Dendreon Hot Going into Thursday's Investor Meeting: BioBuzz
SEATTLE (
) --
Dendreon
(DNDN)
shares are up 24% in the past week, closing Monday just shy of $30, as the company preps to address investors and analysts at a meeting Thursday morning in New York City.
Provenge, the company's prostate cancer immunotherapy (vaccine), will be the big focus of the investor gathering, of course.
Dendreon has been guiding towards a fourth-quarter approval re-filing of Provenge with the Food and Drug Administration, so unless the company's been burning the midnight oil, I wouldn't expect to hear anything different Thursday. Of course, any indication that Provenge's regulatory timeline is slipping would be a negative.
A deal for a Provenge marketing partnership in Europe would definitely get investors excited were it to be announced at the meeting, but again, it's probably a bit early for that. Words investors don't want to hear: "We've decided to go it alone in Europe."
Dendreon is likely to spend most of the three-hour meeting discussing commercial plans for Provenge. The nuts-and-bolts logistics of Provenge treatment -- from the patient's blood draw to the manufacturing of the personalized vaccine at the New Jersey plant to its shipment via air back to the doctor's office and administration to the patient -- is unique in cancer therapy and something the company probably still needs to get investors comfortable with.
Company executives should also discuss sales projections for Provenge.
I'd expect to hear a lot of talk about Provenge manufacturing, including timelines for the expansion and approval of the New Jersey facility, as well as build-out plans for the new plants outside Atlanta and greater Los Angeles.
Finally, expect discussion about future clinical trials, both with Provenge and more broadly, with the company's immunotherapy technology platform. Can Dendreon repeat the clinical success of Provenge in prostate cancer in other tumor types?
Dendreon is trading just above $30 today.
Allos' Big FDA Date Thursday
Thursday is also an important day for
Allos Therapeutics
(ALTH)
. The FDA is expected to make its approval decision on the company's lymphoma drug Folotyn.
I'm on record predicting a Folotyn approval Thursday. Does that make me nervous? My palms are sweating, so yes, it does. The FDA's advisory panel meeting on Sept. 2 was contentious (as I documented
) but approval was recommended by a strong 10-4 vote.
If there is a delay in approval, it may be due to the relatively short amount of time between the advisory panel and Thursday's approval decision deadline. Let's hope there isn't anything more serious.
Allos shares are up about 8-9% since the advisory panel vote. I expect the stock to trade higher on approval, but not by a huge amount given the
over whether or not the company's current valuation prices in Folotyn sales revenue already.
Citi Calls the AMAG Bottom
It looks like Citibank analyst Yaron Werber called the bottom (at least a near-term one) in AMAG Pharmaceuticals when he
on Sept. 10.
Since then, the stock is up 18%.
-- 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;
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