Alexza FDA Approval: Coal in the Christmas Stocking?


Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) is seeing its shareholders get nothing but coal for Christmas this year. The stock is the largest loser on the NASDAQ today with a drop of nearly 14% to $4.99. What is interesting here is that this drop is after an FDA approval of its inhalable antipsychotic drug.

The news out on Friday was that Alexza won FDA approval for ADASUVE as an inhalable powder for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. ADASUVE combines Alexza's proprietary Staccato delivery system with the antipsychotic drug called loxapine with the company's hand-held inhaler that delivers a drug aerosol deep into the lungs for rapid systemic delivery and absorption of a drug.

What is interesting about the reaction here is that this is said to be the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder. One issue which may be putting a damper on things is that the projected launch date is during the third quarter of 2013.

The 10 mg dose met the primary efficacy endpoint with reductions in agitation as compared to placebo at the two-hour post-dose time point, but there were statistically significant reductions in agitation apparent starting at 10 minutes as well. Alexza did say that it identified a risk of bronchospasm in certain asthma and COPD patients following dosing with ADASUVE.

Alexza shares are down by almost 14% to $4.99 so far this Monday ahead of Christmas. The 52-week range is $2.55 to $9.90. The market cap is only $78 million here so we would not expect that much of a following is coming here any time soon.

It is worth noting that the stock's down volume is on 3.04 million shares as of 11:40 AM when the average volume is only about 711,000 shares.


Filed under: 24/7 Wall St. Wire, Biotech, Drug companies, FDA, Healthcare Tagged: ALXA