9 Biotech Companies With FDA Approval Decision Dates In Q1 2012

by: David Zanoni

Biopharmaceutical companies are like heroes, diligently researching for cures and relieving symptoms which can improve and extend the lives of individuals. I’m always happy to discover new drugs on the market where the possibility of breakthroughs or blockbusters can improve the lives of millions of sufferers. Previously, I wrote about 5 companies that are awaiting FDA decision dates in Q1 2012. I have found 9 more companies with FDA decision dates in the 1st quarter of 2012.

INSYS Therapeutics (NEOL.PK) – Decision Date: January 4, 2012

Drug: Fentanyl SL Spray – Treatment: breakthrough cancer pain [BTCP].

Insys also has Dronabinol Oral Solution in Phase 3 clinical trial for the treatment of chemotherapy induced nausea and vomiting [CINV]. It also has Liposomal Encapsulated Paclitaxel in Phase 2 for the treatment of metastic cancers.

Bristol-Meyers Squibb (NYSE:BMY) – Decision Date: January 27, 2012

Drug: Dapagliflozin – Treatment: type 2 diabetes mellitus

There are 25.8 million people in the United States with diabetes, which equates to 8.3% of the population.

BMY is a much larger company as compared to most of the others in this article. It has 42 FDA approved drugs on the market. It pays a dividend of 4% and trades at less than 4 times book value per share. However, BMY is expected to grow earnings at a negative (0.04%) for the next five years.

Columbia Laboratories (CBRX) – Decision Date: January 20, 2012 & February 26, 2012

Drug: Prochieve – Treatment: the January 20 date is for the reduction of risk of pre-term birth, and the February 26 date is for the reduction of risk of pre-term birth in women with short uterine cervical length in the mid-trimester of pregnancy.

Columbia also has an FDA approved drug known as Striant for a deficiency or absence of endogenous testosterone associated with hypogonadism in men. It also has CRINONE, an FDA approved vaginal gel for the treatment of progesterone deficiency in women.

Discovery Laboratories (DSCO) – Decision Date: March 6, 2012

Drug: Surfaxin – Treatment: prevention of respiratory distress syndrome in premature infants.

Discovery Labs also has a few drugs in its pipeline. Aerosurf is in Phase 2 for the treatment of moderate respiratory distress syndrome. Liquid KL4 Surfactant is in Phase 2 to treat a wide range of respiratory diseases. Aerosolized KL4 Surfactant is in early development to treat acute lung injury and bronchiectasis. The same drug is in Phase 2 for treating cystic fibrosis.

NeurogesX (NASDAQ:NGSX) – Decision Date: March 7, 2012

Drug: Qutenza – Treatment: neuropathic pain associated with HIV-associated peripheral neuropathy. Qutenza is a patch that delivers prescription strength capsaicin. Qutenza has been FDA approved to treat peripheral neuropathic pain in non-diabetic adults.

NeurogesX also has five drugs in early development in its pipeline.

Curis (NASDAQ:CRIS) and Roche (RHHPY.PK) – Decision Date: March 8, 2012

Drug: Vismodegib – Treatment: advanced basal cell carcinoma (the most common form of skin cancer).

Vismodegib is also in Phase 2 for the treatment of operable basal cell carcinoma. Curis is collaborating with Roche’s subsidiary Genentech to develop this drug.

Curis also has three other drugs in early development for the treatment of cancer.

Roche is the more established company with a vast array of FDA approved drugs already on the market. It is well valued as it trades at only 3.7 times book value per share. It has a healthy profit margin of 18.1%, but is only expected to grow earnings annually at 5.65% for the next five years.

More than 3.5 million skin cancers in over 2 million people are diagnosed every year. One in five Americans will develop skin cancer over the course of their lives.

Chelsea Therapeutics (NASDAQ:CHTP) – Decision Date: March 28, 2012

Drug: Northera – Treatment: neurogenic orthostatic hypotension (dizzy spell due to a sudden drop in blood pressure from standing up or stretching).

Northera is currently approved and marketed in Japan and is now awaiting FDA approval in the U.S. Northera has acquired 15 years of safety and efficacy and produced an approximate annual revenue of $50 million in Japan.

Northera is also in earlier stages of development to treat fibromyalgia and intradialytic hypotension.

Chelsea also has three other compounds in early stages of development to treat: adult ADHD, chronic fatigue, rheumatoid arthritis, and other autoimmune disorders. Although Chelsea reported negative earnings this year, it is expected to grow earnings next year at 24%.

Onyx Pharmaceuticals (NASDAQ:ONXX) – Decision Date: March 28, 2012

Drug: Carfilzomib – Treatment: multiple myeloma (a relatively uncommon cancer)

Onyx has an FDA approved drug on the market known as Nexavar to treat kidney and liver cancer. Nexavar has been approved in over 100 countries.

Onyx is also working with Bayer (OTCPK:BAYRY) to develop Sorafenib to treat a variety of cancers such as: kidney, liver, lung, breast, thyroid, colorectal, and ovarian. Onyx has 3 other drugs in early development to treat solid tumors and autoimmune disorders. It is also working with Pfizer (NYSE:PFE) to develop a cell cycle kinase inhibitor to treat cancer.


Biotech companies facing FDA approval decisions can experience a lot of volatility in the time leading up to the decision date. Every bit of news either positive or negative regarding the drugs to be approved can cause the stocks to move drastically. This can create some good trading opportunities. Short-term traders can trade between overbought and oversold conditions. Long-term investors can keep their eye on one or more of these developing companies to try to buy-in early on a potential blockbusting drug.

Most importantly, patients will reap the benefits of more advanced treatment options as new drugs become approved.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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