Regulus Therapeutics Inc. (RGLS) shares soared 6.12% in after-hours on Thursday, January 20, 2022, and closed the daily trading at $0.26. Even in the regular trading session of Thursday, RGLS’s stock gained 2.04%. RGLS shares have fallen 80.09% over the last 12 months, and they have moved down 4.71% in the past week. Over the past three months, the stock has lost 48.36%, while over the past six months, it has declined 66.57%.
Let’s have a brief look at its recent news and developments.
RGLS latest meeting with FDA about RGLS8429
On January 20, 2022, Regulus Therapeutics Inc. (RGLS), completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). The meeting was held to obtain input from the FDA on pre-clinical, clinical, and regulatory matters of the Company’s next-generation compound RGLS8429 as a potential treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD).
The successful completion of this interaction with the FDA is an important milestone for the planned Phase 1 trial design. FDA provided overall agreement with the trial design and length of the Phase 1 study, including the proposed starting dose for RGLS8429, as well as sufficiency of the non-clinical package. Regulus Therapeutics is on track to submit an IND application in the second quarter of 2022 to obtain clearance for the initiation of the Phase 1 clinical trial.
RGLS participation at a recent event
Regulus Therapeutics Inc. recently participated at the H.C. Wainwright Virtual BioConnect Conference which was held on January 10-13, 2022. RGLS was presented by President and Chief Executive Officer Jay Hagan during the event.
RGLS new appointment
On December 3, 2021, Regulus Therapeutics Inc. (RGLS) appointed Mohammad Ahmadian, Ph.D., as Vice President, Chemistry and Pharmaceutical Development. In his role, Dr. Ahmadian will assist in managing research and development of the Company’s drug candidates, including RGLS8429, which is being developed for patients with autosomal dominant polycystic kidney disease (ADPKD) and will add significant expertise to Regulus’ existing scientific talent.
RGLS data presentation at an event
On December 1, 2021, Regulus Therapeutics Inc. (RGLS), participated in the first annual Rare & Genetic Kidney Disease Drug Development Summit.
Regulus presentation was a summary of its ongoing efforts to therapeutically target microRNAs (miRs), small non-coding RNAs that play an important role in the regulation of gene expression and are known to be involved in the pathogenesis of numerous genetic kidney diseases representing significant unmet medical needs.
The latest meeting with FDA about RGLS8429 was the reason behind its positive performance on Thursday and we can expect it to continue its momentum on Friday as well.