Every 8-K that GRI Bio, Inc. (GRI) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow GRI and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full GRI filings page.
GRI Bio, Inc. (GRI) reported new Phase 2a data for its lead IPF candidate GRI-0621, an oral RARβ/γ agonist, from the randomized, double-blind, placebo-controlled 12‑week GRI‑0621‑IPF‑02 study in 35 idiopathic pulmonary fibrosis patients. The study met its primary objective of safety and tolerability and generated translational biomarker and lung function signals.
Across four independent modalities (RNA sequencing, serum ECM biomarkers, spectral flow cytometry and clinical readouts), GRI-0621 showed direction‑consistent signals supporting nine mechanistic pillars, including immune re‑balancing, fibrolysis, basement‑membrane repair, re‑epithelialization, FVC stabilization, antitussive effect and GI protection. At Week 12, placebo‑adjusted FVC change from baseline was +99 mL overall and +139 mL on background standard antifibrotic therapy, with 39% of treated patients achieving an FVC increase ≥30 mL versus 20% on placebo and a 60% relative reduction in patients with ≥10% FVC decline.
GRI-0621 was well tolerated with no serious treatment‑emergent adverse events in the active arm, fewer cough, dyspnea and diarrhea events than placebo despite higher nintedanib use, and no hepatic, lipid, visual, auditory or neuropsychiatric safety signals. GRI Bio states that the totality of Phase 2a data supports advancing GRI‑0621 into a longer‑duration, 52‑week study.
GRI Bio, Inc. reported that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead candidate GRI-0621 (tazarotene) for treating idiopathic pulmonary fibrosis, a progressive and ultimately fatal lung disease. This designation is a key regulatory milestone that can support development and potential commercialization.
The status may provide GRI-0621 with potential eligibility for seven years of U.S. market exclusivity upon approval, possible tax credits on qualified clinical expenses, waiver of certain FDA fees and enhanced interaction with the FDA. GRI-0621, a once-daily oral RARβ/γ-selective agonist, previously met primary, secondary and exploratory endpoints in a 35‑patient Phase 2a trial in idiopathic pulmonary fibrosis, most of whom received standard antifibrotic therapy.
GRI Bio, Inc. reported first quarter 2026 results and highlighted new Phase 2a data for its IPF drug candidate GRI-0621. Cash and cash equivalents were approximately $11.0 million as of March 31, 2026, up from about $8.2 million at year-end 2025, which the company expects will fund operations into the second quarter of 2027.
In the 35-patient Phase 2a IPF trial, GRI-0621 added to standard of care showed zero cough versus 25% on placebo, a 76% reduction in dyspnea (4% vs. 17%), no weight loss versus 17% on placebo, and a 61% reduction in diarrhea (13% vs. 33%), with no serious adverse events in the active arm. Exploratory data showed a +99 mL FVC improvement overall and +139 mL in patients on background antifibrotics.
Research and development expenses fell to about $0.4 million from $1.6 million a year earlier as the Phase 2a trial concluded, while general and administrative expenses were approximately $1.6 million versus $1.4 million. Net loss narrowed to roughly $2.0 million from $3.0 million, and the company raised about $6.8 million in gross proceeds through its at-the-market facility.
GRI Bio, Inc. filed a current report describing that it issued a press release on February 4, 2026. The release reiterates the company’s financial results for fiscal year 2025 and summarizes key recent business highlights.
The press release is furnished as Exhibit 99.1 and is not incorporated by reference into other SEC filings or deemed filed for liability purposes.
GRI Bio, Inc. amended its at-the-market stock offering program with H.C. Wainwright & Co., increasing the potential aggregate offering price from $10,000,000 to up to an aggregate of $60,000,000 of common shares under its existing prospectus supplement.
The amendment, effective as of January 28, 2026, is supported by a new prospectus supplement filed on January 29, 2026 and related legal opinion from Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Certain provisions of a December 11, 2025 Securities Purchase Agreement were waived to permit issuances under the updated at-the-market arrangement.
GRI Bio, Inc. filed a report noting that it has released additional data from its Phase 2a clinical trial of GRI-0621 in patients with idiopathic pulmonary fibrosis. The company announced these clinical findings through a press release dated January 28, 2026.
The press release is included as Exhibit 99.1, meaning the detailed trial information and outcomes are provided in that attached document rather than in the body of this report.
GRI Bio, Inc. approved a 1-for-28 reverse stock split of its common stock through a certificate of amendment to its Delaware charter. The split becomes effective at 4:01 p.m. Eastern Time on January 23, 2026, with the stock expected to begin trading on a post-split basis on The Nasdaq Capital Market on January 26, 2026.
At the effective time, every 28 issued and outstanding common shares will automatically convert into 1 share, with no change to the par value. The company will also make proportional adjustments to the exercise prices and share amounts for all outstanding stock options, warrants, convertible securities, and shares under its stock incentive plans, while keeping the total number of authorized common shares unchanged.
Shareholders who would otherwise receive fractional shares will instead get a cash payment equal to the fraction multiplied by the closing sale price of the common stock on January 23, 2026, adjusted for the reverse split. The common stock will continue to trade on Nasdaq under the symbol “GRI”.
GRI Bio, Inc. received formal notice from Nasdaq that it has conditionally regained compliance with the stockholders’ equity listing standard. For companies on the Nasdaq Capital Market with a market value under $35 million and annual net income under $500,000, Nasdaq Listing Rule 5550(b)(1) requires at least $2.5 million in stockholders’ equity.
The company had previously been notified that it was out of compliance based on its Form 10-Q for the quarter ended September 30, 2025. Nasdaq’s latest notice removes the immediate delisting risk, but it warns that if GRI Bio does not continue to meet the equity requirement in future Exchange Act reports, its common stock may again face possible delisting.
GRI Bio, Inc. reported that stockholders approved a reverse stock split authorization at a Special Meeting. The board may implement a split of the common stock at any ratio between one-for-two and one-for-thirty, without changing the number of authorized shares, and may also decide not to proceed even though the authority was granted. Stockholders also approved a proposal allowing postponement or adjournment of the meeting to gather more proxies if needed.
The company disclosed that it previously received a Nasdaq notice on November 26, 2025 for not meeting the minimum stockholders’ equity requirement of $2,500,000. On December 12, 2025 it completed a best efforts public offering of 2,603,331 shares of common stock, 8,063,336 pre-funded warrants, and 10,666,667 Series F warrants, generating gross cash proceeds of about $8.0 million. As a result, the company believes its stockholders’ equity now exceeds the Nasdaq minimum, though Nasdaq will continue to monitor compliance and could still delist the stock if future reports do not show sufficient equity.
GRI Bio, Inc. disclosed that it has increased the maximum amount of common stock that may be issued under its at-the-market offering program with H.C. Wainwright & Co., LLC to up to $7,379,813 of shares. The company notes this figure is in addition to approximately $6,165,114 of shares that have already been sold under the existing sales agreement. Certain provisions of a Securities Purchase Agreement dated December 11, 2025 were waived to permit issuances under this at-the-market arrangement, and a legal opinion from Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding the validity of the shares was filed as an exhibit.
GRI Bio, Inc. reported that it has issued a press release sharing additional data from its Phase 2a clinical trial of GRI-0621 in patients with idiopathic pulmonary fibrosis, a serious lung disease. The filing does not describe the details or outcomes of the new data, only that they were announced.
The company also noted that, following a public offering completed in December 2025, it believes its stockholders’ equity is now above the minimum $2.5 million requirement set by Nasdaq. This suggests the company currently expects to meet the exchange’s stockholders’ equity standard for continued listing.
GRI Bio, Inc. reported that it issued a press release announcing the closing of a best efforts public offering of its common stock, pre-funded warrants to purchase common stock and Series F warrants to purchase common stock.
Immediately following completion of this offering, the company states that its stockholders’ equity exceeds $2.5 million, meaning its net assets are above this level after the transaction.
GRI Bio, Inc. commenced a best efforts public offering of 2,603,331 shares of common stock, 8,063,336 pre-funded warrants and 10,666,667 Series F warrants, with each share or pre-funded warrant sold together with one Series F warrant. The combined price is $0.75 per share and Series F warrant, and $0.7499 per pre-funded warrant and Series F warrant. The company expects approximately $6.7 million in net proceeds.
GRI Bio plans to use the cash for working capital, product candidate development and general corporate purposes, and believes this funding, together with existing cash and cash equivalents, will support planned operations into the fourth quarter of 2026. The pre-funded warrants are exercisable at $0.0001 per share until fully exercised, while the Series F warrants are exercisable at $0.75 per share and expire on December 12, 2030, subject to 4.99% or 9.99% beneficial ownership limits and customary offering and financing restrictions.
GRI Bio, Inc. reported topline Phase 2a data for its oral drug candidate GRI-0621 in idiopathic pulmonary fibrosis, showing the trial met its primary endpoint of safety and tolerability over a 12-week treatment period. The company reports GRI-0621 was well tolerated with no treatment-related serious adverse events and adverse events mainly limited to grade 2 and grade 3 issues such as dry skin, dry lips, and musculoskeletal pain.
Placebo-adjusted changes in lung function, measured by Forced Vital Capacity, improved in patients receiving GRI-0621 alone and in combination with standard of care, and a higher share of treated patients experienced FVC increases compared with placebo. Serum biomarkers of multiple collagen types suggested an anti-fibrotic effect and potential activation of alveolar basement membrane repair, which are important for lung tissue recovery. The randomized, double-blind trial enrolled 35 IPF patients, most on background pirfenidone or nintedanib, and secondary and exploratory biomarker and pharmacodynamic analyses are ongoing.
GRI Bio, Inc. filed a current report to make a new corporate presentation available to the market. The company is furnishing, rather than filing, this information under Regulation FD, which means the materials are provided for informational purposes and are not subject to certain liability provisions of the Exchange Act. The 8-K identifies the presentation as Exhibit 99.1, titled "GRI Bio, Inc. Corporate Presentation" and dated August 20, 2025.
GRI Bio, Inc. reported results from its August 13, 2025 virtual Annual Meeting. Stockholders approved an amendment to the Amended and Restated 2018 Equity Incentive Plan, increasing the number of shares reserved for issuance by 400,000 shares. The company noted 2,496,800 shares issued and outstanding as of the July 8, 2025 record date and a quorum of 1,090,373 shares (approximately 43.67%) was present or represented.
At the meeting the board nominees Roelof Rongen and Camilla V. Simpson were elected with 63,031 and 63,581 votes for, respectively, and the appointment of WithumSmith+Brown, PC as independent registered public accounting firm for fiscal 2025 was ratified with 1,072,167 votes for. Exhibit 10.1 contains the amended equity incentive plan text.
GRI Bio (Nasdaq: GRI) furnished an 8-K under Item 7.01 disclosing a press release that reports interim safety results from its Phase 2a study of GRI-0621 for idiopathic pulmonary fibrosis. The disclosure is provided solely for Regulation FD purposes and is expressly not deemed “filed” under the Exchange Act. No efficacy data, financial metrics, or guidance updates were included. Exhibit 99.1 contains the full press release; no other material items were reported.