HLB Stock Rollercoaster... "No Variables in New Drug Approval Process"

The stock price of HLB, which had nearly doubled this year on expectations of new drug approval by the U.S. Food and Drug Administration (FDA), fluctuated wildly during the trading session. The stock price, which showed an upward trend by hitting an all-time high early in the session, reversed to a decline in the afternoon. HLB responded to malicious rumors through its website, stating that "there are no variables in the new drug approval process," successfully reducing the drop.

On the 13th, HLB closed at 97,000 KRW, down 3.1% from the previous day.

Early in the session, the stock rose to 104,300 KRW, setting a new all-time high again. The stock began to fall after 1 p.m. and dropped to 84,300 KRW around 1:16 p.m. The market capitalization, which had exceeded 13 trillion KRW, shrank to 11 trillion KRW. Within 20 minutes, 2 trillion KRW of market capitalization disappeared.

At 1:28 p.m., the company stated on its website, "There is absolutely no variable in the company's new drug approval process." It added, "Malicious rumors are not worth even a moment's consideration," and further said, "We urgently post this notice hoping that no individual suffers financial loss by being misled by malicious rumors intended to defame the company."

Afterwards, the stock price reduced its losses and rose about 15% from the low point. The market capitalization stood at 12.69 trillion KRW, nearly 1 trillion KRW less than the peak.

HLB recently announced that major U.S. Pharmacy Benefit Managers (PBMs) have consecutively listed its liver cancer drug in their expected prescription lists. PBMs are agencies that play a key role in drug distribution management in the U.S. health insurance market. Since it is practically difficult to sell drugs without being listed by PBMs, it is important to be included in as many PBM insurance formularies as possible in the U.S.

It is expected that, upon FDA new drug approval, negotiations with various PBMs in the U.S. will proceed. The FDA is anticipated to decide on the new drug approval for the Lenvatinib combination therapy by May at the latest. HLB, together with its U.S. subsidiary Eleva, is currently formulating strategies for rapid insurance listing. The Lenvatinib combination therapy demonstrated the longest patient survival period (22.1 months) ever recorded through global Phase 3 trials. It is expected to gain an advantage not only in broad insurance formulary listings but also in negotiations for prescription priority listings.