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Ardelyx Plans Mid-2020 NDA Filing For Tenapanor In Hyperphosphatemia

 
• By Jessica Merrill

The company reported positive Phase III data from a second trial testing the first-in-class therapy as monotherapy for managing hyperphosphatemia in patients on dialysis.

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Aredlyx's tenapanor was successful in a second Phase III trial • Source: Shutterstock

Ardelyx Inc. expects to file a new drug application with the US Food and Drug Administration for tenapanor for the treatment of hyperphosphatemia in patients on dialysis in mid-2020 after data from a second Phase III trial read out positively. The company announced the positive results of the Phase III PHREEDOM trial testing the first-in-class NH3E inhibitor as a monotherapy on 3 December.

The company is ramping up to launch tenapanor in 2021 independently for hyperphosphatemia, even though it is still seeking a...

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• By Manas Mishra

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Investors Back Nuclidium’s Next-Gen Copper-Based Radiopharmaceuticals

 
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The Swiss company believes its platform can make radiopharmaceuticals easier to produce and more accessible to patients.

Finance Watch: Two New Venture Capital Funds Provide $600m For Biopharma

 
• By Mandy Jackson

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Actithera Raises $75m To Enter Competitive FAP-Targeting Radioligand Field

 
• By Andrew McConaghie

While companies such as Eli Lilly and Roche have faced setbacks to their fibroblast activation protein-targeting oncology therapies, Actithera believes its radiopharmaceuticals platform will prove more successful.

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Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 
• By Anju Ghangurde

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.

AbbVie Licenses IGI’s ISB 2001 In Second Myeloma Trispecific Deal For 2025

 
• By Alaric DeArment

IGI CEO Cyril Konto said in an interview that his company picked AbbVie for its agility, drug development acumen and expertise in areas like intellectual property and legal affairs.

Merck & Co. Remains In The BD Game After Verona Takeout

 
• By Jessica Merrill

CEO Rob Davis said the company is in pursuit of more deals as it looks to close the revenue gap looming from the loss of Keytruda in 2028.