Praxis Precision Medicines (PRAX) +13.3% on FDA Breakthrough Therapy Designation

‍

Praxis Precision Medicines surged 13.28% in one session after the FDA granted Breakthrough Therapy Designation (BTD) to ulixacaltamide HCl for the treatment of essential tremor. The designation was based on positive topline Phase 3 data from the Essential3 program and follows a recently completed pre-NDA meeting with the FDA.
‍

BTD is a meaningful regulatory milestone, signaling the FDA’s view that the drug may offer substantial improvement over existing therapies and enabling accelerated development and review. Praxis remains on track to submit its NDA in early 2026, materially improving visibility on a potential approval timeline. With essential tremor affecting roughly 7 million patients in the U.S. and limited effective treatment options, the announcement refocused investor attention on pipeline value and commercialization potential rather than near-term biotech volatility.

‍

Eightco (ORBS) +10.2% on Massive Buyback Authorization

‍

Eightco jumped 10.2% in one day after announcing a share repurchase program of up to $125 million, representing roughly 25% of its market capitalization. Management framed the buyback as a strong vote of confidence in the company’s valuation, strategy, and partnership pipeline.
‍

The authorization is notable given Eightco’s balance sheet and strategic positioning, including its Worldcoin (WLD) treasury, which holds over 10% of the circulating WLD supply, and its focus on digital identity and Proof-of-Human authentication through its Infinity platform.