On the 29th, Kyobo Securities said ABL Bio's phase 2/3 results fell short of market expectations, but the possibility of U.S. Food and Drug Administration (FDA) approval remains, so the previous day's share-price drop was excessive.
It maintained a buy recommendation and a target price of 260,000 won.
The previous day, Compass Therapeutics, ABL Bio's partner, announced phase 2/3 results for the combination therapy of the bile duct cancer treatment "tobesimig" and the chemotherapy drug "paclitaxel."
In the results, overall survival (OS) was 8.9 months for the combination therapy and 9.4 months for monotherapy, showing no meaningful difference and failing to meet the second endpoint. In contrast, progression-free survival (PFS) improved significantly, at 4.7 months for the combination therapy versus 2.6 months for monotherapy.
In a conference call held after releasing the data, Compass Therapeutics said it plans to meet with the FDA on approval after additional endpoint analyses and, if discussions are positive, could submit a biologics license application (BLA) by the end of this year.
Jung Hee-ryeong of Kyobo Securities said, "Compass is likely to seek accelerated approval based on objective response rate (ORR) and PFS data," adding, "According to the FDA's 'guidance on OS assessment approaches in oncology trials,' even if there is uncertainty in OS results, accelerated approval is possible if supplemented by ORR, PFS and the like."
Compass Therapeutics also put the size of the second-line bile duct cancer treatment market at about $1 billion and added that, assuming an 85% eligible patient ratio for tobesimig and a 20% peak market share, the pipeline value of ABL001 at its 2028 launch would be an estimated 238 billion won.
Jung said, "Some expectations were partly priced in before the clinical data disclosure, but a roughly 20% decline after the announcement is excessive."