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 Pharmaceuticals (NASDAQ: KALA) has signed a deal to sell its commercial portfolio, including EYSUVIS and INVELTYS, to Alcon Inc. for $60 million upfront, with additional sales-based milestone payments. This strategic move is aimed at focusing resources on the development of KPI-012, a therapy targeting rare ocular diseases. With this transition, Kala expects a significant reduction in operating expenses, extending its cash runway into Q2 2024. The sale is projected to close in Q3 2022, pending regulatory approvals.
Kala Pharmaceuticals reported Q1 2022 financial results and corporate updates on May 16, 2022. The company achieved 18% growth in EYSUVIS prescriptions and expanded coverage for EYSUVIS to 92% of commercial lives and 30% of Medicare lives. Net product revenues were $1.4 million, a decline from $3.3 million in Q1 2021. Operating loss increased to $30.9 million, with a net loss of $32.9 million, or $0.45 per share. Notably, the company plans to initiate a Phase 2/3 clinical trial for KPI-012 by Q4 2022.
Kala Pharmaceuticals (NASDAQ:KALA) announced it will report its first quarter 2022 financial results on May 16, 2022. A conference call and live audio webcast will follow at 8:00 a.m. ET for discussion of the results and a business update. The public can access the live webcast via the Kala website. The company focuses on innovative eye disease therapies, utilizing its AMPPLIFY® drug delivery technology for products like EYSUVIS® and INVELTYS®. Kala is also advancing its pipeline, including KPI-012 for persistent corneal epithelial defects and new chemical entity programs.
Kala Pharmaceuticals, Inc. (NASDAQ: KALA) announced two major coverage expansions for its product, EYSUVIS. Effective May 1, 2022, the largest Pharmacy Benefit Manager in the U.S. added EYSUVIS to its commercial formularies, increasing total commercial coverage to 155.3 million lives (92% of commercial lives). Additionally, Humana will include EYSUVIS as a Preferred Brand on its Medicare formularies starting June 1, 2022, doubling Medicare coverage to 14.1 million lives (30% of total Medicare lives). These developments aim to enhance prescription fulfillment rates and drive growth.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) announced promising results from its Phase 1b trial of KPI-012, a novel therapy for persistent corneal epithelial defects (PCED). In the study, six out of eight patients (75%) achieved complete healing within four weeks, with all reporting zero pain by week three. KPI-012 was well tolerated, with no significant safety issues. The company plans to file an IND application with the FDA and initiate a Phase 2/3 trial in Q4 2022. This therapy has the potential to address various rare ocular diseases, showcasing its significant therapeutic promise.
Kala Pharmaceuticals (NASDAQ: KALA) announced its presentation of data from a Phase 1b clinical trial of KPI-012 at the 2022 ARVO Annual Meeting in Denver, happening from May 1-4, 2022. The data underscores the potential of KPI-012, a new secretome therapy aimed at treating persistent corneal epithelial defects (PCED). The session will be led by Dr. Valeria Sáanchez-Huerta on May 3, 2022. This presentation supports Kala's ongoing development efforts for innovative ocular therapies, following the successful application of their AMPPLIFY® technology in existing products.
Kala Pharmaceuticals reported $11.2 million in net product revenues for 2021, with $6.3 million from EYSUVIS and $4.9 million from INVELTYS. EYSUVIS prescriptions increased by 21% in Q4 2021. Coverage expanded to 118 million commercial lives and 7.1 million Medicare lives. The company anticipates initiating Phase 2/3 trials for KPI-012 in Q4 2022, following positive clinical results. Despite a significant operating loss of $130.2 million, Kala expects its cash will fund operations through mid-2023.
Kala Pharmaceuticals (NASDAQ:KALA) will announce its fourth quarter and full year 2021 financial results on March 29, 2022. Management will host a conference call at 8:00 a.m. ET to discuss these results and provide a business update. The call can be accessed via domestic and international dial-in numbers or through a live webcast on the company’s website.
Kala focuses on innovative therapies for eye diseases, with products like EYSUVIS® and INVELTYS® using its proprietary AMPPLIFY® drug delivery technology, alongside a pipeline for unmet medical needs.
Kala Pharmaceuticals (NASDAQ:KALA) announced the addition of EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% to UnitedHealthcare's commercial formularies, expanding its coverage to approximately 118 million lives, or 70% of all commercial lives. Cigna Medicare also added EYSUVIS as a preferred brand, increasing its total Medicare coverage to 7.1 million lives, or 15%. EYSUVIS, approved by the FDA in October 2020, is the first FDA-approved treatment for short-term dry eye disease symptoms.
Kala Pharmaceuticals (NASDAQ:KALA) announced the granting of non-statutory stock options to a new employee as an inducement award on February 15, 2022. The options allow the purchase of up to 15,000 shares at an exercise price of $0.77, matching the closing stock price on the grant date. These options have a ten-year term and vest over four years, contingent on the employee's continued service. This move aligns with NASDAQ Listing Rule 5635(c)(4) and is part of the company’s strategy to attract talent to support its growth in innovative ocular therapies.