Highlights

  • In July 2026, the CHMP of the EMA adopted a negative opinion on the arimoclomol MAA; Zevra requested re-examination.
  • Second quarter 2026 revenue was $39,663 thousand and net income was $8,752 thousand, or $0.14 per diluted share.
  • Cash, cash equivalents and investments were $260.2 million at June 30, 2026; term loans were repaid in full on March 12, 2026.
  • A March 13, 2026 Commave settlement sold SDX assets, resolved litigation and produced a $43,314 thousand six-month gain.

Zevra Therapeutics, Inc. (NASDAQ: ZVRA) shares were trading at USD 10.21 on October 27, 2026, up 7.14%, with a relative volume at time of 2.41. The rare disease company repaid its term loans in March 2026, entered a settlement with Commave Therapeutics, announced a CHMP negative opinion on its European application for arimoclomol in July 2026, and filed its Form 10-Q for the quarter ended June 30, 2026 on August 5, 2026.

Zevra Therapeutics is incorporated in Delaware and lists its principal executive offices at 101 Federal Street in Boston, Massachusetts. Its lead product, MIPLYFFA (arimoclomol), is marketed in the United States for Niemann-Pick disease type C, and OLPRUVA remains commercially available for certain urea cycle disorders. The company is also advancing celiprolol for vascular Ehlers-Danlos syndrome in a Phase 3 trial. Its fiscal year ends December 31.

Second Quarter 2026 Results

For the three months ended June 30, 2026, net revenue was $39,663 thousand, compared with $25,881 thousand a year earlier. The company attributed the increase to a $6.4 million increase in revenues under the global expanded access program (EAP) and an $8.7 million increase in MIPLYFFA product sales.

Cost of product revenue was $1,525 thousand, compared with $12,379 thousand. Research and development expenses were $4,486 thousand, compared with $3,433 thousand, and selling, general and administrative expenses were $16,559 thousand, compared with $20,782 thousand. Income from operations was $16,777 thousand, compared with a loss from operations of $71,039 thousand.

Net income was $8,752 thousand, compared with $74,707 thousand. Income tax expense was $4,042 thousand. Diluted net income per share was $0.14, compared with $1.21.

For the six months, revenue was $75,883 thousand and net income was $46,642 thousand, or $0.74 per diluted share. The six months included a $43,314 thousand gain on sale of future royalties, intellectual property and other assets under the Commave settlement and a loss on extinguishment of debt of $2,756 thousand.

Product and Pipeline Developments

In July 2026, the company announced that the CHMP of the EMA adopted a negative opinion regarding the marketing authorization application for arimoclomol, filed in July 2025. Under European regulatory procedures, it has requested a re-examination.

As of June 30, 2026, there were 184 enrollments to receive MIPLYFFA. OLPRUVA generated $0.2 million of revenue in the quarter, and the company said it has scaled back sales and marketing efforts for OLPRUVA and is evaluating strategic alternatives.

The DiSCOVER Phase 3 trial of celiprolol intends to enroll 150 patients and had 66 enrolled participants as of June 30, 2026. The company plans a follow-up FDA meeting in the second half of 2026.

Liquidity, Debt and Cash Flow

Cash, cash equivalents and investments were $260.2 million as of June 30, 2026. Net cash provided by operating activities for the six months was $23,174 thousand, compared with net cash used of $11,823 thousand a year earlier. Net cash used in financing activities was $51,219 thousand, mainly the repayment of debt of $60.1 million, partly offset by $9.2 million from warrant exercises.

On March 12, 2026, the company repaid in full its credit agreement obligations, with approximately $63.1 million of principal outstanding and a make-whole and prepayment premium of $7.2 million. The company has a $75.0 million at-the-market agreement under a registration statement and said sales of common stock could dilute stockholders. It said it believes its cash, investments and operating cash flow are sufficient to fund requirements for at least the next twelve months, and that additional financing may not be available on acceptable terms.

Outlook

The filing contains no numerical financial guidance. The company said it expects expenses to fluctuate as it builds commercial capabilities and continues celiprolol clinical trials, and that it cannot guarantee continued positive net cash flows from operations.