Purple Biotech (PPBT) ehemals KTOV (Mkap $16 M) ( Cash $17 M) US Zulassungsantrag diesen Quartal (Seite 176)
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ISIN: US74638P1093 · WKN: A2QLTP · Symbol: 1YI1
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Antwort auf Beitrag Nr.: 56.720.526 von Niller84 am 15.01.18 16:27:37Nein, gibt wohl auch noch nichts. Bei Stocktwits hat ein User ein Auge auf Uploads von Kitov-Rechtssachen, bis jetzt ist da noch nichts Neues dabei. Ursprünglich war das Update der Börsenaufsicht für November 2017 vorgesehen, vielleicht gibt es ja jetzt die nächste Verzögerung. Wenn das positiv ausgeht, steht einem Uprun aus meiner Sicht nicht viel im Weg.
Antwort auf Beitrag Nr.: 56.713.419 von Kellermeister77 am 14.01.18 19:58:28@kellermeister77
Oha das hatte ich ehrlich gesagt gar nicht mehr auf dem Schirm, hätte mich doch ein wenig besser einlesen sollen! Aber heute konnte ich nichts dazu finden, oder konntest du?
Oha das hatte ich ehrlich gesagt gar nicht mehr auf dem Schirm, hätte mich doch ein wenig besser einlesen sollen! Aber heute konnte ich nichts dazu finden, oder konntest du?
Antwort auf Beitrag Nr.: 56.696.201 von Niller84 am 12.01.18 12:05:39Interessantes Timing Niller84: Morgen könnte/soll es von der israelischen Börsenaufsicht ein Update in Sachen Ermittlungen gegen den CEO geben. Heißt es bei Stocktwits. Die Ermittlungen sowie einige Lawsuits sind mE ein Grund dafür, warum die Aktie so niedrig bewertet ist. Ich bin schon etwas dabei. Wenn sich die Ermittlungen erledigen, wäre der Weg tatsächlich für einen Uprun frei. Hoffen wir mal...
Antwort auf Beitrag Nr.: 56.236.547 von techinvestor69 am 21.11.17 16:03:35Ich bin hier gestern mal mit einer kleinen Position eingestiegen, in Erwartung auf einen Run-Up for den AdCom im März/April? (PDUFA am 31. Mai). Sehe ich das richtig, das Kitov gerade mal 11,2 mio ADS hat?
Das wäre eine Market Cap von ca. $25 mio., ein absolutes Schnäppchen mit einem Produkt kurz vor einer möglichen Zulassung und ich bin mit ziemlich sicher, das sehr bald die Zocker mit auf den Wagen aufspringen wollen!
Das wäre eine Market Cap von ca. $25 mio., ein absolutes Schnäppchen mit einem Produkt kurz vor einer möglichen Zulassung und ich bin mit ziemlich sicher, das sehr bald die Zocker mit auf den Wagen aufspringen wollen!
H.C. Wainwright upgraded Kitov Pharmaceuticals Holdings Ltd (ADR)
from Neutral to Buy. Kitov Pharmaceuticals shares rose 19.3 percent to $2.35 in pre-market trading.
from Neutral to Buy. Kitov Pharmaceuticals shares rose 19.3 percent to $2.35 in pre-market trading.
Trading Spotlight
Kitov Pharmaceuticals Announces Receipt of FDA's Favorable Response to NT219's pre-IND Meeting Package
TyrNovo to Initiate Clinical Development on Advanced Pancreatic Cancer Patients
Long-term Strategy to Develop NT219 for Treatment of Additional Cancers via Collaboration with Pharmaceutical Companies
TEL AVIV, Israel, Nov. 1, 2017 /PRNewswire/ -- Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that it has received the U.S. Food and Drug Administration's (FDA) response to the NT219's pre-IND meeting package. FDA has agreed to the proposed Chemistry Manufacturing and Controls (CMC), preclinical, and clinical development plans for NT219. For the clinical development plan, the FDA agreed with TyrNovo's proposed development plan to test NT219 in combination with gemcitabine for the treatment of advanced pancreatic cancer. The FDA further agreed that the initial clinical trial with NT219 will be a Phase I/II clinical trial, and that "the overall design of proposed first-in-human trial appears reasonable". The FDA further agreed that one-month animal toxicology studies for NT219 would be sufficient to support the IND and that no toxicology studies of NT219 together with gemcitabine would be necessary.
"We are very pleased that FDA's Division of Oncology Products has accepted our chemistry, non-clinical, and clinical development plans for TyrNovo's cancer drug, NT219, and we are moving forward with these development plans. We appreciate FDA's helpful guidance and look forward to continuing to work with the FDA toward an IND submission, which based on our current development plans, we now expect to submit during the first half of 2019," said Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.
Dr. Hadas Reuveni, TyrNovo's Founder and CTO added: "According to the National Cancer Institute, pancreatic cancer is the fourth leading cause of cancer death in the US and is known to be one of the most aggressive and difficult-to-treat cancer types. NT219 works by overcoming drug resistance and can be combined with various oncology drugs. Our drug's efficacy was demonstrated in preclinical patient-derived xenograft (PDX) models with various oncology therapies such as chemotherapy agents, EGFR Antibodies, MEK and mTOR inhibitors, and also in combination with immuno-oncology agents such as Keytruda®. We will initially be clinically testing NT219 in combination with gemcitabine on advanced pancreatic cancer patients, based on our consistent encouraging results in preclinical PDX models. Our long-term strategy is to develop NT219 in combination with other oncology drugs and for additional oncology indications in collaboration with potential strategic partners, who have expressed solid preliminary interest in NT219."
TyrNovo to Initiate Clinical Development on Advanced Pancreatic Cancer Patients
Long-term Strategy to Develop NT219 for Treatment of Additional Cancers via Collaboration with Pharmaceutical Companies
TEL AVIV, Israel, Nov. 1, 2017 /PRNewswire/ -- Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that it has received the U.S. Food and Drug Administration's (FDA) response to the NT219's pre-IND meeting package. FDA has agreed to the proposed Chemistry Manufacturing and Controls (CMC), preclinical, and clinical development plans for NT219. For the clinical development plan, the FDA agreed with TyrNovo's proposed development plan to test NT219 in combination with gemcitabine for the treatment of advanced pancreatic cancer. The FDA further agreed that the initial clinical trial with NT219 will be a Phase I/II clinical trial, and that "the overall design of proposed first-in-human trial appears reasonable". The FDA further agreed that one-month animal toxicology studies for NT219 would be sufficient to support the IND and that no toxicology studies of NT219 together with gemcitabine would be necessary.
"We are very pleased that FDA's Division of Oncology Products has accepted our chemistry, non-clinical, and clinical development plans for TyrNovo's cancer drug, NT219, and we are moving forward with these development plans. We appreciate FDA's helpful guidance and look forward to continuing to work with the FDA toward an IND submission, which based on our current development plans, we now expect to submit during the first half of 2019," said Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.
Dr. Hadas Reuveni, TyrNovo's Founder and CTO added: "According to the National Cancer Institute, pancreatic cancer is the fourth leading cause of cancer death in the US and is known to be one of the most aggressive and difficult-to-treat cancer types. NT219 works by overcoming drug resistance and can be combined with various oncology drugs. Our drug's efficacy was demonstrated in preclinical patient-derived xenograft (PDX) models with various oncology therapies such as chemotherapy agents, EGFR Antibodies, MEK and mTOR inhibitors, and also in combination with immuno-oncology agents such as Keytruda®. We will initially be clinically testing NT219 in combination with gemcitabine on advanced pancreatic cancer patients, based on our consistent encouraging results in preclinical PDX models. Our long-term strategy is to develop NT219 in combination with other oncology drugs and for additional oncology indications in collaboration with potential strategic partners, who have expressed solid preliminary interest in NT219."
Kitov Pharmaceuticals: An Update
https://seekingalpha.com/article/4118024-kitov-pharmaceutica…
Kitov Pharmaceuticals Announces Phase III/IV Clinical Trial for KIT-302 Successfully Meets Primary Endpoint, and also Demonstrates Drug Candidate Improves Renal Function
TEL AVIV, Israel, October 26, 2017 /PRNewswire/ --
Results Validate Primary Efficacy Endpoint Achieved in Previous Successfully Completed Phase III Clinical Trial
KIT-302 Reduces Creatinine Levels Indicating Improved Renal Function, Compared to Negative Effects of other NSAIDs
Company Recently Submitted, and FDA Accepted for Filing, NDA for KIT-302 for Simultaneous Treatment of Osteoarthritis Pain and Hypertension
Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that its randomized double-blind, placebo-controlled renal function clinical trial for its lead drug candidate, KIT-302, successfully met its primary efficacy endpoint. Data from the trial demonstrated that KIT-302 lowered systolic blood pressure a comparable amount to the widely used antihypertension drug, amlodipine besylate, thus meeting the trial's primary efficacy endpoint of achieving at least 50% of the amlodipine reduction (p=0.019).
KIT-302, a combination drug, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc®). The renal function study enrolled 104 patients randomized to three treatment groups: KIT-302, amlodipine besylate, and placebo. The primary efficacy endpoint of the trial was to show that KIT-302 lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients, treated with amlodipine besylate only. Secondary endpoints included various parameters of renal function.
The study also demonstrated that treatment with KIT-302 led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005). In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level.
When comparing the effect of KIT-302 to amlodipine besylate in lowering creatinine, it was found that KIT-302 enhanced the creatinine reduction by an average of 102% over that achieved with amlodipine besylate alone, although there was a slight increase in the rate of edema in the KIT-302 treatment arm. Both this creatinine measure and the edema measure were statistically insignificant.
Kitov submitted its New Drug Application (NDA) for marketing approval of KIT-302 to the U.S. Food and Drug Administration (FDA) in July 2017, and in September 2017, FDA filed the NDA, thereby granting a full review. Although the renal clinical trial was not required as part of the initial KIT-302 NDA submission, the Company anticipates completion and submission of the report to FDA by January 2018.
"We are very pleased with the results of our renal function clinical trial and look forward to submitting the related clinical study report to FDA. Although FDA has publicly warned against using NSAIDs in patients receiving antihypertensive drugs from the diuretic, beta blocker, ACE inhibitor and angiotensin receptor blocker classes, this study once again demonstrated that our combination lacks the toxicities of these other classes and combinations. This makes our combination uniquely suited for the millions of Americans with both osteoarthritis and hypertension. The reduction of creatinine levels by KIT-302, indicating improved renal function, as compared to the negative effects on renal function of other NSAIDs, further demonstrates the value of KIT-302," said Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.
TEL AVIV, Israel, October 26, 2017 /PRNewswire/ --
Results Validate Primary Efficacy Endpoint Achieved in Previous Successfully Completed Phase III Clinical Trial
KIT-302 Reduces Creatinine Levels Indicating Improved Renal Function, Compared to Negative Effects of other NSAIDs
Company Recently Submitted, and FDA Accepted for Filing, NDA for KIT-302 for Simultaneous Treatment of Osteoarthritis Pain and Hypertension
Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that its randomized double-blind, placebo-controlled renal function clinical trial for its lead drug candidate, KIT-302, successfully met its primary efficacy endpoint. Data from the trial demonstrated that KIT-302 lowered systolic blood pressure a comparable amount to the widely used antihypertension drug, amlodipine besylate, thus meeting the trial's primary efficacy endpoint of achieving at least 50% of the amlodipine reduction (p=0.019).
KIT-302, a combination drug, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc®). The renal function study enrolled 104 patients randomized to three treatment groups: KIT-302, amlodipine besylate, and placebo. The primary efficacy endpoint of the trial was to show that KIT-302 lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients, treated with amlodipine besylate only. Secondary endpoints included various parameters of renal function.
The study also demonstrated that treatment with KIT-302 led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005). In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level.
When comparing the effect of KIT-302 to amlodipine besylate in lowering creatinine, it was found that KIT-302 enhanced the creatinine reduction by an average of 102% over that achieved with amlodipine besylate alone, although there was a slight increase in the rate of edema in the KIT-302 treatment arm. Both this creatinine measure and the edema measure were statistically insignificant.
Kitov submitted its New Drug Application (NDA) for marketing approval of KIT-302 to the U.S. Food and Drug Administration (FDA) in July 2017, and in September 2017, FDA filed the NDA, thereby granting a full review. Although the renal clinical trial was not required as part of the initial KIT-302 NDA submission, the Company anticipates completion and submission of the report to FDA by January 2018.
"We are very pleased with the results of our renal function clinical trial and look forward to submitting the related clinical study report to FDA. Although FDA has publicly warned against using NSAIDs in patients receiving antihypertensive drugs from the diuretic, beta blocker, ACE inhibitor and angiotensin receptor blocker classes, this study once again demonstrated that our combination lacks the toxicities of these other classes and combinations. This makes our combination uniquely suited for the millions of Americans with both osteoarthritis and hypertension. The reduction of creatinine levels by KIT-302, indicating improved renal function, as compared to the negative effects on renal function of other NSAIDs, further demonstrates the value of KIT-302," said Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.
Ich hab ein paar knapp bei $3 rausgehauen nach solchen anstiegen ist es nicht verkehrt gewinne zu realisieren .
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