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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Aravive Inc | NASDAQ:ARAV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.0401 | 0.042 | 0.0428 | 0 | 01:00:00 |
Delaware
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001-36361
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26-4106690
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s) |
Name of each exchange
on which registered |
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Common stock, par value $0.0001 per share
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ARAV
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Nasdaq Global Select Market
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-
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Batiraxcept 15 mg/kg in combination with cabozantinib 60 mg has a manageable safety profile in previously treated ccRCC; no dose-limiting toxicities have been observed; a similar safety profile was observed across the 15 mg/kg and 20 mg/kg dose cohorts.
|
-
|
Batiraxcept given every 2 weeks suppressed serum GAS6 to below the level of quantitation in 25/26 patients (1 patient did not have an assessment), showing a clear pharmacokinetic (PK)/pharmacodynamic (PD) relationship; 23/26 patients had batiraxcept trough levels above the minimally efficacious concentration of 13.8 mg/L by Cycle 2.
|
-
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The confirmed + unconfirmed response rate in the total population was 46% with a 50% confirmed response rate in the 15mg/kg (RP2D) batiraxcept group.
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-
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The proportion of patients in the total population who were progression free at 7 months was 71%.
|
-
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The proportion of patients in the total population who had a duration of response of at least 7 months was 75%.
|
-
|
A baseline biomarker enriched the confirmed response rate in the RP2D (15mg/kg) biomarker high population to 67%, increased the proportion of patients progression free at 7 months to 91% and increased the proportion of patients who had a duration of response of at least 7 months to 80%.
|
-
|
58% (15/26) of total population achieved a better response on the batiraxcept trial than they did with their therapy prior to study entry, which was only 23%.
|
-
|
The safety and clinical activity of this combination together with PK/PD data support a RP2D of 15 mg/kg.
|
-
|
Batiraxcept 15 mg/kg in combination with cabozantinib 60 mg has a manageable safety profile in previously treated ccRCC; no dose-limiting toxicities have been observed; a similar safety profile was observed across the 15 mg/kg and 20 mg/kg dose cohorts.
|
-
|
Batiraxcept given every 2 weeks suppressed serum GAS6 to below the level of quantitation in 25/26 patients (1 patient did not have an assessment), showing a clear pharmacokinetic (PK)/pharmacodynamic (PD) relationship; 23/26 patients had batiraxcept trough levels above the minimally efficacious concentration of 13.8 mg/L by Cycle 2.
|
-
|
The confirmed + unconfirmed response rate in the total population was 46% with a 50% confirmed response rate in the 15mg/kg (RP2D) batiraxcept group.
|
-
|
The proportion of patients in the total population who were progression free at 7 months was 71%.
|
-
|
The proportion of patients in the total population who had a duration of response of at least 7 months was 75%.
|
-
|
A baseline biomarker enriched the confirmed response rate in the RP2D (15mg/kg) biomarker high population to 67%, increased the proportion of patients progression free at 7 months to 91% and increased the proportion of patients who had a duration of response of at least 7 months to 80%.
|
-
|
58% (15/26) of total population achieved a better response on the batiraxcept trial than they did with their therapy prior to study entry, which was only 23%.
|
-
|
The safety and clinical activity of this combination together with PK/PD data support a RP2D of 15 mg/kg.
|
Exhibit
Number
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Exhibit Description
|
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99.1 | Press Release of Aravive, Inc. | |
99.2
|
Abstract titled “A Phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib in patients with advanced or metastatic clear cell renal cell (ccRCC) carcinoma who have received front-line treatment (NCT04300140)”
|
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99.3 | Abstract titled “A Phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib, cabozantinib and nivolumab, and as monotherapy in patients with advanced or metastatic clear cell renal cell carcinoma (NCT04300140)” | |
104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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Date: May 26, 2022
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ARAVIVE, INC.
(Registrant)
|
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By:
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/s/ Gail McIntyre
|
||
Name:
|
Gail McIntyre
|
||
Title:
|
Chief Executive Officer
|
1 Year Aravive Chart |
1 Month Aravive Chart |
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