This is a young industry that is largely dependent on the world's legal and medical fraternities to accept and approve medicinal cannabis as a treatment for many conditions and adjust laws accordingly.

The process for change in this regard is incredibly slow, which makes ASX cannabis shares very volatile.

Let's look at what's been happening lately.

News from the United States

Our Fool colleagues in the US report rising new excitement over cannabis stocks, but it's based purely on speculation.

There are two bits of news that have US cannabis shares investors excited.

Firstly, the US Department of Health has recommended a downgrade to the scheduling of marijuana from a Schedule 1 substance — the same category as heroin — to Schedule III.

The recommendation was issued late in August and follows an 11-month review.

The US Drug Enforcement Administration (DEA) defines Schedule III drugs as having a "moderate to low potential for physical and psychological dependence".

Nothing has happened as a result of the recommendation yet.

Meantime, a bipartisan group of US senators are pushing for state-legalised cannabis businesses to receive access to finance.

The group introduced the Secure and Fair Enforcement Regulation (SAFER) Banking Act in the Senate today, according to Bloomberg Law.

The bill has been around for a few years but has been held up at various points.

Its introduction in the Senate is good news, but nothing consequential for US or ASX cannabis shares has happened yet.

How are ASX cannabis shares performing of late?

US cannabis shares such as Aurora Cannabis Inc (NASDAQ: ACB) and Canopy Growth Corp (NASDAQ: CGC) have rocketed since news of the health department's recommendation broke on 30 August.

But not much has happened for ASX cannabis shares.

Over the same time period:

• Botanix Pharmaceuticals Ltd (ASX: BOT) shares have remained steady at 19 cents
• Cann Group Ltd (ASX: CAN) shares have fallen 7.7% to 12 cents
• Incannex Healthcare Ltd (ASX: IHL) shares have fallen 18.8% to 6.5 cents
• Ecofibre Ltd (ASX: EOF) shares have risen 17.7% to 20 cents
• Althea Group Holdings Ltd (ASX: AGH) shares have fallen 15% to 3.4 cents
• Little Green Pharma Ltd (ASX: LGP) shares have fallen 8.8% to 16 cents

As we covered, Botanix was in the news yesterday after the ASX issued a price query.

The Botanix share price hit a 52-week high of 21 cents, up an impressive 160% since the start of June.

Aussie news affecting ASX cannabis shares

Australia legalised medicinal marijuana in 2016.

Recreational use remains illegal except in the ACT.

In June, the Legalise Cannabis party introduced a bill in the Western Australia, Victoria, and New South Wales parliaments to legalise marijuana for personal use as well as medical reasons.

The bill is called the Regulation of Personal Adult Use of Cannabis Bill.

The Australian Therapeutic Goods Administration (TGA) down-classified two psychedelics to enable their use in treating mental illness in July.

The psychedelics are MDMA for post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant major depressive disorder.

Only a psychiatrist can prescribe them.

Reset Mind Sciences CEO Shaun Duffy said the TGA's decision was "truly groundbreaking".

Little Green Pharma said the TGA move meant Australia "will become the first market in the world to recognise psychedelics as medicines … ".

In August, we learned the Victorian Government will conduct an 18-month Australia-first trial to test medicinal cannabis users' driving abilities.

Current roadside drug testing laws allow police to test for the mere presence of tetrahydrocannabinol (THC).

Medicinal cannabis users argue that they are only ingesting tiny amounts of THC in their health therapies.

Therefore, the law should be updated to test for impairment rather than just presence.

Foolish takeaway

All of these small changes represent the slow-moving wheel of the cannabis industry's evolution.

For this reason, ASX cannabis shares remain highly speculative investments.

While some US cannabis stocks have surged on recent news, the same can't be said for ASX shares.

The post Could ASX cannabis shares be set for a resurgence? appeared first on The Motley Fool Australia.

In morning trade, the cannabis-focused pharmaceutical company's shares are up 4.5% to 12 cents.

Why is the Incannex share price rising?

Investors have been buying the company's shares today after it released an update on a clinical trial.

According to the release, Incannex has received approval from Bellberry Human Research Ethics Committee (HREC) for the lead site, Emeritus Research in Melbourne, for its Phase 2 clinical trial.

Management notes that the trial is pivotal in nature and will assess the safety and efficacy of IHL-675A in patients with rheumatoid arthritis (RA). IHL-675A is the company's proprietary anti-inflammatory combination drug product.

This trial follows the successful phase 1 clinical trial, whereby both active pharmaceutical ingredients, cannabidiol (CBD) and hydroxychloroquine sulphate (HCQ) were absorbed using IHL-675A. The drug product was also observed to be well tolerated, with no adverse events of concern.

What is phase 2?

The phase 2 study aims to build on the above and will assess the efficacy, safety, and tolerability of IHL-675A compared to the respective component active pharmaceutical ingredients (APIs), CBD and HCQ, and placebo.

As the treatments will be double-blinded, this means neither the investigators nor patients will know which treatment an individual is receiving.

Management notes the results of the trial will establish the safety and efficacy of IHL-675A in RA and will be a critical component of future regulatory applications. This includes contributing to the combination rule assessment in the US FDA's new drug application dossier.

Incannex Chief Scientific Officer Dr Mark Bleackley said:

HREC approval for the Phase 2 clinical trial is a key step in the development of IHL-675A for treatment of pain and reduced function associated with rheumatoid arthritis. We look forward to working with Emeritus and Avance to assess the effect of IHL675A in this patient population.

It is worth noting that Incannex announced plans to leave the ASX earlier this week. It plans to move its listing to the Nasdaq later this year.

The post Incannex share price races higher on 'pivotal' trial approval appeared first on The Motley Fool Australia.

Four ASX shares that are falling more than most today are listed below. Here's why they are dropping:

Incannex Healthcare Ltd (ASX: IHL)

The Incannex share price is down 8% to 11 cents. This morning, this cannabis-focused pharmaceutical company announced plans to leave the ASX and join the NASDAQ. Shareholders will be asked to vote on the move later this year. Though, it seems that some aren't sticking around to see how the move pans out.

Magellan Financial Group Ltd (ASX: MFG)

The Magellan share price has continued its slide and is down a further 3.5% to $8.32. Investors have been selling this fund manager's shares since the release of a disappointing funds under management (FUM) update. In addition, this morning, analysts at Macquarie downgraded the company's shares to an underperform rating and cut the price target on them to $7.25.

Nexted Group Ltd (ASX: NXD)

The Nexted share price is down 13.5% to $1.25. Investors have been hitting the sell button today after the education services company released an update on its performance in FY 2023. Nexted is expecting to grow its revenue by 118% to 120% and EBITDA by 392% to 406%. Despite how strong this is, some investors appear to have been expecting even stronger growth.

Strandline Resources Ltd (ASX: STA)

The Strandline Resources share price is down 8% to 25.2 cents. This is despite Strandline announcing its seventh shipment of heavy mineral concentrate. However, taking some of the shine off the news was management advising that mining throughput and production have been constrained at times due to commissioning-related issues. This includes equipment failures and plant availability.

The post Why Incannex, Magellan, Nexted, and Strandline shares are dropping today appeared first on The Motley Fool Australia.

That's because this morning, the cannabis-focused clinical-stage pharmaceutical development company has announced plans to redomicile from Australia to the United States.

This will be via proposed schemes of arrangement between Incannex and its shareholders and option holders, subject to their approval, as well as customary regulatory approvals.

Why are Incannex shares leaving the ASX?

According to the release, the Incannex board believes that becoming a U.S. company and trading only on the NASDAQ will provide many and varied benefits to Incannex and its shareholders.

It believes that the company will have greater access to a more cognisant and receptive capital market of Incannex's value proposition. The board also highlights that comparison companies are trading at far greater market valuations and switching would provide it with the ability to expand to a much broader investor base.

Incannex CEO and Managing Director, Joel Latham, said:

The Board is excited to enact this landmark unanimous decision in conjunction with our key shareholders and other stakeholders. It is a decision made with the intention to maximise shareholder value.

Incannex has matured on the ASX to the point that it has a large and diversified drug portfolio with two exciting drug candidates imminently entering pivotal clinical trials. By committing our presence to the United States, we believe that our Company's visibility to international investors will increase markedly, partly due to our value proposition compared to similar emerging biotech companies with a presence in North America.

What's next?

The company expects to allow shareholders to vote on the proposal at a meeting in October.

If the proposal is approved, holders of Incannex shares will be entitled to receive one share of common stock in Incannex US for every 100 shares held on the record date for the share scheme. The value of the holding would remain the same at conversion.

Incannex shares are down 40% since this time last year.

The post Why you soon won't be able to find Incannex shares on the ASX appeared first on The Motley Fool Australia.

That's despite the fact that the cannabis stocks operate in a country where medicinal marijuana is technically legal. That's enabled them to provide valuable health services to many thousands of Australians.

In Victoria alone, around 65,000 people were reported to have medicinal cannabis prescriptions in March this year.

But that hasn't helped lift the fortunes of ASX cannabis shares like Incannex Healthcare Ltd (ASX: IHL), Little Green Pharma Ltd (ASX: LGP), and Cann Group Ltd (ASX: CAN).

Here's how these three ASX cannabis shares have performed over the past 12 months:

• Little Green Pharma shares are down 37%
• Cann Group shares are down 48%
• Incannex Healthcare shares are down 53%

Now these are obviously not the kind of returns any investor wants to see.

But the longer-term outlook for ASX cannabis shares may have just gotten a bit brighter.

Could this help boost ASX cannabis shares?

Medicinal marijuana was legalised in Australia in 2016.

But, with the exception of the ACT, recreational use remains verboten. That's seen police pursue more than 700,000 pot-related offences since 2010 across the nation.

Now, in a move that could boost ASX cannabis shares longer-term, the Legalise Cannabis party has introduced bills to legalise marijuana for personal use as well as medical reasons.

The bills were tabled yesterday to three state parliaments: Western Australia, Victoria, and New South Wales. The Legalise Cannabis party noted this is the first time the same bill has been simultaneously introduced in three states.

It will, however, be some time before ASX cannabis shares might directly benefit from the proposed bills, all called the Regulation of Personal Adult Use of Cannabis Bill 2023.

While the move has broad support from the Liberal Democrats and Greens, it will need some support from the major parties to pass.

Victorian premier Daniel Andrews has already flagged his opposition. "My position is the law as it stands now," he said.

But then laws can and do change all of the time.

What changes are being proposed?

In a nutshell, the new bill would allow adults (18+) to possess modest quantities of marijuana and grow up to six plants at their homes. This is largely in line with the new laws that came into effect in the ACT in 2020.

In itself, this is unlikely to have any short-term material impact on ASX cannabis shares, as it won't directly open up any larger market opportunities.

Commenting on the proposed bill, New South Wales upper house MP Jeremy Buckingham said (quoted by ABC News), "This is a historic move by the Legalise Cannabis Party across Australia to bring a coordinated reform for cannabis legalisation."

Victorian MP David Ettershank added:

The majority of Victorians support the regulation of cannabis, and a huge number of Victorians … regularly consume cannabis. There's a lot of politicians, again from both sides of the house, who use cannabis…

Cannabis needs to be taken out of the world of crime and regulated intelligently.

Now, here's where ASX cannabis shares could potentially receive some major tailwinds over the longer term.

According to police estimates, Australians spend some $8 billion a year on marijuana. And all of that goes straight into the black market.

The next planned step of the legalisation process was highlighted by Legalise Cannabis Party upper house member Brian Walker, a former GP.

Walker said his party is aiming for a regulated, legal cannabis market.

"We want to move further and actually take it to the stage of actually being taxable so we can get some revenue as a government for that," he said.

Not only would the government be dipping in for its tax take if this succeeds, but ASX cannabis shares would find a much larger market for their products.

The post Why ASX cannabis shares just jumped back into the spotlight appeared first on The Motley Fool Australia.

Yes, back in May, investors who had held onto Incannex shares were up a lucrative 425% from May 2018. Today, the same gains hold, with the Incannex share price notching a five-year gain of 435% on current pricing.

However, the fact remains that Incannex shares, while still a great long-term performer, are also down significantly from their recent highs. In fact, this ASX cannabis share is currently trading at a multi-year low.

At present, the Incannex share price is going for 10.7 cents a share, up 1.9% for the day so far. At this level, the company has lost more than 40% from the 19 cents per share levels we saw back in January. Investors are also down a nasty 82% or so from the high we saw back in March 2022, when Incannex touched the 60-cent mark, as you can see below:

So this rather volatile journey might posit the question today: are Incannex shares still worth buying at these multi-year lows?

Are Incannex shares a buy today?

Incannex is certainly doing some exciting work. This ASX cannabis share specialises in finding cannabis-based medical solutions. Back in March, the company announced it would be developing a psilocybin-based drug to help combat anxiety disorders for clinical trials.

Last month, it also announced the appointment of Dr John Hudson and Dr Russell Rosenberg to lead its phase two and three clinical trials for a cannabis-based drug for the treatment of sleep apnoea.

However, hope and dreams are not enough to warrant an investment in my view. At its core, Incannex is still a loss-making company. Its quarterly cash flow statement from April revealed that Incannex has received exactly $0 in revenues while burning through $4.29 million in cash.

As of the report, the company has just over $37 million in cash left over. Its activities are currently being funded through capital raisings and issuances of new shares. In other words, shareholders.

Now if Incannex can pull off the creation of a new cannabis- or psilocybin-based wonder drug, then this might all be worth it and the shares could look cheap in hindsight.

But to me, this looks like a lottery-ticket investment (win big or lose it all). And I don't do lottery ticket investments. So I'll be avoiding Incannex shares for now, although the company has my sincerest best wishes for the future.

The post Should I buy Incannex shares while they're at multi-year lows, or steer clear? appeared first on The Motley Fool Australia.

But the hype has decidedly died down over 2022 and 2023 so far. Yet that doesn't mean ASX cannabis stocks like Incannex Healthcare Ltd (ASX: IHL) haven't been worth owning.

In fact, Incannex shares have been one of the best investments on the ASX in recent years. Five years ago, this cannabis stock was going for just 2 cents a share. Today, the Incannex share price is sitting at 10 cents a share, up a whopping 425% from where it was back in May 2018.

We won't dwell on the fact that back in March last year, Incannex was going for as much as 60 cents a share though. Yep, between May 2018 and March 2022, investors enjoyed a 2,900% return:

Even so, 425% is a stonking return for five years of waiting. It means that an investor who put just $3,000 into Incannex shares back in May 2018 would be looking after a $15,000 investment today.

So what's been the secret behind the success of this ASX cannabis stock?

Why has ASX cannabis stock Incannex shot the lights out?

Well, it's difficult to pinpoint why investors have lit up Incannex shares over the past five years. The company undoubtedly rode the ASX cannabis stock mania over 2021 and into 2022. Sentiment regarding ASX cannabis stocks may have dimmed but Incannex has still made some positive developments that have probably helped it to stay at the forefront of investors' minds.

Last year, Incannex shares got a major boost when the company was selected for inclusion into the S&P/ASX 300 Index (ASX: XKO). The ASX 300 is one of the major stock market indexes on the ASX and is tracked by exchange-traded funds (ETFs) like the Vanguard Australian Shares Index ETF (ASX: VAS).

Mushrooms and the ASX 300

When a share is included in an index like the ASX 300, the ETFs that track it have to buy that share. This can lead to an increase in trading and liquidity, and a boost in valuation. That's probably why we saw the Inannex share price rise by 20% in the lead-up to its ASX 300 initiation last year.

2022 also saw Incannex make some big moves in its own space too, which might have gotten more investors on board with the company's vision. Incannex finalised the acquisition of APIRx Pharmaceuticals in August last year.

This enabled the company to add 22 clinical and pre-clinical projects to its books. Following the acquisition, Incannex declared that it now had the "world's largest portfolio of patented medicinal cannabinoid drug formulations and psychedelic treatment protocols".

And it was only back in March this year that Incannex announced that it would be developing and manufacturing its own psilocybin-based drug for clinical trials. Psilocybin is the active chemical in 'magic mushrooms'. Incannex hopes that its drug will help patients suffering from anxiety disorders.

So it looks like Incannex's success over the past five years can be put down to a combination of all of these factors. No doubt long-term investors in this ASX cannabis stock will be pleased with its share price growth over this period. But let's see how the company fares going forward.

At the current Incannex share price, this ASX cannabis stock has a market capitalisation of around $160 million.

The post A $3k investment in ASX cannabis stock Incannex 5 years ago is now worth $15,000. Here's why appeared first on The Motley Fool Australia.

While the All Ords is falling 0.4% to 7,472.9 points, these stocks are leaping as much as 7% on the back of strong quarterly updates.

2 ASX All Ordinaries stocks surging on quarterly updates

Helloworld Travel Ltd (ASX: HLO)

First up, All Ordinaries travel stock Helloworld is soaring 7.43% today to trade at $2.89.

It comes on news the company's underlying earnings before interest, tax, depreciation, and amortisation (EBITDA) jumped to $14.2 million last quarter. That's up from a $4.9 million loss in the prior comparable period.

Its total transaction value (TTV) also shot 150% higher to $596.2 million while its revenue launched 240% to $46.9 million.

Also excitingly, Helloworld bolstered its full-year guidance on the back of its strong performance.

It now expects to post between $38 million and $42 million of underlying EBITDA for financial year 2023 – a $10 million improvement on its previous forecasts.

Incannex Healthcare Ltd (ASX: IHL)

Joining Helloworld stock in the green is that of Incannex. The pharmaceutical development company's share price is roaring 4.35% higher to trade at 12 cents at the time of writing.

The company released its update on the March quarter this morning, within which it narrowed the timeframe for the commercialisation of its psychedelic-assisted psychotherapy business, Psychedelic Clinics.

The first 'model' clinic is on track to be ready to open in Melbourne before September. It will be capable of treating over 600 patients per year during normal working hours.

The company also continued activities associated with the dosing of trial participants in its bioavailability and bioequivalence (BA/BE) clinical trial, assessing the pharmacokinetics and tolerability of the two active pharmaceutical ingredients in IHL-42X.

It's aiming to submit an investigational new drug (IND) application with the US Food and Drug Administration (FDA) this quarter.

Incannex posted around $4.3 million of cash outflows last quarter to end the period with $37.1 million of cash.

The post 2 ASX All Ordinaries stocks leaping higher following strong quarters appeared first on The Motley Fool Australia.

This follows Incannex shares going into a trading halt shortly after the market open on Friday.

The Incannex share price was frozen on Friday at 14 cents per share.

Let's find out what's happening with this ASX 300 cannabis stock.

ASX 300 cannabis stock on hold…

According to a statement, Incannex asked for a voluntary suspension in trading "pending the release of a material update regarding the company's psychedelic program".

Incannex asked the ASX to suspend trading until the earlier of either its announcement or the start of trading tomorrow.

What's the latest news from Incannex?

Incannex develops medicinal cannabinoid pharmaceutical products.

The last lot of news from the ASX 300 cannabis stock came earlier this month.

Incannex announced it is going to develop and manufacture its own cGMP-grade psilocybin drug for clinical trials.

Investors loved the news and pushed the ASX 300 cannabis stock 12% higher on the day.

Last Thursday, my colleague Bernd reported that the Victorian government is considering amending state drug-driving laws to reflect the legality of medicinal marijuana.

Victoria was the first state to legalise medicinal cannabis in 2016.

Medicinal cannabis comes in a variety of forms. One form is plain cannabidiol oil, or CBD oil, which contains no psychedelic component, so it's perfectly safe to take it and drive.

Another form of CBD oil mixes in a bit of THC, which is the active component in marijuana, and which shows up on roadside drug-driving tests.

The Victorian government is trying to work out a way to distinguish between the presence of THC in a driver's system due to a medicinal cannabis prescription, and impairment as a result of THC ingested from the recreational use of marijuana.

The post ASX 300 cannabis stock Incannex suspended ahead of 'material update' appeared first on The Motley Fool Australia.

All told, the cannabis shares have grown, cured, and prepared medicinal marijuana products for more than 250,000 Australians. That's how many patients have received prescriptions over the past five years, according to data from the Lambert Initiative for Cannabinoid Therapeutics.

In Victoria alone, some 65,000 people currently have medicinal cannabis prescriptions.

And it's ASX cannabis stocks like Incannex Healthcare Ltd (ASX: IHL), Creso Pharma Ltd (ASX: CPH), and Cann Group Ltd (ASX: CAN) that make it all possible.

But using medicinal cannabis comes with an unexpected legal risk. One that Victoria's lawmakers are working on rectifying.

Victoria's road rules up for an overhaul

In what's likely to be welcome news to shareholders in ASX cannabis stocks, and more welcome still to patients taking medicinal marijuana, Victoria is looking to amend its drug-driving laws to reflect the legality of medicinal cannabis.

As The Guardian reports, the Road Safety Amendment Bill was introduced by newly elected Legalise Cannabis MPs. The bill was said to have support from both major parties. Yesterday, Victoria's government announced it would take up the issue within the next few months.

As it stands, it's a crime for a driver to have any trace of THC (the active component in marijuana) in their system. The problem here stems from the fact that THC can often be detected for many weeks after use. This means drivers with a legal prescription can find themselves guilty of drugged driving even if they're in no way impaired.

Under the Road Safety Amendment, the law would treat medicinal cannabis like other prescription medicines.

Labor MP Harriet Shing is a member of the medicinal cannabis and safe driving working group. She said it was a "significant priority" for the law to distinguish between the presence of THC in a person's system "and impairment".

According to Shing (quoted by The Guardian):

This work has been going on for a number of years now. The working group has actually discussed at length the complexities of this matter and the options and opportunities that might be available.

We need … to find a way through all of this so that all drivers are able to be safe on our roads and so that we can provide those medical supports that Victorians need and indeed deserve.

Legalise Cannabis MP Rachel Payne said, "We are hopeful a solution can be found fast, considering the negative impact the law currently has on Victorian patients every day."

How have these ASX cannabis stocks been tracking?

The ASX cannabis stocks we listed above have all seen big falls in their share prices over the last year.

Over the past 12 months:

• Creso Pharma shares are down 76%
• Cann Group shares are down 31%
• Incannex Healthcare shares are down 70%

The post Buying ASX cannabis stocks? Here's what the Victorian government is considering right now appeared first on The Motley Fool Australia.

The Incannex share price is currently 14 cents, up 11.54% for the day so far.

Let's see what's happening.

What news pushed this ASX 300 cannabis share higher?

Incannex is a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic medicine therapies for conditions including generalised anxiety disorder.

Today, Incannex announced it is going to develop and manufacture its own cGMP-grade psilocybin drug for clinical trials.

In a statement, Incannex CEO Joel Latham said:

Having our own source of pharmaceutical grade psilocybin not only allows our company to freely undertake clinical trials, it also creates and assists with number of commercial opportunities which are currently at an advanced stage of investigation by the company, and will be announced in the coming weeks, following board appraisal and approval.

Incannex has engaged Catalent to develop the formulation.

The company said the manufacturing process would be designed so that it can be scaled up to commercial supply levels when appropriate.

'Potential to help millions of people'

Incannex chief scientific officer Dr Mark Bleackley said:

The resulting drug product, and supporting data, will form an important component of future regulatory filings and will facilitate Incannex's development of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder.

This therapy has the potential to help millions of people whose lives are seriously impacted by severe anxiety and for whom current treatment options have not been effective.

Incannex share price snapshot

Cannabis shares are still a highly speculative segment of the share market.

This ASX 300 cannabis share is currently down 18% in the year to date, compared to a 5% bump for the S&P/ASX All Ordinaries Index (ASX: XAO).

Over the past 12 months, Incannex shares are down 78%. Over the past five years, they are up 635%.

The post Why did this ASX 300 cannabis share just rocket 12%? appeared first on The Motley Fool Australia.

Here's why these ASX All Ords shares are on form on Monday:

Incannex Healthcare Ltd (ASX: IHL)

The Incannex share price is up 14% to 20.5 cents. This is despite there being no news out of the cannabis and psychedelics company today.

Though, it is worth noting that the company recently announced that the PsiGAD1 clinical trial has achieved its interim milestone of 29 patients completing primary endpoint assessments, and independent analysis of the interim study data has commenced.

This trial is assessing Incannex's psilocybin-assisted psychotherapy for the treatment of generalised anxiety disorder (GAD). The company notes that the treatment of GAD with currently accepted medications and therapies remains inadequate, with less than half of patients achieving remission. Positively, psilocybin-assisted psychotherapy has shown promise in the treatment of several mental health conditions.

Mesoblast Ltd (ASX: MSB)

The Mesoblast share price has jumped 11% to $1.16. Once again, this is despite there being no news out of the regenerative medicine company this morning.

However, investors have been fighting to get hold of the company's shares in recent sessions thanks to a promising announcement from last week. That announcement revealed that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

This is for the approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The resubmission contains substantial new information as required by the FDA. Investors appear optimistic that this might be enough to finally get the thumbs up from the regulator.

The post 2 ASX All Ords shares going gangbusters on Monday appeared first on The Motley Fool Australia.

The Incannex share price was 23 cents at the close yesterday.

Let's find out what's happening with this ASX cannabis share.

Why is the Incannex share price at a standstill?

According to a statement, Incannex intends to conduct a "strategic institutional capital raising".

Incannex asked the ASX to halt its share trading ahead of an official announcement explaining the detail of the raising.

Incannex shares will remain on ice until the commencement of normal trading on 5 December or upon the release of its announcement.

What's been happening at Incannex?

Incannex develops medicinal cannabinoid pharmaceutical products.

As my Fool colleague Brooke recently noted, Incannex shares had a shocker in October.

The company entered the S&P/ASX 300 Index (ASX: XKO) in September. The following month, the Incannex share price underperformed the index by 15%. And that was despite a series of seemingly positive market updates.

In November, Incannex shares dropped another 11.5%. Ouch.

Cannabis shares are a highly volatile category of the market. One of their biggest hurdles is regulatory restrictions.

Medicinal cannabis is simply not legal in many parts of the world — including numerous states in the enormous nascent United States market.

As my Fool colleague Bernd reports, US President Joe Biden wants marijuana use legalised.

In October, he announced he would pardon everyone convicted of simple possession.

ASX cannabis shares responded to that, with Incannex shares rising 11% over two days.

Incannex performance snapshot

Incannex shares are down 65% in the year to date.

Over the past five years, they are up 1,050%.

The post Why was the Incannex share price put on ice today? appeared first on The Motley Fool Australia.

That's partly because similar headwinds facing cannabis stocks worldwide have hit the sector.

Firstly, there's rocketing interest rates. Higher rates have hit growth shares particularly hard as investor risk appetite has waned. Secondly, there's the slowing pace of legalised markets across the world.

Legislation in the United States, the world's largest economy, is being closely watched. But the future of the legal marijuana market in the highly influential nation remains uncertain.

ASX cannabis shares under pressure

So how have these headwinds impacted ASX cannabis shares?

Well, so far in 2022:

• Incannex Healthcare Ltd (ASX: IHL) shares are down 64%
• Creso Pharma Ltd (ASX: CPH) shares are down 65%
• Bod Australia Ltd (ASX: BOD) shares are down 60%

With the US markets having a big impact here in Australia, investors would do well to keep an eye on the midterm election results. The election is being held tomorrow, 8 November, with results expected over the coming days.

Why the US midterm elections matter to investors Down Under

If you're looking at buying ASX cannabis shares, here's what's a stake in the midterm elections.

First, US President Joe Biden has expressed a desire to legalise marijuana on a Federal level. Currently, it remains illegal federally, despite a growing number of states having given recreational and medicinal use the green light.

As you may recall, on 7 October, Biden said he was pardoning everyone convicted of simple marijuana possession under federal law.

US cannabis shares broadly rallied, as did several on the ASX.

Incannex Healthcare shares leapt 11% over two days from the closing bell on 11 October through the end of trade on 13 October.

Bod Australia also shot 11% higher on 11 October.

Creso Pharma went the other direction. The ASX cannabis share lost 25%. Though it should be noted that came after the company announced a shakeup to its board and a potentially unwanted name and branding change proposal.

Now, if the Republicans retake control of either the House or Senate, it's unlikely that marijuana will be legalised on a federal level anytime soon. And, according to most polls, it's likely the Democrats will lose at least one of those chambers of Congress.

But let's not forget how unreliable polls have been in recent years.

The second thing to watch that could have a knock-on effect on ASX cannabis shares is the referendums taking place on a state level.

Voters in five US states – Maryland, Arkansas, Missouri, North Dakota and South Dakota – will decide whether their state joins the legal bandwagon or maintains the status quo.

Maryland is one to pay particularly close attention to.

According to Bloomberg Intelligence analyst Kenneth Shea, "If four or five approve, it would probably be deemed a positive, but if Maryland does not approve, that would definitely be deemed a negative."

Stay tuned.

The post Looking to buy ASX cannabis shares right now? You'll want to watch this appeared first on The Motley Fool Australia.

That was despite plenty of seemingly positive news being released by the healthcare stock.

The company works to develop medicinal cannabinoid pharmaceutical products.

 After closing September at 27.5 cents, the Incannex share price closed October at its lowest point of the month ­– 25 cents – marking a 9.1% fall. Meanwhile, the ASX 300 lifted 5.9%.

 So, what went wrong for the cannabinoid favourite? Let's take a look.

What went wrong for Incannex stock in October?

The Incannex share price stumbled through October despite three seemingly positive announcements being released by the ASX 300 newbie in that time.

The first detailed a meeting with the United States' Food and Drug Administration (FDA) regarding its drug IHL-216A.

Incannex chief scientific officer Dr Mark Bleackley commented on the regulator's feedback, saying:

The FDA … indicated that the agency is highly interested in the development of IHL-216A for treatment of traumatic brain injury … The FDA has provided essential advice on inhaled drug development that will guide the most efficient development of IHL-216A.

Sadly, the news appeared to disappoint the market. It bid the Incannex share price 8.6% lower on the release. Fortunately, the next announcement from the company inspired its stock to lift by 3.5%.

Days later, Incannex declared dosing in a phase one clinical trial assessing another drug – IHL-675A – was completed successfully. It will now get started on phase two trials of the drug.

But such gains weren't to last. The Incannex share price handed back 3.8% on the release of the company's quarterly report.

It posted a $4 million cash outflow for the three months ended 30 September, $2.26 million of which was related to research and development.

It closed the period with $33.4 million of cash in the bank – enough to fund an estimated eight future quarters.

Incannex share price snapshot

The Incannex share price has struggled this year after posting a near-300% gain in 2021.

As of this morning, it has fallen 61% since the start of 2022. It's also currently 43% lower than it was this time last year.

For comparison, the ASX 300 has fallen 8% year to date and 6% over the last 12 months.

The post Why did the Incannex share price go up in smoke in October? appeared first on The Motley Fool Australia.

While all three are deep in the red today amid wider selling action that sees the All Ordinaries Index (ASX: XAO) down 1.4%, that extra attention could offer some tailwinds for cannabis stocks like Cann Group Ltd (ASX: CAN), Incannex Healthcare Ltd (ASX: IHL) and Creso Pharma Ltd (ASX: CPH).

Though if you're looking for information about ASX cannabis share Creso Pharma in the future, you may need to look up Melodiol Global Health Limited instead.

In a release this morning, Creso management announced their intention to seek shareholder approval for rebranding the company name at a future general meeting. Management said the new name represented "the global ambitions of the organisation".

So, why are ASX cannabis shares moving back into the spotlight?

How Biden could rekindle ASX cannabis shares

Since cannabis shares first began trading on the ASX and international exchanges, moves by US state governments and the vacillating prospects for legalisation by the federal government have alternately pushed them higher and lower.

Numerous US states have legalised medicinal and recreational marijuana in recent years. But cannabis has remained classified as a Schedule I substance under the federal Controlled Substances Act. That defines it as having a high potential for abuse, with no currently accepted medical applications.

But US president Joe Biden is following through with an election promise. Biden has said he will pardon everyone convicted of simple marijuana possession under federal law.

Here's what the president tweeted on Friday:

As I've said before, no one should be in jail just for using or possessing marijuana. Today, I'm taking steps to end our failed approach. Allow me to lay them out.

First: I'm pardoning all prior federal offenses of simple marijuana possession… Second: I'm calling on governors to pardon simple state marijuana possession offenses. Just as no one should be in a federal prison solely for possessing marijuana, no one should be in a local jail or state prison for that reason, either.

Biden also called on the US Attorney General "to initiate the process of reviewing how marijuana is scheduled under federal law". He noted it was currently classified "at the same level as heroin – and more serious than fentanyl. It makes no sense."

This US pot ETF surged on the news

While ASX cannabis shares aren't moving higher on Biden's legalisation push today, marijuana-focused exchange-traded fund (EFT) AdvisorShares Pure US Cannabis ETF (NYSEARCA: MSOS) leapt 41% higher in 30 minutes after the word hit the wires last week.

Though investors should take note that even if the US legalises marijuana on a federal level, not every cannabis share trading on the ASX will benefit. But companies with a significant footprint in US markets or the ability to expand into those markets, like Creso, could find some new opportunities ahead.

The post Why is everyone talking about ASX cannabis shares all of a sudden? appeared first on The Motley Fool Australia.

The company is a clinical-stage pharmaceutical company with a focus on developing medicinal cannabinoid products and psychedelic therapies to help those with unmet medical needs.

Speaking on the company's inclusion in the index, Incanncex CEO and managing director Joel Latham said:

We're delighted to be … listed among the largest and most-recognisable companies in Australia.

Being listed in the index is a precursory investment condition for many domestic and international investment institutions so we are excited for the possibilities this recognition may bring.

But does adding the healthcare share to the ASX 300 expand the index's unprofitable constituents? Let's take a look at the company's balance sheet to find out.

Is ASX 300 healthcare share Incannex profitable?

Healthcare share Incannex is among 16 shares added to the ASX 300 in the September quarterly rebalance. And the company is one of many being included in the rebalance that isn't turning a profit.

Incannex brought in $788,654 of income in financial year 2022. However, that was nowhere near enough to cover the company's costs.

In fact, it wasn't even a third of the company's advertising and investor relations spend – sitting at $2.7 million. Incannex also forked out $5.3 million on research and development and $2 million on employee salaries and benefits.

All in all, the ASX 300 healthcare company posted a total after-tax loss of $14.9 million for financial year 2022.

Though, it ended the period with $37.5 million of cash and no debt, meaning it's not in dire need of capital.

Its cash position was bolstered back in April when it underwent a $24 million options exercise program. Additionally, the company listed on the Nasdaq in March.

Finally, Incannex finalised its acquisition of APIRx Pharmaceuticals in August.

Sadly, the company's productive year hasn't been reflected in its share price's performance.

The stock has fallen 51% in 2022 so far to trade at 32 cents right now, including a 14% gain on Friday. That's 0.6% higher than it was this time last year.

For comparison, the ASX 300 has slumped 11% year to date and 7% over the last 12 months.

The post Is ASX 300 healthcare company Incannex profitable? appeared first on The Motley Fool Australia.

It has rocketed 21.4% over the last fortnight despite no price-sensitive news having been released by the clinical stage developer of medicinal cannabinoid pharmaceuticals.

At the time of writing, the Incannex share price is trading at 34 cents, 1.49% higher than its previous close.

For context, the broader market is also in the green. The All Ordinaries Index (ASX: XAO) has lifted 1.1% right now.

So, what might be driving the ASX healthcare share higher lately? Let's take a look.

What's been going right for Incannex lately?

The Incannex share price has rallied in recent weeks as the company prepared to be included in the S&P/ASX 300 Index (ASX: XKO).

The healthcare stock was added to the index as part of its September rebalance alongside 15 other shares. Monday marked its first day on the ASX 300.

Its addition likely bolstered demand for its stock as funds tracking the ASX 300 were forced to buy in.

Its intended inclusion was announced on 2 September. The company's CEO Joel Latham responded to the news on 6 September, saying:

We're delighted to be recognised for inclusion in the ASX 300 index to be listed among the largest and most-recognisable companies in Australia.

Being listed in the index is a precursory investment condition for many domestic and international investment institutions so we are excited for the possibilities this recognition may bring.

Thus, its new home on the ASX 300 might explain some of the Incannex share price's recent gains.

Incannex is also likely in the front of investors' minds after the company released its annual report this morning.

The report details the company's financial year 2022, a year that Incannex chair Troy Valentine said brought "significant advancements in clinical development across [its] entire portfolio". Valentine continued:

Our strong financial position and having strong investor visibility in Australia and the United States gives us the necessary comfort to conduct our research programs unimpeded and at pace as we focus on delivering our novel pharmaceutical products and therapies to patients in need.

Incannex currently boasts 28 projects for which proof of concept has been established.

Incannex share price snapshot

While the last fortnight has been good for the Incannex share price, its longer-term performance has been less positive.

The stock has slumped 48% since the start of 2022. Though, it's still 5% higher than it was this time last year.

For comparison, the ASX 300 has fallen 11% year to date and 6% over the last 12 months.

The post Why has the Incannex share price rallied 20% in 2 weeks? appeared first on The Motley Fool Australia.

That's far lower than the S&P/ASX 200 Health Care Index (ASX: XHJ), which is down 5.24% for the same period.

However, Incannex is not alone among ASX cannabis shares. Emyria Ltd (ASX: EMD) has shed 42% while Creso Pharma Ltd (ASX: CPH) is down more than 60% so far this year.

Let's make sense of what may have impacted Incannex's performance lately

What's going on with Incannex Healthcare?

The company is now included in the S&P/ASX 300 Index (ASX: XKO) as part of S&P Global's quarterly rebalancing that took place at the beginning of the month.

In August, Incannex also completed its acquisition of APRIx Pharmaceuticals for US$93.3 million after the companies reached an agreement in March this year.

When the deal went through, Incannex claimed it now held "the world's largest portfolio of patented medicinal cannabinoid drug formulations and psychedelic treatment protocols".

Earlier in August, Incannex released an investor presentation giving an overview of its operations and other aspects of the business.

At that time, it noted it had an estimated $290 billion total addressable market for its lead drug candidates and another $2 billion per year in potential revenue from psychedelic treatment therapies.

And finally, the company posted its results for FY22, noting that its net loss from ordinary activities increased 31% to $14.9 million from the prior reporting period while also recording no revenues.

Icannex share price snapshot

The Icannex share price finished 6.78% higher today at 31.5 cents, a long way from its 52-week closing high of 73 cents in early March.

The company's current market capitalisation is around $479 million.

The post Have Incannex Healthcare shares been a good investment in 2022? appeared first on The Motley Fool Australia.

Incannex shares closed the day up 13.04% to 26 cents apiece.

In comparison, the All Ordinaries (ASX: XAO) finished the day up 0.26%.

Why are Incannex shares smoking out the ASX?

Investors bid up Incannex shares on Monday, despite the medicinal cannabis company not releasing any announcements to the market. However, the S&P Dow Jones Indices updated its quarterly rebalance late on Friday.

As a result, a number of shares were on the move today following their addition or removal from the S&P/ASX Indices.

Incannex shares will be added to the S&P/ASX 300 Index effective prior to the open of trading on 19 September.

The inclusion to the ASX 300 Index provides a much-welcomed boost for the company's shares.

This is because fund managers must abide by their investing mandate which permits them to only buy shares included in specific indices.

Each index comprises a number of companies that have the largest market capitalisation of that group.

Incannex share price summary

In March 2022, the Incannex share price rocketed to a multi-year high of 75.5 cents before treading downhill.

Fast-forward to August, and its shares hit a 52-week low of 18.5 cents.

This means that when looking at year to date, Incannex shares are down 58.4%.

Based on today's price, Incannex is worth approximately $350.42 million and has 1.52 billion shares outstanding.

The post Why the Incannex share price leapt 13% on Monday? appeared first on The Motley Fool Australia.