This case was last updated from U.S. District Courts on 03/17/2023 at 06:24:04 (UTC).

LEWAKOWSKI v. AQUESTIVE THERAPEUTICS, INC. et al

Case Summary

On March 1, 2021, Deanna Lewakowski (“Plaintiff”), individually and on behalf of all other persons similarly situated, represented by Gustavo F. Bruckner And Terrence Scudieri, Jr., of Pomerantz LLP, filed a civil action against Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”), Keith J. Kendall (“Kendall”), and John T. Maxwell (“Maxwell”) (collectively, “Defendants”), seeking declaratory relief and damages for alleged wrongful acts of the defendants. This case was filed in the U.S. District Court for the District of New Jersey, with Judges Brian R. Martinotti and Douglas E. Arpert presiding.

In the complaint, the plaintiff alleged, “This is a federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Aquestive securities between December 2, 2019 and September 25, 2020, both dates inclusive (the ‘Class Period’).”

The plaintiff further alleged, “Aquestive is a specialty pharmaceutical company that focuses on identifying, developing, and commercializing various products to address unmet medical needs. The Company’s most advanced proprietary product candidate is Libervant (diazepam), a buccal soluble film formulation of diazepam for the treatment of recurrent epileptic seizures.”

Plaintiff alleged, “On December 2, 2019, Aquestive announced the completion of the rolling submission of a New Drug Application (‘NDA’) to the U.S. Food and Drug Administration (‘FDA’) for Libervant Buccal Film for the management of seizure clusters (the ‘Libervant NDA’). Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies.”

The plaintiff further alleged that “Defendants made false and/or misleading statements and/or failed to disclose that: (i) data included in the Libervant NDA submission showed a lower drug exposure level than desired for certain weight groups; (ii) the foregoing significantly decreased the Libervant NDA’s approval prospects; (iii) as a result, it was foreseeable that the FDA would not approve the Libervant NDA in its current form; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.”

Additionally, the plaintiff alleged, “On September 25, 2020, Aquestive announced receipt of a Complete Response Letter (‘CRL’) from the FDA indicating that the review cycle for the Libervant NDA was complete but the application could not be approved in its current form.”

Plaintiff also alleged, “Aquestive advised investors that ‘[i]n the CRL, the FDA cited that, in a study submitted by the Company with the NDA, certain weight groups showed a lower drug exposure level than desired. The Company intends to provide to the FDA additional information on PK modeling to demonstrate that dose adjustments will obtain the desired exposure levels.’ On this news, Aquestive’s stock price fell $2.64 per share, or 34.69%, to close at $4.97 per share on September 28, 2020.”

Plaintiff stated two claims for relief, including for alleged violations of Section 10(b), Rule 10b-5, and Section 20(a) of the Exchange Act.

In its prayer for relief, the plaintiff requested a judgment for declaratory relief. The plaintiff also requested an award for damages, with pre- and post-judgment interest, as well as reasonable attorneys’ fees, expert fees, and other costs incurred by the plaintiff.

This is a summary of a legal complaint. All statements, claims, and allegations listed herein reflect the position of the plaintiff only and do not represent the position of UniCourt. Additionally, this case summary may not reflect the current position of the parties to this litigation or the current status of this case. To view the latest case updates and court documents, please sign up for a UniCourt account.

Case Details Parties Documents Dockets

 

Case Details

  • Case Number:

    3:21-CV-03751

  • Filing Date:

    03/01/2021

  • Case Status:

    Pending - Other Pending

  • Case Type:

    Finance - Security/Commodity/Exchange

Judge Details

Presiding Judge

Zahid N. Quraishi

Referral Judge

Douglas E. Arpert

 

Party Details

Lead Plaintiff

ARTHUR HAASE

Plaintiffs

DEANNA LEWAKOWSKI

MATTHEW SMOAK

JAMIE KAKUGAWA

Petitioners

DANIEL WESSLER

NATHAN BENNETT

Defendants

KEITH J. KENDALL

JOHN T. MAXWELL

AQUESTIVE THERAPEUTICS, INC.

DANIEL BARBER

Attorney/Law Firm Details

Plaintiff and Lead Plaintiff Attorneys

LAURENCE M. ROSEN

Attorney at THE ROSEN LAW FIRM, P.A.

One Gateway Center, Suite 2600

Newark, NJ 07102

ERICA L. STONE

Attorney at THE ROSEN LAW FIRM PA

275 Madison Avenue, 40Th Floor

New York, NY 10016

GUSTAVO FABIAN BRUCKNER

Attorney at POMERANTZ LLP

600 Third Avenue, 20Th Floor

New York, NY 10016

Petitioner Attorneys

MOSHE O BOROOSAN

Attorney at LAW OFFICE OF MOSHE BOROOSAN, P.C.

1318 Avenue J, 2Nd Floor

Brooklyn, NY 11230

THOMAS HENRY PRZYBYLOWSKI

Attorney at POMERANTZ LLP

600 Third Avenue, 20Th Floor

New York, NY 10016

Defendant Attorney

ANDREW MUSCATO

Attorney at SKADDEN ARPS SLATE MEAGHER & FLOM LLP

One Manhattan West

New York, NY 10001-8602

 

Court Documents

33 #26

Exhibit X - Aquestive Form 8-K (Press Release) dated July 19, 2021

33 #22

Exhibit T - Excerpts from Aquestive Form 10-Q dated May 8, 2019

33 #20

Exhibit R - Excerpts from Aquestive Form 10-Q dated November 5, 2019

33 #14

Exhibit L - Aquestive Form 8-K (Press Release) dated December 2, 2019

33 #9

Exhibit G - Aquestive Form 8-K (Item 7.01 Regulation FD Disclosure) dated Novem

33 #8

Exhibit F - Aquestive Form 8-K (Press Release) dated August 6, 2019

33 #7

Exhibit E - Excerpts from Aquestive Form 10-K dated March 14, 2019

33 #4

Exhibit B - Aquestive Form 8-K (Press Release) dated December 20, 2018

#33

Set Deadlines as to #33 MOTION to Dismiss The Amended Complaint MOTION to Strike Allegations Therein. Motion set for 9/20/2021 before Judge Zahid N. Quraishi. Unless otherwise directed by the Court, this motion will be decided on the papers and no appearances are required. Note that this is an automatically generated message from the Clerk`s Office and does not supersede any previous or subsequent orders from the Court. (abr, ) (Entered: 08/17/2021)

4 #4

Proposed Order

4 #3

Certificate of Good Standing

4 #2

J. Alexander Hood II Declaration

4 #1

Gustavo F. Bruckner Certification

#4

#3

#2

1 #1

Civil Cover Sheet

#1

101 More Documents Available
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Docket Entries

  • 03/14/2023
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  • Docket(#41) ORDER granting in part and denying in part #33 Motion to Dismiss; Defendants Motion to Dismiss the Amended Complaint is granted without prejudice; Defendants Motion to strike the allegations therein is denied; Plaintiff is granted leave to file a final second Amended Complaint by 4/14/2023. Signed by Judge Zahid N. Quraishi on 3/14/2023. (jal, ) (Entered: 03/14/2023)

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  • 03/14/2023
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  • Docket(#40) OPINION Filed. Signed by Judge Zahid N. Quraishi on 3/14/2023. (jal, ) (Entered: 03/14/2023)

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  • 06/15/2022
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  • Docket(#39) Letter from Andrew Muscato to the Hon. Zahid N. Quraishi re: Supplemental Authority. (Attachments: #1 Exhibit A - Amarin Opinion)(MUSCATO, ANDREW) (Entered: 06/15/2022)

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  • 04/06/2022
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  • Docket(#38) ORDER granting #37 Motion to Withdraw as Attorney. Attorney TERRENCE SCUDIERI, JR terminated. Signed by Magistrate Judge Douglas E. Arpert on 4/6/2022. (abr, ) (Entered: 04/06/2022)

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  • 04/05/2022
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  • DocketSet Deadlines as to #37 MOTION to Withdraw as Attorney Terrence W. Scudieri, Jr.. Motion set for 5/2/2022 before Magistrate Judge Douglas E. Arpert. Unless otherwise directed by the Court, this motion will be decided on the papers and no appearances are required. Note that this is an automatically generated message from the Clerk`s Office and does not supersede any previous or subsequent orders from the Court. (abr, ) (Entered: 04/05/2022)

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  • 04/05/2022
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  • Docket(#37) MOTION to Withdraw as Attorney Terrence W. Scudieri, Jr. by DEANNA LEWAKOWSKI. (Attachments: #1 Declaration of Terrence W. Scudieri, Jr., #2 Text of Proposed Order)(SCUDIERI, TERRENCE) (Entered: 04/05/2022)

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  • 11/01/2021
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  • Docket(#36) REPLY BRIEF to Opposition to Motion filed by AQUESTIVE THERAPEUTICS, INC., DANIEL BARBER, KEITH J. KENDALL, JOHN T. MAXWELL re #33 MOTION to Dismiss The Amended Complaint MOTION to Strike Allegations Therein (Attachments: #1 Certification of Andrew Muscato, #2 Exhibit Z - Aquestive Corporate Presentation dated September 2019, #3 Exhibit AA - Lake Street Capital Markets Analyst Report dated December 10, 2019, #4 Exhibit AB - JMP Securities Analyst Report dated August 20, 2018)(MUSCATO, ANDREW) (Entered: 11/01/2021)

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  • 09/30/2021
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  • Docket(#35) DECLARATION re #34 Brief in Opposition to Motion , of Jonathan Horne by ARTHUR HAASE, JAMIE KAKUGAWA, MATTHEW SMOAK. (Attachments: #1 Exhibit 1)(ROSEN, LAURENCE) (Entered: 09/30/2021)

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  • 09/30/2021
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  • Docket(#34) BRIEF in Opposition filed by ARTHUR HAASE, JAMIE KAKUGAWA, MATTHEW SMOAK re #33 MOTION to Dismiss The Amended Complaint MOTION to Strike Allegations Therein (ROSEN, LAURENCE) (Entered: 09/30/2021)

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  • 08/17/2021
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  • DocketSet Deadlines as to #33 MOTION to Dismiss The Amended Complaint MOTION to Strike Allegations Therein. Motion set for 9/20/2021 before Judge Zahid N. Quraishi. Unless otherwise directed by the Court, this motion will be decided on the papers and no appearances are required. Note that this is an automatically generated message from the Clerk`s Office and does not supersede any previous or subsequent orders from the Court. (abr, ) (Entered: 08/17/2021)

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32 More Docket Entries
  • 04/23/2021
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  • Docket(#8) Letter from Andrew Muscato to the Honorable Brian R. Martinotti, Dated April 23, 2021 re: Scheduling. (Attachments: #1 Stipulation and [Proposed] Order Regarding Scheduling)(MUSCATO, ANDREW) (Entered: 04/23/2021)

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  • 04/23/2021
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  • Docket(#7) Letter from Andrew Muscato to the Honorable Douglas E. Arpert, Dated April 23, 2021 with Consent Application for Pro Hac Vice Admission of Jay B. Kasner and Alexander C. Drylewski. (Attachments: #1 Certification of Andrew Muscato, #2 Certification of Jay B. Kasner, #3 Certification of Alexander C. Drylewski, #4 Text of Proposed Order)(MUSCATO, ANDREW) (Entered: 04/23/2021)

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  • 04/23/2021
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  • Docket(#6) Corporate Disclosure Statement by AQUESTIVE THERAPEUTICS, INC.. (MUSCATO, ANDREW) (Entered: 04/23/2021)

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  • 04/23/2021
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  • Docket(#5) NOTICE of Appearance by ANDREW MUSCATO on behalf of AQUESTIVE THERAPEUTICS, INC., KEITH J. KENDALL, JOHN T. MAXWELL (MUSCATO, ANDREW) (Entered: 04/23/2021)

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  • 03/24/2021
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  • DocketSet Deadlines as to #4 MOTION for Leave to Appear Pro Hac Vice J. Alexander Hood II. Motion set for 4/19/2021 before Magistrate Judge Douglas E. Arpert. Unless otherwise directed by the Court, this motion will be decided on the papers and no appearances are required. Note that this is an automatically generated message from the Clerk`s Office and does not supersede any previous or subsequent orders from the Court. (abr, ) (Entered: 03/24/2021)

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  • 03/23/2021
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  • Docket(#4) MOTION for Leave to Appear Pro Hac Vice J. Alexander Hood II by DEANNA LEWAKOWSKI. (Attachments: #1 Gustavo F. Bruckner Certification, #2 J. Alexander Hood II Declaration, #3 Certificate of Good Standing, #4 Proposed Order)(BRUCKNER, GUSTAVO) (Entered: 03/23/2021)

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  • 03/02/2021
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  • Docket(#3) SUMMONS ISSUED as to AQUESTIVE THERAPEUTICS, INC., KEITH J. KENDALL, JOHN T. MAXWELL. Attached is the official court Summons, please fill out Defendant and Plaintiffs attorney information and serve. (jal, ) (Entered: 03/02/2021)

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  • 03/02/2021

  • DocketJudge Brian R. Martinotti and Magistrate Judge Douglas E. Arpert added. (jal, ) (Entered: 03/02/2021)

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  • 03/01/2021
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  • Docket(#2) Request for Summons to be Issued by DEANNA LEWAKOWSKI as to AQUESTIVE THERAPEUTICS, INC., KEITH J. KENDALL, JOHN T. MAXWELL. (SCUDIERI, TERRENCE) (Entered: 03/01/2021)

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  • 03/01/2021
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  • Docket(#1) COMPLAINT against AQUESTIVE THERAPEUTICS, INC., KEITH J. KENDALL, JOHN T. MAXWELL ( Filing and Admin fee $ 402 receipt number ANJDC-12206848) with JURY DEMAND, filed by DEANNA LEWAKOWSKI. (Attachments: #1 Civil Cover Sheet)(SCUDIERI, TERRENCE) (Entered: 03/01/2021)

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