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GRI Bio, Inc.

GRI
Richly ValuedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$1.74
▲ +0.07 · +4.05%

Financials

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52W LOW $1.3652W HIGH $64.12
Volume
3.65 K
Value Traded
485.44 K
Short % Float
-
-14.29%Week
-6.67%1 Month
-3.45%3 Month
-31.43%6 Month
-100%5 Year
-100%All Time

Cash Data

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Key Stats

Market Cap
3.72 M
EPS (TTM)
-4.42
P/E Ratio
-
Ent. Value
-7.27 M
Total Shares
2.19 M
Float Shares
1.73 M
Insiders
0.00%
Institutions
4.28%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

GRI Catalyst Timeline

Dated clinical, regulatory and corporate events for GRI Bio, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for GRI Bio, Inc.

252Total events
4Upcoming
45Tier-1 (high impact)
2020 to 2027Coverage

Upcoming catalysts 2

T2Runway Guidance Update
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TBD
T2Oral Presentation
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GRI-0621

Event history 50

◆Oral PresentationGRI-0621Presentation
CEO Marc Hertz presentation on Phase 2a development insights for immune-modulating therapy in IPF at 10th IPF Summit
idiopathic pulmonary fibrosissource ↗
◆Oral PresentationGRI-0621Presentation
CSO Vipin Kumar presentation on preclinical & translational package for novel IPF therapies at 10th IPF Summit
idiopathic pulmonary fibrosissource ↗
▲Oral PresentationGRI-0621Presentation
Late-breaking oral presentation of Phase 2a GRI-0621-IPF-02 data at ERS 2026
idiopathic pulmonary fibrosissource ↗
▲Poster PresentationGRI-0621Presentation
Three posters presented at ERS 2026 covering translational biomarkers, lung function and safety
idiopathic pulmonary fibrosissource ↗
▲Biomarker DataGRI-0621Clinical Data
New translational biomarker data defining nine mechanistic pillars for GRI-0621 in IPF
idiopathic pulmonary fibrosissource ↗
▲Additional DataGRI-0621Clinical Data
Exploratory FVC and safety results from Phase 2a GRI-0621-IPF-02 presented at ERS 2026
idiopathic pulmonary fibrosissource ↗
▲Safety Data UpdateGRI-0621Clinical Data
Favorable 12-week tolerability data for GRI-0621 in IPF
idiopathic pulmonary fibrosissource ↗
▲Orphan Drug DesignationGRI-0621Designation
FDA grants Orphan Drug Designation for GRI-0621 in IPF
Idiopathic Pulmonary Fibrosissource ↗
◆Oral PresentationPresentation
Fireside chat at A.G.P. Annual Healthcare Company Showcase
▲Full ResultsGRI-0621Clinical Data
Phase 2a topline results: primary safety endpoint met; exploratory pulmonary function and biomarker data reported
idiopathic pulmonary fibrosissource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How GRI actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-10-01GRI-0621 Phase 2a data presentation Phase 2a
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D26 / 100
Pipeline Score
$0M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.0x
rNPV / MCap
Top 80%
Micro Cap
(rank 527 of 658)
Percentile Rank
GRI Bio, Inc. faces pipeline headwinds (26/100), with $66M risk-adjusted pipeline value, led by Tazarotene in Idiopathic Pulmonary Fibrosis (Phase 2).
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Tazarotene Small moleculeCompletedNCT06331624Idiopathic Pulmonary FibrosisPhase 2 COMPLETED 35Sep 30, 2025
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Clinical Trial Results

Readouts, endpoints and source filings for every GRI program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
GRI-0621
Orphan
idiopathic pulmonary fibrosisPhase 2a2026-09-08Approximately 2x · 2.5x as many GRI-0621-treated patients experienced an FVC increase compared with placebo; placebo-adjusted FVC change from baseline at Week 12 was +99 mL overall and +139 mL on background standard-of-care antifibrotic therapyRead MoreGRI Bio Presents New Phase 2a Data at ERS 2026 Defining GRI-0621's Mechanism of Action in IPF Across Nine Mechanistic PillarsRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
John SmithCEOBuy 50,000 150,000 held$45.50 01/10/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in GRI for Q2 2026.
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Shares held by hedge funds each quarter, and who bought or sold.

GRI Institutional Ownership Trends

Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How GRI ranks across every disease it competes in

Competitive Position is a premium feature
See how GRI ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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GRI News

GRI
Sep 28, 2026
GRIConferences/Events

GRI Bio to Highlight Immune Modulation and Phase 2a Development Insights in IPF at the 10th IPF Summit

GRI Bio, Inc. will present insights on immune modulation and Phase 2a development for idiopathic pulmonary fibrosis (IPF) at the 10th IPF Summit. CEO Marc Hertz and CSO Vipin Kumar will discuss the role of immune biology in developing therapies and share findings from their ongoing clinical trials. The summit takes place from September 29 to October 1, 2026, in Boston.

Read more →
GRI
Sep 8, 2026
GRIPhases
▼ -30.6%on this news

GRI Bio Presents New Phase 2a Data at ERS 2026 Defining GRI-0621's Mechanism of Action in IPF Across Nine Mechanistic Pillars

GRI Bio presented promising Phase 2a data for GRI-0621 at the ERS Congress, highlighting its mechanism of action in treating idiopathic pulmonary fibrosis (IPF). The study demonstrated significant improvements in lung function, with a notable increase in forced vital capacity (FVC) among treated patients compared to placebo. The findings support the advancement of GRI-0621 into longer-duration studies, showcasing its potential as a novel therapeutic option for IPF.

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GRI
Aug 27, 2026
GRIConferences/Events
▲ +8.4%on this news

GRI Bio Featured in "Why Now" On-Demand Video Webcast

GRI Bio, Inc. is highlighted in a 'Why Now' video webcast where CEO Marc Hertz discusses the company's innovative approach to treating idiopathic pulmonary fibrosis (IPF) with GRI-0621. This oral RARβ/γ-selective agonist aims to address the significant unmet needs in IPF management. GRI Bio is also set to present supportive data at the upcoming 2026 European Respiratory Society Congress in Barcelona.

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GRI
Aug 24, 2026
GRIPhases
▲ +8.5%on this news· ran to +25% by day 3shared move

GRI Bio to Present Late-Breaking Phase 2a GRI-0621 Data Highlighting Lung Function, Anti-Fibrotic Biomarkers and Favorable Tolerability in IPF at ERS 2026

GRI Bio announced that data from its Phase 2a study of GRI-0621 will be presented at the 2026 ERS Congress. The findings indicate positive effects on lung function and favorable safety profiles for the treatment of idiopathic pulmonary fibrosis (IPF). The presentations include an oral session and three posters, showcasing significant translational biomarkers and the drug's potential impact on IPF management.

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GRI
Jun 18, 2026
GRIFDA Updates
▼ -19%on this news

GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 (Tazarotene) in Idiopathic Pulmonary Fibrosis

GRI Bio has secured FDA Orphan Drug Designation for GRI-0621, an investigational therapy for Idiopathic Pulmonary Fibrosis (IPF). This designation highlights the drug's potential to meet significant unmet medical needs in treating this progressive lung disease. GRI-0621's unique mechanism of action and positive Phase 2a trial results further support its development and potential market impact.

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GRI
May 18, 2026
GRIConferences/Events
▲ +5.4%on this news

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

GRI Bio, Inc. announced that its CEO, Marc Hertz, will present at A.G.P.'s Annual Healthcare Company Showcase on May 20, 2026. The company focuses on developing Natural Killer T (NKT) cell modulators aimed at treating inflammatory, fibrotic, and autoimmune diseases. This webcast will provide insights into GRI Bio's immune-modulating pipeline and its lead program, GRI-0621, which targets idiopathic pulmonary fibrosis. The event emphasizes GRI Bio's commitment to combating unmet medical needs in serious health conditions.

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GRI
May 14, 2026
GRIPhases

GRI Bio Reports First Quarter 2026 Financial Results, New Data Reinforcing Differentiated Profile of GRI-0621 in Idiopathic Pulmonary Fibrosis and Highlights Continued Advancement of Differentiated Immune-Modulating Pipeline

GRI Bio reported strong results for Q1 2026, highlighting the Phase 2a data for GRI-0621 in idiopathic pulmonary fibrosis (IPF). The study demonstrated notable efficacy, including zero cough and significantly lower treatment-related diarrhea compared to placebo, alongside improvements in dyspnea and lung function. Additionally, the company is advancing GRI-0803 towards IND-enabling activities targeting autoimmune diseases. With approximately $11 million in cash, GRI Bio is positioned for continued development and regulatory planning.

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GRI
Apr 8, 2026
GRIGeneral

GRI Bio Receives Notice of Allowance for UAE Patent Application Covering Novel Type 2 Diverse NKT Cell Agonists for the Treatment of Inflammatory Conditions

GRI Bio, Inc. has announced the receipt of a Notice of Allowance for a UAE patent covering novel type 2 diverse NKT cell agonists aimed at treating inflammatory conditions. This development enhances the company's global intellectual property protections and signifies its commitment to expanding its presence in the growing healthcare market in the UAE and the broader MENA region. The patent supports GRI Bio's focus on modulating immune responses that target a range of diseases with significant unmet needs. Furthermore, it positions the company to explore future partnerships and licensing opportunities.

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GRI
Feb 17, 2026
GRIGeneral

GRI Bio CEO, Marc Hertz, Featured in Virtual Investor “What This Means” Segment

GRI Bio, Inc. participated in a Virtual Investor segment featuring CEO Marc Hertz. He discussed promising Phase 2a data for the treatment of Idiopathic Pulmonary Fibrosis (IPF), highlighting significant biomarker improvements related to fibrosis and lung repair. The company focuses on developing therapies targeting Natural Killer T cells to address inflammatory and autoimmune diseases.

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GRI
Feb 5, 2026
GRIConferences/Events
▼ -17%on this news

GRI Bio to Participate in the Corporate Connect Webinar Series Virtual Conference Hosted by Webull Financial

GRI Bio, Inc. will participate in the Corporate Connect Webinar Series hosted by Webull Financial on February 11, 2026. The presentation will be led by CEO Marc Hertz and aims to highlight the company's advancements in immune cell modulators for treating inflammatory and autoimmune diseases. GRI Bio's innovative pipeline includes therapies targeting Natural Killer T cells, with a focus on idiopathic pulmonary fibrosis.

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GRI
Feb 5, 2026
GRIGeneral
▼ -17%on this newsshared move

GRI Bio Reiterates Full Year 2025 Financial Results, Strengthens Balance Sheet and Summarizes Key Recent Highlights

GRI Bio reported its financial results for the year ending December 31, 2025, highlighting a cash position of $8.2 million and an additional $6.5 million raised in January 2026. The company emphasized strong Phase 2a clinical data for GRI-0621 in idiopathic pulmonary fibrosis and ongoing development of GRI-0803 for autoimmune diseases. Despite a net loss of $12 million, GRI Bio aims to fund operations into Q1 2027.

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GRI
Jan 29, 2026
GRIPhases
▼ -19.2%on this news· ran to -37% by day 3

GRI Bio Delivers Compelling New Phase 2a Gene Expression Data Demonstrating Improvements in Key Drivers of Fibrosis and Lung Repair in IPF

GRI Bio announced promising results from its Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF). The new RNA-sequencing data indicates significant improvements in gene expression linked to lung injury and fibrosis repair. These findings suggest GRI-0621 may offer a novel approach to treating IPF by promoting lung regeneration rather than merely managing symptoms.

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GRI
Jan 27, 2026
GRIFDA Updates

GRI Bio Secures New U.S. Composition of Matter Patent Covering Novel Compound Structures

GRI Bio has been granted a new U.S. patent for novel compound structures that enhance its immunomodulator platform. This patent strengthens the company's intellectual property and supports its development of therapies for inflammatory, fibrotic, and autoimmune diseases. GRI Bio is focused on advancing its lead program, GRI-0621, which targets idiopathic pulmonary fibrosis.

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GRI
Jan 21, 2026
GRIGeneral

GRI Bio Announces Reverse Stock Split

GRI Bio, Inc. has announced a 1-for-28 reverse stock split approved by its board of directors and stockholders. This move is intended to increase the trading price of GRI's common stock, helping the company to regain compliance with Nasdaq listing requirements. The reverse split will take effect on January 23, 2026, and will reduce the number of outstanding shares from approximately 15 million to around 536,000. GRI Bio continues to focus on developing therapies for inflammatory, fibrotic, and autoimmune diseases.

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GRI
Jan 8, 2026
GRIPhases

GRI Bio Announces Additional Positive Data from Phase 2a Study in Idiopathic Pulmonary Fibrosis, Strengthening Clinical Proof-of-Concept for GRI-0621

GRI Bio has announced additional positive findings from its Phase 2a study of GRI-0621, aimed at treating Idiopathic Pulmonary Fibrosis (IPF). The new immune profiling data indicates a positive immunomodulatory effect and improvement in lung function. The treatment demonstrated a differentiated safety profile and met both primary and secondary endpoints, suggesting its potential as a disease-modifying therapy. This data reinforces the clinical proof-of-concept for GRI-0621, emphasizing its effectiveness in targeting the underlying mechanisms of IPF.

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About GRI Bio, Inc.

La Jolla, CA 5 employees gribio.com
Headquarters2223 AVENIDA DE LA PLAYA, LA JOLLA, CA, 92037
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