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, 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.
Kala Pharmaceuticals (NASDAQ:KALA) announced on December 17, 2021, the grant of non-statutory stock options to four new employees, totaling 13,500 shares. The options were issued as inducement awards outside the 2017 Equity Incentive Plan and have an exercise price of $1.44 per share, reflecting the stock's closing price on the grant date. Options will vest over four years, with 25% vesting after the first year and the rest in monthly installments, contingent on continued employment.
Kala Pharmaceuticals announced the granting of non-statutory stock options to new employees as inducement awards under Nasdaq Listing Rule 5635(c)(4). A total of 131,500 shares were granted to three new employees following the acquisition of Combangio, including 100,000 shares to Darius Kharabi, the new Chief Business Officer. The options have an exercise price of $2.10 per share and a ten-year term, with vesting over four years. These steps align with the company’s ongoing focus on innovative therapies for eye diseases.
Kala Pharmaceuticals reported $3.1 million in net revenue for Q3 2021, up from a year earlier, with EYSUVIS prescriptions rising by 19% compared to Q2 2021. The company has expanded its pipeline through the acquisition of Combangio, focusing on KPI-012, for treating rare ocular surface diseases. However, the net loss for Q3 2021 was $28.1 million or $0.43 per share, slightly higher than the $27.9 million loss in Q3 2020. The financial outlook expects operational funding through Q2 2023, considering ongoing revenue generation and cost containment strategies.
Kala Pharmaceuticals has acquired Combangio, a clinical-stage company, to enhance its pipeline for severe ocular surface diseases. The acquisition includes KPI-012, a promising therapy for persistent corneal epithelial defect (PCED). The Phase 1b trial showed positive results, with six out of eight patients achieving complete healing. Kala plans to submit an IND application to the FDA and initiate a Phase 2/3 trial in 3Q 2022. Mark S. Blumenkranz joins Kala's Board of Directors as part of this strategic move, expected to strengthen its offerings in eye health.
