ASX Health Stocks: Lumos down 65pc on FDA rejection; and is Hexima belly-up after Phase 2 readout?
Health & Biotech
Health & Biotech
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Some unexpected news have driven a couple ASX healthcare stocks down by double digits this morning.
Diagnostics company Lumos Diagnostics (ASX:LDX) plunged by 65% after saying that its device submission for FebriDX has been rejected by the US FDA.
According to Lumos, the FDA has expressed concerns regarding the risk that false negative viral infection test results could lead to missed opportunities to treat patients, and contribute to the spread of SARS-CoV-2 infections.
Lumos said this decision was unexpected, considering that FebriDx had previously received regulatory registrations in the UK, Europe, Canada, UAE, Brazil and Australia.
“Clearly this was not the outcome that the company was seeking, and this decision from the FDA is a significant disappointment for Lumos,” said CEO, Doug Ward.
“The US launch of FebriDx was a key component of Lumos’ future commercial plans,” he said.
Ward said he will now be actively working with his regulatory team and advisors to review the feedback, and to develop a revised commercial plan for Lumos.
An appeal to the FDA is also on the cards, which will result in a decision within 90 days of submission, or a potential new 510(k) submission.
FebriDx is a rapid, point-of-care diagnostic test that uses a fingerprick blood sample to identify patients with a pathogen that includes SARS-CoV-2 infections.
Meanwhile, Hexima (ASX:HXL) crashed 46% this morning after an unexpected Phase 2 trial readout of pezadeftide (HXP124).
Hexima said overall, HXP124 was tolerated among its 117 trial patients, with with only three Serious Adverse Events (fall, angina and depression).
However, 114 Adverse Events were also reported, with Hexima providing no underlying data.
Overall, the results are evidence of only modest activity of HXP124 in the treatment of onychomycosis.
Hexima says this study is largely complete, and it anticipates no further meaningful related expenditure on this activity.
The company has now initiated a process of exploring strategic options, as it seeks to secure value for its intellectual property and residual cash resources.
As of 30 June 2022, Hexima had a cash balance of $4 million.
Anteris reported that a 30-day follow-up on the second cohort of eight patients showed clinically significant improvements.
Results showed marked improvements in the patients’ valve’s surface area and, hence, improved blood flow.
All 13 patients in this first-in-human DurAVR THV study also continue to show marked improvements in their clinical status compared with pretreatment levels.
“The data so far is extremely encouraging and fulfilling the hypothesis that DurAVR works better and lasts longer,” said Anteris CEO, Wayne Paterson.
DurAVR is a 3D single-piece aortic valve for the treatment of aortic stenosis, and has unique properties that are critical to longer-lasting valves.
Telix says it has now dosed the final patient and completed recruitment into its Phase 3 pivotal study called ZIRCON.
The trial is studying Telix’s investigational renal (kidney) cancer imaging agent, TLX250-CDx.
If the study is successful, TLX250-CDx may provide a non-invasive method to aid in diagnosis and the identification of metastatic disease through whole-body imaging.
Telix also announced today the appointment of Kevin Richardson as its new CEO of Telix Americas.