Latest Fda News

CONNEQT Health delivered sharp FY26 revenue growth and reduced its statutory loss as Pulse sales and clinical subscriptions expanded. But the ASX-listed medtech group ended the year with negative net assets, heavy cash burn and a material uncertainty over its ability to continue as a going concern.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

Vitrafy has added US blood network Versiti to its cryopreservation development programme, with the partnership focused on no-wash platelet preservation and regulatory verification. The deal strengthens the company’s institutional network, but initially generates no revenue and remains subject to US regulatory requirements.

Compumedics Limited (ASX:CMP) returned to profit in FY26 as record revenue, stronger cash generation and a sharp rise in MEG and SaaS sales reshaped its earnings profile. The company enters FY27 with A$28.3 million of open orders, but lower gross margins and uneven US and European execution remain key tests.

Imagion Biosystems has secured central ethics approval for its US Phase 1b/2 trial of the MagSense HER2 imaging agent, removing a key requirement before recruitment can begin. Site activation is now underway, but no patient has yet been enrolled and the announcement provides no clinical data.

Vectus Biosystems has secured a pre-IND Type B meeting with the FDA for its lead IPF drug candidate VB0004. The regulator’s written feedback, expected by mid-November, should clarify the next US development steps but does not yet authorise clinical trials.

Telix has secured FDA Fast Track designation for BiPASS, its Phase 3 program testing 68Ga-PSMA-PET alongside MRI before prostate biopsy. The milestone may support closer FDA engagement and faster review of a planned NDA, but the indication remains investigational and no BiPASS results were disclosed.

Memphasys will receive an A$3.5 million advance from major shareholder Peters Investments to expand Felix production, inventory and sales capacity as repeat orders emerge across international markets. The funding carries a 12.5% interest rate, potential equity dilution and requires shareholder and ASX approvals before the convertible notes can be issued.

EBR Systems has completed the FDA’s pre-approval inspection of its new Santa Clara manufacturing facility, receiving two Form 483 observations. The company says it expects to correct them in the fourth quarter and still anticipates approval by year-end, although the FDA has not yet made its final determination.

EMVision Medical Devices has received a $4.3 million R&D tax refund, adding non-dilutive funding as it progresses clinical work on its emu™ and First Responder devices. The cash arrives against a last reported cash balance of $17.1 million and $4.6 million in remaining grant funding at 30 June 2026.

Nexsen has proposed a 50:50 joint venture with FlashDx Shenzhen to develop and commercialise an enhanced molecular Group B Streptococcus test, using an existing CE-marked platform as its starting point. The proposed venture could shorten Nexsen’s path into hospital and intrapartum testing across Asia-Pacific, but the term sheet remains non-binding and regulatory work is still ahead.

Memphasys says it has identified a potential FDA 510(k) pathway for its Felix sperm separation system, replacing the more complex De Novo route previously contemplated. The company will seek FDA feedback before targeting a formal submission in the first quarter of 2027, while keeping commercial execution focused on existing markets.