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

Actinogen Medical Ltd (ASX: ACW)

The Actinogen Medical share price is down 8.5% to 3.2 cents. This morning, this biotechnology company announced the successful completion of an $8.1 million share placement to existing shareholders and new institutional investors. The funds will be used to accelerate the full enrolment of 220 patients with biomarker-positive Alzheimer's disease (AD) in the 36 week placebo-controlled XanaMIA Phase 2b/3 trial being conducted in Australia and the US. In addition, the funds will allow the trial to be administered according to statistical and quality standards required to achieve pivotal status as one of two potential trials required for marketing approval in the US and globally.

Flight Centre Travel Group Ltd (ASX: FLT)

The Flight Centre share price is down 0.5% to $20.75. The catalyst for this has been the travel agent's shares going ex-dividend this morning for its final dividend of FY 2024. Last month, Flight Centre released its full year results and declared a 30 cents per share fully franked final dividend. Eligible shareholders can now look forward to receiving this payout next month on 17 October.

JB Hi-Fi Ltd (ASX: JBH)

The JB Hi-Fi share price is down almost 2% to $79.33. This is despite there being no news out of the retailer today. However, it is worth noting that JB Hi-Fi's shares have been on fire this year. So much so, they remain up 46% year to date despite today's weakness. As a result, it is possible that some investors are taking a bit of profit off the table during today's session.

Nextdc Ltd (ASX: NXT)

The NextDC share price is down almost 1% to $16.85. This morning, this data centre operator announced the launch of its share purchase plan. NextDC revealed that eligible shareholders in Australia and New Zealand can apply for up to a maximum of $30,000 new fully paid ordinary shares at $17.15 per share. This share purchase plan is not underwritten and is capped at $200 million. Unfortunately, NextDC's shares are now trading below the offer price, so it isn't as attractive as its institutional offering was.

The post Why Actinogen Medical, Flight Centre, JB Hi-Fi, and NextDC shares are falling today appeared first on The Motley Fool Australia.

Four ASX shares that are failing to follow the market's lead today are listed below. Here's why they are falling:

Actinogen Medical Ltd (ASX: ACW)

The Actinogen Medical share price is down a further 7.5% to 2.5 cents. This biotechnology company's shares have crashed deep into the red this week following the release of phase 2a trial topline results from its XanaCIDD trial. It was testing its Xanamem product in patients with cognitive dysfunction and major depressive disorder. Unfortunately, the trial failed with its primary endpoint of improving the "attention composite." Management blamed this failure on an unexpectedly large improvement in the placebo group. Its shares are now down almost 70% since this time last month.

ASX Ltd (ASX: ASX)

The ASX share price is down almost 3% to $64.02. This morning, the stock exchange operator revealed that the Australian Securities and Investment Commission (ASIC) has started proceedings against the company over alleged misleading statements about its Clearing House Electronic Subregister System (CHESS) replacement project. ASIC stated: "We allege that the true state of affairs as at 10 February 2022 was that the project was not "progressing well", contrary to ASX's announcement."

Burgundy Diamond Mines Ltd (ASX: BDM)

The Burgundy Diamond Mines share price is down 5% to 14.7 cents. This is despite the release of an announcement which revealed that its agreement with surety providers in relation to the reclamation bonds has been formally concluded. CEO Kim Truter was pleased with the news. He said: "This is a real game changer. Our revised long-term partnership and arrangement with our surety providers ensures our closure obligations are funded, releases cash to fund our mine extension options, and ensures we maintain a healthy cash reserve. Furthermore it reduces future financial liability related to reclamation requirements."

Lifestyle Communities Ltd (ASX: LIC)

The Lifestyle Communities share price is down almost 5% to $8.59. This follows the release of the retirement communities company's FY 2024 results. Lifestyle Communities reported a 25.6% decline in operating profit after tax to $52.9 million and a 29.4% fall in operating earnings per share to 48.1 cents. In addition, management revealed settlements that were run-rating significantly behind analyst expectations. This has been caused by customer sentiment being negatively impacted due to recent media coverage.

The post Why Actinogen, ASX, Burgundy Diamond, and Lifestyle Communities shares are sinking today appeared first on The Motley Fool Australia.

Four ASX shares that have failed to follow the market higher today are listed below. Here's why they are falling:

Actinogen Medical Ltd (ASX: ACW)

The Actinogen Medical share price is down 54% to 3.5 cents. Investors have been selling this biotechnology company's shares following the release of phase 2a trial topline results from its XanaCIDD trial. This trial was testing its Xanamem product in patients with cognitive dysfunction and major depressive disorder (MDD). While the company achieved clinically meaningful and persistent improvement in depression measured by the key secondary endpoint of MADRS, it failed with its primary endpoint of improving the "attention composite." Management has blamed this failure on an unexpectedly large improvement in the placebo group.

Aurizon Holdings Ltd (ASX: AZJ)

The Aurizon share price is down 7.5% to $3.35. This has been driven by the release of the rail freight operator's full year results this morning. Aurizon deliver a solid result on paper. Its revenue was up 9% to $3.8 billion and its underlying earnings before interest, tax, depreciation and amortisation (EBITDA) increased 14% to $1.6 billion. This allowed it to declare a final dividend of 7.3 cents per share, which lifted its total dividend to 17 cents per share for FY 2024. This is up 13% year over year. However, investors may have been disappointed with its guidance. Management is guiding to group EBITDA in a range of $1.6 billion to $1.7 billion. The low end would be flat year on year.

Beach Energy Ltd (ASX: BPT)

The Beach Energy share price is down 11% to $1.27. This follows the release of the energy company's full year results. Beach reported a 9% increase in sales revenue to $1.8 billion but an 11% decline in underlying net profit to $341 million. Also catching the eye was an update on its oil reserves. Management advised that it has completed an audited 2P reserves revision at its Enterprise field, resulting in a reduction of 11.5 MMboe. Its CEO, Brett Woods, said: "Disappointingly, over recent weeks we have observed pressure decline at Enterprise which is consistent with a smaller reservoir than originally estimated. We have moved rapidly to assess the impact."

PYC Therapeutics Ltd (ASX: PYC)

The PYC Therapeutics share price is down 4.5% to 10.5 cents. This morning, this clinical-stage biotechnology company released a further update on its drug candidate, VP-001, which is currently progressing through multiple concurrent clinical trials in patients with a blinding eye disease called Retinitis Pigmentosa type 11 (RP11). Management revealed that two out of three RP11 patients in a recent cohort had enhanced retinal sensitivity across the entire macula at three months of follow up when compared to baseline. Investors may have been looking for stronger results.

The post Why Actinogen, Aurizon, Beach Energy, and PYC shares are sinking today appeared first on The Motley Fool Australia.

In morning trade, the ASX healthcare stock was down as much as 67% to 2.5 cents.

The neurological and neuropsychiatric diseases focused biotechnology company's shares have recovered a touch but remain down 61% at 3 cents at the time of writing.

Why is this ASX healthcare stock crashing?

Investors have been rushing to the exits after the company released the phase 2a trial topline results from its XanaCIDD trial of Xanamem in patients with cognitive dysfunction and major depressive disorder (MDD).

According to the release, there was a clinically meaningful and persistent improvement in depression measured by the key secondary endpoint of MADRS.

Management notes that this outcome indicates potential modification of the underlying biology of depression as a result of inhibition of tissue cortisol synthesis. This would be a completely novel mechanism for the treatment of depression.

However, importantly, and the reason the ASX healthcare stock is crashing deep into the red today, is that the trial did not meet its primary endpoint.

That primary goal was improving the "attention composite." Management has blamed this failure on an unexpectedly large improvement in the placebo group. It summarises:

The trial did not meet the primary endpoint of an "attention composite" of three Cogstate computerized tests measuring attention and working memory with similar and large improvements in performance observed. Mean improvements in the Xanamem and placebo groups were 0.3 and 0.4 z-score points, respectively (p not significant). The unexpectedly large placebo mean improvement may have impaired the ability of the trial to observe any short-term pro-cognitive effects of Xanamem.

What now?

The ASX healthcare stock's management team remains upbeat.

Actinogen's Chief Medical Officer, Dr Dana C Hilt, said:

This encouraging result on depression is very positive to the whole Xanamem program and confirms 10 mg daily is an active clinical dose with the ability to potentially modify underlying biological processes in the brain. We will continue to examine these topline data in detail and the larger dataset to better understand the complete results and determine next steps for the depression program. The unexpected cognition placebo effect appears to have impaired the ability of Xanamem to show the pro-cognitive effects that we have observed in three previous studies

Its CEO, Dr Steven Gourlay, echoed this sentiment. He said:

The excellent safety profile of Xanamem was again demonstrated in this trial and the significant treatment benefits seen in depression are encouraging for both the depression and Alzheimer's disease programs. We believe the trial confirms the ability of Xanamem 10 mg daily to safely provide benefit to patients by inhibiting the synthesis of the "stress hormone" cortisol in the brain.

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Four ASX shares that are not letting that hold them back are listed below. Here's why they are rising:

A2 Milk Company Ltd (ASX: A2M)

The A2 Milk share price is up over 2% to $6.66. This appears to have been driven by a broker note out of Citi this morning. In response to very positive industry data, the broker is feeling confident about the company's outlook. Particularly given the improving birth rate outlook in China and its belief that domestic brands are not going to limit its growth. As a result, it has reaffirmed its buy rating and $7.85 price target on its shares. This implies potential upside of almost 18% for investors over the next 12 months.

Actinogen Medical Ltd (ASX: ACW)

The Actinogen Medical share price is up 19% to 3.7 cents. This morning, this biotech announced that positive trial data relating to its Xanamem product in patients with elevated blood pTau. The company's chief medical officer, Dr Dana Hilt, said: "To our knowledge Xanamem is the first drug of this class to have such compelling data. The previously published PET study highlighted just how effective Xanamem is at reaching its target enzyme in the brain at safe and well tolerated doses of 5 and 10 mg/day. No other inhibitor of 11β-HSD1 has ever demonstrated robust central nervous system target engagement in this direct way."

Karoon Energy Ltd (ASX: KAR)

The Karoon Energy share price is up 2% to $1.80. This may be a delayed reaction to the energy company's drilling and operational update yesterday. That update confirmed that the Bauna Project restarted production on 11 June as scheduled. In addition, it advised that Who Dat production is currently averaging over 40,000 barrels of oil equivalent (boe) per day on a gross basis. As a result, Karoon Energy expects Who Dat production for the quarter ended 30 June 2024 to be approximately 0.8 million boe.

Race Oncology Ltd (ASX: RAC)

The Race Oncology share price is up 6% to $1.81. Investors have been buying this clinical stage biopharmaceutical company's shares following the release of a positive announcement relating to its RC220 bisantrene formulation. The company is advancing RC220 to address the high unmet needs of patients across multiple oncology indications. According to the release, toxicology and safety pharmacology studies showed no unexpected or unacceptable toxicities. This means that the completed data package supports the use of RC220 bisantrene in human clinical trials.

The post Why A2 Milk, Actinogen Medical, Karoon Energy, and Race Oncology shares are rising appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back are listed below. Here's why they are rising:

Actinogen Medical Ltd (ASX: ACW)

The Actinogen share price has jumped 28% to 12.3 cents. Investors have been buying this biotechnology company's shares after it announced positive Alzheimer's Disease clinical results. The new clinical results show that Actinogen's Xanamem product had a therapeutic effect in patients with a biomarker-positive blood profile.

Core Lithium Ltd (ASX: CXO)

The Core Lithium share price is up 1% to $1.17. This follows news that Core Lithium has transitioned from being a lithium developer to a lithium miner following the official opening of its Finniss Lithium mine. This makes it the first operating mine in the Northern Territory and Australia's only lithium mine outside Western Australia.

Fortescue Metals Group Limited (ASX: FMG)

The Fortescue share price is up over 2% to $17.71. This is despite news that Morgans has downgraded the iron ore miner's shares to a reduce rating and cut the price target of them to $14.50. However, it is worth noting that a number of materials shares are outperforming today.

Galileo Mining Ltd (ASX: GAL)

The Galileo Mining share price has jumped 14% to $1.37. This morning this nickel explorer announced that four RC drill holes completed 400 metres north of the Callisto discovery have intersected disseminated nickel sulphide mineralisation up to 51 metres thick. Management notes that the results confirm Galileo's geological model that the five kilometres of ground to the north of Callisto is highly prospective for new discoveries.

The post Why Actinogen, Core Lithium, Fortescue, and Galileo Mining shares are pushing higher appeared first on The Motley Fool Australia.

The Actinogen Medical Ltd (ASX: ACW) share price soared 56% in early trade before pulling back. The company's share price is up 30% at the time of writing and is currently trading at 12.5 cents.

Let's take a look at why this biotechnology company is having a good day.

Trial results

Actinogen shares are exploding today on the back of news on an Alzheimers Disease (AD) clinical trial.

The company advised of positive phase 2a clinical data from an AD biomarker study.

Xanamem had a therapeutic impact on patients with a biomarker-positive blood profile.

Xanamem is the company's drug candidate to treat Alzheimer's disease.

Patients who had elevated blood pTau showed a "clinically significant Xanamem effect on the CDR-SB endpoint".

CDR-CB is a well known primary endpoint for trials in patients with early-stage AD, Actinogen said.

Actinogen highlighted that this means using this endpoint in future trials will be "straightforward and uncontroversial".

Commenting on the news, CEO and managing director Dr Steven Gourlay said:

Xanamem has the potential to be a novel daily oral therapy for Alzheimer's Disease and other conditions that could be safely used alone or in combination with other therapies.

The results affirm our confidence in the upcoming clinical trials that will confirm if Xanamem can make a significant improvement in the lives of patients and their families living with serious neurological and psychiatric conditions.

Actinogen share price snapshot

The Actinogen Medical share price has climbed 14% in the past year, while it has fallen 22% year to date.

For perspective, the ASX 200 has fallen nearly 9% in the past year and 10.5% in 2022.

This ASX biotech share has a market capitalisation of more than $224 million based on the current share price.

The post Guess which ASX biotech share just rocketed 56% on new Alzheimer's drug trial results appeared first on The Motley Fool Australia.

The S&P/ASX 200 Health Care Index (ASX: XHJ) has climbed almost 9% in the past 12 months. That's a good sign of the strength in the broad sector. It closed the year out with support after knocking some froth off its November highs.

With this in mind, we've picked five of the top performers in the ASX healthcare basket in 2021. Here's the lowdown on each.

Sonic Healthcare Limited (ASX: SHL)

Shares in ASX healthcare giant Sonic Healthcare finished the last 12 months of trading almost 40% up after a fairly strong year on the chart.

In November, Sonic's share price turned sharply and sunk to a two-month low of $38.51. This was alongside the broad index, before December saw both recover swiftly.

Investors began rewarding the company on the release of its Q1 FY22 trading update. Sonic grew revenue 5% year over year (YOY) to $3.08 billion and earnings before interest, tax, depreciation and amortisation (EBITDA) by 16% in the same time.

Given that many analysts were calling for Sonic's revenue to decline in FY22, this was a positive surprise for investors to realise some price discovery.

Sonic also revealed it had acquired Texas-based anatomical pathology company ProPath last month. The acquisition builds in another $110 million in revenue to Sonic's top line. It also builds on the company's plan to integrate anatomical pathology and clinical laboratory services.

Not only that, high demand for COVID-19 testing continues to be a short-term catalyst for the company's share price, given it is Australia's largest provider of pathology services.

In the last month, Sonic has garnered attention once more. In that time investors have bid up the Sonic share price another 9%.

Actinogen Medical Ltd (ASX: ACW)

Shares in Australian biotech Actinogen were a substantial outperformer across the ASX healthcare universe. This small cap jumped more than 733% in 2021, but not without its fair share of volatility.

For instance, shares traded as high as 19 cents and as low as 2.2 cents last year, a substantial spread in pricing. However, the company closed out the year well after announcing a research agreement with Oxford University.

Under the agreement, Actinogen will supply its Xanamem label to the team of researchers. The research is investigating Xanamem's therapeutic potential as a treatment in mild autonomous cortisol secretion (MACS).

Investors were late to the party following the announcement but caught on eventually. In the days afterwards, the company's share price was rewarded.

At the same time, the broad index bounced hard off a three-month low in mid-December. The impulse of which carried through to the majority of ASX healthcare names.

As such, the company finished the year near its 52-week highs after gaining more than 33% in the final week of 2021.

Race Oncology Ltd (ASX: RAC)

Shares in precision oncology company Race Oncology held the fort across 2021. Race finished the year more than 95% in the green.

Most of Race's share price movement came in January and February after it announced its quarterly activities report and half-yearly financial statements.

Shares shot up from a low of $1.72 to a closing high of $4.07 in a matter of two months. They managed to hold this line for the entire year.

At the time of writing, investors are paying $3.65 apiece for Race shares after a small gain of around 3% in the past five days of trading.

Race Oncology also advised that it successfully completed a share purchase plan (SPP) in December. Race raised $29.7 million after a scale back. The SPP resulted in the creation of 9.9 million new shares at $3 each.

Shortly afterwards, Race announced that its lead drug candidate, Zantrene, was shown to be protective for heart muscle fibres against cellular death that can be induced from anti-cancer drug Carfilzomib.

Compounding the findings is that Zantrene showed this ability whilst also improving its ability to kill cancer cells. As such, Race is seeking patent protection over Zantrene's use as a heart protectant in patients receiving oncology treatment.

Both announcements have sent Race's share price 11% higher in the last month of trading.

ResMed Inc (ASX: RMD)

Shares in medical devices player ResMed landed around 30% in the green last year. The ResMed share price offered investors a low-volatility solution to capture some upside in 2021.

At the time of writing, investors are paying $34.90 apiece for ResMed – fairly consistent with its levels since October last year.

ResMed shares traded in a narrow channel the entire way, with most growth occurring mid-year. That's when key competitor Philips announced the voluntary recall of 3.5 million ventilation systems used for managing sleep apnoea.

Philips cited potential user risks from compounds used in the makeup of the device when recalling the ventilators.

ResMed shares popped on the news and remained top heavy for the remainder of the year. This was relevant as Philips' decision was likely to take several months for full effect.

With its positioning as Philips' competitor, it stands to reason that ResMed may capture additional market share and product placements with the recall.

Aside from that, it was business as usual last year for ResMed. The company had another solid year of operations that was reflected in the performance of its share price.

Australian Clinical Labs Ltd (ASX: ACL)

Shares in Australian Clinical Labs are a notable mention given their performance towards the back end of 2021.

For the majority of the time, ACL was trading in a fairly lacklustre and narrow range. It had a peak of $4.50 and a bottom of around $4.10 per share.

Yet, shares in the pathology and diagnostics provider shrugged off weakness in the broader ASX healthcare sector and held onto gains in December, before exploding to close out the year after upgrading its 1H FY22 guidance.

ACL now forecasts a range of $497.3 million to $517.2 million in revenue and net profit after tax (NPAT) of $116.3 million to $128 million.

This calls for a lift of around 14% and 35% for sales and NPAT guidance, respectively. Similarly to its peers, the company noted tailwinds from strong COVID-19 testing demand volumes as the reason for the upgrade.

As legendary investors Warren Buffet and Peter Lynch note in their writings, the market prices securities based on a combination of past earnings history and future earnings expectations.

Hence, an earnings upgrade such as ACL's recent announcement is likely to be viewed positively by the market, inflecting positively on its share price.

Positive effects from COVID-19 testing demand is likely to remain in situ across the remainder of FY22, according to the company's CEO Melinda McGrath.

The post In the green: Here are the 5 best ASX healthcare shares of 2021 appeared first on The Motley Fool Australia.

Shares in the biotechnology company finished the day at 13 cents, up 8.7% on the previous close.

Actinogen is developing a lead compound called Xanamem, a new therapy for Alzheimer's disease.

What did Actinogen announce today?

The Actinogen share price leapt into the green after the company revealed is is linking up with Professor Jeremy Tomlinson and the Oxford University Centre for Diabetes, Endocrinology and Metabolism.

Actinogen will supply Xanamem to researchers, enabling them to investigate its therapeutic potential for people with Mild Autonomous Cortisol Secretion (MACS). MACS is a condition linked to the over-production of the stress hormone cortisol.

Xanamem stops production of cortisol by blocking a specific enzyme in the brain. High levels of cortisol have been linked to Alzheimer's disease, depression and other diseases.

Researchers at Oxford will conduct a 12-week clinical trial involving 40 people with MACS and funded by a UK Medical Research Council grant. The trial will evaluate the effects of Xanamem on metabolism, bone density, and cognitive function. The final results are expected in 2024.

Actinogen will supply Xanamem to Oxford free of charge and will also provide trial design support.

Commentary from management

Speaking about the news driving the Actinogen share price today, CEO and managing director Dr Steve Gourlay said:

The MACS collaboration represents an important opportunity to investigate the potential benefits of Xanamem on the cortisol system outside of the brain.

We are pleased to be working with Oxford University, an academic centre of excellence in this area.

Chief investigator of the MACS study, Professor Tomlinson, added:

This is a hugely important clinical problem and currently there are no licenced treatments. This study may not only provide a detailed understanding of the processes that drive the condition, but also offer potential for an entirely novel treatment.

Actinogen share price snapshot

The Actinogen share price is soaring this year to date, up 495%. It is also up 468% over the past 12 months.

For perspective, the benchmark All Ordinaries Index (ASX: XAO) is up 10% over the last year.

Actinogen has a market capitalisation of roughly $220 million.

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

Actinogen Medical Ltd (ASX: ACW)

The Actinogen Medical share price has sunk 15% to 16.2 cents. This is despite Actinogen announcing the receipt of approval from the US FDA for its Investigational New Drug (IND) application. This application is for a Phase 2 protocol which will test Xanamem in treating male adolescents and young adults with Fragile X Syndrome. The trial will enrol approximately 50 patients for a 12-week treatment period, with results expected in 2023.

AVITA Medical Inc (ASX: AVH)

The AVITA Medical share price is down 12% to $4.48 following the release of its first quarter update. The regenerative medicine company announced a 39% increase in revenue to US$7 million but still recorded a loss of US$5.9 million. Looking ahead, management isn't expecting sequential growth in the second quarter. It has guided to revenue of US$7 million for the period. This reflects the anticipated impact of hospital staffing challenges as well uncertainty with the pandemic.

Inghams Group Ltd (ASX: ING)

The Inghams share price is down a further 3% to $3.43. Investors continue to sell this poultry company's shares in response to its annual general meeting update last week. At the event, management warned that its financial performance was being impacted by sustained input cost pressures.

National Australia Bank Ltd (ASX: NAB)

The NAB share price is down almost 2% to $28.62. This follows the release of the banking giant's full year results this morning. Although NAB delivered a 76.8% increase in cash earnings to $6,558 million, this was slightly below expectations. For example, Morgans was forecasting cash earnings of $6,597 million for FY 2021. In addition, management warned that competitive pressures are expected to continue in FY 2022, impacting housing lending margins.

The post Why Actinogen, AVITA, Inghams, and NAB shares are falling appeared first on The Motley Fool Australia.

Investors are selling Actinogen shares today despite the company receiving clearance from the US Food and Drug Administration (FDA) to commence a phase 2 trial on its Xanamem label.

Here are the details.

But first – what even is Actinogen Medical?

Actinogen is a biotechnology and research company. It is working on a medical breakthrough in neurological disorders that cause cognitive impairment.

Its lead drug candidate, Xanamem, is being investigated for potential breakthroughs in Alzheimer's disease, Fragile X syndrome and other neurological diseases.

Many kinds of neurological conditions are either genetic, irreversible or have no known effective treatments – and unfortunately, no cure.

The compound works by modulating the 'stress hormone' cortisol, which has been shown to impair brain function and has been associated with several neurodegenerative conditions.

At the time of writing, Actinogen Medical has a market capitalisation of $317 million.

Why is the Actinogen share price sinking lower?

Actinogen advised it has received approval from the FDA to commence a Phase 2 trial on its Xanamem candidate, under an Investigational New Drug (IND) designation.

Being a Phase 2 trial, it is investigating the efficacy and safety of the Xanamem compound in treating male adolescents and young adults with Fragile X syndrome.

Fragile X syndrome is a hereditary disorder that causes mild to moderate intellectual disability, alongside behavioural and learning challenges.

It is thought to affect 1 in 4,000 males and 1 in 5,000–8,000 females worldwide. As observed, it primarily affects males, as it relates to genetics and the passing down of genes from parent to child.

Actinogen's trial will enrol around 50 patients. The cohort will receive treatment over 12 weeks to observe the effects of Xanamem on Fragile X syndrome.

Investors can expect readouts from the study's results sometime in 2023, per the announcement.

Aside from this, Actinogen also advised it had signed a letter of intent with Worldwide Clinical Trials Limited (WWC) to 'operationalise' the trial.

The move appears to be strategic from Actinogen, given that WWC is a research organisation that specialises in neurological, paediatric and rare diseases.

The letter of intent was signed for an amount of $944,724 and funds will be used "for start-up activities to enable prompt activation of [trial] sites".

It has a duration of 60 days whilst a full contract is negotiated but can be cancelled with a full refund of any unused monies.

Actinogen Medical share price snapshot

It's been a year of outsized returns for the Actinogen Medical share price, having posted a gain of 627% in the last 12 months after rallying 662% this year to date.

Each of these results has shot past the benchmark S&P/ASX 200 index (ASX: XJO)'s climb of around 20% in that time.

The post Why the Actinogen (ASX:ACW) share price is sinking 16% on Tuesday appeared first on The Motley Fool Australia.

According to the release, the first patient has been enrolled in Part A of XanaMIA's 2-part trial. The trial targets patients with mild cognitive impairment due to Alzheimer's Disease.

At the time of writing, Actinogen shares are swapping hands for 15 cents – that's 13.04% higher than their previous closing price.

Let's take a closer look at today's news from the biotechnology company.

The latest from Actinogen

Today, Actinogen announced the first of 105 Australian volunteers has signed up to be involved in part A of XanaMIA's trial.

The news has sent the Actinogen share price rocketing upwards.

The first stage of the trial is a dosing study that will determine if it's safest and more effective to treat patients with either 5mg or 10mg doses of XanaMIA.

Additionally, participants will be tested for improvements to their memory and cognitive abilities.

Part A of the XanaMIA trial will take place over 6 weeks. The first stage will include participants aged between 50 and 80 years old. It will take place at 4 Australian outpatient sites.

If the dosing study is successful, the resulting dosage of XanaMIA will be used in Part B of the drug's trial.

Part B will assess the efficacy of XanaMIA in patients with bio-market positive Alzheimer's Disease. It will be testing the effects of XanaMIA on biomarkers indicative of Alzheimer's Disease.

In addition, Part B will assess if XanMIA can aid the cognitive function of those with underlying Alzheimer's Disease.

The trial received the approval of an ethics committee on 2 June, sending the Actinogen share price soaring 18% higher.

Actinogen share price snapshot

This year has been a good one so far for Actinogen shares, having gained more than 500% year to date.

The biotechnology company has a market capitalisation of around $190 million, with approximately 1.6 billion shares outstanding.  

The post Here's why the Actinogen (ASX:ACW) share price is rocketing 13% today appeared first on The Motley Fool Australia.

Four ASX shares that have not let that hold them back today are listed below. Here's why they are pushing higher:

Actinogen Medical Ltd (ASX: ACW)

The Actinogen share price has jumped 14% to 16.5 cents. This morning the biotechnology company provided an update on its dealings with the US Food and Drug Administration (FDA). The release explains that Actinogen has received written supportive US FDA advice in response to its Pre-Investigational New Drug Application (Pre-IND) submission for its fragile X syndrome (FXS) program.

Novonix Ltd (ASX: NVX)

The Novonix share price is up over 3% to $2.21. This morning the battery materials company announced plans to purchase a new plant. Once renovations are complete, the plant will produce up to 8,000 tonnes per annum of anode materials. Combined with its existing operations, Novonix will have total capacity of 10,000 tonnes per year. The new facility will come online by the 2023 calendar year.

ResMed Inc. (ASX: RMD)

The ResMed share price is up 1.5% to $32.50. This appears to have been driven by a broker note out of Macquarie this morning. That note reveals that the broker has upgraded the sleep treatment focused medical device company's shares to an outperform rating with a $34.85 price target. It believes ResMed can win market share following the recent recall of the Philips DreamStation devices.

Zip Co Ltd (ASX: Z1P)

The Zip share price is up 5.5% to $8.53. A number of tech shares are pushing higher today after a strong night for the Nasdaq index. This has led to the S&P/ASX All Technology Index (ASX: XTX) climbing 0.9% this afternoon. In addition to this, news that Paypal is increasing its BNPL pricing may have given Zip's shares a boost.

The post Why Actinogen, Novonix, ResMed, & Zip shares are pushing higher appeared first on The Motley Fool Australia.

At the time of writing, the shares of the biotechnology company developing an innovative treatment for cognitive impairment are up 17% to 17 cents.

This means the Actinogen share price is now up an incredible 750% since the start of the year.

Why is the Actinogen share price charging higher?

Investors have been bidding the Actinogen share price higher today after it provided an update on its dealings with the US Food and Drug Administration (FDA).

According to the release, the company has received written supportive US FDA advice in response to its Pre-Investigational New Drug Application (Pre-IND) submission for its fragile X syndrome (FXS) program. FXS is an inherited genetic disease passed down from parents to children that causes intellectual and developmental disabilities.

Actinogen sought a Pre-IND meeting with the FDA to discuss its lead molecule, Xanamem, and the FXS clinical program. Today's release reveals that the advice received indicates that the data package and trial design proposed for the IND submission would be sufficient, subject to final review of all supportive documentation submitted. As a result, the company plans to file the full IND submission during the third quarter of 2021.

In addition, Actinogen advised that the two parties are also in agreement on the proposed Phase II adolescent patient population to be studied. The Phase II XanaFX study will be a randomised, placebo-controlled, double-blind, 12-week trial investigating the safety and efficacy of Xanamem in male adolescents who suffer from FXS.

The study will be conducted in Australia and is expected to commence in the fourth quarter of this year.

Actinogen's CEO and MD, Dr Steven Gourlay, commented: "The FDA's positive Pre-IND advice for FXS marks a significant milestone in the clinical development of our second disease program. It provides greater confidence that we will obtain support from the FDA for the investigation of Xanamem in this disease that has a high unmet medical need for effective therapies."

"There are no currently approved therapies for FXS. The Company is advancing the planning for its Phase II XanaFX trial which is expected to commence by the end of the year. Actinogen is now positioned to progress its clinical programs with multiple Phase II trials and is well funded to advance the development pipeline," he concluded.

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At market close, the Actinogen share price was trading at 16 cents – 19.23% higher than its previous close.

Let's take a closer look at today's news from the biotech company.

XanaMIA study

Today, Actinogen announced it has made deals with several companies to run the XanaMIA Part A dose-ranging study.

The dose-ranging study is the company's first step towards testing whether XanaMIA can treat cognitive ability in volunteers and patients with mild cognitive impairment, the first clinical stage of Alzheimer's disease.

The study will enrol 105 healthy volunteers aged 50 or older, starting next month. The volunteers will be given either 5 milligrams or 10 milligrams of XanaMIA to determine the minimum effective dose.

Actinogen also advised today that research organisation Avance Clinical will manage the XanaMIA study. Avance will charge Actinogen around $1.25 million for the service.

Additionally, Actinogen has employed Paratus Clinical to recruit the dose-ranging study's subjects, for which Actinogen will provide a budget of around $850,000.

Paratus will also provide the 4 Australian clinical-trial sites that will house the study.

Finally, Actinogen has made an agreement with CogState Limited (ASX: CGS) to use the neuroscience technology company's Neuropsychological Test Battery in the dose-ranging study.

CogState's Neuropsychological Test Battery is a platform that delivers highly sensitive cognition tests.

Actinogen will pay CogState around US$300,000 for access to the platform.

Today's news comes nearly 3 weeks after Actinogen announced the XanaMIA study received approval from the Bellberry Human Research Ethics Committee.

Following the XanaMIA Part A dose ranging study, Actinogen will begin its XanaMIA Part B study.

The Part B study will see people with early-stage Alzheimer's disease treated with XanaMIA. It will try and find if the drug can treat mild cognitive impairment.

Actinogen share price snapshot

The Actinogen share price has performed exceptionally well on the ASX this year.

Currently, the Actinogen share price is a whopping 675% higher than it was at the start of 2021.

The company has a market capitalisation of around $215 million, with approximately 1.6 billion shares outstanding.

The post Here's why the Actinogen Medical (ASX: ACW) share price is up 20% appeared first on The Motley Fool Australia.

While past performance is not an indicator of future performance, there are always valuable lessons to be learnt. As the saying goes, "History doesn't repeat itself, but it often rhymes."

So, without further ado, here are the 5 best performing ASX shares of the year as of today.

Top 5 ASX shares countdown

Renascor Resources Ltd (ASX: RNU)

While all the top 5 best performers are small-cap shares, Renascor Resources is the smallest with a market capitalisation of $152 million. The company operates as a vertically integrated battery anode manufacturer.

It had been a quiet couple of years for Renascor prior to 2021. The South Australian graphite miner's share price had been bouncing between 1 to 2 cents per share. However, with electric vehicles (EVs) booming in popularity, analysts are expecting demand to outstrip supply.

Currently, graphite represents a large portion of the material constituents in lithium-ion batteries. Renascor touts the largest graphite reserve outside of Africa. Which is possibly a contributing factor to the Renascor Resources share price surging 567% year-to-date (YTD).

Sayona Mining Ltd (ASX: SYA)

Sayona Mining is another ASX small-cap share riding the EV wave. Valued at $329 million, this emerging lithium producer is the biggest on our list by market cap.

The initial jump in the company's share price followed a partnership with US-based lithium corporation, Piedmont Lithium Inc (ASX: PLL). That partnership involved Piedmont investing US$12 million into Sayona to become a strategic investor and offtake partner.

President and CEO of Piedmont at the time said, "Piedmont is building a world-class spodumene-to-hydroxide business in North Carolina, and we are now very pleased to be partnering with Sayona to advance a similar business in Quebec."

The Sayona Mining share price has returned 622% since the start of 2021.  

Actinogen Medical Ltd (ASX: ACW)

This Aussie biotechnology company has been busy in 2021. Actinogen has a large addressable market, developing drugs for Alzheimer's disease and the cognitive decline associated with other neurological and metabolic diseases.

A major milestone occurred on 5 February 2021, when the United States Food and Drug Administration (FDA) granted Actinogen's Xanamem drug a Rare Paediatric Disease Designation for the treatment of Fragile X syndrome. Momentum in this ASX share continued as it progressed its clinical development program and appointed a new CEO.

These steps forward have come been greeted with plenty of share price positivity. The Actinogen share price has rewarded shareholders with a 638% return YTD.

Oneview Healthcare PLC (ASX: ONE)

Oneview Healthcare is a cloud-based software provider that offers solutions used in the healthcare sector. These solutions help healthcare workers deliver better and more tailored bedside care. Oneview is our first official 10 bagger on the list. That's right, a 10X return since the start of the year.

This ASX share started the year with a distribution agreement with Samsung SDS America, which is "the enterprise IT solutions provider of Samsung". The deal sent the Oneview share price flying 140% higher in a single day. Since then, the company has entered an investor awareness agreement with S3 Consortium and made a global launch of its CXP Cloud Enterprise software using Microsoft Azure.

Partnering with such iconic brands has undoubtedly drawn investors' attention. And if that hasn't, the 900% share price appreciation YTD should turn a few heads.

Province Resources Ltd (ASX: PRL)

Last, but certainly not least… the best performing ASX share so far this year is Province Resources. This small-cap company is riding another prominent trend of 2021 – hydrogen. Stemming from mineral exploration, Province Resources pivoted towards the booming green hydrogen market early in the year with the acquisition of Ozexco Pty Ltd.

From there, the company entered a memorandum of understanding with global renewable energy leader Total Eren to develop a potential 8-gigawatt green hydrogen project in Australia. By combining wind/solar power and electrolysis, Province Resources hopes to create a green hydrogen production facility in Carnarvon, Western Australia.

The bold, green ambitions have certainly captured the eyes of the market. Province, being the best performing ASX share, has delivered a return of 1,054% in 2021 so far.

The post These 5 ASX shares are delivering the biggest gains in 2021 appeared first on The Motley Fool Australia.

Actinogen has a large addressable market, developing drugs for Alzheimer's disease and the cognitive decline associated with other neurological and metabolic diseases. Its main focus is a drug called Xanamem, a molecule enzyme inhibitor that restrains excess cortisol production inside brain cells. Cortisol is otherwise known as the stress hormone.

So what's there to like about Actinogen?

On 5 February, the United States Food and Drug Administration (FDA) granted Actinogen's drug Xanamem a rare paediatric disease designation for the treatment of Fragile X syndrome. The approval is significant as it includes commercial, development and regulatory benefits, as well, it allows a priority review designed to increase overall speed to market.  

Fragile X syndrome is a rare and serious genetic disorder, typically diagnosed in children but with life-long symptoms. The announcement put the company front and centre on the world stage, and investors took note.

Recently, on 2 June, Actinogen announced the progression of its clinical development program to treat patients with Alzheimer's Disease. The company received approval from the Bellberry Human Research Ethics Committee to commence the first part of the XanaMIA study, designed to study improvements in cognitive ability in older volunteers, and patients with Mild Cognitive Impairment, the first clinical-stage of Alzheimer's Disease. 

A new CEO is taking the wheel

The appointment of the company's new CEO, Dr Steven Gourlay, on 15 March, also appears to have had a positive effect on the Actinogen share price.

Gourlay's CV is impressive; he was the founding chief medical officer at US-based Principia Biopharma Inc and was responsible for the supervision of multiple preclinical, first-in-human, Phase 2 and 3 clinical trial programs. The trials focused on four small molecules in orphan immunological diseases, multiple sclerosis and cancer. Dr Gourlay's work supported a successful NASDAQ IPO of Principia Biopharma Inc. in 2018,  subsequently followed by an acquisition by Sanofi for US$3.7B in 2020.  

In addition, investors like to see insiders who increase their skin in the game. At the end of March, Actinogen director George Morstyn acquired 2,550,000 shares in the company at a value of almost $72,000. 

With proven management, trials progress globally and insiders willing to invest in the company, it seems the stars are aligning quite nicely. The Actinogen share price is trading at 16 cents at the time of writing.

The post Why is the Actinogen (ASX:ACW) share price up 414% in 3 months? appeared first on The Motley Fool Australia.

Actinogen is a biotechnology company that develops drugs for Alzheimer's disease and the cognitive decline associated with other neurological and metabolic diseases. Geographically, it operates in and derives revenue from Australia.

The company's main product is called Xanamem. Xanamem is a brain-penetrant, small-molecule enzyme inhibitor that works to inhibit excess cortisol production inside brain cells.

What Actinogen's quarterly report stated

Actinogen shares have fallen off a cliff today following the release of the company's latest updates. Actinogen advised that it continues to focus on the development of its lead drug, Xanamem, as a treatment for multiple indications. According to the company, it is leveraging the positive phase I XanaHES results, in which a significant improvement in multiple cognition domains was achieved in healthy older volunteers.

Now the company is seeking to progress its Xanamem treatments into an Alzheimer's population with a phase II XanaMIA trial planned to target patients with mild cognitive impairment due to Alzheimer's Disease.

In its update, the company advised that whilst it has "data supporting [the] efficacy of Xanamem in doses as low as 5mg" part of the phase II study's purpose will be to confirm the dose.

The company's uncertainty surrounding the drug's dosage could be a potential reason investors are driving down the Actinogen share price today. Actinogen has advised it will hold a shareholder teleconference on 23 April during which it will provide an update on the company's "dose ranging study seeking to confirm [the] minimum effective Xanamem dose".

In parallel, Actinogen remains focused on progressing study planning for anxiety, sleep and behavioural problems in Fragile X syndrome (FXS). These symptoms have a substantial impact on day-to-day functioning of patients and their carers and there are currently no approved treatment options that specifically target these symptoms associated with FXS.

Actinogen says it is "well advanced" with the planning for its Phase II XanaFX, with the trial expected to commence in the second half of this year.

During the quarter, Xanamem was also awarded a Rare Paediatric Disease Designation (RPDD) for Xanamem in the treatment of FXS in patients under the age of 18. The RPDD program is designed to incentivise the development of drugs for rare childhood illnesses, such as FXS, with potential clinical, development and commercial benefits.

Management comments

Actinogen CEO and MD Steven Gourlay was upbeat about the company's ability to deliver future shareholder value, saying: 

After many years of working in the biopharma industry, I am excited by the huge potential of Actinogen. In my last major role at Principia Biopharma as Chief Medical Officer, I steered two small molecules from a microcap company valuation, through successful Phase II development and into Phase III, resulting in a significant value appreciation for shareholders when the company was acquired for US$3.7B.

I find Actinogen to be a similar investment opportunity: excellent science, a promising Phase II molecule for multiple indications, with an attractive valuation, and so accepted the role as CEO / MD, and personally invested over A$300K into the Company prior to my appointment. We are now planning for multiple shots on goal and strongly believe the upcoming trials are designed to achieve informative and positive outcomes. I look forward to working with the team to further develop Xanamem as we progress the development pipeline.

Actinogen share price snapshot

Following today's releases, the Actinogen share price is falling against its 52-week high of 6.2 cents set on Monday this week. Actinogen shares are up from just over two cents per share at the beginning of March. The company has a current market capitalisation of around $96 million.

The post Why is the Actinogen (ASX:ACW) share price falling 17% today? appeared first on The Motley Fool Australia.

At the time of writing, the Actinogen share price is trading 23.26% higher for the day so far at 5.3 cents, up from just 2 cents at the start of March.

The company's focus is the development of Xanamem, a novel treatment for Alzheimer's disease and the cognitive deficiency associated with other neurological and metabolic diseases.

What's been driving the Actinogen share price?

Whilst there is no news out of the company today, it's possible the Actinogen share price is still riding the wave of several announcements released by the company over the last couple of months. At the end of March, Actinogen director George Morstyn acquired 2,550,000 shares in the company at a value of $71,782.73. 

Actinogen shares have also been responding positively since the appointment of the company's new CEO, Dr Steven Gourlay, on 15 March. Gourlay has more than 30 years' experience in the development of novel therapeutics.

Investors are clearly confident that Gourlay brings considerable skills and experience to Actinogen, as the company moves into further clinical development of its lead compound, Xanamem.

But perhaps most pertinent to the company's recent surge in value is the growing recognition of Xanamem on the international stage. 

On 5 February, the United States Food and Drug Administration granted Actinogen's drug Xanamem a Rare Paediatric Disease Designation for the treatment of Fragile X syndrome (FXS).

Fragile X syndrome is a rare and serious genetic disorder, typically diagnosed in children but with life-long symptoms. It is characterised by a range of developmental problems including behavioural problems, autism features, severe anxiety, cognitive impairment and disordered sleep.

Management commentary

Dr Bill Ketelbey, former CEO and MD of Actinogen Medical, said at the time that the FDA designation was extremely important for the company:

We are delighted to receive the Rare Paediatric Disease Designation from the FDA. The significant strategic advantages from this approval include commercial, development and regulatory benefits for the development of Xanamem in FXS, with priority review designed to increase overall speed to market.

Additionally, [this] designation includes the potential for the Company to receive a second, transferable priority review voucher that holds substantial additional value in it's own right Actinogen has devoted increased resources to broadening Xanamem's clinical development pipeline, with Fragile X syndrome selected as the second indication to pursue alongside Alzheimer's disease.

Foolish takeaway

The Actinogen share price is having a stellar start to 2021, thanks to a series of announcements since the beginning of the year. Reaching a new 52-week high of 5.6 cents in intraday trading today, Actinogen shares are now up by around 30% in a week. Over the past year, the company's shares have outperformed the healthcare sector by around 170%. 

Actinogen has a current market capitalisation of around $71 million.

The post Actinogen (ASX:ACW) share price surges 23% today, 165% this year appeared first on The Motley Fool Australia.

What does Actinogen Medical do?

Actinogen Medical is an ASX biotech company. It specialises in developing novel therapies of a range of conditions. These include neurological, psychiatric and metabolic diseases associated with chronically elevated cortisol. This is a metabolic disorder caused by overproduction of corticosteroid hormones by the adrenal cortex. Often it is associated with obesity and high blood pressure.

The lead compound currently being developed by Actinogen is called "Xanamem". This compound is a new type of therapy for Alzheimer's disease, Fragile X syndrome, schizophrenia and diabetes. According to the company, solutions to effectively address these conditions and the burdens for patients have not yet adequately been met. It is therefore focusing on the gap in this market.

Why are these patents important?

The two patents filed this week are to expand and extend the company's IP estate. 

The first patent filed requests protection for a method of improving cognition or treating cognitive decline in cognitively healthy subjects. Expansion of the IP estate is a key goal here.

The second patent filed provided protection to a commercial scale-up manufacturing process for Xanamem. This patent is the result of a collaborative effort between Actinogen Medical and a Switzerland-based contract development and manufacturing organisation.

Actinogen holds a large number of patents, either granted or pending. The new patents filed this week have the ability to extend patent life. Protection around Xanamem is now effective until 2040 at least. This gives the company a long runway of breathing room to continue its research and development.

In statement to the ASX today, Actinogen Medical CEO and managing director Dr Bill Ketelbey had this to say:

Strengthening our IP portfolio and extending the patent life of protection over Xanamem is aligned with our broader commercialisation strategy for Xanamem. The potential to treat cognitively healthy subjects, a population in which XanaHES demonstrated clear efficacy results, as well as treat those at risk of cognitive impairment, is a significant medical and commercial opportunity. Equally, the patented and optimised manufacturing methodology provides an efficient and commercially viable process which provides a substantial new barrier to competition. Actinogen remains focused on maintaining and extending the protection of Xanamem to maximise its commercial potential.

Foolish takeaway

The Actinogen Medical share price opened 4.5% higher on this positive news today. However, overall this year the Actinogen Medical share price is down more than 30%. 

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