With pixantrone's approval a Spring 2010 event, investor attention will likely turn now to the European review of Cell Therapeutics' lung cancer drug Opaxio (nee Xyotax.) The company is supposed to be meeting with European regulators this month to discuss Opaxio, with the possibility of an approval decision before year's end, according to the company. I've had my say on Opaxio and its chances for approval already.

Whether the longer pixantrone review will impact Cell Therapeutics guidance for reaching break even by the fourth quarter and a possible licensing deal with Novartis ( NVS) is also unclear.

Cell Therapeutics is scheduled to present at the Rodman & Renshaw Global Investment Conference Wednesday, so perhaps a significant update is coming.

The Summer's Best and Worst Biotech Stocks

It's been a remarkable summer for stocks and biotech was no exception. The Nasdaq Biotechnology Index rose 21% between Memorial Day and Labor Day, exceeding the 15% gain in the S&P 500 for the same time period.

The biggest story of the summer, of course, was the monster gains in small- and mid-cap biotech and drug stocks. Here are the top-10 biggest returns from Memorial to Labor Day, according to Capital IQ:

Jazz Pharmaceuticals ( JAZZ): 1,017%
Human Genome Sciences ( HGSI): 938%
Targacept ( TRGT): 466%
Inovio Biomedical ( INO): 364%
Helicos Biosciences ( HLCS): 355%
Gentium ( GENT): 317%
IsoRay ( ISR): 311%
Opexa Therapeutics ( OPXA): 292%
Somaxon Pharmaceuticals ( SOMX): 284%
Sinovac Biotech ( SVA): 278%

The summer's biggest losers: Repros Therapeutics ( RPRX): -88%
Star Scientific ( STSI): -75%
Matrixx Initiatives ( MTXX): -65%
ARCA Biopharma ( ABIO): -59%
Catalyst Pharmaceutical Partners ( CPRX): -59%
RXi Pharmaceuticals ( RXII): -57%
Discovery Labs ( DSCO): -55%
Quigley ( QGLY): -53%
GTC Biotherapeutics ( GTCB): -51%
Insmed ( INSM): -49%

-- Reported by Adam Feuerstein in Boston
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. 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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