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Oyster Point Pharma (Nasdaq: OYST) announced the publication of results from its Phase 3 clinical trial (ONSET-2) for TYRVAYATM Nasal Spray, which treats dry eye disease. The study demonstrated consistent outcomes compared to the ONSET-1 trial, showing significant improvements in tear film production. TYRVAYA is the first FDA-approved cholinergic agonist nasal spray specifically for dry eye disease. The study involved a diverse participant population and measured key outcomes including Schirmer’s Score and Eye Dryness Score.
Oyster Point Pharma (Nasdaq: OYST) will present multiple scientific papers at the American Academy of Ophthalmology Annual Meeting 2021 from November 12-15 in New Orleans, LA. Key highlights include data on TYRVAYATM (varenicline solution) Nasal Spray, recently approved for dry eye disease treatment. Notable presentations will feature studies on OC-01 Nasal Spray from clinical trials ONSET-1 and ONSET-2, exploring age stratifications and clinical outcomes. Dry eye disease affects 38 million people in the U.S., highlighting the urgency of effective therapies.
On November 4, 2021, Oyster Point Pharma (OYST) announced the FDA's approval of TYRVAYA™ Nasal Spray for dry eye disease on October 15, 2021. The company reported $17.9 million in revenue from Ji Xing Pharmaceuticals in Q3 2021, alongside a $5 million milestone payment. Following a completed field force onboarding, the U.S. launch of TYRVAYA commenced on November 1, 2021. Financially, the company reported a net loss of $17.7 million for Q3 2021, an increase from $16.3 million a year earlier. Cash reserves stood at $184.2 million as of September 30, 2021.
Oyster Point Pharma has launched TEAMTyrvaya™, a patient support program aimed at making TYRVAYA™ nasal spray accessible for those with dry eye disease. TYRVAYA is the first FDA-approved nasal spray for dry eye symptoms, allowing patients to pay as little as $0 with eligible insurance. The product is a cholinergic agonist that stimulates tear production and is administered twice daily. Approximately 38 million people in the U.S. suffer from dry eye disease. The spray is available via prescription, with each bottle providing 15 days of treatment.
Oyster Point Pharma (Nasdaq: OYST) announced the availability of TYRVAYA™ Nasal Spray for treating dry eye disease, approved by the FDA on October 15, 2021. This unique nasal spray activates the trigeminal parasympathetic pathway to enhance basal tear production, offering a new option for patients, especially those struggling with traditional eye drops. The company has initiated a patient support program, TEAMTyrvaya, to assist those affected by dry eye disease—an increasing issue impacting 38 million Americans.
Oyster Point Pharma (Nasdaq: OYST) announced its participation at the American Academy of Optometry Annual Meeting 2021, occurring from November 3-6 in Boston, MA. The company will present multiple data from clinical trials focused on its recently FDA-approved product, TYRVAYA™ (varenicline solution) Nasal Spray, designed to treat dry eye disease. Presentations will cover efficacy, treatment outcomes, and safety assessments related to TYRVAYA. Dry eye disease affects approximately 38 million individuals in the U.S., highlighting the importance of innovative treatments in this growing market.
Oyster Point Pharma (Nasdaq: OYST) will announce its third quarter 2021 financial results on November 4, 2021, after market close. Following this announcement, a live audio webcast and conference call will occur at 4:30 p.m. ET. The company recently received FDA-approval for TYRVAYA™ (varenicline solution) Nasal Spray, targeting dry eye disease, impacting approximately 38 million people in the U.S. This approval marks a key milestone in its drug development strategy to address unmet needs in ophthalmic treatment.
Oyster Point Pharma (Nasdaq: OYST) has received FDA approval for TYRVAYA™ (varenicline solution) Nasal Spray 0.03 mg to treat dry eye disease. This innovative nasal spray is the first of its kind, providing an alternative treatment method that activates tear production without irritating the ocular surface. Clinical trials demonstrated significant improvements in tear film production and symptom relief within four weeks. TYRVAYA will be available by prescription in November 2021, supporting the growing need for effective dry eye treatments in the U.S., where over 38 million people are affected.
Oyster Point Pharma, Inc. (Nasdaq: OYST) announced the grant of non-qualified stock options to 110 new employees, totaling 177,000 shares, under the 2021 Inducement Incentive Plan. The exercise price is set at $13.44 per share, coinciding with the closing price on the grant date. The options will vest over four years, contingent upon continued employment. This move aims to enhance talent acquisition and retention, aligning employee interests with company performance. Oyster Point is focused on developing first-in-class therapies for ophthalmic diseases, particularly the OC-01 nasal spray for dry eye disease.
Oyster Point Pharma reported second quarter 2021 results, highlighting a net loss of $22.0 million, or $(0.85) per share, compared to a loss of $15.5 million, or $(0.66) per share, in 2020. The company is preparing for the potential U.S. launch of OC-01 (varenicline) nasal spray by Q4 2021 if approved by the FDA. It has initiated hiring for 150-200 sales representatives and secured a $125 million loan facility with OrbiMed. An exclusive license agreement with Ji Xing Pharmaceuticals will provide $17.5 million upfront and up to $204.8 million in milestones for developing OC-01 and OC-02 in Greater China.