- Shares in New York-based biotechnology company Immunovant and its main shareholder Roivant Sciences jumped higher Tuesday after Immunovant disclosed early clinical results for a closely watched autoimmune disease drug.
- Immunovant’s drug, a so-called neonatal fragment crystallizable receptor, or FcRn, inhibitor, consistently reduced levels of a blood antibody in healthy adults, without also affecting other lipid and protein values, according to the company. Initial data from a second phase of the trial testing higher doses were similar.
- The company is developing the drug, dubbed IMVT-1402, for autoimmune diseases associated with immunoglobulin G autoantibodies. Both IMVT-1402, and a more advanced drug called batoclimab that Immunovant is also developing, are meant to degrade and remove the harmful autoantibodies.
While it’s early data from a study of healthy adults, the results unveiled Tuesday by Immunovant are viewed by analysts as an important barometer of the drug’s potential.
For Roivant, which owns about half of Immunovant, they may also serve to catalyze business development discussions. Matt Gline, Roivant’s CEO, indicated last month that his company wouldn’t make “any decisions of substance” on whether to sell its Immunovant stake or another promising therapy in its pipeline until it had the Immunovant data in hand.
According to analysts, Tuesday’s results could put Roivant and its subsidiary in a stronger position. “It’s hard to poke holes in the data,” Raymond James’ Danielle Brill wrote in an investor note.
Alex Thompson, an analyst at Stifel, wrote to clients that while he wants to see the complete data, “this looks like a fairly definitive statement around [the drug’s] safety.”
Immunovant said it plans to share additional data from the multiple ascending dose portion of the Phase 1 trial in November. Shares in the company rose by more than 80% in Tuesday morning trading, inflating its market value to nearly $5 billion. Roivant stock also jumped higher by about one-quarter.
Immunovant isn’t alone in developing FcRn inhibitors for autoimmune diseases. Dutch biotech Argenx has one, Vyvgart, approved in the U.S. for generalized myasthenia gravis, as does Belgian drugmaker UCB. Johnson & Johnson is developing another, called nipocalimab, that it expects could eventually earn it billions of dollars in sales.
Yet Louise Chen, an analyst at Cantor Fitzgerald, thinks that with batoclimab and IMVT-1402 together, Immunovant is well-positioned to “have a competitive anti-FcRn franchise, even against larger, more established players like [J&J] and [Argenx].”
Shares in Argenx fell by more than 5% in Tuesday morning trading.
Roivant’s other closely watched asset is a gut disease drug code-named RVT-3101. In July, The Wall Street Journal reported that Roivant was in talks to sell RVT-3101 to Roche in a deal potentially worth more than $7 billion.