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) closed a registered direct offering on Dec 5, 2025, selling 10,000,000 shares (or pre-funded warrants) at $1.00 per share, generating approximately $10 million in gross proceeds before fees.
The offering was priced at-the-market under Nasdaq rules, used a shelf registration (File No. 333-270263 declared effective May 11, 2023), and named H.C. Wainwright & Co. as exclusive placement agent. The company intends to use net proceeds to repay certain indebtedness and for general corporate purposes. Prospectus materials are available on the SEC website.
KALA BIO (NASDAQ:KALA) entered definitive agreements for a registered direct offering of 10,000,000 shares (or pre-funded warrants) at $1.00 per share, expected to close on or about December 5, 2025. Gross proceeds are expected to be approximately $10 million before placement agent fees and offering expenses. H.C. Wainwright & Co. is the exclusive placement agent. The company intends to use net proceeds to repay certain indebtedness and for general corporate purposes. The securities are offered under a shelf registration (File No. 333-270263) declared effective May 11, 2023; offering materials will be filed with the SEC and available on the SEC website.
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.