Dernières nouvelles pour GRI Bio (NASDAQ:GRI) Stock

GRI BIO INC

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GRI Bio

GRI Bio Inc is a clinical-stage biotech company focused on discovering, developing, and commercializing therapies targeting serious diseases associated with dysregulated immune responses that to inflammatory, fibrotic, and autoimmune disorders. GRI Bio's program, GRI-0621, is a small molecule RAR-beta and gamma dual agonist that inhibits the activity of human NKT I cells, returning the immune system to homeostasis. It is also an oral formulation of tazarotene, a synthetic RAR-beta and gamma selective agonist for the topical treatment of psoriasis and acne. The company's other product candidate GRI-0803 is a novel oral agonist of type 2 Natural Killer T (type 2 NKT) cells which can be a potential treatment for autoimmune disorders.

GRI Bio Inc

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Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival
2- and 6-week interim safety results demonstrated GRI-0621 to be safe and well-tolerated in the first 12 and 24 patients evaluated, respectively
Results on track for 6-week interim biomarker analysis (n=24) in July 2025 and topline data in Q3 2025
LA JOLLA, CA, July 01, 2025 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=baPDKYdp3BSWHP45JArGos_yUZqEn9JWMuXvfBdwYAxdL6IgP7Iji95uzky4X6ZrOY7DGAUopvYZfr1F87uU4g==">GRI Bio, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the completion of patient enrollment for its Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF").

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GRI Bio Completes Enrollment In Phase 2a Trial Of GRI-0621 For Idiopathic Pulmonary Fibrosis; 2- And 6- Week Interim Safety Results Demonstrated GRI-0621 To Be Safe And Well-Tolerated In The First 12 And 24 Patients Evaluated, Respectively

GRI Bio Reports Safety Results At Interim 6-Week Analysis From Phase 2a Study Of GRI-0621; Independent Data Monitoring Committee Recommended To Continue Study As Planned

HC Wainwright &amp; Co. analyst Joseph Pantginis reiterates GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) with a Buy and maintains $10 price target.

Price Target

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Buy on GRI Bio, Maintains $10 Price Target

Ascendiant Capital analyst Edward Woo maintains GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) with a Buy and lowers the price target from $40 to $34.

Ascendiant Capital Maintains Buy on GRI Bio, Lowers Price Target to $34

Data presented at the 2025 American Thoracic Society (ATS) International Conference
Pre-clinical and interim clinical results underscore GRI-0621's potential to have both anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis
Results from 6-week interim analysis (n=24) in ongoing Phase 2a study of GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) anticipated in Q2 2025
LA JOLLA, CA, May 22, 2025 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=Dkqi3pZ9VucxPLCXj1Wqvjz5xEa5z8X1S19YO0zR4g7huJRAdHrRDWnkt145eg4xy_VQmll1DrP4-P9EHIotkw==">GRI Bio, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the presentation of positive preclinical data demonstrating its lead program GRI-0621 has anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis.

GRI Bio Presents Preclinical Data Demonstrating Lead Program GRI-0621 Has Anti-Inflammatory And Anti-Fibrotic Effects In Pulmonary Fibrosis At 2025 ATS International Conference

GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) reported quarterly losses of $(5.80) per share which missed the analyst consensus estimate of $(4.11) by 41.12 percent. This is a 94.26 percent increase over losses of $(101.05) per share from the same period last year.

Earnings

Earnings Misses

GRI Bio Q1 EPS $(5.80) Misses $(4.11) Estimate

GRI Bio Reports Interim Biomarker Results From Phase 2a Study Evaluating GRI-0621 In Idiopathic Pulmonary Fibrosis; Independent Data Monitoring Committee Recommended Study Continue As Planned, As No Safety Concerns Were Seen In The Data Reviewed

Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled&nbsp;
Company on track to report interim biomarker data from the first 12 patients imminently
Completion of patient enrollment and topline results expected Q3 2025

GRI Bio Completes Enrollment With 24 Of 36 Planned Patients Randomized In Its Ongoing Phase2a Study Evaluating GRI-0621 For Idiopathic Pulmonary Fibrosis

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GRI Bio shares are trading lower after the company announced a $5 million public price offering.

Offerings

GRI Bio Prices $5.0M Public Offering Of 1,388,888 At $3.60

GRI Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) stock is trading on Tuesday with a strong session volume of 6.9 million compared to an average volume of 17.35K, as per data <a href="https://www.benzinga.com/pro/feature/newsfeed" target="_blank" rel="noreferrer noopener">from Benzinga Pro</a>.
GRI Bio reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">Idiopathic Pulmonary Fibrosis (IPF)</a>.
In preliminary clinical trials to date and previous clinical trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44584630/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-" rel="noreferrer noopener">and injury in patients</a>.
The pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol.
Hyperlipidemia (high cholesterol) was not seen in the 12 patients assessed at the 2-week visit.
There were no meaningful changes in cholesterol levels in patients receiving GRI-0621, and all subjects remained within normal ranges.
The interim analysis committee recommended the study should continue as planned.
The interim results show that GRI-0621&#8217;s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks.
The company expects to report interim biomarker data in Q2 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025.
Price Action: GRI stock is up 95.9% at $6.27 at the last check Tuesday.
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Why Is Nano Cap GRI Bio Stock Skyrocketing On Tuesday?

GRI Bio Shares Resumed Trade And Then Again Halted On Circuit Breaker To The Downside, Stock Now Up 154.1%

&nbsp;GRI Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). &nbsp;
The pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol. Hyperlipidemia, as assessed by LDL, HDL and triglyceride (TG) levels, was not seen in the 12 patients assessed at the 2-week visit. There ere no meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, and all subjects remained within normal ranges. The interim analysis committee recommended the study should continue as planned. The interim results show that GRI-0621's receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks. &nbsp;

GRI Bio Reported Interim 2-Week Safety Results From Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis

GRI Bio Expands Intellectual Property Portfolio With Granting of Two Global Patents in Europe and Japan

<h3>Gainers</h3>
<ul>
<li>vTv Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares increased by 65.2% to $24.53 during Monday's regular session. The market value of their outstanding shares is at $64.0 million. </li>
<li>Monogram Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MGRM#NASDAQ">MGRM</a>) stock increased by 52.35% to $3.55. The company's market cap stands at $121.8 million. As per the news, the Q4 earnings report came out 3 days ago. </li>
<li>Regencell Bioscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) stock rose 46.67% to $18.51. The market value of their outstanding shares is at $240.8 million. </li>
<li>Scienture Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SCNX#NASDAQ">SCNX</a>) stock moved upwards by 42.95% to $2.13. The company's market cap stands at $18.3 million. </li>
<li>Hyperfine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HYPR#NASDAQ">HYPR</a>) shares increased by 34.92% to $1.24. The market value of their outstanding shares is at $96.0 million. As per the news, the Q4 earnings report came out today. </li>
<li>CervoMed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVO#NASDAQ">CRVO</a>) shares moved upwards by 28.11% to $8.25. The company's market cap stands at $68.1 million. As per the press release, Q4 earnings came out today. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Revelation Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REVB#NASDAQ">REVB</a>) stock declined by 19.7% to $2.73 during Monday's regular session. The market value of their outstanding shares is at $2.4 million. </li>
<li>bioAffinity Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIAF#NASDAQ">BIAF</a>) stock declined by 17.93% to $0.3. The market value of their outstanding shares is at $4.6 million. </li>
<li>Palisade Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PALI#NASDAQ">PALI</a>) stock decreased by 14.88% to $0.85. The company's market cap stands at $2.5 million. </li>
<li>Plus Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTV#NASDAQ">PSTV</a>) stock decreased by 12.7% to $0.59. The market value of their outstanding shares is at $3.4 million. </li>
<li>NRX Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NRXP#NASDAQ">NRXP</a>) shares declined by 12.56% to $2.06. The market value of their outstanding shares is at $34.7 million. The company's, Q4 earnings came out today. </li>
<li>GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) stock declined by 12.14% to $5.26. The company's market cap stands at $2.7 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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HYPR

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PALI

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12 Health Care Stocks Moving In Monday's Intraday Session

Summary of Financial Results for Full Year 2024 &nbsp;
Net loss was $8.2 million for the year ended December 31, 2024.
Research and development expenses were $3.8 million and $3.2 million for the years ended December 31, 2024 and 2023, respectively. The $0.6 million increase in research and development expenses was primarily due to increased expenses related to the registrational development program of GRI-0621.
General and administrative expenses were $4.5 million and $8.2 million for the years ended December 31, 2024 and 2023, respectively. The $3.7 million decrease was primarily due to a decrease of $3.4 million in accounting, legal, investment banking and other fees related to the merger with Vallon Pharmaceuticals, Inc. in April 2023.
As of December 31, 2024, the Company had cash and cash equivalents of approximately $5.0 million. Based on the Company's current operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

GRI Bio Reports As Of December 31, 2024, The Company Had Cash And Cash Equivalents Of ~$5M; Cash Runway Expected To Fund Operations Into Q2 2025, Including Interim Data Readout From GRI-0621

GRI Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that it received notice on March 10, 2025 from The Nasdaq Stock Market LLC ("Nasdaq") stating that the Company regained compliance with Nasdaq Listing Rule 5550(a)(2), also known as the "minimum bid price rule."

GRI Bio Regains Compliance With Nasdaq's Minimum Bid Price Rule

Trading Halt: Halted at 7:50:00 p.m. ET - Trading Halt: Halt News Pending

GRI Bio shares are trading lower after the company announced a 1-for-17 reverse stock split.

Press Releases

GRI Bio Announces Closing of $5.0 Million Public Offering

GRI Bio Announces Abstract Selected for Poster Discussion Session at the 2025 American Thoracic Society (ATS) International Conference

GRI Bio Continues to Drive Enrollment in Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis ("IPF")

GRI Bio's Interim Biomarker Data Demonstrate Positive Trend Towards Anti-Fibrotic Effect of GRI-0621 in First Twelve Patients of Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis ("IPF")

GRI Bio Reports First Quarter 2025 Financial Results and Confirms GRI-0621 Phase 2a IPF Trial on Track for 6-Week Interim Data in Q2 2025 and Topline Data in Q3 2025

GRI Bio to Present at A.G.P.'s Annual Healthcare Company Showcase

GRI Bio to Participate in the Virtual Investor Closing Bell Series

GRI Bio Presents Positive Pre-Clinical Data Demonstrating GRI-0621 Resolves Inflammation and Fibrosis in Bleomycin-Induced Fibrosis and Reiterates Promising Preliminary Phase 2a Clinical Results

GRI Bio's GRI-0621 Demonstrates Encouraging Safety Results at Planned Interim 6-Week Analysis in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis ("IPF")

GRI Bio Completes Enrollment in Phase 2a Study of GRI-0621 for the Treatment of Idiopathic Pulmonary Fibrosis ("IPF")

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