Shares of Kala Pharmaceuticals Inc. (KALA) touched a new 52-week high of $12.51 in intraday trading yesterday, before closing at $12.01.
The stock was trading around $6.41 when we alerted readers to it on March 4, 2020 (Stock To Watch: Here’s Why You Need To Keep An Eye On Kala Pharma (KALA)).
The Company resubmitted its New Drug Application to the FDA for EYSUVIS, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease, early this month.
Dry eye disease is a condition in which the eyes do not produce sufficient tears or the tears are of low quality. This can result in tear film instability, inflammation, discomfort, visual disturbance, and ocular surface damage. There are approximately 17 million diagnosed dry eye patients in the U.S., according to Kala Pharma.
Allergan’s Restasis, Novartis’ Xiidra, and Sun Pharma’s Cequa are the FDA-approved treatments for dry eye disease.
Kala Pharma’s EYSUVIS, proposed for dry eye disease, was denied approval last August, and the Company was asked to submit efficacy data from an additional clinical trial then.
The resubmitted NDA includes positive results from an additional trial, which evaluated EYSUVIS for signs and symptoms of dry eye disease. If the resubmitted EYSUVIS NDA is recognized as a Class 2 resubmission by the FDA, a decision can be expected within 6 months.
Kala Pharma has 1 marketed product by the name Inveltys, a twice-daily ocular corticosteroid, for the treatment of postoperative inflammation and pain after ocular surgery.
Launched in January 2019, Inveltys logged in annual sales of $6.1 million last year. For the first quarter ended March 31, 2020, net product revenue relating to sales of Inveltys declined to $1.1 million from $1.4 million in the first quarter of 2019.
With the federal, state, and local governments implementing restrictions on elective procedures, including most ocular surgeries, due to the ongoing COVID-19 pandemic, Inveltys prescriptions and revenue have been adversely impacted beginning in March 2020 and continuing into the second quarter of 2020.
The Company, which ended March 31, 2020, with cash of $196.5 million, received an additional $7.2 million in net proceeds as a result of the partial exercise of the underwriters’ option to purchase additional shares in last month’s public offering.
It is estimated that the current cash resources will be adequate to finance the activities of the Company until at least the second quarter of 2022.
KALA has traded in a range of $3.24 to $12.51 in the last 1 year.
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