Idorsia: een Zwitsers biotech parel

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Re: Idorsia: een Zwitsers biotech parel

Bericht door medaar »

16 juli werd het uitrollen van een verkoopsteam in Amerika bekendgemaakt
23 juli bekendmaking resultaten 2de kwartaal







Volg Beursig.com op Twitter en Facebook


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Re: Idorsia: een Zwitsers biotech parel

Bericht door JacGob »

The H1 financials speak for themselves:

https://www.idorsia.com/media/news-deta ... Id=2338761
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Re: Idorsia: een Zwitsers biotech parel

Bericht door Bankpas »

JacGob schreef:
22 jul 2020 06:36
Een artikel op Seeking Alpha met een aantal interessante feiten over de verkoop van het belang bij Cilag.

https://seekingalpha.com/article/435975 ... ted-shares
Kan ik mee leven :lol: :lol: :lol:

The recent announcement for forming a US operation is in my opinion related to daridorexant being launched in the US and being handled without a partnership being involved. This indicates two things 1) Confidence they have a potential blockbuster drug. 2) Controlling the drug and not splitting profits will enhance the time and amount of profits Idorsia will be able to generate. If all goes well, Idorsia should start reporting product revenues the second half of 2021, and then in 2022, the insomnia product should kick-in--big time!
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Re: Idorsia: een Zwitsers biotech parel

Bericht door NewB76 »

IDORSIA LTD : Morgan Stanley initiates with equal-weight, CHF 35 target price

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Re: Idorsia: een Zwitsers biotech parel

Bericht door Bankpas »

NewB76 schreef:
27 jul 2020 16:29
IDORSIA LTD : Morgan Stanley initiates with equal-weight, CHF 35 target price
Idorsia initiated with a Buy at Deutsche Bank Deutsche Bank analyst Rajan Sharma initiated coverage of Idorsia with a Buy rating and CHF 38 price target. The analyst believes combined peak sales of Idorsia's Phase III assets could exceed $4.5B, with first launches from 2022.
:up: :up: :up:
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Re: Idorsia: een Zwitsers biotech parel

Bericht door JacGob »

Klein nieuwtje dat nog niet gepost was:

Idorsia Japan confirms daridorexant dose response in Japanese patients with insomnia – preparation for a local registration program advancing.

https://www.idorsia.com/media/news-deta ... Id=2347059

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Vuurwerk op komst?

Bericht door Bankpas »

Allschwil, Switzerland – August 13, 2020

Idorsia Ltd (SIX: IDIA) today announced that the positive results from the first pivotal Phase 3 study investigating 25 and 50 mg doses of its dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia, are to be presented at SLEEP 2020. Due to the COVID-19 pandemic, the Associated Professional Sleep Societies (APSS) is turning SLEEP 2020, the world’s largest meeting devoted entirely to clinical sleep medicine, and sleep and circadian research, into a virtual meeting from August 27 – 30, 2020. The meeting has live-streamed content as well as on-demand recorded sessions to view.

The abstract entitled “A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Polysomnography Study to Assess Efficacy and Safety of Daridorexant in Adult and Elderly Insomnia Patients” will be presented as an oral presentation by Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, and will be available on demand to registered attendees of SLEEP 2020 as part of the late-breaking program.

More information and the late breaking abstract is available in the Virtual Sleep 2020 meeting guide.

The Phase 3 program design will also be presented as a poster entitled “0521 – Daridorexant (ACT-541468), a dual orexin receptor antagonist for the treatment of insomnia disorder: double blind, randomized, Phase 3 studies for efficacy and safety in adult and elderly patients”. The poster will be available on demand to registered attendees of SLEEP 2020 and the abstract can be found in the Abstract Supplement.

In April and July 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia. More details and commentary can be found in the dedicated press releases (first study release), (second study release) and the investor webcasts (first study webcast), (second study webcast) which are available for replay on the corporate website.

---

Notes to the editor

About the Phase 3 registration program
The Phase 3 registration program comprises two confirmatory studies of 3-month duration, together with a long-term extension study. Both pivotal studies are complete, having enrolled around 1,850 patients with insomnia at over 160 sites across 18 countries. As insomnia often presents later in life, around 40% of the recruited population was aged 65 years or older. The confirmatory multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography studies investigated three doses of daridorexant (10 mg, 25 mg, and 50 mg) on sleep and daytime functioning parameters, objectively in a sleep lab by polysomnography and subjectively with a daily patient diary at home.

The impact of insomnia on patients’ daytime functioning was measured daily using the sleepiness domain score from the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) a Patient Reported Outcome (PRO) instrument, validated according to the US Food and Drug Administration (FDA) Guidance for Industry. 806 patients decided to continue treatment in the ongoing 40-week extension study which will measure the effect of all three doses vs. placebo, generating data for long-term treatment of insomnia.

About insomnia
Insomnia is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime performance. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.

Insomnia is, worldwide, the most commonly reported sleep disorder and its impact is often underestimated. In reality, it can be a distressing condition that can impair quality of life. Sleepless nights can leave people feeling irritable and out of sorts – this may affect many aspects of daily life, from studying and employment to social activities and relationships. People who suffer from insomnia may lack the energy or motivation to exercise or to take part in social activities. It can also have a significant economic impact as it increases the risk of accident and injury on the road or in the workplace, and is a leading cause of absenteeism and reduced productivity at work. People with insomnia are more likely to experience feeling down or depressed, lack concentration, and suffer from poor energy levels during the day compared with people who sleep well. In addition, worrying about sleep can cause stress and may lead to negative thought patterns which may in turn make it more difficult to sleep, setting up a vicious cycle. Chronic insomnia is associated with cardiovascular and cerebrovascular diseases, and increased mortality.

The goal of treatment for insomnia is to improve sleep quality and quantity, as well as to reduce insomnia-related impaired daytime performance, while avoiding adverse events and next morning residual effects. Current treatment of insomnia includes cognitive behavioral therapy, sleep hygiene recommendations, and pharmacotherapy. The most widely prescribed products on the market that are indicated for insomnia enhance the effects of gamma-aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. Such medications are only approved for short-term use and are associated with side effects such as next-day effects, anterograde amnesia, and risk of tolerance and dependence.

About Dr. Thomas Roth, PhD
Dr. Roth has been the Director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, since 1978. Dr. Roth is also a Professor in the Department of Psychiatry at Wayne State University, School of Medicine in Detroit, Michigan, and serves as a Clinical Professor in the Department of Psychiatry at the University of Michigan, College of Medicine in Ann Arbor.

After serving as president of the Sleep Research Society, and the founding president of the National Sleep Foundation (NSF), Dr. Roth became chairman of the National Center on Sleep Disorders Research advisory board. In addition, he was a member of the board of directors of the Associated Professional Sleep Societies (APSS), chaired the Association's Scientific Program Committee and the governing board of the World Federation of Sleep Research Societies.

Dr. Roth was instrumental in the formation of the Association of Sleep Disorders Center (ASDC) and served as the organization's second president. He is also the former Chairman of the World Health Organization's worldwide project on sleep and health. In addition to authoring and co-authoring numerous articles, Dr. Roth serves as past editor-in-chief of the journal Sleep. He currently sits on the editorial boards of Sleep Reviews, Stress Medicine, and Advances in Therapy and Human Psychopharmacology.

In 2002, Dr. Roth received the NSF's Lifetime Achievement Award for his accomplishments and contributions to sleep science, sleep medicine and public health. He received a Distinguished Research Award from the Sleep Research Society as well as the Nathanial Kleitman Award from the Academy of Sleep Medicine. Dr. Roth's contributions to the sleep field are expansive, ranging from prolific research productivity and scholarship to multiple national leadership positions, as well as the mentoring of many students and colleagues. Dr. Roth serves as a consultant to Idorsia.
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Presentatie op SLEEP convention!!!

Bericht door Bankpas »

Allschwil, Switzerland – August 28, 2020

Idorsia Ltd (SIX: IDIA) today announced that the positive results from the first pivotal Phase 3 study (evaluating 25 and 50 mg doses) of its investigational dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia, were presented by Dr Thomas Roth at SLEEP 2020. The study demonstrated efficacy of treatment with daridorexant on objective and subjective sleep parameters, and daytime functioning, with no next-morning residual effect.

The Associated Professional Sleep Societies (APSS) event, SLEEP 2020, is the world’s largest meeting devoted entirely to clinical sleep medicine, and sleep and circadian research and is currently taking place as a virtual meeting. The presentation, entitled “Efficacy and safety of daridorexant in adult and elderly patients with insomnia”, is available for on-demand replay for registered participants through August 1, 2021.

Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, commented:
“Daridorexant, a new dual orexin receptor antagonist, has a pharmacokinetic and pharmacodynamic profile optimized for sleep onset and duration of action to improve night-time efficacy, without residual effects. These pharmacological properties led us to hypothesize that daridorexant could also improve the impaired daytime functioning frequently observed in insomnia. A new patient-reported outcome instrument was developed – and validated according to FDA requirements – to specifically assess daytime functioning in patients with insomnia and we included it in the Phase 3 program. The results have been outstanding.”

The Phase 3 trial was designed to measure the impact of daridorexant on objective and subjective sleep parameters as well as on daytime functioning, and to evaluate safety, in patients with moderate to severe insomnia. Sleep variables were assessed using polysomnography for wake after sleep onset (WASO) and latency to persistent sleep (LPS). A sleep diary questionnaire was used to measure subjective total sleep time (sTST). Daytime functioning was assessed using a newly developed and validated patient-reported outcome instrument, the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). The IDSIQ comprises 14 items grouped into three domains that reflect daytime effects of insomnia that are commonly encountered in clinical practice: Alert/Cognition, Mood, and Sleepiness/Tiredness.

Daridorexant significantly improved sleep maintenance as measured by a larger decrease in WASO from baseline compared to placebo. The mean change from baseline in WASO (minutes) for placebo, 25 mg and 50 mg was -6.2, -18.4, and -29.0 at 1 Month and -11.1, -23.0 and -29.4 at 3 Months, respectively (all p values vs. placebo <0.0001).

Daridorexant significantly improved sleep onset as measured by a larger decrease in LPS from baseline compared to placebo. The mean change from baseline in LPS (minutes) for placebo, 25mg and 50mg was -19.9, -28.2 (p=0.0005) and -31.2 (p<0.0001) at 1 Month and, -23.1, -30.7 (p=0.0015) and -34.8 (p<0.0001) at 3 Months, respectively (p-values vs placebo).

Subjective total sleep time assessed daily by patients increased more with daridorexant from baseline compared to placebo. The mean change from baseline in sTST (minutes) for placebo, 25mg and 50mg was 21.6, 34.2 (p=0.0013), and 43.6 (p<0.0001) at 1 Month, and 37.9, 47.8 (p=0.0334), 57.7 (p<0.0001) at 3 Months, respectively (p-values vs placebo).

Daridorexant improved daytime functioning, as measured in a secondary efficacy endpoint by the Sleepiness/Tiredness domain of the IDSIQ. For this domain, the improved daytime functioning was demonstrated by a mean score reduction from baseline for placebo, 25mg and 50mg of -2.0,
-2.8 (p=0.0547) and -3.8 (p<0.0001) at 1 Month, and of -3.8, -4.8 (p=0.0534) and -5.7 (p=0.0002) at
3 Months, respectively (p-values vs placebo). In addition, other efficacy endpoints from the IDSIQ patient-reported outcome instrument, namely the “Alert/Cognition” domain, “Mood” domain, and the “Total IDSIQ” scores, consistently showed a dose-dependent improvement, as presented.

The most frequent AEs, nasopharyngitis and headache, were balanced between arms. Somnolence was reported in 6 (1.9%) patients on placebo, 11 (3.5%) patients on daridorexant 25mg, and 5 (1.6%) of patients on daridorexant 50mg.

The late breaking abstract (LBA 4) is available in the Virtual Sleep 2020 meeting guide.

Dr Roth concluded:
“As hypothesized, the optimized profile of daridorexant not only translated in this study into a dose-dependent improvement on objective and subjective sleep parameters, but also into improved daytime functioning, all of which was sustained over time. Very importantly, safety was comparable with daridorexant 25 mg and 50 mg, with no dose-limiting safety findings, no observed next-morning sleepiness compared to placebo, no signals suggestive of rebound insomnia compared to baseline sleep parameters, and no withdrawal effects. With these results daridorexant addresses important needs of patients with insomnia.”

The Phase 3 program design was also presented as a poster entitled “Daridorexant (ACT-541468), a dual orexin receptor antagonist, for the treatment of insomnia disorder: Phase 3 program for assessing efficacy and safety in adult and elderly patients”. The poster is available on demand to registered attendees of SLEEP 2020 and the abstract can be found in the Abstract Supplement.

In April and July 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia. More details and commentary can be found in the dedicated press releases (first study release), (second study release) and the investor webcasts (first study webcast), (second study webcast) which are available for replay on the corporate website.
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Re: Idorsia: een Zwitsers biotech parel

Bericht door Bankpas »

Idorsia: Reaching Out For More And Delivering On Their Promises

Nov. 02, 2020 11:11 AM ETIdorsia Ltd (IDRSF)JNJ, NBIX, SYNH1 Comment5 Likes
Summary

I will provide background information for my new readers.
Readers will see the interim data created since my last article.
Near-term binary events that should have major benefits will be outlined.
First major drug candidate is scheduled for NDA filing by end of 2020.
IDORSIA--Reaching Out for More



Sourced from Idorsia's Website

On July 16th, 2019, I shared my first article about Idorsia (OTCPK:IDRSF) (IDIA.SW). I cited for my readers that I had opened a small position in the stock at $16.42. In the ensuing 15 months, the stock did not escape the massive sell-off in March of this year, due to the pandemic. In fact, the 52-week range in pricing of the stock has been a low of $18.75 to a high of $34.75. During this period, I have added constantly to my position, albeit, at prices higher than my initial purchase.

Idorsia is a unique Swiss biotech company with a management and research team that created the predecessor biotech company and subsequently sold the company to Johnson & Johnson (JNJ) for $30 billion. After Johnson & Johnson concluded the buy-out, they turned around and funded the creation of Idorsia where they transferred over a huge number of drugs that were in advanced clinical trials. Now into the 15th month since my first article, the fruits of the clinical trials Idorsia is guiding through the FDA approval process, they are ready to achieve results for their efforts. With this article, I will update the status of the clinical trials and the other relevant information relating to the preparations being made for their first launch of a drug they fully control.

I would suggest for my new readers, take the time and read my first article and obtain the foundational information about the uniqueness of the Idorsia story-and understanding the leadership team for the predecessor biotech, this husband and wife team own a stake of nearly 30% of the outstanding Idorsia shares.

Chronology of 2020 Events:

March 4th, 2020- Janssen Pharmaceutical, a part of Johnson & Johnson, announced ponesimod, a treatment for adult patients with relapsing multiple sclerosis-MS, had been submitted to the European Marketing Authorization for their approval. Based on net quarterly sales, Idorsia will receive an 8% royalty for this drug.
March 19th, 2020 - Janssen submitted ponesimod a new drug application to the FDA for their approval. Idorsia will receive the same 8% royalty rate as cited for the European sales.
April 20th, 2020 - Idorsia announced the 1st of two Phase 3 clinical studies for daridorexant, their drug for the treatment of insomnia. This trial involved 930 adults and it provided excellent results for the efficacy of the drug. It is projected that 10% of the world's general population have conditions relating to sleep deprivation due to insomnia disorders.
May 12th, 2020 - Neurocrine Biosciences (NBIX) exercised their option to license Idorsia's potential treatment for a rare form of pediatric epilepsy -ACT-709418. Neurocrine has plans to start a Phase 2 clinical trial by the end of the year. Idorsia received $45 million in an upfront cash payment and is in line to receive future royalty payments for net sales revenue.
July 16th, 2020- Idorsia announces their new US commercial operations that will be located in Radnor, PA.
August 6th, 2020 - Idorsia (Japan) announced the positive trial results for daridorexant that is planned for the Japanese market based on clinical results generated in Japan and with Japanese trial patients.
August 31st, 2020 - Idorsia announced they had partnered with Syneos Health (SYNH) as their commercialization partner for the US launch of daridorexant. Syneos is the industry's leading Contract Commercial Organization and the longest tenured US provider of outsourced sales teams. Over the last five (5) years, Syneos has launched more new products, created more sales teams than any other biopharmaceutical solutions company.
September 22nd, 2020-Idorsia announced they had chosen Veeva to hand their digital marketing for the marketing of daridorexant.
October 21st, 2020- Idorsia announced the results of their direct issuance of 23.8 million new shares where they raised 535.5 million Swiss francs ($592.30 million) of new capital to fund the launch and marketing of daridorexant. It should also be noted, Idorsia's principal shareholders, Jean-Paul and Martine Clozel, remain fully committed to Idorsia over the long term by acquiring an aggregate of 8,082,266 Offered Shares in the Offering, thereby increasing their shareholdings from 28.4% to 29.2% of the Company's share capital registered in the commercial register.
Key Metrics from 3rd-Q SEC financial filings:

On October 27th, Idorsia announced their third quarter financial results. At this stage of development their revenue stream is negligible. For investors seeing the caliber of collaborations Idorsia has in place, the following are the comments made in this recent SEC filing and relates to their US GAAP revenues for the first three quarters of 2020:

US GAAP revenue of CHF 66 million in the first nine months of 2020 consisted of contract revenue recognized in connection with the collaboration agreements with Neurocrine Biosciences, Inc. (CHF 49 million), Janssen Biotech, Inc. (CHF 8 million), Roche (CHF 4 million), Mochida Pharmaceutical Co., Ltd (CHF 3 million) and Santhera Pharmaceuticals Ltd (CHF 2 million) - see further update with regards to Santhera below - compared to a revenue of CHF 20 million in the first nine months of 2019.
US GAAP operating expenses in the first nine months of 2020 amounted to CHF 354 million (CHF 375 million in 9M 2019), of which CHF 290 million relates to R&D (CHF 327 million in 9M 2019), which includes a one-off expense of CHF 32 million as explained in the legal update in the HY 2020 financial reporting and repeated below, and CHF 64 million to SG&A expenses (CHF 47 million in 9M 2019).
US GAAP net loss in the first nine months of 2020 amounted to CHF 308 million compared to CHF 352 million in the first nine months of 2019. The decrease of the net loss was mainly driven by higher contract revenues and lower operating expenses.
The US GAAP net loss resulted in a net loss per share of CHF 2.25 (basic and diluted) in the first nine months of 2020 compared to a net loss per share of CHF 2.68 (basic and diluted) in the first nine months of 2019.
(Sourced from Idorsia's 3rd-Q, SEC Filing)

At this stage of their path to meaningful and sustainable revenue, their current liquidity and indebtedness is a more relevant metric. At the end of the first nine months of 2020, Idorsia's liquidity (including cash, cash equivalents, short- and long-term deposits) amounted to CHF 816 million. It should be noted the October direct placement that generated 535.5 million Swiss Francs is not reflected in the 3rd-Q filing. When you add these funds, their total liquidity amounts to 1.351.5 billion CHF, less any depletions during the month of October.

(in CHF millions)

Sep 30, 2020

Liquidity

Cash and cash equivalents

148

Short-term deposits

668

Long-term deposits

-

Total liquidity*

816

Indebtedness

Convertible loan

386

Convertible bond

199

Other financial debt

-

Total indebtedness

585

Sourced from Idorsia's 3rd-Quarter Financial Report to the SEC

* In collaboration with Janssen Biotech to jointly develop aprocitentan, Janssen Biotech has sole commercialization rights worldwide

Neurocrine Biosciences has a global license to develop and commercialize our ACT-709478, a novel T-type calcium channel blocker, for the treatment of a rare form of pediatric epilepsy. In May 2020, Neurocrine announced plans to initiate a Phase 2 study for ACT-709478 in the second half of 2020.

Current Pipeline in Development:

Compound

Mechanism of Action

Target Indication

Status

Daridorexant

Dual orexin receptor antagonist

Insomnia

FDA NDA

Filing 2020

Aprocitentan*

Dual endothelin receptor antagonist

Resistant hypertension management

Phase 3

Clazosentan

Endothelin receptor antagonist

Vasospasm associated with aneurysmal subarachnoid hemorrhage

Phase 3

Lucerastat

Glucosylceramide synthase inhibitor

Fabry disease

Phase 3

Selatogrel

P2Y 12 receptor antagonist

Suspected acute myocardial infarction

Phase 3

Cenerimod

S1P 1 receptor modulator

Systemic lupus erythematosus

Phase 2

ACT-774312

CRTH2 receptor antagonist

Nasal polyposis

Phase 2

ACT-539313

Selective orexin 1 receptor antagonist

Psychiatric disorders

Phase 2

Sinbaglustat

GBA2/GCS inhibitor

Rare lysosomal storage disorders

Phase 1

ACT-1004-1239

-

Immunology / Cancer immunotherapy

Phase 1

ACT-1014-6470

-

Immunology

Phase 1

Near Term Major Events:

Daridorexant-Idorsia is currently completing their NDA and it should be filed by the end of the year. This is a major event for Idorsia.
Clazosentan - They have a registration program in Japan, to assess the efficacy and safety of clazosentan in reducing vasospasm and vasospasm-related morbidity and mortality events in adult patients with aSAH- Subarachnoid Aneurysmal Hemorrhage, has completed recruitment in the first half of 2020. The results are on target to be announced by the end of 2020, with a rapid turnaround for filing of the dossier with the Japanese health authority.
Lucerastat-Their phase 3 clinical trial should have reportable results by the end of 2020. This phase 3 study is to determine the efficacy and safety of lucerastat oral monotherapy in adult patients with Fabry disease. Enrollment will be completed by the end of 2020 with 90 to 100 patients ultimately being randomized to lucerastat or placebo in a 2:1 ratio. Results of this study are targeted for the second half of 2021.
Ponesimod -This drug candidate is not listed on Idorsia pipeline data due to it being controlled by Janssen. Janssen filed an NDA with the FDA in March 2020. If the FDA follows the historical trend for approval, they should issue their decision before March 2021. There is the chance the decision can come well before this date if there are no issues found with the submission. Idorsia is scheduled to receive an 8% royalty for net sales of the drug, upon approval.
Concluding Remarks



Sourced from Idorsia's Website

In the short three years that Idorsia has been in existence, they have a remarkable record of accomplishments. The number of drugs in their pipeline and the partnership deals that will provide a revenue stream, speaks volumes to the abilities the management and the R&D team brings to the potential success for Idorsia and their shareholders.

The fact they have more than 1 billion CHF to commercialize their first drug, daridorexant, indicates they have a great marketing plan in place for what could be a blockbuster that will make Idorsia a profitable company in short-order, after the FDA approval.

Assuming current events maintain a positive flow of results, the next few months should be exciting times to own Idorsia's shares.

Good luck with your future investing decisions!
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