Immunovant’s Stock Skyrockets as Positive Phase I Results Shine Light on Autoimmune Antibody Breakthrough

In a morning that set the stock market abuzz, Immunovant’s groundbreaking autoimmune antibody, IMVT-1402, revealed spectacular Phase I results, propelling the company’s stock prices over 60% higher in premarket trading.

During the trial, IMVT-1402 displayed dose-dependent reductions in Immunoglobulin G (IgG) levels, rivaling or surpassing those seen in Immunovant’s other promising therapy, batoclimb. This subcutaneous antibody injection targets the neonatal fragment crystallizable receptor (FcRn), paving the way for the degradation of harmful IgG autoantibodies responsible for autoimmune diseases.

While the company eagerly anticipates sharing data from the multiple-ascending dose (MAD) cohort in November, they’ve already noted that safety data looks overwhelmingly positive. Importantly, there were no concerning decreases in serum albumin or increases in low-density lipoprotein (LDL) cholesterol.

The potential impact of an FcRn-inhibitor is nothing short of vast. According to Immunovant, over two million individuals are grappling with conditions driven by harmful IgG autoantibodies. Back in May, analysts predicted a staggering 200% surge in stock prices if the forthcoming MAD data—expected in November—reveals an impeccable safety profile with broad applicability.

Should this endeavor succeed, Immunovant won’t be the first player in the FcRn-inhibitor arena. In June 2023, the FDA granted approval for UCB’s Rystiggo (rozanolixizumab) to treat two forms of myasthenia gravis (MG) after a Phase III trial showcased remarkable improvements in quality of life, including the ability to breathe, speak, swallow, and rise from a chair.

Argenx’s Vyvgart (efgartigimod) was the pioneer, securing approval in 2021 for a specific subset of MG patients positive for anti-acetylcholine receptor antibodies. A self-administered, subcutaneous version of the drug also won FDA approval in June 2023.

Vyvgart’s positive Phase II data release for adults grappling with chronic inflammatory demyelinating polyneuropathy (CIDP) allowed argenx to raise a staggering $1.1 billion in a global stock offering in July 2023. CIDP is a neurological disorder triggered when the immune system attacks the myelin sheaths surrounding nerve cells.

It seems that myasthenia gravis has become a favored initial target for the FcRn inhibitor class. Immunovant’s batoclimab is currently undergoing Phase III trials for the condition, alongside early-stage testing for thyroid eye disease, Graves’ disease, and CIDP.

As of now, Immunovant hasn’t specified a particular autoimmune target for IMVT-1402. According to Roivant CEO Matthew Gline, the data “opens up a multitude of possible avenues for this drug.”

The stock of Roivant, Immunovant’s parent company and largest shareholder, soared by nearly 13% ahead of the opening bell on Tuesday morning.

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