BLU.TO (Mkap $22 M) Big Rare Disease Drug in Phase3 = 500%++ Potential (Seite 3)
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ISIN: CA07987C2040 · WKN: A2PQKK · Symbol: BLU
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Hallo
Die Aktie steigt und steigt - ist noch jemand dabei ?
Die Aktie steigt und steigt - ist noch jemand dabei ?
Und um weitere 24% nach oben - noch immer ohne News...
M@trix
M@trix
Bei Bellus scheint "irgendwas im Busch zu sein". Ist zumindest heute auf meiner Watchlist ein auffälliger Ausreißer ohne News.
M@trix
M@trix
Bellus Health Reports Financial and Operating Results for the Year Ended December 31, 2016
LAVAL, QC , Feb. 28, 2017 /CNW/ - BELLUS Health Inc. (BLU.TO) (BELLUS Health or the Company), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, today reported its financial and operating results for the year ended December 31, 2016 . All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.
2016 and early 2017 Highlights
Announced on February 28, 2017 the acquisition of an exclusive worldwide license to develop and commercialize BLU-5937 (formerly NEO5937), a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for chronic cough;
Announced that its partner, Auven Therapeutics, continues to evaluate the conduct of a Phase 2/3 study for KIACTA™ in pulmonary sarcoidosis;
Received positive regulatory feedback from the FDA regarding the design of a potential Phase 2 study for Shigamab™ in Shiga-toxin-induced hemolytic uremic syndrome (sHUS);
Provided a progress update on its legacy portfolio of partnered drug candidates, including AMO-01 for the treatment of Fragile X Syndrome and ALZ-801 for the treatment of Alzheimer's Disease in APOE4 homozygous patients;
Announced that the KIACTA™ program for AA amyloidosis was terminated by its partner Auven Therapeutics in December 2016 ;
Completed simplification of its capital structure by issuing 13.7 million common shares to settle two convertible securities; the only remaining dilutive securities are those related to the Company's stock option plan; and
Concluded the year with cash, cash equivalents and short-term investments totaling $6.8 million , which the Company believes is sufficient to finance its operations for more than 12 months.
"As we continue to make progress on our project pipeline, we are excited to focus our drug development efforts on our recently in-licensed chronic cough candidate, BLU-5937," said Roberto Bellini , President and CEO of BELLUS Health. "In addition to its potential as a superior treatment option for the millions of patients who suffer from chronic cough, BLU-5937 adds a potentially best-in-class drug candidate to our pipeline and a solid base to grow the Company."
BLU-5937 for chronic cough
On February 28, 2017 , BELLUS Health announced that it had obtained from the NEOMED Institute (NEOMED) an exclusive worldwide license to develop and commercialize BLU-5937 (formerly NEO5937), a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for chronic cough. BLU-5937 is a promising best-in-class drug candidate that has the potential to help millions of chronic cough patients who do not respond to current therapies.
Under the terms of the agreement, BELLUS Health will pay NEOMED an upfront fee of $3.2 million , consisting of $1.7 million in cash and $1.5 million with 5,802,177 BELLUS Health common shares. NEOMED will be entitled to receive a royalty on net sales-based revenues. In lieu of milestone payments, a certain portion of all other revenues received by BELLUS Health from BLU-5937 will be shared with NEOMED according to a pre-established schedule whereby the shared revenue portion decreases as the program progresses in development.
The P2X3 antagonist program was initiated by AstraZeneca scientists in Montreal , and assigned to NEOMED in October 2012 . BLU-5937 was selected as a drug candidate to advance towards the clinic based on development efforts and extensive pre-clinical work in chronic cough done at NEOMED.
Chronic cough is a cough that lasts more than eight weeks and is associated with significant adverse social, psychosocial and physical effects on quality of life. It is estimated that, in the United States alone, more than 2.7 million patients suffer from chronic cough that is not controlled by currently available medications.
KIACTA™ for Sarcoidosis
BELLUS Health's partner, Auven Therapeutics, is currently evaluating whether to further pursue the development of KIACTA™ for the treatment of patients suffering from active pulmonary sarcoidosis. Auven Therapeutics has developed a clinical Phase 2/3 study protocol to evaluate the safety and efficacy of KIACTA™ in pulmonary sarcoidosis, a rare condition that can seriously impair lung function.
BELLUS Health is partnered with global private equity firm Auven Therapeutics for the development of KIACTA™, who acquired the KIACTA™ rights from the Company in 2010.
Shigamab™ for sHUS
In November 2016 , BELLUS Health received positive regulatory feedback from the FDA in relation to the clinical Phase 2 study protocol for the assessment of the efficacy and safety of Shigamab™ in the treatment of children suffering from sHUS. BELLUS Health is currently planning the next steps for the initiation of this clinical Phase 2 study and is seeking to secure a strategic partner for the further development of Shigamab™.
Shigamab™ is a monoclonal antibody therapy being developed for the treatment of sHUS, a rare disease which principally affects the kidneys and often leads to patients requiring acute dialysis. In certain cases, sHUS can cause chronic kidney disease and death, primarily in children. Shigamab™ was acquired through the acquisition of Thallion Pharmaceuticals Inc. (Thallion) in 2013.
AMO-01 for Fragile X Syndrome
In 2014, BELLUS Health entered into a development and license agreement with AMO Pharma Limited (AMO Pharma) for the worldwide rights to AMO-01 (formerly TLN-4601) for the treatment of neurologic and psychiatric disorders in return for revenue sharing and royalties on sales.
LAVAL, QC , Feb. 28, 2017 /CNW/ - BELLUS Health Inc. (BLU.TO) (BELLUS Health or the Company), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, today reported its financial and operating results for the year ended December 31, 2016 . All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.
2016 and early 2017 Highlights
Announced on February 28, 2017 the acquisition of an exclusive worldwide license to develop and commercialize BLU-5937 (formerly NEO5937), a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for chronic cough;
Announced that its partner, Auven Therapeutics, continues to evaluate the conduct of a Phase 2/3 study for KIACTA™ in pulmonary sarcoidosis;
Received positive regulatory feedback from the FDA regarding the design of a potential Phase 2 study for Shigamab™ in Shiga-toxin-induced hemolytic uremic syndrome (sHUS);
Provided a progress update on its legacy portfolio of partnered drug candidates, including AMO-01 for the treatment of Fragile X Syndrome and ALZ-801 for the treatment of Alzheimer's Disease in APOE4 homozygous patients;
Announced that the KIACTA™ program for AA amyloidosis was terminated by its partner Auven Therapeutics in December 2016 ;
Completed simplification of its capital structure by issuing 13.7 million common shares to settle two convertible securities; the only remaining dilutive securities are those related to the Company's stock option plan; and
Concluded the year with cash, cash equivalents and short-term investments totaling $6.8 million , which the Company believes is sufficient to finance its operations for more than 12 months.
"As we continue to make progress on our project pipeline, we are excited to focus our drug development efforts on our recently in-licensed chronic cough candidate, BLU-5937," said Roberto Bellini , President and CEO of BELLUS Health. "In addition to its potential as a superior treatment option for the millions of patients who suffer from chronic cough, BLU-5937 adds a potentially best-in-class drug candidate to our pipeline and a solid base to grow the Company."
BLU-5937 for chronic cough
On February 28, 2017 , BELLUS Health announced that it had obtained from the NEOMED Institute (NEOMED) an exclusive worldwide license to develop and commercialize BLU-5937 (formerly NEO5937), a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for chronic cough. BLU-5937 is a promising best-in-class drug candidate that has the potential to help millions of chronic cough patients who do not respond to current therapies.
Under the terms of the agreement, BELLUS Health will pay NEOMED an upfront fee of $3.2 million , consisting of $1.7 million in cash and $1.5 million with 5,802,177 BELLUS Health common shares. NEOMED will be entitled to receive a royalty on net sales-based revenues. In lieu of milestone payments, a certain portion of all other revenues received by BELLUS Health from BLU-5937 will be shared with NEOMED according to a pre-established schedule whereby the shared revenue portion decreases as the program progresses in development.
The P2X3 antagonist program was initiated by AstraZeneca scientists in Montreal , and assigned to NEOMED in October 2012 . BLU-5937 was selected as a drug candidate to advance towards the clinic based on development efforts and extensive pre-clinical work in chronic cough done at NEOMED.
Chronic cough is a cough that lasts more than eight weeks and is associated with significant adverse social, psychosocial and physical effects on quality of life. It is estimated that, in the United States alone, more than 2.7 million patients suffer from chronic cough that is not controlled by currently available medications.
KIACTA™ for Sarcoidosis
BELLUS Health's partner, Auven Therapeutics, is currently evaluating whether to further pursue the development of KIACTA™ for the treatment of patients suffering from active pulmonary sarcoidosis. Auven Therapeutics has developed a clinical Phase 2/3 study protocol to evaluate the safety and efficacy of KIACTA™ in pulmonary sarcoidosis, a rare condition that can seriously impair lung function.
BELLUS Health is partnered with global private equity firm Auven Therapeutics for the development of KIACTA™, who acquired the KIACTA™ rights from the Company in 2010.
Shigamab™ for sHUS
In November 2016 , BELLUS Health received positive regulatory feedback from the FDA in relation to the clinical Phase 2 study protocol for the assessment of the efficacy and safety of Shigamab™ in the treatment of children suffering from sHUS. BELLUS Health is currently planning the next steps for the initiation of this clinical Phase 2 study and is seeking to secure a strategic partner for the further development of Shigamab™.
Shigamab™ is a monoclonal antibody therapy being developed for the treatment of sHUS, a rare disease which principally affects the kidneys and often leads to patients requiring acute dialysis. In certain cases, sHUS can cause chronic kidney disease and death, primarily in children. Shigamab™ was acquired through the acquisition of Thallion Pharmaceuticals Inc. (Thallion) in 2013.
AMO-01 for Fragile X Syndrome
In 2014, BELLUS Health entered into a development and license agreement with AMO Pharma Limited (AMO Pharma) for the worldwide rights to AMO-01 (formerly TLN-4601) for the treatment of neurologic and psychiatric disorders in return for revenue sharing and royalties on sales.
BELLUS Health and The NEOMED Institute Announce an Exclusive Worldwide License Agreement for the Development of a Treatment for Chronic Cough
MONTREAL , Feb. 28, 2017 /CNW/ - BELLUS Health (BLU.TO), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, and The NEOMED Institute (NEOMED), a not-for-profit organization bridging the gap between basic research and the commercialization of new drugs, today announced that BELLUS Health has obtained an exclusive worldwide license to develop and commercialize BLU-5937 (formerly NEO5937) for the treatment of chronic cough. BLU-5937 is a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor.
Under the terms of the agreement, BELLUS Health will pay NEOMED an upfront fee of CAD $3.2 million , consisting of CAD $1.7 million in cash and CAD $1.5 million with 5,802,177 BELLUS Health common shares. NEOMED will be entitled to receive a royalty on net sales-based revenues. In lieu of milestone payments, a certain portion of all other revenues received by BELLUS Health from BLU-5937 will be shared with NEOMED according to a pre-established schedule whereby the shared revenue portion decreases as the program progresses in development.
"This transaction adds a potentially best-in-class drug candidate to our pipeline that will be a core focus of our drug development efforts going forward," said Roberto Bellini , President and CEO of BELLUS Health. "BLU-5937 targets a clinically validated target, the P2X3 receptor, in the chronic cough pathway, and based on its high potency and selectivity for the P2X3 receptor, we believe it has the potential to become a superior treatment option for the millions of patients who suffer from chronic cough."
The P2X3 antagonist program was initiated by AstraZeneca scientists in Montreal , and assigned to NEOMED in October 2012. BLU-5937 was selected as a drug candidate to advance towards the clinic based on development efforts and extensive pre-clinical work in chronic cough done at NEOMED.
"I am extremely pleased to announce this collaboration with BELLUS Health to further the development of our P2X3 program which was discovered and developed at our Ville St. Laurent R&D facility. NEOMED's mission is to advance innovative Canadian science programs to the point where they can be successfully progressed by a partner. We have strong confidence in the ability of the scientific and clinical team at BELLUS Health to rapidly and efficiently develop this program for the benefit of providing a new and much needed therapeutic option for these underserved patients," declared Donald Olds , President & CEO of the NEOMED Institute.
Chronic cough is a cough that lasts more than eight weeks and is associated with significant adverse social, psychosocial and physical effects on quality of life. It is estimated that, in the United States alone, more than 2.7 million patients suffer from chronic cough that is not controlled by currently available medications.
Jacky Smith, MB, ChB, MRCP, PhD, Professor and Honorary Consultant in Respiratory Medicine, University of Manchester and University Hospital Manchester NHS Foundation Trust, and a leading investigator in the field of chronic cough, said, "Millions of adults suffer from poorly-controlled chronic cough and often experience significant physical, social and psychosocial complications. These complications include sleep deprivation, exhaustion, incontinence, work disruption, social exclusion, anxiety and depression, illustrating this significant unmet medical need. BLU-5937's potency and selectivity for the P2X3 receptor support its promise as an efficacious and safe treatment option for chronic cough patients, with the potential to significantly improve their quality of life."
Further Details
A more detailed presentation on BLU-5937, chronic cough, the role of P2X3 in chronic cough and this transaction can be found on the BELLUS Health website, www.bellushealth.com. A redacted version of the exclusive license agreement between BELLUS Health and NEOMED will be available on SEDAR (www.sedar.com) under BELLUS Health's profile.
MONTREAL , Feb. 28, 2017 /CNW/ - BELLUS Health (BLU.TO), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, and The NEOMED Institute (NEOMED), a not-for-profit organization bridging the gap between basic research and the commercialization of new drugs, today announced that BELLUS Health has obtained an exclusive worldwide license to develop and commercialize BLU-5937 (formerly NEO5937) for the treatment of chronic cough. BLU-5937 is a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor.
Under the terms of the agreement, BELLUS Health will pay NEOMED an upfront fee of CAD $3.2 million , consisting of CAD $1.7 million in cash and CAD $1.5 million with 5,802,177 BELLUS Health common shares. NEOMED will be entitled to receive a royalty on net sales-based revenues. In lieu of milestone payments, a certain portion of all other revenues received by BELLUS Health from BLU-5937 will be shared with NEOMED according to a pre-established schedule whereby the shared revenue portion decreases as the program progresses in development.
"This transaction adds a potentially best-in-class drug candidate to our pipeline that will be a core focus of our drug development efforts going forward," said Roberto Bellini , President and CEO of BELLUS Health. "BLU-5937 targets a clinically validated target, the P2X3 receptor, in the chronic cough pathway, and based on its high potency and selectivity for the P2X3 receptor, we believe it has the potential to become a superior treatment option for the millions of patients who suffer from chronic cough."
The P2X3 antagonist program was initiated by AstraZeneca scientists in Montreal , and assigned to NEOMED in October 2012. BLU-5937 was selected as a drug candidate to advance towards the clinic based on development efforts and extensive pre-clinical work in chronic cough done at NEOMED.
"I am extremely pleased to announce this collaboration with BELLUS Health to further the development of our P2X3 program which was discovered and developed at our Ville St. Laurent R&D facility. NEOMED's mission is to advance innovative Canadian science programs to the point where they can be successfully progressed by a partner. We have strong confidence in the ability of the scientific and clinical team at BELLUS Health to rapidly and efficiently develop this program for the benefit of providing a new and much needed therapeutic option for these underserved patients," declared Donald Olds , President & CEO of the NEOMED Institute.
Chronic cough is a cough that lasts more than eight weeks and is associated with significant adverse social, psychosocial and physical effects on quality of life. It is estimated that, in the United States alone, more than 2.7 million patients suffer from chronic cough that is not controlled by currently available medications.
Jacky Smith, MB, ChB, MRCP, PhD, Professor and Honorary Consultant in Respiratory Medicine, University of Manchester and University Hospital Manchester NHS Foundation Trust, and a leading investigator in the field of chronic cough, said, "Millions of adults suffer from poorly-controlled chronic cough and often experience significant physical, social and psychosocial complications. These complications include sleep deprivation, exhaustion, incontinence, work disruption, social exclusion, anxiety and depression, illustrating this significant unmet medical need. BLU-5937's potency and selectivity for the P2X3 receptor support its promise as an efficacious and safe treatment option for chronic cough patients, with the potential to significantly improve their quality of life."
Further Details
A more detailed presentation on BLU-5937, chronic cough, the role of P2X3 in chronic cough and this transaction can be found on the BELLUS Health website, www.bellushealth.com. A redacted version of the exclusive license agreement between BELLUS Health and NEOMED will be available on SEDAR (www.sedar.com) under BELLUS Health's profile.
Trading Spotlight
Antwort auf Beitrag Nr.: 53.562.876 von Jano82 am 27.10.16 09:26:14Klingt doch nicht schlecht. ..ob da ein schneller verdoppler drin ist?
KIACTA™ for Sarcoidosis
Auven Therapeutics is currently evaluating the potential use of KIACTA™ for the treatment of patients suffering from active pulmonary sarcoidosis. Auven Therapeutics has developed a clinical Phase 2/3 study protocol to evaluate the safety and efficacy of KIACTA™ in sarcoidosis and an investigational new drug application (IND) for this clinical study could be filed with the U.S. Food and Drug Administration (FDA) in the first quarter of 2017. The sarcoidosis program is currently under review by Auven Therapeutics and a decision is expected to be made in the coming months.
Sarcoidosis is a rare condition that causes patches of red and swollen tissue - called granulomas - that can develop in multiple organs in the body, but mostly in the lungs and skin. There is no cure for chronic sarcoidosis, and treatment options are limited and can have serious adverse effects.
Read more at http://www.stockhouse.com
KIACTA™ for Sarcoidosis
Auven Therapeutics is currently evaluating the potential use of KIACTA™ for the treatment of patients suffering from active pulmonary sarcoidosis. Auven Therapeutics has developed a clinical Phase 2/3 study protocol to evaluate the safety and efficacy of KIACTA™ in sarcoidosis and an investigational new drug application (IND) for this clinical study could be filed with the U.S. Food and Drug Administration (FDA) in the first quarter of 2017. The sarcoidosis program is currently under review by Auven Therapeutics and a decision is expected to be made in the coming months.
Sarcoidosis is a rare condition that causes patches of red and swollen tissue - called granulomas - that can develop in multiple organs in the body, but mostly in the lungs and skin. There is no cure for chronic sarcoidosis, and treatment options are limited and can have serious adverse effects.
Read more at http://www.stockhouse.com
Antwort auf Beitrag Nr.: 53.512.614 von calvin1977 am 19.10.16 23:27:19Nachdem die Phase 3 Daten ja nicht das Ergebnis gebracht haben wie erhofft muss jetzt ja erst einmal alles neu beurteilt werden . Es war ja geplant nach diesen Daten Kiatca zu verkaufen und man kann ja davon ausgehen das es Interessenten gab . In wiefern diese jetzt noch Interesse haben oder wie man weiter vorgeht ( Phase 3 wiederholen oder doch vorher verkaufen ) muss halt genau geprüft werden und das bedeutet Zeit . Ich habe keinen Zweifel daran das Bellini die richtigen Entscheidungen treffen wird . Man hat ja genug Geld und die anderen Projekte werden normal fortgeführt . Ich hoffe aber auch bald etwas Neues zu hören
Antwort auf Beitrag Nr.: 53.204.010 von Jano82 am 04.09.16 18:36:46...sehr ruhig.. .wird Zeit, dass langsam mal news kommen...
Antwort auf Beitrag Nr.: 53.177.478 von calvin1977 am 31.08.16 18:44:11Hi . Ich denke das alle abwarten wie die genaue Auswertung ausfallen wird und welche Schritte danach angekündigt werden . So lange ist abwarten angesagt . Das Gute ist das es Finanziell gut aussieht . Ich für meinen Teil lege noch etwas nach da ja auch weitere Produkte in der Pipeline warten
Sehr ruhig hier. ...ist noch jemand investiert? Eure Einschätzungen???
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