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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) has appointed Jeff Farrow as Chief Financial Officer and Chief Strategy Officer, effective immediately. Farrow succeeds Leo Greenstein, who left to pursue other interests. Jeff brings over 20 years of experience in finance and corporate strategy within the life sciences sector, notably serving as CFO at Global Blood Therapeutics and holding similar roles at ZS Pharma and Hyperion Therapeutics. CEO Bobak Azamian expressed confidence in Farrow's leadership to drive Tarsus' transition into a commercial organization, particularly in developing therapies for eye care. Tarsus is advancing its lead candidate, TP-03, for treating Demodex blepharitis, which could potentially benefit millions of patients. The New Drug Application for TP-03 has been submitted to the FDA, with a target decision date of August 25, 2023. Tarsus is focused on addressing unmet needs in eye care and other therapeutic areas.
Tarsus Pharmaceuticals reports progress in eye care treatments, with a focus on Demodex blepharitis. The NDA for TP-03 was accepted, targeting FDA action by August 25, 2023. Market research showed over 90% of optometrists would prescribe TP-03 if approved. Completion of the Ersa Phase 2a trial for Meibomian Gland Disease is expected to yield topline data in H2 2023. Cash runway is projected into H2 2026, supporting ongoing development, including TP-04 for rosacea, which has shown positive Phase 1 results. However, the company reported a net loss of $62.1 million for 2022, a notable increase from $13.8 million in 2021.
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) has announced its participation in several upcoming healthcare conferences. CEO Bobby Azamian will engage in virtual and in-person Fireside Chats at the Oppenheimer Healthcare Conference on March 13 and Guggenheim’s Healthy Altitudes Summit on March 15. CFO Leo Greenstein will also speak at the Barclays Global Healthcare Conference on the same day, March 15. Live webcasts of these events will be available on Tarsus' website, with replays archived after the events. The company continues to advance its pipeline in eye care and infectious disease prevention, notably with TP-03, targeting Demodex blepharitis, and TP-05 for Lyme disease prevention.
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) has been selected for inclusion in the NASDAQ Biotechnology Index, effective December 19, 2022. This index tracks biotech and pharmaceutical companies listed on Nasdaq, providing Tarsus with significant visibility and potential investment from index funds. The company is advancing its pipeline targeting high unmet medical needs in eye care and other therapeutic areas, with its lead candidate TP-03 showing positive results in pivotal trials and a New Drug Application accepted by the FDA, expected to be reviewed by August 25, 2023.
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.
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