aktienanzahl 11,16 Mio.

Period  Ending Sep 30, 2012 Jun 30, 2012 Mar 31, 2012 Dec 31, 2011
Total Revenue 932 763 647 653
Cost of Revenue 762 616 557 550
Gross Profit 170 147 91 104

Operating Expenses

Research and  Development 371 501 877 1,044
Sales, General  and Admin. 559 627 655 568
Non-Recurring Items - - - -
Other - - - -
Operating Income (760) (982) (1,441) (1,508)

Income From Continuing Operations

Add'l  Income/Expense Items 1 2 2 2
Earnings Before Interest and Tax (759) (980) (1,439) (1,506)
Interest Expense - - - -
Earnings Before  Tax (759) (980) (1,439) (1,506)
Income Tax - - - -
Minority  Interest - - - -
Equity Earnings  Unconsolidated Subsidiary - - - -
Net  Income Cont. Operations (759) (980) (1,439) (932)

Non Recurring Events

Discontinued  Operations - - - -
Extraordinary  Items - - - -
Effect of  Accounting Changes - - - -
Other Items - - - -
Net Income (759) (980) (1,439) (932)
Preferred Stock and Other Adjustments - - - -
Net  Income Applicable to Common Shareholders (759) (980) (1,439) (932)

http://www.otcmarkets.com/stock/SNGX/financials

 

Ich persönlich bin sehr gespannt auf die Zahlen aus Q4

Desweiteren erwarte ich ein uplisting zur Nasdaq in küze

Wednesday, 23. Januar 2013
Chris Schaber, Präsident & CEO von Soligenix (OTC: SNGX) erzählt Proactiveinvestors dass die Firmenphilosophie, um das Geschäft zu wachsen, mit Regierung und staatliche Unterstützung, soweit möglich. Mit, was Chris sagt, ist ein erfahrenes Management-Team und Vorstand will das Unternehmen, um voranzukommen mit der Investment-Community und auch an einem gewissen Punkt, sollten Sie eine vollständige Nasdaq Auflistung.
www.youtube.com/watch?feature=player_embedded&v=qpY_RCiVNsc

ich hoffe das mit dem video funktioniert :)

ich freu mich über eine sachliche offene Disskusion

 
Seite: 1 | 2 | 3 | 4 | 5 | 6 | 6   
116 Postings ausgeblendet.

20.10.19 21:43

7561 Postings, 2044 Tage S3300Da hat der Berliner ja

ein feines Investment gefunden . Läuft, too Sache.  

21.11.19 21:47

7561 Postings, 2044 Tage S3300Minus 92 Prozent in 5 Jahren

ganz schön heftig. Mein beileid an alle investieren.  

21.05.20 10:18

4274 Postings, 3086 Tage clint65spekulativ hier mit kleiner Posi rein ...

https://finviz.com/quote.ashx?t=SNGX

Chart erscheint interessant ...

Vielleicht kann jemand etwas zur Pipeline anmerken

https://www.soligenix.com/pipeline-programs/

insbesondere SGX301 T-Cell Lymphoma ...

Ist auch ein Impfstoff-Zock auf Covid in der klinischen Erprobung im frühen Tierstadium.

Es kommen einige Meldungen in den nächsten Monaten und die Marktkapitalisierung ist unter 50 Millionen Dollar. Allerdings scheint wohl ein ATM zu laufen ...

Das sind die Gründe für ein kleines Investment hier. Allerdings ist es für mich auch nur ein kurzfristiger Covid-Zock, d. h. bis zu einer Meldung hierzu.

Und wie jeder sehen kann, der sich den Chart anschaut, hat das Unternehmen noch nie etwas geliefert und ist eine einzige Kapitalvernichtung in der Historie.

Keine Kaufempfehlung!  

22.05.20 22:06

1101 Postings, 2379 Tage BiotecfanDie akte könnte durchaus

Interessant sein,  Problem für den Kurs ist die dünne Kapitaldecke.  

19.11.20 12:30
1

109 Postings, 3348 Tage Saga 55neue Phase3 Daten stehen an + covid 19 Spekulation

06.12.20 21:08
1

4686 Postings, 3742 Tage centsucherDie stehen doch auch noch aus!?

We also continue to progress our pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study for SGX942 (dusquetide), for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.  With enrollment of 268 subjects completed, top-line final results continue to be expected before the end of the year."

http://ir.soligenix.com/...s-And-Third-Quarter-2020-Financial-Results

 

22.12.20 15:12

11554 Postings, 2481 Tage VassagoSGNX 1.29$ (vorbörslich -52%)

22.12.20 17:44

4686 Postings, 3742 Tage centsucherHm,

so genau wollte ich das gar nicht wissen!  

24.12.20 03:14

10 Postings, 1191 Tage VerlynneaLöschung


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12.02.21 12:50

1101 Postings, 2379 Tage Biotecfansoligenix

kommt wohl wieder zurück  

12.02.21 15:20

6 Postings, 1599 Tage Vuk04Bist du dabei?

12.02.21 16:11

1101 Postings, 2379 Tage BiotecfanJa

ich bin schon dabei, nach den Handelszahlen müssen eigentlich etliche hier investiert sein
 

12.02.21 17:48

6 Postings, 1599 Tage Vuk04Freut mich bin ebenfalls dabei.

14.02.21 09:19

1101 Postings, 2379 Tage Biotecfander Börsenumsatz in den

USA ist in den letzen Tagen sehr hoch, mehr als 10 Millionen am Tag, die Aktie wird schon sehr stark getradet.  

24.04.21 02:16

10 Postings, 1070 Tage StephaniethrzaLöschung


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24.04.21 13:22

10 Postings, 1070 Tage BirgitdvubaLöschung


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25.04.21 03:18

10 Postings, 1069 Tage UrsulatzuhaLöschung


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25.04.21 10:35

10 Postings, 1069 Tage JaninaiojwaLöschung


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10.05.21 16:11

11554 Postings, 2481 Tage VassagoSNGX 1.06$ (-16%)

HyBryte (SGX301) Zulassungsantrag soll erst in H1/22 gestellt werden, statt wie bisher geplant als "fortlaufende Einreichung des Antrages". Damit verschiebt sich auch eine mögliche Zulassung (auf mind. H1/2023)
https://www.benzinga.com/general/biotech/21/05/...on-submission-for-h  

14.02.23 13:59

11554 Postings, 2481 Tage VassagoSNGX

RTF Letter

Die FDA hat den Zulassungsantrag des Arzneimittels von HyBryte zur Behandlung von kutanem T-Zell-Lymphom abgelehnt

"Nach einer vorläufigen Prüfung stellte die FDA fest, dass die am 14. Dezember 2022 eingereichte NDA nicht vollständig genug war, um eine inhaltliche Prüfung zu ermöglichen."

https://ir.soligenix.com/...he-Treatment-of-Cutaneous-T-Cell-Lymphoma

 

14.04.23 16:03

11554 Postings, 2481 Tage VassagoSNGX 1.44$ (-12%)

  • um eine NDA-Einreichung für HyBryte zu akzeptieren, verlangt die FDA positive Ergebnisse aus einer zweiten klinischen Studie zusätzlich zu der Phase-3-FLASH-Studie, die zuvor in dieser Indikation durchgeführt wurde

https://ir.soligenix.com/...-Provides-Regulatory-Update-on-HyBryte-TM


 

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