GRI Bio stock holds Buy rating at H.C. Wainwright as Phase 2a trial completes enrollment

Published 02/07/2025, 12:30
GRI Bio stock holds Buy rating at H.C. Wainwright as Phase 2a trial completes enrollment

Investing.com - GRI Bio, Inc. (NASDAQ:GRI), a clinical-stage biotech company with a market capitalization of $3.22 million, has completed enrollment in its Phase 2a clinical trial evaluating GRI-0621 in patients with idiopathic pulmonary fibrosis (IPF), the company announced on July 1. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, despite challenging market conditions.

The randomized, double-blind, multi-center, placebo-controlled study enrolled approximately 36 IPF patients who were randomized in a 2:1 ratio to receive either 4.5mg GRI-0621 or placebo. The primary endpoint of the trial is safety and tolerability of oral GRI-0621 after 12 weeks of treatment, with secondary endpoints including changes in serum biomarkers, pharmacokinetics, and pharmacodynamic activity.

H.C. Wainwright reiterated a Buy rating and $10.00 price target on GRI Bio following the announcement. The firm noted that GRI Bio remains on track to disclose a six-week interim biomarker analysis of the first 24 randomized patients this month.

According to H.C. Wainwright, the biomarker data will be critical for identifying subgroups responsive to GRI-0621, which could be essential for selecting appropriate clinical signals, increasing chances of Phase 3 success, and strengthening the overall regulatory package.

Topline results from the Phase 2a study are expected in the third quarter of 2025, as the trial also includes exploratory endpoints to assess GRI-0621’s effect on pulmonary function, conduct flow cytometry analysis, and examine differential gene expression at various timepoints.

In other recent news, GRI Bio, Inc. has reported positive interim safety data from its Phase 2a study of GRI-0621 for the treatment of idiopathic pulmonary fibrosis (IPF). The trial showed that the drug was safe and well-tolerated, with no adverse events related to hyperlipidemia observed among the first 24 patients. The Independent (LON:IOG) Data Monitoring Committee has recommended continuing the trial, which aims to assess the safety and tolerability of GRI-0621 over 12 weeks. H.C. Wainwright reiterated a Buy rating on GRI Bio, highlighting the importance of biomarker data in identifying responsive patient subgroups for future trial phases. Additionally, GRI Bio has expanded its at-the-market offering capacity, allowing for the issuance of up to $1,758,934 of its common stock, as part of its capital management strategy. Financially, the company reported a net loss of $3.0 million for the first quarter of 2025, with research and development expenses accounting for $1.6 million. GRI Bio’s ongoing efforts include securing patents in Europe and Japan and preparing for presentations at the 2025 American Thoracic Society International Conference. These developments reflect the company’s commitment to advancing its IPF treatment and managing its financial resources effectively.

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