Vagnum wrote:
QuoteDisplay Moreboersenspiel wrote:
nope...
Quote:
die trades im bear raid bleiben stehen...
Da sind wahrscheinlich einige Stopp-Loss-Aufträge ausgelöst worden? Bin gespannt, wie es weiter geht... :roll:
ok, es werden bigger news sein. T1 Halted. im Moment gibt es noch keine Angabe wann der Handel wieder eröffnet wird.
sharewatch wrote:
QuoteSchaut mal DDSS an. Ich habe leider schon eine Portion zu einem höheren EP, aber es ist gerade eine gute Kaufgelegenheit.
0.900
+0.016 (1.83%)
ICGN
3.20
+0.93 (40.97%)
sharewatch wrote:
QuoteICGN3.20
+0.93 (40.97%)
Sobald das Volumen (Interesse) schwindet, shorte ich ICGN. Aber das könnte noch eine Weile dauern, da das Volumen jetzt einwenig zunimmt.
jmd. aus chur umgebung da? mich wunderts wies mit schnee aussieht da..muss morgen früh arbeiten da und hinfahren..
Vagnum wrote:
Quoteok, es werden bigger news sein. T1 Halted. im Moment gibt es noch keine Angabe wann der Handel wieder eröffnet wird.
Quote:
QuoteMNKD. MannKind Corporation Receives Complete Response Letter from the FDA for AFREZZA(R)Display More
Last update: 1/19/2011 3:34:00 PM
VALENCIA, Calif., Jan 19, 2011 (BUSINESS WIRE) -- MannKind Corporation (MNKD) today announced that it has received a complete response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA(R) (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.
A complete response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.
The principal issue raised by the FDA concerned the usage of in vitro performance data and clinical pharmacology data to bridge MannKind's next-generation inhaler to the phase 3 trials conducted using its MedTone(R) inhaler. The FDA has requested that MannKind conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the two devices. In the complete response letter, the FDA stated that after an adequate titration of study medication there should be at least twelve weeks of relatively stable insulin dosing at the end of the treatment period.
The FDA has also requested additional information concerning the performance characteristics, usage, handling, shipment and storage of the next-generation device, an update of safety information related to AFREZZA as well as information on proposed user training and changes to the proposed labeling of the device, blister pack, foil wrap and cartons.
"As we reported last fall, we have already begun a series of studies of the next-generation device in patients with type 1 (Affinity 1) and type 2 (Affinity 2) diabetes," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "Consistent with the direction we received in the complete response letter, these trials are designed to focus on careful titration of insulin dose and include at least twelve weeks of stable dosing. We plan to meet with the agency as quickly as possible in order to be confident that these trials, with appropriate modifications to incorporate a comparison to the MedTone device, will suffice in addressing the agency's questions about patient use and robustness of the next-generation device."
Mr. Mann continued, "While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program. We remain committed to working with the FDA to make AFREZZA available to people with diabetes."
MannKind will host a conference call at 4:00 pm (Eastern Time) on January 19, 2011. To participate in the live call by telephone, please dial 888-942-9866 or 415-228-3901 and use the participant passcode: MANNKIND. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at . A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing 888-562-4434. A replay will also be available on MannKind's website for 14 days.
also es geht runter, die frage ist jetzt nur wie tief.
hätte drauf setzen sollen... was mir ausnahmsweise bei MNKD sicher, dass es bestenfalls einen CRL gibt.
Die einzige Frage, die noch bleibt ist: wann kaufen wir? Sofort wenn der Handel losgeht AH, morgen beim open oder erst nach 2-3 Tagen?
Hab heute übrigens nochmals 2000 CLDX dazugekauft... Hab jetzt 8000 Stück. Wenn man sich das Yahoo board anschaut, könnte man meinen, morgen ginge die Welt unter. Etwas Geduld, dann liegt ein guter Gewinn drin. Guter Trading Stock, hab letztes Jahr 9000$ damit verdient, obwohls nur "abwärts" ging und ich long war... 
lol, yihi. 
sehn wir mal ob MNKD bouncen kann. ich werde nur probiern einen daytrade in der regulären Handelszeit zu realisieren sofern es die volatilität zu lässt. müsste ja wie mit CLDX kann man auch mit anderen aktien die fallen long geld machen. :lol:
naja, warum nicht... mir kommt gerade spontan kein Beispiel eines Biotechs mit einem ordentlichen Produkt in den Sinn, das nicht gebouncet ist in letzer Zeit.
Amylin war ja ne ähnliche Geschichte, ist sehr schön gebounced.
Alexza auch schön, Intermune traumhaft, ...
edit: bin gestern nachbörslich rein... hab denn Gewinn dann aber realisiert bei 5.17. Vielleicht heute wieder rein...
Soligenix Receives FDA Orphan Drug Designation for RiVax™ for the Prevention of Ricin Intoxication
Quote:
QuoteBETHESDA, Md., Jan. 20, 2011 /PRNewswire/ -- Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that it has entered into definitive agreements to sell $2.77 million of shares of its common stock and warrants to purchase shares of its common stock in a registered direct offering to institutional investors. Spherix will issue an aggregate of 4,269,000 shares of common stock to the institutional investors together with warrants to purchase an additional 2,134,500 shares of common stock.Display More
Each investor will receive one share of common stock and a warrant to purchase 0.5 shares of common stock for a purchase price of $0.65. The warrants have an exercise price of $0.80 per share, and are exercisable 6 months after issuance and terminate 60 months after the date of issuance.
The Company intends to use the net proceeds from the offering to continue the development of Dtagatose for diabetes and triglycerides, as well as for general corporate purposes.
The closing of the offering is expected to occur on January 24, 2011, or earlier, subject to customary closing conditions, at which time Spherix will receive the cash proceeds and deliver the securities.
http://www.prnewswire.com/news…77-million-114269634.html
Quote:
QuoteJNapodano Jason Napodano, CFA
$SPEX to raise $2.7m + wars @ 80c. They now have enough to conduct p2 program with D-Tag in triglycerides. Prob start Q2, data Q4. @ Neu/$1
sharewatch wrote:
QuoteSoligenix Receives FDA Orphan Drug Designation for RiVax™ for the Prevention of Ricin Intoxication
ob da die Welt drauf gewartet hat?.... :roll:
Teva Pharmaceutical Increases Its Investment in Rexahn for the Continued Research and Development of the Pre-Clinical Anti-Cancer Compound, RX-3117
Quote:
QuoteROCKVILLE, Md.--(BUSINESS WIRE)--Rexahn Pharmaceuticals, Inc. (NYSE Amex:RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and central nervous system (CNS) therapeutics, announced that Teva Pharmaceutical Industries Limited (Teva) purchased 2,334,515 shares of Rexahn’s common stock in a private offering for $3.95 million, or $1.692 per share. This investment by Teva was made pursuant to the terms of the Securities Purchase Agreement, dated June 26, 2009, as amended. The investment money will be used for the purpose of supporting the research and development program for the pre-clinical stage, anti-cancer compound RX-3117. After this transaction, Teva will own 6.29% of the outstanding shares of Rexahn.
“We are also pleased with RX-3117’s development to date, and we are working to advance the compound into clinical trials in 2011.”
“We are excited by Teva’s increased commitment to this collaboration and the development of RX-3117,” said Dr. Chang Ahn, Rexahn’s Chairman and Chief Executive Officer.
Quote:
QuoteBy Brett Chase Jan 19, 2011 3:00 pmDisplay MoreThe two companies are seeking mediation over a pain drug marketing agreement, and a renegotiated deal may be in the works.
Is Abbott Laboratories’ (ABT) 11th-hour maneuver to exit a partnership with Depomed (DEPO) merely a negotiating move?
Depomed says partner Abbott is reneging on an agreement to help it launch a pain drug that may get US approval by the end of this month. Abbott, which inherited the deal with its takeover of Solvay last year, says there’s a dispute over the terms but adds little else.
Now the two companies are heading toward mediation, and, according to Depomed CEO Carl Pelzel, renegotiating the terms is not out of the question.
“We have been very open with Abbott and have not shut the door on any kind of discussions,” Pelzel told investors on a conference call. “If there were a desire to amend the contract we would have been and are very open to listen.”
According to Depomed, Abbott told the smaller company that it won’t continue a marketing relationship that was struck with drug maker Solvay, which Abbott acquired last year. The news comes as Abbott and Depomed await word from the the Food and Drug Administration, which has a January 30 deadline for deciding approval of the companies’ treatment for pain caused by shingles.
Given the timing, the move seems odd. Depomed received $25 million from Solvay in 2009 after the companies partnered to develop and market the drug, known for the time being only as DM-1796. Abbott paid Depomed $10 million when the FDA agreed to review the drug application. Abbott, which filed the application with the FDA, even sought and won so-called orphan drug status for DM-1796. That orphan status gives a drug maker a seven-year monopoly on a treatment. It’s a carrot the government offers to encourage development of treatments for rare diseases.
But there’s certainly a lot more money to come Depomed’s way now that it looks as though the drug has a shot at approval. If approved, Abbott would pay Depomed more milestone payments and royalties of up to 20%. If the drug is approved and launched, Abbott would pay Depomed up to $135 million within two years, according to Depomed.
“It’s a very good deal for Depomed,” says Jason Napodano, an analyst with Zacks Investment Research.
Napodano thinks Abbott may want to renegotiate the terms because it was a generous contract. He estimates the drug eventually may reach as much as $500 million in sales. He has an $8 a share price target on the stock.
Shares of Depomed fell 11% to $5.86 in early afternoon trading Wednesday. They fell about 8% Tuesday before the news was disclosed after markets. The stock is still up 85% over the past year.
If a deal can’t be reached with Abbott, Napodano says a number of specialty pharmaceutical companies may be interested in taking its place, including Forest Laboratories (FRX), Meda Pharmaceuticals or Purdue Pharma.
The bottom line: If you believe Depomed’s drug will be approved, it may be an opportunity to buy when the shares are down, Napodano says. The company’s partnership with Abbott may be screwed up in the short term but the drug is still expected to get US approval.
And if Abbott didn’t think the drug would get the approval, why wouldn’t it wait until the FDA rejected the application and then wriggle out of its contract?
b00n wrote:
QuoteSoligenix, Inc.Display More
(Public, OTC:SNGX)
bin durch bio med darauf gestossen und hab mir das etwas näher angeschaut..
wenn ich nicht bei KBLB nochma zuschlag werd ich wohl etwas in SNGX investieren
Soligenix, Inc. is a late-stage, biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents
Value Proposition
1.
Low current valuation of approximately $50 million
•
Potential for exponential growth with the achievement of a single milestone –A positive confirmatory Phase 3 clinical trial of orBec®
•
Relatively low risk and late stage drug development proposition due to existing orBec®Phase 3 data
2.
Four active clinical trials
3.
Clean capital structure with no debt or preferred stock outstanding
4.
FDA SPA and EMEA agreement on Phase 3 protocol supports regulatory path to approval in US and EU
5.
35% royalty generating North American partnership with Sigma-Tau on orBec®
6.
orBec®addresses a potential $400 million global GVHD market, where there is an unmet medical need with poor therapeutic options
7.
Oral BDP application in other GI areas -Radiation Enteritis and Crohn’s Disease; markets in excess of $500 million worldwide
8.
LPM™ -novel oral delivery system for drugs such as leuprolide
9.
Diversified portfolio: BioTherapeutics and BioDefense
•
BioDefense -Grant funded and revenue generating –New $9.4 million NIH grant
−
Soligenix is world leader in ricin toxin vaccine research
Aktuell bei 0.22 USD
man spekuliert hierfür auf folgende Pipeline:
http://www.dorbiopharma.com/pipeline.shtml
beachtet die Orphan und Fast Track Designation
letzte News;
Wednesday, September 15, 2010
Soligenix to Present at the Rodman & Renshaw Healthcare Conference on September 15, 2010 at 10AM EDT
Thursday, September 02, 2010
Soligenix Announces Publication of Article Identifying Domains Within the Ricin Toxin A Subunit as Targets of Protective Antibodies
Monday, August 23, 2010
Soligenix Announces Award of $1.2 Million FDA Orphan Products Development Grant
näheres hierzu
http://www.dorbiopharma.com/news.aspx
PRICETARGET 1.50 von
Brean Murray, Carret & Co., LLC
570 Lexington Avenue
New York, NY 10022-6895
We should note that SNGX had previously submitted an NDA for orBec® to the FDA and was notified they would need additional clinical data. This was likely associated with the study not achieving the primary endpoint, however, the secondary endpoints were very promising. Specifically, “orBec® did not achieve statistical significance in the primary endpoint of its pivotal trial, namely median time-to-treatment failure through Day 50 (p-value 0.1177), orBec® did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005) and the median time to treatment failure through Day 80 (p-value 0.0226), as well as a 66% reduction in mortality among patients randomized to orBec® at 200 days post-transplant with only 5 patient (8%) deaths in the orBec® group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139). At one year post randomization in the Phase 3 trial, 18 patients (29%) in the orBec® group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, p-value 0.04).”
If their Phase 3 didn’t meet the primary endpoint, then why run another trial? The extremely promising secondary endpoints are the difference maker. The new Phase 3 trial under the SPA with the FDA is a replica of the first initial trial, however, the primary endpoint is now the secondary endpoint from the first trial, which was highly-significant (p=0.005). Clearly, the FDA recognizes the unmet medical need which orBec® addresses and the efficacy signal seen in the secondary endpoints. Hence, we believe SNGX’s confirmatory Phase 3 trial will likely be successful and demonstrate the needed efficacy. Top-line results are targeted in the first half of 2011. It’s important to note that SNGX expects to get a 6-month review when it does file a response to the FDA.
We also agree with the analysis by National Securities Inc. and Brean Murray, Carret & Co. They both have price targets of $1.50, representing a potential 600% gain from current levels. We have also included the September 2010 corporate presentation. SNGX also has candidates in their pipeline for radiation enteritis, Crohn's disease and a promising delivery technology (called LPM™) for Leuprolide. They also have a biodefense program that has brought in needed cash. The long-term outlook for SNGX looks good and we feel management has positioned themselves adequately to succeed.
http://www.soligenix.com/pdfs/corp_fact-sheet.pdf
post vom sept.. schnell zum SNGX auffrischen
Vagnum wrote:
QuoteTeva Pharmaceutical Increases Its Investment in Rexahn for the Continued Research and Development of the Pre-Clinical Anti-Cancer Compound, RX-3117
Quote:
cool thx, da hab ich natürlich freude
Radient Pharmaceuticals Receives Updated European Union Certification for Onko-Sure®; CE Mark Opens Large Market for Company's IVD Cancer Test
Sauberes Gap-Close.
Wenn man noch an den FDA Entscheid denkt, so könnte es tatsächlich bis Freitag (nächste Woche) einen kleinen Run-Up geben. Wenn Ihr merkt, dass der Chart am Freitag plötzlich gerade, bzw. flach wird, dann empfehle ich wärmstens die Order bereit zu halten.
