FDA Clears Investigational NDA for Sonnet’s SON-1010; Shares Skyrocket

Shares of the biopharmaceutical company Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) rose around 87% at Wednesday’s close. The surge in price followed the company’s announcement that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) Application for SON-1010 to treat advanced solid tumors. 

SON-1010 is a proprietary version of Interleukin 12 (IL-12), which is designed using Sonnet’s Fully Human Albumin Binding (FHAB) technology. The regulator’s clearance permits the company to commence its first-of-its-kind Phase 1 trial in adult oncology patients in the second quarter of 2022. 

As per the company’s press release, the Phase 1 trial is designed for the “evaluation of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 in adult patients” suffering from advanced solid tumors. It will be a multiple ascending dose study.  

CEO’s Comments 

Encouraged by the FDA approval, Sonnet CEO Pankaj Mohan said, “We are excited about the progress we have made with our FHAB platform, which we believe will set the stage for improved efficacy of monospecific and bispecific cytokines, each differentiated by tumor targeting and retention in the tumor microenvironment.” 

Wall Street’s Take 

Following the FDA’s clearance, Chardan Capital analyst Keay Nakae maintained a Buy rating and a price target of $2.50 (385.44% upside potential) on the stock.  

Nakae views the FDA’s clearance as a “significant milestone for the company”. 

Consensus among analysts is a Strong Buy based on three unanimous Buys. The average Sonnet price target of $2.17 implies 321.36% upside potential from current levels. Shares have lost 18.25% over the past six months. 

Investors  

TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on Sonnet, with 20.1% of investors maintaining portfolios on TipRanks increasing their exposure to SONN stock over the past 30 days.

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