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  • T
    TW
    The court in the Hatch-Waxman litigation has dismissed UTHR's motion to add claims that LQDA and a former UTHR employee conspired to misappropriate certain trade secrets of UTHR.



    On November 17, 2021, the Court denied United Therapeutics’ motion to add these claims to the Hatch-Waxman Litigation, but without prejudice to United Therapeutics’ ability to bring these additional claims in a separate action. The Company continues to disagree with United Therapeutics’ allegations and denies any liability for misappropriation of any trade secrets.
  • B
    Bernard
    FDA Grants Tentative Approval for Liquidia’s YUTREPIA™ (Treprostinil) Inhalation Powder

    LQDA
    -4.18%
    Liquidia Corporation
    Mon, November 8, 2021, 5:45 AM
    In this article:

    LQDA
    -4.18%

    First dry-powder formulation of treprostinil to meet criteria required for FDA approval

    Final FDA approval may occur in October 2022 or earlier upon resolution of on-going litigation

    Conference call and webcast scheduled for today at 9:00 a.m. Eastern Standard Time

    MORRISVILLE, N.C., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder, previously referred to as LIQ861. YUTREPIA is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. Tentative approval indicates that YUTREPIA has met all regulatory standards for quality, safety and efficacy required for approval in the United States.

    Dr. Tushar Shah, Chief Medical Officer of Liquidia, said: “We would like to take the opportunity to thank the patients and investigators who participated in the clinical development of YUTREPIA. The tentative approval for YUTREPIA is another step toward providing an important option for patients with PAH in the U.S. We believe YUTREPIA can improve the limitations of current nebulized therapies by allowing the administration of an expanded dose range of inhaled treprostinil using a proven, convenient, palm-sized device.”

    The addressable market for inhaled treprostinil is significant and expected to grow. In 2020, United Therapeutics reported that its nebulized formulation of treprostinil indicated for PAH achieved sales of more than $480 million. The attributes of YUTREPIA including ease-of-use, convenience, direct lung delivery, and higher dosage range may not only make YUTREPIA a preference to nebulized therapy, but also an alternative to oral treatments, and possibly a treatment option to delay the use of parenteral therapies in PAH. There may also be future expansion opportunities for inhaled treprostinil into additional indications.

    Damian deGoa, Chief Executive Officer of Liquidia added: “This is a significant milestone for Liquidia. We are really proud of our team. Not only does the tentative approval establish the safety and efficacy of YUTREPIA for PAH patients but, in the process, we have validated our proprietary PRINT® technology to engineer discrete drug particles with uniform composition, size, and shape. There is more work to be done. We will now focus our efforts on pre-commercial launch activities and the growing market opportunity for YUTREPIA in PAH and potential new indications.”

    Due to a regulatory stay pursuant to the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act), YUTREPIA cannot yet be marketed in the United States. In June 2020, United Therapeutics filed a lawsuit against Liquidia for alleged infringement of three patents related to Tyvaso®. As a result, the FDA cannot give final approval of YUTREPIA until the expiration of the regulatory stay on October 27, 2022, or earlier resolution or settlement of the ongoing litigation.

    Webcast and Conference Call
    Liquidia will host a webcast and conference call Monday, November 8, 2021, at 9:00 a.m. EST to discuss this regulatory update for YUTREPIA™ (treprostinil) inhalation powder. The live call may be accessed by dialing 1-877-707-8711 (domestic) or 1-857-270-6219 (international) and entering the conference code: 8254404. A live and archived webcast of the webcast will also be available on the Events & Presentations page of the Liquidia website at https://liquidia.com/index.php/investors/events-and-presentations.

    Tyvaso® is a registered trademark of United Therapeutics.

    About YUTREPIA™(treprostinil) inhalation powder
    YUTREPIA is an investigational, inhaled dry powder formulation of treprostinil delivered through a proven, convenient, palm-sized device. On November 5, 2021, the FDA issued a tentative approval for YUTREPIA, which is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. YUTREPIA was designed using Liquidia’s PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape, and composition, and that are engineered for optimal deposition in the lung following oral inhalation. Liquidia has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso (nebulized treprostinil). YUTREPIA was previously referred to as LIQ861 in investigational studies.

    About Liq
  • A
    Anonymous
    $MNKD conversation
    Affrezza dpi shows the utter failure of technosphere. Just look at terrible script numbers. Tyvasso(treprostinil) dpi technosphere just got a CRL ( rejection) from FDA. Don't forget that $LQDA Receives Favorable Ruling in Inter Partes Review against United Therapeutics $UTHR Patent of treprostinil inhalation .
  • N
    Nomdguer
    $MNKD conversation
    Remember, UTHR has a treprostinil pill. $UTHR admits loads of pah drugs being marketed. UTHR has lost treprostinil patent lawsuits. UTHR's future is with their over $1,200,000,000 oral ralinepeg pill. While they have no piece of MNKD stock, They did buy a stake in a private pharma that has cutting edge transdermal pah technology and are working heavily with them. They know how old mnkd tech is and how big a flop the only drug that has used technosphere in 28yrs is. Wonder how happy $uthr is about losing the Inter Partes Review of treprostinil Patent to $LQDA and throwing away $105MM for an accelerated FDA review voucher for Tyvaso DPI only to get rejected CRL by FDA.
  • H
    Heavy Duty
    Liquidia Corporation (NASDAQ:LQDA)

    Shares of Liquidia have continued climbing during the fourth quarter. In early October, the company received a favorable ruling in an Inter Partes review against United Therapeutics and its U.S. Patent No. 9,604,901. The ruling found that 7 of the 9 claims were unpatentable. Damian deGoa, President and Chief Executive Officer of Liquidia said: “We are very pleased with this decision by the PTAB. This is a clear win in our on-going patent dispute with United Therapeutics, and we remain confident that we will ultimately prevail on all patent claims they have asserted against us. We will continue to vigorously defend our right to commercialize LIQ861 as soon as possible.”

    Liquidia focuses on developing products for pulmonary hypertension and operates through two subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC. They act as a uniquely integrated pair with Liquidia Technologies developing the company’s LIQ861, an inhaled dry powder formulation of treprostinil in treating pulmonary arterial hypertension. Meanwhile, Liquidia PAH is the commercialization provider for pharmaceutical products including generic treprostinil injections.

    What To Watch With LQDA Stock In November

    Now that there’s a bit of background on the company, what’s happening this month that might attract some interest from the market? Earlier this year, the FDA accepted its New Drug Application for the company’s LIQ861. This was actually a resubmission in response to a letter issued in late-2020 that clearly showed the treatment didn’t quite pass the bar. Now, November 7 is the next date to focus on this year. This is the Prescription Drug User Fee Act date given by the Administration.

    According to Liquidia’s June update, “If the FDA determines, following its substantive review of the NDA, that all requirements for approval have been met, the FDA may issue tentative approval on a timeline generally informed by the PDUFA goal date.”
  • S
    ST
    Good entry point
  • R
    Raji
    $UTHR conversation
    So UTHR wasted $105 million to get a voucher to speed up FDA review of $mnkd Tyvaso dpi. They got a CRL instead. LOL!!!!! To top it off they also lost inter partes review of treprostinil patent to $lqda.
  • T
    TW
    Looks like this is going to be a wild ride but given the recent news flow this is headed for double figures.
  • M
    Mark
    Sold and got out...Didn't feel right about LQDA....Insiders are dumping big time...
  • S
    ST
    A $LQDA director also bout 32k shares on 11/10 (after tentative approval) @ 4.24
  • S
    ST
    Someone try to push the price down so they can negotiate a better settlement. Only 400k traded today.
  • S
    ST
    Still good entry point . Oversold on good news. Hold till 15+.
  • S
    ST
    $LQDA Schundler Russell (General Counsel) Buys 117,908 @ Avg Price: $4.21.
  • S
    ST
    77k shares bought up in last minute- strong close. Consolidation almost over.
  • S
    ST
    Lqda is ready for the next step up
  • M
    Mike2874
    I think UTHR is going to make a better offer for LQDA and get the buyout done. They made an undisclosed offer before that was lowball. I think now they make a fair offer. Let's see.
  • M
    Mark
    I just bought some LQDA. shares....My other choices are DXLG , AEHR , EVGO......
  • G
    Green Lantern
    Liquidia Technologies reports Q3 EPS (14c), consensus (12c) :
    No one cares because FDA Approval is the sole focus.
  • t
    thahn
    I am going to wait for a few months or until UHTR Vs LQDA litigations over.
  • K
    Kasper
    Reaching 4.40 today ?