Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
News moves fast in the biotech space, so let's check in on three stocks that are making waves this morning: Chelsea Therapeutics (NASDAQ: CHTP ) , Novartis (NYSE: NVS ) , and The Medicines Company (NASDAQ: MDCO ) .
Chelsea soars on Northera news
The first stock to check this morning is Chelsea Therapeutics, which is up more than 35% this morning after the FDA approved its lead drug, Northera. Northera is a treatment for dizziness in patients with neurogenic orthostatic hypotension (NOH). NOH affects an estimated 300,000 people in the U.S. and Europe, who also typically suffer from neurological disorders such as Parkinson's disease.
The drug is expected to generate peak sales of $450 million -- a big boost for Chelsea, a company with no reported revenue.
The announcement wasn't a huge surprise since an FDA advisory panel had already recommended Northera for approval last month, but it allayed some concerns about the overall safety of the drug. The main concern about the drug is the fact that it is converted into a hormone that raises blood pressure levels.
Due to this risk, Northera will carry a boxed warning that tells patients to sleep with their upper bodies elevated, as lying flat after taking the medication can cause a stroke. The most common side effects of the drug were dizziness, headache, nausea, fatigue, and high blood pressure.
Besides its NOH indication, Chelsea is also testing Northera (droxidopa) in two phase 2 studies as possible treatments for intradialytic hypotension (a decrease in blood pressure) and fibromyalgia (a type of chronic pain). It also has a drug in mid-stage trials, CH-4051, which is being tested as a treatment for rheumatoid arthritis.
The big question now is just how high shares of Chelsea -- which are already up more than 500% over the past 12 months -- can continue to climb.
Novartis announces positive results for its new skin cancer drug
Meanwhile, Novartis just announced positive results from a pivotal phase 2 trial of an oral compound LDE225 for advanced or metastatic basal cell carcinoma. BCC is a type of skin cancer that is different from melanoma-type skin cancers, which can be treated by Roche/Daiichi Sankyo's Zelboraf and Bristol-Myers Squibb's Yervoy.
Although melanoma is generally considered more dangerous, BCC is the most common type of skin cancer, and accounts for 80% of all non-melanoma cases. LDE225 targets the Hedgehog signalling pathway which is also targeted by Roche and Curis' Erivedge, which has been approved for the treatment of BCC in the U.S. and Europe. Sales of Erivedge are expected to eventually hit peak sales of $500 million if it is approved for additional indications, which may bode well for LDE225 if it is approved. LDE225 is also in clinical trials for various other cancers, such as the blood cancers myelofibrosis and leukemia, as well as pancreatic, breast, and small cell lung cancers.
LDE225 represents another positive step in Novartis' growth of its oncology pipeline, which it hopes will offset generic competition for its two top sellers: the blood pressure treatment Diovan, which went off patent in 2012, and the blood cancer drug Gleevec, which will lose patent exclusivity in 2015. Some other notable highlights in Novartis' oncology portfolio include its breast cancer drug LEE011 and its new portfolio of PD-1 cancer treatments, which it acquired from CoStim Pharmaceuticals.
The FDA accepts The Medicines Company's NDA for oritavancin
Last but not least, The Medicines Company just announced that the FDA has accepted its new drug application (NDA) for oritavancin, an investigational intravenous antibiotic, for priority review. This isn't a catalyst for the company today and simply means that the FDA has agreed to review the drug for approval (the FDA's decision is expected by Aug. 6). The company is seeking the approval for oritavancin to treat acute bacterial skin and skin culture infections caused by susceptible gram-positive bacteria.
If approved, oritavancin could generate peak sales of $400 million for The Medicines Company, which would be a major boost for a company that reported sales of $662.5 million in the last four quarters.
This bit of positive news could help The Medicines Company bounce back from the FDA advisory panel's recommendation against the approval of cangrelor, its intravenous anticoagulant, on Feb. 12. Cangrelor was also expected to hit peak sales of $400 million if approved.
Shares of The Medicines Company, which is best known for the anticoagulant Angiomax, have fallen more than 20% over the past month.
One more stock to watch this morning...
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