ReveraGen BioPharma, Inc.
ReveraGen BioPharma is dedicated to developing innovative therapies for neuromuscular diseases, with a focus on Duchenne muscular dystrophy. The company leverages a venture philanthropy model, collaborating with international non-profit foundations and government programs to de-risk drug development and bring new treatments to patients more efficiently and at lower costs.
Industries
Nr. of Employees
small (1-50)
ReveraGen BioPharma, Inc.
155 Gibbs Street, Suite 433, Rockville, MD 20850
Patents
Products
Oral dissociative steroidal small-molecule therapeutic (development candidate)
An oral dissociative glucocorticoid-analogue small molecule developed for the treatment of Duchenne muscular dystrophy; progressed through preclinical studies and multiple clinical trial phases and subject to regulatory review and approvals.
Oral dissociative steroidal small-molecule therapeutic (development candidate)
An oral dissociative glucocorticoid-analogue small molecule developed for the treatment of Duchenne muscular dystrophy; progressed through preclinical studies and multiple clinical trial phases and subject to regulatory review and approvals.
Services
Design and execution of multicenter Phase I–III trials, including dose escalation, randomized controlled and extension study formats, and international site coordination.
Development and qualification of pharmacodynamic biomarker panels with defined context-of-use to enable shorter, quantitative drug effect assessments.
Preparation and coordination of regulatory filings and interactions with authorities, including securing expedited designations and supporting NDA/MAA submissions.
Support for chemistry, manufacturing and controls including formulation development and multi-kilogram GMP synthesis to supply clinical programs.
Design and administration of multi-stakeholder funding agreements and management of government and foundation grants to finance and de-risk development programs.
Implementation of programs to return participant-level and aggregate clinical data to study participants and families, and conduct of associated ethics research.
Design and execution of multicenter Phase I–III trials, including dose escalation, randomized controlled and extension study formats, and international site coordination.
Development and qualification of pharmacodynamic biomarker panels with defined context-of-use to enable shorter, quantitative drug effect assessments.
Preparation and coordination of regulatory filings and interactions with authorities, including securing expedited designations and supporting NDA/MAA submissions.
Support for chemistry, manufacturing and controls including formulation development and multi-kilogram GMP synthesis to supply clinical programs.
Design and administration of multi-stakeholder funding agreements and management of government and foundation grants to finance and de-risk development programs.
Implementation of programs to return participant-level and aggregate clinical data to study participants and families, and conduct of associated ethics research.
Expertise Areas
- Clinical trial management (Phase I–III)
- Biomarker development and qualification
- Clinical pharmacology and PK/PD modeling
- Preclinical development and toxicology
Key Technologies
- Dissociative steroid small-molecule therapeutics
- Oral small-molecule formulation
- Population pharmacokinetics (PopPK) modeling
- Pharmacodynamic biomarker panels
News & Updates
The EMA approved AGAMREE (vamorolone) for Duchenne muscular dystrophy (DMD), ages 4 years and older on 18 December 2023. The US FDA previously approved AGAMREE for DMD on 26 October 2023, making it the first therapy for DMD to receive full approval in both the US and EU.
Santhera Pharmaceuticals and ReveraGen BioPharma announced the successful completion of the mid-cycle review meeting by the FDA for the new drug application of vamorolone for DMD.
Santhera Pharmaceuticals submitted an MAA to the UK Medicines and Healthcare products Regulatory Agency for vamorolone for the treatment of Duchenne muscular dystrophy.
EMA has validated the MAA for vamorolone, confirming the submission is complete and the review has begun.
Santhera Pharmaceuticals and ReveraGen BioPharma presented data on long-term efficacy and bone health in DMD patients treated with vamorolone.
Research indicates vamorolone is effective in DMD and has safety advantages over traditional corticosteroids.
The EMA approved AGAMREE (vamorolone) for Duchenne muscular dystrophy (DMD), ages 4 years and older on 18 December 2023. The US FDA previously approved AGAMREE for DMD on 26 October 2023, making it the first therapy for DMD to receive full approval in both the US and EU.
Santhera Pharmaceuticals and ReveraGen BioPharma announced the successful completion of the mid-cycle review meeting by the FDA for the new drug application of vamorolone for DMD.
Santhera Pharmaceuticals submitted an MAA to the UK Medicines and Healthcare products Regulatory Agency for vamorolone for the treatment of Duchenne muscular dystrophy.
EMA has validated the MAA for vamorolone, confirming the submission is complete and the review has begun.
Santhera Pharmaceuticals and ReveraGen BioPharma presented data on long-term efficacy and bone health in DMD patients treated with vamorolone.
Research indicates vamorolone is effective in DMD and has safety advantages over traditional corticosteroids.