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Charlie Sheen: Kein HIV mehr im Blut nachweisbar

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eröffnet am: 03.12.16 15:53 von: GameChange. Anzahl Beiträge: 35
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03.12.16 15:53

479 Postings, 2238 Tage GameChangerCharlie Sheen: Kein HIV mehr im Blut nachweisbar

Bei Charlie Sheen hat offenbar das von Cytoyn entwickelte Pro-140 gewirkt. Obwohl noch keine Daten zur aktuell laufenden Studie (Phase III) veröffentlicht wurden, ist der Fall Sheen ggf. stark indikativ für die Wirksamkeit von Pro-140.
Link: https://www.welt.de/vermischtes/article159939879/...-nachweisbar.html

Kurs hat gestern schon etwas angezogen.

Meinungen?

Natürlich keine Kauf- oder Verkaufsempfehlung von mir..  
Seite: 1 | 2  
9 Postings ausgeblendet.

05.01.17 21:34
1

2128 Postings, 1602 Tage XaropeCytoDyn

https://www.sec.gov/Archives/edgar/data/1175680/.../d511999dex991.htm

Auszug:

- We are on track to reach a major clinical and business inflection point and expect to report initial efficacy results from our pivotal Phase 3 trial with PRO 140 as a combination therapy during the first half of 2017;

- We are encouraged by the interest shown by clinicians and patients alike in our Phase 3 clinical trial with PRO 140 as a monotherapy and anticipate rapid enrollment in this trial;

- We expect to treat the first patient in our Phase 2 trial with PRO 140 in graft versus host disease (GvHD); and

- We are encouraged by recent developments in evaluating PRO 140 for autoimmune diseases and cancer.  

06.01.17 09:08
1

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn's CEO Dr. Nader Pourhassan Presents Investment Community Conference (Transcript)
http://seekingalpha.com/article/...ranscript?source=feed_all_articles


kleiner Auszug:

Specifically, we overcame many difficult obstacles and undertook many tough challenges, and here we are, two Phase 3 clinical trials and the potential to submit a BLA, Biologic Licensing Agreement for final approval in this year 2017. As you know, we have a clear regulatory path for U.S. approval of PRO 140 for treating HIV patients.

Important milestones for 2017 for our HIV program are; regard to our Phase 3 pivotal trial, now this is the trial we will use to get our first approval for PRO 140. We are on track to reach a major clinical and business inflection point by the end of March by reporting efficacy results from our pivotal Phase 3 trial with PRO 140 as a combination therapy.  

06.01.17 09:13
1

2128 Postings, 1602 Tage XaropeCytoDyn

Aus der Konferenz noch kleiner Zusatz:

Turning now to corporate development update number five. We entered 2017 with the strengthened balance sheet, having raised $13 million late last year in support of advancing the development of PRO 140. We are proud to have raised more than $32 million in all of 2016 and more than 70 million since I became CEO in 2012. Obviously, under my leadership we never failed to deliver on this important task.  

11.01.17 20:28

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn Files for Breakthrough Therapy Designation With the FDA for PRO 140 in HIV Therapy
https://www.bloomberg.com/press-releases/...or-pro-140-in-hiv-therapy

Auszug:
CytoDyn Inc.
(OTC.QB:CYDY), a biotechnology company focused on the development of new
therapies for combating human immunodeficiency virus (HIV) infection, today
announced the Company filed a request for Breakthrough Therapy Designation
with the FDA for PRO 140 as a treatment for HIV-1 infection in
treatment-experienced patients with virologic failure.

While the standard of care for HIV infection has been a combination of
medications from different antiretroviral classes that interfere with
different steps of the HIV lifecycle, there is now a significant number of
long-term survivors who are facing issues of drug resistance and need new
treatment options. The Company believes this request for Breakthrough Therapy
Designation addresses this unmet need for novel therapies for the growing
number of heavily treatment-experienced HIV patients.

Based on results from four completed and ongoing clinical trials, the Company
believes the PRO 140 treatment option addresses the unmet medical need for
therapy options for HIV-1 infected patients with uncontrolled viral load,
despite conventional Antiretroviral Therapy (ART).
 

30.01.17 18:38

2128 Postings, 1602 Tage XaropeCytoDyn

eigentlich poste ich ja nicht unbedingt personalien,
aber wenn ichs richtig lese gehts auch langsam um die vermarktung von Pro140
(man möge mich gerne berichtigen)

CytoDyn Strengthens Executive Management With Appointment of Anthony D. Caracciolo as Executive Chairman
https://www.bloomberg.com/press-releases/...olo-as-executive-chairman

Auszug:
CytoDyn Inc.
(OTC.QB:CYDY), a biotechnology company focused on the development of new
antibody therapies for combating human immunodeficiency virus (HIV) infection,
announces the appointment of Anthony D. Caracciolo as Executive Chairman of
CytoDyn effective immediately.  In this new capacity, Mr. Caracciolo will
assume an active leadership role in the Company’s strategic planning, business
development and operations.  Nader Pourhassan, Ph.D., will continue to serve
as President and Chief Executive Officer, and Mr. Caracciolo will retain his
position as Chairman of the Board.

“We are committed to increasing shareholder value and this appointment is
aimed at strengthening our management team and driving our corporate
strategy,” said Dr. Pourhassan. “Mr. Caracciolo’s significant industry and
operational experience is expected to be highly valuable in directing our
ongoing clinical trials and enhancing business development efforts as we
pursue broader strategic opportunities for our late-stage PRO 140 technology
to increase the franchise value of our pipeline.”  

31.01.17 19:03

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn commences $1.2M direct capital raise; shares ease 3%
http://seekingalpha.com/news/...s-ease-3-percent?source=feed_news_all


- CytoDyn (OTCQB:CYDY -3.3%) inks agreements with certain investors for the direct placement of 1,534,999 shares of common stock at $0.75/share. Buyers will also receive five-year warrants to purchase 767,498 shares of common at $1.

- Net proceeds of ~$1M will fund clinical trials and general corporate purposes. Closing date is today.

- Yesterday's close was $0.73.
 

14.02.17 21:16
1

2128 Postings, 1602 Tage XaropeCytoDyn

Two-Year Update From CytoDyn’s PRO 140 Monotherapy Study in HIV to be Featured in Two Events at CROI 2017
https://www.bloomberg.com/press-releases/...n-two-events-at-croi-2017

Auszug:
CytoDyn  Inc.
(OTC.QB:CYDY), a  biotechnology  company focused  on  the development  of  new
antibody therapies for combating human immunodeficiency virus (HIV) infection,
announces that data from its ongoing Phase 2b extension study with PRO 140  as
a monotherapy for the treatment of  HIV-infected patients will be the  subject
of a poster  presentation on  February 15  and will  be featured  in a  Themed
Discussion on February 16 at the Conference on Retroviruses and  Opportunistic
Infections (CROI) being  held in  Seattle.  Dr. Kush  Dhody, Senior  Director,
Clinical Operations at  Amarex Clinical Research,  will make the  presentation
and participate in the discussion on behalf of CytoDyn.

denke mal wird bei uns dann auf die nacht zum donnerstag sein.
da ich donnerstags trainier werd ich eventuell erst freitag erfahren wies ausschaut.
aber vielleicht kann ja einer der stillen mitleser schon eher was einstellen zu den daten.  

16.02.17 08:48

2128 Postings, 1602 Tage XaropeCytoDyn

Data Presented at CROI Show CytoDyn’s Pro 140 as a Single Agent Provided Maximal Virologic Suppression in HIV Patients for Ne
https://www.bloomberg.com/press-releases/...on-in-hiv-patients-for-ne

2 hervorzuhebende Sätze:
"It is indeed an honor to present this data to attendees at CROI 2017.”
und
“We are excited about both Phase 3 trials with PRO 140,”

so weit ichs versteh sind da wirklich paar gute Neuigkeiten bei.  

16.02.17 13:10

505 Postings, 5537 Tage enrihi

Nachrichten sind nicht so wichtig schau auf den Kurs der sagt alles
Gestern +8%
bleibt abzuwarten ob und wie viel  jemand bereit ist auf den Tisch zu Legen
der CEO spricht von Goldenen Jahr

http://seekingalpha.com/article/...nt-community-conference-transcript

Hoffe auch für uns Kleinanleger ;-))
ciao  

16.02.17 14:02

2128 Postings, 1602 Tage XaropeCytoDyn

bei guten News/Fortschritten sind die leute eher bereit geld aufn tisch zu legen ;)  

16.02.17 21:28

505 Postings, 5537 Tage enriHi

Die Leute
Ich glaube Gilead , Glaxo oder sonst wer kennen schon die News/Fortschritte
was bleibt
A-es gibt schon Verhandlungen
B- alle warten ab je weiter Fortgeschritten um so Sicherer
C-es ich doch nicht so Toll
es gibt Gerüchte Gilead hätte schon Leute drin bei Cyto Dyn
ciao
 

04.04.17 18:18

2128 Postings, 1602 Tage XaropeCytoDyn

SHAREHOLDER ALERT: Purcell Julie & Lefkowitz LLP Is Investigating CytoDyn Inc. for Potential Breaches Of Fiduciary Duty By Its Board of Directors
https://www.bloomberg.com/press-releases/...-of-fiduciary-duty-by-its

wasn da los????  

19.04.17 18:13

2128 Postings, 1602 Tage XaropeCytoDyn

Potential for CytoDyn’s PRO 140 for Treating HIV Patients Deemed Too Broad for Orphan Drug Designation by the FDA
https://www.bloomberg.com/press-releases/...ug-designation-by-the-fda

wenns ichs richtig les hat FDA abgelehnt weil se mehr potential in Pro140 sehen???  

22.04.17 08:51

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn's (CYDY) CEO Nader Pourhassan Hosts Investment Community Conference Call (Transcript)
https://seekingalpha.com/article/...munity-conference-call-transcript

da fragt auch jemand zu FDA:

Frage:
My first question is does the recent decision that FDA decision not to grant you the orphan drug designation have any impact whatsoever on the regulatory review timeframe?

Antwort:
Yes, this is Tony. In terms of the orphan drug designation, we were a little disappointed that they did not grant us orphan drug designation. But if you go back a little bit, we actually applied for orphan drug designation with the combination trial in mind and had not negotiated the actual conclusion of monotherapy trial with the FDA at that time. So, we were quite pleased that we were able to have the FDA agreed to move forward with the protocol from monotherapy. And so consequently, after accepting reviewing and approving the monotherapy protocol, I suspect the FDA went back and felt that providing us with orphan drug designation for the combination therapy was not appropriate. So, to specifically answer your question, the denial of orphan drug has virtually no impact on timeline related to completing the combination therapy and then moving forward and completing the monotherapy which would be a second approval.  

20.05.17 08:50

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn Treats First Patient with PRO 140 in Phase 2 Trial for Graft versus Host Disease
https://www.bloomberg.com/press-releases/...graft-versus-host-disease

 

12.08.17 08:53

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn Provides Update on Enrollment in its Pivotal Phase 2b/3 HIV
Combination Trial
https://www.bloomberg.com/press-releases/...b-3-hiv-combination-trial  

08.10.17 19:17

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn Receives Orphan Drug Designation for PRO 140 for Prevention of Graft
Versus Host Disease
https://www.bloomberg.com/press-releases/...graft-versus-host-disease  

14.10.17 08:36

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn Provides Update on PRO 140 Combination Therapy Pivotal Trial in HIV
Patients Following Constructive Meeting With FDA
https://www.bloomberg.com/press-releases/...tructive-meeting-with-fda

...
announces that in a
meeting held on October 12, 2017, the U.S. Food and Drug Administration (FDA)
confirmed the number and type of evaluable patients required for submission of
a Biologics License Application (BLA) for PRO 140 as a combination therapy.
...  

21.10.17 09:19

2128 Postings, 1602 Tage XaropeCytoDyn

CytoDyn Dresses HIV Patients In CCR5 Halloween 'Mask'
https://seekingalpha.com/article/...-hiv-patients-ccr5-halloween-mask

- CytoDyn has received FDA guidance on fully enrolling its phase 3 pivotal study in HIV for lead candidate PRO 140.

- The company is developing a feline treatment for FIV in the burgeoning veterinary markets.

- Label expansion into rare disease indication graft versus host disease may put PRO 140 on a faster regulatory track.

- Company plans to submit BLA for PRO 140 in 1H 2018

...  

04.11.17 09:07

2128 Postings, 1602 Tage XaropeCytoDyn

8-K
https://www.sec.gov/Archives/edgar/data/1175680/...088/d455199d8k.htm


On November 1, 2017, CytoDyn, Inc., a Delaware corporation (the “Company”), held a special meeting of stockholders at which the stockholders approved a proposal to effect a reverse stock split at a ratio of any whole number between one-for-two and one-for-fifteen, as determined by the board of directors, and a simultaneous reduction in the total number of authorized shares of common stock to 200,000,000 at any time before August 24, 2018, if and as determined by the board of directors.

The stockholders also approved an adjournment of the special meeting, if it had been necessary to solicit additional proxies, had there been insufficient votes to approve the reverse stock split.

The final results for each proposal are set forth below. A more detailed description of each proposal is set forth in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on October 2, 2017.  

02.02.19 07:57

505 Postings, 5537 Tage enrihi

so langsam müsste doch der Kurs ins laufen kommen
https://seekingalpha.com/pr/...arding-first-bla-submission-leronlimab
das da immer noch keiner Großer Pharma Interesse hat bei dem Preis ?
ciao
 

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