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After phase 3 setbacks, troubled Marinus inks $151M sale to Immedica Pharma
  • Publisher:Phexcom
  • Publication:2024/12/31

Marinus Pharmaceuticals, working through a tumultuous period marked by two phase 3 blows, layoffs and a shareholder lawsuit, has inked an end-of-year sale to Immedica Pharma AB worth $151 million.

With the deal, Immedica brings Marinus’ seizure med Ztalmy (ganaxolone) under its fold, expanding the Swedish drugmaker's U.S. presence through an “immediate revenue-generating rare disease product” and an experienced commercial team, the company noted in a Dec. 30 press release.

Ztalmy was approved by the FDA in 2022 as the first treatment for seizures associated with CDKL5 deficiency order and has since picked up nods in Europe, the U.K. and China.

“The acquisition of Marinus represents a transformative step in Immedica’s journey to further strengthen our position as a leading rare disease company,” CEO Anders Edvell, M.D., Ph.D., said in the release.

Marinus, meanwhile, expects the merger to allow for Ztalmy to make an “even greater impact on patients while providing value for Marinus’ stockholders,” the company’s CEO Scott Braunstein, M.D., added.

The transaction is expected to close during the first quarter of this year and follows Marinus’ review of “strategic alternatives” that had been disclosed in late October.

Marinus’ troubles began brewing in April, when the phase 3 RAISE study assessing an intravenous version of ganaxolone in refractory status epilepticus (RSE) failed to meet pre-defined early “stopping criteria” and sent shares spiraling as the company ended enrollment and moved to evaluate “potential cost-saving strategies," the drugmaker said at the time.

Top-line results unveiled days after shareholders filed a lawsuit revealed that the drug met only one of its two primary endpoints. Still, the company kept its hopes alive in RSE and in November announced that it was granted a Type C meeting with the FDA to discuss a potential path forward in the indication.

Then in October, a phase 3 studying Ztalmy in tuberous sclerosis complex (TSC)-associated seizures missed the mark, leading the company to pump the brakes on further Ztalmy development and begin a search for “strategic alternatives” to maximize value for shareholders. An FDA filing for the drug in TSC-associated seizures had initially been planned for April 2025.

Marinus previously reported that it had enough cash and cash equivalents to fund operations through the second quarter of 2025. Its flagship seizure med picked up $8.5 million during the third quarter of 2024, good for 56% year-over-year growth. Still, the company trimmed down its full-year 2024 revenue guidance to between $33 million and $34 million after recording quarterly losses of $24.2 million and laying off 45% of its workforce.