Diurnal Group Plc Clarity for Chronocort regulatory pathway

Hardman & Co Report Report Downloads

Diurnal Group Plc (LON: DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products are targeting rare conditions where medical need is currently unmet, with the aim of building a long-term ‘Adrenal Franchise’. The first product, Alkindi®, is being launched in key EU markets, and this was expected to be followed by the adult version, Chronocort®. After unexpected Phase III results, positive feedback from the EMA has cleared the path for regulatory submission of Chronocort for adult CAH in Europe before the end of 2019, and allowed DNL to revise the primary endpoint in the protocol for the US Phase III trial.

Strategy: DNL’s goal is to create a valuable ‘Adrenal Franchise’ that can treat patients with chronic cortisol deficiency diseases from birth and for the rest of their lives. The long-term vision, once Alkindi and Chronocort are established in Europe and the US, is to expand the product offering to other endocrine conditions.

Interims: The focus during 1H’19 has been to build-up the launch of Alkindi in Europe and establish commercial partners in other key territories. Sales during 1H’19 were in line with forecasts at £0.19m. Events around Chronocort caused some volatility in R&D spend, which left net cash of £6.9m at 31 December 2018.

EMA feedback: Following a Scientific Advice meeting with EMA representatives to discuss the Phase III Chronocort results in CAH patients, the EMA has confirmed that the MAA for Chronocort can be submitted with no further trials needed; DNL expects to submit this in 4Q’19.

Risks: Concerns about the US prospects for Chronocort have been allayed by the positive EMA outcome, which has allowed DNL to change the US Phase III protocol. However, it has added extra time into the US development process and delayed the point at which DNL is expected to become cashflow-positive.

Investment summary: Alkindi, a cortisol replacement therapy designed for children under 18 years of age, is DNL’s first product on the market. It is expected to be followed by Chronocort for adults – a larger market – which now has a clear pathway for regulatory approval in both Europe and the US. Despite this, the share price is still languishing well below valuations determined by peer group and DCF (225p) analyses, possibly due to the need for more capital later in 2019.

Click to view all articles for the EPIC:
Or click to view the full company profile:
    Share on facebook
    Facebook
    Share on twitter
    Twitter
    Share on linkedin
    LinkedIn
    Hardman & Co

    More articles like this

    Hardman & Co

    Diurnal Group: All set for three pivotal trials

    Diurnal Group plc (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its drugs target conditions where medical need is currently unmet, with the aim of becoming a global endocrine leader. Alkindi®, soon

    Hardman & Co

    Diurnal Group: And then there were three

    Diurnal Group plc (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its products are targeting rare conditions where medical need is currently unmet, with the long-term aim of building an “Adrenal Franchise”.

    Hardman & Co

    Diurnal Group: Closely watching the regulators

    Diurnal Group plc (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its products are targeting rare conditions where medical need is currently unmet, with the long-term aim of building an “Adrenal Franchise”.

    Hardman & Co

    Diurnal Group Flow of regulatory approvals

    Diurnal Group plc (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its products are targeting rare conditions where medical need is currently unmet, with the long-term aim of building an “Adrenal Franchise”.

    Hardman & Co

    Diurnal Group $52.5m US deal strengthens balance sheet further

    Diurnal Group PLC (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products are targeting rare conditions where medical need is currently unmet, with the aim of building a long-term

    Hardman & Co

    Diurnal Group … and more to come (news flow)

    Diurnal Group PLC (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products are targeting rare conditions where medical need is currently unmet, with the aim of building a long-term

    Hardman & Co

    Diurnal Group Plc Successful DITEST Phase I trial outcome

    Diurnal (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products, Alkindi and Chronocort, are in late-stage clinical trials, with Alkindi already licensed in Europe. With the successful outcome of

    Hardman & Co

    Diurnal Group Approaching a number of near-term milestones

    Diurnal (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products are targeting rare conditions where medical need is currently unmet, with the aim of building a long-term ‘Adrenal Franchise’.

    Hardman & Co

    Diurnal Group Chronocort – seeking regulatory advice

    Diurnal Group (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products target rare conditions where medical needs are currently unmet, with the aim of building a long-term ‘Adrenal Franchise’.

    Hardman & Co

    INTERVIEW: Diurnal Group Unexpected Phase III trial outcome

    Diurnal Group (LON:DNL) is the topic of conversation when Hardman & Co Analyst Dr Martin Hall joins DirectorsTalk to discusses the recent Phase lll Chronocort trial. Martin explains how it differs from the Phase ll trial, what affect

    Hardman & Co

    Diurnal Group Unexpected Phase III trial outcome

    Diurnal Group (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products target rare conditions where medical needs are currently unmet, with the aim of building a long-term ‘Adrenal Franchise’.

    Hardman & Co

    Diurnal Group – Capital increase to support commercial plans

    Diurnal Group Plc (LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products target rare conditions where medical needs are currently unmet, with the aim of building a long-term ‘Adrenal

    Hardman & Co

    Diurnal Group Alkindi®: On route to Europe

    Diurnal Group Plc (LON:DNL) is a clinical stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead candidates are targeted at rare diseases with unmet medical need, with the aim of building a long-term

    Hardman & Co

    Diurnal Group Plc Ready to press the button

    Diurnal Group Plc (LON:DNL) is a clinical stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead candidates are targeted at rare diseases with unmet medical need, with the aim of building a long-term

    No more posts to show