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KALA BIO, Inc.

KALA
Pharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$0.36
▼ -0.01 · -3.85%

Financials

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52W LOW $0.3452W HIGH $95.50
Volume
654.43 K
Value Traded
96.32 K
Short % Float
2.4%
-14.16%Week
-33.07%1 Month
-73.33%3 Month
-96.07%6 Month
-99.98%5 Year
-99.99%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
6.96 M
EPS (TTM)
-0.52
P/E Ratio
-
Ent. Value
-266.68 K
Total Shares
19.35 M
Float Shares
18.59 M
Insiders
3.89%
Institutions
3.63%

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.

KALA Catalyst Timeline

Dated clinical, regulatory and corporate events for KALA BIO, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for KALA BIO, Inc.

209Total events
3Upcoming
50Tier-1 (high impact)
2017 to 2026Coverage

Upcoming catalysts 2

T1Partnership / License
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T2Timing Guidance
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Event history 50

▲Partnership / LicenseCorporate
Kala Bio and Virotek sign non-binding LOI with U.S. DNA testing platform to resell Virotek genetic testing products
●Management ChangeCorporate
Yenvy Truong joins KALA BIO advisory team
▲Partnership / LicenseCorporate
Exclusive U.S. distribution and reseller agreement between Kala and Virotek for genetic testing and screening program
ophthalmologysource ↗
▲Partnership / LicenseCorporate
Kala Bio and Virotek announce LOI for exclusive U.S. distribution partnership
▼Reverse Stock SplitCorporate
Reverse stock split at 1-for-50 ratio effective May 8, 2026; trading on split-adjusted basis begins May 11, 2026
▲Other Regulator MilestoneEx-US Regulatory
President Trump signs Executive Order directing FDA to prioritize psychedelic review, DEA to reduce research restrictions, and establishing expanded patient access pathways
▲Product LaunchPost-Market
Initial commercial deployment of Bionic Intelligence Research Agent (BIRA)
◆Product LaunchPost-Market
First commercial AI product expected to ship in approximately 14 days
▲Partnership / LicenseCorporate
Red Light Holland engages Kala Bio's Researgency.ai platform to support PEX010 clinical development
▲Debt Royalty FinancingCorporate
Settlement of approximately $10.6 million debt with Oxford Finance
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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 KALA actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2019-12-31KPI-121 0.25% Phase 3 topline data readout Phase 3
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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

D20 / 100
Pipeline Score
$0M
Pipeline Value
Not rated
Valuation Signal
1
Drugs Scored
-
rNPV / MCap
Top 95%
Micro Cap
(rank 625 of 658)
Percentile Rank
KALA BIO, Inc. faces pipeline headwinds (20/100), with 1 assets in development.
Showing 0 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
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Every scored asset with PTRS, rNPV, enrollment velocity and trial design quality.
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Clinical Trial Results

Readouts, endpoints and source filings for every KALA program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
KPI-012 persistent corneal epithelial defect (PCED)Phase 2b2025-12-01did not meet the primary endpoint; failed to achieve statistical significance for key secondary efficacy endpoints; did not show any meaningful difference between either KPI-012 treatment arm and the placebo armRead MoreKALA BIO Enters Into $6 Million Securities Purchase Agreement with Investor David E. LazarRead 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
Iwicki Mark TDirectorSell -154,894 103,540 held$0.81 10/23/2025
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
BAKER BROS. ADVISORS 0 % 1.00 M 1.80 M 83.14% ( 818.96 K)
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

KALA Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
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Today vs avg

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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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How KALA ranks across every disease it competes in

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

-KALA
Sep 24, 2026
KALAGeneral

Kala Bio and Virotek Sign Letter of Intent with U.S. DNA Testing Platform to Resell Virotek's Suite of Genetic Testing Products

Kala Bio and Virotek have signed a non-binding letter of intent with a U.S. DNA testing platform to resell Virotek's genomic testing products. This partnership aims to expand distribution beyond ophthalmology, with Kala benefiting from a profit-split structure. However, the agreement remains subject to final negotiations and does not guarantee revenue generation.

Read more →
-KALA
Sep 17, 2026
KALAGeneral
▲ +8.2%on this news

KALA BIO Adds Healthcare Operator Yenvy Truong to Advisory Team

KALA BIO, Inc. has appointed Yenvy Truong to its advisory team to support business growth and explore expansion opportunities, including acquisitions. With two decades of experience in healthcare operations, Truong aims to leverage her expertise to identify suitable opportunities for KALA. The company is focused on diagnostics and AI-enhanced health services.

Read more →
-KALA
Sep 3, 2026
KALAGeneral
▲ +7.4%on this news

Kala Bio and Virotek Finalize Definitive Agreement Establishing Exclusive U.S. Distribution Partnership for Ophthalmology Genetic Testing Program

Kala Bio and Virotek have finalized an exclusive distribution agreement for Virotek's ophthalmology genetic testing program in the U.S. This partnership, effective September 4, 2026, allows Kala to market and resell the program while achieving commercial milestones. The agreement also includes a profit-sharing structure and potential for future collaborations in other clinical areas.

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-KALA
Sep 1, 2026
KALAGeneral
▼ -20.9%on this newsshared move

Kala Bio and Virotek Announce Letter of Intent to Establish an Exclusive U.S. Distribution Partnership for Ophthalmology Genetic Testing Program

Kala Bio and Virotek have entered a letter of intent for an exclusive U.S. distribution partnership focused on genetic testing for ophthalmology. Kala will market Virotek's testing program, leveraging its existing relationships in the eye care community. The collaboration may expand into additional clinical areas, subject to future agreements and approvals.

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-KALA
May 7, 2026
KALAGeneral
▼ -27.8%on this news· ran to -46% by day 3

KALA BIO Announces Reverse Stock Split

KALA BIO, Inc. has announced a reverse stock split at a ratio of 1-for-50, effective May 8, 2026. The split is designed to reduce the total number of outstanding shares from approximately 929 million to about 18.5 million. This decision follows stockholder approval granting the Board discretion over the split. Shareholders will not need to exchange certificates as adjustments will be made automatically by brokers.

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-KALA
May 7, 2026
KALAGeneral
▼ -27.8%on this news· ran to -46% by day 3

KALA BIO Announces Reverse Stock Split Stock Will Begin Trading on Split-Adjusted Basis on May 11, 2026

KALA BIO, Inc. announced a reverse stock split of its common stock at a ratio of 1-for-50, effective May 8, 2026. This action will reduce the total number of outstanding shares from approximately 929 million to about 18.6 million. The company's common stock will continue to be listed on the Nasdaq under the ticker KALA. Stockholders are advised that they will not require new certificates, as shares held via brokerage accounts will automatically adjust to the new ratio.

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-KALA
Apr 21, 2026
KALAFDA Updates
▼ -7.4%on this news· ran to -32% by day 3

Kala Bio Celebrates Trump Executive Order as Game-Changer for Psychedelic Medicine

Kala Bio has welcomed a transformative Executive Order signed by President Trump, which prioritizes the review of psychedelic compounds and reduces research restrictions. The initiative also establishes improved patient access pathways under the Right to Try Act and allocates $50 million for psychedelic therapy research. KALA is uniquely positioned to leverage these regulatory advancements through its partnership with Red Light Holland Corp., enhancing the development of psychedelic therapies supported by its AI platform, Researgency.ai. This policy shift marks a significant transition for the integration of psychedelic medicine into mainstream healthcare.

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-KALA
Apr 1, 2026
KALAGeneral
▼ -5.8%on this news

Kala Bio Engages Dr. Saeid Babaei as Senior Scientific Advisor to Evaluate Clinical Assets and Precision Development Opportunities

Kala Bio Inc. has announced the appointment of Dr. Saeid Babaei as Senior Scientific Advisor. His role will focus on the evaluation of Kala's clinical assets using AI-enabled analytics and securing data integration. This collaboration aims to enhance the scientific and commercial value of existing assets, particularly in the MSC secretome space, which is projected to grow significantly in the coming years. The company plans a thorough review of its datasets to identify potential developments and indications for future growth.

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-KALA
Mar 30, 2026
KALAGeneral

KALA BIO Delivers Industry-Leading AI Infrastructure: Bionic Intelligence Research Agent Now Live

KALA BIO has launched the Bionic Intelligence Research Agent (BIRA), an autonomous AI solution for the biotechnology sector. This deployment marks a significant step in KALA's transformation into an AI infrastructure partner. BIRA operates within secure environments, ensuring data sovereignty and compliance with pharmaceutical standards. The platform is designed to enhance research capabilities while maintaining enterprise-grade security.

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-KALA
Mar 18, 2026
KALAGeneral

Red Light Holland Engages Kala Bio’s Researgency.AI Platform to Support Clinical Development of Filament’s Patented PEX010 Botanical Psilocybin Drug Candidate

Red Light Holland has partnered with Kala Bio to utilize its Researgency.ai platform for the clinical development of PEX010, a botanical psilocybin drug candidate. This collaboration aims to enhance research planning and protocol optimization as PEX010 progresses through clinical trials. The drug candidate is being studied for various mental health conditions and has received authorization for clinical trials from both Health Canada and the FDA.

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-KALA
Mar 11, 2026
KALAGeneral
▲ +24.2%on this news

Kala Bio Launches a Revolution for Biotech- First AI Agent Deploying in 14 Days as $180 Billion Agentic AI Healthcare Revolution Accelerates

KALA BIO is set to launch its first commercial AI product through its Researgency.ai platform within the next 14 days. This marks a significant transition from a clinical-stage biotech to a dual-engine growth model that combines its drug pipeline with AI technology for the healthcare industry. The company aims to streamline operations in biotech and pharmaceuticals, addressing complex and time-sensitive processes. However, it faces challenges related to the efficacy of AI technologies and market competition.

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-KALA
Mar 4, 2026
KALAGeneral

KALA BIO Announces Strategic Initiative to Deploy and Continue to Develop an On-Premises AI Infrastructure Platform for the Biotech Industry; Enters Into Platform Development and Exclusive License Agreement for Proprietary AI Research Platform “Researgency”

KALA BIO has launched a strategic initiative to develop an on-premises AI infrastructure platform called Researgency, aimed at serving the biotechnology industry. This platform allows biotech companies to deploy AI capabilities while retaining control of their proprietary data. KALA will initially use the platform for its own datasets before offering it to external clients. The company believes this approach addresses a significant technology adoption gap in the biotech sector.

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-KALA
Jan 5, 2026
KALAGeneral

KALA BIO Settles Approximately $10.6 million of Debt

KALA BIO, Inc. has completed a significant loan settlement with Oxford Finance, resolving approximately $10.6 million of debt obligations. This settlement included a $2 million payment made by KALA, which satisfied both the Settlement Agreement and the underlying Loan Agreement. The CEO highlighted that this milestone enhances the company's strategic flexibility by alleviating financial burdens, creating a more promising outlook for KALA's future. Additionally, KALA has granted stock awards to new employees as part of its ongoing growth initiatives.

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-KALA
Dec 8, 2025
KALAGeneral
▼ -6.9%on this news· ran to -23% by day 3

KALA BIO Announces Closing of $10 Million Registered Direct Offering of Common Stock Priced At-The-Market Under Nasdaq Rules

KALA BIO, Inc. has announced the successful closing of a $10 million registered direct offering of common stock priced at-the-market under Nasdaq rules. The offering involved 10 million shares sold at $1.00 each, with proceeds intended for debt repayment and corporate purposes. H.C. Wainwright & Co. acted as the exclusive placement agent.

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-KALA
Dec 4, 2025
KALAGeneral

KALA BIO Announces $10 Million Registered Direct Offering of Common Stock Priced At-The-Market Under Nasdaq Rules

KALA BIO, Inc. announced a registered direct offering of 10,000,000 shares of common stock priced at $1.00 per share, expected to raise approximately $10 million. The proceeds will be utilized to repay specific debts and for general corporate purposes. The offering is set to close around December 5, 2025, pending customary conditions. This initiative is conducted under SEC regulations, ensuring it adheres to legal standards.

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-KALA
Dec 1, 2025
KALAGeneral
▲ +37.7%on this newsshared move

KALA BIO Enters Into $6 Million Securities Purchase Agreement with Investor David E. Lazar

KALA BIO has entered a $6 million securities purchase agreement with investor David E. Lazar, who will also serve as the new CEO. This investment comes after the company's Phase 2b trial for KPI-012 failed to meet its primary endpoint. Despite this setback, KALA plans to continue evaluating its therapeutic candidates and explore strategic options for growth.

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-KALA
Sep 29, 2025
KALAPhases

KALA BIO Announces Topline Results from CHASE Phase 2b Clinical Trial Evaluating KPI-012 for the Treatment of Persistent Corneal Epithelial Defect (PCED) Did Not Meet Primary Endpoint

KALA BIO announced that its CHASE Phase 2b clinical trial for KPI-012 did not meet its primary endpoint of complete healing of persistent corneal epithelial defect (PCED). The trial also failed to achieve statistical significance for secondary endpoints. As a result, KALA plans to discontinue the development of KPI-012 and explore strategic options to preserve cash.

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-KALA
Sep 3, 2025
KALAConferences/Events

KALA BIO to Present at H.C. Wainwright 27th Annual Global Investment Conference

KALA BIO, a clinical-stage biopharmaceutical company, will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025. The management team will also hold one-on-one meetings with investors. KALA is focused on developing therapies for rare eye diseases and has received FDA designations for its lead product candidate, KPI-012.

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-KALA
Sep 2, 2025
KALAGeneral

KALA BIO Appoints Todd Bazemore as President, Chief Executive Officer and Director

KALA BIO has appointed Todd Bazemore as President and CEO, following his interim role since February 2025. Bazemore's leadership is anticipated to guide the company through a pivotal phase as it approaches a key data readout for its KPI-012 treatment in a Phase 2b trial. The company aims to transition towards commercialization of its innovative therapies for rare eye diseases.

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About KALA BIO, Inc.

Arlington, MA 6 employees kalarx.com
Headquarters1167 MASSACHUSETTS AVENUE, ARLINGTON, MA, 02476
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