RESEARCH TRIANGLE PARK, N.C. — It was not only a $4.1 million influx of additional federal research money to Durham drug development company BioCryst (Nasdaq: BCRX) Pharmaceuticals.
It was also a valuable reminder of the tough slog involved in medical progress.
The National Institute of Allergy and Infectious Diseases (NIAID) just added the money to a $22 million, five-year grant made a year ago, to help propel one of the company’s lead drug candidates. It’s code-named BCX4430 – an injectable liquid that‘s seen as a possible treatment or cure for hemorrhagic fevers caused by viruses, such as Ebola.
It’s tempting to think BioCryst might have the club that could beat down the frightening disease that’s producing daily headlines out of West Africa. So far it’s believed to have infected more than 2,100 people in 2014 and killed 1,145 in Guinea, Liberia, Nigeria and Sierra Leone. But this Ebola outbreak will most likely be history by the time BCX4430 becomes a useful clinical weapon.
map has never been right on even one of these outliars.
Down a whole dollar from yesterday.
The good news is that "down a whole dollar from yesterday" would have been catastrophic not too many month ago.
good call map, i did not know that the FDA was "an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices."
HHS calls the shots…kick 'em in the pants HHS…
Exactly what insider selling are you referring to? Last I checked there has not been any and the tutes have not been selling.
This stock is another overvalued biotech stock. The company is extremly overvalued and able to drop below 2 USD in future.
Investors should take a look at the insider selling. Ebola has no businuess to BCRX and is of no relevance.
If the Ebola hype is gone, the PPS of BCRX will decline sharply.
Do your own due dilligence.
Sentiment: Strong Sell
PLEASE SIGN THIS PETITION
"IMHO being a seller is intrinsically more favorable than a buyer... usual strategy for me is to sell naked puts on a company I want to own which initiates the position at a price below the target price I had originally set... then, depending on how events develop for the company selling covered calls is a terrific way to generate cash an"
Hey wood. I tend to agree with this. My next play here is to sell out of the money naked Puts in Jan '15 and/or '16 if/when there is a pullback in the stock. I'll take the premium and effectively lower my cost basis dramatically if the stock goes low enough and I'm put the shares for purchase at the strike I sold. Not sure that's going to happen though as it's showed remarkable relative strength as of late, but we'll see.
We expect strong growth momentum in our coming quarters, led by our Pharmaceuticals segment. This growth in Pharmaceuticals will be driven by new products and new markets, expanding volumes in CMO operations and revenue increase in Radiopharmaceuticals. Life Science Ingredients should continue its robust performance on account of higher capacity utilization, better pricing of our key products and expansion into new markets.
Sentiment: Strong Buy
FAST TRACK offers a variety of benefits but necessarily ALL of them apply to a fast tracked drug:
FDA website: A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
P was funded to the finish line b/c HHS saw enough efficacy and safety but apparently not enough to push it into Priority Review. Now that doesn't mean FDA doesn't approve prior to the pdufa date but they are not obligated to a Priority Review timetable.
Also, the manufacturer, Jubilant Hollisterstier, is just NOW finally getting up to code so early approval would have been useless if they couldn't make P due to code issues. Jubilant recently stated that they expect to be fully operational mid Aug. and have FDA acceptance this quarter.
Peramivir approval is more of a "when" and not "if"....and then we get to see the Marketing Plan the BCRX is currently working on as they prepare for approval.
Peramivir is a potent, intravenously administered investigational antiviral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an enzyme that is critical to the spread of influenza within the host. Peramivir is an inhibitor of influenza A and B viruses, including strains of influenza viruses that may be resistant to available neuraminidase inhibitors. In January 2006, BioCryst received United States Food and Drug Administration (FDA) Fast Track designation for peramivir. The availability of an intravenous (i.v.) neuraminidase inhibitor may be important in treating certain groups of patients, such as those who cannot take or tolerate oral or inhaled anti-influenza agents.
Peramivir had been developed under a $234.8 million contract from the Biomedical Advanced Research and Development Authority (BARDA) within the United States Department of Health and Human Services (HHS).
Does peramivir have the fast track designation or not? I've read conflicting information. I was under the impression that the FDA had until Dec 23rd to issue a response and accordingly was not on a "fast track". This seems to be too late to ramp up production for '14-'15 flu season.
These guys seem to think it is fast-tracked.
stay for gout-
(Reuters) - AstraZeneca (AZN.L), which fended off a $118 billion (70.14 billion pounds) takeover approach from Pfizer (PFE.N) in May, reported positive results for an experimental gout drug on Wednesday that could boost its sales modestly.
The drug, lesinurad, is not forecast by analysts to be a major seller but its success in three late-stage clinical trials is a vindication of AstraZeneca's ability to develop new medicines and comes after recent progress in cancer treatments.
The three Phase III studies all showed the potential of lesinurad, a selective uric acid re-absorption inhibitor, for use in combination with existing medicines as a treatment for gout - a painful joint condition caused by the build-up of uric acid in the blood.
However, the drug did also cause more side effects, especially at higher doses, than seen with the older drugs used on their own.
The company said detailed results would be submitted to a scientific meeting later this year, and it would prepare a regulatory submission for a 200 mg dose of the drug in combination therapy.
Industry analysts forecast annual sales of lesinurad to reach $281 million by 2019, according to consensus forecasts compiled by Thomson Reuters Pharma.
"and it would prepare a regulatory submission for a 200 mg dose of the drug in combination therapy."
"Meanwhile, the company also announced data from the CRYSTAL study on lesinurad (200 mg and 400 mg once daily) in combination with Takeda Pharmaceuticals' (TKPYY) XO inhibitor Uloric (febuxostat) in gout patients with tophi. In the study, lesinurad 400 mg in combination with febuxostat met the primary endpoint, while lesinurad 200 mg failed to do so at 6 months."
declare victory, file for a drug that doesn't work…
and oh yeah, there's those side effects…
NEW BCX4161 study. Small study, only 7 patients. Estimated data in Sept.
***Study to Determine the How BCX4161 is Metabolized and Eliminated by the Body***
A Phase 1 Study to Evaluate the Absorption, Metabolism and Excretion of BCX4161 Following Administration of a Single, Oral Dose of [14C]-Radiolabelled BCX4161 to Healthy Male Subjects
Estimated Enrollment: 7
Study Start Date: August 2014
Estimated Study Completion Date: September 2014
Dad: IMHO being a seller is intrinsically more favorable than a buyer... usual strategy for me is to sell naked puts on a company I want to own which initiates the position at a price below the target price I had originally set... then, depending on how events develop for the company selling covered calls is a terrific way to generate cash and if you don't get too aggressive with the strikes you can maintain your position... selling calls is especially effective with bio's that may have spikes here and there but basically trade in a range while waiting for trial data... you may get called away but there's no law that says you can't buy the stock again... the only big downside is a surprise significant event that you miss but they are rare and happen to very, very few stocks...