Meanwhile, due for a March 25 decision but unlikely to gain approval is TG Therapeutics’ combination of Ukoniq and ublituximab, dubbed U2. The treatment, for chronic lymphocytic leukemia, was put on clinical hold in January for concerns that it increased the risk of death.

Ukoniq was previously approved for relapsed or refractory marginal zone lymphoma a year ago. But a CLL nod would catapult it into blockbuster territory, according to Cantor Fitzgerald analyst Alethia Young who projects its peak sales will reach $1.6 billion.

Other drugs due for a March decision

While a phase 3 study of an intravenous version of Marinus’ ganaxolone was recently halted because of a supply disruption in clinical trial material caused by the pandemic, the oral version of the drug still has an FDA target date of March 20. There are better drugs on the market for the epilepsy condition it treats, but some patients who don’t respond to GW’s Epidolex or Novartis’ Afinitor have had success with ganaxolone. The med is expected to generate sales of $384 million in 2026.

Evive Biotech’s Ryzneuta, which treats a common side effect of chemotherapy, neutropenia, is up for a potential approval on March 30. The drug, which ensures infection fighting white blood cell counts remain high, allows patients to continue chemo treatments without interruption.

Hugel America and Croma Pharma GmbH’s Botulax for the treatment of frown lines is up for a decision on March 31. Already approved in 28 countries, including South Korea where it is the market leader, Botulax’s sales are pegged to reach $249 million in 2026.

One more drug has a pending decision date. Sol-Gel Technologies and Galderma’s Epsolay for the skin condition rosacea was due for a decision last year but inspection delays forced a postponement. The inspection was set to be conducted last month, so a decision could happen quickly.