Kala Pharmaceuticals Announces Update to KPI-121 0.25% Development Plan
Kala Pharmaceuticals, Inc. (KALA)
Last kala pharmaceuticals, inc. earnings: 2/12 07:00 am
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Source: Business Wire
– Expects to submit NDA for KPI-121 0.25% in the second half of 2018 – – Expects to initiate Phase 3 STRIDE 3 trial in the third quarter of 2018 – WALTHAM, Mass.--(BUSINESS WIRE)-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), today provided an update on the development plan for KPI-121 0.25%, which if approved could be the first FDA-approved product for the short-term treatment of dry eye disease. The Company announced that it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018. The NDA will include data from three clinical trials studying approximately 2000 patients, including one Phase 2 trial and two Phase 3 efficacy and safety trials. In addition, based upon the recommendation of the FDA, Kala plans to initiate an additional Phase 3 clinical trial evaluating KPI-121 0.25% for the temporary relief of the s
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KALA
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KALA
Earnings
- 3/29/24 - Beat
KALA
Sec Filings
- 3/29/24 - Form 424B5
- 3/29/24 - Form S-8
- 3/29/24 - Form 10-K
- KALA's page on the SEC website