Camaro1093 Stocks!

[TH_Stockhunter]

Congrats on CHTP!

CHTP - Chelsea: Northera Phase III Study Succeeds

Up 43% in PM ($7.25).

CHARLOTTE, N.C. (TheStreet) -- Chelsea Therapeutics(CHTP) reported positive results Monday from a late-stage study of its experimental drug Northera in patients with neurogenic orthostatic hypotension, a disease characterized by a chronic drop in blood pressure upon standing.

The benefit of Northera demonstrated in this most recent phase III study comes after disappointing results from an earlier phase III study in October 2009. After that initial failure, Chelsea amended the design of the current phase III study with the permission of U.S. regulators.

Chelsea said treatment with Northera provided clinically meaningful and statistically significant improvement in symptoms associated with neurogenic orthostatic hypotension (NOH) compared to treatment with a placebo.

The study's primary endpoint was measured using a questionnaire specifically designed to rate the severity of symptoms resulting from low blood pressure and the degree those symptoms interfere with a patient's ability to perform activities of daily living.

"We are extremely excited by these top-line results which provide validation of the safety and efficacy of Northera as a novel treatment for symptomatic neurogenic orthostatic hypotension, a serious condition for which there is an urgent need for improved treatments," said Chelsea CEO Simon Pedder. "Symptoms of chronic neurogenic orthostatic hypotension are severe, not only putting patients at high risk for falls and associated injuries but also severely impacting their quality of life and generating significant added health care costs."

Chelsea said secondary endpoints in the Northera clinical trial were also met and that the drug was generally safe and well tolerated, with headaches the most common adverse event reported. No falls were reported in patients treated with Northera compared to three patient falls reported in the placebo arm.

Another phase III study of Northera in patients with NOH associated with Parkinson's disease is underway, with data expected in the second quarter of next year.

Chelsea closed Friday at $5.06.

--Written by Adam Feuerstein in Boston.

http://www.thestreet.com/print/story/10865110.html

[Camaro1093]

Thanks for the link!

[Camaro1093]

Currently holding: ALXA and CHTP.

CHTP is my favorite of the two -- phase 3 trial results will be out sometime this month, IMO it has high potential for success. More detailed post coming soon...

[mlkrborn]

21 stocks with FDA reviews: Adam F.
http://www.thestreet.com/story/10847027/7/21-drugs-facing-fda-approval-decisions.html

[Camaro1093]

BioShockers.com Seeking Alpha Article on CHTP: http://seekingalpha.com/article/220389-chelsea-therapeutics-not-just-a-short-term-trade

[Camaro1093]

BioShockers Alert

Bought shares of CHTP at 2.94 and 2.92 yesterday afternoon.

GLTA.

[biomanbaba]

what about VVUS 7/15 advisory meeting?

[Camaro1093]

Back then I thought it would be in the .50-.60 range by now. But then tehy announced $100M stock offering and potential reverse split.. Bad call on my part.

[mlkrborn]

Camaro Why insist on HNAB like humblehawk? is it 0175 now? why pull back?
tia
GL

[peewee]

Got Antisoma ??


WEE WEE WEE WEEE

[peewee]

FDAnews Drug Daily Bulletin
June 4, 2010 | Vol. 7 No. 109

Antisoma’s AS1413 Gains FDA Fast Track Status for Myeloid Leukemia
Cancer drug developer Antisoma Thursday announced that the FDA has granted Fast Track designation to the Company’s novel DNA intercalator, AS1413 (amonafide L-malate), for the treatment of secondary acute myeloid leukemia.



http://www.fdanews.com/newsletter/...sueId=13751&articleId=127580

Antisoma IHUB board:
http://investorshub.advfn.com/boards/board.aspx?board_id=17986

[peewee]

Antisoma leukaemia treatment to be fast-tracked
Thu 03 Jun 2010

LONDON (SHARECAST) - Cancer drug developer Antisoma’s Leukaemia treatment AS1413 has been granted Fast Track designation by the US Food and Drug Administration (FDA).

The Fast Track programme affords drugs that have shown the potential to meet an unmet medical need in serious or life-threatening diseases a speedier review process than would otherwise be the case.

‘We're very pleased to have gained FDA Fast Track status for AS1413,’ said Antisoma chief executive Glyn Edwards.

‘This drug could represent a major advance in the options available to patients with secondary AML [acute myeloid leukaemia], and we look forward to completing the ongoing phase III trial and sharing the data with FDA and other regulators.’


http://www.sharecast.com/cgi-bin/sharecast/story.cgi?story_id=3495656

[Camaro1093]

BioShockers Alert

Bought into JAV earlier today @ $1.21.

[Camaro1093]

ASCO abstracts to be released tomorrow at 6PM EDT.

HNAB & SNSS are both presenting at ASCO this year...

[Den]

uw - good work

[Camaro1093]

BioShockers Alert

Added more HNAB @ 0.30

[Camaro1093]

Thanks for the mark!

[Den]

board marked -
keep up the gd work -thnx

[Camaro1093]

BioShockers Alert

Bought ALXA @ $3.85
Added SNSS @ $0.95

[Camaro1093]

Awesome! I added more in the .95s today...

GL.

[peewee]

ARIA Chart !

[TH_Stockhunter]

Bought SNSS at .97! Nice reversal and big volume coming in... Holding for potential run-up at the upcoming ASCO! IMO

[Camaro1093]

BioShockers Alert

Sold CLDX @ $7.85.
Bought JAZZ @ $8.43.

[Camaro1093]

BioShockers Alert

Bought shares of CLDX @ $7.65.

[Camaro1093]

Great news!

[TH_Stockhunter]

AEZS (1.44) + 16% pre-market....

[TH_Stockhunter]

AEZS news --> Aeterna Zentaris Receives Orphan-Drug Designation from the FDA for AEZS-108 in Ovarian Cancer

QUEBEC CITY, May 6, 2010 (Canada NewsWire via COMTEX) -- Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), ("the Company") a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received from the U.S. Food and Drug Administration (FDA), orphan-drug designation for AEZS-108, its doxorubicin targeted conjugate compound, for the treatment of ovarian cancer. AEZS-108 is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.

Juergen Engel, Ph. D., President and CEO of Aeterna Zentaris stated, "We are very pleased with AEZS-108 gaining orphan-drug designation for ovarian cancer from the FDA as it would provide it with extra market exclusivity protection. We look forward to reporting the final results from our ongoing European Phase 2 study in ovarian and endometrial cancer, later this year."

About Orphan-Drug Designation

Orphan-drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication. It also provides tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About Ovarian Cancer

Ovarian cancer is one of the most common gynaecologic malignancies and the fifth most frequent cause of cancer death in women, with most of the cases occurring in women between 50 and 75 years of age. Overall, ovarian cancer accounts for 4% of all cancer diagnoses in women and 5% of all cancer deaths. Approximately 26,000 new cases and 17,000 deaths from this disease are estimated in the European community every year (Source: Gynaecologic Oncology 2004; 92:819-26). The National Cancer Institute estimates that in 2009, in the United States alone, there were 21,550 news cases of ovarian cancer and 14,600 related deaths.

About AEZS-108

AEZS-108 represents a new targeting concept in oncology using a cytotoxic peptide conjugate which is a hybrid molecule composed of a synthetic peptide carrier and a well-known cytotoxic agent, doxorubicin. The design of this product allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH-receptor-positive tumors. The binding of AEZS-108 to cancerous cells that express these receptors results in its accumulation and preferential uptake in the malignant tissue.

[Camaro1093]

Nice buy!

[Camaro1093]

BioShockers Alert

Out all ITMN @ $11.38 from $10.68 entry.

[peewee]

ITMN entered @10$ today

[peewee]

ARIA entered @3.80 today

[Camaro1093]

Very possible, imo. Thanks for the link -- great post!

GL.

[zigzagman]

Me too...

I scalped it twice in after-hours very successfully...

And then went IN @ $10.37 with 500 shares to hold to $15. by end of this week?...

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=49785504

[Camaro1093]

BioShockers Alert

Bought shares of ITMN after-hours @ $10.68. In for a quick bounce.

[TH_Stockhunter]

FDA plays coming up:

Updates for: Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), Santarus, Inc. (NASDAQ:SNTS), Questcor Pharmaceuticals, Inc. (NASDAQ:QCOR), and Shire Plc. (ADR) (NASDAQ:SHPGY)

Progenics Pharmaceuticals, Inc.

(NASDAQ:PGNX)

PGNX announced a deal with Wyeth to re-acqurie all of the worldwide rights to the RELISTOR franchise after a one-year transition period. RELISTOR (subcutaneous injection) is the only drug approved to treat opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. PGNX will aggressively continue development to expand the utility of both subcutaneous and oral RELISTOR into a new population for patients with chronic pain who experience OIC. On 8/4/09, Wyeth and PGNX announced submission of a supplemental New Drug Application (sNDA) to the FDA and an Extension Application to the European Medicines Agency (EMEA) for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes. RELISTOR was approved last year in single-use vials. RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. If approved, pre-filled syringes of RELISTOR are expected to be available in the U.S. and Europe as early as the first half of 2010. Single-use vials of RELISTOR will continue to be available. The estimated PDUFA action date is for a standard, 10-month review period.

Santarus, Inc.

(NASDAQ:SNTS)

SNTS announced that the FDA approved the Company’s NDA for immediate-release omeprazole / sodium bicarbonate / magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. The NDA for the new prescription tablet product was approved for all indications the company was seeking, including for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, or GERD. The Agency has not yet approved a trade name for the new product. Santarus has submitted an NDA supplement requesting approval of a proposed trade name that includes the “ZEGERID” brand name and anticipates that the FDA will complete its review of this NDA supplement within 180 days.

[TH_Stockhunter]

FDA CALENDAR UPDATE

http://www.rttnews.com/CorpInfo/FDACalendar.aspx

05/04 ITMN FDA decision on Esbriet
05/06 QCOR FDA panel to review H.P. Acthar Gel
05/07 CYTX Clinical Trial
05/12 NICXF FDA Advisory Committee meeting
05/23 PUMD Estimated FDA Decison for 510k device clearance
5/27 THTCF FDA Advisory Committee meeting
05/29 PTXRF Clinical trial

06/04 SNTS FDA Decision
06/04 CLDX Clinical Trial
06/04 OXGN Clinical Trial
06/04 IMMU Clinical Trial
06/04 MYRX Clinical Trial
06/04 PGNX FDA Decision
06/04 CYCC Clinical Trial
06/06 PKNGF FDA Decision
06/06 SNSS Clinical Trial
06/09 MELA FDA Decision
06/11 QCOR Clinical Trial
06/30 ABIO Clinical Trial
06/30 ANTH Clinical Trial
06/30 YMI Clinical Trial
06/30 GENT FDA Filling
06/30 ANDS Clinical Trial
06/30 NBY Clinical Trial
06/30 DARA Clinical Trial
06/30 ATHX Clinical Trial
06/30 SQNM Clinical Trial
06/30 RNN Clinical Trial
06/30 INO Clinical Trial
06/30 CBMX Clinical Trial
06/30 OMER Clinical Trial
06/30 AVNR FDA Filling
06/30 KERX Clinical Trial
06/30 CYTR Clinical Trial
06/30 ACCP Clinical Trial
06/30 BIEL 510K clearance
06/30 SNTA Clinical Trial
06/30 RPRX FDA response
06/30 PVCT Clinical Trial
06/30 ARRY Clinical Trial
06/30 SNGX Clinical Trial
06/30 TTHI Clinical Trial
06/30 ZIOP Clinical Trial

[Camaro1093]

Yeah, IMO it's undiscovered as of now, but when they present at ASCO, it should bring in some much-needed attention..

[Camaro1093]

Website updated: www.bioshockers.com

[TH_Stockhunter]

HNAB - that stock will have its day IMO!

[TH_Stockhunter]

ALERT: Sold POZN at $11.35 where I bought it... Only played the FDA approval, but fridays bear raid killed the run IMO!

[Camaro1093]

BioShockers Alert

Added more HNAB... Can't get enough of this stock.

[TH_Stockhunter]

POZN 12.85 pre-market so far... Gonna be interesting what FDA approval can do to shareprice... Huge short position in POZN that could make it run even harder, when they have to cover! Looking for minimum $18 as it looks right now!

[Camaro1093]

AEZS moving...

[Camaro1093]

Very nice!! Congrats!

[TH_Stockhunter]

POZN $12.15!

[Camaro1093]

BioShockers Alert

Added more SNSS @ .943, this selloff is way overdone, IMO.

[Camaro1093]

Nice buy.. Already @ $11.81!

[TH_Stockhunter]

Looks like good timing from my part! :)

[Camaro1093]

Awesome... POZN looks very promising! Having the SPA really helps chances for approval, IMO.

GL.

[TH_Stockhunter]

Bioshockers Alert

Bought POZN at $11.35 on hope for approval of Vimovo tommorow!

Potential run-up EOD and then $14-18 target on approval....