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Biotech cash calls and FDA delays drive a mixed healthcare week

MARKET NEWS By Logan Eniac 7 min read

Biotech funding and regulatory setbacks drove the week’s biggest healthcare share moves, while larger companies delivered stronger earnings and deal activity. Telix’s proposed ITM takeover, Ramsay’s demerger plans and a mixed group of clinical updates kept investors focused on cash, approvals and sales.

  • Nyrada fell 28.77% after announcing a $12 million placement that will fund trials but dilute existing holders.
  • Memphasys dropped 16.67% as investors weighed a possible US approval route that still needs FDA feedback.
  • Nexsen fell 15.15% after delaying its StrepSure submission and suspending trading pending a contract update.
  • Telix plans to buy ITM for US$1.65 billion, gaining control of a radiopharmaceutical supply chain but taking on dilution and regulatory risk.
  • Ramsay, Sonic Healthcare and Biome reported stronger results, although each still faces a specific test in the year ahead.

Biotech funding drove the week’s biggest healthcare share falls. Nyrada (ASX:NYR) dropped 28.77% after raising A$12 million at 62 cents a share. The cash should fund its heart attack and stroke drug trials, but the issue creates new shares and reduces the ownership of existing investors. A proposed A$5.125 million investment by directors also needs shareholder approval.

Memphasys (ASX:MEM) fell 16.67%. The company may use a simpler US approval process for its Felix sperm separation device, but it has not yet confirmed that the FDA will accept the proposed comparison product or evidence. Investors therefore received a possible improvement in the plan, not an approval.

Nexsen (ASX:NXN) lost 15.15% after pausing clinical enrolment for its StrepSure test. An interim review found that the device needs performance improvements before a US submission. Trading was then suspended while the company prepared an announcement about a potentially important device contract. The delay gave investors less certainty about when sales could begin.

Cash buys time, but not certainty

Across smaller biotechnology companies, new money arrived alongside fresh questions. Dimerix (ASX:DXB) drew A$17 million from a non-share funding facility to support its Phase 3 kidney trial and a second drug programme. That avoids immediate dilution, but repayment may depend on licensing income, milestone payments or later access to investors. Prescient Therapeutics (ASX:PTX) raised about $6 million to carry PTX-100 beyond its December review. The next decision will depend on results from a study that has enrolled half of its planned evaluable patients.

Clinical progress also came with long waits for proof. Neurotech International (ASX:NTI) dosed the first child in a planned 200-patient Phase 3 autism study. A Phase 3 trial is the large test used to see whether a treatment works reliably against a dummy treatment. Actinogen Medical (ASX:ACW) completed the final patient visit in its 247-person Alzheimer’s study, with results still due in November 2026. AdAlta (ASX:1AD) will meet the FDA on 3 November US time to discuss its first human study for a mesothelioma cell therapy.

Large transactions and supply control shaped the sector’s bigger end. Telix Pharmaceuticals (ASX:TLX) plans to buy ITM for US$1.65 billion, including about US$1.25 billion in Telix shares. ITM generated US$273 million in 2025 and supplies the radioactive lutetium-177 used in cancer treatments. The deal could give Telix more control over supplies and add a commercial product base. It also brings new shares for ITM owners, integration work and an unresolved FDA review for ITM-11. Telix fell 10.92% for the week, with the stock still below its latest reopening price.

Earnings improve while product launches build slowly

Ramsay Health Care (ASX:RHC) reported a 22.9% rise in underlying net profit to $364.1 million and lifted its fully franked dividend by 13.8% to 91 cents. The company’s funding group debt measure improved to 1.83 times earnings. Investors must still vote on the Ramsay Santé separation on 24 November 2026. Sonic Healthcare (ASX:SHL) lifted underlying profit by 17% to A$621 million, helped by its LADR acquisition and planned US cost savings. Swiss fee cuts and a slower UK contract start remain concerns.

Biome Australia (ASX:BIO) grew revenue 30% to $23.9 million and produced positive operating cash flow of $1.6 million. Its reported $3.6 million profit included a $2.4 million tax benefit, so the next year will show whether sales growth can support the business without that benefit. ReNerve (ASX:RNV) completed its first commercial surgeries in Hong Kong and Malaysia, while Orthocell (ASX:OCC) recorded its first Remplir sales in Thailand. These launches add new markets, but sales are still at an early stage.

Diagnostic and medical device companies made steady regulatory progress. EBR Systems (ASX:EBR) secured higher US Medicare payment rates for WiSE procedures from 1 October 2026. Hospitals must still adopt the treatment and perform enough procedures to create a material sales effect. BCAL Diagnostics (ASX:BDX) began a phased Australian launch of an eight-cancer blood test, but its 56.2% sensitivity means a negative result does not rule out cancer. Mesoblast (ASX:MSB) won FDA approval for an additional quality test for Ryoncil, supporting manufacturing checks without providing new sales or patient results.

Bottom Line?

The next major dates are the FDA meeting for AdAlta’s EW-001 on 3 November 2026, Actinogen’s XanaMIA results in November 2026 and the Ramsay Santé demerger vote on 24 November 2026. Investors will also watch whether Telix can complete its proposed ITM acquisition and resolve the FDA issues affecting ITM-11.

Questions in the middle?

  • Will Nyrada’s funded trials produce useful results before the extra shares weigh further on existing holders?
  • Can Telix fix ITM-11’s manufacturing and facility issues while integrating a US$1.65 billion acquisition?
  • Will the new Medicare rates help EBR turn better hospital payments into repeat procedure volumes?