Pull to refresh
Logo
Biohaven epilepsy drug hits FDA hold nine days after SK Biopharma licensing deal

Biohaven epilepsy drug hits FDA hold nine days after SK Biopharma licensing deal

New Capabilities

A rodent-metabolite finding freezes new enrollment in the drug's pivotal trials, splitting the programs's timeline

Today: Biohaven discloses hold;shares sink, timelines split

Overview

Updated 1 hour ago

Nine days after Biohaven signed a licensing deal worth up to $795 million with SK Biopharmaceuticals for its epilepsy drug platform, the FDA halted new enrollment in the drug's two late-stage trials. The hold came not because BHV-7000 (opakalim) showed safety problems in humans—over 1,200 people have taken it and tolerability has been generally clean—but because a metabolite found in rat studies raised questions the agency couldn't fully assess. Biohaven says the finding's significance to people is uncertain and may be rodent-specific.

The split isfateful: BHV7000-303 (RISE 3), one of two pivotal trials in refractory focal epilepsy, finished enrolling in June and remains on track for top-line data in H2 2026. But BHV7000-302 (RISE 2), which had not yet completed recruitment, now sits frozen at new-patient entry, likely delaying its readout. Two weeks earlier, that same drug had been the centerpiece of a deal designed to share development costs with a deep-pocketed Korean licensee. Now the FDA's request for more nonclinical data—expected in the coming weeks—determines whether that deal's central asset limps or flies.

Why it matters

If the partial hold pushes BHV-7000 off schedule, Biohaven loses its main value driver and SK Biopharmaceuticals' $795M bet stalls—leaving both with few options.

Questions about this story

Free account needed to ask — your question is kept and asked for you right after sign-up. Answers are public.

No questions yet — be the first to ask.

Key Indicators

$795M
SK Biopharma licensing deal value
Upfront and milestone payments for worldwide rights to the Kv7 platform,BHV-7000 included.
600+
Patients already randomized can continue dosing
Existing participants across BHV-7000 trials keep treatment;only new enrollment is paused.
1,200+
Participants dosed across BHV-7000 program
Clinical safety has been generally good, with no signal in humans tied to the rodent metabolite.
13%+
Biohaven premarket share drop after disclosure
Reuters reported shares down more than 13% in premarket trading the morning of Sept 10.

Voices

Curated perspectives — historical figures and your fellow readers.

Ever wondered what historical figures would say about today's headlines?

Sign up to generate historical perspectives on this story.

Play

Exploring all sides of a story is often best achieved with Play.

Most of these play right now — no account needed. Sign up to save scores, keep a streak, and unlock Debate and Predict. Log in Sign Up
Predict 3 ways this could play out. Back the one you believe — contrarian picks score more when a scenario has a resolution date. Log in to play

Organizations Involved

Timeline

January 2024 September 2026

6 events Latest: Today
Tap a bar to jump to that date
  1. Biohaven discloses hold;shares sink, timelines split

    Today Market

    SEC filing and Reuters report;stock drops 13%+ premarket. RISE 3 unaffected, but RISE 2 enrollment stays paused, delaying its readout.

  2. FDA issues partial clinical hold

    Regulatory

    Agency pauses new enrollment citing insufficient info on a rodent metabolite's potential human risk.Biohaven extends pause globally.

  3. Biohaven licenses Kv7 platform to SK Biopharmaceuticals

    Commercial

    SK gets worldwide rights including BHV-7000, valued at up to $795 million in upfront and milestones.

  4. RISE 3 fully enrolled

    Clinical

    Enrollment completes in BHV7000-303,one of two pivotal trials,robo-pulsing dosing continues.

  5. Troriluzole rejection forces R&D cuts

    Regulatory

    FDA turns away Biohaven's ataxia drug, prompting a 60% budget slash and a near-half stock collapse.

  6. Biohaven clears FDA phase-2 gate

    Regulatory

    Completes end-of-phase-2 meeting;advances BHV-7000 into two pivotal phase-3 focal epilepsy trials.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

February 2017 – March 2019

Sage Therapeutics' brexanolone (2017–2019)

Sage's postpartum-depression drug brexanolone hit an FDA clinical hold over a metabolite question yet despite initial data, the agency eventually approved it—two years later—after resubmission with additional safety analyses.

Then

A two-year delay and added trial costs pushed Sage deep intoins the red, forcing equity raises.

Now

The drug reached market on the strength of the original efficacy data, but its launch stalled on reimbursement and route-of-administration issues;Sage later restructured around newer CNS assets.

Why this matters now

Shows unmetabolite-relatedholds can resolve without killing a drug—but they still cost years and large sums, which is exactly what BHV-7000's partners hope to avoid.

June 2019 – May 2020

Intercept Pharmaceuticals' Ocaliva (2019–2020)

FDA issued a complete-response letter then a clinical hold on Intercept's NASH drug obeticholic acid over a drug-induced liver-injury signal,and subsequent data failed to win approval, eventuallydooming the program.

Then

Intercept's shares lost roughly 80% of value within a year,and the company abandonedthe NASH indication.

Now

The case became a cautionary tale about how regulator-requested safety analyses, whenunfavorable, can torpedo even late-stage programs.

Why this matters now

Contrast scenario:if Biohaven's rodent-metabolite data come back inconclusive or worse, a similar fate awaits—making the upcoming nonclinical results existential,not a formality.

Sources

(11)