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Biotech Stock Mailbag: Celldex, TG Therapeutics, Sarepta

@robpichardo asks, "What would cause $SRPT not to file for AA accelerated approval. ? Or, does FDA have to give permission to even file? Trying to determine upcoming risk."

Technically, Sarepta can seek accelerated approval for eteplirsen regardless of the FDA's recommendation. Filing when FDA says not to would be stupid because the drug would be rejected. Time would be wasted and credibility destroyed. So, I hope Sarepta brings a convincing case to the FDA for accelerated approval and the agency concurs. That's the best outcome. I also hope Sarepta is smart enough to not cross the FDA if it says don't file.


@Ultimate_disc tweets, "I can't believe you haven't opined on $OSIR."

Osiris Therapeutics! My favorite stem-cell stock. Let's see, Osiris reported 2012 product revenue of $7.8 million, which means the stock trades at a trailing price-to-enterprise value ratio of 25. Over-valued! Care to look ahead? Okay, let's say Osiris does $30 million in revenue from its stem-cell band-aid products this year (it won't, but bulls can dream.) At the current stock price, Osiris will trade at almost seven times sales. Still over-valued.

Osiris claims it can generate $75-$130 million in annual sales from its stem-cell band-aids (When? The company doesn't say.) Sales in the fourth quarter were $2.9 million. Call me unconvinced.

Remember Prochymal, heralded by Osiris as the "WORLD'S FIRST APPROVED STEM CELL THERAPY!!!!?" Sales since approval in Canada and New Zealand last year: Zero. Plans to seek U.S. approval? On hold. Partners? None.

I'm still waiting for Osiris to answer the questions about missing data from its Prochymal cardiac trial.

Osiris shares rallied on Wednesday's fourth-quarter financials, which reminds us all that CEO Randy Mills is really just a caretaker for a group of Swiss investors who control most of the shares. How do I know this? Mills admitted it last year!


Conny is mad, reasons unknown. "Why don't you go back to school or try to get an internship somewhere and forget about trying to be an analyst. You obviously are not qualified to do that. And I'm sorry to say you're not a journalist either. Maybe a McDonalds franchise at a busy train station might be the right thing for you. Think about your future. Stay away from the internet and try to put some meaning into your life."

-- 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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