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Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) is a clinical-stage biopharmaceutical company based in Irvine, California, dedicated to the development and commercialization of novel therapeutic candidates for ophthalmic conditions. Founded in 2016, Tarsus stands at the forefront of eye care innovation with a mission to revolutionize treatments for patients by addressing unmet needs through proven science and new technology.
The company’s flagship product, XDEMVY® (lotilaner ophthalmic solution) 0.25%, was approved by the FDA in 2023. XDEMVY is a pioneering eye drop designed to treat Demodex blepharitis, a common eyelid inflammation caused by an infestation of Demodex mites. Clinical trials involving more than 800 patients demonstrated its efficacy, meeting primary and secondary endpoints with no serious treatment-related adverse events.
Beyond XDEMVY, Tarsus is advancing a diverse pipeline of therapeutic candidates. TP-03 is under investigation for the treatment of Meibomian Gland Disease (MGD), a condition often comorbid with Demodex infestation. TP-04 is being developed for the treatment of papulopustular rosacea (PPR), while TP-05 is explored as a groundbreaking oral prophylactic for Lyme disease and community malaria reduction.
The company’s recent achievements underscore its commitment to advancing therapeutic options in ophthalmology and beyond. Tarsus reported significant clinical improvements in MGD with TP-03, highlighting its potential to address underlying causes of the disease. Additionally, TP-05 showed promising results in early trials, demonstrating high tick mortality rates and suggesting potential as an on-demand prophylactic against Lyme disease.
Tarsus Pharmaceuticals collaborates with leading institutions like Tufts University School of Medicine to bolster its research endeavors. The company is also gaining traction in the marketplace, evidenced by strong quarterly financial results and strategic partnerships with major investment firms such as Goldman Sachs, BofA Securities, and Guggenheim Securities.
With ongoing consumer awareness campaigns such as “Mite Party” for XDEMVY, Tarsus is actively engaging patients and healthcare providers to improve diagnosis and treatment outcomes for Demodex blepharitis. This multi-channel initiative aims to educate the public about the prevalence and impact of Demodex infestation, encouraging patients to seek professional care.
Committed to patient-centric innovation, Tarsus Pharmaceuticals continues to expand its footprint in eye care and explore new therapeutic frontiers, striving to make a significant impact on public health through scientifically driven solutions.
Tarsus Pharmaceuticals (NASDAQ: TARS) announced positive topline results from the Phase 1b Callisto trial of TP-05, an oral therapeutic aimed at preventing Lyme disease. The trial demonstrated that TP-05 was well tolerated with no serious adverse effects and indicated potential for a less frequent dosing regimen. The company is also moving forward with the Carpo Phase 2a trial, which will further assess TP-05's safety and effectiveness against ticks. Lyme disease presents a significant health concern, with 300,000 to 400,000 cases annually in the U.S., highlighting the need for effective prophylactic options.
Tarsus Pharmaceuticals announced a key milestone with the FDA's acceptance of its New Drug Application for TP-03, targeting Demodex blepharitis. The Prescription Drug User Fee Act (PDUFA) action date is set for August 25, 2023. The company has launched a disease education campaign and engaged with eye care professionals to enhance diagnosis rates. Financially, Tarsus reported a net loss of $22.5 million for Q3 2022, up from $15.7 million in Q3 2021, while holding $227 million in cash reserves, expected to last into 2026.
Tarsus Pharmaceuticals (NASDAQ: TARS) announced the presentation of follow-up data from the pivotal Phase 3 Saturn-2 trial on TP-03, an investigational treatment for Demodex blepharitis, at the upcoming American Academy of Optometry meeting in San Diego. The data supports TP-03's efficacy, with both Saturn-1 and Saturn-2 trials meeting all primary and secondary endpoints, leading to a New Drug Application submission to the FDA. The absence of FDA-approved treatments for Demodex blepharitis underscores the potential market opportunity for TP-03.
Tarsus Pharmaceuticals (NASDAQ: TARS) announced significant board transitions, with co-founder Michael Ackermann planning to step down from the Board of Directors. Wendy Yarno is set to become Lead Independent Director, while CEO Bobak Azamian will take on the role of Chairman upon Ackermann's departure. Ackermann, who contributed greatly to Tarsus' success, will focus on early-stage biotech ventures. The company advances its pipeline, particularly with TP-03, aimed at treating Demodex blepharitis and Meibomian Gland Disease, with a New Drug Application submitted to the FDA.
Tarsus Pharmaceuticals (NASDAQ: TARS) has appointed Scott Morrison as Board Member and Audit Committee Chair, effective immediately. With over 40 years of experience in finance and operations within the life sciences sector, Morrison previously held leadership roles at Ernst & Young. Tarsus is preparing for potential FDA approval of TP-03, its lead product for treating Demodex blepharitis. This strategic addition to the board aims to strengthen Tarsus's leadership as it advances its R&D pipeline and transitions to a commercial-ready organization.
Tarsus Pharmaceuticals (NASDAQ: TARS) has launched the "Look at the Lids" education campaign aimed at raising awareness about Demodex blepharitis, a common eye condition affecting about 25 million U.S. patients. The campaign will be showcased at the upcoming American Academy of Ophthalmology and Optometry meetings and includes resources for eye care professionals to improve diagnosis rates. The initiative reflects Tarsus's commitment to advancing eyelid health and enhancing disease screening practices among eye care professionals.
Tarsus Pharmaceuticals (NASDAQ: TARS) announced the upcoming presentation of positive data from the pivotal Phase 3 Saturn-2 trial of TP-03 at the World Cornea Congress VIII and AAO 2022. The company has submitted a New Drug Application (NDA) to the FDA, supported by favorable results from the Saturn-1 and Saturn-2 trials, which met primary and secondary endpoints. With no FDA-approved treatments for Demodex blepharitis currently available, TP-03 represents a significant advancement in addressing a condition affecting over 25 million patients in the U.S.
Tarsus Pharmaceuticals (NASDAQ: TARS) has submitted a New Drug Application (NDA) to the FDA for TP-03, an ophthalmic solution aimed at treating Demodex blepharitis. This condition, affecting approximately 25 million Americans, currently lacks FDA-approved treatments. The NDA is based on two pivotal trials involving over 800 patients, where TP-03 met all endpoints and was well-tolerated. If approved, TP-03 could revolutionize care for patients suffering from this common eyelid disease, which is caused by Demodex mite infestation.
Tarsus Pharmaceuticals (TARS) announced promising developments in its TP-03 drug for treating Demodex blepharitis, successfully meeting all endpoints in the Saturn-2 Phase 3 trial. The company expects to submit a New Drug Application (NDA) this year. Additionally, Tarsus has initiated a Phase 2a trial for TP-03 targeting Meibomian Gland Disease. Financially, Tarsus reported a net loss of $5.7 million for Q2 2022, a decrease from a net income of $6.3 million in Q2 2021, while cash reserves are projected to support operations through 2026.
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) has initiated a Phase 2a clinical trial to study TP-03 (lotilaner ophthalmic solution, 0.25%) for Meibomian Gland Disease (MGD) associated with Demodex mites. MGD affects approximately 22 million Americans and currently has no FDA-approved treatments. TP-03 showed significant efficacy in prior pivotal trials for Demodex blepharitis, enrolling over 800 patients. Tarsus plans to submit a New Drug Application for TP-03 for blepharitis later this year, signaling a strong commitment to expanding eye care therapeutics.
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