$KDMN is set up well both technically and fundamentally. The FDA just approved CLOVIQUE (TM), A Room-Temperature Stable Trientine Hydrochloride Product. This bodes well for the company as it moves forward. According to the press release:
Product Offers Room Temperature Stability, Improving Convenience for Patients
NEW YORK, NY / ACCESSWIRE / October 21, 2019 / Kadmon Holdings, Inc. (KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved CLOVIQUE™ (Trientine Hydrochloride Capsules, USP), a room-temperature stable, branded generic product. Trientine hydrochloride is used for the treatment of Wilson's disease in patients who are intolerant of penicillamine.
CLOVIQUE is the first FDA-approved trientine product in a portable blister pack that offers room temperature stability for up to 30 days, potentially providing patients more convenience. In a recently published survey, approximately 30% of Wilson's disease patients cited product storage as a medication-associated inconvenience of disease management.1
"CLOVIQUE is an innovative treatment option that can be stored at room temperature, which is an added convenience for Wilson's disease patients," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We are pleased to offer CLOVIQUE to patients in need as part of our goal to develop novel therapies for chronic, rare diseases."
Kadmon has immediately commenced commercialization activities for CLOVIQUE through Kadmon Pharmaceuticals, its wholly-owned commercial operation.
In September 2019, the FDA approved Kadmon's generic Trientine Hydrochloride Capsules USP, 250 mg, available in 100-count bottles. The FDA had determined Kadmon's Trientine Hydrochloride Capsules to be bioequivalent and therapeutically equivalent to the reference listed drug, Syprine® Capsules, 250 mg.
About Wilson's Disease
Wilson's disease is a rare genetic disorder causing excess copper accumulation in the body that results in neurological and metabolic adverse events.
About Kadmon
Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.
As always, use protective stops and trade with caution.
Good luck to all!
Product Offers Room Temperature Stability, Improving Convenience for Patients
NEW YORK, NY / ACCESSWIRE / October 21, 2019 / Kadmon Holdings, Inc. (KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved CLOVIQUE™ (Trientine Hydrochloride Capsules, USP), a room-temperature stable, branded generic product. Trientine hydrochloride is used for the treatment of Wilson's disease in patients who are intolerant of penicillamine.
CLOVIQUE is the first FDA-approved trientine product in a portable blister pack that offers room temperature stability for up to 30 days, potentially providing patients more convenience. In a recently published survey, approximately 30% of Wilson's disease patients cited product storage as a medication-associated inconvenience of disease management.1
"CLOVIQUE is an innovative treatment option that can be stored at room temperature, which is an added convenience for Wilson's disease patients," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We are pleased to offer CLOVIQUE to patients in need as part of our goal to develop novel therapies for chronic, rare diseases."
Kadmon has immediately commenced commercialization activities for CLOVIQUE through Kadmon Pharmaceuticals, its wholly-owned commercial operation.
In September 2019, the FDA approved Kadmon's generic Trientine Hydrochloride Capsules USP, 250 mg, available in 100-count bottles. The FDA had determined Kadmon's Trientine Hydrochloride Capsules to be bioequivalent and therapeutically equivalent to the reference listed drug, Syprine® Capsules, 250 mg.
About Wilson's Disease
Wilson's disease is a rare genetic disorder causing excess copper accumulation in the body that results in neurological and metabolic adverse events.
About Kadmon
Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.
As always, use protective stops and trade with caution.
Good luck to all!
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We are not financial advisors. Always conduct your own research and read our full disclaimer at insiderfinancial.com/disclaimer/