interssante articolo si alxa del 30 /11
Alexza Pharma (ALXA)
Alexza engages in the research, development, and commercialization of novel proprietary products for the acute treatment of central nervous system conditions worldwide. Its product candidates are based on a proprietary technology, the Staccato system, which vaporizes an excipient-free drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. The company's lead product candidate includes Adasuve (Staccato loxapine) for the acute treatment of agitation in adults with schizophrenia or bipolar disorder.
The first catalyst event for Alexza is a decision on its Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA) for Adasuve. This decision is scheduled for the middle of December, 2012.
The second catalyst event for the company is Adasuve 's Prescription Drug User Fee Act (PDUFA) date of 12/21/12, which is the bigger catalyst driver.
In May of this year, Alexza received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Adasuve inhalation powder -- 5 mg and 10 mg.
In the CRL, the FDA noted,
During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved.
The CRL went on to state that discussions can continue on the proposed Risk Evaluation and Mitigation Strategy (REMS) after the response to the action letter has been submitted. The CRL also contained comments on Alexza's draft product labeling. The company now believes there is a substantial agreement with the FDA on the REMS and product labeling.
Senior Vice President of R&D Jim Cassella said recently:
The issue that the FDA noted was an inspectional issue, so that was the only thing really in the letter. We addressed the issues with the CDRH reviewers who had raised the issue and then we responded to their questions. We resubmitted the NDA, which is basically a labeling resubmission, so there is not a lot of work left to do. We believe that we have addressed the inspectional issues and we have resubmitted an advanced draft of the label and we have probably a little bit of work left to do on some of the REMS documents.
Since there was no clinical or safety issues identified, and no other deficiencies outlined in the CRL, Adasuve has a good chance at approval this go around in my opinion. Manufacturing, labeling, and REMS can be dealt with -- efficacy and serious safety concerns cannot.
Share Statistics
Avg Vol (3 month):
506,563
Avg Vol (10 day):
801,857
Shares Outstanding:
15.69M
Float:
14.80M
% Held by Insiders:
19.55%
% Held by Institutions:
18.10%
Shares Short (as of Oct 31, 2012):
1.96M
Short Ratio (as of Oct 31, 2012):
3.70
Short % of Float (as of Oct 31, 2012):
17.10%
Shares Short (prior month):
1.99M
Alexza has a very small float of which over 17% of it is held short. An FDA approval for Adasuve would likely cause a short squeeze. It's a good bet the smarter shorts will be covering their positions as we draw close to both catalyst event dates. Again, if safety and efficacy issues were the main concern here, then I could understand shorts holding their positions. However, this is not the case.
Recently, we saw a 200% jump in Acadia Pharma's (ACAD) stock price when its drug Pimavanserin showed positive Phase III clinical results. Pimavanserin is designed for the treatment of Parkinson's disease psychosis. Adasuve is similar to Pimavanserin in that both are designed to treat psychosomatic disorders, and both drugs saw initial failures. Also, Acadia still needs to engage in another clinical study for Pimavanserin, so there still remains considerable uncertainty in Acadia. On a related note, I feel Acadia is overvalued at its current price level and there remains too much downside risk at this time for me to consider it a good long trade/investment.
I would not be surprised to see a double of the company's stock on FDA approval. However, there is considerable risk for traders and investors holding through the PDUFA date. If the FDA rejects Adasuve again, it's likely Alexza as a company will not survive because they will simply run out of cash. At the very least, the company would have to engage in dilutive financing to survive. While I believe this will not occur, it's wise to consider this possibility.
(click to enlarge)
Alexza was beaten down after its last CRL, but since then it has begun to reverse leading into the December PDUFA date. The stock is wedged between two trend lines and poised to break out as sentiment remains strong. There is a psychological support level at $5.00 and the stock could break out to test the $6.00 level it touched earlier this year or perhaps even higher.
With a market cap of around $80M, I strongly feel Alexza is undervalued at this time.
My price target opinion before the PDFUA date is $6. If approval is confirmed, $12/share is my expectation.
