Hot Pharma Stocks / Ideen / Blockbuster

Hot Pharma Stocks / Ideen / Blockbuster

Der lustigste Teil war echt der mit Charlie Sheen.

Der Film war mir aber viel zu dramatisch.

VOCALTEC COMMUNICATIONS ORD (CALL)

Kennt jemand diese Firma näher oder ist sogar investiert? Ich würde meinen der Kurs ist auf rein technischer Basis momentan attraktiv für einen Einstieg

High impact catalysts mark this week in healthcare sector

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Arena Pharmaceuticals Inc.(NASDAQ:ARNA) received a Complete Response Letter(CRL) from the FDA regarding their NDA for Lorcaserin. The FDA cited a number ofnon-clinical and clinical reasons for their decision including marginal efficacy, rat tumors, and recommended that ARNA submit the final study report of the BLOOM-DM(Lorcaserin in diabetes) trial.

I don’t see this news as positive in any way. There appear to be too many what-if’s along the road for ARNA. BLOOM-DM trial results aren’t likely to be significant for their case due to marginal efficacy. It’s also unclear how much work will be needed in order to alleviate the rat tumor issue. A resubmission from ARNA will certainly not happen until spring 2011, since it will take at least a month for them just to meet with the FDA, then there will be considerable work to be done.

ARNA receives CRL from FDA for Lorcaserin: http://bit.ly/aWUwq9

AVANIR Pharmaceuticals Inc.(NASDAQ: AVNR) has a PDUFA date of October 30th(Saturday) for AVP-923(dextromethorphan/quinidine) for the treatment of patients with a neurological condition known as pseudobulbar affect (PBA). AVNR’s complete response includes data from their STAR trial which was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Both doses of AVP-923 met the primary efficacy endpoint in the STAR trial.

You can expect increased volume to continue into this week as investors finalize their decision on whether to hold thru FDA approval. It is possible that AVNR will hear from the FDA before Saturday. AVNR management has answered questions about the safety data in the STAR trial and most potential issues appear accounted for. The active ingredient in AVP-923 is in most cough suppressants sold over-the-counter and quinidine decreases gastrointestinal adverse events. I believe AVNR has demonstrated that AVP-923 offers the FDA an acceptable efficacy/safety profile for treatment of PBA.

AVNR Q&A about Safety Data http://bit.ly/c3Xd51

Biodel Inc.(NASDAQ: BIOD) has a PDUFA date of October 30th(Saturday) for Linjeta, which is a new injectable formulation of rapid-acting insulin for the treatment of type 1 and type 2 diabetes. Linjeta also appears to cause less weight gain and lower incidence of hypoglycemia, which are common side effects of current treatment options. BIOD also used the 505(b)(2) NDA, which typically has lower regulatory risk.

Shares of BIOD have taken quite the beating throughout October falling 30%. Many questions surround their Phase 3 data and how the FDA will view certain data from India that appear anomalous. Non-inferiority of Linjeta to Humulin was achieved without the data from India, it wasn’t achieved when the data from India was included. If and when this reaches the market, Linjeta could be a better insulin treatment for diabetics, especially those prone to hypoglycemic episodes or weight gain.

EXACT Sciences (NASDAQ: EXAS) will be presenting the results of three pre-clinical validation studies at American Association of Cancer Research Conference(AACR) in Philadelphia on 10/28/10 at 1PM EDT(see link below). They expect to start their pivotal study during 2nd/3rdQ 2011 to eventually support a FDA filing in 2012. In late July(see link below), EXAS reported preliminary results demonstrating their DNA methylation technology “detected 100 percent of colorectal cancers and precancers at a specificity cutoff of 100 percent in a preliminary study with colorectal tissue.”

EXAS is up more than 130% from the July lows, so expectations for positive results are high. Positive results would lead the way forward for EXAS to capitalize on the colorectal screening market which sees roughly 25-30M screening tests per year, with another 20-25M patients who are not up-to-date with colon cancer screening. The company has been using 30% market penetration for their test which yields $1.2B market potential. There has also been noticable insider buying at EXAS. Keep in mind that EXAS has a $150M shelf registered, which is likely to be used once results are known.

EXAS 3Q 2010 Results, Validation Study Data Conference Calls - http://bit.ly/9OETtW

EXAS Methylation Detection Technology Achieves 100 Percent Sensitivity, Specificity http://bit.ly/d0B2zX

VIVUS Inc.(NASDAQ: VVUS) has a PDUFA date of October 28th(Thursday) for Qnexa for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity. After the trading volatility that ARNA saw last week, it’s likely that VVUS could see some movement for those speculating on approval.

In my opinion, VVUS has a stronger case for approval than ARNA. Considering ARNA was given a CRL with uncertain terms, this could give VVUS a boost tomorrow. The FDA questioned the marginal efficacy of Lorcaserin(for ARNA), a problem that Qnexa does not have. Another important fact to consider: VVUS had an SPA for their pivotal trial results, which demonstrated very significant efficacy. Recently released results from their long-term(2-year) SEQUEL study did not show any safety problems and reiterated the considerable efficacy seen with Qnexa. Weight-loss of 11.4%(26 lbs) in the high-dose Qnexa and 10.4%(23 lbs) in the low-dose group. It is unclear if the FDA will have had time to review this data. They might not get approval now, but they appear to have the quickest route to approval.

VVUS 2-year data http://bit.ly/9xP1FG

Disclosure: Long AVNR

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Hot Pharma Stocks / Ideen / Blockbuster

heute hat noch VVUS FDA Zulassungstermin...

Hot Pharma Stocks / Ideen / Blockbuster

wollte ich auch grad posten.

Selbes Spiel wie bei ARNA?

(kleiner Shortsqueeze?)

Hot Pharma Stocks / Ideen / Blockbuster

VVUS ein CRL von der FDA = Not aprooved, gelichzeitig kommen upgrades rein. Die Aktie ist 20% im plus im Premarket. lol

DSCO

Ich werde mir mal folgende 3 Firmen ins Auge nehmen. DSCO ist meiner Meinung nach unterbewertet und das Medikament Surfaxin ist au dem guten Weg.

folgendes habe ich aus einem Blog:

To Phamer : I have no idea, sorry. I like very much Biotech but I have no time (what a pity) to study every Biotech. My focus for the next monthes are : ANX, ARIA and for the next year, be focus on DSCO… I expect that 2011 will be the year for DSCO (this share price is very, very low due to FDA hurdles but the way to get approval is now clear and DSCO is on the good way…)

At your disposal…

BIOD sollte heute FDA Entscheidung bekommen.

Drug: Linjeta

hier noch eine interessante Seite:

http://www.thestreet.com/story…rug-approval-pickers.html

Hot Pharma Stocks / Ideen / Blockbuster

DSCO scheint ein interessanter Titel zu sein, vor allem relativ günstig..

hat man da genaue daten bei dsco oder ist das alles noch offen?

Für BIOD wird ja prozentual ein CRL erwartet.. mal schaun.. hatte einen guten run im vorfeld...

Hot Pharma Stocks / Ideen / Blockbuster

Novartis drug Afinitor® approved by FDA as first medication for children and adults with a benign brain tumor associated with tuberous sclerosis

http://tinyurl.com/386a59s

Hot Pharma Stocks / Ideen / Blockbuster

danke für die info b00n.

Biotechstocks to watch:

SNTS CADX ASTM

Hot Pharma Stocks / Ideen / Blockbuster

RPC

könnte wieder mal zu einem run ansetzen... das letzte mal gings von 0.40 - 0.97

Hot Pharma Stocks / Ideen / Blockbuster

CADX: Donnerstag PDUFA

RPC: Bei 0.40 sollte sie eigentlich abprallen. Mal sehen.

Hot Pharma Stocks / Ideen / Blockbuster

equity holder wrote:

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CADX: Donnerstag PDUFA

RPC: Bei 0.40 sollte sie eigentlich abprallen. Mal sehen.

CADX:

Cadence Pharmaceuticals (CADX) has a PDUFA date with the FDA this Thursday for Ofirmev, its intravenous acetaminophen therapy for pain. Short interest is astronomical on this stock, currently making up over 50% of float. Generally, a short interest that high makes the stock a bit on the squirrelly end, indeed. Expect the unexpected in terms of price action this week.

That’s it. I think we could all use a lighter week after the excitement of the last month.

http://biotechinvestmentparadigm.com/?p=723

Hot Pharma Stocks / Ideen / Blockbuster

Ich muss schon wieder an die Araber und bear raid denken. Ich werde dabei sein, wenns einen gibt.

Hot Pharma Stocks / Ideen / Blockbuster

CADX Top Biotech für diese Woche. Preisziel bei 11$, gute chancen auf aprooval und hohe short position, Bear Raid chance. ok mal sehn.

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In March 2006, we in-licensed the exclusive U.S. and Canadian rights to OFIRMEV™, an intravenous formulation of acetaminophen that is currently marketed in Europe for the treatment of acute pain and fever by Bristol-Myers Squibb Company, or BMS, under the brand name Perfalgan®. According to IMS data, since its introduction beginning in 2002, over 250 million doses of intravenous acetaminophen have been sold in Europe and it has become the market share leader among injectable analgesics.

We are developing OFIRMEV (acetaminophen) injection in the U.S. market for the treatment of acute pain. According to IMS, approximately 292 million units of injectable analgesics, typically used to treat pain, were sold in the United States in 2008. Opioids represent the majority of unit volume in the market but are associated with a variety of unwanted side effects including sedation, nausea, vomiting, constipation, cognitive impairment and respiratory depression. Ketorolac, a non-steroidal anti-inflammatory drug, or NSAID, is the only other injectable analgesic available in the U.S. for the treatment of acute pain. However, ketorolac carries strong warnings from the FDA for various side-effects, including an increased risk of bleeding - a particularly troubling side-effect in the surgical setting.

Acetaminophen was first available for sale in the U.S. in 1955 when it was introduced under the brand name Tylenol®. Acetaminophen is the most widely used drug for pain relief and the reduction of fever in the U.S. and is currently available in over 600 pharmaceutical products. Historically, poor stability in aqueous solutions and inadequate solubility of acetaminophen prevented the development of an intravenous dosage form. We believe that OFIRMEV is the only stable, pharmaceutically-acceptable intravenous formulation of acetaminophen.

Cadence Pharmaceuticals' products have not been approved by FDA, and Cadence Pharmaceuticals does not make any claims related to the safety, effectiveness, or other attributes of its products.

Pefalgan® is a registered trademark of Bristol-Myers Squibb Company

Tylenol® is a registered trademark of Johnson & Johnson

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http://www.cadencepharm.com/products/apap.html

Hot Pharma Stocks / Ideen / Blockbuster

Vagnum wrote:

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CADX Top Biotech für diese Woche. Preisziel bei 11$, gute chancen auf aprooval und hohe short position, Bear Raid chance. ok mal sehn.

Jawohl! 20% Short Float! Fast wie bei AVNR.

Hot Pharma Stocks / Ideen / Blockbuster

CADX Termin ist am 4.11. ?