Progenics Pharmaceuticals (PGNX) has good news today. The U.S. Food and Drug Administration (FDA) has accepted for review the firm’s New Drug Application (NDA) for its product Azedra® for recurrent and/or unresectable pheochromocytoma and paraganglioma — rare neuroendocrine tumors. The FDA has also granted Progenics’ request for Priority Review and has set an action date of April 30, 2018, under the Prescription Drug User Fee Act (PDUFA).
The NDA is supported by data from a pivotal phase 2b open-label, multi-center trial that was conducted under a Special Protocol Assessment (SPA) with the FDA. The trial met the primary endpoint evaluating the proportion of pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medication for at least six months, and showed favorable results from a key secondary endpoint evaluating the proportion of patients with overall tumor response as measured by Response Evaluation Criteria in Solid Tumors (RECIST).
Azedra was also shown to be safe and generally well tolerated.
The Drug
AZEDRA (iobenguane I 131) is a high-specific-activity radiotherapeutic product candidate in development as a treatment for malignant, recurrent, or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors of neural crest origin.
The product is a substrate for norepinephrine reuptake transporter which is highly expressed on the cell surface of neuroendocrine tumors. Azedra has been granted Orphan Drug designation, Fast Track status, and Breakthrough Therapy designation in the U.S. Under an SPA agreement with the FDA, a phase 2b pivotal study has been completed in patients with malignant, recurrent, or unresectable pheochromocytoma and paraganglioma.
There are currently no FDA-approved therapies for the treatment of this ultra-rare disease.
Pheochromocytoma and Paraganglioma
Pheochromocytoma and paraganglioma are rare neuroendocrine tumors that arise from cells of the autonomic nervous system. Pheochromocytoma forms in the adrenal medulla, whereas paragangliomas form outside the adrenal gland.
Standard treatment options for these tumors include surgery, palliative therapy and symptom management.
Pheochromocytoma and paraganglioma tumors frequently secrete high levels of hormones that can lead to life-threatening hypertension, heart failure, and stroke in these patients.
Malignant and recurrent pheochromocytoma and paraganglioma may result in unresectable disease with a poor prognosis, representing a significant management challenge with very limited treatment options and no approved anti-tumor therapies.
Progenics
Progenics Pharmaceuticals, of Tarrytown, NY is a biopharmaceutical company focusing on the development and commercialization of therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases.
Pipeline
– Therapeutic agents designed to precisely target cancer (Azedra® and 1095),
– PSMA-targeted imaging agents for prostate cancer (1404 and PyL™), and
– Imaging Analysis Tools.
Progenics’ marketed product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation is partnered with Valeant Pharmaceuticals International, Inc.
Progenics’ Stock
Symbol: PGNX
Stock Exchange: NASDAQ
Stock Price: $6.55 UP $0.70 on Today’s News
Market Cap: $461.67
Prohost Observations
Progenics is a biotech firm that managed to put a product on the market. Today’s news might be the beginning of the evolution of this firm towards bringing revenues that make it self-sufficient and earning growing firm. We will follow up on this firm.
We will not forget that April 30, 2018, is Azedra’s action date under the Prescription Drug User Fee Act (PDUFA).
Do Not miss Prohost Letter “The Year in Review”, coming soon.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives. Also, investing in stocks includes certain risks. Our advice is that you should consult with your own financial adviser before making an investment.
News & Comments
December 28, 2017
Progenics: The FDA Accepted the NDA for Its Cancer Product Azedra® and Granted It Priority Review
Progenics Pharmaceuticals (PGNX) has good news today. The U.S. Food and Drug Administration (FDA) has accepted for review the firm’s New Drug Application (NDA) for its product Azedra® for recurrent and/or unresectable pheochromocytoma and paraganglioma — rare neuroendocrine tumors. The FDA has also granted Progenics’ request for Priority Review and has set an action date of April 30, 2018, under the Prescription Drug User Fee Act (PDUFA).
The NDA is supported by data from a pivotal phase 2b open-label, multi-center trial that was conducted under a Special Protocol Assessment (SPA) with the FDA. The trial met the primary endpoint evaluating the proportion of pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medication for at least six months, and showed favorable results from a key secondary endpoint evaluating the proportion of patients with overall tumor response as measured by Response Evaluation Criteria in Solid Tumors (RECIST).
Azedra was also shown to be safe and generally well tolerated.
The Drug
AZEDRA (iobenguane I 131) is a high-specific-activity radiotherapeutic product candidate in development as a treatment for malignant, recurrent, or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors of neural crest origin.
The product is a substrate for norepinephrine reuptake transporter which is highly expressed on the cell surface of neuroendocrine tumors. Azedra has been granted Orphan Drug designation, Fast Track status, and Breakthrough Therapy designation in the U.S. Under an SPA agreement with the FDA, a phase 2b pivotal study has been completed in patients with malignant, recurrent, or unresectable pheochromocytoma and paraganglioma.
There are currently no FDA-approved therapies for the treatment of this ultra-rare disease.
Pheochromocytoma and Paraganglioma
Pheochromocytoma and paraganglioma are rare neuroendocrine tumors that arise from cells of the autonomic nervous system. Pheochromocytoma forms in the adrenal medulla, whereas paragangliomas form outside the adrenal gland.
Standard treatment options for these tumors include surgery, palliative therapy and symptom management.
Pheochromocytoma and paraganglioma tumors frequently secrete high levels of hormones that can lead to life-threatening hypertension, heart failure, and stroke in these patients.
Malignant and recurrent pheochromocytoma and paraganglioma may result in unresectable disease with a poor prognosis, representing a significant management challenge with very limited treatment options and no approved anti-tumor therapies.
Progenics
Progenics Pharmaceuticals, of Tarrytown, NY is a biopharmaceutical company focusing on the development and commercialization of therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases.
Pipeline
– Therapeutic agents designed to precisely target cancer (Azedra® and 1095),
– PSMA-targeted imaging agents for prostate cancer (1404 and PyL™), and
– Imaging Analysis Tools.
Progenics’ marketed product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation is partnered with Valeant Pharmaceuticals International, Inc.
Progenics’ Stock
Symbol: PGNX
Stock Exchange: NASDAQ
Stock Price: $6.55 UP $0.70 on Today’s News
Market Cap: $461.67
Prohost Observations
Progenics is a biotech firm that managed to put a product on the market. Today’s news might be the beginning of the evolution of this firm towards bringing revenues that make it self-sufficient and earning growing firm. We will follow up on this firm.
We will not forget that April 30, 2018, is Azedra’s action date under the Prescription Drug User Fee Act (PDUFA).
Do Not miss Prohost Letter “The Year in Review”, coming soon.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives. Also, investing in stocks includes certain risks. Our advice is that you should consult with your own financial adviser before making an investment.
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