RedHill Biopharma (NASDAQ / TASE: RDHL)
Ich hoffe auf ca. 11 Dollar bei Fortschritten Corona ... aber RDHL ist deshalb ein so schöner Wert, weil ich der Meinung bin bis 2022 sollten wir die 16 Dollar oder darum sehen ...
keine zu hohen Erwartungen - Covid-19 ...
- Movantik 7,9 Millionen Dollar Umsatz (revenue im englischen Umsatz und nicht Gewinn?), wie viel bleibt da wohl hängen?
- Aemcolo und Talicia keine Angaben (Aemcolo, keiner reist), Talicia werden wohl auch keine reelvanten Umsätze erzielt worden sein (shutdown und es soll wohl ein Test verpflichtend sein, bevor Talicia verschrieben werden kann)
- Our cash position was approximately $115 million at the end of the first quarter and approximately $62.5 million immediately following the Movantik acquisition from AstraZeneca as of April 1. While net cash used in operating activities were $10.6 million in the first quarter.
- Operating loss for the first quarter of 2020 was $17 million
- As of May 25, 2020, about 600,000 American Depositary Shares, (ADSs), of the company were issued under the company's ATM, generating net proceeds of approximately $4.7 million. Läuft das ATM?
- ee still are in line to achieve operational breakeven in 2021
- Specifically in relation to the COVID-19 compassionate use program with opaganib in Israel, all 6 severe-to-critical patients analyzed and treated demonstrated pronounced clinical improvement following treatment initiation with opaganib and substantial improvement in biomarkers, including decreased required supplemental oxygenation, higher lymphocyte counts and decreased C-reactive protein, CRP, levels. Importantly, all 6 patients were weaned from oxygen and discharged from the hospital on room air without having required to receive mechanical ventilation.
- And following additional positive new data from ongoing supportive nonclinical programs, we are now on track, subject to further input from FDA, to initiate in the third quarter of this year a single, pivotal Phase III study evaluating RHB-204 as a first-line stand-alone NTM treatment.
- We aim to become a specialty GI pharma leader in the United States, utilizing both our organic growth capabilities, driven by RedHill's own late-stage clinical pipeline, as was the case with Talicia; and our nonorganic growth competencies, as we have shown with Aemcolo and Movantik, driven by continued rollout of synergistic commercial product acquisition.
lanfristig (!) bullish
-Talicia Umsatz aus dem 1. Quartal rausgenommen. Meine persönliche Meinung, vielleicht war es wenig erfolgreich "Sure. We have not booked any sales into the channel. In Q1, we have decided to exclude those out of our general conservative approach to this."
- Thanks. Great questions. With relation to COVID-19 and our program, this is certainly not a distraction. Those are products that we know inside out, that we have been developing for years. Those are products that have been administered to hundreds of subjects, so we have the data to analyze and work with. Our team has the capacity. We are very experienced, and we are moving very fast with what we have got. And what we are seeing so far makes us cautiously optimistic about the prospects. Davon sind sie überzeugt!
-Thank you, Dror. So the NTM study should be initiated at Q3. And we're talking about a pivotal Phase III study, which per discussions with FDA should support submission of an accelerated NDA under Subpart H. We are looking at the primary endpoint for that accelerated NDA submission of the conversion of the sputum at 6 months from treatment initiation. So we anticipate that the readout of that primary endpoint should be approximately 18 to 24 months from initiation of the study once we complete enrollment of the entire cohort and analyze that data set -- data point. Zeitfenster RHB 204
- "In the U.S., we hope we can enroll the full cohort in the next weeks once we start the study and be able to have readout of this study still within this wave by the summer -- by the end of the summer." Opaganib - also US Juli, August ... nur US, oder kommt da noch was von Italien oder Israel?
-And we are planning, as Dror mentioned, a third arm of a combination of opaganib with RHB-107 based on preclinical models in cholangiocarcinoma that show potential additive or synergistic effects. das wäre natürlich ein big point - beide Produkte von RDHL kombiniert ...
-Jeb, I can add a little bit of color, if you're interested, about this. So a lot of the times, it is sort of chronic treatment. Now it depends, as Rick said, on the patients. If the patient, as was expanded label from 2017, is an oncology survivor that is no longer receiving treatment for her or his prior cancer, but suffering from chronic pain associated with those treatments that they received in the past, and all the cancer they had in the past, then it could last long because they remain on the pain treatment on the underlying opioid for longer. If it's post-surgery with orthopedics, it's a different story. So it really depends, but refills tend to be for longer. And typically, you see patients on the medication for several months. Interessant!
Nur meine Meinung: könnte erst noch ein Rücksetzer kommen bis Ende Juni, Mitte Juli, bis dann auf die Ergebnisse Covid US gesetzt wird ...
positiv für opaganib, negativ für die Allgemeinheit ...
Verlust wird bestimmt nicht weniger geworden sein, weil so viele PII/III in Sachen COVID gestartet wurden. Das frisst Geld nach meinem Verständnis. Und das TALICIA sofort fette Umsätze generiert, wäre hoffenswert, aber...
https://www.jpost.com/health-science/...put-out-new-remdesivir-638042
Klingt weiter echt gut, was die zu Opaganib schreiben... aber ich hab schon mehrfach die Pferde kurz vor dem Ziel der FDA-Zulassung vor der Apotheke kotzen sehen. Also nur leise vorfreuen...
Da steckt so viel Phantasie drin in RDHL. Ich hoffe, dass die zumindest teilweise in Erfüllung geht.
- FDA clearance to enter a pivotal Phase 3 study with RHB-204 for first-line NTM infections has been granted last week.
- we still are in line to achieve operational breakeven in 2021.
- In addition, ongoing parallel global Phase 2/3 and US Phase 2 COVID-19 studies with opaganib are going well, and preliminary data for the potential emergency use applications are expected as early as Q4 2020. hier hoffe ich auf eine gute interim-Analyse, welche jederzeit eintrudeln könnte und wenn sie gut ist, endlich einmal den Preis pushen würde
- RHB-204 has been cleared by FDA for pivotal Phase 3 study as first-line stand-alone orally administered treatment for pulmonary nontuberculous mycobacteria, or NTM disease, and as many of you saw the PR announced this morning, we have our exciting new Cosmo deal. We are expanding our relationship with this great company, Cosmo has been a fantastic partner. We have a great strategic collaboration and working relationship with them, and we look forward to doing great things with them in the future. Sie sind also sehr zufrieden mit Cosmo!
- his transaction is anticipated to initially provide RedHill with $12 million non-dilutive funding and will allow us to accelerate the development plans with a new next-generation H. pylori treatment in the planned Phase 3 study with RHB-204 for first-line NTM infections. Also ist next generation Behandlung von H. Pylori RHB-204 gemeint ...
-In parallel, our ongoing US randomized, placebo-controlled Phase 2 study is approximately halfway through enrollment of the planned 40 severe patients, and we expect to complete its enrollment later this month. Diese Studie zu Opaganib ist wohl die bedeutendste von allen. Klever, das RDHL die Studien dazu auch in Mexiko, GB, Brasilien, Russland usw. startet; damit können sich diese Länder direkt selber ein Urteil zu Opaganib bilden.
- Slide 12. After extensive preparations, we are advancing RHB-204 into a pivotal Phase 3 study in nontuberculous mycobacterial infections termed NTM. As announced earlier today, the NTM study is now supported by funding from our strategic partner, Cosmo Pharmaceuticals. NTM is a debilitating rare disease with no FDA-approved therapy for first-line treatment. RHB-204 is a simple all-in-one orally administered stand-alone therapy intended to be the first approved first-line therapy if approved by FDA. We have received FDA clearance for our pivotal Phase 3 study, which is planned to enroll 125 patients across approximately 50 sites in the US. With FDA granted QIDP designation, RHB-204 is eligible for fast track development, priority review and potentially 12 years of market exclusivity with orphan drug designation, for which we have already applied. sehr schön, Kosten gespart und positive Zukunft
- Rick also brought with him many of his colleagues from Salix. Salix was a number one GI-dedicated company in the US before it was purchased by Valeant, and we have several of that highly dedicated and experienced team leading our efforts here, along with many other seasoned pharma executives. Die sollen sehr gut sein, wenn man die Kommentare in anderen Foren liest!
- We are well positioned for reaching planned operational profitability in some point next year. Strong revenue growth with net revenues of approximately $21 million in Q2 and reduced operating loss of $12.5 million due to efficient commercial structure and cost discipline supporting also low cash burn. Cash position of approximately $53 million as of June 30, 2020 and approximately $56 million as of yesterday before additional expected $12 million upfront payment from Cosmo Pharmaceuticals in the coming weeks. also könnten Sie den break even erreichen und brauchen keine Dilution mehr, wenn das ATM weiter läuft und nichts dazwischen kommt ...
Quelle ist der transcript der cc für Q2
- But in terms of ex-US and, in particular Japan where we know there is higher incidence of stomach cancer and willingness to treat asymptomatic patients. Have you had any thoughts about that we launching Talicia there, and any discussions with ex-US partners in that regard? und die Antwort, welche mich sehr beruhigt:
"Indeed, we are in discussions with potential partners in some very important territories. There is a lot at stake with such transactions because you have to make sure the partner is the right one. You have to make sure that the pricing is the right one. You have to make sure that the consideration. That's right. The shareholders benefit from is appropriate and so on and so on. Therefore, we are not rushing into an ex-US transaction. If and when we decide to strike one, and we did receive proposals already to be clear, which we declined for the most part. We will announce publicly."
-Opaganib: "We will be ready with a commercial and pricing strategy by the time that all goes well, the study that we are running currently with opaganib will yield positive results. If the results are positive, and assuming we are able to successfully file applications for emergency use not only in the US but globally, we will have the strategy in place that we have been working on for several months now."
- "We see Talicia growing very nicely in the coming quarters and years. But we think ahead and we are thinking hard, what else can we do in order to provide patients with the next-generation improved Talicia with a number of parameters, which I will not go into. That is the essence of the agreement with Cosmo, which has a very strong well proven formulation capabilities, manufacturing capabilities, and the plan is to be ready with the next-generation Talicia on time as part of the natural cycle of such products. I cannot go into details, given that this is a development program." noch zu früh aber Phantasie!
- "Thank you, Scott, for the question. So, the range that we think we can achieve the desired stability breakeven point is in the neighborhood of $30 million, $40 million per quarter of net revenues." Kann ich nicht einschätzen, ob das möglich ist ...
-RHB 204 Zeitfenster: "So, the study is planned to enroll 125 patients, randomized to RHB -- versus placebo, and of course first-line patients, naive patients, and we hope to enroll in up to 50 sites in the US up to a year of enrollment. And then, the study is for a year of treatment post-conversion. So we hope to have results along that time frame."
Sehr gute Fragen zu Opaganib und Break Even als auch die weitere Zukunft betreffend RHB 204 und next generation "Talicia"
Viel Glück
https://www.benzinga.com/general/biotech/20/08/...-to-continue-us-pha
Ich denke, dass der Hebel(/die Bekanntheit) für Heidelberg Pharma ein sehr guter wird.
Siehe letzter Abschnitt dieses Artikels bzw im Heidelberg Pharma Thread auf ariva.de :
https://microbiozindia.com/pharma-news/...e-inhibition-of-sars-cov-2/
RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany’s Heidelberg Pharmaceuticals (formerly WILEX AG) for all indications.
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Bei einem Impfstoff bin ich skeptisch, ist aber nur meine persönliche Meinung ...
Das macht es besonders interessant, weil es bisher nicht viel gibt was bei einer akuten Covid Infektion zuverlässig hilft.
Impfstoffkandidaten gibt's über 100, es stellt sich nur die Frage wer zuerst das Rennen macht.
Außer dem Malaria- und dem Ebola- Mittel ist mir kein Medikament bekannt das die Infektion merklich in den Griff bekommt.
https://www.finanznachrichten.de/...ge-hemmung-von-sars-cov-2-382.htm
Was dagegen spricht, ist, das RDHL Geld braucht (nur meine Meinung), das ATM noch laufen sollte und die Marktkapitalisierung relativ hoch ist, so dass sich ein Erfolg hier nicht so stark auswirken wird. Zudem ist der Wirkstoff, ich glaube Mesupron von Wilex jetzt Heidelberg Pharma einlizensiert mit einer Beteiligung am Verkauferlös.
Aber RDHL steht generell gut da, mit der Pipeline, der bereits installierten sales force in USA. Auffällig aus meiner Sicht ist hier nur der abstruse Kursverlauf. Damit meine ich, das RDHL nicht kurstechnisch aus dem Quark kommt. Vielleicht weil Talicia eine Kombo aus Antibiotika ist, aber gleichwohl die bevorzugte Behandlung in dem Bereich. ODer RDHL ein israelisches Unternehmen ...
Aus meiner Sicht hat RDHL vieles richtig gemacht und fleigt noch unter dem Radar ...