On Tuesday, Regulus (NASDAQ:RGLS) Therapeutics (NASDAQ:RGLS) maintained a Buy rating and a $10.00 stock price target from H.C. Wainwright. The firm's endorsement comes following Regulus Therapeutics' disclosure of additional exploratory results from its Phase 1b study of RGLS8429, a treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD).
The recent study focused on patients with high risks of rapid kidney function decline, classified as MIC 1C/1D/1E, according to the Mayo Imaging Classification which utilizes total kidney volume (TKV) to predict kidney outcomes in ADPKD.
The data revealed that RGLS8429, administered at dosages of 2 mg/kg and 3 mg/kg, consistently impacted the height-adjusted total kidney volume (htTKV) across these high-risk classes. Furthermore, increases in PC1 and PC2 proteins corresponded with greater reductions in htTKV.
Importantly, the safety profile of RGLS8429 met expectations in terms of kidney function during the study. H.C. Wainwright's report highlighted the drug as a risk-mitigated asset based on the additional data. The management of Regulus Therapeutics anticipates releasing data from Cohort 4 of the study in late 2024 or early 2025. Moreover, an end-of-Phase 1 meeting with the FDA is projected for the fourth quarter of 2024.
Looking ahead, Regulus is expected to initiate a pivotal Phase 2 trial in mid-2025, aiming for accelerated approval. The subsequent post-approval Phase 3 trial is set to provide data on estimated glomerular filtration rate (eGFR) to confirm the clinical benefits of RGLS8429. With these developments, H.C. Wainwright reaffirmed their positive stance on the stock and its potential.
In other recent news, Regulus Therapeutics has reported positive topline results from the third cohort of its Phase 1b study for RGLS8429, a treatment candidate for Autosomal Dominant Polycystic Kidney Disease (ADPKD).
The study showed that RGLS8429 was well-tolerated and did not raise any safety concerns. The findings indicated a dose response in urinary biomarkers and a reduction in kidney volume in a majority of patients at the 3 mg/kg dose level. Following the announcement, H.C. Wainwright raised its price target for Regulus Therapeutics shares to $10 from $9, maintaining a Buy rating on the stock.
Jones Trading also reiterated their Buy rating on Regulus, maintaining a price target of $8.00. The company has begun enrollment for the fourth cohort of the study, which will involve a fixed dose of 300 mg of RGLS8429 administered every other week for three months. Regulus anticipates an End-of-Phase 1 meeting with the FDA in the fourth quarter of this year.
InvestingPro Insights
As Regulus Therapeutics (NASDAQ:RGLS) continues to show promise with its RGLS8429 treatment, a glance at the company's financials through InvestingPro offers a mixed picture. With a market capitalization of $114.57 million, Regulus holds more cash than debt on its balance sheet, which is a positive sign for investors looking at the company's financial stability.
On the flip side, the company's gross profit margins remain weak, with a gross profit of -$22.27 million over the last twelve months as of Q1 2024, reflecting the challenges it faces in achieving profitability.
InvestingPro Tips indicate that while the company is quickly burning through cash and has not been profitable over the last twelve months, its liquid assets exceed short-term obligations, which may provide some cushion against financial headwinds.
Moreover, the stock price has been quite volatile, and analysts do not anticipate the company will be profitable this year. However, a noteworthy uptick in price over the last six months could signal growing investor confidence in the potential of RGLS8429 and the company's pipeline.
For investors seeking a deeper dive into Regulus Therapeutics' financial health and stock performance, InvestingPro provides additional tips and metrics. By using the coupon code PRONEWS24, you can get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, unlocking access to these valuable insights. There are 11 more InvestingPro Tips available for RGLS, which could help investors make more informed decisions.
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