Proactiveinvestors United Kingdom Circassia Pharmaceuticals https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Circassia Pharmaceuticals RSS feed en Sun, 21 Jul 2019 18:01:07 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190709133544_14142062/ Tue, 09 Jul 2019 13:35:44 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190709133544_14142062/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190708170224_14140676/ Mon, 08 Jul 2019 17:02:24 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190708170224_14140676/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190705120742_14138534/ Fri, 05 Jul 2019 12:07:42 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190705120742_14138534/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190702175607_14134054/ Tue, 02 Jul 2019 17:56:07 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190702175607_14134054/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190702175600_14134053/ Tue, 02 Jul 2019 17:56:00 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190702175600_14134053/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190702175551_14134052/ Tue, 02 Jul 2019 17:55:51 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190702175551_14134052/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190701165529_14132097/ Mon, 01 Jul 2019 16:55:29 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190701165529_14132097/ <![CDATA[RNS press release - Total Voting Rights ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190628070002_14128011/ Fri, 28 Jun 2019 07:00:02 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190628070002_14128011/ <![CDATA[RNS press release - Block Listing Application ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190625165722_14124184/ Tue, 25 Jun 2019 16:57:22 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190625165722_14124184/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190617163545_14113843/ Mon, 17 Jun 2019 16:35:45 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190617163545_14113843/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190607180014_14103862/ Fri, 07 Jun 2019 18:00:14 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190607180014_14103862/ <![CDATA[RNS press release - Result of AGM ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190607161848_14103727/ Fri, 07 Jun 2019 16:18:48 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190607161848_14103727/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190606182332_14102188/ Thu, 06 Jun 2019 18:23:32 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190606182332_14102188/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190606161105_14102021/ Thu, 06 Jun 2019 16:11:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190606161105_14102021/ <![CDATA[RNS press release - Total Voting Rights ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190531070002_14093191/ Fri, 31 May 2019 07:00:02 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190531070002_14093191/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190528175812_14089778/ Tue, 28 May 2019 17:58:12 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190528175812_14089778/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190528175617_14089776/ Tue, 28 May 2019 17:56:17 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190528175617_14089776/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190521090522_14081603/ Tue, 21 May 2019 09:05:22 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190521090522_14081603/ <![CDATA[RNS press release - Annual report and notice of AGM ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190514162434_14073824/ Tue, 14 May 2019 16:24:34 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190514162434_14073824/ <![CDATA[News - Circassia Pharmaceuticals study data published in leading medical journal ]]> https://www.proactiveinvestors.co.uk/companies/news/219847/circassia-pharmaceuticals-study-data-published-in-leading-medical-journal-219847.html Circassia Pharmaceuticals PLC (LON:CIR) said findings from a recent clinical trial of one of its key drugs will appear in a prestigious scientific publication.

The Journal of the American Medical Association will carry the results from the ASCENT phase IV study, which assessed the potential of Tudorza to treat moderate-to-very severe chronic obstructive pulmonary disease (COPD).

The data showed the inhaled powder was effective at combating exacerbations (worsening of the symptoms) of COPD with no increase in major cardiovascular events.

Heart disease often goes hand in hand with COPD and 30% of patients die as a result of related conditions.

The phase IV trial provided what’s called a label extension for Tudorza, which means the drug can be administered to a wider patient group.

Circassia chief executive Steve Harris said: "The publication of these clinical results in the prestigious Journal of the American Medical Association further demonstrates Tudorza's safety and efficacy, particularly in this group of at-risk patients. 

“We are delighted at this recognition of the importance of these data, and of the recent inclusion of this new information in Tudorza's prescribing information."

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Wed, 08 May 2019 07:31:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219847/circassia-pharmaceuticals-study-data-published-in-leading-medical-journal-219847.html
<![CDATA[RNS press release - Publication of Tudorza Phase IV ASCENT in JAMA ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190508070003_14065612/ Wed, 08 May 2019 07:00:03 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190508070003_14065612/ <![CDATA[RNS press release - Issue of Equity ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190503141812_14062972/ Fri, 03 May 2019 14:18:12 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190503141812_14062972/ <![CDATA[Media files - Circassia sets platform for strong growth in 2019 after period of consolidation ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/13169/circassia-sets-platform-for-strong-growth-in-2019-after-period-of-consolidation-13169.html Wed, 01 May 2019 09:41:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/13169/circassia-sets-platform-for-strong-growth-in-2019-after-period-of-consolidation-13169.html <![CDATA[News - Circassia Pharmaceuticals makes strong start to new financial year ]]> https://www.proactiveinvestors.co.uk/companies/news/219438/circassia-pharmaceuticals-makes-strong-start-to-new-financial-year-219438.html Respiratory specialist Circassia Pharmaceuticals PLC (LON:CIR) said it made a strong start to 2019 with revenues up 38% year on year.

Annual results, meanwhile, charted a period of consolidation and operational progress.

It has taken full commercial control of Tudorza, a treatment for chronic obstructive pulmonary disease (COPD), while sales of its asthma product NIOX continued to grow.

Circassia has also added AirNOvent, a late-stage nitric oxide candidate, to its pipeline, which, when approved, should aid the sales effort.

Financially, the company is well endowed. It had £40.7mln of cash at the end of 2018 with AstraZeneca subscribing just over £20mln to the firm’s share sale.

Sales growth 

Last year, Circassia saw its sales grow by 5% to £27.4mln with China, where there was de-stocking and a move to a direct sales operation, exerting the drag.

As is common with companies at this formative phase of their commercial development, the business was loss-making. The loss on continuing operations was £25.9mln.

“We made good progress in 2018 completing our strategic transition into a commercially-focused specialty pharmaceutical business focused on respiratory disease,” said chief executive Steven Harris.

“Our revenues continued to grow and we maintained our commercial investment and broad cost control activities. As a result, we dramatically reduced our net cash outflow and decreased the loss in our underlying business."

Looking ahead, he added: “We are making good progress building a robust business with growing revenue potential and an exciting commercial future."

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Wed, 01 May 2019 07:44:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219438/circassia-pharmaceuticals-makes-strong-start-to-new-financial-year-219438.html
<![CDATA[RNS press release - Final Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190501070009_14058432/ Wed, 01 May 2019 07:00:09 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190501070009_14058432/ <![CDATA[RNS press release - Total Voting Rights ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190430070004_14056243/ Tue, 30 Apr 2019 07:00:04 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190430070004_14056243/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190415115535_14041380/ Mon, 15 Apr 2019 11:55:35 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190415115535_14041380/ <![CDATA[Media files - Two US approvals spell big business potential for Circassia ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12853/two-us-approvals-spell-big-business-potential-for-circassia-12853.html Wed, 03 Apr 2019 16:13:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/12853/two-us-approvals-spell-big-business-potential-for-circassia-12853.html <![CDATA[News - Circassia on track to achieve underlying profitability in 2020 after recent US approvals ]]> https://www.proactiveinvestors.co.uk/companies/news/217753/circassia-on-track-to-achieve-underlying-profitability-in-2020-after-recent-us-approvals-217753.html  

What it does...

Circassia Pharmaceuticals PLC (LON:CIR) is a specialty pharma company focused on treating patients with respiratory diseases.

It currently markets two products: NIOX, which is used to help manage asthma, and Tudorza, a chronic obstructive pulmonary disease (COPD) treatment.

Circassia, which is backed by star fund manager Neil Woodford, recently added another COPD product to its portfolio after the Food and Drug Administration (FDA) approved its Duaklir inhaler for sale in the US.

Tudorza and Duaklir have both been in-licensed from FTSE 100 giant AstraZeneca PLC (LON:AZN).

It has several other asthma and COPD treatments in its pipeline, as well as AirNOvent – a portable system that uses electricity to make nitric oxide which is used to dilate blood vessels in the lungs.

 

How it’s doing

The final week of a March was always going to be a big one for Circassia, with the FDA due to give its verdict on both Duaklir and a label extension for Tudorza. Both went in Circassia’s favour.

Duaklir can now be sold into the US, one of the most important medical markets in the world.

The inhaler is a combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and long-acting beta-agonist (LABA) formoterol fumarate.

It is the only twice-daily LAMA-LABA COPD treatment available in the States.

As for Tudorza, the label extension included extra cardiovascular safety data which its rivals aren’t able to boast.

In theory, this means doctors might be more likely to prescribe it to patients with both COPD and a heart condition.

Progress is also being made with AirNOvent, with Circassia’s partner recently completing a pre-submission meeting with regulators across the pond. Subject to approvals, the plan is to launch the product in the first half of 2020.

Full-year results are due in early May, but the half-year numbers back in September showed revenue of £28.4mln, while underlying losses narrowed to £12.1mln.

 

What the boss is saying

“We are delighted with the FDA approval of Duaklir, which we believe will provide a valuable treatment option for the significant number of patients with COPD in the United States,” said chief executive Steve Harris.

“The addition of Duaklir to our portfolio further strengthens our range of marketed respiratory products.

“We look forward to launching it in the US in the coming months alongside our aclidinium monotherapy, Tudorza, as part of the significant LAMA / LABA market that is predicted to grow rapidly over the coming years.”

 

What analysts are saying…

“US FDA approved both pending applications on Circassia’s respiratory drugs Tudorza and Duaklir, for which it has commercial rights in the US under its collaboration with AstraZeneca,” said analysts at Peel Hunt in a recent note.

“The details of the approval and funding of the associated milestones is fully consistent with Circassia’s previous guidance, and supports the top-line forecasts in our model that should see Circassia achieve EBITDA positivity in 2020.

“The stock trades at less than a third of our conservative estimate of fair value, an irrationally big discount in view of this significant de-risking event.”

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Tue, 02 Apr 2019 07:00:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/217753/circassia-on-track-to-achieve-underlying-profitability-in-2020-after-recent-us-approvals-217753.html
<![CDATA[RNS press release - FDA approval of Duaklir for treatment of COPD ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190401070006_14022462/ Mon, 01 Apr 2019 07:00:06 +0100 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190401070006_14022462/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329164036_14022132/ Fri, 29 Mar 2019 16:40:36 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329164036_14022132/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329163557_14022121/ Fri, 29 Mar 2019 16:35:57 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329163557_14022121/ <![CDATA[News - Circassia gets a double shot in the arm from US regulators ]]> https://www.proactiveinvestors.co.uk/companies/news/217561/circassia-gets-a-double-shot-in-the-arm-from-us-regulators-217561.html Circassia Pharmaceuticals PLC (LON:CIR) was given a double shot in the arm late on Friday after US regulators gave the green light for not one, but two of its chronic obstructive pulmonary disease (COPD) treatments.

The Food and Drug Administration approved Circassia’s Duaklir drug for use in the US, as well as giving the thumbs-up to a label extension for its Tudorza inhaler.

READ: Circassia set for pivotal week

By using data from a recent Phase IV study, Circassia was able to show the FDA that its Tudorza drug can reduce COPD exacerbations without increasing the likelihood of major cardiovascular events.

Cardiovascular disease is the most common and significant co-morbidity of COPD, with approximately 30% of COPD patients dying from cardiovascular conditions.

Tudorza is the only LAMA inhaler in the US with this cardiovascular safety data in its label.

In theory, that means doctors might be more likely to prescribe it to patients with both COPD and a heart condition as no other treatment boasts of this kind of safety data.

Tudorza only COPD drug with this safety data

“This approval adds unique new clinical data to Tudorza's label, which further differentiates this important COPD treatment option within the US$2bn US LAMA market,” said chief executive Steve Harris.

“Cardiovascular disease is a major co-morbidity of COPD, and the inclusion of comprehensive data demonstrating COPD exacerbation reductions and cardiovascular safety provides physicians with important new information, helping to further serve this significant patient group.”

He added: “Following our recent option exercise acquiring the full US commercial rights to Tudorza, and this subsequent label expansion, we look forward to implementing our strategy targeting product growth in this major market.”

Duaklir approved too

As for Duaklir, another COPD drug that Circassia acquired from AstraZeneca a couple of years ago, the FDA has approved that for use in the US.

Duaklir is a combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and long-acting beta-agonist (LABA) formoterol fumarate.

It is the only twice-daily LAMA/LABA treatment in the US with COPD exacerbation data included in its label.

“With guidelines recommending combined LAMA and LABA therapy for a number of COPD patient groups, we believe Duaklir will make an important contribution to the treatment of this debilitating disease,” said Michael Asmus, Circassia’s vice president of US medical affairs.

CEO Harris added: “We are delighted with the FDA approval of Duaklir, which we believe will provide a valuable treatment option for the significant number of patients with COPD in the United States.”

Financing discussions underway

Under the terms of the deal, Circassia is to pay US$20mln to Astra within 30 days, with a final US$100mln consideration due by the end of June.

The company has confirmed it is in discussions with third-party lenders to fund all or part of the payments, although there is also the option for Astra to provide a vendor loan.

"As AZN is a major shareholder (c20%) in Circassia, we think there is therefore strong alignment of interests around the provision of the vendor loan," noted analysts at 'house'  broker Peel Hunt.

They added: “The details of the approval and funding of the associated milestones is fully consistent with Circassia’s previous guidance, and supports the top-line forecasts in our model that should see Circassia achieve EBITDA positivity in 2020.

“The stock trades at less than a third of our conservative estimate of fair value, an irrationally big discount in view of this significant de-risking event."

Peel Hunt reiterated a ‘buy’ rating and 90p price target on Circassia shares, which in afternoon trading on Monday were 17.9% higher at 33p.

US is a key market

The US is arguably the world’s most important and lucrative pharma industry, so the FDA's decisions are undoubtedly important.

There is plenty of competition in the US COPD market, but if Duaklir can secure even a slither of it, it would likely add tens of millions every year to Circassia’s top-line.

The inhaler already generates almost US$100mln a year for AstraZeneca PLC (LON:AZN), and that is obviously without any sales in the US, where COPD is the third biggest killer that affects more than 10mln people.

 -- Updates share price --

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Fri, 29 Mar 2019 16:12:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/217561/circassia-gets-a-double-shot-in-the-arm-from-us-regulators-217561.html
<![CDATA[RNS press release - FDA website posts Duaklir NDA approval ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329155846_14022034/ Fri, 29 Mar 2019 15:58:46 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329155846_14022034/ <![CDATA[RNS press release - Circassia announces FDA approval of Tudorza sNDA ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329153448_14021993/ Fri, 29 Mar 2019 15:34:48 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329153448_14021993/ <![CDATA[RNS press release - Total Voting Rights ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329070002_14020374/ Fri, 29 Mar 2019 07:00:02 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190329070002_14020374/ <![CDATA[News - Circassia enters pivotal week with two big FDA decisions due ]]> https://www.proactiveinvestors.co.uk/companies/news/217140/circassia-enters-pivotal-week-with-two-big-fda-decisions-due-217140.html Circassia Pharmaceuticals PLC (LON:CIR) shares edged higher on Monday ahead of what looks set to be a pivotal week for the junior drug developer.

After ten months of analysis and reviews, the company will know whether US regulators have approved its Duaklir chronic obstructive pulmonary diseases (COPD) drug by 31 March.

It will also have found out about a supplemental new drug application (NDA) for Tudorza, another COPD drug it acquired from Astra two years ago.

READ: Circassia coughs up US$32mln for PPHN drug

The US is arguably the world’s most important and lucrative pharma industry, so the Food and Drug Administration’s (FDA) decisions are undoubtedly important.

There is plenty of competition in the US COPD market, but if Duaklir can secure even a slither of it, it would likely add tens of millions every year to Circassia’s top-line.

The inhaler already generates almost US$100mln a year for AstraZeneca PLC (LON:AZN), and that’s obviously without any sales in the US, where COPD is the third biggest killer that affects more than 10mln people.

AstraZeneca investors will also be keeping an eye out on the decisions as the pharma giant will receive a US$100mln pay-out should Duaklir gets the thumbs-up.

Positive data from two Phase III studies, as well as exacerbation data from another late-stage trial support the new drug application (NDA), so bosses are, as ever, upbeat about the drug’s prospects.

Initial decision not everything – ask Motif Bio

But even if the worst does happen, and there is no evidence to suggest it will, can Circassia take heart from Motif Bio PLC’s (LON:MTFB) recent disappointment?

Last month, the FDA rejected Motif’s NDA for its iclaprim antibiotic, saying that it required more data.

But AIM-quoted Motif asked for talks to iron out the issues and the pair are now meeting in a few weeks.

The company remains upbeat about its drug prospects. It is not going there merely for an explanation, it hopes the talks will help determine “the best way to move iclaprim towards marketing approval”.

Circassia shares were up just over 1% to 33.5p on Monday.

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Mon, 25 Mar 2019 14:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/217140/circassia-enters-pivotal-week-with-two-big-fda-decisions-due-217140.html
<![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190305165319_13991224/ Tue, 05 Mar 2019 16:53:19 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190305165319_13991224/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190304160436_13989560/ Mon, 04 Mar 2019 16:04:36 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190304160436_13989560/ <![CDATA[RNS press release - Total Voting Rights ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190228070006_13984396/ Thu, 28 Feb 2019 07:00:06 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190228070006_13984396/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190211171707_13965477/ Mon, 11 Feb 2019 17:17:07 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190211171707_13965477/ <![CDATA[RNS press release - Notice of Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190208090002_13963142/ Fri, 08 Feb 2019 09:00:02 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190208090002_13963142/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190206164453_13960850/ Wed, 06 Feb 2019 16:44:53 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190206164453_13960850/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190206070003_13959537/ Wed, 06 Feb 2019 07:00:03 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190206070003_13959537/ <![CDATA[RNS press release - Holding(s) in Company ]]> https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190204175730_13957755/ Mon, 04 Feb 2019 17:57:30 +0000 https://www.proactiveinvestors.co.uk/companies/rns/8408/LSE20190204175730_13957755/ <![CDATA[Media files - Circassia's AirNOvent drug a step closer to market with FDA pre-submission meeting ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12091/circassia-s-airnovent-drug-a-step-closer-to-market-with-fda-pre-submission-meeting-12091.html Mon, 04 Feb 2019 13:25:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/12091/circassia-s-airnovent-drug-a-step-closer-to-market-with-fda-pre-submission-meeting-12091.html <![CDATA[News - Circassia Pharmaceuticals says partner AIT Therapeutics successfully completes FDA pre-submission meeting ]]> https://www.proactiveinvestors.co.uk/companies/news/213883/circassia-pharmaceuticals-says-partner-ait-therapeutics-successfully-completes-fda-pre-submission-meeting-213883.html Circassia Pharmaceuticals PLC (LON:CIR) revealed that its partner, AIT Therapeutics Inc. has successfully completed a pre-submission meeting with the US FDA for the ventilator-compatible nitric oxide product AirNOvent.

The AIM-listed specialty pharmaceutical company, which is focused on respiratory disease, said AIT anticipates submitting a Premarket Approval application (PMA) for AirNOvent in the second quarter of 2019 for use in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN).

WATCH: Circassia's AirNOvent drug a step closer to market with FDA pre-submission meeting

Circassia said it anticipates launching the product in the first half of 2020, once approved.

The group announced on 24 January 2019 that it had entered a definitive agreement to acquire the exclusive commercialisation rights to AirNOvent in the United States and China from AIT. 

Under the agreement, the successful completion of the FDA meeting triggers a milestone payment of US$3.15mln, which Circassia said it intends to satisfy through the issuance of new ordinary shares in the company to AIT.

Steve Harris, Circassia's CEO, commented: "Successful completion of this pre-submission meeting represents a further key milestone in advancing AirNOvent towards the market. 

“We are excited at the potential benefits offered by AirNOvent, once approved, and look forward to AIT submitting this novel nitric oxide product for regulatory approval in the coming months."

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