• Several ASX health stocks are seeking US FDA approval for drugs/devices in the near future
  • Telix Pharmaceuticals is chasing renal cancer imaging approval for TLX-250 CDx
  • Aroa is awaiting an FDA decision on the required regulatory pathway for new product Enivo


As Neuren Pharmaceuticals (ASX:NEU) continues to savour the sweet taste of US Food and Drug Administration approval, which other ASX health stocks are hoping to follow in its footsteps?

NEU’s large pharmac partner Acadia (Nasdaq:ACAD) announced on March 10 that the FDA had approved trofinetide, now dubbed Daybue, for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.

As Stockhead’s very own small-cap share analyst Tim Boreham told readers after the announcement Trofinetide is one of only a handful of drugs developed from scratch in Australia (with help from the Kiwis in Neuren’s case) and approved by the FDA.

It’s the first since the FDA granted approval to Telix Pharmaceuticals (ASX:TLX) for its Illucix prostate cancer diagnostic in December 2021.

Petra Capital healthcare analyst Tanushree Jain said FDA approval is a watershed event for a company and can transform them from a risk perspective and financially.

News of the FDA approval saw the NEU share price soar 60% in the five days following announcement of the FDA approval.


The NEU share price today:



Other ASX health stocks seeking FDA approval

There are several ASX health stocks also seeking regulatory approval for drugs and devices with the US FDA in 2023 heading into 2024, to position in the world’s biggest healthcare market.


Telix Pharmaceutical

TLX announced last week the FDA has approved a supplementary New Drug Application for Illuccix, a kit for the preparation of gallium Ga 68 gozetotide (also known as Ga 68-PSMA-11) injection.

The FDA this time gave approval for use of Illuccix on patients with metastatic prostate cancer, for whom lutetium-177 (177Lu) PSMA-directed therapy is indicated.

To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent.

This expansion means Illuccix can now be used in the US to identify and select patients who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA)-directed radioligand therapy (Pluvicto).

This in addition to the original approved uses for primary staging of patients with suspected metastatic prostate cancer, and in suspected recurrence.

TLX specialises in developing and commercialising radiopharmaceuticals for the imaging and treatment of cancers and rare diseases.

With more than 20 clinical studies underway worldwide, a core pipeline aims to address significant unmet medical needs in prostate, renal, brain, and blood cancers. TLX also has a growing research pipeline focused on novel targets and technologies.

In the near term, In the near term, TLX is preparing to file two additional new drug applications with the FDA for TLX101-CDx, a brain cancer imaging agent and TLX-250 CDx, a PET imaging candidate for renal cancer, based on positive Phase III results.

In both cases, the goal is to gain approval and be ready to launch commercially in 2024, initially in the U.S.

TLX managing director and group CEO Dr Christian Behrenbruch told Stockhead the additional indication for Illuccix further demonstrates its continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them.

“We are also excited to commence filing regulatory submissions for our brain and renal cancer imaging agents during 2023,” he said.

“TLX250-CDx for renal cancer is the perfect follow-on product to Illuccix and builds on the strong engagement we have established in the urology field.

“Data strongly validates that this agent could be potentially as ground-breaking in renal cancer as PSMA-PET imaging has been for prostate cancer.”


Aroa Biosurgery (ASX:ARX) 

Wound care company ARX is awaiting a decision later this month from the FDA on the required regulatory pathway for new product Enivo.

Enivo­­­­ is a new tissue apposition system designed to close tissue cavities at a surgical site created by surgical dissection or tissue removal.

ARX started operations in 2008 as a soft tissue regenerative company and listed on the ASX in July 2020. The company has four approved products including Endoform/Endoform Microbial for ulcers, Myriad for trauma, Ovitex for hernia repair and Ovitex PRS for breast reconstruction.

Morgans health analyst Scott Power said the products are based on the Aroa ECM proprietary soft tissue regeneration technology platform which is derived from ovine forestomach.

Power said a decision by the FDA on a regulatory path for Enivo should help the share price, particularly if it’s a shorter path.


Avita Medical (ASX:AVH)

Regenerative medicine and wound care and company AVH also has an application before the FDA. AVH has a submission of a premarket approval (PMA) supplement application to the FDA for its burn treatment RECELL system.

The supplement, if approved, will expand the indication of RECELL to include soft tissue repair.

AVH is leading the development and commercialisation of devices and autologous cellular therapies
for skin restoration.

Its approved device known as the RECELL System is targeting mainly the acute burns market in the US, which is estimated at US$600m.

Leading Australian burns doctor Professor Fiona Woods, a Perth-based plastic surgeon, was a founder of AVH, which developed her patented spray-on skin technology. It changed its name from Clinical Cell Culture in 2008.


CardieX (ASX:CDX)

CDX is waiting on a 510k clearance for its PULSE device for central blood pressure and associated cardiovascular health monitoring.

While it has been in process since June 2022, CDX has completed the additional information request process from FDA with a response expected in coming months.

Pulse will be the first cloud-connected, customisable, multi-use arterial biometric monitor to include CardieX subsidiary ATCOR’s SphygmoCor central aortic blood pressure technology.


EBR Systems (ASX:EBR)

EBR has been working on a new kind of leadless pacemaker system called WiSE. The company is due to release top-line results in May from its pivotal SOLVE-CRT trial into WiSE.

Power said the results will be a major catalyst for the ASX company and it can then put in a submission to the US FDA, which it is expected to do by the end of CY23 with hopefully approval by mid-2024.

“We have a high degree of confidence that the results will be positive and if it is you will see the share price lift significantly higher,” Power said.


The TLX, ARX, AVH, CDX & EBR share price today:



Cyclopharm (ASX:CYC)

The radiopharmaceutical company is another ASX health stock seeking US FDA approval for its flagship product called Technegs, which is a lung-imaging agent used primarily to diagnose the presence of blood clots in the lungs known as Pulmonary Emboli (PE).

The agent is produced in a specially designed machine called the TechnegasPlus Generator by heating Technetium-99m in a carbon crucible for a few seconds at 2,750 degrees Celsius.

Once inhaled by the patient suspected of having PE, the patient’s lung is then imaged under a gamma camera.

In June 2021, the FDA declined to immediately approve Technegs and issued what’s known as a Complete Response letter.

In its February results summary CYC said over the course of 2022 it invested significant time and resources in addressing items raised by the FDA in both the site inspection report and the Complete Response Letter.

“In response to the site inspection, the company has submitted 12 bi-monthly updates providing the objective evidence that demonstrates process and environmental control improvements along with manufacturing data capture enhancements,” CYC said.

“These bi-monthly updates will continue until approval is received or until a new inspection is conducted.”

CYC said it has completed all external testing and is on track to finalise and submit its reply to the USFDA Complete Response Letter in the coming weeks.

Once submitted, the USFDA will initiate a six-month review process.

“This review process is the last step in achieving the approval to sell Technegs in the USA market,”CYC said.

“Cyclopharm remains confident of commencing US sales in 2023.”


Opitscan Imaging (ASX:OIL)

OIL announced earlier this month it has received feedback from the US FDA in relation to its Pre-Market Notification (510(k)) application for the InVivage product intended for oral tissue imaging.

OIL CEO and managing director Dr Camile Farah said the FDA provided feedback that due to the first-in-class nature of the InVivage and the novelty of its intended use, it could not evaluate substantial equivalence of its device/drug combination product due to the absence of a predicate.

“As such they have deemed that the De Novo Classification Request pathway is more suitable for our purposes,” he said in the announcement.

“While this advice differs from that previously provided to the company by the FDA in Q Submission, we are encouraged by the review process and feedback offered in our recent meetings with the FDA, which have been extremely positive and productive.

Farah said the the review period has been time well spent as it strengthens our next submission.

In addition to discussions around novelty, first-in-class, and available pathways for clearance, the FDA recommended additional studies to expedite a future De Novo submission.

OIL said regulatory clearance of the company’s combination product mandates that both the fluorescent contrast agent drug and the device used to visualise microscopic structures are cleared for use in the intended clinical setting.

The additional data requested by the FDA for inclusion in the company’s De Novo submission relates mostly to novelty of the contrast agent and its intended application to oral tissues.


Dimerix (ASX:DXB) 

DXB is expecting first data from their DMX-200 trial into Focal Segmental Glomerulosclerosis (FSGS) kidney disease by the end of 2023.

FSGS is an orphan indication (a rare disease or condition, and in the US is defined as affecting fewer than 200,000 people).

DXB already has orphan drug designation in by the FDA, and European Medicines Agency (EMA) and MHRA (UK) which means the company has a potential accelerated, or faster pathway to market than non-orphan drugs.

“The advantage of having orphan drug designation means that we only have to do one single phase 3 study, and we have built in two interim end points – so we don’t have to wait for the full study to know how it is progressing, and could get marketing approval halfway through the study” DXB CEO and MD Dr Nina Webster said.


Mesoblast (ASX:MSB)

The FDA has accepted biological licence resubmission for Remestemcel-L to treat children with SR-aGVHD (steroid-refractory acute graft versus host disease).

The FDA said that it considered the resubmission to be a complete response, and has now set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023.

If approved, Remestemcel-L will be the first allogeneic “off-the-shelf” cellular medicine in the US, and the first therapy for children under 12 years old with SR-aGVHD.

“Over the last two years we have worked tirelessly to address the issues previously raised by FDA,”  MSB CEO Silviu Itescu said in an announcement.

“We look forward to working closely with the agency over the review period, with the aim to make Remestemcel-L available as a therapy for children suffering from SR-aGVHD.”


The CYC, OIL, DXB & MSB share price today:


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At Stockhead, we tell it like it is. While Dimerix is a Stockhead advertisers, it did not sponsor this article.