In morning trade on Thursday, the All Ordinaries Index (ASX: XAO) is up 0.2%, while shares in this biopharmaceutical company just rocketed 96.9% to 13 cents apiece.

The ASX healthcare stock closed on Monday trading for 6.6 cents. Shares entered a trading halt on Tuesday and Wednesday ahead of today's big United States Food and Drug Administration (FDA) announcement.

Any guesses?

If you said Immuron Ltd (ASX: IMC), give yourself a virtual gold star.

Here's what's got ASX investors excited today.

Why are ASX investors sending the Immuron share price soaring?

Investors are bidding up the ASX healthcare stock after the company reported it was proceeding to a Phase 3 registration strategy with the US FDA for its patented Travelan drug.

Travelan will be the first product developed with Immuron's platform technology to proceed into Phase 3 clinical trials.

This comes after interim clinical results confirmed that a single daily dose of Travelan was effective in preventing moderate to severe diarrhea after subjects were exposed to enterotoxigenic Escherichia coli (ETEC).

The company designed the Phase 2 study to compare the preventative effects of one dose per day relative to the standard recommended three daily doses.

In January 2022, the US Department of Defense awarded the ASX healthcare stock $4.8 million to assist with evaluating a dosing regimen best suited to US troops deployed in developing countries.

The company said the latest interim analysis summarised the completed data for 60 subjects of the current clinical study. Management expects the final clinical study report will be completed in the second half of 2024.

Immuron said it is exploring non-dilutive funding opportunities for its Phase 3 clinical trial.

How has the ASX healthcare stock been tracking longer-term?

Immuron shares are often thinly traded. And they frequently see some sizeable moves higher or lower following price-sensitive news.

With today's big intraday gains factored in, the ASX healthcare stock is up 62.5% in 12 months.

The post Guess which ASX healthcare stock is rocketing 97% on big FDA news appeared first on The Motley Fool Australia.

This follows a massive trading day as the company cemented its place as one of the best performers on the ASX yesterday with its share price seeing a whopping 31% increase.

So what happened with this Melbourne-based biotech company to make it reach such impressive prices?

Let's take a look…

Diarrhoea drug to hit Europe

At its core, Immuron focuses on creating and commercialising oral immunotherapies that both prevent and treat gut-related ailments.

It has two main products — Travelan, an over-the-counter oral medicine used to treat traveller's diarrhoea — and Protectyn, an immune supplement (sold by practitioners) supporting both digestive and liver function.

Today, the biotech company announced it had received a European patent for its treatment of traveller's diarrhoea.

Immuron advised that European Patent 3159357 — the "composition and method for the treatment and prevention of enteric bacterial infections — would give it the exclusive rights in several European countries.

The company already holds an existing patent position in Australia, India, Canada and the United States.

Once the patent is validated, Immuron will be able to sell its drug composition in France, Spain, Sweden, Austria, Germany, Denmark, Finland, Greece and the United Kingdom.

US military focus on Travelan

According to Immuron, traveller's diarrhoea not only is the most common form of illness for visitors to developing countries but also afflicts US troops that are deployed overseas.

In fact, prevention of the illness is a high priority for the US Military.

"The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgement, decreases morale and declines operational readiness," Immuron said in today's announcement.

And its not just only the short term effects Immuron considers worrisome — the medical community is now recognising that the illness can have serious post-infectious after-effects, inducing irritable bowel syndrome and other autoimmune diseases.

As such, the biotech company was awarded a $6.2 million Travelan clinical trial agreement by the United States Department of Defence yesterday — the first of several trials expected to undertaken with the military this year.

After releasing the news, the Immuron share price jumped just over 30% before lunchtime trade.

Immuron share price snapshot

Despite its recent positive moves, the Immuron share price has dropped 36% over the past 12 months. In fact, it saw its 52-week-low on Tuesday, when it hit 9 cents.

Since then, shares in the company have rebounded an impressive 55%.

The biotech company has a market capitalisation of $31 million and more than 277 million shares issued.

The post Why the Immuron (ASX:IMC) share price rocketed another 17% today appeared first on The Motley Fool Australia.

At the time of writing, the biopharma company's shares are swapping hands for 12.2 cents, up 31.18%.

A clinical-stage medical company, Immuron is focused on the development and commercialisation of a novel class of specifically targeted polyclonal antibodies. The company researches and develops hyperimmune products for markets in Australia, the United States, and Canada.

Product sales comprise Travelan and Protectyn, used for the prevention of travellers' diarrhoea.

Let's take a look at the company's latest news…

What did Immuron announce?

Investors are buying up Immuron shares after the company announced funding on a new research agreement.

According to its release, Immuron advised it has been awarded funding from the United States Department of Defence for Travelan. This will be aimed at examining a dosing regimen of the oral immunotherapeutic for use by the military.

In total, US$4.45 million (A$6.2 million) will be allocated to conduct a controlled human infection model (CHIM) clinical trial.

Up to 60 volunteers will be enrolled in the study. They will be randomly selected to receive either a once-daily dose of 1200 mg of Travelan or placebo.

The results of the trial will also provide information on dosing in the future Phase 3 registration trials.

Immuron noted that a project meeting has been scheduled for the end of January with the US government sponsors.

Infectious diarrhea is the most common illness reported by travellers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale, and declines operational readiness.

While the first line of treatment for infectious diarrhea is the prescription of antibiotics, this has waned over the last decade. Several enteric pathogens have evolved to become increasingly resistant to commonly prescribed antibiotics.

Immuron CEO Dr Jerry Kanellos commented:

This new project expands our clinical development program and represents the first of several significant clinical trials which the company expects to undertake with the US Military in 2022.

…The new funding is testament to the value proposition our hyperimmune bovine polyclonal colostrum technology offers to benefit the U.S. Military as well as the civilian international travelling population.

Immuron share price snapshot

A disappointing 12 months has led Investors to recorded losses of almost 60% on the Immuron share price. In the past month alone, the company's shares have declined around 20%, highlighting a strong downward trend since July 2020.

Based on today's boosted share price, Immuron has a market capitalisation of roughly $28 million, with approximately 227 million shares on issue.

The post Here's why the Immuron (ASX:IMC) share price is rocketing 31% today appeared first on The Motley Fool Australia.

Researchers from the Hebrew University's Hadassah Medical Center tested if the company's proprietary product, IMM124E, has potential antiviral benefits.

They found IMM124E might boost antiviral immunity across certain viral strains, including severe acute respiratory syndrome coronavirus-2, the virus that causes COVID-19.

Immuron also announced it has filed a Patent Cooperation Treaty application to seek patent protection for IMM124E.

At the time of writing, the Immuron share price is 14.5 cents, 11.54% higher than its previous close. Earlier today it was up 25% to 17 cents before partially retreating.

Let's take a closer look at today's news from Immuron.

Data suggests IMM124E may help treat COVID-19

The Immuron share price is surging upwards on news the company's IMM124E drug could have the potential to treat COVID-19.

Recently published research on IMM124E has detailed the results of a mouse model and human clinical study that attempted to find if the drug could promote antiviral interferon γ T cell responses.

The trial saw 5 human volunteers given 600mg of IMM124E daily for four days and 1200mg on the fifth day.

After the fifth day, researchers took blood samples from the volunteers. They then tested the samples for the number of T cell clones secreting antiviral interferon γ in response to viral antigens of SARS-CoV-2 and hepatitis B virus.

The data suggests IMM124E could enhance antiviral responses against COVID-19 and hepatitis B.

Meanwhile, data from the mouse model suggested IMM124E might enhance antiviral immunity for swine flu, New Caledonia influenza, and cytomegalovirus.

The results won't be validated until more detailed research on IMM124E's potential to treat certain viruses has been completed. However, it's an encouraging outcome.

Though, it's not the first time IMM124E has been linked to the treatment of COVID-19.

The most recent time the company announced similar news was in May, when researchers from Monash University found the drug may inhibit COVID-19 infection.

Immuron share price snapshot

Despite today's boost, the Immuron share price is still well and truly in the red on the ASX.

The company's share price has fallen 31% since the start of 2021. It is also 40% lower than it was this time last year.

The post Immuron (ASX:IMC) share price surges 11% on COVID-19 treatment data appeared first on The Motley Fool Australia.

At the time of writing, Immuron shares are swapping hands for 18.5 cents, up 8.8%

What did Immuron announce?

Investors are buying up Immuron shares after the company provided a positive result on its SARS-CoV-2 (COVID-19) program.

According to its release, Immuron advised that Monash University scientists have conducted two tests using IMM124E against SARS-CoV-2. The immunologically-based assays were developed with two recombinant reagents, the SARS-CoV-2 spike protein and a receptor protein. The latter was obtained from Melbourne's Peter Doherty Institute for Infection and Immunity.

Initial findings indicate that IMM124E neutralises activity in which the SARS-CoV-2 virus does not bind with the spike protein or receptor. Essentially, this means that when the virus comes into contact with IMM124E, it cannot latch and infect cells.

Pleasingly, the research team will now look into identifying the inhibitory molecule in IMM124E which causes the reaction.

Deputy director of the Monash Biomedicine Discovery Institute, Professor Lyras commented:

Our initial results suggest the inhibitory substance/s in the products are binding to other antigens present on the SARS-CoV-2 virus which interfere with the mechanism the virus uses to gain entry and infect human cells. We do not yet know which compound/s in the products are responsible for this interference. However, we are excited to try and identify them.

He went on to say, "it does not matter whether antagonists to the SARS-CoV-2 virus block the binding of the spike protein directly or indirectly as long as they can prevent or reduce infection"

In addition to the encouraging announcement, Immuron will appoint Dr Dan Peres as its chief medical officer. Dr Peres will oversee the company's clinical development programs, predominately focusing on COVID-19.

Immuron share price snapshot

Since the beginning of the year, Immuron shares have recorded a loss of almost 20%, despite clinical progress. Over the last 12 months, however, the company's shares have soared to register a gain of more than 110%.

Immuron has a market capitalisation of roughly $42 million, with approximately 227 million shares on issue.

The post Why the Immuron (ASX:IMC) share price is surging 8% higher appeared first on The Motley Fool Australia.

The slide follows the release of the biotechnology company's half-year (1H21) results for the period ended 31 December 2020.

Let's take a closer look at how Immuron has been performing recently.

What did Immuron report?

The company reported a 98.7% revenue crash for the period, with 1H21 revenue coming in at $20,000.

Immuron incurred a $5.7 million loss for the period, which was 277.2% greater than the $1.5 million loss of 1H20.

Compared to 30 June 2020, the group's net assets increased from $5.6 million to $28.5 million as of 31 December 2020. Cash reserves also increased over this period from $3.3 million to $26.4 million.

The business received $358,280 during the period via the government's research and development (R&D) income tax concession program.

The Immuron share price lost 2.6 cents a share for the 1H21 period, versus a loss of 9 cents a share for 1H20.

Clinical progress and updates

Immuron's focus is the development and sale of oral immunotherapeutics to prevent and treat unmet medical needs. The company's orally active polyclonal antibodies provide a targeted delivery inside the gastrointestinal tract so they do not cross into the bloodstream

The company advised that it continued to progress a number of clinical developments during the 1H21 period. 

Some milestones reached include receiving written guidance from the US Food and Drug Administration (FDA) in relation to a new drug the company is developing, completing a successful vaccination campaign, and executing a research agreement with Monash University.

Immuron also recommenced its Travelan US registration strategy. Travelan is an over-the-counter supplement that can be taken to reduce the risk of travellers' diarrhoea. The company notes that the coronavirus has significantly disrupted international travel throughout the world. According to Immuron, COVID continues to impact every Travelan market.

Immuron share price snapshot

The Immuron share price has gained 60.7% over the previous year, however, it's fallen 29.7% over the past 6 month period.

The company's market capitalisation is approximately $51.1 million and there are 227.2 million shares outstanding.

The post Why the Immuron (ASX:IMC) share price fell today appeared first on The Motley Fool Australia.

Immuron is clinical-stage biopharmaceutical company focused on the development and commercialisation of a novel class of specifically targeted polyclonal antibodies. The company researches and develops hyperimmune products for markets in Australia, the United States and Canada.

Product sales comprise Travelan and Protectyn, which is used for the prevention of travellers' diarrhoea.

What's pushing the Immuron share price higher?

The Immuron share price has been a positive mover today compared to the broader All Ordinaries Index (ASX: XAO) which is down 0.3% to 6.877 points.

According to today's release, Immuron advised that its hyperimmune bovine colostrum, called 'IMM-124E' has shown antiviral activity against COVID-19 in a laboratory. The hyperimmune bovine colostrum is used currently in the company's key products, Travelan and Protectyn.

To further support the promising results, Immuron has partnered with Monash University to undertake further research. The agreement will see Monash University examine and evaluate the efficacy of IMM-124E against the COVID-19 virus.

This follows the company's previous efforts in engaging with domestic and international researchers to advance its work.

What is hyperimmune bovine colostrum?

Bovine colostrum is a milky fluid that comes from the udder of cows the first few days after giving birth.

This fluid contains proteins called antibodies that can fight bacteria and viruses that cause diseases. Antibody levels in bovine colostrum can be 100 times higher than levels in regular cow's milk.

Researchers have created a special type of bovine colostrum called 'hyperimmune bovine colostrum'. It's produced by cows that have received vaccinations against specific disease-causing organisms and is high is specific kinds of antibodies.

Bovine colostrum is most commonly used to treat diarrhea and other infections.

What did the research team from Monash University say?

Microbiology Department deputy head, Professor Dena Lyras, said the university had been fortunate to obtain access to the SARS-CoV-2 recombinant proteins developed at the Peter Doherty Institute for Infection and Immunity.

Dr Melanie Hutton went on to talk about the research team's plan, saying:

These reagents will be used to initiate the research work and to develop a suitable assay for evaluating the inhibitory efficacy of IMM-124E.

Furthermore, specific immune components will be purified from IMM-124E and will be used to evaluate their ability to inhibit the binding of an antibody positive human serum sample to specific COVID-19 proteins, such as the spike protein which is crucial for cell entry.

Immuron share price summary

Investors are likely to have a mixed response to the Immuron share price. Although its shares have risen more than 85% in the past 12 months, short-term charts show the Immuron share price on a gradual decline.

The company's shares did see a sharp spike in July reaching 95 cents, following a market update to IMM-124E. However, the share price quickly came crashing down as investors pocketed the profit.

The post Why the Immuron (ASX:IMC) share price is rocketing up 10% today appeared first on The Motley Fool Australia.

This comes after the company announced positive results to one of its vaccines.

Today's gains put Immuron's share price up 104% in 2020 at 26 cents per share, though that's still well below the 86 cents per share Immuron briefly hit on 21 July. That spike followed a report that one of its flagship drugs, Travelan, could help treat respiratory issues in patients with COVID-19.

Despite retracing since then, long-term investors likely won't be complaining about the 104% gains in 2020 in a year that's seen the All Ordinaries Index (ASX: XAO) fall by 6%.

What does Immuron do?

Immuron Limited is an Australian biopharmaceutical company. Its focus is the development and sale of oral immunotherapeutics to prevent and treat unmet medical needs. The company's orally active polyclonal antibodies provide a targeted delivery inside the gastrointestinal tract so they do not cross into the bloodstream

Immuron's shares first began trading on the ASX in April 1999.

What did Immuron announce to see its share price rocket 18% today?

In this morning's announcement to the ASX, Immuron revealed that the US Medical Research Center has confirmed its experimental vaccine produced "a robust immunological response in cows".

Immuron's vaccine targets Campylobacter and Enterotoxigenic E.coli (ETEC). The company's goal is to develop a multi-pathogen anti-diarrhoeal colostrum supplement to help protect against both afflictions, which are the main cause for infectious diarrhoea for people visiting developing countries.

This is also a critical issue for the US military, whose personnel are often deployed to remote regions, and report that infectious diarrhoea is their most common illness.

No surprise then, that the US Department of Defense (DoD) is interested in pursuing Immuron's experimental vaccine. According to this morning's release, PCI Clinical Services has been contracted to manufacture its drug product for the DoD to evaluate in clinical trials. Manufacturing is slated to start in November and be complete by the end of 2020.

Two human phase II clinical trials are scheduled for 2021. The US Naval Medical Research Center plans to file a request with the US Food and Drug Administration (FDA) for an Investigational New Drug application in the first quarter of 2021.

As these trials progress, Immuron's share price will be one to watch.

The post Why the Immuron (ASX:IMC) share price is rocketing 18% higher today appeared first on The Motley Fool Australia.

Once again, the buy now pay later sector was popular with investors and accounted for three of the top five shares.

They were joined by two healthcare shares – one industry giant and one name that many investors will not have come across before.

Here's the data:

Zip Co Ltd (ASX: Z1P)

For a second week in a row, Zip shares were the most traded on the ASX by CommSec customers. The buy now pay later company's shares accounted for 3.2% of total trades made on the CommSec platform. Although the buying and selling was relatively even over the period, it didn't stop the Zip share price from pushing 8.1% higher.

Afterpay Ltd (ASX: APT)

The Afterpay share price was popular with investors again. Its shares accounted for 2.2% of all CommSec trades last week. Approximately 53% of these trades were sell orders, possibly due to concerns over Shopify's buy now pay later launch. However, despite this, the Afterpay share price was able to carve out a 3.6% gain last week.

CSL Limited (ASX: CSL)

CommSec customers were buying this biotherapeutics company's shares last week by the boatload. CSL accounted for 2% of all trades by CommSec customers last week, with almost 80% of these trades reported as buy orders. Though, this couldn't stop the company's shares from recording a decline of 4% over the period. Investors appear divided on whether its FY 2021 earnings will be impacted materially by lower plasma collections.

Immuron Limited (ASX: IMC)

This biotech company's shares were on fire last week and more than doubled in value after its study indicated that IMM-124E therapy had neutralising activity against the severe acute respiratory syndrome coronavirus-2. This is the virus that causes COVID-19. Immuron's shares accounted for 2% of all trades on the CommSec platform.

Openpay Group Ltd (ASX: OPY)

Finally, junior buy now pay later provider Openpay made the list again. It was responsible for 1.7% of total trades on the CommSec platform last week. This was despite there being no news out of the company. However, a week earlier it reported a 98.2% increase in total transaction value to $192.8 million for FY 2020. The Openpay share price recorded a 5.3% gain for the week

The post Afterpay and Immuron were among the most traded shares on the ASX last week appeared first on The Motley Fool Australia.

Why is the Immuron share price falling?

The Immuron share price is today falling following the announcement that the company is raising US$20 million through a registered direct offering. The company announced it has entered into agreements with several healthcare-focused institutional investors for their participation in a registered direct offering of 1,066,668 American Depositary Shares (ADSs). Each of these ADSs represents 40 of the company's ordinary shares. The price of these ADSs is $18.75. This is a premium with the company's US dual listed cousin Immuron Ltd/S ADR (NASDAQ: IMRN) currently trading at US$14.81. However the large drop in the Immuron share price is no doubt due to the considerable dilution of the share value the offering causes. The offering is set to close around 23 July.

Immuron intends to use the net proceeds from this offering to fund its Research and Development and preclinical and clinical programs. The funding is also being used to support marketing initiatives surrounding the company's flagship product, Travelan, and provide ongoing working capital.

What now for Immuron?

In recent days there has been plenty of news out of Immuron. On Monday, the Immuron share price shot 11% higher after receiving FDA guidance for its new developmental drug. Subsequently in further exciting news, the Immuron share price rose nearly 250% yesterday as its flagship drugs, Travelan and Protectyn, demonstrated antiviral activity against COVID-19 in laboratory testing. It is not surprising today that we are seeing a pull back in the share price as it becomes heavily diluted. While this may be seen as a negative, it can also be seen as investors having confidence in the company moving forward, investing their money at higher prices.

The post Immuron share price falls 27% on registered direct offering appeared first on The Motley Fool Australia.

This follows on from another positive announcement yesterday that the U.S. Food and Drug Administration (FDA) provided guidance about the development pathway for Immuron's new oral therapeutic drugs.

What sent Immuron's share price skyrocketing?

The Immuron share price has shot higher in early trade following news that IMM-124E, which is used in the manufacture of Immuron's flagship drugs Travelan and Protectyn, demonstrates antiviral activity against COVID-19 in laboratory testing.

Trevelan is Immuron's only drug that currently generates revenue and is predominantly used to reduce the risk of traveller's diarrhoea and minor gastro-intestinal disorders. It is licensed in Australia, Canada and sold as a dietary supplement in the US.

The company reports that the cytopathic effect inhibition cell-based assay was established and performed by 360 biolabs, a Melbourne-based contract research organisation. All 4 of the tests performed saw inhibition of Covid-19 of at least 50%. Higher concentrations of IMM-124E stemmed the virus replication by up to 90%. None of the tests demonstrated any cell toxicity.

Commenting on the early results, Immuron CEO Dr Jerry Kanellos stated: 

The preliminary data set we have generated potentially offers a new oral therapeutic approach to target and directly inhibit the virus in the Gastrointestinal tract and warrants further evaluation to identify the inhibitory substances in our products. The company has filed a provisional patent application in respect of the findings.

What now for Immuron?

Immuron is an Australian biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the prevention and treatment of gut-mediated pathogens such as campylobacteriosis and E. coli (ETEC).

After languishing around the 12 cent mark over the past year, the Immuron share price has seen a stark reversal in fortunes, jumping 275% on 9 June alone, in response to news of briefing documentation being submitted to the FDA. The Immuron share price is up 253% year to date, and currently sits at 46 cents per share.

The post Immuron share price shoots 90% higher on potential COVID-19 treatment news appeared first on The Motley Fool Australia.

The oral therapeutics are being developed to treat campylobacteriosis and E. coli (ETEC) infections. The Immuron share price was trading over 11% higher following the release, before retreating to its current level of 24 cents per share.

What does Immuron do?

Immuron is an Australian biopharmaceutical company that focuses on developing and commercialising orally delivered antibodies, used in the treatment of inflammatory and infectious diseases.

Immuron has a novel and safe technology platform with one current drug generating revenue, Trevelan. Trevelan reduces the risk of traveller's diarrhea and minor gastro-intestinal disorders, and is antimicrobial. It is licensed in Australia, Canada and sold as a dietary supplement in the US.

What caused the Immuron share price to jump?

The Immuron share price jumped after the company released news it had received written guidance for its new investigational drug. The FDA review provided a written response to the non-clinical questions posed in its briefing documentation submitted in early June. The FDA also provided additional guidance and comments to support the new drug submission.

There are set to be two human phase II clinical trials for the company's oral therapeutics, to be conducted in 2021. One trial will focus on the ability of the hyperimmune product to protect volunteers against campylobacteriosis. The other trial will focus on ETEC infections.

Immuron CEO Dr. Jerry Kanellos commented: "This is an important milestone in the development of any new drug for therapeutic evaluation. The information obtained from this review will assist in the development of the IND application and provides a clear roadmap forward for conducting the two planned clinical studies next year."

What now for Immuron?

The Immuron share price has seen a stark reversal in fortunes this year, jumping 275% on 9 June in response to news of the briefing documentation mentioned above being submitted to the FDA.

While this is good news, Immuron's drug is still in its very early days and will need a lot of stones to fall into place for it to hit the market. In saying this, the FDA guidance is a huge step forward, hence today's movement in the Immuron share price.

The post Immuron share price shoots 6% higher after receiving FDA guidance for new drug appeared first on The Motley Fool Australia.