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MSTX hosted a conference on sickle cell disease on Sept 19th. They're presenting at a rare disease roundtable today and they are presenting at the 12th annual bio investor forum on Oct 8th. Could be why they're up today. And CPRX already is a winner.
CPRX $3.33
CPRX $3.33
CPRX $3.18 HOD $3.23
PGNX Salix and Progenics Announce FDA Advisory Committee Scheduled to Review Relistor sNDA for Opioid-Induced Constipation in Patients with Chronic Pain
Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) today announced that the FDA will convene an Advisory Committee on March 10-11, 2014 at which time Salix's Supplemental New Drug Application (sNDA) for RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain will be considered. The date and agenda for the Advisory Committee will not be definitive until publication in the Federal Register.
The FDA's action to convene an Advisory Committee was taken in response to the formal appeal by Salix of the complete response action taken by the FDA on July 27, 2012 regarding the RELISTOR sNDA for chronic pain. The FDA has stated that it will take action under the appeal within 30 days after receiving input from the Advisory Committee.
http://finance.yahoo.com/news/salix-progenics-announce-fda-advisory-183000775.html
CPRX I added @ $2.94 and $2.98
$IMUC Red Acre Investments Week Ending September 20 2013
Submitted by Rajesh Patel, Ph.D. on Sun, 09/22/2013 - 20:42 "we are long IMUC and have been accumulating lately, we'll go into details of why we're accumulating at these levels next week."
You are correct. Ihub had it wrong.
$RMTI short interest 1.85 mil, short % of float 12.4%.
http://ih.advfn.com/p.php?pid=squote&symbol=rmti
$PSDV WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (PSDV) (PVA.AX), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that its financial results for the fourth quarter and fiscal year 2013 will be released after the market close on Wednesday, September 25, 2013, followed the same day by a conference call and live webcast scheduled for 4:30 p.m. ET.
http://yhoo.it/1et4WGp
$PBMD I was at the hospital early this morning so I didn't see news on $PBMD until I got home. By the time I sold I lost 50%.....ouch. Live and learn. Should have been out of this one weeks ago.
$PBMD Matthew Lehman, the CEO of Prima BioMed Ltd. (PBMD), Interviews with The Wall Street Transcript
In the following excerpt from the Biotechnology and Pharmaceuticals Report, the CEO of Prima BioMed Ltd. (PBMD) discusses company strategy and the outlook for this vital industry:
TWST: Give us your thoughts on what the market potential is for CVac, and what pricing and revenue opportunities do you see for Prima BioMed within that the overall market.
Mr. Lehman: Let's start with the big picture. This immune therapy space - or using products that can effect, manipulate or retrain our immune system - this is a large growing class in the industry. Currently, there are two approved products on the market, using the general scientific concepts of manipulating the immune system or the immune defenses of cancer. We do expect this space will grow significantly from these two products. A number of analysts have predicted it will become a multibillion dollar business in the next 10 years. For example, one analyst is predicting $35 billion per year in revenue in immune therapy by 2023. It's quite an interesting space.
If you take a look at where we are in development with our products in ovarian cancer, for example, we believe there is a significant market opportunity for a product such as CVac with approximately 35,000 patients diagnosed per year. As another example, if we take a look at colorectal cancer, there are approximately 180,000 patients diagnosed per year that would benefit from our product. There are approximately 100,000 patients per year diagnosed with triple- negative breast cancer. Pancreatic cancer certainly is more rare, with a few thousand patients per year being diagnosed. In this case, we are looking at...
http://yhoo.it/1aQ98iY
AMRN..$6.77..Buy Amarin Into Oct. FDA Panel Meeting - Leerink. http://streetinsider.com/r/8683598
Lovaza still has side effects including afib warning. This is a good opp to buy more $AMRN cheaper. I did.
Yes it is. Just waiting. This could have been a shakeout prior to data release info.
$NVAX 1st key Catalyst in coming weeks on Sept 12th. http://yhoo.it/15q96oX
OT: TEVA won ruling for generic lovaza.
$NVAX ICAAC Presentations Highlight Potential Protective Effects of Novavax' RSV Vaccine Candidate
ROCKVILLE, Md., Sept. 11, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX) a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported positive findings from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado.
In a Phase 1 clinical study of 220 healthy elderly adults 60 years of age and older (Poster B-501d: "RSV F Protein Vaccine Is Well-Tolerated and Immunogenic in Elders"), Novavax' RSV F vaccine candidate was found to be compatible with co-administration of an influenza vaccine, well-tolerated and elicited increases in antibodies with potentially protective effects. In the study, subjects were randomized to receive one dose of 60 or 90 micrograms of RSV F protein with or without an aluminum adjuvant, or placebo. All subjects received trivalent inactivated influenza vaccine to mimic anticipated co-administration of both vaccines. The RSV F vaccine elicited up to a 5 fold increase in serum anti-F IgG with titers of palivizumab-competing antibodies reaching 184ug/ml. Changes in all measures of RSV antibodies, including microneutralization assays, were positively correlated. The RSV F vaccine did not interfere with responses to the influenza vaccine. Top-line results from this study were reported previously by Novavax in July.
In a separate preclinical study (Poster B-501a: "Passive Immunization with RSV F Vaccine-Induced Polyclonal Antibodies Protect Cotton Rats From RSV A Challenge"), investigators evaluated whether palivizumab-competing antibodies induced by the RSV F vaccine could provide passive protection in a relevant model. Palivizumab (Synagis(R)), a monoclonal antibody currently used to prevent RSV disease, was previously studied in the cotton rat model, which provided guidance for later licensing studies.
"These presentations reflect our progress in defining the importance of the palivizumab-like antibody and confirm that the RSV F vaccine induces promising immune responses in the elderly population," said Gregory Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax. "These two studies are important because they demonstrate the potential of our vaccine candidate to prevent a major public health problem in the elderly and also provide protection to infants through passive maternal immunization. These are critical unmet needs which we plan to address in later-stage efficacy studies."
http://yhoo.it/17pSkul
OT:Have you tried using your snipping tool in Windows?
Happy Birthday $heff. Hope all your wishes come true.
$CPRX No this is called biotech. It happens all the time. Good chance to get shares cheaper.
$ASTX I bought @$7.06 and sold @ $9.00
Yesterday's news stated a buyout price of $9.50/sh, that's why it hit $9.39.
$CHTP I've seen nothing on that yet. Agree it would be good trading catalyst.
Chelsea Therapeutics Announces FDA Acceptance of NORTHERA(TM) (droxidopa) NDA Resubmission
FDA Deems Resubmission a Complete Response; PDUFA Date Set as February 14, 2014
CHARLOTTE, N.C., Sept. 4, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (CHTP) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The resubmission includes additional information to resolve certain technical deficiencies previously noted by the Agency. The FDA has deemed the current resubmission a complete response to its March 28, 2012 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of February 14, 2014.
Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.
http://yhoo.it/17PcIHR
Chelsea Therapeutics Announces FDA Acceptance of NORTHERA(TM) (droxidopa) NDA Resubmission
FDA Deems Resubmission a Complete Response; PDUFA Date Set as February 14, 2014
CHARLOTTE, N.C., Sept. 4, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (CHTP) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The resubmission includes additional information to resolve certain technical deficiencies previously noted by the Agency. The FDA has deemed the current resubmission a complete response to its March 28, 2012 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of February 14, 2014.
Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.
http://yhoo.it/17PcIHR
$APPY Steve Lundy, President and CEO of Venaxis, stated, "While the results of the study remain blinded to Venaxis, we are very pleased that the pivotal clinical trial has passed this important interim analysis step successfully. The APPY1 Test performed very well in the previous 500-patient study, so we regard this outcome as encouraging and we look forward to the next assessment. Enrollment in the pivotal study continues to accelerate as our recently initiated sites ramp-up their enrollment. We expect to complete enrollment for the pivotal study by the end of 2013, and if the results are positive, file for FDA clearance in the first quarter 2014. In the meantime, we continue to execute on our commercial milestones in Europe, where we are preparing to initiate economic outcomes studies at leading hospitals. Importantly, with our recent financing, we have sufficient capital to achieve major regulatory and commercial milestones. While we remain prudent with the use of cash, we see no financial obstacles to reaching these significant value inflection points."
http://bit.ly/178UdLL
$NVAX Just kidding with you. It is due for a rest by looking at the chart. But with bios you never really know. Educated guess is the best you can do. glty
$NVAX 3.50 before it rests.
$NVAX Words of wisdom from a penny trader.
$ASTX bought out for 9.50/sh
Otsuka To Buy U.S. Start-Up Astex Pharmaceuticals
http://e.nikkei.com/e/fr/freetop.aspx