Welcome to our dedicated page for KALA BIO news (Ticker: KALA), a resource for investors and traders seeking the latest updates and insights on KALA BIO stock.
KALA BIO, Inc. (Nasdaq: KALA) is a clinical-stage biopharmaceutical company that specializes in the development and commercialization of innovative therapies for rare and severe eye diseases. Leveraging its proprietary mesenchymal stem cell secretome (MSC-S) platform, KALA is pioneering treatments that aim to address significant unmet medical needs.
The company's lead product candidate, KPI-012, is a human MSC-S with numerous biofactors, such as growth factors, protease inhibitors, matrix proteins, and neurotrophic factors, aimed at correcting impaired corneal healing. Currently in Phase 2b clinical development for the treatment of persistent corneal epithelial defect (PCED), KPI-012 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration.
KALA BIO is also exploring the potential of KPI-012 for additional rare, front-of-the-eye diseases, such as Limbal Stem Cell Deficiency. Beyond KPI-012, the company has initiated preclinical studies for KPI-014, targeting inherited retinal degenerative diseases like Retinitis Pigmentosa and Stargardt Disease.
Recent corporate updates show substantial progress, including a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the KPI-012 program. Financially, the company reported having $56.1 million in cash and equivalents as of September 30, 2023, with resources expected to fund operations into 2025.
For more information, please visit www.kalarx.com.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) announced that Express Scripts has added EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% to its National Preferred Formularies, effective February 5, 2021. EYSUVIS is the first therapy approved for the short-term treatment of dry eye disease symptoms. This addition is seen as a milestone to enhance patient access to treatment. EYSUVIS, approved in October 2020, utilizes proprietary AMPPLIFY Drug Delivery Technology for improved efficacy. The company plans to further increase formulary coverage in upcoming months.
Kala Pharmaceuticals, Inc. (NASDAQ: KALA) announced the grant of non-statutory stock options to two new employees as inducement awards outside the Company’s 2017 Equity Incentive Plan. A total of 8,000 stock options were granted on January 15, 2021, at an exercise price of $7.49 per share. The options have a ten-year term and vest over four years, with 25% vesting at the first anniversary of employment. This move complies with NASDAQ Listing Rule 5635(c)(4) and aims to incentivize new hires as they join Kala Pharmaceuticals.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) has launched EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, approved for the short-term treatment of dry eye disease. It is now available in U.S. pharmacies. The company has expanded its ophthalmology sales force to 91 professionals and aims for 125 by 2021, pending COVID-19 conditions. With approximately $153.5 million in cash as of December 31, 2020, Kala expects to fund operations through 2022, leveraging EYSUVIS sales for financial stability.
Kala Pharmaceuticals (NASDAQ: KALA) will participate in two investor conferences in January 2021. Mark Iwicki, Chairman and CEO, is set to present at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 9:10 a.m. ET. He will also have a pre-recorded fireside chat at the H.C. Wainwright BioConnect Conference, available on the Kala website starting January 11, 2021, at 6:00 a.m. ET. Kala focuses on innovative therapies for eye diseases, with products like EYSUVIS™ and INVELTYS®.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) has granted non-statutory stock options to 46 new employees, totaling 233,500 shares, as inducement awards outside its 2017 Equity Incentive Plan. The options were issued on December 15, 2020, with an exercise price of $7.63, corresponding to the closing stock price on that date. Vesting occurs over four years, with 25% vesting on the first anniversary and the remainder monthly thereafter. This grant aligns with NASDAQ Listing Rule 5635(c)(4) and supports the firm's commitment to attract talent in the biopharmaceutical sector focused on ocular therapies.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) has granted non-statutory stock options to four new employees as inducement awards outside its 2017 Equity Incentive Plan, following NASDAQ Listing Rule 5635(c)(4). A total of 34,500 stock options were granted on November 13, 2020, with an exercise price of $7.42 per share, matching the closing stock price on that date. The options vest over four years, with 25% vesting on the first anniversary and the remainder in monthly installments, contingent on continued employment.
Kala Pharmaceuticals (NASDAQ:KALA) is preparing to launch EYSUVIS, an ophthalmic suspension for treating dry eye disease, with plans to begin shipping by mid-December. The company has expanded its sales force, targeting 125 representatives by 2021. EYSUVIS, approved by the FDA on October 26, 2020, will retail at a wholesale acquisition cost of $465 per 10 mL bottle. With $159.1 million in cash as of September 30, 2020, Kala anticipates its financial position will support operations at least until Q3 2022.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) will present at the Jefferies 2020 Virtual London Healthcare Conference on November 17, 2020, at 2:05 p.m. GMT. CEO Mark Iwicki will participate in a fireside chat, highlighting the company's innovative therapies for eye diseases. Notable products include EYSUVIS™, approved in October 2020 for treating dry eye disease, and INVELTYS®, launched in January 2019 for post-operative inflammation.
Access the live webcast and recordings on the Kala website under the 'Investors' section.
Kala Pharmaceuticals, Inc. (NASDAQ:KALA) has announced it will report its third quarter 2020 financial results on November 5, 2020. The conference call will take place at 8:00 a.m. ET, where management will discuss financial results and business updates. Kala is noted for its AMPPLIFY® Drug Delivery Technology, which led to the recent approval of EYSUVIS™ for dry eye disease and the launch of INVELTYS® for post-operative inflammation. Investors can access the call via dial-in or the company's website.
Kala Pharmaceuticals (NASDAQ: KALA) announced FDA approval for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, marking it as the first prescription therapy for short-term treatment of dry eye disease. This innovative therapy utilizes Kala's AMPPLIFY Drug Delivery Technology to enhance the drug's effectiveness. EYSUVIS is set to launch in the U.S. by year-end, aiming to address the significant unmet needs of approximately 80% of patients experiencing episodic dry eye flares. The FDA's approval is based on substantial clinical trial results demonstrating rapid relief from symptoms.
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