Oyster Point Pharma, Inc. - OYST STOCK NEWS

Oyster Point Pharma (Nasdaq: OYST) presented data from its Phase 3 ONSET-2 clinical trial of OC-01 (varenicline) nasal spray for dry eye disease at the ARVO 2021 Virtual Annual Meeting. The nasal spray targets the trigeminal parasympathetic pathway to enhance natural tear production. Dry eye disease affects over 30 million in the U.S., indicating a significant unmet need for effective treatments. OC-01 nasal spray remains investigational and has not yet received regulatory approval.

Oyster Point Pharma (Nasdaq: OYST) has scheduled a conference call and webcast for May 6, 2021, at 4:30 p.m. Eastern Time, following the release of its first quarter 2021 financial results. The company specializes in developing innovative treatments for ocular surface diseases, particularly through its lead candidate, OC-01 (varenicline), a nasal spray targeting dry eye disease. This innovative treatment aims to address the significant unmet need for effective therapies in a condition affecting over 30 million Americans.

Oyster Point Pharma announces the appointment of George Eliades, Ph.D., as a new member of its Board of Directors as of April 5, 2021. Dr. Eliades brings extensive experience from Jazz Pharmaceuticals, where he served as Senior Vice President and Chief Transformation Officer. He aims to help Oyster Point transition from a development to a high-growth commercial organization. The company is focused on developing innovative therapies for ocular surface diseases, particularly its lead candidate, OC-01 nasal spray, which targets dry eye disease.

Oyster Point Pharma has announced that the FDA accepted its New Drug Application for OC-01 (varenicline) nasal spray, aimed at treating dry eye disease. The PDUFA target action date is set for October 17, 2021. The FDA has indicated it will not hold an advisory committee meeting regarding the application. The NDA submission was supported by clinical trial data showing significant improvements in tear production and related symptoms among over 1,000 subjects. Successful approval could pave the way for the planned U.S. launch in Q4 2021.

Oyster Point Pharma, a clinical-stage biopharmaceutical company, announced its participation in the 41st Annual Cowen Healthcare Conference on March 2, 2021, at 11:10 a.m. ET. The company focuses on developing innovative therapies for ocular surface diseases, including its lead product candidate, OC-01 (varenicline) nasal spray, aimed at treating dry eye disease. OC-01 activates the trigeminal parasympathetic pathway to enhance natural tear production. This investigational product has yet to be approved.

Oyster Point Pharma announced key developments regarding its OC-01 (varenicline) nasal spray for dry eye disease. The company submitted its New Drug Application (NDA) to the FDA on December 17, 2020, and is tracking for patient enrollment in the OLYMPIA Phase 2 study in early 2021. Positive results from the IMPERIAL Phase 2 study showcased significant clinical efficacy. Financially, by year-end 2020, cash reserves were $192.6 million. However, the company reported a net loss of $22.2 million in Q4 2020, highlighting increased SG&A expenses and ongoing R&D investments.

Oyster Point Pharma (Nasdaq: OYST) will announce its Q4 and full year 2020 financial results on February 18, 2021, after market close. A conference call will follow at 4:30 PM ET. The company focuses on developing OC-01 (varenicline) nasal spray for treating dry eye disease, a condition affecting over 30 million people in the U.S. Despite its potential, OC-01 remains an investigational drug, with safety and efficacy not yet established.

Oyster Point Pharma (Nasdaq: OYST) announced its participation in the virtual 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 10:50 a.m. ET. The conference will facilitate investor meetings and a live webcast is accessible on the Oyster Point Pharma website.

The company is dedicated to developing first-in-class therapies for ocular surface diseases. Its lead candidate, OC-01 nasal spray, aims to treat dry eye disease and utilizes a novel mechanism to stimulate natural tear production.

Oyster Point Pharma has submitted a 505(b)(2) New Drug Application (NDA) to the FDA for OC-01 (varenicline) nasal spray to treat dry eye disease. The NDA is supported by results from three clinical trials involving over 1,000 subjects, demonstrating significant improvements in tear production and symptom relief compared to control. No serious adverse events were reported. The CEO expressed optimism about providing innovative treatments for patients.