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Hot Stocks
Aquestive Therapeutics announces FDA acceptance of Libervant NDA resubmission » 09:30
07/19/21
07/19
09:30
07/19/21
09:30
AQST

Aquestive Therapeutics

$3.34 /

-0.07 (-2.05%)

Aquestive Therapeutics…

Aquestive Therapeutics announced that the U.S. Food and Drug Administration has accepted for filing the resubmission of the New Drug Application for Libervant Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act target goal date of December 23, 2021. Aquestive received a Complete Response Letter from the FDA in September 2020, completed a Type A meeting with the FDA in November 2020 and received further guidance from the FDA in February 2021. Based upon the Agency's guidance, the submission included additional statistical modeling and supporting analyses of the existing clinical data. The Company continues to believe that no additional clinical studies will be required for FDA approval of Libervant for U.S. market access.

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AQST Aquestive Therapeutics
$3.34 /

-0.07 (-2.05%)

AQST Aquestive Therapeutics
$3.34 /

-0.07 (-2.05%)

06/24/21 Lake Street
Aquestive approval likely by year-end after Libervant NDA, says Lake Street
04/06/21 RBC Capital
Aquestive Therapeutics transferred with an Outperform at RBC Capital
09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
AQST Aquestive Therapeutics
$3.34 /

-0.07 (-2.05%)

AQST Aquestive Therapeutics
$3.34 /

-0.07 (-2.05%)

Over a month ago
Recommendations
Aquestive approval likely by year-end after Libervant NDA, says Lake Street » 12:18
06/24/21
06/24
12:18
06/24/21
12:18
AQST

Aquestive Therapeutics

$4.29 /

-0.16 (-3.60%)

After Aquestive…

After Aquestive Therapeutics announced the resubmission of its New Drug Application, or NDA, to the FDA for Libervant Buccal Film for the management of seizure clusters, Lake Street analyst Thomas Flaten said he expects to hear confirmation by the end of July along with the PDUFA date and he sees approval as likely by year-end based on what he calls Libervant's "safety and efficacy merits." Flaten views the commercialization of Libervant as critical to bridging the gap to the launch of an epinephrine product that "has potential blockbuster written all over it." He keeps a Buy rating and $7 price target on Aquestive shares.

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AQST Aquestive Therapeutics
$4.29 /

-0.16 (-3.60%)

AQST Aquestive Therapeutics
$4.29 /

-0.16 (-3.60%)

04/06/21 RBC Capital
Aquestive Therapeutics transferred with an Outperform at RBC Capital
09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
AQST Aquestive Therapeutics
$4.29 /

-0.16 (-3.60%)

AQST Aquestive Therapeutics
$4.29 /

-0.16 (-3.60%)

Hot Stocks
Aquestive Therapeutics resubmits new drug application for Libervant » 08:02
06/24/21
06/24
08:02
06/24/21
08:02
AQST

Aquestive Therapeutics

$4.45 /

+0.32 (+7.75%)

Aquestive Therapeutics…

Aquestive Therapeutics announced the resubmission of its New Drug Application to the U.S. Food and Drug Administration for Libervant Buccal Film for the management of seizure clusters in response to the September 25, 2020 Complete Response Letter from the FDA. The submission included additional statistical modeling and supporting analyses of the existing clinical data based upon the guidance received from the Agency. "As we have committed in previous statements regarding the filing of our NDA for Libervant, yesterday we resubmitted the NDA. The resubmission for Libervant marks a significant milestone for Aquestive. We believe that the resubmission addresses all of the issues raised in the CRL based upon the guidance we received from the FDA," remarked Keith Kendall, CEO of Aquestive. "We look forward to continuing our dialogue with the FDA during the review period as we remain focused on bringing our non-invasive and innovative product to the underserved population of patients with refractory epilepsy." Aquestive received a CRL from the FDA in September 2020, completed a Type A meeting with the FDA in November 2020 and received further guidance from the FDA in February 2021. The company anticipates a six-month review process and expects to receive a PDUFA goal date in late 2021.

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AQST Aquestive Therapeutics
$4.45 /

+0.32 (+7.75%)

AQST Aquestive Therapeutics
$4.45 /

+0.32 (+7.75%)

04/06/21 RBC Capital
Aquestive Therapeutics transferred with an Outperform at RBC Capital
09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
AQST Aquestive Therapeutics
$4.45 /

+0.32 (+7.75%)

AQST Aquestive Therapeutics
$4.45 /

+0.32 (+7.75%)

Hot Stocks
Aquestive Therapeutics appoints A. Ernest Toth to SVP, CFO » 09:32
06/21/21
06/21
09:32
06/21/21
09:32
AQST

Aquestive Therapeutics

$4.05 /

+0.01 (+0.25%)

Aquestive Therapeutics…

Aquestive Therapeutics announced that A. Ernest Toth, Jr., a seasoned financial executive and currently serving the Company as the interim Chief Financial Officer, has transitioned to the permanent role of Senior Vice President and Chief Financial Officer effective immediately.

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AQST Aquestive Therapeutics
$4.05 /

+0.01 (+0.25%)

AQST Aquestive Therapeutics
$4.05 /

+0.01 (+0.25%)

04/06/21 RBC Capital
Aquestive Therapeutics transferred with an Outperform at RBC Capital
09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
AQST Aquestive Therapeutics
$4.05 /

+0.01 (+0.25%)

AQST Aquestive Therapeutics
$4.05 /

+0.01 (+0.25%)

Earnings
Aquestive Therapeutics reports Q1 EPS (41c), consensus (43c) » 20:00
05/04/21
05/04
20:00
05/04/21
20:00
AQST

Aquestive Therapeutics

$3.66 /

-0.315 (-7.93%)

Reports Q1 revenue…

Reports Q1 revenue $11.12M, consensus $8.97M. "We are focused on continuing to make progress this year in advancing our proprietary products. In response to feedback from the FDA, we are developing additional analyses of the existing clinical data in the NDA for Libervant and expect to refile by the end of the second quarter of 2021. We recently initiated the first-in-human Phase 1 PK study with our second generation epinephrine candidate AQST-109 and anticipate reporting top-line data in the second half of the year," said Keith Kendall, CEO.

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AQST Aquestive Therapeutics
$3.66 /

-0.315 (-7.93%)

AQST Aquestive Therapeutics
$3.66 /

-0.315 (-7.93%)

04/06/21 RBC Capital
Aquestive Therapeutics transferred with an Outperform at RBC Capital
09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
AQST Aquestive Therapeutics
$3.66 /

-0.315 (-7.93%)

AQST Aquestive Therapeutics
$3.66 /

-0.315 (-7.93%)

AQST Aquestive Therapeutics
$3.66 /

-0.315 (-7.93%)

Over a quarter ago
Recommendations
Aquestive Therapeutics transferred with an Outperform at RBC Capital » 16:48
04/06/21
04/06
16:48
04/06/21
16:48
AQST

Aquestive Therapeutics

$4.95 /

-0.22 (-4.26%)

RBC Capital transferred…

RBC Capital transferred coverage of Aquestive Therapeutics to analyst Daniel Busby and kept an Outperform rating and $7 price target on the stock.

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AQST Aquestive Therapeutics
$4.95 /

-0.22 (-4.26%)

AQST Aquestive Therapeutics
$4.95 /

-0.22 (-4.26%)

09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
09/28/20 JMP Securities
Aquestive Therapeutics price target lowered to $17 from $23 at JMP Securities
AQST Aquestive Therapeutics
$4.95 /

-0.22 (-4.26%)

AQST Aquestive Therapeutics
$4.95 /

-0.22 (-4.26%)

AQST Aquestive Therapeutics
$4.95 /

-0.22 (-4.26%)

Syndicate
Aquestive Therapeutics files $250M mixed securities shelf  16:37
03/26/21
03/26
16:37
03/26/21
16:37
AQST

Aquestive Therapeutics

$4.30 /

-0.19 (-4.23%)

 
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AQST Aquestive Therapeutics
$4.30 /

-0.19 (-4.23%)

AQST Aquestive Therapeutics
$4.30 /

-0.19 (-4.23%)

09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
09/28/20 JMP Securities
Aquestive Therapeutics price target lowered to $17 from $23 at JMP Securities
AQST Aquestive Therapeutics
$4.30 /

-0.19 (-4.23%)

AQST Aquestive Therapeutics
$4.30 /

-0.19 (-4.23%)

AQST Aquestive Therapeutics
$4.30 /

-0.19 (-4.23%)

Hot Stocks
Aquestive demonstrates oral sublingual film administration of epinephrine » 08:46
03/25/21
03/25
08:46
03/25/21
08:46
AQST

Aquestive Therapeutics

$4.38 /

-0.38 (-7.98%)

Aquestive Therapeutics…

Aquestive Therapeutics will provide later this morning an in-depth overview of its systemic epinephrine drug delivery program combining its novel prodrug technology and its PharmFilm technology. At the R&D event, the management team and KOLs will share an extensive review of the science, clinical results, and development strategy associated with two prodrug candidates in development for the treatment of allergic reactions including anaphylaxis. Aquestive has submitted multiple U.S. and foreign patent applications that cover the technology and formulations for its two prodrug candidates, AQST-108 and AQST-109. If granted, Aquestive anticipates patent protection for both drug candidates through at least 2037. Aquestive plans to outline in the R&D event that its "first of its kind" oral sublingual film candidate delivering systemic epinephrine, AQST-108, is composed of the prodrug dipivefrin, which is contained within a unique polymeric matrix of Aquestive's PharmFilm technology. Dipivefrin is currently approved by the FDA for ophthalmic indications. Dipivefrin is enzymatically cleaved systemically into epinephrine after administration. Aquestive previously completed an initial PK trial. This study featured a single ascending dose design with between 6-12 healthy subjects completing each dosing level during Part I and Part II of the study. During the study, both PK and pharmacodynamic markers were measured. At the target dose level, the observed range for time to reach maximal concentration for AQST-108 was 15-35 minutes, and the observed maximal concentration was 1487 pg/mL. In addition, this study indicated that AQST-108 was rapidly converted to epinephrine with an observed epinephrine Tmax range of 20-60 minutes and an observed Cmax of 261 pg/mL. Aquestive recently completed its second Phase 1 PK trial in 28 healthy adult subjects, which featured a four-treatment crossover design comparing PK, safety and pharmacodynamics of AQST-108 to that of epinephrine administered via both subcutaneous and intramuscular injections. In this study, the observed range for Tmax for AQST-108 was 10-40 minutes and the observed Cmax for AQST-108 was 1276 pg/mL. In addition, this study indicated that AQST-108 was rapidly converted to epinephrine with an observed Tmax range of 11-106 minutes and an observed Cmax of 205 pg/mL. This was compared to an epinephrine Tmax range of 4-75 minutes and 8-68 minutes and Cmax of 475 pg/mL and 388 pg/mL for the intramuscular and subcutaneous injections, respectively. In addition, several pharmacodynamic markers were measured during the second Phase 1 PK study. AQST-108 demonstrated changes from baseline in heart rate, systolic blood pressure, and diastolic blood pressure which are relevant in the context of anaphylaxis treatment and epinephrine's mechanism of action. For instance, for the area under the effect curve for systolic blood pressure, the median values for AQST-108 and intramuscular injected epinephrine were 452 and 428, respectively, indicating a comparable effect from both treatments on systolic blood pressure in healthy volunteers. A similar pattern was demonstrated for other pharmacodynamic measures as well. Aquestive plans on meeting with the FDA in the second half of 2021 to review these results and discuss next steps in the development of AQST-108.

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AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
09/28/20 JMP Securities
Aquestive Therapeutics price target lowered to $17 from $23 at JMP Securities
AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

Conference/Events
Aquestive Therapeutics to host conference call » 08:25
03/25/21
03/25
08:25
03/25/21
08:25
AQST

Aquestive Therapeutics

$4.38 /

-0.38 (-7.98%)

Management provides a…

Management provides a review of the epinephrine drug delivery program on a conference call to be held on March 25 at 9 am. Webcast Link

ShowHide Related Items >><<
AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
09/28/20 JMP Securities
Aquestive Therapeutics price target lowered to $17 from $23 at JMP Securities
AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

Conference/Events
Aquestive Therapeutics to host conference call » 04:55
03/25/21
03/25
04:55
03/25/21
04:55
AQST

Aquestive Therapeutics

$4.38 /

-0.38 (-7.98%)

Management provides a…

Management provides a review of the epinephrine drug delivery program on a conference call to be held on March 25 at 9 am. Webcast Link

ShowHide Related Items >><<
AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

09/28/20 Lake Street
Aquestive Therapeutics price target lowered to $7 from $10 at Lake Street
09/28/20 RBC Capital
Aquestive Therapeutics price target lowered to $7 from $8 at RBC Capital
09/28/20 BMO Capital
Aquestive Therapeutics price target lowered to $13 from $18 at BMO Capital
09/28/20 JMP Securities
Aquestive Therapeutics price target lowered to $17 from $23 at JMP Securities
AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

AQST Aquestive Therapeutics
$4.38 /

-0.38 (-7.98%)

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