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Details:
MNKD-101 (clofazimine) possesses antimicrobial and anti-inflammatory properties. It is active against both slowly growing and rapidly growing mycobacteria and most Gram-positive bacteria in vitro. It is currently being developemnt for pulmonary nontuberculous mycobacteria.
Lead Product(s): Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: MNKD-101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2024
Details:
RHB-204 (clarithromycin) is a 70s Bacterial ribosome inhibitor combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2023
Details:
The Company intends to use the net proceeds for the development of RHB-204, a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by MAC.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 03, 2023
Details:
The net proceeds will be used in the development of RHB-204, a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 30, 2023
Details:
RHB-204 (clarithromycin) is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $6.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 08, 2023
Details:
RHB-204 is a Phase 3-stage proprietary, xed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM disease caused by MAC.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2023
Details:
MNKD-101 (clofazimine) possesses antimicrobial and anti-inflammatory properties. It is active against both slowly growing and rapidly growing mycobacteria and most Gram-positive bacteria in vitro. It is currently being developemnt for pulmonary nontuberculous mycobacteria.
Lead Product(s): Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: MNKD-101
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2023
Details:
During the MAD portion of the study, 16 adults were enrolled in one of two cohorts (n = 8 per cohort) that received a daily inhaled dose of 30 mg or 90 mg MNKD-101 (clofazimine) for a seven-day period.
Lead Product(s): Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: MNKD-101
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC).
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2022
Details:
U.S. patents for opaganib combination for the treatment of Ebola virus disease provides patent protection until 2035. Opaganib also undergoing two oncology Phase 2 U.S. studies as well as several development programs for inflammatory and viral indications, including Ebola.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Gastroenterology Product Name: RHB-104
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2021
Details:
RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Financing March 02, 2021
Details:
The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Gastroenterology Product Name: RHB-104
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 01, 2021
Details:
The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Gastroenterology Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering January 11, 2021
Details:
RedHill recently initiated a Phase 3 study evaluating the safety and efficacy of RHB-204 as a first-line treatment for pulmonary NTM disease, to be conducted at up to 40 sites across the U.S.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
Details:
RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease - a rare condition with no FDA-approved first-line therapy.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2020
Details:
Orphan Drug Designation, along with RHB-204’s FDA QIDP priority designation, will extend U.S. potential market exclusivity to a total of 12 years.
Lead Product(s): Clarithromycin,Rifabutin,Clofazimine
Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
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