GRI Bio Says FDA Clears IND For GRI-0621 For Treatment Of IPF; Stock Up 19%

RTTNews | hace 565
Stocktwits
GRI Bio Says FDA Clears IND For GRI-0621 For Treatment Of IPF; Stock Up 19%

(RTTNews) - Biotechnology company GRI Bio, Inc. (GRI) announced Monday that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug (IND) application for GRI-0621 for the treatment of IPF.

The Company plans to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, on track to commence before year end.

The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study will enroll approximately 36 subjects with IPF whom will be randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks.

The company said interim data from the Phase 2a biomarker study is expected in the first half of 2024 and topline results are expected in the second half of 2024.

IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. GRI is developing and repurposing GRI-0621 as a once-daily oral capsule for the treatment of IPF with the potential to expand into additional fibrotic indications.

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Canadian Dollar Higher Amid Rising Oil Prices

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RTTNews | hace 23h 40min
Swiss Stock Market Heads South On Friday

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RTTNews | hace 1
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RTTNews | hace 1
CPSC Recalls: 1.2 Mln Anker Power Banks, Hedge Trimmers, High Chairs, Mattresses, Pool Covers

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RTTNews | hace 1
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RTTNews | hace 1
Eurozone Trade Surplus Declines To 3-Month Low

Eurozone Trade Surplus Declines To 3-Month Low

Eurozone trade surplus declined to a three month low in April as demand from the US softened following tariff hikes, official data revealed on Friday. The trade surplus declined to EUR 9.9 billion in April from EUR 37.3 billion in March, Eurostat reported. This was the lowest surplus since January. In the same period last year, the surplus totalled EUR 13.6 billion.
RTTNews | hace 1
Geopolitical Tensions Drag Down CAC 40

Geopolitical Tensions Drag Down CAC 40

An escalation in geopolitical tensions in the Middle East triggered by the Israel-Iran conflict weighed on market sentiment dragging down the CAC 40. Concerns about the trade dispute between the U.S. also weighed on sentiment.
RTTNews | hace 1
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