|Over a month ago|
Oyster Point Pharma 2.5M share Secondary priced at $28.00 » 05:5905/1505/15/20
The deal size was…
The deal size was increased to 3.75M shares from 2.5M shares. JPMorgan, Cowen and Piper Sandler acted as joint book running managers for the offering.
H.C. Wainwright reiterates Buy on Kala after 'underwhelming' competitor data » 07:2205/1305/13/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Yi Chen reiterates a Buy rating on Kala Pharmaceuticals (KALA) with a $14 price target after Oyster Point Pharma (OYST) earlier this week reported data from the ONSET-2 Phase 3 trial of OC-01 nasal spray for the treatment of dry eye disease. OC-01's efficacy on dry eye disease symptoms is "hit-and-miss," and neither dose met the symptom endpoint twice in the two studies, Chen tells investors in a research note. In comparison, Kala's Eysuvis 0.25% has met the sign endpoint thrice and the symptom endpoint twice in three Phase 3 studies, says the analyst. Chen views OC-01 as an "underwhelming" product compared to Eysuvis.
Oyster Point Pharma announces offering of 2.5M shares of common stock » 16:2105/1205/12/20
Oyster Point Pharma…
Oyster Point Pharma announced that it has commenced an underwritten public offering of 2.5M shares of its common stock. J.P. Morgan Securities, Cowen and Company, and Piper Sandler are acting as joint book-running managers for the offering.
Oyster Point Pharma files to sell 2.5M shares of common stock 16:1205/1205/12/20
Piper says Oyster Point 'highly likely' to get dry eye approval, superior label » 11:3605/1105/11/20
After Oyster Point…
After Oyster Point Pharma's Phase 3 ONSET-2 trial achieved both its primary and key secondary endpoints, Piper Sandler analyst Tyler Van Buren noted that the results were consistent with the first pivotal ONSET-1 trial. The analyst, who called the latest results and the total of the safety database "impressive," added that "Oyster Point is now the first company to achieve statistical significance on both key signs and symptoms endpoints in one - much less two - Phase 3 trials." Van Buren believes an approval in dry eye disease with a superior label is "highly likely" next year and keeps an Overweight rating on Oyster Point shares.
Oyster Point Pharma reports Q1 EPS (77c), consensus ($1.06) » 06:1905/1105/11/20
Jeffrey Nau, PhD, MMS…
Jeffrey Nau, PhD, MMS CEO, Oyster Point Pharma, said, "The ability to show statistically significant sign and symptom endpoints within the same clinical trial has been elusive in dry eye disease. ONSET-1 and ONSET-2 have independently met endpoints of both signs and symptoms in their respective trial populations. The ability to meet this high bar in the ONSET-2 population consisting of mild, moderate, and severe subjects is even more notable and speaks to the broad applicability of OC-01 to treat dry eye patients. We look forward to submitting the New Drug Application to FDA for OC-01 nasal spray to treat signs and symptoms of dry eye disease in the second half of 2020. If approved by the FDA, we remain on track for a planned U.S. launch in the fourth quarter of 2021."
Oyster Point Pharma announces ONSET-2 study meets primary, secondary endpoints » 06:1605/1105/11/20
Oyster Point Pharma…
Oyster Point Pharma announced top-line results from the Phase 3 ONSET-2 study in dry eye disease. The ONSET-2 trial met the primary endpoint, where a greater percentage of subjects treated with 0.6 mg/ml and 1.2 mg/ml of OC-01 gained greater than 10 mm on Schirmer's score, a measure of tear film production, compared to control. Key secondary endpoints were met, including an improvement in eye dryness score, or EDS, in the normal clinic environment as well as mean change in Schirmer's score in the 1.2 mg/ml dose group. The ONSET-2 Phase 3 trial was a multicenter, randomized, double-masked, vehicle-controlled clinical trial designed to evaluate the safety and efficacy of OC-01, or varenicline, nasal spray for the signs and symptoms of dry eye disease. The study enrolled 758 subjects at 22 centers in the United States and investigated two doses of OC-01 nasal spray, 0.6 mg/ml and 1.2 mg/ml, as compared to control nasal spray. Subjects were administered OC-01 nasal spray twice daily for four weeks. For the primary endpoint, both tested doses of OC-01 showed a statistically significant improvement in subjects gaining greater than 10 mm in Schirmer's score at Week four as compared to control. In the 0.6 mg/ml subject dose group, the percentage of subjects gaining greater than10 mm on Schirmer's score was 44%. In the 1.2 mg/ml subject dose group, the percentage of subjects gaining greater than10mm on Schirmer's score was 47%. In the control group, the percentage of subjects gaining greater than10mm on Schirmer's score was 26%.Additionally, consistent with the ONSET-1 clinical trial, there was a statistically significant improvement in mean change in Schirmer's score at Week 4 in both doses tested as compared to control. In the group of subjects treated with the 0.6 mg/ml dose at Week 4, the mean change from baseline in Schirmer's score was 11 mm. In the 1.2 mg/ml dose group at Week 4, the mean change from baseline on Schirmer's score was 11.2 mm. Mean change from baseline on Schirmer's score in the control group was 5.9 mm. Multiple secondary endpoints were assessed in ONSET-2 including measurement of symptoms in the normal clinic environment as well as in a controlled adverse environment chamber. Eye Dryness Score measured in the normal clinic environment demonstrated statistically significant results in the 1.2 mg/ml dose group at Week 4, although the 0.6 mg/ml dose was not statistically significant. The 0.6 mg/ml and 1.2 mg/ml doses of OC-01 nasal spray did not meet the secondary endpoint for patient-reported symptoms of eye dryness in the Controlled Adverse Environment, or AE, at Week 4. However, both OC-01 doses exhibited a directional benefit as compared to control. The statistical power for assessing this endpoint was negatively impacted by a decrease in the sample size due to the subjects being unable to be assessed as a result of the coronavirus pandemic. In addition, there were a number of subjects who did not meet criteria for treatment in the chamber, which further reduced statistical power. Additionally, the 0.6 mg/ml and 1.2 mg/ml dose of OC-01 nasal spray showed statistical significance in Eye Dryness Score measured at Week 2. OC-01 was well-tolerated in the ONSET-2 clinical trial, and the adverse event profile was consistent with the ONSET-1 clinical trial. The most common adverse event experienced in the treatment groups was sneeze, which occurred with 50% of nasal spray administrations, was transient and mild in severity. There were no reports of serious adverse events related to nasal administration. The number of subjects with treatment emergent adverse events related to study drug leading to discontinuation was 2% or less in either treatment group.
|Over a quarter ago|
Oyster Point ONSET-2 trial barely impacted by COVID-19, says Piper Sandler » 13:4503/3003/30/20
Piper Sandler analyst…
Piper Sandler analyst Tyler Van Buren says he is "pleased" to learn Oyster Point has completed enrollment in the Phase III ONSET-2 trial earlier this month, with topline data expected by the end of Q2. Van Buren, who made no change to his Overweight rating and $60 price target, tells investors in a research note that the majority of patients have likely completed the 28-day study and only 3-4 out of 23 sites were mildly affected by the COVID-19 pandemic due to closures, adding that this has little-to-no significant impact on the probability of success as the trial remains 98%-99% powered to meet its key Schirmer's and EDS clinical endpoints.
Oyster Point Pharma participates in a conference call with JPMorgan » 10:2503/3003/30/20
SMid Biotech Analyst Rama…
SMid Biotech Analyst Rama holds a conference call with CEO Nau on March 30 at 11 am hosted by JPMorgan.
Oyster Point Pharma experiences impact to trial sites amid COVID-19 » 07:5703/3003/30/20
Due to the COVID-19…
Due to the COVID-19 pandemic, Oyster Pharma Point has experienced an impact to select clinical trial sites during the month of March where ophthalmology practices were closed, or subjects were unable to attend protocol specified visits. This impact was limited primarily to Day 28 study visits, with minimal impact to earlier timepoints and data collection. In close cooperation with the excellent staff at the study's clinical centers, Oyster Point Pharma has instituted additional safety measures for ongoing clinic visits and implemented remote collection of data where applicable. Based on the data collected to date for the primary endpoint, and assuming consistency with the effect size seen in the ONSET-1 clinical trial, the study is expected to have approximately 99% power to detect a difference for each dose tested. Similarly, for the secondary endpoints assessing symptoms using the EDS scale, and assuming the effect size seen in the ONSET-1 clinical trial, the study is expected to have approximately 98% power to detect a difference.