Summary
- FDA-approved molecules (Fanapt and Hetlioz) are generating significant revenues.
- Potential approval for other indications to drive further sales growth.
- Hetlioz is highly likely to gain additional approvals (and to service the substantial markets of jet lag and Smith-Magenis syndrome).
Only July 21, 2017, Vanda Pharmaceuticals (NASDAQ:VNDA), a firm that specializes in the development and commercialization of drugs to serve the unmet needs in psychiatry, received negative opinions from the EMA (re Fanaptum for schizophrenia treatment). The Agency stated that therapeutic benefits are not robust to justify potential risks. In response, the company intends to resubmit its application in the foreseeable future. Despite the negative news, we strongly believe that there is much value in this small cap bioscience firm.
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