Fulcrum Therapeutics Stock Climbs In Pre-market On License Deal With Sanofi For Losmapimod

(RTTNews) - Shares of Fulcrum Therapeutics, Inc. (FULC) were gaining more than 16 percent in the pre-market activity on the Nasdaq after the company announced a collaboration and license agreement with French drug major Sanofi (SNY) for the development and commercialization of losmapimod in Facioscapulohumeral Muscular Dystrophy or FSHD.

Under the deal, Fulcrum retains full U.S. commercialization rights, while Sanofi obtains exclusive commercialization rights for losmapimod outside of the U.S.

As per the terms of the agreement, Fulcrum will receive an upfront payment of $80 million and is eligible to receive up to an additional $975.0 million in specified regulatory and sales-based milestones. This is along with tiered escalating royalties starting in the low-teens on annual net sales of losmapimod outside the U.S.

In addition, Fulcrum and Sanofi will equally share future global development costs.

Losmapimod is an oral small molecule being investigated for the treatment of FSHD, a chronic and progressive genetic muscular disorder that is characterized by significant muscle cell death and fat infiltration into muscle tissue.

FSHD is a serious, rare, progressive and debilitating disease for which there are no approved treatments.

Losmapimod is currently being evaluated in a global Phase 3 clinical trial for the treatment of FSHD. The company noted that the results from ReDUX4, the Phase 2 clinical trial evaluating losmapimod for the treatment of FSHD, demonstrated a slowing of disease progression and improved muscle health.

Fulcrum expects to report topline data from REACH, the global Phase 3 clinical trial, in the fourth quarter of 2024. Following positive data from the Phase 3 trial, Fulcrum and Sanofi plan to submit marketing applications in the U.S., Europe, Japan, and other geographies.

In pre-market activity on the Nasdaq, Fulcrum shares were gaining around 16 percent to trade at $8.67.

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