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Osmotica Pharmaceuticals has announced positive outcomes from Phase 3 trials of Upneeq (oxymetazoline hydrochloride ophthalmic solution), the first FDA-approved treatment for acquired ptosis. The study involved 304 participants, showing significant improvements in visual field and eyelid elevation after 14 days of treatment. Upneeq demonstrated a well-tolerated safety profile, with 31% experiencing treatment-emergent adverse events, primarily mild. This advancement positions Osmotica as a leader in addressing an often-overlooked ophthalmic condition.
Osmotica Pharmaceuticals (Nasdaq: OSMT) will present at the 2020 Wells Fargo Virtual Healthcare Conference on September 10, 2020, at 11:20 a.m. Eastern Time. CEO Brian Markison and COO James "JD" Schaub will lead the presentation, which can be accessed via a live webcast. The presentation will also be archived for 30 days after the event on the company's website. Osmotica is a biopharmaceutical company focused on developing specialty products for underserved patient populations, with operations in the U.S., Argentina, and Hungary.
On August 11, 2020, Osmotica Pharmaceuticals plc (Nasdaq: OSMT) will release its 2020 second quarter financial results following the close of U.S. markets. A conference call led by CEO Brian Markison, COO James Schaub, and CFO Andrew Einhorn is scheduled for 4:30 p.m. ET, providing insights into the company's financial performance. Osmotica is focused on developing specialty products for underserved patient populations, boasting a diverse portfolio that includes four promoted products and about 30 non-promoted products.
Osmotica Pharmaceuticals (OSMT) has entered into an exclusive licensing agreement with Santen Pharmaceutical for RVL-1201, an FDA-approved ophthalmic solution for acquired blepharoptosis. Under this deal, Santen will handle development and commercialization rights in Japan, China, and EMEA regions. Osmotica will receive $89 million, comprising an upfront payment of $25 million and milestone payments, in addition to royalties on future sales. This partnership aims to fulfill a significant unmet need for ptosis treatment, potentially enhancing market access for both companies.
Osmotica Pharmaceuticals plc (Nasdaq: OSMT) announced that the FDA has categorized its resubmission for arbaclofen extended release (ER) tablets as a complete response, with a user fee goal date set for December 29, 2020. This NDA is significant for treating spasticity in patients with multiple sclerosis (MS). The company aims to demonstrate the clinical efficacy and safety of its product. As a fully integrated biopharmaceutical firm, Osmotica is focused on addressing underserved markets with its diverse portfolio.
Osmotica Pharmaceuticals (NASDAQ: OSMT) announced a public offering of 5,000,000 ordinary shares priced at $6.55 each, which is set to close on July 16, 2020, pending customary closing conditions. The company is also granting underwriters a 30-day option to purchase an additional 750,000 shares. This offering is part of Osmotica's ongoing strategy to enhance its capital position. The shares are being offered under an effective registration statement with the SEC, ensuring compliance and transparency for potential investors.
Osmotica Pharmaceuticals has announced a proposed public offering of 5,000,000 ordinary shares, with an expectation to grant underwriters a 30-day option for an additional 750,000 shares. The offering will be managed by Credit Suisse Securities and is based on the effective registration statement filed with the SEC. The company focuses on developing specialty products targeting underserved markets, with operations in the U.S., Argentina, and Hungary. Investors can access further details about the offering through the SEC's EDGAR database.
Osmotica Pharmaceuticals has announced FDA approval of Upneeq (oxymetazoline hydrochloride ophthalmic solution), the first and only pharmacologic treatment for acquired blepharoptosis. This condition, affecting millions, causes drooping eyelids and can impair vision. Upneeq demonstrated significant efficacy in pivotal trials, showing improvements in visual fields and eyelid elevation. The company plans to launch Upneeq next month and aims to expand its market presence internationally. This approval positions Upneeq as a key growth driver for Osmotica, addressing an unmet medical need.
Osmotica Pharmaceuticals has resubmitted its New Drug Application (NDA) for arbaclofen extended release (ER) tablets to the FDA, targeting spasticity associated with Multiple Sclerosis (MS). This resubmission includes results from a 12-month open-label study demonstrating safety and tolerability for the 80 mg/day dose. Two Phase 3 studies indicated statistically significant improvement in spasticity for arbaclofen ER compared to placebo. The long-term study showed sustained efficacy over one year, marking arbaclofen ER as a notable treatment option for MS spasticity.
Osmotica Pharmaceuticals plc (Nasdaq: OSMT) announced that CEO Brian Markison and COO James Schaub will present at the Jefferies Virtual Optical Health Summit on June 17, 2020, at 2:30 p.m. Eastern Time. The presentation will be available via live webcast and can be accessed on the Company's website, where it will be archived for 30 days. Osmotica focuses on developing specialty biopharmaceuticals targeting underserved patient populations and has operations in the U.S., Argentina, and Hungary.
