Roivant Sciences Inks $294M Deal with Bayer for Global Rights to Inhaled sGC Activator Mosliciguat; Launches Pulmovant Subsidiary

Local time TuesdayRoivant Sciences announced that it has obtained the global rights to Mosliciguat from Bayer for a $14 million upfront payment and committed to paying up to $280 million in future development, regulatory, and commercial milestones.Bayer will also be eligible to receive high single-digit royalties from the sales of Mosliciguat.

Mosliciguat is designed as a once-daily inhaled therapy and acts as an activator of the soluble guanylate cyclase (sGC) enzyme, which is central to a complex signaling cascade that ultimately leads to vasodilation. According to Roivant Sciences,By activating sGC, Mosliciguat offers a new and potentially optimal treatment option for PH-ILD (pulmonary hypertension associated with interstitial lung disease).This disease affects about 200,000 patients in the United States and Europe, with little or no effective treatment available.

On the same day,Roivant Sciences Launches New Subsidiary Pulmovant to Focus on Development of Soluble Guanylate Cyclase Activator Mosliciguat

"We believe Mosliciguat can change the lives of patients with pulmonary arterial hypertension," Roivant CEO Matt Gline said in a statement, noting Mosliciguat's "differentiated mechanism of action" could "have the greatest impact on patients with PH-ILD."

According to investors, Pulmovant will advance the Phase 2 development of Mosliciguat. The mid-stage study, named PHocus, will "start immediately." Preliminary data from PHocus could be released as early as the second half of 2026. If the Phase 2 study results of Mosliciguat are positive, Roivant estimates that a single registration trial will be sufficient to pave the way for its approval.

Data from the Phase 1b ATMOS study presented by Pulmovant at the 2024 European Respiratory Society Congress in Vienna showed that Mosliciguat reduced mean peak pulmonary vascular resistance by 25.9%, 38.1%, and 36.3% from baseline at doses of 1mg, 2mg, and 4mg, respectively.According to Roivant, this effect is "clinically significant" and represents one of the "largest reductions seen to date."

Early data from 170 healthy volunteers also suggest that Mosliciguat is safe and well-tolerated, while its 40-hour half-life could enable a more practical dosing regimen. "Mosliciguat has an incredibly rare advantage across three key areas: efficacy, safety, and ease of dosing," said Gline.

The last time Roivant and MNC were linked together was in October 2023.Roivant Sciences Sold Its Inflammatory Bowel Disease Candidate Drug to Roche for a Surprising $7.1 Billion in October 2023.RVT-3101 is an experimental anti-TL1A antibody developed by Televant Holdings for ulcerative colitis and Crohn's disease. The two companies completed the transaction in December 2023.

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