Tarsus to buy Alkeus for $800 million in retina push

Tarsus Pharmaceuticals agreed to buy Alkeus for up to $800 million, adding a Phase 3 oral therapy for Stargardt disease, an inherited retinal disorder with no approved US treatment that affects more than 36,000 people.

"From the beginning, our strategy has been to build a leading eye care company by identifying significant diseases where patients have been starving for innovation and bringing forward medicines with the potential to change the standard of care," Bobby Azamian, chief executive and chairman of Tarsus, said.

The deal includes an upfront payment of about $450 million, split between $270 million in cash and $180 million in Tarsus common stock priced at $61.38 a share. Alkeus stockholders can receive up to $350 million more tied to regulatory approval and first commercial sale milestones, plus low-single-digit royalties on net sales of gildeuretinol, the experimental therapy also known as ALK-001. The transaction is expected to close in 2026, subject to US antitrust clearance. Barclays advised Tarsus and Jefferies advised Alkeus.

Tarsus shares fell 3 percent in premarket trading. The company, which held $449.7 million in cash at the end of June, raised its full-year 2026 XDEMVY net product sales guidance to $685 million to $705 million after second-quarter sales of the Demodex blepharitis treatment jumped more than 69 percent year over year to $173.9 million.

Gildeuretinol targets the root cause of Stargardt disease

Gildeuretinol is a once-daily oral small molecule designed to reduce the accumulation of toxic vitamin A dimers in the retina while preserving the normal visual cycle, slowing retinal damage and preserving vision longer. The drug has been evaluated in more than 400 individuals and holds Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations from the FDA.

Stargardt disease often begins in childhood or adolescence and progressively damages the macula, the central portion of the retina responsible for detailed vision, eroding patients' ability to read, recognize faces, drive and live independently. The disease is driven by toxic vitamin A dimer buildup that damages retinal cells.

The ongoing Phase 3 NORTHSTAR trial is expected to enroll about 230 patients, with the primary endpoint measuring the rate of retinal atrophic lesion growth over 24 months and a secondary endpoint assessing change in low light visual acuity. The trial design was agreed with the FDA and the European Medicines Agency, with topline data expected in the second half of 2029.

Building a retina franchise

The Alkeus deal follows Tarsus's acquisition of iRenix Medical, which added IRX-101, an investigational ocular antiseptic designed to reduce pain and corneal toxicity in the more than 11 million annual intravitreal injection procedures in the US. Together, the two deals expand Tarsus's presence in retina, one of the largest and fastest-growing specialties in eye care.

Tarsus's existing portfolio centers on XDEMVY, approved in 2023 for Demodex blepharitis, an eyelid inflammation caused by an overgrowth of microscopic mites. The company is also developing TP-04 for ocular rosacea and TP-05, an oral prophylactic designed to kill ticks carrying Lyme disease, both in Phase 2, with topline data expected in the first half of 2027.

To fund the expansion, Tarsus priced a $125 million private placement that included participation from top-tier funds and several existing Alkeus investors. The company's second-quarter net loss narrowed to $18.6 million from $20.3 million a year earlier.

Tarsus shares, which fell 3 percent in premarket trading, trade with the company's cash position providing runway as it funds the Alkeus deal and its clinical programs. The acquisition gives Tarsus a potential blockbuster in a disease with no approved therapy, but investors will wait until the second half of 2029 for the NORTHSTAR readout that determines whether gildeuretinol delivers on its promise.

This article is for informational purposes only and does not constitute investment advice.