These were the best ASX biotechs as Health Care sprang back to life in FY23
Health & Biotech
Health & Biotech
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There are signs that the biotech sector is coming back to life as we reached the end of FY23.
The NASDAQ Biotechnology Index (NBI), the often used barometer for the sector, is up almost 4% in the last 12 months after slumping 10% in 2022.
At home, the ASX 200 Health Care (XHJ) is also 3% higher in FY23 after tumbling 8% in 2022.
The rally comes as big institutional funds slowly begin to re-enter the picture. ARK fund manager Cathie Wood, for example, loaded up on US biotech names as she went on a shopping spree in May.
There are several good reasons why the current market landscape may be conducive to a rebound in biotech stocks.
First, as inflation begins to soften, central banks would be thinking about pausing or lowering rates – leading investors to rotate out of value and back into growth stocks like biotech.
The IPO market also appears to be coming back, with several biotechs being listed in the US in 2023. Acelyrin, which raised US$550m in the IPO round, was a notable listing as its shares began trading on the Nasdaq in May.
The biggest ASX biotech breakthrough in 2023 was arguably that of market darling, Neuren Pharma.
In March, Neuren announced that its North American partner Acadia Pharma received a “historic” US FDA approval of DAYBUE (trofinetide) – making the drug the first and only approved treatment for Rett syndrome in the world.
Neuren is eligible to receive ongoing royalties on net sales of trofinetide in North America, plus milestone payments of up to US$350 million on achievement of a series of four thresholds of total annual net sales, amongst other payments.
Zelira announced that its diabetic nerve pain drug outperforms multi-billion dollar Pfizer’s drug, Lyrica – achieving a significant reduction in NRS pain scores, indicating a decrease in symptom severity.
ZLT-L-007 was found to be safe and well-tolerated, meeting the primary endpoint for safety with no Serious Adverse Events (SAE).
The study also met its secondary endpoints, including significant decreases in Visual Analog Scale (VAS) and Short-form McGill scores, among others.
These compelling outcomes have provided confidence for Zelira to evaluate further progression of ZLT-L-007 into formal FDA clinical trials.
The medical software technology company surged after being given clearance by the US FDA for its SOZO Pro product.
SOZO Pro is the company’s next generation bioimpedance spectroscopy (BIS) system, providing personalised health metrics to quickly inform clinical decisions to health workers at the point of care.
Compared to SOZO, SOZO Pro offers a new, higher standing weight capacity (SOZO: 170kg; SOZO Pro: 220kg), and an updated stand design allowing for easier transition between the standing and seated measurement position.
Telix has been rising after announcing the expansion of its artificial intelligence (AI) capability with the signing of an agreement to acquire Vienna-based Dedicaid GmbH, a spin-off of the Medical University Vienna.
Dedicaid’s core asset is a clinical decision support software (CDSS) AI platform capable of rapidly generating indication-specific CDSS applications from available datasets, for use with positron emission tomography (PET) and other imaging modalities.
Each CDSS application is trained to predict outcomes such as the severity of disease, risk to the patient and/or inform treatment decisions.
Dermatology company Botanix Pharma shares have risen this year after the US FDA conducted a midcycle review meeting for its lead product, Sofpironium Bromide.
The FDA has indicated that continued discussions will focus on labelling, clinical outcome assessments, patient instructions and brand name.
Planned approval date in September 2023 remains on track.
Additionally, Botanix secured a new sub-licence and distribution agreement for Sofpironium Bromide product in South Korea.
Botanix’s partner Kaken and in turn Botanix, will receive a share of upfront payments, milestones and royalties based on net sales of the product.
ALA’s share price more than doubled in April after saying that lead drug ALA-101 confers significant anti-tumour effect and survival benefit in aggressive leukemia models.
The company presented new data at the American Association for Cancer Research (AACR) Annual Meeting for CAR19-iNKT cells.
ALA says clinical data indicated that ALA-101 has the potential to be a novel ‘off-the-shelf’ cell therapy to treat CD19-expressing leukemias and lymphomas.
Medical equipment and radiopharmaceutical company Cyclopharm announced the US FDA will be coming to inspect the company’s facility in Kingsgrove NSW, between 24 July through 4 August.
The inspection follows a confirmation by the FDA of its six-month review period for Cyclopharm’s New Drug Application of lung ventilation imaging agent, Technegas.
Technegas is an ultra-fine dispersion of radioactive labelled carbon, produced by using dried Technetium-99m in a carbon crucible, micro furnaced for a few seconds at around 2,700 degrees Celsius.
Cyclopharm says that the FDA approval will create an initial addressable market in the USA of US$180 million per annum in the diagnosis of Pulmonary Embolism (PE).
The exosome and precision diagnostics company surged after announcing excellent results from an independent clinical validation study of its SubB2M/CA15-3 test for breast cancer detection.
The study showed high accuracy (87%), sensitivity (81%), and specificity (93%) for INOVIQ’s SubB2M test, outperforming a leading approved CA15-3 test.
INOVIQ now intends to present these data and its development plans to potential partners and key opinion leaders to advance commercial discussions for its SubB2M/CA15-3, SubB2M/CA125 and SubB2M multi-cancer tests.
The US FDA has accepted Mesoblast’s biological licence resubmission for Remestemcel-L in the treatment of children with SR-aGVHD (steroid-refractory acute graft versus host disease).
The agency said that it considered the resubmission to be a complete response, and has now set a potential approval date of August 2.
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.
Immuno-oncology biotech Imugene has received a US FDA Investigational New Drug (IND) clearance to initiate a Phase 1 clinical study of its oncolytic virotherapy candidate, onCARlytics.
The clearance allows Imugene to start patient recruitment and dosing of CARlytics (CF33-CD19), combined with blinatumomab in patients with advanced or metastatic solid tumors.
The radiopharmaceutical company said that the FDA has granted Orphan Drug Designation to its Ga68-Trivehexin (RAD 301) radiopharmaceutical technology.
Trivehexin is used to image patients with pancreatic ductal adenocarcinoma (PDAC).
Radiopharm has signed an exclusive licensing agreement with TRIMT GmbH for development and commercialisation of Trivehexin in the US, Australia, China, Hong Kong, and Japan.
The US FDA has removed the clinical hold on its New Campylobacter ETEC Therapeutic IND application, paving the way for a clinical trial involving Immuron’s drug.
This comes after the US Naval Medical Research Center (NMRC) received an approval from the FDA to proceed with the clinical evaluation of a new oral therapeutic targeting ETEC disease, developed in collaboration with Immuron.
Aroa has just received US FDA 510K clearance for its Enivo pump and catheter solution.
The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery.
It has been cleared for use in the removal of surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery, or other general surgeries where large flaps are formed.
Nova Eye confirmed that the US FDA has cleared the company’s newest generation canaloplasty device for canal-based glaucoma surgery, the iTrack Advance, for sale to surgeons in the US to treat glaucoma.
The original iTrack was the pioneering canaloplasty device that first established canal surgery for glaucoma. To date, approximately 120,000 surgeries have been performed by surgeons worldwide using that device.
At Stockhead we tell it like it is. While Nova Eye Medical is a Stockhead advertiser, it did not sponsor this article.