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Flexion Therapeutics (Nasdaq:FLXN) announced positive preliminary results from a Phase 1 trial of FX201, a gene therapy for osteoarthritis (OA). In the low-dose cohort, 40% of patients reported significant pain relief lasting to Week 24, with FX201 generally well-tolerated. No systemic biodistribution or shedding of the therapy was observed, indicating its confinement to the joint space. The complete data will be presented at the ASGCT meeting on May 11, signaling potential for further therapeutic development.
Flexion Therapeutics (Nasdaq:FLXN) reported preliminary net sales of approximately $24.6 million for ZILRETTA in the first quarter of 2021. Full-year net sales are anticipated to range between $120 million to $130 million, reflecting 40-50% year-over-year growth. Operating expenses are expected to be $195 million to $205 million. Despite challenges such as COVID-19 vaccine rollout delays, the company remains optimistic about ZILRETTA's position as a leading treatment for osteoarthritis knee pain. The complete Q1 financial results will be published in early May.
Flexion Therapeutics (Nasdaq:FLXN) announced that Dr. Michael Clayman, the company's President and CEO, will engage in an analyst-led fireside chat during the Needham 20th Annual Healthcare Conference. This virtual event is set for 9:30 a.m. ET on April 15, 2021. Participants can access the live webcast through the Flexion Therapeutics website. The company is dedicated to developing novel therapies for musculoskeletal conditions such as osteoarthritis, highlighting its commitment to innovation and transparency.
Flexion Therapeutics (Nasdaq:FLXN) announced equity inducement grants to five new employees comprising 60,880 restricted stock units. This decision, approved by the Compensation Committee on April 1, 2021, aligns with Nasdaq Listing Rule 5635(c)(4). The restricted stock units will vest over four years, with 25% vesting annually, contingent on continued employment. These grants fall under the terms of the Company’s 2013 Equity Incentive Plan, designed to enhance employee retention and incentivize performance.
Flexion Therapeutics (Nasdaq:FLXN) has initiated a Phase 1b proof-of-concept trial for FX301, a NaV1.7 inhibitor, aimed at evaluating its safety and tolerability as a peripheral analgesic nerve block in bunionectomy patients. This trial addresses the need for non-opioid pain management in over seven million orthopedic surgeries annually in the U.S. FX301 aims to provide extended pain relief while preserving motor function, with initial results expected later this year, supporting its potential as a first-in-class analgesic agent.
Flexion Therapeutics (Nasdaq:FLXN) announced that CEO Michael Clayman will participate in an analyst-led fireside chat at the Oppenheimer 31st Annual Healthcare Conference. The virtual event is set for 10:00 a.m. ET on March 17, 2021. Interested parties can access the live webcast through the Flexion website.
Flexion specializes in developing and commercializing innovative therapies for musculoskeletal conditions, focusing on osteoarthritis.
Flexion Therapeutics reported a robust performance in 2020, with net sales of ZILRETTA reaching $85.6 million, a 17% increase over 2019. Despite a net loss of $113.7 million, improvement from $149.8 million in 2019 occurred. The company anticipates key clinical trials for FX201 and FX301 to progress in 2021, promising significant advancements. Notably, Flexion has approximately $175.3 million in cash, deemed sufficient for operations into mid-2022. The conference call will provide further insights into their strategy and outlook.
Flexion Therapeutics (Nasdaq:FLXN) announced equity inducement grants for four new employees, totaling 14,565 restricted stock units. Approved by the Compensation Committee, these grants became effective on March 1, 2021. The restricted stock units will vest over four years, with 25% vesting annually, contingent on the employees' ongoing service. This action is aligned with Nasdaq Listing Rule 5635(c)(4) and follows the company's 2013 Equity Incentive Plan.
Flexion Therapeutics (Nasdaq:FLXN) will release its fourth-quarter and full-year 2020 financial results on March 10, 2021, after U.S. market close. Investors can access a live webcast of the conference call via the company’s website, with an option to submit questions. This biopharmaceutical company focuses on local treatment therapies for musculoskeletal conditions, including osteoarthritis. The company emphasizes values like focus and ingenuity in its operations.
Flexion Therapeutics announced that the FDA has cleared its IND application for FX301, a NaV1.7 inhibitor known as funapide, designed for peripheral analgesic nerve block. FX301 aims to provide non-opioid pain relief for 3 to 5 days while maintaining motor function post-surgery. A Phase 1b clinical trial in bunionectomy patients is expected to start in the first half of 2021, with initial results anticipated late in the year. Preclinical studies suggest FX301 offers significant pain relief compared to existing treatments without affecting mobility.
