Nephrology

Goldfinch Bio, Inc

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United States

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Gilead-partnered Goldfinch Bio lands $100M as it pivots to clinical stage biotech

Lead Product(s): GFB-887

Therapeutic Area: Nephrology Product Name: GFB-887

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Eventide Asset Management

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Funding June 30, 2020

Details:

Proceeds from the Series B financing will enable the advancement of GFB-887 and GFB-024 through three potential clinical proof-of-concept readouts and will also support continued development of the Company’s discovery platform and preclinical pipeline.

KBP Biosciences

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United States

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KBP Biosciences Announces Publication of Trial Design Manuscript for Ongoing BLOCK CKD Phase 2b Study of KBP-5074

Lead Product(s): KBP-5074

Therapeutic Area: Nephrology Product Name: KBP-5074

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

Details:

BLOCK-CKD is a Phase 2b, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of KBP-5074, on top of current therapy, in patients with Stage 3B/4 CKD and uncontrolled hypertension.

Ardelyx

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Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor

Lead Product(s): Tenapanor

Therapeutic Area: Nephrology Product Name: RDX5791

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

Details:

The submission is supported by three successful Phase 3 trials involving over 1,000 patients that evaluated the use of tenapanor for Hyperphosphatemia, a condition which affects approximately 85% of CKD Patients on Dialysis.

Aduro Biotech

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Aduro Biotech Announces First Patient Dosed in Phase 1 Study of BION-1301 in IgA Nephropathy

Lead Product(s): BION-1301

Therapeutic Area: Nephrology Product Name: BION-1301

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 24, 2020

Details:

Part 3 of the Phase 1 multi-center trial is evaluating the safety and tolerability of BION-1301 in two cohorts of 20 total adult subjects with IgA nephropathy in an open-label multiple dose design.

Mallinckrodt Plc

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United States

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Real-World Data of Terlipressin in Hospitalized Patients in U.K. with Hepatorenal Syndrome Type 1 (HRS-1) Published in Alimentary Pharmacolo...

Lead Product(s): Terlipressin

Therapeutic Area: Nephrology Product Name: Teripress

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

Details:

The study found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine (SCr).

Aurinia Pharmaceuticals

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CANADA Canada

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Aurinia Presents Additional AURORA Pivotal Trial Safety Data at the ERA-EDTA Virtual Congress 2020

Lead Product(s): Voclosporin

Therapeutic Area: Nephrology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2020

Details:

The data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin group and 10.2% in the control arm.

Kezar Life Sciences

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United States

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Kezar Announces Pricing of a Public Offering of $46.7 Million of Common Stock and Pre-Funded Warrants

Lead Product(s): KZR-616

Therapeutic Area: Nephrology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Jefferies

Deal Size: $46.7 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 08, 2020

Details:

Kezar intends to use the net proceeds from the offering primarily to fund the research and development of its product candidates, acquire or license products or technologies that are complementary to its own.

AstraZeneca PLC

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United Kingdom

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Astrazeneca Presents New Data Across Continuum of Care from its Broad Renal Portfolio at ERA-EDTA 2020 Virtual Congress

Lead Product(s): Sodium Zirconium Cyclosilicate

Therapeutic Area: Nephrology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2020

Details:

The 20 abstracts being presented, will include data on Lokelma (sodium zirconium cyclosilicate), roxadustat & Farxiga (dapagliflozin) across different stages of CKD and AstraZeneca’s ongoing commitment to exploring treatment options across the full continuum of renal care.

Aurinia Pharmaceuticals

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CANADA Canada

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Aurinia Presents AURORA Pivotal Trial Subgroup Analysis at the EULAR 2020 E-Congress

Lead Product(s): Voclosporin

Therapeutic Area: Nephrology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2020

Details:

The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race.

Calliditas Therapeutics AB

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SWEDEN Sweden

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Calliditas Therapeutics Prices its Initial Public Offering on The Nasdaq Global Select Market in the United States

Lead Product(s): Budesonide

Therapeutic Area: Nephrology Product Name: Nefecon

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Jefferies LLC

Deal Size: $90.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 05, 2020

Details:

Calliditas intends to use the net proceeds for the purposes of funding of its ongoing Phase 3 clinical trial and related trials of Nefecon, pre-commercialization and, if approved, commercialization activities for Nefecon and development of additional product candidates.

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Find Nephrology Clinical Drug Pipeline Developments & Deals

Product Type

Development Status

Goldfinch Bio, Inc

Gilead-partnered Goldfinch Bio lands $100M as it pivots to clinical stage biotech

KBP Biosciences

KBP Biosciences Announces Publication of Trial Design Manuscript for Ongoing BLOCK CKD Phase 2b Study of KBP-5074

Ardelyx

Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor

Aduro Biotech

Aduro Biotech Announces First Patient Dosed in Phase 1 Study of BION-1301 in IgA Nephropathy

Mallinckrodt Plc

Real-World Data of Terlipressin in Hospitalized Patients in U.K. with Hepatorenal Syndrome Type 1 (HRS-1) Published in Alimentary Pharmacolo...

Aurinia Pharmaceuticals

Aurinia Presents Additional AURORA Pivotal Trial Safety Data at the ERA-EDTA Virtual Congress 2020

Kezar Life Sciences

Kezar Announces Pricing of a Public Offering of $46.7 Million of Common Stock and Pre-Funded Warrants

AstraZeneca PLC

Astrazeneca Presents New Data Across Continuum of Care from its Broad Renal Portfolio at ERA-EDTA 2020 Virtual Congress

Aurinia Pharmaceuticals

Aurinia Presents AURORA Pivotal Trial Subgroup Analysis at the EULAR 2020 E-Congress

Calliditas Therapeutics AB

Calliditas Therapeutics Prices its Initial Public Offering on The Nasdaq Global Select Market in the United States