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Nabriva Therapeutics

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Nabriva Therapeutics Completes Patient Enrollment in Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis

Details:

Xenleta (lefamulin) is a novel, first-in-class, IV and oral pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S. aureus, including MRSA and strains obtained from patients with CF.

Lead Product(s): Lefamulin Acetate

Therapeutic Area: Genetic Disease Product Name: Xenleta

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 August 11, 2022

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Nabriva Therapeutics

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Nabriva Therapeutics Announces First Patient Enrolled in Phase 1 Trial of XENLETA (lefamulin) in Adult Patients with Cystic Fibrosis

Details:

XENLETA has the potential to provide a well-tolerated oral and intravenous anti-MRSA treatment option with a novel mechanism for this difficult to treat patient population. We look forward to sharing the results of this study with the medical community.

Lead Product(s): Lefamulin Acetate

Therapeutic Area: Genetic Disease Product Name: Xenleta

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 11, 2022

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Prothena

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Prothena and Novo Nordisk Announce Acquisition Agreement for Prothena’s ATTR Amyloidosis Programme

Details:

PRX004 is a phase 2 ready anti-amyloid immunotherapy designed to deplete the amyloid deposits that are associated with the disease pathology of ATTR amyloidosis.

Lead Product(s): PRX004

Therapeutic Area: Genetic Disease Product Name: PRX004

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Novo Nordisk

Deal Size: $1,200.0 million Upfront Cash: $100.0 million

Deal Type: Acquisition July 12, 2021

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Prothena

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Prothena Presents Phase 1 Study Results of PRX004 in Oral Presentation at AAN 2021

Details:

In this Phase 1 study, PRX004 was found to be generally safe and well tolerated across all dose levels. Positive clinical findings suggest PRX004’s depleter mechanism of action can result in benefits in both neuropathy and cardiac function.

Lead Product(s): PRX004

Therapeutic Area: Genetic Disease Product Name: PRX004

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 April 18, 2021

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Prothena

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Prothena Reports Positive 9 Month Results from Phase 1 Long-term Extension Study of PRX004

Details:

In the first report of clinical results with this depleter mechanism of action, PRX004 showed favorable results as demonstrated by slowing of neuropathy progression for all 7 evaluable patients at 9 months.

Lead Product(s): PRX004

Therapeutic Area: Genetic Disease Product Name: PRX004

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 December 09, 2020

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Inflazome

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FDA Grants Orphan Drug Designation for Inflazome’s Inzomelid for the Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Details:

Inzomelid is a potent, selective, orally-available, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases.

Lead Product(s): Inzomelid

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 14, 2020

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Inflazome

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Inzomelid completes Phase I studies and shows positive results in the treatment of Cryopyrin-Associated Periodic Syndrome

Details:

The Phase I study demonstrated Inzomelid has an excellent safety, tolerability and pharmacokinetic profile in healthy subjects, with dose-dependent target engagement.

Lead Product(s): Inzomelid

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 26, 2020

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