Amneal’s Brekiya autoinjector approved by FDA for migraines

Published 15/05/2025, 13:06
Amneal’s Brekiya autoinjector approved by FDA for migraines

BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX), a pharmaceutical company with a market capitalization of $2.3 billion and robust revenue growth of ~13% over the last twelve months, announced today that the U.S. Food and Drug Administration (FDA) has approved its Brekiya® autoinjector, marking it as the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and cluster headaches in adults. According to InvestingPro analysis, the company appears undervalued at current levels, with analysts setting price targets suggesting significant upside potential. The Brekiya autoinjector is designed for self-administration and offers potential sustained pain relief for patients.

The device, which contains the same DHE medication administered in hospitals, allows patients to deliver a dose subcutaneously without the need for refrigeration, assembly, or priming. This development is significant for those who do not respond to oral therapies or experience nausea and vomiting during attacks. The autoinjector can be used at any point during a migraine attack and may prevent headache recurrence.

Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty at Amneal, expressed excitement about providing this innovative therapeutic option to patients, emphasizing its convenience and effectiveness.

With approximately 39 million Americans affected by migraines and up to one million experiencing cluster headaches, the Brekiya autoinjector addresses a substantial need for alternative treatment options beyond emergency room visits. This market opportunity aligns with the company’s strong financial position, as InvestingPro data shows an EBITDA of $605 million and a healthy free cash flow yield. For deeper insights into Amneal’s growth potential and comprehensive financial analysis, investors can access the detailed Pro Research Report, available exclusively to InvestingPro subscribers.

The company cautions against using the Brekiya autoinjector with strong CYP3A4 inhibitors, as serious or life-threatening reductions in blood flow can occur. Other contraindications include heart problems, peripheral vascular disease, allergies to dihydroergotamine or latex, and specific medications taken within the last 24 hours.

Patients are advised to consult healthcare providers before using the autoinjector and to report any adverse reactions to Amneal Specialty or the FDA. The Brekiya autoinjector is expected to be available to appropriate patients in the second half of 2025.

This announcement is based on a press release statement from Amneal Pharmaceuticals.

In other recent news, Amneal Pharmaceuticals reported its first-quarter 2025 earnings, exceeding analysts’ expectations with an adjusted EPS of $0.21, compared to the projected $0.15. The company achieved a revenue of $695 million, which was slightly below the anticipated $726.49 million. Despite the revenue miss, the strong earnings performance was attributed to improved operational efficiencies and a focus on high-margin products. Amneal’s strategic expansion in biosimilars and new product launches contributed to a 5% year-over-year revenue growth. Notably, the company’s gross margin improved to 43.1%, up 120 basis points from the previous year. The pharmaceutical firm also expects net revenue for the full year 2025 to range between $3.0 billion and $3.1 billion, representing a growth of 7-11%. Additionally, Amneal projects an adjusted EBITDA of $650-675 million and an adjusted EPS of $0.65-0.70 for the year. The company’s focus on biosimilars is expected to bring in significant revenue, with projections ranging from $105 to $160 million in 2025.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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