In afternoon trade, shares in the biotechnology company are up 5.56% to 19 cents. Despite the gain, shareholders are still nearly 46% away from the 52-week high set in October.

Let's take a closer look at what could be driving the Antisense share price higher today.

What has Antisense been up to?

Investors are bidding up the Antisense share price today as they are reminded of what the company has been doing in recent times.

As per the AGM presentation, the company's key focus remains developing ATL1102. Antisense informed shareholders of its United States regulatory plans today. As already known, the company has submitted its protocol synopsis to the US Food and Drug Administration (FDA) for a 9-month chronic monkey toxicology study.

Furthermore, the company highlighted it could be in a position to receive a rare pediatric disease priority review voucher (PRV). In order to land the PRV, Antisense will need to get FDA approval for ATL1102 in use for people with Duchenne Muscular Dystrophy before 30 September 2026.

Notably, in the past (2017 to 2021) PRVs have sold for between US$80 million to US$150 million. Such a deal would be significant for the company considering its annual revenue has been sub-$1 million since 2017.

In addition, the Antisense share price might be finding strength today as the company emphasises its ambition to expand the clinical application of ATL1102 beyond DMD.

Lastly, Antisense shareholders may be pleased with the company's current financial position. Thanks to a recent $20 million placement, Antisense is funded into the second half of the 2023 calendar year. This includes costs associated with setting up the Phase IIb/III DMD trial in Europe.

Antisense share price recap

Despite losses widening to about $8 million in the past financial year, the Antisense share price has performed strongly in 2021.

Since January, the company's shares have gained 35.7% in value. For context, the S&P/ASX 200 Index (ASX: XJO) is up 9.7% over the same time span.

The post Here's why the Antisense (ASX:ANP) share price is climbing 5% today appeared first on The Motley Fool Australia.

At the time of writing, the biotechnology company's shares are up 5.56% to 19 cents.

What did Antisense announce?

Investors are driving up the Antisense share price today following news about an extended study of ATL1102.

According to its release, Antisense has submitted the protocol synopsis for a 9-month chronic monkey toxicology study to the FDA. This is expected to support the clinical dosing of patients with ATL1102 beyond 6 months for Duchenne Muscular Dystrophy (DMD).

As such, the company is hoping to receive feedback from the FDA on the protocol in the first quarter of 2022.

In June, the FDA provided clarification on the company's Type C guidance meeting regarding the chronic monkey study and design of a Phase IIb/III trial.

The study will run for 52 weeks in the United States and will assess muscle strength among participants.

However, Antisense is considering taking the European Phase IIb/III data to the FDA to support a future marketing application.

Antisense hopes the information will be enough to get ATL1102 approved without further trials.

In addition, the FDA has previously granted a Rare Paediatric Disease Designation to ATL1102 for the treatment of DMD. Should its European trial be successful, Antisense could receive a rare pediatric disease priority review voucher from the FDA.

This is provided the company receives the green light for ATL1102 before 30 September 2026. If granted, it could sell the priority review voucher and use it as a source of non-dilutive capital. The value of these vouchers ranges from US$80 million to US$150 million.

About ATL1102 and the Antisense share price

Founded in 2000, Antisense develops and commercialises antisense pharmaceuticals for patients suffering from rare diseases.

Antisense is developing ATL1102, an antisense inhibitor of the CD49d receptor, for DMD patients.

Antisense recently reported promising Phase II trial results showing a significantly reduced number of brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS).

Over the past 12 months, the Antisense share price has almost doubled, up 90%.

The post Antisense (ASX:ANP) share price accelerates 5% on FDA news appeared first on The Motley Fool Australia.

At the time of writing, the Antisense share price is trading at 22 cents, down 8.33%. This means that its shares have now fallen more than 20% in the past week alone.

What's driving Antisense shares lower?

A catalyst for today's fall in Antisense shares is that investors may be concerned about an impending share dilution.

According to its release, Antisense advised that both institutional and sophisticated investors took part in the placement. The firm commitments received will raise $20 million for the company through the issuance of around 83.33 million ordinary shares.

The offer price will be listed at 24 cents apiece and includes one free attaching unlisted option with every 2 shares subscribed. The strike price of the exercisable option will be at a price of 48 cents for each share applied. These options will have an expiry date on the earlier of either 20 December 2024 or 20 business days after the acceleration trigger date.

The board noted that many of the company's shareholders did not have the opportunity to participate in the offer. As such, an entitlement offer has been put forward which will enable eligible shareholders to apply for 1 new share for every 9.4 existing shares owned.

The issue price is also listed at 24 cents per new share whilst also receiving one free unlisted option for every 2 new shares issued. This is expected to raise an additional $16.8 million for the company.

Funds collected from the placement will be allocated towards covering a number of costs for the ATL1102 Phase IIb/III clinical study. The clinical trial will run for 52-weeks and will be assessed for muscle strength among a number of participants.

About the Antisense share price

It's been a wild ride for Antisense shareholders, with the company's shares accelerating by almost 80% year to date. Looking at a longer time frame, the Antisense share price is up around 140% since this time last year.

Based on today's price, Antisense presides a market capitalisation of around $137.87 million, with approximately 574 million shares outstanding.

The post Antisense Therapeutics (ASX:ANP) share price tumbles 8% amid capital raise appeared first on The Motley Fool Australia.

The Antisense Therapeutics share price fell sharply after the company released a key update to the market today regarding its current and upcoming clinical programs.

Here are the details.

What did Antisense announce?

Antisense advised that it received the thumbs up from European regulators regarding the next steps to authorisation of its drug candidate ATL1102. The drug is being investigated as a potential remedial and medical breakthrough in the treatment of non-ambulant boys with Duchenne muscular dystrophy (DMD).

As the company is currently running a Phase IIb/III trial for the compound, the news ensures the study will be completed in accordance to European standards. This earmark is an integral step of approval for getting drugs to market in the EU.

As a result of the update, Antisense also announced that it has "received firm commitments in an oversubscribed institutional placement" to raise $20 million via an issue of approximately 83.3 million new fully paid ordinary shares.

About the placement

The placement was at a value of 24 cents per share – a corresponding 16% discount from Antisense's opening price on Monday – and represents around 12% of Antisense's fully diluted float at the time of writing.

Shareholders will therefore be diluted by that amount once the transaction and share allotment settles on Thursday.

Antisense noted that the placement was "strongly supported by existing shareholders, with the company also welcoming a number of new institutional investors to the share register".

Aside from this placement, the company also intends to conduct a non-underwritten 1 for 9.4 entitlement offer to raise an additional $16.8 million at the same 24 cents per share.

One caveat embedded into both placement includes 1:2 free-attaching options issued to participants in both offers.

If all options are fully exercised, this will raise a further $36.8 million to "fund the clinical program through to Phase IIb/III trial results in mid-2024 whilst also funding the open label extension study at the same point".

What's the money for?

All-in-all, Antisense intends to use the monies from both financing rounds to fund a series of advancements, including:

• Progression of the current Phase IIb/III DMD clinical trial
• Startup costs for an open label expansion study
• Drug manufacturing costs
• Ongoing research and development (R&D) commitments
• Working capital requirements for ongoing operations.

Antisense laid out additional details of its operations, the capital raising plans, and its ongoing clinical programmes in an investor presentation today as well.

Management commentary

Speaking on the announcement, Antisense managing director Mark Diamond said:

We are both pleased and extremely proud to have received this positive opinion… which provides us with great confidence to undertake our Phase IIb/III trial in DMD in a manner consistent with the expectations of the regulator and which if successfully completed, could bring us an approval to market ATL1102 for the treatment of DMD in Europe, the world's second largest pharmaceutical market.

Antisense Therapeutics share price snapshot

The Antisense Therapeutics share price has been an outsized performer this last 12 months, gaining 123% in that time after rallying 88% since January 1 this year.

Both of these results are a step ahead of the benchmark S&P/ASX 200 index (ASX: XJO)'s climb of around 25% in the same time.

The post Here's why the Antisense Therapeutics (ASX:ANP) share price has plummeted 19% on Monday appeared first on The Motley Fool Australia.

The company provided an update on its meeting with the United States Food and Drug Administration (FDA) in relation to the inhibitor ATL1102. At close of trading today, the biotechnology company's shares were up 15.79% to 22 cents. This followed gains on Thursday's session as well.

What's drove the Antisense share price higher?

The rise in Antisense shares followed the release earlier this week of the FDA's official minutes on the company's Type C guidance meeting.

According to the statement, the FDA has given the nod for Antisense to explore higher dosage limits of ATL1102 in future studies. This follows the recent data findings of Antisense's Phase II open-label study in Melbourne. A total of 9 Duchenne muscular dystrophy (DMD) patients received 25 milligrams of ATL1102 per week for 24 weeks.

Furthermore, Antisense said the FDA has accepted the company's proposed design of its Phase IIb/III study. The clinical trial will run for 52 weeks during which time participants will be assessed for muscle strength. The FDA also suggested Antisense submits a study protocol, outlining primary and secondary endpoints.

A 9-month monkey toxicology study will also be conducted into the effects of ATL1102. However, the FDA said once the animal study is at the report-writing stage, the Phase IIb/III human trial can begin.

Antisense is now consulting with US-based regulatory advisors regarding the next steps towards starting the Phase IIb/III human trial. In addition, the company is evaluating the cost and feasibility of the 9-month monkey study.

About Antisense and ATL1102

Founded in 2000, Antisense is focused on developing and commercialising antisense pharmaceuticals for patients suffering from rare diseases. Antisense is the non-coding DNA strand of a gene.

The company is developing ATL1102, an antisense inhibitor of the CD49d receptor, for DMD patients. Recently Antisense reported promising Phase II trial results, indicating a significantly reduced number of brain lesions in patients with relapsing-remitting multiple sclerosis.

DMD is a severe type of muscular dystrophy that primarily affects boys. According to Antisense, it occurs as a result of mutations in the dystrophin gene which cause a substantial reduction in, or absence of, the dystrophin protein.

Ongoing deterioration in muscle strength affects lower limbs, leading to impaired mobility, and can also affect upper limbs, leading to further loss of function and self-care ability.

Over the past 12 months, the Antisense share price has jumped by almost 230%. Antisense shares are also up by around 70% year to date.

The post Why the Antisense (ASX:ANP) share price rocketed 16% today appeared first on The Motley Fool Australia.

At market close, shares in the biotechnology company ended the day at 21 cents, up 5%.

What did Antisense announce?

In its announcement, Antisense advised that the manufacture of its ATL1102 active pharmaceutical ingredient (API) was undertaken by oligonucleotide therapeutic manufacturing company, Nitto Denko Avecia.

This completes the batch for its planned Phase 2b clinical trial of ATL1102 in non-ambulant Duchenne Muscular Dystrophy (DMD) patients.

Antisense stated that Nitto Denko Avecia fulfilled the batch last month, and shipped the material to Pyramid Laboratories in Southern California. The latter specialises in injectable drug product manufacturing. Since then, Pyramid Laboratories has formulated the ATL1102 API into an injectable product for use in the Phase 2b trial.

The finished product is undergoing product release testing for clinical use, and is expected to release the results next month.

Antisense CEO, Mark Diamond commented:

We are very pleased with how the manufacture of clinical supplies for our planned Phase IIb trial of ATL1102 has proceeded particularly given the challenges that have presented to all CMO's during the global covid pandemic.

We are indeed fortunate to be partnered with such high quality CMOs that have a deep experience with antisense drugs and both of which we have been working with for over 15 years and that can support manufacture all the way through to commercial sale of product.

About the Antisense share price

Founded in 2000, Antisense is focused on developing and commercialising antisense pharmaceuticals for patients suffering from rare diseases.

The Company is developing ATL1102, an antisense inhibitor of the CD49d receptor, for DMD patients. Recently Antisense reported promising phase II trial results, indicating a significantly reduced number of brain lesions in patients with relapsing-remitting multiple sclerosis.

Over the past 12 months, the Antisense shares have jumped more than 170%, with 55% gains on year-to-date performance.

The post Why the Antisense (ASX:ANP) share price finished 5% higher today appeared first on The Motley Fool Australia.

The Antisense share price is up 7.5% at the time of writing, trading at 21.5 cents per share.

Antisense is an Australian publicly listed biotechnology company and drug manufacturer, developing and commercialising antisense pharmaceuticals for large unmet markets in rare diseases. 

Its products are in-licensed from a US-listed company, Ionis Pharmaceuticals, an established leader in antisense drug development. 

In medical parlance, antisense refers to drugs that inhibit the RNA strand of human DNA, preventing human genes from undertaking the purpose that they are genetically programmed to perform.

This is a particularly effective way of combatting serious genetic disorders, and in Antisense Therapeutics' case, it's currently tackling muscular dystrophy.

Antisense's FDA update

Today, Antisense advised that its guidance meeting with the FDA was held to discuss the further development of the company's trial drug, called ATL1102, in preventing Duchenne muscular dystrophy (DMD), in the US.

Antisense expects to provide further details about the meeting to its investors, after it receives the official minutes of the meeting from the FDA in late May 2021.

Antisense said the meeting was constructive and provided clarification on a path towards initiating a Phase IIb/III study in the US. Non-clinical requirements for trialling its drug is to be "further reviewed and agreed with the FDA to assess if and how they may impact on the timing of clinical study initiation".

The feedback will be reviewed by Antisense's internal team and incorporated into its global clinical development and commercialisation plans.

What management said

Antisense Therapeutics CEO Mark Diamond said Antisense was already acting on the meeting.

Based on the guidance meeting with the FDA, together with prior feedback from EMA and world-leading DMD experts, we are reassured that the data from our Phase II study is encouraging and that it is reasonable and appropriate to advance the program towards potentially pivotal clinical studies.

It is our goal to bring this medication to as many DMD patients worldwide as possible.

Antisense share price snapshot

The Antisense share price has been rising across the board, up 65% so far in 2021 and 347% higher over the past 12 months.

The post The Antisense (ASX:ANP) share price is surging 7% today. Here's why appeared first on The Motley Fool Australia.

At the time of writing, the Antisense share price is up an astonishing 31.82% to 14 cents, after rocketing by as much as 45% earlier this afternoon. Indeed, the All Ordinaries Index (ASX: XAO) pales in comparison, moving 0.9% higher to 6,976 points.

What's rocketing the Antisense share price higher?

Investors are running in droves to get a hold of Antisense shares after this latest development.

Just days ago, the European Commission advised it had granted orphan drug designation for Antisense's ATL1102 medicinal product for Duchenne muscular dystrophy.

The positive outcome was a result of the favourable opinion issued by the European Medicines Agency (EMA) Committee last month. The company also recently obtained orphan drug designation and rare paediatric disease designation for ATL1102 in the United States.

Achieving orphan status in the European Union allows Antisense to receive development and marketing incentives. These concessions include reduced fees on scientific advice and the marketing authorisation application. In addition, the company will be granted market exclusivity for 10 years upon regulatory approval. A further 2 years can be added for its paediatric use in the treatment of Duchenne muscular dystrophy.

What did the head of Antisense say?

Mr Mark Diamond, Antisense managing director and CEO, commented on the result:

We are very pleased the EC has adopted the decision to designate ATL1102 for DMD as an Orphan Drug in the EU. We have now successfully achieved orphan drug designation in Europe and orphan drug and rare paediatric disease designations the US, the world's major pharmaceutical markets.

We expect that the incentives that come from such designations including marketing exclusivity periods will be of very significantly commercial value should ATL1102 be successful in its progress through development and ultimately achieve marketing approval.

How has the Antisense share price performed recently?

The Antisense share price has reached a multi-year high today on the back of the European Commission's decision.

At the start of the year, its shares were swapping hands for 9 cents and now they are trading for 14 cents per share — a gain of more than 55%.

The post Recent development sends the Antisense (ASX:ANP) share price soaring 45% appeared first on The Motley Fool Australia.