Fulcrum Therapeutics To Rally Around 120%? FDA Update Removes Overhang On Pivotal Program

Tuesday, the FDA lifted the clinical hold on Fulcrum Therapeutics Inc's FULC Investigational New Drug (IND) application for FTX-6058 for the potential treatment of sickle-cell disease (SCD).

Following the update, HC Wainwright updated the stock from Neutral to Buy with a price target of $14, up from $5.

The analysts Andrew Fein and Andres Maldonado see an attractive risk/reward ratio for the stock moving forward. 

HC Wainwright's confidence is focused on the potential for positive developments arising from '6058, which could gradually mitigate the past setbacks linked to the FDA's hold due to hematological malignancy risks and a high rate of management turnover. 

The management team has successfully redefined the '6058' program's target patient population, expanding the Total Addressable Market (TAM) and attracting new investor interest.

Investors can anticipate data to emerge in late 2023 or the first half of 2024.

Given the clinical data thus far, the analysts say that approval may be warranted if the efficacy and safety continue to translate well from preclinical studies. Taken together, HC Wainwright is highly encouraged by Fulcrum's choice to select 12 and 20 mg as the next key dose updates, given how FTX-6058 has previously performed in the clinic in SCD patients and healthy volunteers.

Price Action: FULC shares are up 17.1% at $6.36 on the last check Wednesday.