With just 10 days to go before the U.S. FDA rules on its liver cancer drug, HLB is pushing back against swirling rejection rumors while making a bold acquisition to expand into obesity treatments.
In a Monday morning statement, the company dismissed speculation that the FDA is leaning toward rejecting CAM-RIVO—a combination of rivoceranib and Jiangsu Hengrui’s camrelizumab—as “malicious rumors.” HLB assured investors that the FDA has yet to make a decision and promised to announce the outcome via YouTube “as soon as we receive official notification.”
“As the approval date approaches, we expect rumors to intensify,” the company wrote on its blog. “Notably, today is Sunday in the U.S.”
HLB is rejecting speculation about its liver cancer drug approval, stating that the FDA has yet to make a decision. (Credit: Getty Images)
HLB is rejecting speculation about its liver cancer drug approval, stating that the FDA has yet to make a decision. (Credit: Getty Images)
The approval process for CAM-RIVO has been anything but smooth. HLB submitted its new drug application in 2023, but the FDA handed it a complete response letter, demanding more data and stalling the approval timeline. Now under priority review, the drug faces a make-or-break decision by March 20.
HLB traded at 79,200 won ($54.39) as of 11 a.m. Tuesday after skidding more than 20 percent Monday before closing at 79,800 won, down 6.99 percent. Group affiliates HLB Therapeutics (-10.98 percent), HLB Pharmaceutical (-8.72 percent), and HLB Life Science (-7.24 percent) also took steep hits, with several stocks touching 52-week lows.
“Any dip in stock price triggers panic selling,” an HLB spokesperson said Tuesday, noting that retail investors are particularly skittish. “Some investors are capitalizing on those fears with market manipulation tactics.”
Even as it braces for the FDA decision, HLB is making moves beyond cancer drugs. The company announced Monday afternoon that it has acquired ANYGEN, Korea’s only GMP-certified peptide manufacturer, in a 60 billion won ($41 million) deal aimed at expanding into obesity drugs and contract development and manufacturing (CDMO).
Shares of ANYGEN surged more than 11 percent as of 10:07 on Tuesday, jumping to 12,490 won, after initially spiking 25.57 percent to 14,240 won at market open.
HLB’s acquisition of ANYGEN expands its biotech portfolio, strengthening its position in peptide-based drug development. (Credit: ANYGEN)
HLB’s acquisition of ANYGEN expands its biotech portfolio, strengthening its position in peptide-based drug development. (Credit: ANYGEN)
The acquisition gives HLB a strong foothold in peptides, a growing area in GLP-1 obesity treatments, which have become pharma’s red-hot battleground after the blockbuster success of Eli Lilly and Novo Nordisk.
Seven HLB affiliates are investing 15 billion won in a third-party capital increase and acquiring 5 billion won in convertible bonds (CBs). Financial investors are adding another 5 billion won in equity and 35 billion won in CBs.
With fresh capital, ANYGEN aims to accelerate its next-generation GLP-1 obesity treatment, designed to deliver stronger efficacy and improved pharmacokinetics. The company is also deepening its collaboration with HLB Pharmaceutical, which is developing a long-acting injectable obesity drug.
ANYGEN produces active pharmaceutical ingredients for Leuprorelin and Ganirelix injections, both of which are awaiting cGMP certification from the FDA. HLB’s HBS (HLB Bio eco-System) is positioning ANYGEN’s peptide technology as a potential driver for next-gen oncology drugs, including peptide-drug conjugates (PDCs).