KALA BIO (KALA) FDA Approvals $2.17 -0.06 (-2.69%) As of 12:53 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock KALA BIO's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by KALA BIO (KALA). Over the past two years, KALA BIO has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as KPI-012. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. KPI-012 FDA Regulatory Timeline and Events KPI-012 is a drug developed by KALA BIO for the following indication: Clinical diagnosis of PCED. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Endpoint Missed - September 29,2025Endpoint Missed Phase 2bDrug: KPI-012Announced Date: September 29, 2025Indication: Clinical diagnosis of PCEDAnnouncementKALA BIO, Inc. announced that its CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect (PCED) did not meet the primary endpoint of complete healing of PCED as measured by corneal fluorescein staining.Read AnnouncementTop-line results - July 9,2025Top-Line Results Drug: KPI-012Announced Date: July 9, 2025Target Action Date: Q3 2025Estimated Target Date Range: July 1, 2025 - September 30, 2025Indication: Clinical diagnosis of PCEDAnnouncementKALA BIO, Inc. announced that Topline results from the CHASE trial expected by end of Q3 2025 --AI SummaryKALA BIO, Inc. recently announced that it has completed patient enrollment in its CHASE Phase 2b clinical trial, which is testing KPI-012 for treating persistent corneal epithelial defect (PCED). The company expects to report topline data by the end of the third quarter of 2025. These results are critical because, if positive, the trial could become a pivotal study used to support a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The CHASE trial is conducted across multiple centers in the United States and Latin America, and it compares two doses of KPI-012 against a placebo over a 56-day period. KALA BIO aims to address the significant unmet need for an effective PCED treatment by potentially offering a product that covers all underlying causes of the condition.Read AnnouncementEnrollment Completion - July 9,2025Enrollment Completion Drug: KPI-012Announced Date: July 9, 2025Indication: Clinical diagnosis of PCEDAnnouncementKALA BIO, Inc. announced the completion of patient enrollment in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for the treatment of persistent corneal epithelial defect (PCED).AI SummaryKALA BIO, Inc. announced that patient enrollment is now complete for its CHASE Phase 2b clinical trial. This study is testing KPI-012, a human mesenchymal stem cell secretome therapy, as a new treatment for persistent corneal epithelial defect (PCED). The multicenter, randomized, double-masked, vehicle-controlled trial will compare two doses of KPI-012 with a vehicle treatment, enrolling patients from 37 sites in the United States and Latin America. The primary goal is to assess safety and effectiveness by measuring complete healing of PCED through corneal fluorescein staining. Topline results are expected by the end of Q3 2025. If the outcomes are positive, this trial could be pivotal in supporting a Biologics License Application submission to the U.S. Food and Drug Administration, offering a much-needed treatment option for the approximately 100,000 U.S. patients with PCED.Read AnnouncementProvided Update - July 7,2025Provided Update Drug: KPI-012Announced Date: July 7, 2025Indication: Clinical diagnosis of PCEDAnnouncementKALA BIO, Inc. announced that the Company will host a webcast event with Key Opinion Leaders (KOLs) to discuss the potential of KPI-012 for the treatment of persistent corneal epithelial defect (PCED).AI SummaryKALA BIO, Inc. announced it will host a webcast event on July 16, 2025, at 4:00 p.m. ET featuring Key Opinion Leaders (KOLs) in the field of ophthalmology. The event will center on the potential of KPI-012, the company’s lead product candidate, for treating persistent corneal epithelial defect (PCED), a rare condition where the cornea fails to heal properly. During the webcast, experts will discuss the challenges patients face with PCED and explore how KPI-012, derived from a mesenchymal stem cell secretome (MSC-S), could offer a new solution. Todd Bazemore, the interim CEO and President, will also review the commercial prospects and upcoming milestones of KPI-012. The presentation will include a Q&A session, allowing participants to engage directly with the specialists. Further details and registration information are available on the KALA BIO website.Read Announcement KALA BIO FDA Events - Frequently Asked Questions Has KALA BIO received FDA approval? As of now, KALA BIO (KALA) has not received any FDA approvals for its therapy in the last two years. What drugs has KALA BIO submitted to the FDA? In the past two years, KALA BIO (KALA) has reported FDA regulatory activity for KPI-012. What is the most recent FDA event for KALA BIO? The most recent FDA-related event for KALA BIO occurred on September 29, 2025, involving KPI-012. The update was categorized as "Endpoint Missed," with the company reporting: "KALA BIO, Inc. announced that its CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect (PCED) did not meet the primary endpoint of complete healing of PCED as measured by corneal fluorescein staining." What conditions do KALA BIO's current drugs treat? Currently, KALA BIO has one therapy (KPI-012) targeting the following condition: Clinical diagnosis of PCED. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events BioCardia FDA EventsClimb Bio FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsFate Therapeutics FDA EventsGH Research FDA EventsIncyte FDA EventsJazz Pharmaceuticals FDA EventsLyell Immunopharma FDA EventsMoleculin Biotech FDA EventsMirum Pharmaceuticals FDA EventsNextCure FDA EventsPharming Group FDA EventsRegeneron Pharmaceuticals FDA EventsTravere Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Turn Therapeutics FDA Events NRx Pharmaceuticals FDA Events TuHURA Biosciences FDA Events Assertio FDA Events Connect Biopharma FDA Events Corbus Pharmaceuticals FDA Events Spruce Biosciences FDA Events Black Diamond Therapeutics FDA Events Cardiff Oncology FDA Events vTv Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:KALA last updated on 9/29/2025 by MarketBeat.com Staff. 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Endpoint Missed - September 29,2025Endpoint Missed Phase 2bDrug: KPI-012Announced Date: September 29, 2025Indication: Clinical diagnosis of PCEDAnnouncementKALA BIO, Inc. announced that its CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial of KPI-012 for the treatment of persistent corneal epithelial defect (PCED) did not meet the primary endpoint of complete healing of PCED as measured by corneal fluorescein staining.Read Announcement
Top-line results - July 9,2025Top-Line Results Drug: KPI-012Announced Date: July 9, 2025Target Action Date: Q3 2025Estimated Target Date Range: July 1, 2025 - September 30, 2025Indication: Clinical diagnosis of PCEDAnnouncementKALA BIO, Inc. announced that Topline results from the CHASE trial expected by end of Q3 2025 --AI SummaryKALA BIO, Inc. recently announced that it has completed patient enrollment in its CHASE Phase 2b clinical trial, which is testing KPI-012 for treating persistent corneal epithelial defect (PCED). The company expects to report topline data by the end of the third quarter of 2025. These results are critical because, if positive, the trial could become a pivotal study used to support a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The CHASE trial is conducted across multiple centers in the United States and Latin America, and it compares two doses of KPI-012 against a placebo over a 56-day period. KALA BIO aims to address the significant unmet need for an effective PCED treatment by potentially offering a product that covers all underlying causes of the condition.Read Announcement
Enrollment Completion - July 9,2025Enrollment Completion Drug: KPI-012Announced Date: July 9, 2025Indication: Clinical diagnosis of PCEDAnnouncementKALA BIO, Inc. announced the completion of patient enrollment in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for the treatment of persistent corneal epithelial defect (PCED).AI SummaryKALA BIO, Inc. announced that patient enrollment is now complete for its CHASE Phase 2b clinical trial. This study is testing KPI-012, a human mesenchymal stem cell secretome therapy, as a new treatment for persistent corneal epithelial defect (PCED). The multicenter, randomized, double-masked, vehicle-controlled trial will compare two doses of KPI-012 with a vehicle treatment, enrolling patients from 37 sites in the United States and Latin America. The primary goal is to assess safety and effectiveness by measuring complete healing of PCED through corneal fluorescein staining. Topline results are expected by the end of Q3 2025. If the outcomes are positive, this trial could be pivotal in supporting a Biologics License Application submission to the U.S. Food and Drug Administration, offering a much-needed treatment option for the approximately 100,000 U.S. patients with PCED.Read Announcement
Provided Update - July 7,2025Provided Update Drug: KPI-012Announced Date: July 7, 2025Indication: Clinical diagnosis of PCEDAnnouncementKALA BIO, Inc. announced that the Company will host a webcast event with Key Opinion Leaders (KOLs) to discuss the potential of KPI-012 for the treatment of persistent corneal epithelial defect (PCED).AI SummaryKALA BIO, Inc. announced it will host a webcast event on July 16, 2025, at 4:00 p.m. ET featuring Key Opinion Leaders (KOLs) in the field of ophthalmology. The event will center on the potential of KPI-012, the company’s lead product candidate, for treating persistent corneal epithelial defect (PCED), a rare condition where the cornea fails to heal properly. During the webcast, experts will discuss the challenges patients face with PCED and explore how KPI-012, derived from a mesenchymal stem cell secretome (MSC-S), could offer a new solution. Todd Bazemore, the interim CEO and President, will also review the commercial prospects and upcoming milestones of KPI-012. The presentation will include a Q&A session, allowing participants to engage directly with the specialists. Further details and registration information are available on the KALA BIO website.Read Announcement
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