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3 Stocks Moving On FDA Verdicts: Alexion, AstraZeneca, Foamix

3 Stocks Moving On FDA Verdicts: Alexion, AstraZeneca, Foamix

The FDA has cleared three therapies since Friday, sending shares of the sponsor companies higher Monday morning.

Foamix Preps For Maiden Commercial Launch 

Specialty pharma company Foamix Pharmaceuticals Ltd (NASDAQ: FOMX) said late Friday the FDA approved its Amzeeq topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years and older.

Amzeeq is the first topical minocycline to be approved by the FDA for any condition, the company said. 

Foamix said it plans to bring Amzeeq to the market in January 2020, marking its first commercial launch.

"Minocycline has been a trusted staple in acne treatment for decades, but has only been available in oral or systemic formulations. With the approval of AMZEEQ, I can now offer my patients a new, effective topical treatment option with a favorable tolerability profile," said Linda Stein Gold, a dermatologist at the Henry Ford Health System in Detroit,.

At last check, Foamix shares were rising 1.81% to $3.22. 

Related Link: The Week Ahead In Biotech: Earnings Trickle In, While Glaxo, Melinta And Eton Await FDA Verdict

Alexion's Ultomoris Snags Second Approval As Soliris Patent Threat Looms

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) announced late Friday FDA approval for its Ultomiris for the treatment of atypical hemolytic uremic syndrome, or aHUS, to inhibit complement-mediated thrombotic microangiopathy, or TMA, for adult and pediatric patients.

Ultomiris was originally approved for paroxysmal nocturnal hemoglobinuria in December 2018. It is widely seen as a successor therapy for Alexion's lead blockbuster drug Soliris, which faces a threat in the wake of the U.S. Patent and Trademark Office's decision to review key patents related to the drug.

Alexion recently announced a deal to buy Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN).

aHUS is an ultra-rare disease that can cause progressive injury to vital organs, primarily the kidneys, through damage to the walls of blood vessels and blood clots.

The FDA required a boxed warning in the label conveying the risks of meningococcal infections that have occurred in patients treated with Ultomiris.

At last check, Alexion shares were adding 2.25% to $100.62. 

AstraZeneca's Diabetes Drug Wins Label Expansion To Treat Heart Failure

AstraZeneca plc (NYSE: AZN)'s Farxiga secured label expansion for reducing the risk of hospitalization for heart failure in adults with Type 2 diabetes and established cardiovascular disease, or multiple cardiovascular risk factors.

It was initially approved in January 2014 to treat Type 2 diabetes in adults.

"This is promising news for the 30 million people living with Type 2 diabetes in the U.S., as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure," said Ruud Dobber, executive vice president of AstraZeneca's biopharma unit, said in a statement.

At last check, AstraZeneca shares were slipping 0.28% to $43.74. 


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