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Hidden Gem - Pieris Pharmaceuticals - 2017
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Looking good, men schiet wakker! Nu wachten op nieuwe collaboratie met een grote partner, dan zitten we snel boven de $10. Dit is een aandeel om nog jaren in de portefeuille te houden! Succes
Vandaag gesloten op $6.53. Ik verwacht geen grote deal meer dit jaar. Wel verwacht ik dat zowel de PRS-060 en PRS-080 studies starten in het lopende kwartaal. Eerst na het afronden van de PRS-080 fase IIa studie kan Aska de optie uitoefenen en verwacht ik dat ze een partner zullen aankondigen voor het voortzetten van de onderzoeken met PRS-080 in Europa en de USA. De start van het PRS-060 studie zal een mijlpaal betaling van $12,5 miljoen van Zeneca opleveren. Aandelen stevig vasthouden. fc
FatCool schreef op 5 oktober 2017 22:12 :
Vandaag gesloten op $6.53.
Ik verwacht geen grote deal meer dit jaar. Wel verwacht ik dat zowel de PRS-060 en PRS-080 studies starten in het lopende kwartaal.
Eerst na het afronden van de PRS-080 fase IIa studie kan Aska de optie uitoefenen en verwacht ik dat ze een partner zullen aankondigen voor het voortzetten van de onderzoeken met PRS-080 in Europa en de USA. De start van het PRS-060 studie zal een mijlpaal betaling van $12,5 miljoen van Zeneca opleveren.
Aandelen stevig vasthouden.
fc
Dan verwacht je nog wel een grote deal dit jaar ;) Ze geven zelf in hun pr's aan dat ze bij goede studieresultaten naar nieuwe partners zullen zoeken. Die resultaten zouden er in de loop van Q4 moeten komen! Ik denk dat beleggers meer en meer zullen wakkerschieten, onder andere wanneer ze de stevige kaspositie bij de Q3 cijfers zullen zien. Dit aandeel is inderdaad zeer stevig te behouden voor een decennia met mogelijk een vertiendubbeling van je inleg tegen dan!!
Topperke schreef op 11 oktober 2017 08:34 :
Dan verwacht je nog wel een grote deal dit jaar ;)
Neen, studie is nog niet begonnen, loopt op zijn minst voor drie maanden. Studie afgerond ergens tijdvak april tot juli 2018. Deal ergens rond midden volgend jaar op zijn vroegst. fc
PIERIS PHARMACEUTICALS APPOINTS INGMAR BRUNS, M.D., PH.D., AS VICE PRESIDENT OF CLINICAL DEVELOPMENTir.pieris.com/press-releases/detail/576
Sinds het persbericht van 12 oktober steil naar beneden gestort. Duidelijk was dat niet het persbericht waar de beleggers op zaten te wachten. Het ontbreken van de onderzoeken op clinical trials en het steeds slippen van de data van de onderzoeken geeft goed aan dat Pieris de boel nog niet op orde heeft. Wellicht dat de dure benoemingen daar voor moeten zorgen, maar de koers van Pieris was vooruitgelopen op de voortgang van de operatie. Een koers tussen de $5 en de $5.50 geeft de actuele waarde aan als ze tenminste de twee beloofde onderzoeken in het lopende kwartaal laten starten. We zullen zien. fc
Item 7.01 Regulation FD Disclosure. Pieris Pharmaceuticals, Inc. announced today that it has enrolled the first patient in its multi-dose Phase IIa study of PRS-080, Pieris’ Anticalin® protein targeting hepcidin, in functional iron deficiency (FID) anemic patients with chronic kidney disease undergoing hemodialysis. The Company is conducting this Phase IIa study in Germany and the Czech Republic where it previously filed separate clinical trial applications (CTAs) with the relevant regulatory authorities. The study will be conducted in a randomized, placebo-controlled manner with two dose cohorts of 4 mg per kg and 8 mg per kg body weight, with 4 patients receiving drug at each dosage level and 2 patients on placebo within each cohort. The information set forth under this “Item 7.01. Regulation FD Disclosure,” including the exhibits attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: October 17, 2017
Een week geleden heeft Cramer een negatief advies gegeven. Die heeft geen zak verstand van biotech en roeptoetert maar wat, maar hij en zijn vriendjes gaan dan collectief kloten. Dat gaf flink wat druk op de koers. Volgende week betere tijden?! fc
Weinig verkeer hier, fijn dat je wat spaarzaam nieuws meldt, FC.
Vannacht kreeg ik een update van het bedrijf in mijn mail. Is naar alle beleggers gegaan die ingeschreven staan op de mail alert. Een mooie samenvatting van het hele jaar. Maar dankzij die mail heb ik eindelijk een antwoord gekregen op een vraag die ik al een paar weken geleden heb gesteld: waarom de clinical trials niet wordt bijgehouden. Vandaag kreeg ik een antwoord van Pieris: I received your email information from Bob Prag and was also planning to respond to your email inquiry to our main inbox once items get posted to clinicaltrials.gov. Be assured everything has been filed on time (21 days from first dose). That does not ensure the site posts it immediately as there are always a few items to clarify with them. Best Regards, Allan Zo, hopelijk kunnen we de binnenkort de Phase I van PRS-343 en de Phase IIa studie van PRS-080 volgen op Clinical trials. fc
FatCool schreef op 12 oktober 2017 00:22 :
Neen, studie is nog niet begonnen, loopt op zijn minst voor drie maanden. Studie afgerond ergens tijdvak april tot juli 2018. Deal ergens rond midden volgend jaar op zijn vroegst.
Klopt helemaal :)clinicaltrials.gov/ct2/show/NCT033256... Kleine studie in 6 klinieken. 6 op 4 mg/kg en 6 op 8 mg/kg: vier op PRS-080 en 2 op placebo. fc
Ik denk dat we na de cijfers woensdag wel eens terug naar de 6$ zouden kunnen gaan. PIRS zal door meer en meer beleggers ontdekt worden naarmate de clinical trials vorderen. Van de 4 sterke producten zou er normaal minstens 1 de markt moeten kunnen halen over enkele jaren. 1 blockbuster is voor mij meer dan genoeg, want er wordt gezegd dat de producten beter zijn dan grote spelers op de markt (bv PRS-060) Rustig bijhouden die aandelen, er komt zo wel weer opwaartse beweging in!
ir.pieris.com/press-releases/detail/579 Met als belangrijkste nieuws: PRS-060: The Company is on track to initiate a first-in-human clinical study for PRS-060, an IL-4 receptor alpha antagonist, by year end. The Company is the Phase 1 clinical trial sponsor for PRS-060, which is partnered with AstraZeneca as part of a respiratory alliance signed in May 2017, with AstraZeneca funding the cost of this study. Dosing of the first subject will trigger a milestone payment of $12.5 million by AstraZeneca to Pieris. fc
Ze zijn zeer optimistisch over PRS-060. Daar wordt in de CC over gezegd: Looking beyond our immuno-oncology efforts, I would like to now provide you with an update on our lead respiratory program, PRS-060. As indicated earlier, in May of this year, we signed a transformative global strategic partnership with AstraZeneca anchored around this program. This partnership allows us to leverage Astra's established expertise in complex inhalation formulations and devices for respiratory diseases as well as their global commercialization capabilities as a leader in this space. The collaboration covers up to 5 programs, including PRS-060, with codevelopment and separate cocommercialization opportunities for both PRS-060 and multiple additional programs within this alliance. PRS-060 itself is an anticalin that blocks IL-4 receptor alpha, thereby inhibiting the activity of 2 key cytokines, both IL-4 and IL-13. This is similar to Regeneron's and Sanofi's drug, dupilumab, which is also an IL-4 receptor alpha inhibitor, but is dosed systemically via subcutaneous injection, unlike PRS-060, which is targeting the disease locally via direct inhalation into the lung. Phase III results for dupilumab were released in September of this year and demonstrated, again, a robust effect in moderate to severe asthma patients with elevated levels of eosinophils. We believe these data validate the goal of blocking IL-4 and IL-13 via the IL-4 receptor alpha in the pathogenesis of overactive airway disease and is an example of our strategy of addressing known targets in new ways, mainly deriving benefits of a localized therapy on a target highly validated in the clinic with a systemic therapy. As far as future milestones are concerned, we remain on track to initiate a first-in-human clinical trial for PRS-060 before year-end. As trial sponsor, we plan to dose healthy subjects in a clinical trial which will be funded by AstraZeneca. The dosing of the first subject would trigger a milestone payment of USD 12.5 million by AstraZeneca, which comes in addition to the $45 million upfront payment Pieris already received. Following the successful completion of Phase I, Pieris would hand the program over to AstraZeneca, who would be responsible for executing a Phase IIa trial in collaboration with Pieris. And looking farther ahead, following the first proof-of-concept Phase IIa trial in asthma patients, again, to be funded and sponsored by AstraZeneca, Pieris may exercise an option to codevelop and, separately, to cocommercialize this program in the United States. Exercising this codevelopment option will entitle Pieris to a larger royalty, up to the high teens, or a gross margin share of future sales, depending on the level of codevelopment investment by Pieris. We look forward to providing an update on PRS-060 and other programs within this alliance at a future date. fc
Ze schieten mooi op met hun verschillende klinische studies. 2de helft 2018/ eerste helft 2019 wordt een belangrijke periode volgens met met een 3tal fase 2 studies die dan zullen vallen. Als bv een PRS-060 daar doorgeraakt en sterke resultaten toont, zal de market cap fors toenemen en hebben we een enorm mooie toekomst als aandeelhouder. Ik verwacht die tijd ook minstens nog 1 nieuwe, grote samenwerkingspartner ( voor PRS-080 in Europa waarschijnlijk). Daarbij is een kapitaalronde totaal uit den boze bij deze hoge cashposititie die waarschijnlijk amper nog zal slinken door alle mijlpaalbetalingen. Het ziet er goed uit!
Pieris Pharmaceuticals Appoints James Geraghty as Chairman of the Board of Directors BOSTON, MA - 11/21/17 - Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, announced today that James Geraghty has been appointed Chairman of the Board of Directors. Mr. Geraghty replaces Chau Q. Khuong, who is stepping down from the Board after helping guide Pieris through platform validation and partnerships to its transition into a fully-integrated research and clinical development company. "On behalf of the Company, I am thrilled to welcome Jim to this new leadership role and look forward to working closely with him as we move our drug candidates into and through clinical trials," said Stephen S. Yoder, President and CEO. "Jim's proven track record of success and deep experience in the biopharmaceutical industry will be instrumental in guiding Pieris through its next chapter of development, particularly as we advance PRS-343, our proprietary lead immuno-oncology program, into later stage development. We are also excited about the continuing progress of our partnered programs, including our lead respiratory program, PRS-060, anticipated to soon enter a phase 1 clinical study with AstraZeneca, our important oncology partnership with Servier, and others." "I would also like to thank Chau for his years of service to Pieris, steering our Company through its public offering, significant partnerships with a number of pharmaceutical companies and advancement of key programs to a clinical stage," added Mr. Yoder. "We are privileged to have had his guidance as we matured from a privately-held company founded in Germany to a publicly-traded U.S. corporation with trans-Atlantic operations." "I have greatly enjoyed working with the Pieris team and Board and am pleased with the excellent progress at the Company," said outgoing Chairman Chau Q. Khuong. "Under Steve's leadership, Pieris has become a bona fide drug development company and executed on a corporate strategy that preserves global rights on its lead immuno-oncology program, PRS-343, while closing strategic alliances to advance its respiratory franchise and other IO assets, all the while selectively retaining U.S. rights within those alliances. Steve and the entire Pieris team deserve all the credit for these transformative programs and partnerships." "It is with great pleasure that I welcome Jim to his expanded role as Chairman of the Pieris Board. Having now worked with him extensively, I am confident that Jim's experience in running international drug development businesses and commercial operations will be invaluable as Pieris continues to progress its programs and partnerships," added Mr. Khuong. "I'd like to thank Chau for his service to the Company and his dedication to its success," said Jim Geraghty. "I look forward to working with the board and the Pieris team to further advance its programs. The Anticalin technology has great potential as a therapeutic protein class, particularly in immuno-oncology and respiratory diseases, and Pieris is now on track to bring selected novel therapeutics directly to market." Jim Geraghty has served as member of the Pieris Board of Directors since May 2017 and is an industry leader with thirty years of strategic and leadership experience, including more than twenty years as a senior member of executive teams at biotechnology companies developing and commercializing innovative therapies. Mr. Geraghty was most recently an Entrepreneur in Residence at Third Rock Ventures, a leading biotech venture and company-formation fund, and previously served as Senior Vice President, North America Strategy and Business Development at Sanofi, which he joined upon its acquisition of Genzyme. Mr. Geraghty spent twenty years at Genzyme, where his roles included Senior Vice President International Development, President of Genzyme Europe, and General Manager of Genzyme's cardiovascular business. Mr. Geraghty is Chairman of the Board of Idera Pharmaceuticals and Juniper Pharmaceuticals and serves on the Board of Voyager Therapeutics and Fulcrum Therapeutics. He is also a member of the BIO Ventures for Global Health Board of Directors. He started his career in healthcare strategy consulting at Bain and Company. A graduate of the Yale Law School, Mr. Geraghty holds an M.S. from the University of Pennsylvania and a B.A. from Georgetown University.
Nieuwe investor presentation: content.equisolve.net/pierisag/media/... Een flinke uitbreiding van informatie over PRS-060. Deze presentaties moeten geregeld worden bekeken/bewaard. fc
Alle objectives voldaan in 2017. Ook nieuwe milestone payment van 12mil dollar, waardoor de kaspositie rond de 100mil zal blijven! 2018 wordt volgens mij een belangrijk jaar, met een eventuele nieuwe partner voor PRS-080 en fase 2 PRS-343 als grootste triggers. Volgend jaar staan we zeker boven de $10, mark my words! Ethics and Regulatory Clearance to Begin Clinical Testing of Inhaled Respiratory Program, PRS-060/AZD1402 Pieris Pharmaceuticals, Inc. (PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, announced today that it has received approval from the Human Research Ethics Committee and authority from the Therapeutic Goods Administration to initiate its first-in-human study in Australia for PRS-060/AZD1402, an inhaled Anticalin protein that targets IL-4Ra for the treatment of moderate to severe asthmatic patients that are not controlled on standard of care. This phase 1 study will be conducted in healthy subjects and is being developed as part of Pieris' strategic alliance with AstraZeneca, which is funding the trial, with Pieris being responsible for conducting the study. "We look forward to dosing the first subject in our first clinical trial for PRS-060/AZD1402 by year end, triggering a milestone payment by AstraZeneca to Pieris," commented Stephen S. Yoder, President and CEO of Pieris. "This program represents the first inhaled Anticalin protein to enter clinical development and will cap an ambitious year of pipeline progression, which included the clinical initiation of PRS-343, our lead immuno-oncology bispecific program.
7.18+0.81 (+12.64%) Dat noem ik nu eens met veel swung door de weerstand vliegen! Zit al op een mooie 40% winst nu, hoop rond de 8$ ergens te verkopen als de TA een daling aantoont & het aandeel wat later terug op te pakken. 2018 wordt alleszins een mooi jaar voor dit prachtaandeel, dus ga ik er blijven inzitten.
Een wel erg grote stijging zonder verder nieuws. Blijkbaar wil iedereen er inzitten. Primair zit ik er in voor de bloedarmoede en astma middelen; kanker is een langdurig traag proces. PRS-343 ziet er prachtig uit, maar voordat dat op de markt komt zitten we wel ergens tussen 2025 en 2030. Simpelweg aanhouden!! Met aankopen zou ik thans even wachten... fc
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