Welcome to our dedicated page for Kala Pharmaceuticals news (Ticker: KALA), a resource for investors and traders seeking the latest updates and insights on Kala Pharmaceuticals stock.
Kala Pharmaceuticals Inc (NASDAQ: KALA) is a clinical-stage biopharmaceutical company pioneering novel therapies for severe ocular diseases through its proprietary MSC-S platform and nanoparticle drug formulations. This page provides authorized updates on KALA's clinical developments, regulatory milestones, and research advancements.
Investors and researchers will find verified press releases covering Phase 2/3 trial progress for lead candidate KPI-012 in PCED treatment, FDA designations for rare disease therapies, and peer-reviewed study publications. All content is curated to meet strict journalistic standards for accuracy in biopharmaceutical reporting.
The news archive includes updates on corneal healing therapies, retinal disorder research collaborations, intellectual property developments, and scientific conference presentations. Content is organized chronologically with clear sourcing to enable efficient tracking of the company's progress in ocular regenerative medicine.
Bookmark this page for direct access to Kala Pharmaceuticals' official announcements, including trial enrollment updates, partnership disclosures with academic institutions, and manufacturing scale-up progress. Check regularly for the latest validated information on this innovative developer of first-in-class ocular biologics.
KALA BIO (NASDAQ:KALA) has completed enrollment in its CHASE Phase 2b clinical trial for KPI-012, a treatment for persistent corneal epithelial defect (PCED). The trial enrolled 79 patients across 37 sites in the US and Latin America, evaluating two doses of KPI-012 ophthalmic solution versus vehicle control.
The study aims to assess the safety and efficacy of KPI-012, a human mesenchymal stem cell secretome (MCS-S), with topline results expected by Q3 2025. If successful, the CHASE trial could potentially serve as a pivotal trial for a Biologics License Application (BLA). The treatment targets an estimated 100,000 PCED patients in the US, addressing an unmet need as there are currently no FDA-approved products for all PCED etiologies.
[ "KPI-012 has received both Orphan Drug and Fast Track designations from FDA", "Trial could potentially serve as pivotal study for BLA submission", "Addresses large market opportunity of 100,000 PCED patients in US", "Successfully completed enrollment with 79 patients across 37 sites" ]KALA BIO (NASDAQ:KALA) has announced a virtual Key Opinion Leader (KOL) event scheduled for July 16, 2025, at 4:00 p.m. ET. The event will focus on KPI-012, their investigational treatment for persistent corneal epithelial defect (PCED).
The webcast will feature presentations from distinguished ophthalmology experts including Dr. Francis Mah from Scripps Clinic, Dr. Anthony Aldave from Jules Stein Eye Institute, Dr. Stephen Pflugfelder from Baylor College of Medicine, and Dr. Melissa Toyos from Toyos Clinic. The discussion will cover PCED disease overview, unmet needs, and insights into the CHASE clinical trial. Todd Bazemore, interim CEO, will discuss KPI-012's commercial potential and upcoming milestones.
KALA BIO (NASDAQ: KALA), a clinical-stage biopharmaceutical company focused on developing innovative eye disease therapies, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The company's management will deliver a presentation on Thursday, June 5, 2025, at 1:25 p.m. ET in New York, NY. Additionally, the management team will be available for one-on-one meetings throughout the day. Interested parties can access the webcast and subsequent recording through the "Presentations" section on KALA's website at www.kalarx.com.
KALA BIO reported its Q4 and full year 2024 financial results, highlighting progress in its Phase 2b CHASE trial of KPI-012 for Persistent Corneal Epithelial Defect (PCED). The company has randomized 87 patients and expects topline data in Q3 2025.
Key financial highlights include:
- Raised $10.75 million in private placement financing
- Cash position of $51.2 million as of December 31, 2024
- Q4 2024 net loss of $8.2 million ($1.74 per share)
- Full year 2024 net loss of $38.5 million ($10.15 per share)
The company's cash runway extends into Q1 2026. KALA's lead product candidate, KPI-012, targets PCED, which affects approximately 100,000 patients in the U.S. The CHASE trial could potentially serve as the first of two pivotal studies required for FDA approval.
KALA BIO (NASDAQ: KALA), a clinical-stage biopharmaceutical company focused on developing innovative eye disease therapies, has announced its participation in the TD Cowen 45th Annual Health Care Conference. The presentation is scheduled for March 5, 2025, at 11:50 a.m. ET in Boston, MA.
The company's management team will deliver the presentation and will be available for one-on-one meetings throughout the day. Interested parties can access the webcast and subsequent recording through the 'Presentations' section on www.kalarx.com.
KALA BIO (NASDAQ:KALA) announced a leadership transition with CEO Mark Iwicki stepping down and Todd Bazemore, the company's President and Chief Operating Officer, appointed as interim CEO, effective immediately. Iwicki will continue as Chair of the Board of Directors.
Bazemore, who has served as KALA's President since December 2021 and COO since November 2017, brings over 30 years of experience in the pharmaceutical industry. The transition comes as the company approaches topline data from its Phase 2b clinical trial of KPI-012 for PCED (Persistent Corneal Epithelial Defect) in the second quarter of 2025.
Prior to KALA, Bazemore held executive positions at Santhera Pharmaceuticals, Dyax Corp, and Sunovion Pharmaceuticals. The company continues to focus on developing innovative therapies for rare and severe eye diseases using its MSC-S platform.
KALA BIO has secured a $10.75 million private placement through the sale of common stock and Series I Convertible Non-Redeemable Preferred Stock to institutional investors, including SR One, Cormorant Asset Management, and Woodline Partners. The company will sell 1,340,603 common shares at $6.44 per share and 3,286 preferred shares at $644.00 per share.
The funding, expected to close by December 31, 2024, will extend KALA's operations into Q1 2026. Proceeds will support the clinical development of KPI-012 for persistent corneal epithelial defect. The CHASE trial has achieved over 80% enrollment across 40+ clinical sites, with topline data expected in Q2 2025.
KALA BIO (NASDAQ:KALA) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York. Kim Brazzell, Ph.D., Head of R&D and Chief Medical Officer, will deliver a presentation on December 4, 2024, at 11:30 a.m. ET. The company, which focuses on developing innovative therapies for rare and severe eye diseases, will also be available for one-on-one meetings during the conference. A webcast of the presentation will be accessible through the 'Presentations' section on KALA's website.
KALA BIO reported Q3 2024 financial results and provided updates on its Phase 2b CHASE trial of KPI-012 for Persistent Corneal Epithelial Defect (PCED). The company reported cash and equivalents of $49.2 million as of September 30, 2024, expecting to fund operations into Q4 2025. Q3 net loss was $9.0 million ($1.93 per share), compared to $8.7 million in Q3 2023. The company initiated five clinical trial sites in Argentina and expects topline results from the CHASE trial in Q2 2025. KPI-012 aims to be a first-in-class treatment for PCED, targeting an estimated U.S. market of 100,000 patients.
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