Drugs in Dev. Nephrology
Phase III
Sweden 
Lead Product(s) : Pegcetacoplan
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Apellis Gets FDA Priority Review for EMPAVELI in C3G & Primary IC-MPGN
Details : Aspaveli (pegcetacoplan) is the first and only approved therapy for geographic atrophy. Now it is being evaluated for the treatment of C3 glomerulopathy & IC-MPGN.
Product Name : Aspaveli
Product Type : Peptide
Upfront Cash : Inapplicable
April 01, 2025
Lead Product(s) : Pegcetacoplan
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegcetacoplan
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Apellis Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Validates Aspaveli® for C3G and Primary IC-MPGN Treatment
Details : Aspaveli (pegcetacoplan) is the first and only approved therapy for geographic atrophy. Now it is being evaluated for the treatment of C3 glomerulopathy & IC-MPGN.
Product Name : Aspaveli
Product Type : Peptide
Upfront Cash : Inapplicable
February 20, 2025
Lead Product(s) : Pegcetacoplan
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Apellis Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Updated Regulatory Timeline for Review of MAA in Europe
Details : Nefecon, is a proprietary, novel oral formulation of budesonide got MAA for IgA Nephropathy. With revised standard assessment timeline Calliditas estimates potential impact of 3 months on previously communicated timelines with expected decision by EMA in...
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : Inapplicable
September 16, 2021
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
PDUFA Goal Date Extension for Nefecon NDA in the U.S.
Details : Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN).
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : Inapplicable
September 14, 2021
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : STADA Arzneimittel
Deal Size : $115.0 million
Deal Type : Partnership
Details : The partnership relates to a novel oral formulation, developed under the project name ‘Nefecon’, of a potent and well-known active substance – budesonide – designed to target down regulation of IgA1 with a view to be disease modifying.
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : $24.0 million
July 21, 2021
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : STADA Arzneimittel
Deal Size : $115.0 million
Deal Type : Partnership
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Priority Review for Nefecon, for Patients with IgA Nephropathy
Details : The NDA submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients ...
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : Inapplicable
April 28, 2021
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Calliditas Seeks US FDA Approval for Nefecon to Treat Primary IgA Nephropathy
Details : Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN.
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : Inapplicable
March 15, 2021
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Calliditas Announces Full Enrollment of the Phase 3 NefIgArd Trial
Details : The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon.
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : Inapplicable
January 21, 2021
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Calliditas Announces Poster and Presentation at ASN Digital Kidney Week 2020
Details : The poster describes the design of the NefIgArd trial, which is exploring the effect of Nefecon in patients with IgA Nephropathy (IgAN) who are at risk of developing End Stage Renal Disease.
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : Inapplicable
October 19, 2020
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Calliditas Announces Positive Topline Results from Pivotal Ph 3 NefIgArd Trial
Details : The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg of Nefecon compared to placebo, with significant continued improveme...
Product Name : Nefecon
Product Type : Steroid
Upfront Cash : Inapplicable
August 11, 2020
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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