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Tarsus Pharmaceuticals Inc

Tarsus Pharmaceuticals, Inc., a commercial stage biopharmaceutical company, focuses on the development and commercialization of therapeutic candidates for eye care in the United States. The company offers XDEMVY, a lotilaner ophthalmic solution for the treatment of demodex blepharitis caused by the infestation of Demodex mites. It sells its products to specialty pharmacies and distributors, as well as clinics, hospitals, pharmacies, and federal healthcare programs. The company also develops TP-04, a sterile aqueous gel formulation of lotilaner in Phase 2 trial for the treatment of ocular rosacea; and TP-05, an oral tablet formulation of lotilaner in Phase 2 trial for the prevention of Lyme disease, as well as in pre-clinical studies for community malaria reduction. In addition, it is developing the lotilaner active pharmaceutical ingredient (API) to address diseases in human medicine, including eye care and infectious disease prevention. The company has a development and license agreement with Xi An Grand Chang An Pharmaceutical Co., Ltd. for the development and commercialization of TP-03 in China for the treatment of Demodex blepharitis and meibomian gland disease. Tarsus Pharmaceuticals, Inc. was incorporated in 2016 and is headquartered in Irvine, California.

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Biotech & Genomic Medicine

FTC grants early termination for Tarsus-Alkeus acquisition

The Federal Trade Commission has granted early termination for Tarsus Pharmaceuticals' acquisition of privately held Alkeus Pharmaceuticals. The deal terms call for Tarsus to pay $450 million upfront, consisting of $270 million in cash and $180 million in common stock, with up to $350 million in additional milestone payments. Alkeus' lead asset is gildeuretinol (ALK-001), an oral therapy for the rare inherited retinal disorder Stargardt disease.
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Biotech & Genomic Medicine

Tarsus Pharmaceuticals to acquire Alkeus Pharmaceuticals for up to $800 million

Tarsus Pharmaceuticals has entered into a definitive agreement to acquire Alkeus Pharmaceuticals for up to $800 million, including upfront and milestone-based payments tied to regulatory and commercial achievements. Alkeus' lead candidate, Gildeuretinol, is an investigational once-daily oral therapy in Phase 3 development for Stargardt disease, a rare inherited retinal disorder with no FDA-approved treatment that affects more than 36,000 people in the U.S. The pivotal Phase 3 NORTHSTAR trial is expected to deliver top-line results in the second half of 2029, and the program has received Breakthrough Therapy, Orphan Drug, and Rare Pediatric Disease designations from the FDA. The acquisition, which is expected to close in 2026 subject to customary conditions, builds on Tarsus' recent acquisition of iRenix Medical and its investigational program IRX-101, further strengthening the company's pipeline across eye care. Tarsus stock closed Wednesday at $61.29, up 0.29%, and was down 3.02% in pre-market trading.
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Biotech & Genomic Medicine3

Tarsus Pharmaceuticals Acquires iRenix Medical, Adding IRX-101 to Pipeline

Tarsus Pharmaceuticals has closed its acquisition of iRenix Medical, adding the late-stage investigational ocular surface antiseptic IRX-101 to its pipeline and establishing its first strategic position in the retina market. The upfront cost was approximately $75 million, split evenly between cash and Tarsus common stock, with up to $490 million in potential approval and commercial milestones plus tiered royalties. IRX-101 is designed to replace povidone-iodine for patients receiving repeated intravitreal injections, aiming to reduce pain, irritation, and ocular surface damage, and in a Phase IIb/III trial it showed statistically significant improvements in post-procedural pain and corneal staining. Tarsus plans to begin a pivotal Phase III COMFORT study in the first half of 2027, with top-line data expected in 2028, and estimates the cost to approval at $20 million to $30 million. The company sees a focused commercial opportunity among roughly 3,500 retinal specialists, with an initial target market of patients highly sensitive to Betadine that could represent a $200 million to $300 million opportunity.
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