Oyster Point Pharma, Inc. - OYST STOCK NEWS

Oyster Point Pharma (Nasdaq: OYST) will announce its second quarter 2021 financial results on August 5, 2021, after market close. A conference call and audio webcast will follow at 4:30 p.m. Eastern Time. The company's lead program, OC-01 (varenicline) nasal spray, is under review by the FDA, with a PDUFA action date set for October 17, 2021. If approved, the product is expected to launch in Q4 2021. Dry eye disease affects over 30 million people in the U.S., highlighting a significant market opportunity for effective therapies.

Oyster Point Pharma (Nasdaq: OYST) announced the grant of non-qualified stock options for 93,600 shares to 58 new employees under the 2021 Inducement Incentive Plan. The exercise price is set at $14.11 per share, aligning with the closing price on the grant date. Options will vest over four years, with 25% vesting after the first anniversary. This action follows NASDAQ Listing Rule 5635(c)(4), aimed at incentivizing new hires.

The company is focused on developing innovative ophthalmic therapies, including its lead product OC-01 nasal spray for dry eye disease and neurotrophic keratopathy, with FDA action expected by October 17, 2021.

Oyster Point Pharma announced the appointment of Donald Santel as the new non-executive Chairperson of the Board of Directors, effective July 30, 2021. He succeeds Ali Behbahani, M.D., who remains a Director. Santel brings extensive pharmaceutical experience, having previously served as CEO of several companies including Hyperion Therapeutics and Adicet Bio. The company is preparing for the potential approval and launch of its lead product, the OC-01 nasal spray, aimed at treating dry eye disease. The FDA's target action date for the New Drug Application is October 17, 2021.

Oyster Point Pharma (Nasdaq: OYST) announced promising preclinical data indicating that the OC-01 (varenicline) nasal spray effectively inhibits SARS-CoV-2 viral replication in non-human primates. Key findings include a significant reduction in subgenomic RNA levels, suggesting potential effectiveness against infection and transmission. In vitro studies showed that both OC-01 and OC-02 (simpinicline) exhibit antiviral activity against various SARS-CoV-2 variants. The FDA's target action date for OC-01 is October 17, 2021, with potential market launch in Q4 2021 if approved.

Oyster Point Pharma (OYST) announced that its OC-01 (varenicline) nasal spray remains free of impurities amid an unrelated manufacturer's recall of varenicline oral tablets. The company tested multiple samples of the active pharmaceutical ingredient and finished product, confirming no detectable nitrosamine levels. The FDA's target action date for OC-01 is October 17, 2021, with a potential U.S. launch in Q4 2021, contingent on approval. OC-01 is being developed to treat dry eye disease and is currently an investigational new drug.

Oyster Point Pharma (Nasdaq: OYST) will participate in the virtual LifeSci Partners Genetic Medicines Summit on June 22, 2021, at 2:00 p.m. ET. The event aims to showcase the company's innovative approaches to treating ophthalmic diseases. Interested parties can access the live webcast through the 'Investors and News' section of their website. As a clinical-stage biopharmaceutical firm, Oyster Point Pharma is dedicated to the discovery and commercialization of first-in-class therapies targeted at ophthalmic conditions.

Oyster Point Pharma (Nasdaq: OYST) has announced the enrollment of the first subject in the OLYMPIA Phase 2 clinical trial for OC-01 (varenicline) nasal spray, aimed at treating Stage 1 Neurotrophic Keratopathy (NK). This multicenter, randomized trial will assess safety and efficacy in approximately 100 subjects across 18 sites. The primary endpoint is complete resolution of fluorescein corneal staining at Day 56. NK affects many patients, and OC-01 may activate natural tear production, potentially improving corneal health.

Oyster Point Pharma (Nasdaq: OYST) announces a collaboration with Adaptive Phage Therapeutics (APT) to utilize APT's PhageBank™ technology for developing treatments for ophthalmic diseases. This partnership aims to create novel therapies that address antibiotic resistance in ocular infections. Oyster Point Pharma has the option to license APT's technology and will discuss this at its Analyst Day on July 15, 2021. The FDA's PDUFA target action date for Oyster Point's lead product, OC-01 nasal spray, is set for October 17, 2021.

Oyster Point Pharma (Nasdaq: OYST) has introduced its proprietary Enriched Tear Film (ETF™) Gene Therapy along with the first gene candidate, OC-101, aimed at treating Stages 2 and 3 Neurotrophic Keratopathy (NK). A 42-day proof-of-concept study showed that a single injection of OC-101 significantly increased nerve growth factor (NGF) in tear film, beginning as early as Day 7. The study also indicated that the nasal spray OC-01 could enhance NGF levels. Safety results showed no adverse findings. The company plans to present these findings on July 15, 2021.