Regulus Therapeutics Inc. (RGLS) stock prices were down by 0.053% as of the market closing on October 12th, 2021. This brought the price per share down to USD$0.76 at the end of the trading day. Subsequent premarket fluctuations have seen the stock dip by 24.17%, bringing it down to USD$0.58.
RGLS Stock’s Prioritization
October 12th, 2021 saw RGLS stock announce the prioritization of its next-generation candidate, RGLS8429. The biopharma company’s treatment is designed to address Autosomal Dominant Polycystic Kidney Disease (ADPKD). The company recently concluded the dosing period of the in-life portion of the IND-enabling toxicity studies for RGLS8429. The company anticipates submitting an Investigational New Drug Application to the United States Food and Drug Administration in the near future based on the results from its study. Contingent on the FDA’s approval, the company plans to initiate a Phase 1 study in the second quarter of fiscal 2022.
Justification of Transition
RGLS stock is confident that a strategic prioritization of RGSL8429 will represent a more judicious use of its resources. This development is on the basis of discussions with the FDA and data from the second cohort of patients in the Phase 1b trial of first-generation RGLS4326. The continued development of RGLS4326 is expected to face limitations on dose and duration of therapy, thereby making RGLS8429 a more viable candidate in the short term. The cumulative work conducted on RGLS4326 will directly inform the development of RGLS8429, which the company believes will make the transition of prioritization both speedy and productive. This shift in prioritization is supported by robust data from preclinical models, where clear improvements have been observed in kidney function, size, and other measures of disease severity. The transition is also supported by the compound’s superior pharmacological profile.
Strength of RGLS8429
The completion of the dosing phase of the IND-enabling toxicity studies have established RGLS8429’s superior profile. This includes the absence of the off-target CNS effects that were seen with RGLS4326 at the top doses tested in chronic preclinical toxicology studies as well as equal potency to RGLS4326 for its molecular target (miR-17) in both in-vitro and in-vivo efficacy studies.
Future Outlook for RGLS Stock
The company reported a strong quarter, consolidated by the potential of its transition of prioritization. RGLS stock is keen to push for the accelerated development and commercialization of its RGLS8429 treatment. Current and potential investors are hopeful that management will be able to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value.