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 BIO, Inc. develops a dual strategy that combines a clinical-stage biologics pipeline for rare and severe eye diseases with an on-premises artificial intelligence infrastructure platform for biotechnology and pharmaceutical clients. Company updates cover the MSC-S platform, the KPI-012 clinical program, Researgency.ai, and the Bionic Intelligence Research Agent for secure research, clinical, regulatory, and data-workflow applications.
News also addresses capital-structure actions and corporate-status developments, including registered equity offerings, debt settlement, Nasdaq listing matters, governance changes, and the completed 1-for-50 reverse stock split of KALA common stock.
KALA BIO (NASDAQ:KALA) entered a $6.0 million securities purchase agreement with investor David E. Lazar on Dec 1, 2025, receiving $1.8 million at the first closing and issuing non-voting convertible Series AA preferred stock. Effective immediately, Mr. Lazar was appointed CEO and Chairman; former CEO Todd Bazemore remains on the board. The company previously announced on Sept 29, 2025 that its CHASE Phase 2b trial of KPI-012 failed the primary endpoint and key secondaries, prompting a temporary development pause. KALA plans to redevelop candidates and pursue a potential strategic transaction; the $4.2 million second closing requires stockholder approval expected in Q1 2026.
KALA BIO (NASDAQ:KALA) announced that its CHASE Phase 2b clinical trial evaluating KPI-012 for persistent corneal epithelial defect (PCED) treatment has failed to meet its primary endpoint of complete PCED healing at Week 8. The trial also did not achieve statistical significance for key secondary efficacy endpoints, showing no meaningful difference between KPI-012 treatment arms and placebo.
As a result, KALA will cease development of KPI-012 and its mesenchymal stem cell secretome (MSC-S) platform. The company plans to preserve cash through workforce reduction and other cost-saving measures while evaluating strategic options and engaging in discussions with its secured lender.
KALA BIO (NASDAQ:KALA), a clinical-stage biopharmaceutical company focused on developing innovative eye disease treatments, will participate in the H.C. Wainwright 27th Annual Global Investment Conference. The presentation is scheduled for September 10, 2025, at 2:00 p.m. ET in New York. Management will also be available for one-on-one meetings during the conference.
Investors can access the webcast and recording through the "Presentations" section on www.kalarx.com.
KALA BIO (NASDAQ:KALA) has appointed Todd Bazemore as permanent President, CEO, and Board Director, following his interim CEO role since February 2025. Bazemore, who previously served as the company's President and COO, brings over 30 years of biopharmaceutical industry experience, particularly in rare diseases.
The appointment comes at a crucial time as KALA approaches the readout of its Phase 2b CHASE trial of KPI-012 for persistent corneal epithelial defect (PCED). The company is positioning itself for a potential transition from clinical-stage to a commercial organization, leveraging its mesenchymal stem cell secretome (MSC-S) platform for rare and severe ocular diseases.
KALA BIO (NASDAQ:KALA) reported Q2 2025 financial results and provided updates on its clinical programs. The company completed enrollment for its Phase 2b CHASE trial of KPI-012 for Persistent Corneal Epithelial Defect (PCED), with topline data expected by end of September 2025. The trial enrolled 79 patients across 37 sites in the US and Latin America.
The company's cash position stands at $31.9 million as of June 30, 2025, expected to fund operations into Q1 2026. Q2 2025 resulted in a net loss of $11.2 million ($1.71 per share), compared to $9.6 million ($3.16 per share) in Q2 2024. The CHASE trial could potentially serve as a pivotal trial for BLA submission, subject to positive results and regulatory discussions.
KALA BIO (NASDAQ:KALA), a clinical-stage biopharmaceutical company focused on developing innovative eye disease therapies, will participate in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference on August 13, 2025.
The company's management will deliver a pre-recorded presentation available from 7:00 a.m. ET and participate in a panel discussion on "Novel Treatments for Front-of-the-Eye Indications" at 1:00 p.m. ET. One-on-one meetings with management will be available throughout the conference.
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.