Polynovo share price halted amid FDA news

It could be a nail-biting weekend for fans of the company.

| More on:
A person wrapped in warm clothing with head, eyes and face covered by a hat, glasses and a scarf is coated in a layer of snow and ice. representing Strike Energy's trading halt today

Image source: Getty Images

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

Key points

  • The Polynovo share price has been placed in a trading halt this afternoon
  • The halt comes as the company prepares to announce FDA clearance of a major new product
  • The company's stock last traded at $1.36

The Polynovo Ltd (ASX: PNV) share price has been thrown into the freezer this afternoon as the company gets ready to release what could be big news.

The medical devices developer appears to be preparing to announce a major product has received United States Food and Drug Administration (FDA) clearance.

The Polynovo share price was trading flat at $1.36 prior to being frozen ahead of the anticipated announcement.

Let's take a closer look at what's going on with the S&P/ASX 300 Index (ASX: XKO) stock today.

Polynovo stock in the freezer ahead of FDA news

The Polynovo share price isn't going anywhere this afternoon. Meanwhile, fans are likely on the edge of their seats as they prepare to learn of the company's latest news.

In requesting its trading halt, the company hinted that a "major" product had received clearance from the US food and drug regulator.

The approval could have a huge impact on the company's ability to market the product in the North American nation.

However, eager market watchers will likely be left waiting over the weekend. The stock will remain frozen until Tuesday's open unless the anticipated announcement drops between now and then.

Polynovo develops medical devices using its patented bioabsorbable polymer technology, Novosorb.

Its NovoSorb Biodegradable Temporising Matrix (BTM) brought in $37.6 million of sales last financial year. The product is a dermal scaffold for the regeneration of dermis that's lost through surgery or burn.

The company lodged an application for FDA clearance for its Novosorb MTX product early last month.

Polynovo share price snapshot

This year has been a rough one for the Polynovo share price.

The stock has slumped 13% since the start of 2022. It's also trading for 30.5% less than it was this time last year.

For comparison, the ASX 300 has slipped 11% year to date and 10% over the last 12 months.

Motley Fool contributor Brooke Cooper has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has positions in and has recommended POLYNOVO FPO. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

More on Healthcare Shares

A group of people in a corporate setting do a collective high five.
Healthcare Shares

Why 4DMedical shares are jumping 14% today

4DMedical shares climb on a new CFO appointment as investors focus on US expansion and rising use of its lung…

Read more »

A business woman flexes her muscles overlooking a city scape below.
Healthcare Shares

Why I plan to buy this incredible ASX 200 stock in 2026

A 33% pullback has put Pro Medicus back in focus. Here’s why I’m preparing to buy its shares in 2026.

Read more »

research with microscope
Healthcare Shares

This ASX healthcare stock just changed its debt. Here's why it matters

Shares in Mesoblast edge higher after the company announces a major change to its debt and funding structure.

Read more »

stock growth chart
Healthcare Shares

Will CSL shares crash again in 2026?

CSL shares have fallen almost 40% in 2025. Investors are now asking if the worst is already behind the stock.

Read more »

Stethoscope with a piggy bank and hundred dollar notes.
Healthcare Shares

Here's the dividend forecast out to 2030 for Sigma shares

This business could pay healthy dividends in the coming years…

Read more »

A medical researcher rests his forehead on his fist with a dejected look on his face while sitting behind a scientific microscope with another researcher's hand on his shoulder as if giving comfort.
Healthcare Shares

Mayne Pharma signals short-term pain as it resets for growth

It has been a turbulent year for Mayne Pharma after the terminated takeover bid by US company Cosette Pharmaceuticals.

Read more »

A man packs up a box of belongings at his desk as he prepares to leave the office.
Healthcare Shares

Regis Healthcare shares down 2% as CEO resigns

Dr Mellors will step down as CEO after more than six years in the role.

Read more »

Beautiful young woman drinking fresh orange juice in kitchen.
Healthcare Shares

Telix shares storm higher on big US and China news

Let's see why this biotech is getting attention on Monday.

Read more »