Last month, a second phase 3 blow for Marinus Pharmaceuticals prompted the Pennsylvania-based drugmaker to turn an eye toward layoffs and scrap further development of its flagship seizure med. Now, Marinus says it's moving toward a potential refractory status epilepticus (RSE) expansion opportunity with 45% fewer employees.

The totality of the workforce reduction was revealed as the company reported $8.5 million in third-quarter Ztalmy (ganaxolone) sales, representing 56% growth from last year’s third quarter. As it stands, Ztalmy is approved in an oral suspension formulation for patients with seizures associated with CDKL5 deficiency disorder (CDD) following its FDA nod in 2022.

Since the approval, Marinus’ expansion hopes for the franchise have recently been hit by two phase 3 trial misses. In June, the drugmaker reported that while an IV ganaxolone formulation was associated with a statistically significant improvement in statis epilepticus cessation in RSE patients, the trial’s proportion of patients not progressing to IV anesthesia failed to reach statistical significance. The one-for-two showing on the co-primary endpoints resulted in a trial miss.

Still, the company saw the findings from the first randomized phase 3 study as “valuable insights that will guide our ongoing research and development in our mission to bring innovative and effective treatment options to those in need,” CEO Scott Braunstein, M.D, said at the time.

Not all hope is lost for IV ganaxolone in RSE, as the FDA has since granted Marinus a Type C meeting, Marinus saidthis week. During the meeting, the agency and the company will discuss a potential path forward for the drug in the indication. The meeting will be held this year, Marinus said.

Meanwhile, oral ganaxolone development came to a grinding halt last month with a study failure in tuberous sclerosis complex (TSC)-associated seizures. In that phase 3 trial, reductions in seizure frequency “favored” the treatment arm but didn’t lead to statistical significance.

At the time,Braunstein acknowledged that those results are “not likely” to be sufficient for an FDA filing, which had been planned for April 2025. The study prompted Marinus to move toward layoffs and end further ganaxolone development, plus look to “explore strategic alternatives” to maximize shareholder value. 

While the company continues to support the drug’s use in its approved indication, Marinus ultimately narrowed its full-year revenue guidance to between $33 million and $34 million, down from a prior range of $33 to $35 million. The company had $42.2 million in cash and cash equivalents as of September to fund operations through the second quarter of next year. Net losses during the quarter totaled $24.2 million, Marinus reported.

Editor's note: This article's headline was updated at 2:40 p.m. ET to reflect a potential expansion opportunity for ganaxolone despite the trial miss.