Pharmaceutical Executive Daily: FDA Approves Pasatru

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, a partnership roundup covers IntraGel Therapeutics' investment and licensing agreement with UroGen Pharma and Lupin's licensing deal with Tenpoint Therapeutics for the presbyopia treatment Yuvezzi, FDA approves Regeneron's Pasatru as a new treatment for adults with the ultra-rare disorder fibrodysplasia ossificans progressiva, and Rohit Tripathi of RELEX weighs in on whether tariffs can successfully reshore pharmaceutical manufacturing to the U.S.

Two partnership agreements advance drug development and commercialization pipelines this week. IntraGel Therapeutics, developer of the SRGel sustained-release drug delivery platform, has entered an equity investment agreement and a strategic option and research license agreement with UroGen Pharma, under which UroGen invests up to $7 million in IntraGel and gains an exclusive option to license Tumocure, an investigational cisplatin therapy for advanced head and neck cancer, following Phase II development, along with an option on up to three additional SRGel-based oncology products. Separately, Lupin's VISUfarma subsidiary has signed an exclusive licensing agreement with Tenpoint Therapeutics, a subsidiary of Visus Therapeutics, to commercialize Yuvezzi, an eye drop for presbyopia, across the European Union, the United Kingdom, Switzerland, Norway, and Iceland, with Tenpoint eligible for milestone payments and tiered royalties on net sales.

FDA has approved Pasatru for adults with fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder affecting an estimated 900 people worldwide that causes soft tissue to progressively turn to bone. In the Phase III Optima trial, patients receiving Pasatru show up to a 94% reduction in new heterotopic ossification lesions at 56 weeks compared to placebo, along with an 88% reduction in clinician-assessed flare-ups. Regeneron plans a pediatric Phase III trial later this year and has additional regulatory submissions pending in the EU and Japan.

Finally, Rohit Tripathi, vice president of industry strategy for manufacturing and CPG at RELEX, speaks on whether newly phased tariffs can meaningfully reshore pharmaceutical manufacturing to the U.S. and reduce reliance on Chinese and Indian active pharmaceutical ingredients. Tripathi argues that pharma reshoring cannot follow the same playbook as reshoring a standard assembly plant, since it requires qualified suppliers, validated processes, and FDA-ready facilities, and warns that reshoring finished-dose manufacturing alone leaves the supply chain exposed if APIs remain offshore. He points to thin profit margins as a risk that tariff costs get passed to consumers, potentially worsening drug shortages rather than resolving them.

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