Pharmaceutical companies with set PDUFA dates usually have a runup leading into the action date. I usually try to buy the stocks 3-9 months before the PDUFA date to make profit from the runup. I screened for companies that have a PDUFA date set during the first quarter of 2013. Here is a look at five companies that I found.
1. Zogenix (ZGNX) is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, Sumavel DosePro (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro ER (hydrocodone bitartrate) is an oral, single-entity (without acetaminophen) novel extended-release formulation of various strengths of hydrocodone intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. Zogenix's second DosePro investigational product candidate, Relday, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.
On July 16, 2012, Zogenix announced that the U.S. Food and Drug Administration had accepted for review the New Drug Application (NDA) for Zohydro. Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an NDA is 10 months from NDA submission, and the FDA has assigned a target action date of March 1, 2013 for the Zohydro ER NDA.
The company reported the second-quarter financial results on August 8 with the following highlights:
|Net loss||$0.26 per share|
2. NuPathe (PATH) is a biopharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system, including neurological and psychiatric disorders. NuPathe's lead product candidate, NP101, is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. In addition to NP101, NuPathe has two proprietary product candidates based on its LAD, or Long-Acting Delivery, biodegradable implant technology that allows delivery of therapeutic levels of medication over a period of months with a single dose.
NP201, for the continuous symptomatic treatment of Parkinson's disease, utilizes a leading FDA-approved dopamine agonist, ropinirole, and is being developed to provide up to two months of continuous delivery.
NP202, for the long-term treatment of schizophrenia and bipolar disorder, is being developed to address the long-standing problem of patient noncompliance by providing three months of continuous delivery of risperidone, an atypical antipsychotic. NuPathe is actively seeking partnerships to maximize the commercial potential for its pipeline products in the U.S. and territories throughout the world.
On July 31, 2012, NuPathe announced that the company's New Drug Application resubmission for its migraine patch (NP101) has been accepted for filing by the U.S. Food and Drug Administration. NuPathe has received a Prescription Drug User Fee Act date of January 17, 2013.
The company reported the first-quarter financial results on May 10 with the following highlights:
|Net loss||$0.43 per share|
|Shares outstanding||$14.7 million|
The stock has a $11.75 price target from the Point and Figure chart. I believe the target price is achievable after the FDA approval of NP101.
3. Raptor Pharmaceutical (RPTP) seeks to research, produce, and deliver medicines that improve life for patients with severe, rare disorders. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, Non-alcoholic Steatohepatitis (NASH), Huntington's Disease (HD), aldehyde dehydrogenase deficiency (ALDH2), and thrombotic disorder. Raptor's preclinical programs are based upon bioengineered novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein and related proteins that are designed to target cancer and infectious diseases.
In June 2012, the U.S. Food and Drug Administration accepted for filing the company's New Drug Application for its investigational drug candidate, Cysteamine Bitartrate Delayed-Release Capsules (RP103), for the potential treatment of nephropathic cystinosis. The FDA has assigned a user fee review goal date of January 30, 2013. In March 2012, Raptor announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application for RP103 and that the MAA is under review by the EMA. The company expects a decision from the EMA in the first half of calendar 2013.
The company reported the third-quarter fiscal 2012 (ending May 31) financial results on July 10 with the following highlights:
|Net loss||$0.06 per share|
|Shares outstanding||$49 million|
The stock has a $14.25 price target from the Point and Figure chart. I believe the target price is achievable after the FDA approval of RP103.
4. Isis Pharmaceuticals (ISIS) is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 25 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Isis' partner Genzyme plans to commercialize Isis' lead product Kynamro in the United States and Europe following regulatory approval. Isis' patents provide strong and extensive protection for its drugs and technology.
On May 29, 2012, Genzyme and Isis Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for filing the New Drug Application for Kynamro (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The application will be subject to a standard review and will have a PDUFA date of January 29, 2013.
The company reported the second-quarter financial results on August 6 with the following highlights:
|Net loss||$0.01 per share|
The stock has a $8.5 price target from the Point and Figure chart. If the target price will be reached I would consider buying the shares.
5. Dynavax Technologies Corporation (DVAX), a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The company's lead product candidate is Heplisav, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and earlier protection with fewer doses than currently licensed vaccines.
On June 26, 2012, Dynavax announced that the Food and Drug Administration has accepted for review the U.S. Biologics License Application (BLA) for Heplisav, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age.
Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said,
"The FDA has established February 24, 2013, as the PDUFA action date. We look forward to working with the FDA in moving Heplisav through the regulatory review process over the next few months."
The company reported the second-quarter financial results on August 1 with the following highlights:
|Net loss||$0.09 per share|
The stock has a $11.75 price target from the Point and Figure chart. I believe the target price is achievable after the FDA approval of Heplisav.
Disclosure: I am long PATH.