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10 Best-Performing Biopharma Stocks of 2012 and Their 2013 Outlook

Threshold shares rose more than six-fold in value between Feb. 1 and March 30, reaching a high of $8.80 per share. Unfortunately, investor enthusiasm for TH-302 has waned, clipped by concerns about the drug's ability to prolong survival in a phase III study expected to start next year. The recently announced positive results from a phase III study of Celgene's (CELG) Abraxane in pancreatic cancer also added competitive pressure to Threshold. At $4.46, the Threshold market value has been cut in half since those heady days of February and March.

6. Hemispherx Biopharma (HEB - Get Report) +292%

Hemispherx's performance this year looks impressive on a blind percentage basis, but less so when you consider the stock began the year's trading at 20 cents per share. Shares closed at $1 just once.

The only attention Hemispherx is getting comes from day traders and biotech "run-up" traders anticipating the Dec. 20 FDA advisory panel for the company's chronic fatigue syndrome therapy Ampligen. [At 5%, Hemispherx has even less institutional investor support than Galena.] This FDA panel isn't likely to end well for Ampligen, just like Hemispherx's previous stabs at getting Ampligen approved based on overly massaged data from a failed clinical trial.

5. Sunesis Pharmaceuticals (SNSS) +327%

Sunesis' stock price rose significantly in September after the company announced plans to enroll an additional 225 acute myeloid leukemia patients in an ongoing phase III study of vosaroxin. The market looked favorably on the upsizing of the vosaroxin pivotal study, backstopped by a cash infusion from existing and new investors.

Enrollment in the vosaroxin AML study is expected to complete in 2013 with top-line results in the first half of 2014.

4. Celsion (CLSN - Get Report) +359%

Celsion's stock price traded flat for the first six months of the year but has picked up considerable momentum this fall now that results from the phase III study of its liver cancer therapy Thermodox have been confirmed for release in January.

The stock could easily double from here if Thermodox is successful in delaying tumor growth in liver cancer patients. If the phase III study should fail, Celsion will be on the list of worst performing biotech stocks for 2013.

3. Arena Pharmaceuticals (ARNA - Get Report) +404%

It is best to think of Arena's high ranking on this year's Top 10 list as a momentary suspension of reality-based investing. The approval of Belviq was easy relative to the formidable challenge Arena and its partner Eisai face when the mediocre weight-loss pill goes on sale next year. Belviq's approval in Europe, widely expected by Arena bulls, is also far from certain. I agree with my colleague Nate Sadeghi, who considers Arena to be one of the best shorts in 2013, especially if the stock continues to run up ahead of Belviq's DEA scheduling and launch.

2. BioDelivery Sciences (BDSI) +448%

BioDelivery shares began the year trading for 81 cents, which valued the drug delivery technology company at approximately $24 million. At Monday's close of $4.41, BioDelivery's market cap has grown to $135 million. It's hard to pinpoint a singular event over the past year to explain the company's second-place ranking on this year's top performers list. Perhaps it was the January partnership with Endo Pharmaceuticals (ENDP) for BioDelivery's BEMA buprenorphine, a quick-dissolving oral film formulation of the commonly used chronic pain drug. Or it might just be that BioDelivery was so oversold and ridiculously cheap entering 2012 that a sharp rebound was inevitable.

One of two phase III trials of BEMA buprenorphine in chronic pain is expected to read out results at the end of 2013.

1. Sarepta Therapeutics (SRPT) +593%

How fitting that Sarepta is the best performing biopharma stock of 2012 given the company's lead drug eteplirsen shows tremendous promise as a groundbreaking treatment for Duchenne muscular dystrophy (DMD), a rare genetic disorder that forces patients into wheelchairs in their teens and can be fatal shortly after.

Initial results in April from a phase II study of eteplirsen in DMD patients were tantalizing but essentially ignored by Wall Street. Follow-up data from the same study announced in July and presented in October were nothing short of astonishing. The eteplirsen data are so good that Sarepta is hoping to convince the FDA to approve the drug early. DMD advocates are already mobilizing to lobby FDA on the company's behalf.

Sarepta will be meeting with FDA officials early next year to plot a course for eteplirsen's approval. If FDA agrees to review eteplirsen based on the small phase II study and the drug is ultimately approved next year, Sarepta could very easily find itself topping the Top 10 list in 2013.

The list of top-performing biopharma stocks using data from CapitalIQ and excludes stocks that trade over the counter or on bulletin boards.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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