Switzerland

Santhera Pharmaceuticals

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UK’s MHRA renews EAMS Scientific Opinion for Santhera’s Idebenone in Duchenne Muscular Dystrophy

Lead Product(s): Idebenone

Therapeutic Area: Genetic Disease Product Name: Puldysa

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 23, 2020

Details:

Uk's Medicines and Healthcare products Regulatory Agency has renewed for a further year the Early Access to Medicines Scheme scientific opinion for idebenone for patients with Duchenne muscular dystrophy in respiratory function decline who are not taking glucocorticoids.

Santhera Pharmaceuticals

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Santhera Receives Financing Commitment of up to CHF 20 Million from Fund Managed by Highbridge Capital Management

Lead Product(s): Idebenone

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Highbridge Capital Management

Deal Size: $21.1 million Upfront Cash: Undisclosed

Deal Type: Financing June 04, 2020

Details:

In combination with Santhera's existing cash and cash equivalents, this financing will provide the Company with sufficient funding to complete regulatory work for Puldysa®, including the CHMP review, and with the achievement of Company milestones.

Santhera Pharmaceuticals

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Santhera Completes Enrollment of Phase 3 SIDEROS Study with Puldysa® (Idebenone) in Duchenne Muscular Dystrophy (DMD)

Lead Product(s): Idebenone

Therapeutic Area: Genetic Disease 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 May 20, 2020

Details:

The large Phase 3 SIDEROS study was designed to confirm the efficacy of idebenone in patients with respiratory function decline who are concurrently taking glucocorticoids.

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Santhera Pharmaceuticals

UK’s MHRA renews EAMS Scientific Opinion for Santhera’s Idebenone in Duchenne Muscular Dystrophy

Santhera Pharmaceuticals

Santhera Receives Financing Commitment of up to CHF 20 Million from Fund Managed by Highbridge Capital Management

Santhera Pharmaceuticals

Santhera Completes Enrollment of Phase 3 SIDEROS Study with Puldysa® (Idebenone) in Duchenne Muscular Dystrophy (DMD)