Progenics Pharmaceuticals, Inc. (PGNX) reported second-quarter 2013 loss of 24 cents per share, marginally narrower than the Zacks Consensus Estimate of a loss of 25 cents and significantly lower than the year-ago loss of 32 cents.
Quarter in Details
Quarterly revenues remained flat at $1.8 million year over year. However, revenues were marginally lower than the Zacks Consensus Estimate of $2 million.
Research and development (R&D) expenses increased 26.5% to $10 million. Increased clinical trial costs and expenses incurred due to lease termination resulted in higher R&D expenses. However increased R&D expenses were partially offset by reduced compensation expense.
G&A expenses decreased 15.1% to $3.4 million.
Relistor global sales came in at $7.9 million, down 27% year over year as reported by Salix Pharmaceuticals Ltd. (SLXP) to Progenics. Relistor is the only marketed product of Progenics.
Relistor is a subcutaneous injection that is currently approved for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
Progenics has a license agreement with Salix for the development and commercialization of Relistor worldwide except in Japan, where Progenics has licensed the rights to the subcutaneous formulation to Ono Pharmaceuticals Co. Ltd.
Meanwhile, in Jun 2013, Progenics and Salix announced that the FDA’s advisory panel will review Salix’ supplemental new drug application (sNDA) for Relistor for opioid-induced constipation (OIC) in patients with chronic pain. The FDA will act within 30 days of receiving an opinion from the panel. Details regarding the meeting should be available by next month. Salix had received a complete response letter (CRL) from the FDA in Jul 2012 for the Relistor sNDA. In the CRL, the FDA had asked for additional data.
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