PHVS: Initiating Coverage at OW on Compelling Positioning in HAE

Research evidence excerpt

PHVS: Initiating Coverage at OW on Compelling Positioning in HAE

Biotechnology Equity Research

DANAZOL

DANAZOL is an attenuated androgen (200-fold less potent than testosterone) that has been used

historically as an HAE prophylaxis (in both males and females). DANAZOL was approved by the FDA in

1976, and currently it is no longer widely used in the United States.

Market Opportunity in HAE

Pharvaris estimates the US HAE market to be $2.7B as of 2024 and expects it to grow to $4.7B by

2036. They believe that 38% of patients are only using ODT therapy, despite this high number the

total sales of on-demand therapy is approximately $600M. More than half of ODT sales is generic

icatibant, offering room for market growth if patients switch to newer branded medications.

The U.S. prophylactic market is at least $2.1B and remains dominated by TAKHZYRO, which generated

$1.4B in worldwide revenue in 2025. Despite comparatively lower efficacy, ORLADEYO has captured

meaningful share, with $601.8M in total revenue last year. Pharvaris’ management cites ORLADEYO’s

success as evidence that patients are willing to switch from injectable therapies to oral options. The

company argues that physicians are more likely to prescribe oral therapies because adherence is higher,

and its market research suggests that patient preference for oral treatment does not meaningfully

decline until injectable dosing intervals extend to six months, at which point preferences split roughly

50:50. Management has stated they envision capturing 45% of the total prophylactic market.

Potential for launch synergies

If deucrictibant is approved first for on-demand therapy and later for prophylaxis, the initial on-

demand launch should create meaningful infrastructure advantages for the prophylactic formulation.