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Today, THTX announced that it filed Prior Approval Supplement (PAS) to the FDA for the current F4 formulation of Egrifta (Egrifta SV). Typically, the FDA could take up to 4 months to review. In this case, there is a chance that the review process could be expedited - Egrifta is the only FDA-approved drug for its indication and management is working closely with the FDA (shortage committee) to potentially minimize the Egrifta SV PAS review time. The company has sufficient inventory for Egrifta SV until mid-Jan 2025, and once an approval is obtained more batches are underway (LINK). Investors should note that on Dec 10, THTX announced a PDUFA goal date of Mar 25, 2025 for the new F8 formulation - meaning that in the worst case that the approval of the current Egrifta SV formulation delays, the new F8 formulation could take up the place by Mar 2025 assuming F8 obtains approval. One way or the other, we believe that the ongoing supply disruption of Egrifta should resolve early 2025 – then Egrifta should provide a solid stream of cash inflow while THTX is paving the way for the recently in-licensed Olezarsen and Donidalorsen, which in our understanding should provide the most significant growth in the upcoming years. We maintain our view that THTX’s stock is significantly discounted and investors should look at this as a buying opportunity. We are maintaining our SPECULATIVE BUY rating and US$3.80 TP.
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