This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

First 90 Days of 2013 Are Live or Die For These Biotech Stocks

BOSTON ( TheStreet) -- The first quarter of 2013 is shaping up to be action-packed for biotech investors.

Volatility junkies rejoice because I count six clinical trials that should read out in the first three months of next year. Four of these trials carry life-or-death stakes for the companies involved.

Celsion (CLSN - Get Report) is up first. Last week, the company announced the passing of the 380th progression event in its pivotal study of the liver cancer therapy Thermodox study. Celsion is now locking up the study and analyzing data, with results expected in January.

Celsion's market cap of $186 million is low for a company with looming phase III cancer drug data, making this stock an easy double on positive results. Celsion will crater if Thermodox fails.

Oncothyreon (ONTY) will also live or die based on first-quarter clinical trial results. Final data from the phase III study of the lung cancer drug Stimuvax will be ready in the first quarter, Merck KGaA CEO Karl-Luwdwig Kley told Reuters last Thursday.

The German Merck is Oncothyreon's development partner for Stimuvax, a cancer immunotherapy. Oncothyreon shares were cut in half last March because an interim analysis of the Stimuvax lung cancer study wasn't robust enough to demonstrate a survival advantage. Expectations for Stimuvax are low right now, so Oncothyreon is another easy double if the cancer "vaccine" can buck the odds and win when the final results from the lung cancer study are announced.

The other four late-stage studies expected to read out in the first quarter:
  • Ziopharm's (ZIOP) palifosfamide in first-line soft-tissue sarcoma.
  • Exact Sciences' (EXAS) Cologuard for colon cancer screening.
  • Two phase III studies involving Gilead Sciences' (GILD - Get Report) hepatitis C pill GS-7977.
  • Celgene (CELG) has already announced positive results from the Abraxane phase III study in pancreatic cancer but the actual survival benefit won't be disclosed until data are presented at a cancer conference starting Jan. 24.

Biotech investors have obsessed over Amarin (AMRN) and Arena Pharmaceuticals (ARNA) for most of 2012 -- a trend that will only escalate as both companies are expected to roll out commercial launches of their respective drugs in the first quarter.

Will Amarin launch Vascepa, its triglyceride-lowering fish-oil pill, on its own, without a Big Pharma partner? And will Arena and its partner Eisai be more successful with the initial marketing of their obesity pill Belviq than Vivus (VVUS) has been with Qsymia.?

Lastly, FDA drug approval decisions on the calendar for the first three months of 2013:
  • NuPathe (PATH): Zelrix migraine patch on Jan. 17.
  • Impax Pharmaceuticals (IPXL): Rytary for idiopathic Parkinson's disease on Jan. 21.
  • Hyperion Therapeutics (HPTX): Ravicty for urea cycle disorders on Jan. 23.
  • Sucampo Pharmaceuticals (SCMP): Amitiza for opioid-induced constipation in patients with chronic, non-cancer pain on Jan. 25.
  • Isis Pharmaceuticals (ISIS) and Sanofi (SNY): Kynamro for homozygous familial hypercholesterolemia on Jan. 29.
  • Raptor Pharmaceuticals (RPTP - Get Report): RP103 for nephropathic cystinosis on Jan. 30.
  • Hemispherx Biopharma (HEB - Get Report): Ampligen for chronic fatigue syndrome on Feb. 2
  • Celgene: Pomalidomide for multiple myeloma on Feb. 8.
  • Dynavax (DVAX): Heplisav for immunization against hepatitis B on Feb. 22.
  • Roche (RHHBY) and ImmunoGen (IMGN): T-DM1 for metastatic breast cancer on Feb. 26.
  • Zogenix (ZGNX): Zohydro for moderate to severe chronic pain on March 1.
  • AP Pharma (APPA): APF530 for prevention of nausea and vomiting due to chemotherapy on March 27.
  • Biogen Idec (BIIB): BG-12 for multiple sclerosis on March 28.

-- 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.

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
AMRN $2.49 -1.20%
CLSN $2.36 0.43%
HEB $0.21 4.20%
GILD $115.53 0.43%
ONTY $3.67 -0.81%

Markets

DOW 17,643.33 -40.25 -0.23%
S&P 500 2,068.76 -8.02 -0.39%
NASDAQ 4,991.94 -17.2740 -0.34%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs