Spruce Biosciences has named Dale Hooks as chief commercial officer, securing a leader with experience launching 21 products as the company heads toward a filing for its first FDA approval.
After starting off his career in marketing positions at GSK, Novartis and Galderma, Hooks rose through the ranks at Genentech for nearly a decade, then joined Clovis Oncology in 2014 as VP of sales and, ultimately, chief commercial officer. After Clovis, Hooks took on a commercial leadership role at Reata Pharmaceuticals, which was bought by Biogen in 2023, then joined Applied Therapeutics as CCO in 2024.
Hooks was one of several executives who recently lost their jobs in connection with Cycle Pharmaceuticals' takeover of Applied, according to a Securities and Exchange Commission filing last month.
California-based Spruce has provided a soft landing for Hooks. Weeks after Applied disclosed his exit, the executive has signed on to use his decades of experience shaping commercial strategy and building drug launch infrastructure to support Spruce’s tralesinidase alfa enzyme replacement therapy (TA-ERT).
Spruce pivoted last year, responding to the back-to-back failures of its then-lead candidate by regrouping around the former BioMarin asset. Allievex first licensed TA-ERT from BioMarin in 2019 for use in the rare disease Sanfilippo syndrome type B, but Allievex eventually liquidated after failing to reach alignment on the path to market with the FDA, clearing Spruce to snap up the program.
Detecting a shift in the FDA’s thinking, Spruce has spotted an opportunity to seek accelerated approval using existing data. The company reported this week that it recently left a meeting with the FDA with a path to a fourth-quarter filing for approval.
Speaking at a Leerink event the day of Hooks’ appointment, Spruce CEO Javier Szwarcberg, M.D., noted that the company previously worked with experienced CCO Jeff Ajer to outline its commercial strategy.
Szwarcberg worked with Ajer at BioMarin and tapped into his experience while he was between roles. With Ajer now leading the commercial team at Mendra, Spruce has hired Hooks to build on the foundations he provided.
Szwarcberg said the commercial strategy has three prongs: identifying patients, re-educating the medical community about TA-ERT and planning pricing and market access. The CEO said Spruce forecasts that the company will have about 500 patients in the U.S. and 500 patients globally at peak.