A Wall Street executive says his four-and-a-half-year-old son experienced a rapid transformation in social behavior after receiving an experimental autism drug through the FDA’s expanded-access program. Matthew Bielski, whose son Lev Bielski struggled with self-harm and limited eye contact, described the change as happening "almost overnight." The drug, L1-79, developed by Yamo Pharmaceuticals, is designed to target core social symptoms of autism, an area not directly addressed by currently approved medications. While the family celebrates the results, the treatment remains experimental, with phase three trials scheduled for 2027.
Lev Bielski’s parents reported that before receiving L1-79, he was withdrawing from family members and at risk of requiring more restrictive measures to prevent self-harm. Matthew Bielski stated that the change was immediate. "It was the next day," Bielski told the New York Post. "It was right away and other people in all the phases said the same thing." He added, "It changed everything for us." Bielski has become an advocate for the drug, predicting it could become the "Ozempic of autism," a term referencing the rapid weight-loss effects of the popular diabetes drug.
What the Right Is Saying
Conservative commentators and free-market advocates focus on the regulatory pathway that allowed access to the drug. Matthew Bielski utilized the FDA’s expanded-access program, which permits patients with serious conditions to access investigational drugs when no comparable or satisfactory therapies are available. Bielski, a Wall Street executive, has personally invested in Yamo and launched an Autism Impact ETF through his firm, Defiance ETFs, pledging to donate net advisory profits to autism-related causes. This perspective highlights the role of private investment and individual choice in navigating federal health regulations to obtain experimental treatments.
What the Left Is Saying
Progressive advocates and patient families highlighted in the reporting emphasize the urgent need for treatments that address core social deficits rather than just associated symptoms like irritability. Corrie Niesse, another parent featured in the report, noted that her daughter Payton began talking significantly more and was able to engage in conversations. "Payton later said she wanted to resume taking the medication," the report stated. Families argue that the current standard of care leaves many with autism without options for improving fundamental communication and social connection, viewing L1-79 as a potential breakthrough for quality of life.
What the Numbers Show
L1-79 has not received FDA approval. Yamo Pharmaceuticals describes the drug as a twice-daily oral treatment. The company reports that L1-79 received FDA Fast Track designation and is moving toward phase three trials in 2027. Early data includes a 2019 case series published in Clinical Therapeutics involving eight people with autism over eight weeks; seven showed improvements on behavioral rating scales, and four of six assessed with a separate diagnostic tool improved. In a later phase two trial involving 58 adolescents and young adults, Yamo reported statistically significant improvements in socialization scores compared to placebo during the first treatment period. However, the authors of the 2019 study noted that findings needed confirmation in double-blind studies.
The Bottom Line
While individual anecdotes like Lev Bielski’s suggest potential efficacy, L1-79 remains in the early stages of clinical validation. Yamo Chief Medical Officer Dr. Tom Megerian described the drug as "a new treatment candidate aimed at social connection, not a cure." The drug’s future depends on the outcome of phase three trials expected to begin in 2027. Until then, access for most patients will likely remain limited to clinical trial participants or those qualifying for expanded-access programs. Investors and families will watch for peer-reviewed data from larger, double-blind studies to determine if the rapid changes observed in early users are reproducible across a broader population.