Biohaven Cuts Quarterly Loss To $129.3 Million, With $350 Million From SK Still Waiting On A Closing
The drug developer's research spending fell to $101.9 million, but an FDA hold on new opakalim enrollment hangs over its biggest licensing deal.
Biohaven, a biopharmaceutical company developing treatments in immunology, neuroscience and oncology, lost $129.3 million in the third quarter, or $0.86 a share, down from a $173.4 million loss, or $1.64 a share, a year earlier, the company reported Thursday. Its balance sheet now leans on two licensing deals, one of which, a $400 million epilepsy-drug sale to SK Biopharmaceuticals, has yet to close.
Spending down, deficit deeper
Research and development spending fell to $101.9 million from $141.2 million. The company credited lower direct program and preclinical costs, largely from a program reprioritization it put in place in the fourth quarter of 2025. General and administrative costs slipped to $24.6 million from $28.2 million.
On an adjusted basis, which strips out non-cash stock pay and derivative fair-value changes, the loss was $110.7 million, or $0.73 a share, against $155.9 million, or $1.47 a share.
The balance sheet is thinner. Cash, equivalents, marketable securities and restricted cash totaled about $164.0 million at September 30. Shareholders' equity at September 30 was a deficit of $98.2 million, against positive equity of $52.1 million at the end of 2025. Notes payable rose to $264.3 million from $238.9 million.
Two licenses carry the cash
Biohaven received $80.0 million on October 20 from Ono Pharmaceutical, which licensed its MoDE IgG degrader portfolio, led by BHV-1300 in a late-stage Graves' disease trial, for Japan, South Korea, Taiwan and the ASEAN region. Biohaven can earn another $20 million on a milestone it expects within a year, plus royalties of about 20% on Ono's net sales there, and keeps rights in the U.S., Europe and China.
The SK deal covers Biohaven's Kv7 platform, including opakalim, being tested for epilepsy. It pays $400 million in cash: $350 million at closing and $50 million a year later, with up to $150 million more in development and regulatory milestones. The antitrust waiting period expired October 28, leaving other closing conditions.
CEO Vlad Coric said the quarter reflected a strategy of "building differentiated platforms and partnering them."
A partial hold on opakalim
The FDA issued a partial clinical hold on September 4 after rodent studies showed metabolites of opakalim whose risk to humans could not be assessed. New enrollment is paused until further nonclinical studies are done. Dosing continues for the more than 600 patients already randomized.
The company said the RISE 3 trial is fully enrolled and its topline results remain on track for the second half of 2026. Biohaven said the rodent findings may not matter for humans, and that opakalim has generally been well tolerated among more than 1,200 participants dosed.
Separately, the FDA accepted the resubmitted application for Vyglxia (troriluzole) in spinocerebellar ataxia, with a user fee goal date in the first quarter of 2027 and an advisory committee meeting planned.
RISE 3 topline data are due in the second half of 2026, and the SK payment of $350 million arrives only when that deal closes.
Sources
- 8-K Filing — Biohaven Ltd. (BHVN) — SEC EDGAR
- Exhibit a2026q3bhvnearningsprex991.htm — Biohaven Ltd. 8-K exhibit — SEC EDGAR
- Biohaven Reports Recent Business Developments and Third Quarter 2026 Financial Results — prnewswire.com
