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Handa Biotech Shares Surge After FDA Approval for Cancer Drug
Health Technology · Pharmaceuticals: Major · economic_daily · 2026-09-09
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Handa Biotech's stock rallied following the FDA's final approval of its cancer drug HND-039, as the company released its July financial results.
What Happened
FDA Approval: Handa Biotech has received final approval from the U.S. FDA for its self-developed cancer drug, HND-039 (Omcazio capsules). Given that the original drug generated $2.13 billion in U.S. sales in 2025, this approval is expected to be a significant revenue driver for the company.
Financial Results: In response to a regulatory request, Handa disclosed that its July net profit was approximately NT$4 million, with an EPS of NT$0.02. The company's second-quarter EPS was NT$0.19, down from NT$2.06 in the same period last year, reflecting short-term earnings volatility.
Market Reaction: Driven by the positive news regarding the FDA approval, Handa's stock price has surged since September 4, climbing over 20% to reach a high of NT$132 by September 9. Investors are showing strong optimism regarding the drug's commercial potential.
Long-term Outlook: Looking at the past four quarters, Handa has recorded a cumulative net profit of NT$490 million, with a cumulative EPS of NT$3.08. Market attention will now shift to the drug's launch and its impact on the company's bottom line.