Provention Bio, Inc. (PRVB) saw a push of 4.25% in aftermarket. However, the last trading session closed at $5.88 with a decrease of 3.13%.
Regulatory Update for Teplizumab At-Risk Type 1 Diabetes
On 22 November 2021, PRVB provided a regulatory update for the Teplizumab At-Risk Type 1 Diabetes Approval Pathway. The company is ecstatic that they were able to achieve an agreement with the FDA on moving forward with the popPK model. This allows them to create comparability data.
PRVB is pleased by these preliminary findings, which they feel are compatible with the knowledge of teplizumab’s target-mediated clearance process and might potentially explain the discrepancies seen in the initially disclosed single, fractional low dosage PK/PD investigation in healthy volunteers. Last but not the least, they intend to continue the conversations with the FDA as they examine the data and determine the next steps toward the Company’s aim of eventually giving teplizumab to T1D patients at risk of developing the end-stage insulin-dependent illness.
New Appointment in PRVB – Latest Updates
PRVB announced the appointment of Jan Hillson on 17th November 2021. Dr. Hillson has more than two decades of expertise in academic research, patient care, education, and medical research, and molecular medicine program planning and operations. Moreover, Dr. Hillson most recently worked for Alpine Immune Sciences as Senior Vice President, Clinical Development. At ChemoCentryx, Dr. Hillson was also Senior Vice President of Clinical and Translational Research. Furthermore, Dr. Hillson has worked with Momenta Pharmaceuticals, ZymoGenetics, Bristol Myers Squibb, and Xcyte Therapies, where he held positions of increasing importance.
Jan will have an immediate impact as the medical lead for the PREVAIL-2 research, where she has extensive expertise in treating patients with systemic lupus erythematosus. In addition, Jan’s immune-focused drug development track record of effectively progressing innovative medicines to patients broadens the capacity to uncover more product candidates to tackle autoimmune illnesses with large unmet medical needs.
PRVB is a biopharmaceutical firm that aims for the development of experimental medicines to diagnose and reduce severe and life-threatening, completely resistant illnesses. In autoimmune disorders, such as type 1 diabetes, celiac disease, and lupus, the firm’s strategy comprises clinical-stage product candidates that have shown proof-of-mechanism and/or proof-of-concept in preclinical or clinical investigations.