The life sciences sector has emerged into the spotlight ever since the pandemic began.

In the US, the share prices of major vaccine-producing companies have surged astronomically as COVID-19  ravaged the world.

Nasdaq-listed BioNTech, which co-produces a vaccine alongside Pfizer, rose by a massive 253% in 2021.

Moderna rallied by 150%, while Pfizer is up 40% for the year.

In Australia, the Healthcare sector is also one of the top performers in 2021, beating the likes of Tech as well as the benchmark index.

Despite the strong returns, investing in the life-sciences sector is still considered by many to be high risk.

Statistically speaking, life sciences companies have a 5 to 15 per cent success rate on products they attempt to commercialise, according to a research report released by the ASX.

And generally speaking, it takes those companies about 10 to 15 years to achieve commercialisation, longer than the average in other sectors.

Most early stage biotechs operate for long periods of time before they achieve some sort of measurable revenue.

Like investors in the mining industry, biotech investors have to tolerate high levels of risk, but significant returns could be enjoyed when investments are successful.

Biotech companies also have to navigate unique challenges around regulatory compliance, clinical innovations, costs, and pricing.

But when it comes to healthcare research and development (R&D), Australia has always ranked in the top 10 OECD member nations for its total investment on R&D.

The ASX healthcare sector represents a very small market globally, with approximately 1% of the global medicinal sales, but we stand to capitalise on the rapid growth of our densely populated neighbours.

Biggest medical breakthroughs this year

Breakthroughs in the medical world often represent life-changing events not only for the investors, but also for suffering patients.

Outside of COVID-19 vaccines, the biggest medical breakthrough this year was arguably Biogen’s controversial US FDA approval of Aducanumab, a drug that treats Alzheimer’s disease.

It was the first FDA approval for Alzheimer’s in 18 years, but experts are sceptical and the Biogen stock price has tanked 40% since the announcement was made in May.

On the ASX, there were also major groundbreaking announcements.

In early December, Neuren Pharma (ASX:NEU) share price doubled in one day after revealing that it was close to launching the first ever drug for Rett syndrome to the market.

The company reported positive top-line results from the Phase 3 Lavender study of trofinetide, its lead asset used to treat indications of autism.

It was the first drug that’s ever been approved for Rett (a rare genetic neurological disorder that affects girls), and will result in a payday for Neuren worth hundreds of millions of dollars.

Earlier in the year, Patrys (ASX:PAB) announced that new preclinical data for its deoxymab antibody, PAT-DX1, has been published in the leading, peer-reviewed Journal of Clinical Investigation – Insight.

The groundbreaking results demonstrated the ability of Patrys’ PAT-DX1 antibody to cross the blood-brain barrier, which could significantly inhibit the growth of cancers in the brain.

ImpediMed (ASX:IPD) announced that SOZO has received a US FDA Breakthrough Device Designation for treatment and diagnosis of renal failure.

This was a major breakthrough for the medical world as the current process, which utilises weight scales to determine accumulation of fluid, has significant deficiencies.

Meanwhile, Dimerix (ASX:DXB) announced the first ever Phase III study in patients with focal segmental glomerulosclerosis (FSGS).

FSGS is a rare disease that attacks the kidney’s filtering units that could lead to permanent kidney damage and failure.

ASX Healthcare IPOs this year

 

On the IPO front, Argenica Therapeutics (ASX:AGN) and Trajan (ASX:TRJ) were the best performers.

Argenica’s lead asset is ARG-007, a therapeutic compound which has been shown in animal models to reduce brain cell death following a stroke.

Earlier this month, Argenica received a notice of allowance from the US Patent and Trademark Office, potentially giving the company the go ahead to commercialise the drug.

The John Eales-chaired Trajan meanwhile, designs and manufactures a portfolio of precision consumable products, devices and solutions.

These products and solutions are used in the analysis of biological, food and environmental samples.

Founded in 2011 by a husband and wife team, the company has been on an acquisition trail, with the latest one being the US$7.7 million takeover of North Carolina based LEAP PAL.

Best performing ASX biotechs in 2021

These are the best performing biotech stocks in 2021.

Actinogen (ASX:ACW)

The neurological diseases specialist has been rising on the back of its lead drug candidate, Xanamem.

The drug blocks the production of the stress hormone cortisol in the brain, which is often associated with Alzheimer’s disease.

The share price has also been buoyed by the FDA’s first ever approval of an Alzheimer’s disease drug earlier this year.

A trial of Xanamem in patients with Fragile X Syndrome is currently under way in North America following an FDA approval, with results expected in 2023.

Imugene (ASX:IMU)

The biotech darling has been on a high this year on the back of the rapid development of its lead cancer drug, HER-Vaxx.

HER-Vaxx is a B-cell immuno-therapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

In November, Imugene announced that it was collaborating with global giants Pfizer and Merck for the Phase 2 trial of HER-Vaxx.

Prescient (ASX:PTX)

The biotech is undergoing multiple cancer programs, including cellular therapies.

Prescient’s cancer-fighting drug therapy PTX-100 has shown significant promise for the company, with early stage trials showing benefit to patients with hard-to-treat cancers.

Its OmniCAR platform meanwhile, was developed to overcome challenges and limitations of CAR-T treatments – a new type of intervention used in immunotherapy and cancer treatment.

The company’s most recent work concluded that OmniCAR-T cells begin antigen-directed killing of tumour cells in vitro as soon as they are armed.

Incannex Healthcare (ASX:IHL)

Incannex took a hit from a TGA ruling to ban psychedelics for public use, but its IHL-42X cannabinoid drug for the treatment of obstructive sleep apnoea is still on the cards.

In October, IHL engaged Colombian-based manufacturer Procaps to develop a soft-gel capsule which will be used for the Phase 2, Phase 3 and open label clinical trials of IHL-42X.

Patient dosing for the Phase 2 trials is expected to be finalised before year end and results will be used to support an investigational new drug application with the US FDA.

IDT Australia (ASX:IDT)

IDT has been one of the best performing stocks this year, despite the recent decision by the Australian government to reject IDT’s proposal to establish an onshore mRNA manufacturing facility in Australia.

Earlier in the year, the company had successfully built an mRNA vaccine jab in collaboration with the Monash Institute of Pharmaceutical Sciences and Doherty Institute.

However, IDT says the ruling won’t affect its MMI Collaboration Stream Grant application, an $800 million government initiative to fund large projects that help Australian manufacturing businesses collaborate, innovate and build economies of scale.

Neuren Pharma (ASX:NEU)

In a groundbreaking announcement in early December, Neuren Pharma said that it was close to launching the first ever drug for Rett syndrome to the market.

The company announced that its North American partner, Acadia Pharma (Nasdaq: ACAD) reported positive top-line results from the Phase 3 Lavender study of trofinetide, Neuren’s lead asset.

These results meant the $400m-capped Neuren will earn material revenues to the tune of hundreds of millions if the drug gets approved by the FDA.

A Pre-New Drug Application meeting with the FDA is planned for Q1 2022, and the all important New Drug Application (NDA) is slated for mid-year.

Telix Pharmaceutical (ASX:TLX)

An FDA approval in December sent the Telix share price to a record high.

The company is now expected to earn its first sales for its prostate cancer imaging product, Illucix, beginning in early 2022.

Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide, also known as PSMA-11 injection used in prostrate cancer diagnosis.

With a distribution network of more than 140 pharmacies through its agreements with Cardinal Health and PharmaLogic, Telix will now be able to provide Illuccix to more than 85% of eligible PET imaging sites throughout the US.

 

 

 

And here are the worst performing biotechs in 2021.

 

At Stockhead we tell it like it is. While Incannex Healthcare is a Stockhead advertiser, it did not sponsor this article.