RedHill Biopharma

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RedHill Biopharma Receives Approval for Phase 2/3 COVID-19 Study in Russia

Lead Product(s): Opaganib

Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

Highest Development Status: Phase II/ 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

Details:

The Ministry of Health of the Russian Federation has approved RedHill's Clinical Trial Authorization (CTA) application for a Phase 2/3 study evaluating opaganib (Yeliva®) in patients hospitalized with severe SARS-CoV-2 infection and pneumonia.

RedHill Biopharma

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RedHill Biopharma Receives Approval for COVID-19 Phase 2/3 Study with Opaganib in the UK

Lead Product(s): Opaganib

Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2020

Details:

The Phase 2/3 multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib aims to enroll 270 severe COVID-19 patients in up to 40 clinical sites across the UK, Italy, Russia and additional countries.

RedHill Biopharma

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RedHill Biopharma Submits COVID-19 Clinical Trial Application for Phase 2/3 Study with Opaganib

Lead Product(s): Opaganib

Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

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 10, 2020

Details:

The multi-center, open-label Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors with the goal of identifying a recommended dose and schedule. Curis expects to initiate this study in the second half of 2020.

RedHill Biopharma

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RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.

Lead Product(s): Opaganib

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

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 May 08, 2020

Details:

IND application for a Phase 2a clinical study evaluating RedHill's investigational drug, opaganib, in patients with confirmed moderate-to-severe SARS-CoV-2 infection (the cause of COVID-19).

RedHill Biopharma

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RedHill Biopharma Announces Agreement with NIAID to Evaluate RHB-107 Against COVID-19

Lead Product(s): Upamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Preclinical Product Type: Small molecule

Partner/Sponsor/Collaborator: NIAID

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 20, 2020

Details:

RedHill Biopharma will provide its investigational drug, RHB-107 (upamostat, WX-671), for testing in non-clinical studies for activity against SARS-CoV-2.

RedHill Biopharma

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IND for COVID-19 with Opaganib Submitted to the FDA by RedHill Biopharma

Lead Product(s): Opaganib

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 17, 2020

Details:

Proposed study intended to evaluate the safety and efficacy of opaganib in up to 60 patients hospitalized with positive SARS-CoV-2 infection and pneumonia in the U.S.

RedHill Biopharma

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Initial Data Shows Improvement In Covid-19 With Redhill’s Opaganib

Lead Product(s): Opaganib,Hydroxychloroquine Sulphate

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Undisclosed Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 14, 2020

Details:

Opaganib was administered in addition to standard-of-care, including hydroxychloroquine background therapy, and was well tolerated.

RedHill Biopharma

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AZ licences Movantik rights to RedHill

Lead Product(s): Naloxegol

Therapeutic Area: Gastroenterology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Recipient: AstraZeneca PLC

Deal Size: $67.5 million Upfront Cash: $52.5 million

Deal Type: Divestment April 02, 2020

Details:

In 2015, AstraZeneca entered into a co-commercialisation agreement with Daiichi Sankyo, Inc. for Movantik in the US, which has now been transferred to RedHill.

RedHill Biopharma

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RedHill Biopharma Provides Update on Opaganib (Yeliva®)

Lead Product(s): Opaganib,Upamostat,Hydroxychloroquine Sulphate

Therapeutic Area: Oncology Product Name: Undisclosed

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 March 11, 2020

Details:

Recruitment initiated in 2nd arm of Phase 1/2a study evaluating opaganib in combination with hydroxychloroquine in advanced cholangiocarcinoma.

RedHill Biopharma

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RedHill Biopharma Enters $115 Million Non-Dilutive Financing Agreement with HealthCare Royalty Partners

Lead Product(s): Omeprazole Magnesium,Amoxycillin,Rifabutin

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: HealthCare Royalty Partners

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Financing February 25, 2020

Details:

The non-dilutive financing will support the acquisition of rights to Movantik® from AstraZeneca, the planned U.S. launch of Talicia® this quarter and the ongoing promotion of Aemcolo®.

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RedHill Biopharma

RedHill Biopharma Receives Approval for Phase 2/3 COVID-19 Study in Russia

RedHill Biopharma

RedHill Biopharma Receives Approval for COVID-19 Phase 2/3 Study with Opaganib in the UK

RedHill Biopharma

RedHill Biopharma Submits COVID-19 Clinical Trial Application for Phase 2/3 Study with Opaganib

RedHill Biopharma

RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.

RedHill Biopharma

RedHill Biopharma Announces Agreement with NIAID to Evaluate RHB-107 Against COVID-19

RedHill Biopharma

IND for COVID-19 with Opaganib Submitted to the FDA by RedHill Biopharma

RedHill Biopharma

Initial Data Shows Improvement In Covid-19 With Redhill’s Opaganib

RedHill Biopharma

AZ licences Movantik rights to RedHill

RedHill Biopharma

RedHill Biopharma Provides Update on Opaganib (Yeliva®)

RedHill Biopharma

RedHill Biopharma Enters $115 Million Non-Dilutive Financing Agreement with HealthCare Royalty Partners