The S&P/ASX 200 Index (ASX: XJO) ended the week with a wobbly performance despite strong gains among energy shares. The index closed Friday’s session 0.02% higher at 7,114.5 points.

That marks a 1.16% gain for the week and the ASX 200 closed four out of five sessions in the green.

The S&P/ASX 200 Energy Index (ASX: XEJ) soared 4% on Friday, likely on the back of rising oil prices and concerns a European energy crisis could increase demand for coal. The Brent crude oil price lifted 3.1% to US$96.59 a barrel overnight while the US Nymex crude oil price rose 2.7% to US$90.50 a barrel.

It wasn’t such a good day on the S&P/ASX 200 Utilities Index (ASX: XUJ). It fell 0.7% as AGL Energy Limited (ASX: AGL) released its earnings and APA Group (ASX: APA) revealed a $32 million impairment.

Speaking of earnings, TPG Telecom Ltd (ASX: TPG) shares slumped on the telco’s results while Cochlear Limited (ASX: COH) shares lifted on the results of the healthcare giant.

Never fear if you missed out on much of today’s earnings excitement; there’s plenty more to come next week.

At the end of Friday’s session, five of the ASX 200’s 11 sectors were in the green.

But which share outperformed all others to be crowned the final daily top performer of this week? Let’s take a look.

Top 10 ASX 200 shares countdown

Today’s top performing ASX 200 share was none other than Santos Ltd (ASX: STO). It lifted alongside its home sector on Friday. Find out more about the company and what it’s been up to here.

Today’s biggest gains were made by these ASX shares:

ASX-listed company	Share price	Price change
Santos Ltd (ASX: STO)	$7.52	6.36%
Whitehaven Coal Ltd (ASX: WHC)	$7.36	6.2%
Coronado Global Resources Ltd (ASX: CRN)	$1.845	5.13%
Woodside Energy Group Ltd (ASX: WDS)	$33.50	4.17%
New Hope Corporation Ltd (ASX: NHC)	$4.93	4.01%
Sims Ltd (ASX: SGM)	$16.04	3.68%
Newcrest Mining Ltd (ASX: NCM)	$19.35	3.64%
Beach Energy Ltd (ASX: BPT)	$1.695	3.35%
Magellan Financial Group Ltd (ASX: MFG)	$14.43	3.15%
Medibank Private Ltd (ASX: MPL)	$3.65	2.82%

Our top 10 ASX 200 shares countdown is a recurring end-of-day summary to let you know which companies were making big moves on the day. Check in at Fool.com.au after the weekday market closes to see which stocks make the countdown.

The post Here are the top 10 ASX 200 shares today appeared first on The Motley Fool Australia.

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More reading

• Is the AGL share price in the buy zone following the company’s latest results?
• Here are the 3 most heavily traded ASX 200 shares on Friday
• Why Accent, Cochlear, Newcrest, and Santos shares are charging higher today
• Why is the Whitehaven Coal share price leaping 7% to a record high?
• Why is the Santos share price soaring 6% on Friday?

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 Cochlear Ltd. The Motley Fool Australia has positions in and has recommended APA Group. The Motley Fool Australia has recommended Cochlear Ltd. and TPG Telecom Limited. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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The Global Lithium Resources Ltd (ASX: GL1) share price edged higher on Friday.

During the day, the lithium explorer’s shares rose to an intraday high of $1.93 before pulling back before market close. Its shares finished 1.87% higher at $1.905 apiece.

Let’s take a look at what news surrounded the company today.

What did Global Lithium announce?

Investors drove up the Global Lithium share price after the company provided the ASX with a positive update this afternoon. 

In its release, Global Lithium announced it received positive initial metallurgical test work results at the Marble Bar Lithium Project (MBLP).

The site is located around 150km southeast of Port Hedland in the Pilbara region of Western Australia. MBLP is situated close to major roads, with direct links into Port Hedland for shipping bulk commodities, including spodumene concentrate.

Global Lithium has a 100% controlling interest in MBLP.

The company rendered the services of GR Engineering Services Ltd (ASX: GNG) specialists to oversee the test work program.

The results included 5.9% of lithium oxide (Li 2O) spodumene concentrates with a very high recovery rate of 76%.

Global Lithium advised it was currently working towards completion of the current 60,000 metre reverse drilling programme at the MBLP. 

Management plans to conduct further metallurgical test work, focusing on optimising flowsheet options to improve concentrate grade and Li 2O recovery.

Management commentary

Global Lithium managing director Ron Mitchell had this to say:

These initial results from the ongoing metallurgical test work from our MBLP are very promising for the future of this project. The grades and recoveries produced from this test work from diamond core can meet industry expectations and will further support the prospect of MBLP becoming a standalone lithium operation in the years ahead.

Ongoing project development and test work at MBLP will focus on tailoring the flow sheet to match the evolving lithium market and customer expectations.

… Global Lithium notes that the results of this test work are very positive in that they indicate that samples from the Marble Bar Lithium deposit can be used to generate quality spodumene concentrates.

Global Lithium share price snapshot

Over the last 12 months, the Global Lithium share price has rocketed by more than 430%.

Its shares reached an all-time high of $2.79 in April before market volatility saw a strong retracement across the sector.

Based on today’s price, Global Lithium presides a market capitalisation of around $296 million.

The post Global Lithium shares edged higher today amid ‘very promising’ results appeared first on The Motley Fool Australia.

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More reading

• Why are ASX lithium shares having such a cracking start to the week?
• Why is the Global Lithium share price rocketing 13% on Wednesday?
• Why are ASX lithium shares having such a top run on Wednesday?
• 2 ASX lithium shares lifting on new discoveries today
• ‘Great results’: Here’s why the Global Lithium share price is leaping 6% today

Motley Fool contributor Aaron Teboneras has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. 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.

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It’s been a big week for the AGL Energy Limited (ASX: AGL) share price, but unfortunately, not in a good way.

AGL ended the trading week with the release of its full-year earnings report for FY22. Investors haven’t responded kindly through, with the AGL share price closing 3.9% lower on Friday at $7.84 a share.

This latest move means that AGL is now down almost 8% over the past five trading days. But the company has still been a strong performer over 2022 thus far, with a recorded year-to-date gain of 24%.

So as we covered this morning, AGL recorded a 20.8% rise in revenues to $13.22 billion. However, underlying earnings before interest, taxes, depreciation, and amortisation (EBITDA) fell 27% to $1.21 billion.

Underlying profit after tax was also down 58% to $225 million. AGL also slashed its final dividend to 10 cents per share. That’s down significantly from last year’s dividend of 28 cents.

But now we know what AGL’s FY22 books look like, could the company be a buy today?

Is the AGL share price in the bargain bin yet?

Well, one ASX broker isn’t going that far. According to reporting in The Australian on Friday, Sarah Xie, analyst at Moody’s, was not enamoured with AGL’s results. Even so, she still said they “nevertheless sit within Moody’s expectations”.

Xie reckons things could be looking up for the energy company, stating she “expects earnings pressures to ease in FY23-24” as the company’s pricing hedges roll off. This means it can receive higher prices for its energy. However, Xie also noted that “AGL’s heightened exposure to ESG and policy risks remain a key challenge”.

Here’s some more of what she said:

The company’s generation earnings reduced due to lower realised wholesale energy prices from its hedge positions, generator outages at its increasingly unpredictable aging thermal assets, insufficient insurance coverage for these outages, as well as increased fuel cost for the gas peakers…

The cost competitiveness of AGL’s thermal generation and its ability to source fuel at contained cost will continue to remain its strengths – which supports cash flows as the company navigates uncertainties regarding the board and management renewal, and the direction of its strategic review.

So this view paints a potentially positive future for AGL. But it’s hardly what AGL investors might call a ringing endorsement, which would certainly have been welcome after Friday’s share price moves.

 At the last AGL share price, the ASX 200 energy company had a market capitalisation of $3 billion, with a trailing dividend yield of 6.41%.

The post Is the AGL share price in the buy zone following the company’s latest results? appeared first on The Motley Fool Australia.

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More reading

• Why AGL, Fisher & Paykel, Inghams, and TPG shares are sinking today
• Here are the 3 most heavily traded ASX 200 shares on Friday
• Is this ASX 200 share ESG-challenged or a recession-proof buy?
• Everything you need to know about the latest AGL dividend
• AGL share price dips after 58% profit slash

Motley Fool contributor Sebastian Bowen has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. 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.

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It has been another busy week for Australia’s top brokers. This has led to the release of a large number of broker notes.

Three broker buy ratings that you might want to know more about are summarised below. Here’s why brokers think these ASX shares are in the buy zone:

Blackmores Ltd (ASX: BKL)

According to a note out of Credit Suisse, its analysts have upgraded this health supplements company’s shares to an outperform rating with a $90.00 price target. Although the broker was not overly impressed with Blackmores’ full year results, it believes that its shares have fallen to an attractive level with more upside potential than downside risk. The Blackmores share price is trading at $71.09 today.

CSL Limited (ASX: CSL)

A note out of Macquarie reveals that its analysts have retained their outperform rating and lifted their price target on this biotherapeutics company’s shares to $329.50. Macquarie was pleased with the company’s guidance for FY 2023 and believes it is well-placed to build on this in FY 2024. Particularly given improving trading conditions and the new Rika plasma collection platform. The CSL share price is fetching $294.63 on Friday.

Pro Medicus Limited (ASX: PME)

Analysts at Morgans have retained their add rating and lifted their price target on this health imaging technology company’s shares to $58.18. This follows the release of a strong result for FY 2022 earlier this week. Morgans was particularly pleased with the company’s margins, which were well ahead of expectations. It feels this highlights the operating leverage of the business. The broker also notes that the company’s outlook remains as strong as ever, highlighted by an increasing number of requests for tender proposals. The Pro Medicus share price is trading at $54.00 today.

The post Brokers name 3 ASX shares to buy today appeared first on The Motley Fool Australia.

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More reading

• Buy this ASX 200 company as its costs are actually falling: Firetrail
• Blackmores share price dives 10% despite revenue boost
• Here are the top 10 ASX 200 shares today
• Why Blackmores, Codan, Lake Resources, and Xero shares are falling today
• Why CSL, IPH, Renascor, and Treasury Wine shares are pushing higher

Motley Fool contributor James Mickleboro 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 CSL Ltd. and Pro Medicus Ltd. The Motley Fool Australia has positions in and has recommended Pro Medicus Ltd. The Motley Fool Australia has recommended Blackmores Limited. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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In late afternoon trade, the S&P/ASX 200 Index (ASX: XJO) is on track to record a small decline. At the time of writing, the benchmark index is down slightly to 7,112.2 points.

Four ASX shares that are falling more than most are listed below. Here’s why they are sinking:

AGL Energy Limited (ASX: AGL)

The AGL share price is down 4% to $7.81. Investors have been selling this energy company’s shares after the release of disappointing full year results for FY 2022. AGL reported an underlying profit after tax of $225 million, which was down 58% year over year.

Fisher & Paykel Healthcare Corp Ltd (ASX: FPH)

The Fisher & Paykel share price is down over 5% to $18.14. This follows the release of the medical device company’s guidance for FY 2023. The company revealed that it expects to report revenue of NZ$670 million and net profit after tax of NZ$85 million to NZ$95 million. This will be a big decline on the prior corresponding period which saw revenues of NZ$900 million thanks to COVID tailwinds.

Inghams Group Ltd (ASX: ING)

The Inghams share price is down 9% to $2.69. This morning this poultry company posted a 57.9% decline in net profit after tax to $35.1 million for FY 2022. Management blamed this on higher feed costs and supply chain disruptions. Inghams was forced to slash its dividend by 58% to 7 cents per share due to its lower profits.

TPG Telecom Ltd (ASX: TPG)

The TPG share price is down over 13% to $5.74. This follows the release of the telco giant’s half year results. TPG reported an adjusted net profit after tax of $331 million, which was up 3.8% over the prior corresponding period. According to a note out of Goldman Sachs, TPG’s profits missed by 15%. It also highlights “disappointing opex and Mobile ARPU growth.”

The post Why AGL, Fisher & Paykel, Inghams, and TPG shares are sinking today appeared first on The Motley Fool Australia.

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More reading

• Everything you need to know about the latest AGL dividend
• Inghams share price tumbles 8% as FY22 dividends slashed
• AGL share price dips after 58% profit slash
• Fisher & Paykel share price slides hard following FY23 guidance update
• TPG share price tumbles 9% on first half results

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has recommended TPG Telecom Limited. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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The Commonwealth Bank of Australia (ASX: CBA) share price is trading 1.4% lower in early afternoon trading. That leaves shares in Australia’s biggest bank down 1.2% since the closing bell last Friday.

The CBA share price isn’t the only one in the red today.

While the S&P/ASX 200 Index (ASX: XJO) is up 0.01%, the other big four banks are all posting losses as well. That’s likely partly driven by losses posted by the top US banks yesterday (overnight Aussie time).

Unless CommBank sees a big late-day rally, this will mark its second day of losses for the week, with shares gaining on Monday, Tuesday, and Thursday.

Why did the CBA share price fall on Wednesday?

The CBA share price closed down 1.8% on Wednesday, the day the bank’s shares traded ex-dividend.

That means anyone buying CommBank shares commencing market open on Wednesday was no longer eligible for the $2.10 fully franked final dividend the bank declared. Investors holding shares before Wednesday can expect that payment to land in their accounts on 29 September.

Generally, a stock will fall on the day it trades ex-dividend, as any new investors won’t receive that payment. While its common for stocks to fall by a similar amount to their dividend payout, the CBA share price closed only $1.84 lower on Wednesday.

CommBank’s full FY22 dividend works out to $3.85 per share, reflecting a trailing yield of 3.9% at the current price.

Also on Wednesday…

In other news on Wednesday, unlikely to have had a material impact on the CBA share price, CEO Matt Comyn announced a change to the bank’s executive leadership team.

Gavin Munroe, currently global chief information officer of wealth and personal banking for HSBC, will take over the role of CBA’s group executive, technology and group chief information officer from Pascal Boillat.

Boillat, according to the release, is heading back to the Northern Hemisphere to be closer to his family. Munroe will assume his role commencing 14 November.

Commenting on the executive leadership change, Comyn said:

Gavin is a seasoned financial services technology leader with deep experience driving digital transformations.

Gavin has a proven track record of delivering technology solutions at a global scale, managing and building strong teams, and leading large programs aligned to business strategies and goals.

The post What’s moving the CBA share price this week? appeared first on The Motley Fool Australia.

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More reading

• Why is the CBA share price sliding today?
• Is the CBA share price overvalued compared to other ASX 200 banks?
• The CBA share price has been making big news this week. What can ASX 200 investors expect next?
• How big is the CBA dividend yield right now?
• What does CommBank’s latest update mean for NAB shares?

Motley Fool contributor Bernd Struben has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. 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.

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The S&P/ASX 200 Index (ASX: XJO) is having a jittery end to the trading week as it currently stands. At the time of writing, the ASX 200 has gained just 0.02% and now stands at 7,114 points, having also spent time in the red on Friday.

But rather than worry too much about that, let’s now dig deeper into the ASX 200 shares that are presently topping the market’s trading volume charts, according to investing.com.

The 3 most traded ASX 200 shares by volume this Friday

Pilbara Minerals Ltd (ASX: PLS)

First up today is ASX 200 lithium stock Pilbara Mienrals. This Friday has seen a hefty 13.55 million Pilbara shares so far take flight. There hasn’t been any news out of the company itself today.

However, as my Fool colleague Aaron pointed out this morning, the lithium producer has had a lot of attention this week. No doubt Pilbara’s bouncy share price movements today have also influenced volumes, although the company is currently flat for the day at $3.06 a share.

Lake Resources N.L. (ASX: LKE)

Another ASX 200 lithium share in Lake Resources is next up today. So far this Friday, Lake has had a sizeable 20.22 million shares swap hands. Again, we haven’t had any price-sensitive news out from the company.

So this volume looks to have been sparked by the notable volatility we have seen in the Lake Resources share price itself today. The company is currently up a decent 2.1% at $1.215 a share. But Lake rocketed as high as $1.285 a share (up more than 7%) this morning before settling down to the current level.

Telstra Corporation Ltd (ASX: TLS)

Our third, final and most traded ASX 200 share today is none other than blue-chip telco Telstra. This Friday has seen a chunky 23.94 million Telstra shares call up a new owner thus far. This could be a result of the Telstra share price adding another 0.5% to $4.12 a share today – a six-month high for the telco.

Perhaps some investors are enjoying some schadenfreude with the company too, given the disappointing reaction from the market to rival TPG Telecom Ltd (ASX: TPG)’s earnings this morning.

The post Here are the 3 most heavily traded ASX 200 shares on Friday appeared first on The Motley Fool Australia.

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More reading

• Could Porsche’s new test run threaten the outlook for ASX lithium shares?
• Why did the Lake Resources share price pop and then stop on Friday?
• Is this ASX 200 share ESG-challenged or a recession-proof buy?
• TPG share price tumbles 9% on first half results
• 2 ASX 200 shares set to soar if we manage to avoid a recession: experts

Motley Fool contributor Sebastian Bowen has positions in Telstra Corporation Limited. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has positions in and has recommended Telstra Corporation Limited. The Motley Fool Australia has recommended TPG Telecom Limited. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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In afternoon trade, the S&P/ASX 200 Index (ASX: XJO) is on course to record the smallest of gains. At the time of writing, the benchmark index is up slightly to 7,114 points.

Four ASX shares that are climbing more than most are listed below. Here’s why they are charging higher:

Accent Group Ltd (ASX: AX1)

The Accent share price is up 10% to $1.66. Investors have been buying this footwear retailer’s shares following the release of its full year results. Although Accent posted a sizeable 59.2% decline in net profit after tax to $31.5 million, this was largely expected. As a result, investors appear to be focusing on its very strong start to FY 2023 instead.

Cochlear Limited (ASX: COH)

The Cochlear share price is up 2.5% to $219.75. This morning this hearing solutions company released its FY 2022 results and revealed record sales revenue of $1.6 billion and an 18% increase in underlying profit to $277 million. Looking ahead, management expects its underlying profit to grow to between $290 million and $305 million in FY 2023.

Newcrest Mining Ltd (ASX: NCM)

The Newcrest share price is up 4% to $19.39. This follows the release of FY 2022 results that were ahead of the market’s expectations. The gold miner delivered a full year net profit after tax of US$872 million. While this was down 25% year over year, it was ahead of consensus estimate of US$843.5 million.

Santos Ltd (ASX: STO)

The Santos share price is up 6% to $7.48. Investors have been buying this energy producer’s shares after oil prices charged higher overnight. Traders were buying oil after data showed that US crude stockpiles fell significantly more than expected last week. The S&P/ASX 200 Energy index is up almost 4% today.

The post Why Accent, Cochlear, Newcrest, and Santos shares are charging higher today appeared first on The Motley Fool Australia.

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More reading

• Why is the Santos share price soaring 6% on Friday?
• Cochlear share price takes off despite guidance miss
• Accent share price jumps despite 59% profit drop
• Everything you need to know about the latest Newcrest dividend
• Newcrest share price lifts despite profit falling 25%

Motley Fool contributor James Mickleboro 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 Cochlear Ltd. The Motley Fool Australia has recommended Accent Group and Cochlear Ltd. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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The Sayona Mining Ltd (ASX: SYA) share price is powering upward today amid further government commentary on the need for an increased uptake of electric vehicles (EVs) in Australia.

At the time of writing, the Sayona share price is 27 cents, up 8%.

What’s been said about electric vehicles today?

Speaking at the National Electric Vehicle Summit in Canberra, Energy and Climate Change Minister Chris Bowen pledged that the government would provide “policy leadership” on EVs.

According to reporting in The Australian, Bowen said:

We believe now is the time to have a sensible discussion about whether fuel efficiency standards could help improve the supply of electric vehicles into our market …

Apart from Russia, Australia is the only OECD country not to have or be in the process of developing fuel efficiency standards.

Other government ministers have also given their support for increasing EV uptake in Australia.

NSW Energy Minister and Treasurer Matt Kean said he was working with political peers on both sides of the aisle “who are continuing to push reform to support the uptake of EVs”, according to The Guardian.

Kean said EVs were “absolutely essential to our emission reduction goals”.

What’s this doing for the Sayona share price?

Well, the discussion at the summit simply provides further momentum for the shift to EVs in Australia. And that’s great news for lithium miners like Sayona, given lithium is a crucial element in the batteries that make EVs run.

Other ASX lithium shares are also trading higher today. Allkem Ltd (ASX: AKE) shares are up 1.32% at the time of writing, and Pilbara Minerals Ltd (ASX: PLS) shares are 0.16% higher. Lake Resources NL (ASX: LKE) shares are up by 1.68%.

Perhaps Sayona is getting a bigger benefit today after some exciting announcements this month.

These include restarting its North American Lithium operation and bolstering its financial base by increasing its at-market subscription agreement (ATM) with existing shareholder Acuity Capital.

What’s next for EVs in Australia?

A draft of Australia’s first National Electric Vehicle Strategy will be released in September.

This was among a range of promises made by the Labor Party during the election campaign to boost EVs in Australia. Another commitment was to introduce an electric car discount.

This would exempt EVs below the luxury car tax threshold ($77,565 in FY21) from import tariffs and fringe benefits taxes.

What’s next for the Sayona share price?

As my Fool colleague Raymond pointed out this week, the Sayona share price has been volatile of late.

But overall, it’s a lush green picture. In the year to date, Sayona shares are up 93%. Over the past month, they have risen more than 80%.

ASX lithium shares received a new tailwind this week when the United States Congress passed a $US430 billion bill “that is seen as the biggest climate package in the country’s history”, as abc.net.au reported.

The post Why is the Sayona Mining share price surging 8% on Friday? appeared first on The Motley Fool Australia.

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More reading

• Why is the Sayona Mining share price so volatile?
• Why are ASX lithium shares having such a cracking start to the week?
• Why is the Lake Resources share price up so much more than other ASX lithium shares today?
• Why has the Sayona Mining share price rocketed almost 100% in a month?
• Why is the Sayona Mining share price surging 15% on Monday?

Motley Fool contributor Bronwyn Allen has positions in Allkem Limited. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. 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.

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The broader market is struggling to make ground today but there is one ASX healthcare share that is zooming ahead this afternoon.

This is the Invex Therapeutics Ltd (ASX: IXC) share price, which is currently surging 17.86% to 66 cents. If it closes at this level, it will mark a more than three-month high for the share.

In contrast, the All Ordinaries Index (ASX: XAO) is trading flat as falls in ASX big banks offset gains by ASX resource shares.

Why this ASX healthcare share is exciting the market today

Invex got the attention of investors today when it announced that its Investigational New Drug (IND) application had been approved by the US Food and Drug Administration (FDA).

The approval is for its Presendin drug, and it comes as the ASX healthcare company commences its phase III clinical trial, called IIH EVOLVE, in the United States.

The trial is for patients with idiopathic intracranial hypertension (IIH). This is a condition where pressure inside the skull increases for no obvious reason.

The condition can cause vision changes and headaches – symptoms that are similar to a brain tumour (but with no tumour present).

Why is the FDA’s IND approval so important?

Securing the IND is essential to the phase III trial in the US. A clinical study sponsor has to obtain this before it can administer an investigational drug to humans.

According to the US FDA’s website, the IND must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics Product License Application.

The chief scientific officer and executive director of Invex, Professor Alex Sinclair, said:

We are excited to have received the IND for Presendin and IIH EVOLVE from the US FDA, based on the study protocol where we have already secured regulatory clearances in the UK and Australia.

We anticipate that a positive efficacy outcome of the study will facilitate further discussions with the FDA on the future registration requirements of Presendin for IIH patients in the US.

High hopes for this ASX healthcare company

Invex claims there are no existing regulatory approved drug therapies for IIH. This leaves invasive neurosurgical and ophthalmic surgeries as options for those with a severe case of the condition.

The microcap ASX healthcare share intends to open several clinical sites across the US to support the IIH EVOLVE trial. Invex will now complete the necessary institutional contracts and human ethics committee approvals.

Clinical trial details

The IIH EVOLVE study is a randomised, placebo-controlled, double-blind trial that will randomise 240 patients.

These patients are newly diagnosed with IIH and the trial will help determine the efficacy and safety of Presendin versus placebo.

The drug/placebo will be administered once a week over 24 weeks. The primary endpoint of the trial is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures. Invex intends to open up to 40 clinical sites globally.

Invex annual report

The company also released its annual report for FY22 today.

Invex recorded a net loss after tax of $3.950 million, an increase of 73% on the prior corresponding period. This was attributed largely to higher research and development costs of $2.642 million (compared to $1.139 million in FY21), reflecting the expenditure required to commence the IIH EVOLVE study.

The company reported an overall cash burn from operations of $3.377 million (up from $1.678 million in FY21).

Invex said it remained “in a strong financial position” with cash and cash equivalents of $29.339 million at 30 June 2022 (down from $32.777 million in FY21).

Invex share price snapshot

The Invex share price is almost 1% in the green over the past year, thanks to today’s big rally. This is better than many other ASX healthcare shares and biotech shares.

These include the Mesoblast Limited (ASX: MSB) share price and Starpharma Holdings Limited (ASX: SPL) share price. These shares are both down around 40% over the past 12 months.

The post This ASX healthcare company just got FDA approval, and its share price is soaring 18% appeared first on The Motley Fool Australia.

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More reading

• Why is the Sayona Mining share price surging 8% on Friday?
• Investors are leaning away from ESG investing, but here’s why you shouldn’t follow the crowd
• 3 ASX All Ordinaries shares cracking new highs on Friday
• The Aussie-born crypto platform taking on Ethereum
• Could Porsche’s new test run threaten the outlook for ASX lithium shares?

Motley Fool contributor Brendon Lau 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 Starpharma Holdings Limited. The Motley Fool Australia has recommended Starpharma Holdings Limited. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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