Pulmovant reports positive phase 1 data for inhaled PH treatment

WALTHAM, Mass. - Pulmovant, a subsidiary of Roivant (NASDAQ:ROIV) - a $7.7 billion market cap biotech company with a strong financial health score according to InvestingPro - announced Monday the publication of Phase 1 pharmacokinetic data for mosliciguat, an inhaled soluble Guanylate Cyclase activator being developed for pulmonary hypertension.

The studies, published in Clinical Pharmacokinetics, involved healthy male volunteers and support once-daily administration of the drug with no evidence of serious systemic side effects, according to the company’s press release.

Mosliciguat is being developed as a potential first-in-class dry powder inhalation treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD), a condition affecting up to 200,000 patients across the U.S. and Europe with limited treatment options.

The data from three Phase 1 studies showed the drug was well tolerated without major systemic effects on heart rate or blood pressure. Researchers observed a long residence time in the lungs and slow, continuous release into systemic circulation. Wall Street analysts maintain a bullish outlook on Roivant’s prospects, with price targets ranging from $12 to $22 per share. For deeper insights into Roivant’s financial health and growth potential, investors can access the comprehensive Pro Research Report available on InvestingPro, which covers this and 1,400+ other top US stocks.

"These PK results from completed studies indicate that mosliciguat achieves measurable, effective systemic exposure via inhalation with no evidence of serious side effects reported to date," said Ubaldo Martin, Senior Vice President and Head of Clinical Development at Pulmovant. The company’s development efforts are supported by a solid financial foundation, as revealed in additional financial metrics available on InvestingPro, including multiple ProTips and detailed valuation analysis.

Unlike other compounds targeting the same pathway, mosliciguat is an sGC activator that works independently of heme and nitric oxide, potentially offering advantages in treating pulmonary hypertension.

The company is currently conducting a Phase 2 clinical trial called PHocus (NCT06635850) evaluating mosliciguat in adult patients with PH-ILD.

Pulmonary hypertension is characterized by high blood pressure in lung blood vessels, while interstitial lung disease describes a group of conditions causing progressive lung damage.

In other recent news, Roivant Sciences has maintained a positive outlook from analysts, with H.C. Wainwright reiterating a Buy rating and an $18.00 price target. This follows a series of strategic updates, including the addition of two new potential indications for its therapeutic candidate IMVT-1402, targeting Sjogren’s syndrome and cutaneous lupus erythematosus. The company has also undergone significant management changes, with Eric Venker, MD, appointed as the new CEO of Immunovant, a subsidiary of Roivant Sciences. These developments coincide with a strategic narrowing of Immunovant’s focus, reducing the number of indications for IMVT-1402 from ten to six. Cantor Fitzgerald also maintained an Overweight rating, highlighting the potential of the new indications due to the absence of effective treatment options and a large market. Additionally, Roivant Sciences has finalized a consulting agreement with its former Chief Accounting Officer, Rakhi Kumar, to provide advisory services during a transition period. Meanwhile, Immunovant reported promising results from a Phase 3 study of its drug batoclimab for Myasthenia Gravis and a Phase 2b study for Chronic Inflammatory Demyelinating Polyneuropathy. Despite these positive outcomes, the focus remains on advancing IMVT-1402, with pivotal studies expected to commence soon.

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