Foresee Pharmaceuticals Welcomes Brian Groch as Chief Commercial Officer to Launch FP-001 for CPP

Foresee Pharmaceuticals Appoints Brian J. Groch as CCO

Foresee Pharmaceuticals has taken a significant step forward in its commercial strategy by announcing the appointment of Brian J. Groch as the Chief Commercial Officer (CCO), effective July 1, 2026. This strategic move comes as Foresee prepares to launch its innovative product, FP-001 42 mg, a treatment aimed at addressing central precocious puberty (CPP).

Who is Brian J. Groch?

Brian brings an extensive history of leadership within the pharmaceutical sector, spanning over three decades. His experience includes high-level roles at prominent companies such as Remi Therapeutics, Shield Therapeutics, and Veru Inc. He has successfully led various global market access strategies, demonstrating an impressive track record in the commercialization of treatments across multiple therapeutic domains.

Before joining Foresee, Groch held key positions at Novartis, where as a Director of Health Policy, he contributed significantly to the firm’s strategic direction. Additionally, he spent more than thirteen years at Merck, focusing on large-scale commercial and marketing initiatives that have paved the way for numerous successful product launches.

Dr. Ben Chien, Chairman and CEO of Foresee Pharmaceuticals, expressed his enthusiasm regarding Groch's appointment, emphasizing the importance of his role in building a commercial team dedicated to launching FP-001 in markets like the United States and Taiwan, along with potential expansions into other territories. This shake-up reflects Foresee's commitment to transitioning from a research-focused organization to one with direct commercialization capabilities.

FP-001: A Game-Changer for CPP

The FP-001 product is an investigational six-month ready-to-use subcutaneous long-acting injectable formulation of leuprolide mesylate. It targets children suffering from CPP, a condition characterized by the premature onset of puberty due to early activation of the pituitary-gonadal axis. Left untreated, CPP could lead to not only accelerated bone maturation and reduced adult height but also significant psychosocial challenges for impacted children.

Currently, the standard treatment for CPP involves GnRH agonists, which halt pubertal progression. FP-001, however, introduces a less frequent dosing regimen, requiring a single subcutaneous injection that lasts for six months. This innovative approach not only simplifies treatment for patients but also significantly reduces the frequency of healthcare visits, making it more manageable for families.

Regulatory Roadmap and Future Plans

Foresee is systematically executing its regulatory strategies for the CPP program, with critical milestones ahead. A New Drug Application (NDA) is expected to be submitted to the U.S. FDA in the latter half of 2026. Concurrently, marketing authorization applications will also be filed in Taiwan and other strategic markets between late 2026 and early 2027. These actions highlight Foresee’s commitment to ensuring timely access to FP-001 for children in need.

The leadership of Brian Groch will be pivotal as Foresee engages in crucial pre-NDA discussions with regulatory bodies, aiming to facilitate a smooth review process for their groundbreaking treatment. The successful completion of the Phase 3 Casppian clinical trial, which achieved its primary endpoint in December 2025, further solidifies confidence in FP-001's market readiness.

A Vision for the Future

Foresee Pharmaceuticals continues to innovate in the biopharmaceutical landscape, maintaining its focus on developing treatments for rare and severe conditions with high unmet medical needs. With ground-breaking technologies, such as their proprietary Stabilized Injectable Formulation (SIF), the company aims to diversify its product portfolio and expand its reach into various therapeutic areas, including Central Nervous System (CNS) conditions.

The transition toward commercialization under Groch’s leadership marks an exciting chapter in Foresee's evolution. As they prepare to launch FP-001, the company positions itself to make a significant impact on the lives of children affected by central precocious puberty across the globe. With Groch at the helm of commercialization, Foresee is set to redefine how treatments for this condition are accessed and delivered.

For more information on Foresee Pharmaceuticals and its advancements, visit www.foreseepharma.com.