The company released the secondary endpoint ON SCHEDULE- I don't know if they were trying to pump up share price.
Yes, I can and will recommend this stock, which is priced for failure on primary end point when in fact the chances of success are quite high. Keep in mind that the company picked the group with the best response, secondary AML, in two ph 2 studies. Furthermore, as indicated in the press release, remission rate is highly correlated with PFS and OS data.
Despite great advances in several hematologic malignancies such as CML, CLL, multiple myeloma and lymphomas, there has been no significant improvement in AML therapy in over 30 years. CPX-351 holds
orphan drug status and has fast track designation from the FDA, and the study has been supported by the Leukemia and Lymphoma Society. Even if the OS data in early 2016 fails to be +, I think the drug still stands a good chance of gaining approval based on the improved rate of CR. so far demonstrated. CR is needed to perform bone marrow transplant, which if successful, offers the best chance for a durable remission in AML. The drug could certainly garner a few hundred mil in revenue per year, which would be huge for this company with such a tiny market cap..
Also keep in mind that Heron has a second CINV drug, HTX-019, in clinical development. The company says HTX-019 could be submitted for approval in the second half of 2016. Heron is also working on a post-surgical pain drug, HTX-011, which is likened to Pacira Pharmaceuticals' (PCRX) commercially successful Exparel. I spoke with one significant investor in Heron who believes HTX-011 is the company's "sleeper hit" pipeline product.
Significantly improved response rate and overall survival in 60 with refractory disease or early relapse seems assured based on data from EHA, and the drug almost certainly will be used in off label cases as well.
Food distributor Sysco Corp said on Friday that a record U.S. outbreak of avian flu would limit its chicken and egg supply for nine to 18 months, based on information provided to the company by its suppliers.
Sysco is the biggest U.S. food distributor, whose clients include restaurants, hotels and hospitals. The company is discussing options with its customers, including creating alternative menu items during the period, a Sysco spokesman said in an email.
It is too soon to tell whether the supply squeeze will have a material impact on financial results, spokesman Charley Wilson said. Poultry accounted for 10 percent of Sysco's revenue in 2014, according to filings.
Read MoreNebraska declares state of emergency over bird flu
The U.S. poultry and egg industry is grappling with the country's biggest outbreak on record of avian influenza, which has proven highly infectious and deadly for poultry. Governors in Nebraska, Wisconsin, Minnesota and Iowa have declared a state of emergency, and the outbreak has shown few signs of waning.
Earlier this week, Cargill Inc said it has implemented increased biosecurity measures at its facilities receiving liquid egg tankers and shell eggs from impacted states and that it is working with egg suppliers to ensure they are employing measures to prevent spread of the flu.
Meanwhile, on Thursday, Post Holdings Inc, calling the flu a "force majeure event," said it now estimates that 25 percent of its egg supply has been affected. Sysco is a major customer for Post's Michael Foods business, which sells egg products, according to filings.
Stifel Nicolaus analyst Christopher Growe expects Post's previous estimate of a $20 million financial impact in 2015 to at least double, according to a research note.
Growe said that Post's contracts require the company to go to the open market and to third parties to replace the lost supply at high prices. "We believe that by declaring force majeure, the company will be able to either pass higher
Yes, I think there is an excellent chance that the FDA will approve for elderly AML. In fact, I am optimistic that the filing will get fast track status. There is a compelling need for new Rx.
I think that the pipeline of early stage drugs is under appreciated.
This stock is a strong recommendation of the medical G news letter. They point out that the current price of the stock has already discounted the walls of Angiomax, and they emphasize the powerful pipeline. There are three other drugs likely to get FDA approval this year.