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Akari Therapeutics

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Akari Therapeutics to Present Its Phase III Plans for Nomacopan in Patients with Bullous Pemphigoid

Details:

The aim of the ARREST-BP Phase III trial is to assess the safety of nomacopan in BP patients, and to test nomacopan’s ability to rapidly control the symptoms of BP and reduce exposure to systemic steroids to potentially decrease steroid related morbidity and mortality.

Lead Product(s): Nomacopan

Therapeutic Area: Dermatology Product Name: rVA576

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 10, 2021

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Akari Therapeutics

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Akari Therapeutics Receives FDA Fast Track Designation for Nomacopan for the Treatment of Bullous Pemphigoid

Details:

Nomacopan has potential to replace long term steroid treatment (standard of care) in BP, which has multiple adverse effects and increases mortality in this elderly and frail population.

Lead Product(s): Nomacopan

Therapeutic Area: Dermatology Product Name: rVA576

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 28, 2021

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Akari Therapeutics

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Akari Therapeutics Open IND with FDA for Bullous Pemphigoid Treatment

Details:

Akari Therapeutics have opened an investigational new drug application (IND) with the FDA for its multicentre Phase III study with nomacopan, for the treatment of moderate and severe bullous pemphigoid (BP).

Lead Product(s): Nomacopan

Therapeutic Area: Dermatology Product Name: rVA576

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 12, 2021

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MC2 Therapeutics

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MC2 Therapeutics Announces Submission of Marketing Authorization Application in EU for Wynzora ® Cream

Details:

The MAA is supported by two comprehensive Phase 3 trials1 including a trial conducted in EU evaluating the efficacy and safety of Wynzora® Cream compared to vehicle and active comparator Dovobet/Daivobet® Gel in patients with psoriasis vulgaris.

Lead Product(s): Calcipotriol,Betamethasone

Therapeutic Area: Dermatology Product Name: Wynzora

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 July 16, 2020

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