Biohaven Stock Stumbles As Protein-Degrading Drug Falls Short Of Expectations In Early-Stage Study

Biohaven Ltd’s BHVN shares are trading lower on Wednesday. The company reported new interim data from the ongoing Phase 1 study of BHV-1300, Biohaven’s lead investigational drug, from its Molecular Degrader of Extracellular Proteins (MoDE) platform.

Shares plunged as the data fell short of investor expectations.

The drug demonstrated a 30% reduction of Immunoglobulin G (IgG), a type of blood protein, in the 3rd and a 37% reduction in the 4th cohorts within 96 hours.

William Blair analyst, writes, “While this is below the high bar for 60% IgG lowering we had heard as a single-dose bogey from many investors, the results for each cohort are in line with the company’s modeling, and the company noted it still plans to dose two more cohorts, which modeling suggests it will achieve >70% lowering of IgG using doses compatible with subcutaneous administration.”

The analyst highlights Immunovant Inc’s IMVT clinical results from the FcRn-targeting IMVT-1402, which showed 45% IgG depletion in a single ascending dose study and 63% IgG depletion in the multiple ascending dose study.

Across doses, dose- and time-dependent IgG lowering was observed even in initial low-dose cohorts, with mean reductions in IgG of 5% and 15%. Some subjects experienced IgG reductions as low as 50 to 70% of baseline.

William Blair adds, ” In terms of rapidity of effect, BHV-1300 reached these levels of IgG depletion within 96 hours (4 days), compared with 50% depletion of IgG from baseline in five to seven days for Argenx Inc’s ARGX Vyvgart (efgartigimod).

The analyst says that the safety profile looks promising overall. Although the initial single ascending dose data didn’t meet high investor expectations, the product’s unique mechanism shows potential, particularly in combination studies.

Price Action: BHVN shares were down 15.6% to $32.02 at the last check on Wednesday.