Mirum Pharmaceuticals Slides as FDA Feedback Clouds Volixibat Timeline

Mirum Pharmaceuticals (MIRM) is down 10.4% today. Here is some analysis on what might have caused this price movement.

Analysis: The selloff appears tied to a regulatory setback for volixibat, even though quarterly sales were strong and full-year product sales guidance was raised. Investors seem focused on the FDA recommending a Phase 3 study in PSC, which pushes the company’s potential NDA timing further out and adds execution risk to an important pipeline program.

Details:

Mirum reported second-quarter 2026 net product sales of about $176 million, ahead of Wall Street revenue expectations, while earnings per share missed consensus estimates.

The company raised 2026 net product sales guidance to $680 million to $700 million, up from its prior range, showing continued commercial strength in the business.

Volixibat received Breakthrough Therapy and Orphan Drug designations for cholestatic pruritus due to PSC, but a recent pre-NDA meeting led the FDA to recommend a Phase 3 study before submission.

Mirum now targets a potential volixibat NDA submission in the first half of 2027 after additional FDA discussions, a slower path than investors may have hoped for after the positive VISTAS data.

Sources:

SEC, Mirum Pharmaceuticals, MarketBeat

Disclaimer: This price movement analysis was generated with the help of AI. Please double-check the information provided for mistakes.

$MIRM Insider Trading Activity

$MIRM insiders have traded $MIRM stock on the open market 30 times in the past 6 months. Of those trades, 0 have been purchases and 30 have been sales.

Here’s a breakdown of recent trading of $MIRM stock by insiders over the last 6 months:

CHRISTOPHER PEETZ (CHIEF EXECUTIVE OFFICER) has made 0 purchases and 11 sales selling 90,985 shares for an estimated $9,090,199.
ERIC BJERKHOLT (CHIEF FINANCIAL OFFICER) has made 0 purchases and 8 sales selling 17,287 shares for an estimated $1,750,593.
PETER RADOVICH (PRESIDENT AND COO) sold 16,515 shares for an estimated $1,519,015
JOLANDA HOWE (SVP, GLOBAL CONTROLLER) has made 0 purchases and 4 sales selling 11,887 shares for an estimated $1,219,951.
SAIRA RAMASASTRY has made 0 purchases and 5 sales selling 11,977 shares for an estimated $1,196,140.
JOANNE QUAN (CHIEF MEDICAL OFFICER) sold 7,287 shares for an estimated $670,242

To track insider transactions, check out Quiver Quantitative's insider trading dashboard. You can access data on insider stock transactions through the Quiver Quantitative API insider transaction endpoint.

$MIRM Hedge Fund Activity

We have seen 173 institutional investors add shares of $MIRM stock to their portfolio, and 115 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

FMR LLC added 1,318,909 shares (+204.0%) to their portfolio in Q1 2026, for an estimated $121,840,813
TCG CROSSOVER MANAGEMENT, LLC added 1,000,000 shares (+1611.6%) to their portfolio in Q1 2026, for an estimated $92,380,000
FRAZIER LIFE SCIENCES MANAGEMENT, L.P. added 884,563 shares (+13.0%) to their portfolio in Q1 2026, for an estimated $81,715,929
CAPITAL WORLD INVESTORS added 724,415 shares (+inf%) to their portfolio in Q1 2026, for an estimated $66,921,457
EVENTIDE ASSET MANAGEMENT, LLC removed 684,711 shares (-32.7%) from their portfolio in Q1 2026, for an estimated $63,253,602
PARADIGM BIOCAPITAL ADVISORS LP added 625,000 shares (+inf%) to their portfolio in Q1 2026, for an estimated $57,737,500
POLAR CAPITAL HOLDINGS PLC removed 510,158 shares (-64.3%) from their portfolio in Q1 2026, for an estimated $47,128,396

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard. You can access data on hedge funds moves and 13F filings through the Quiver Quantitative API 13F endpoint.

$MIRM Analyst Ratings

Wall Street analysts have issued reports on $MIRM in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.

Here are some recent analyst ratings:

TD Cowen issued a "Buy" rating on 05/07/2026

To track analyst ratings and price targets for $MIRM, check out Quiver Quantitative's $MIRM forecast page.

$MIRM Price Targets

Multiple analysts have issued price targets for $MIRM recently. We have seen 14 analysts offer price targets for $MIRM in the last 6 months, with a median target of $141.5.

Here are some recent targets:

Lisa Walter from RBC Capital set a target price of $148.0 on 07/07/2026
Jessica Fye from JP Morgan set a target price of $125.0 on 07/02/2026
Jonathan Wolleben from Citizens set a target price of $146.0 on 06/15/2026
Michael Ulz from Morgan Stanley set a target price of $150.0 on 06/11/2026
Yigal Nochomovitz from Citigroup set a target price of $145.0 on 06/02/2026
Kalpit Patel from Wolfe Research set a target price of $145.0 on 05/19/2026
Brian Skorney from Baird set a target price of $129.0 on 05/07/2026

This article is not financial advice. See Quiver Quantitative's disclaimers for more information. Note that there may be inaccuracies due to mistakes in ticker-mapping, and other anomalies.