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Early Opportunities
Get in Before the Crowd

April 29, 2024

Shares of Soleno Therapeutics (SLNO) are rallying today after the FDA granted the company’s lead drug candidate (DCCR) Breakthrough Therapy Designation for the treatment of adults and children ages four years and older with Prader-Willi syndrome (PWS). The award was based on data from the Phase 3 program and it means accelerated review of DCCR. Recall that we are awaiting submission of an NDA for DCCR in mid-2024, and eventual FDA approval (which is now expected to happen more quickly) would mean Soleno can begin selling the therapy. Like most biotech stocks, SLNO can move around a lot. Today’s action shows why frustrating drawdowns on no news (like the one over the last three months) can “not really matter” when good news strikes. Will keep SLNO at hold and look for follow-through. HOLD

Soleno Therapeutics (SLNO) +30% on Breakthrough Designation

Shares of Soleno Therapeutics (SLNO) are rallying today after the FDA granted the company’s lead drug candidate (DCCR) Breakthrough Therapy Designation for the treatment of adults and children ages four years and older with Prader-Willi syndrome (PWS). The award was based on data from the Phase 3 program and it means accelerated review of DCCR. Recall that we are awaiting submission of an NDA for DCCR in mid-2024, and eventual FDA approval (which is now expected to happen more quickly) would mean Soleno can begin selling the therapy. Like most biotech stocks, SLNO can move around a lot. Today’s action shows why frustrating drawdowns on no news (like the one over the last three months) can “not really matter” when good news strikes. Will keep SLNO at hold and look for follow-through. HOLD


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Tyler Laundon is chief analyst of the limited-subscription advisory, Cabot Small-Cap Confidential and grand slam advisory Cabot Early Opportunities. He has spent his entire career managing, consulting and analyzing start-up and small-cap companies. His hands-on experience has taught Tyler that the development of a superior business model is the biggest factor in determining a company’s long-term success. Accordingly, his research focuses on assessing the viability of management’s growth strategies, trends in addressable markets and achievement of major developmental milestones.