Helixmith Plunges On Warning Of Possible Offering Delay
Investment Losses Also Concern Shareholders
Korean venture Helixmith faces another setback following a missed Phase III endpoint for its plasmid DNA neuropathy candidate, with its shares plunging after it warned of a possible delay in a planned rights offering, amid concerns from minority shareholders over other investment losses.
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South Korean pharma and biotech companies are opting to spin off certain businesses and set up new subsidiaries to speed up R&D progress and tap funding opportunities. The move, which has become more visible in the past few years is in line with global biopharma trends, although the reasons may vary.
After probing pharmacokinetic data flaws in the first US Phase III study for its gene therapy Engensis, Korea's Helixmith concludes that these stemmed from clinical operation issues. As a result, it admits a failure to meet the primary endpoint but is still moving forward with new trials given signals of efficacy and safety in an extended study.
Helixmith delays making conclusions on disappointing first top-line data from lead US Phase III study of plasmid DNA therapeutic Engensis, citing unexpected pharmacokinetic results in the placebo and treatment groups. The South Korean biotech vows to improve strategy for upcoming trials, but much may hinge on their success.