Regulus Therapeutics (NASDAQ:RGLS) soared 55% after the clinical-stage biotech firm disclosed that the FDA had accepted its RGLS8429 Investigational New Drug Application in hereditary kidney disorders. The IND application was submitted in order to obtain regulatory approval to examine RGLS8429 in hereditary autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a genetically based disease that is a leading cause of end-stage renal failure.
Trading Data
On Wednesday, RGLS stock soared 55% to $0.2660 with 59.28 million shares, compared to its average volume of 1.99 million shares. The stock moved within a range of $0.1860 – 0.3250 after opening trade at $0.1890.
Regulus Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
The company intends to begin the product candidate’s Phase 1 study in Q2 2022, utilizing healthy subjects as participants. A Phase 1b multiple ascending dosage trial in adult patients will follow the first Phase 1 single ascending dose investigation.
The company’s CEO, Jay Hagan, stated that they are on track to commence the study in Q2 and anticipate data from the healthy volunteer trial and commencement of patient dosing in the second half of 2021. In the last 12 months, the stock has lost almost two-thirds of its value. Therefore, with the acceptance of the NDA, RGLS is worth watching in the coming weeks.
Key Quote
“With FDA’s acceptance of our IND and the Phase 1 trial preparations well underway, we look forward to advancing this program which ultimately may provide a transformative treatment option for patients with ADPKD,” said Jay Hagan, President and Chief Executive Officer of Regulus Therapeutics. “We are on track to initiate the study in the second quarter and expect data from the healthy volunteer study and initiation of dosing in patients with ADPKD in the second half of this year.”
Technical Data
RGLS stock is above the 20-Day and 50-Day Moving averages of $0.21 and $0.26 respectively. However, the stock is trading below the 200-Day moving average of $0.42.
