3 November Catalysts For Biotech Traders

Includes: ACAD, DVAX, EXEL
by: Bio Insights

There are probably a lot of traders and investors who are getting sick of watching the S&P bounce in the 1400-1410 level, which isn't giving stocks of larger companies much leeway regarding their own trends. This is why many turn to biotech stocks, which behave very differently.

While biotech stocks will move with the broader market sometimes, their most significant (and interesting) movements are almost always event-driven. Here are upcoming events/catalysts for the month of November that provides some fun opportunities for stock speculators.

Acadia's Phase III Data For Pimavanserin

(before November 30th)

Acadia (NASDAQ: ACAD) stock has freakishly high price targets by those who expect the drug to become a standard of care treatment for Parkinson's Disease Psychosis. However, the optimistic outlook does assume that the drug actually works without doing any harm. Acadia has other drugs in the pipeline, and other potential designations for Pimavanserin, but the focus is currently on the potential revenue in the treatment of Parkinson's Disease Psychosis.

If you go back to 2009, you'll remember that pimavanserin actually failed a phase III trial since it didn't meet its primary endpoints (as measured by SAPS, or "Scale for the Assessment of Positive Symptoms") despite measurable improvement in pimavanserin-arm patients. The company has restructured the upcoming phase III trial, and we will see the data some time before the end of the month. ACAD stock has been tame in anticipation of the big release, but expect bigger moves in either direction when the results do come in.

Dynavax's Heplislav Waits On FDA Advisory Committee Meeting

(November 14-15th)

Dynavax (NASDAQ: DVAX) has a hepatitis B vaccine that has successfully passed phase III trials, and is now waiting on an BLA that was submitted to the FDA on April 26th 2012 for its flagship compound Heplislav. Under 10-month review, a PDUFA action date of February 24th, 2013 was established. Hepatitis B treatments, as you may know, are very popular on Wall Street due to significant unmet need and huge patient population.

Luckily, for those who are less patient, we will see a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee in mid-November that will discuss and vote on the approval of heplislav. A majority vote in favor of approval doesn't obligate the FDA to agree with the decision when the PDUFA action date comes, but it usually does. If the vote is strongly in favor of approval or rejection, the market usually prices in the decision as if it were basically an FDA decision. Dynavax could see some major share appreciation if the vote turns out good.

Exelixis Anticipates Approval For Cabozantinib In MTC Treatment

(November 29th)

Exelixis (NASDAQ: EXEL) struggled a lot after a huge share dilution in early August, but recovered some of the damage and stabilized in recent trading. Exelixis investors are finally going to see an FDA decision for the company's lone, flagship drug cabozantinib which is being studied as a treatment for a wide variety of cancers.

The upcoming PDUFA action date of November 29th is designated for Exelixis' NDA for cabozantinib in the treatment of Medullary Thyroid Cancer (MTC). Investors are more excited about cabozantinib's sales potential in the much larger prostate cancer drug market, but an approval on November 29th would still be perceived well.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.