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    Mannkind, Game-Chancer in Sachen Diabetik? (Seite 6)

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     Ja Nein
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      schrieb am 09.08.23 15:15:32
      Beitrag Nr. 6.768 ()
      Die 5,63$ sind eine Wand und die Entwicklungen von z.B. Sernova bewegen sich auch immer weiter---also Vorsicht ist besser als Nachsicht
      MannKind | 4,828 €
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      schrieb am 08.08.23 16:40:17
      Beitrag Nr. 6.767 ()
      Mnkd
      + 20 %, ich rieche burned shorts und das ist erst der Anfang, Mnkd ist mit UTHR bald eine cash cow und wird Zweistellig übernommen, ratet mal von wem, UTHR, US 15!:eek:
      MannKind | 5,500 $
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      schrieb am 08.08.23 14:12:45
      Beitrag Nr. 6.766 ()
      Mannkind
      MannKind (MNKD) PT Raised to $7.50 at Cantor Fitzgerald:D
      MannKind | 4,375 €
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      schrieb am 08.08.23 08:13:07
      Beitrag Nr. 6.765 ()
      und ich vergass was machen die shorts
      es gibt reichlich s
      shorts
      dürfem wir auf einen squeeze hoffen ?
      MannKind | 4,463 €
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      schrieb am 08.08.23 08:09:23
      Beitrag Nr. 6.764 ()
      bald dürfte mnkd ( nächstes Quartal ) in die Gewinnzone drehen
      MannKind | 4,463 €
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      Avatar
      schrieb am 07.08.23 22:34:45
      Beitrag Nr. 6.763 ()
      Mnkd
      Wow, Mannkind übertrifft die Erwartungen um Meilen, 157 % revenues Steigerung gegenüber letztem Jahr, cash flow positiv....short squeeeeeeeeeeeeeeezeeeeeeeeeeeeeee steht vor der Tür:

      MannKind Corporation Reports 2023 Second Quarter Financial Results

      MannKind
      Mon, August 7, 2023 at 10:00 PM GMT+2
      In this article:

      MNKD
      -2.5424%
      Watchlist
      Performance Outlookyahoo plus badge
      2W-6W
      6W-9M

      9M+

      MannKind
      MannKind

      Conference Call to Begin Today at 5:00 p.m. (ET)

      2Q 2023 Total revenues of $49M; +157% vs. 2Q 2022

      2Q 2023 Tyvaso DPI royalties of $19M; +63% vs. 1Q 2023

      2Q 2023 Endocrine Business Unit net revenues of $18M; Afrezza net revenues +27% vs. 2Q 2022

      2Q 2023 Income from operations of $2M; Non-GAAP income from operations of $8M

      DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended June 30, 2023.

      “We are excited to report positive income from operations in the second quarter driven by growing patient demand for Tyvaso DPI® and Afrezza as well as manufacturing revenues from Tyvaso DPI,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “In addition, we have optimized our commercial operations supporting Afrezza® and V-Go®, which is expected to get our Endocrine Business Unit to profitability starting in 2024.”
      :eek::D

      Second Quarter 2023 Results

      Revenue Highlights







      Three Months
      Ended June 30,










      2023








      2022








      $ Change








      % Change










      (Dollars in thousands)




      Net revenue – Afrezza





      $


      13,527








      $


      10,649








      $


      2,878











      27


      %

      Net revenue – V-Go








      4,818











      2,073








      $


      2,745








      *




      Revenue – collaborations and services








      11,211











      5,868








      $


      5,343











      91


      %

      Royalties – collaborations








      19,055











      304








      $


      18,751








      *




      Total revenues





      $


      48,611








      $


      18,894








      $


      29,717











      157


      %

      ________________________
      * Not meaningful

      Afrezza net revenue for the second quarter of 2023 increased $2.9 million, or 27%, compared to the same period in 2022 as a result of higher product demand and price. V-Go was acquired in the second quarter of 2022 and achieved $22.0 million in cumulative net revenues one year post-acquisition, which was at the high end of our forecasted range. The increase in collaborations and services revenue was primarily attributable to revenues associated with the commercial supply agreement (the "CSA") with United Therapeutics ("UT"). In the second quarter of 2022, revenue associated with the CSA was deferred until we began commercial manufacturing and subsequently selling Tyvaso DPI in June 2022. Royalties related to Tyvaso DPI, launched in late second quarter of 2022 by UT, were $19.0 million in the second quarter of 2023 and continued to grow based on strong patient demand.

      Commercial product gross margin in the second quarter of 2023 was 72% compared to 64% for the same period in 2022, primarily attributable to an increase in Afrezza net revenue, which has a higher gross margin than V-Go.

      Cost of revenue – collaborations and services for the second quarter of 2023 was $9.0 million compared to $8.3 million for the same period in 2022, an increase of $0.7 million, due to an increase in manufacturing activities for Tyvaso DPI.

      Research and development ("R&D") expenses for the second quarter of 2023 were $6.5 million compared to $4.9 million for the same period in 2022. The $1.6 million increase was primarily attributed to development activities for MNKD-101 (inhaled clofazimine) and an Afrezza post-marketing clinical study (INHALE-3), which commenced in the second quarter of 2023.

      Selling expenses for the second quarter of 2023 were $14.0 million compared to $15.9 million for the same period in 2022. The $1.9 million decrease was primarily attributable to the termination of an Afrezza pilot promotional effort targeting primary care physicians, which ended in the third quarter of 2022, partially offset by increased headcount after the acquisition of V-Go in the second quarter of 2022.

      General and administrative expenses for the second quarter of 2023 were $11.9 million compared to $10.2 million for the same period in 2022. The $1.8 million increase was primarily attributable to higher stock-based compensation and increased headcount.

      Interest income was $1.5 million for the second quarter of 2023 compared to $0.5 million for the same period in 2022. The increase was primarily due to higher yields on our marketable securities and money market funds.

      Interest expense on financing liability was $2.4 million for the second quarter of 2023 and remained consistent with the same period in 2022.

      Interest expense was $6.9 million in the second quarter of 2023 compared to $6.6 million for the same period in 2022, which remained consistent due to fixed interest rates on notes and consistent recognition of interest expense related to the achievement of Afrezza milestones.

      Gain on available-for-sale securities for the second quarter of 2023 was $0.9 million as a result of the change in the fair value of the investment that related to credit risk.

      First half of 2023

      Revenue Highlights







      Six Months
      Ended June 30,










      2023








      2022








      $ Change








      % Change




      Net revenue — Afrezza





      $


      25,951








      $


      20,475








      $


      5,476











      27


      %

      Net revenue — V-Go








      9,956











      2,073








      $


      7,883








      *




      Revenue — collaborations and services








      22,597











      8,034








      $


      14,563











      181


      %

      Royalties — collaborations








      30,733











      304








      $


      30,429








      *




      Total revenues





      $


      89,237








      $


      30,886








      $


      58,351











      189


      %

      ________________________
      * Not meaningful

      Afrezza net revenue for the first half of 2023 increased $5.5 million, or 27%, compared to the same period in 2022 primarily as a result of higher product demand and price. V-Go was acquired in the second quarter of 2022 and achieved $22.0 million in net revenues one year post-acquisition, which was at the high end of our forecasted range. The increase in collaborations and services revenue was primarily attributable to the deferral of revenue associated with the CSA until we began commercial manufacturing and subsequently selling Tyvaso DPI in June 2022. Royalties related to Tyvaso DPI, launched in the late second quarter of 2022 by UT, reached $30.7 million in the first half of 2023 based on strong patient demand.

      Commercial product gross margin in the first half of 2023 was 70%, which was consistent with the same period in 2022.

      Cost of revenue – collaborations and services for the first half of 2023 was $19.7 million compared to $17.0 million for the same period in 2022, an increase of $2.7 million, due to an increase in manufacturing activities for Tyvaso DPI.

      R&D expenses for the first half of 2023 were $12.1 million compared to $8.4 million for the same period in 2022. The $3.6 million increase was primarily attributed to development activities for MNKD-101 and INHALE-3.

      Selling expenses for the first half of 2023 were $27.3 million compared to $28.6 million for the same period in 2022. The $1.3 million decrease was primarily due to the termination of an Afrezza pilot promotional effort targeting primary care physicians, which ended in the third quarter of 2022, partially offset by increased headcount and promotional expenses after the acquisition of V-Go in the second quarter of 2022.

      General and administrative expenses for the first half of 2023 were $22.5 million compared to $18.1 million for the same period in 2022. The $4.3 million increase was primarily attributable to higher stock-based compensation and increased headcount.

      Interest income was $2.8 million for the six months ended June 30, 2023 compared to $0.9 million for the same period in 2022. The increase was primarily due to higher yields on our marketable securities and money market funds.

      Interest expense on financing liability was $4.9 million for the first half of 2023 and remained consistent with the same period in 2022.

      Interest expense on notes was $9.7 million in the first half of 2023 compared to $9.4 million for the same period in 2022, which remained consistent due to fixed interest rates on notes and consistent recognition of interest expense related to the achievement of Afrezza milestones.

      Gain on available-for-sale securities for the first half of 2023 was $0.9 million as a result of the change in the fair value of the investment that related to credit risk.

      Cash, cash equivalents and investments as of June 30, 2023 were $146.6 million.

      Non-GAAP Measures

      To supplement our unaudited condensed consolidated financial statements presented under U.S. generally accepted accounting principles (GAAP), we are presenting non-GAAP income (loss) from operations, non-GAAP net loss and non-GAAP net income (loss) per share, which are non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

      These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our unaudited condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

      The following tables reconcile our financial measure for income (loss) from operations, net loss and earnings (loss) per share ("EPS") for basic and diluted weighted average shares as reported in our condensed consolidated statement of operations to a non-GAAP presentation as adjusted for the non-cash stock-based compensation expense and non-cash gain (loss) on foreign currency transactions for the periods presented:




      Three Months








      Six Months







      Ended June 30,








      Ended June 30,







      2023








      2022








      2023








      2022







      (In thousands except per share data)




      GAAP Income (loss) from operations


      $


      1,721








      $


      (20,454


      )





      $


      (4,277


      )





      $


      (41,710


      )

      Increase (decrease) for excluded non-cash items:


































      Stock compensation





      5,580











      4,422











      9,235











      7,228




      Loss (gain) on foreign currency transaction





      251











      (4,503


      )








      1,205











      (6,486


      )

      Non-GAAP income (loss) from operations


      $


      7,552








      $


      (20,535


      )





      $


      6,163








      $


      (40,968


      )




































      GAAP net loss


      $


      (5,265


      )





      $


      (29,023


      )





      $


      (15,060


      )





      $


      (55,021


      )

      Increase (decrease) for excluded non-cash items:


































      Stock compensation





      5,580











      4,422











      9,235











      7,228




      Loss (gain) on foreign currency transaction





      251











      (4,503


      )








      1,205











      (6,486


      )

      Gain on available-for-sale securities





      (932


      )




















      (932


      )













      Non-GAAP net loss


      $


      (366


      )





      $


      (29,104


      )





      $


      (5,552


      )





      $


      (54,279


      )




































      GAAP net loss per share - basic and diluted


      $


      (0.02


      )





      $


      (0.11


      )





      $


      (0.06


      )





      $


      (0.22


      )

      Increase (decrease) for excluded non-cash items:


































      Stock compensation





      0.02











      0.02











      0.03











      0.03




      Loss (gain) on foreign currency transaction





      0.00











      (0.02


      )








      0.00











      (0.03


      )

      Gain on available-for-sale securities





      0.00











      0.00











      0.00











      0.00




      Non-GAAP net loss per share - basic and diluted


      $


      0.00








      $


      (0.11


      )





      $


      (0.03


      )





      $


      (0.22


      )




































      Weighted average shares - basic and diluted





      265,626











      253,644











      264,802











      252,775




      Conference Call

      MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind's website for 14 days.

      About MannKind

      MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.

      We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation.

      With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.

      Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, Twitter or Instagram.

      Forward-Looking Statements

      Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding the optimization of our commercial operations for Afrezza and V-Go and the potential for our Endocrine Business Unit to reach profitability starting in 2024. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with manufacturing and supply, risks associated with product commercialization, risks associated with developing product candidates, risks associated with MannKind’s ability to manage its existing cash resources or raise additional cash resources, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 23, 2023, and under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, being filed with the SEC later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

      Tyvaso DPI is a trademark of United Therapeutics Corporation.

      AFREZZA, MANNKIND, and V-GO are registered trademarks of MannKind Corporation.

      MannKind Contact:
      Rose Alinaya, Investor Relations
      (818) 661-5000
      IR@mannkindcorp.com


      MANNKIND CORPORATION AND SUBSIDIARY
      CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS







      Three Months
      Ended June 30,








      Six Months
      Ended June 30,










      2023








      2022








      2023








      2022










      (In thousands except per share data)




      Revenues:





































      Net revenue – commercial product sales





      $


      18,345








      $


      12,722








      $


      35,907








      $


      22,548




      Revenue – collaborations and services








      11,211











      5,868











      22,597











      8,034




      Royalties – collaborations








      19,055











      304











      30,733











      304




      Total revenues








      48,611











      18,894











      89,237











      30,886




      Expenses:





































      Cost of goods sold








      5,224











      4,617











      10,754











      6,901




      Cost of revenue – collaborations and services








      9,013











      8,298











      19,696











      17,012




      Research and development








      6,453











      4,893











      12,058











      8,429




      Selling








      14,002











      15,868











      27,312











      28,596




      General and administrative








      11,947











      10,175











      22,489











      18,144




      Loss (gain) on foreign currency transaction








      251











      (4,503


      )








      1,205











      (6,486


      )

      Total expenses








      46,890











      39,348











      93,514











      72,596




      Income (loss) from operations








      1,721











      (20,454


      )








      (4,277


      )








      (41,710


      )

      Other income (expense):





































      Interest income, net








      1,547











      516











      2,849











      893




      Interest expense on financing liability








      (2,449


      )








      (2,443


      )








      (4,873


      )








      (4,814


      )

      Interest expense








      (6,873


      )








      (6,642


      )








      (9,659


      )








      (9,390


      )

      Gain on available-for-sale securities








      932























      932
















      Other expense








      (143


      )




















      (32


      )













      Total other expense








      (6,986


      )








      (8,569


      )








      (10,783


      )








      (13,311


      )

      Loss before income tax expense








      (5,265


      )








      (29,023


      )








      (15,060


      )








      (55,021


      )

      Benefit from income taxes

















































      Net loss





      $


      (5,265


      )





      $


      (29,023


      )





      $


      (15,060


      )





      $


      (55,021


      )

      Net loss per share – basic and diluted





      $


      (0.02


      )





      $


      (0.11


      )





      $


      (0.06


      )





      $


      (0.22


      )

      Weighted average shares used to compute net loss per share – basic and diluted








      265,626











      253,644











      264,802











      252,775





      MANNKIND CORPORATION AND SUBSIDIARY
      CONDENSED CONSOLIDATED BALANCE SHEETS



























      June 30, 2023








      December 31, 2022










      (In thousands except share
      and per share data)




      ASSETS



















      Current assets:



















      Cash and cash equivalents





      $


      86,184








      $


      69,767




      Short-term investments








      58,163











      101,079




      Accounts receivable, net








      27,789











      16,801




      Inventory








      25,290











      21,772




      Prepaid expenses and other current assets








      32,807











      25,477




      Total current assets








      230,233











      234,896




      Property and equipment, net








      69,510











      45,126




      Goodwill








      1,931











      2,428




      Other intangible asset








      1,113











      1,153




      Long-term investments








      2,282











      1,961




      Other assets








      8,353











      9,718




      Total assets





      $


      313,422








      $


      295,282
























      LIABILITIES AND STOCKHOLDERS' DEFICIT



















      Current liabilities:



















      Accounts payable





      $


      17,127








      $


      11,052




      Accrued expenses and other current liabilities








      36,833











      35,553




      Financing liability – current








      9,686











      9,565




      Midcap credit facility – current








      16,667
















      Deferred revenue – current








      3,489











      1,733




      Recognized loss on purchase commitments – current








      13,164











      9,393




      Total current liabilities








      96,966











      67,296




      Mann Group convertible note








      8,829











      8,829




      Accrued interest – Mann Group convertible note








      55











      55




      Financing liability – long term








      94,395











      94,512




      Midcap credit facility – long term








      22,811











      39,264




      Senior convertible notes








      226,124











      225,397




      Recognized loss on purchase commitments – long term








      56,063











      62,916




      Operating lease liability








      4,646











      5,343




      Deferred revenue – long term








      60,248











      37,684




      Milestone liabilities








      3,772











      4,524




      Total liabilities








      573,909











      545,820




      Stockholders' deficit:



















      Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2023 and December 31, 2022

























      Common stock, $0.01 par value – 800,000,000 and 400,000,000 shares authorized as of June 30, 2023 and December 31, 2022, respectively, and 268,235,145 and 263,793,305 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively








      2,682











      2,638




      Additional paid-in capital








      2,968,917











      2,964,293




      Accumulated other comprehensive income








      443
















      Accumulated deficit








      (3,232,529


      )








      (3,217,469


      )

      Total stockholders' deficit








      (260,487


      )








      (250,538


      )

      Total liabilities and stockholders' deficit





      $


      313,422








      $


      295,282
      MannKind | 4,432 €
      Avatar
      schrieb am 07.08.23 11:29:07
      Beitrag Nr. 6.762 ()
      Mannkind
      Heute Q 2 Zahlen 2023 mit 100 % Steigerung der revenues gegenüber Q2 2022? Bald zweistellig!




      $MNKD The consensus EPS Estimate is -$0.04 (+63.6% Y/Y) and the consensus Revenue Estimate is $42.95M (+127.4% Y/Y).
      MannKind | 4,405 €
      Avatar
      schrieb am 04.08.23 14:23:08
      Beitrag Nr. 6.761 ()
      MannKind | 4,005 €
      steigt
      Avatar
      schrieb am 24.07.23 19:14:16
      Beitrag Nr. 6.760 ()
      Mannkind
      Super Meldung für Mannkind und UTHR, unser Konkurrent Liquida bleibt wegen Patentverletzung bis 2027 vom Markt:

      United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation

      Mon, July 24, 2023 at 5:45 PM GMT+2
      In this article:

      UTHR
      -0.28%
      Watchlist
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      OvervaluedSee why

      SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C., July 24, 2023--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.

      The Federal Circuit affirmed the district court’s decision that Liquidia would induce infringement of various claims of the ’793 patent by marketing Yutrepia and that Liquidia failed to prove any claim of that patent invalid. The ‘793 patent relates to a method of administering treprostinil via inhalation.

      The Federal Circuit also affirmed the district court’s decision that certain claims of another United Therapeutics patent, U.S. Patent No. 9,593,066 (the ’066 patent), are either invalid or not infringed by Liquidia. The ’066 patent relates to a method of making treprostinil, the active pharmaceutical ingredient in both Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI® (treprostinil) Inhalation Powder.

      "Today’s decision vindicates our position, as confirmed earlier by the district court, that Yutrepia is an infringing product. We will continue to vigorously defend our intellectual property," said Shaun Snader, Vice President and Associate General Counsel – IP and Litigation at United Therapeutics.

      Both parties have the opportunity to request rehearing by the Federal Circuit with respect to the adverse portions of the Federal Circuit’s affirmance.

      Last year, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office issued a final written decision in an inter partes review (IPR) of the ’793 patent initiated by Liquidia finding all claims of the patent to be unpatentable. United Therapeutics appealed that decision to the Federal Circuit, and that appeal is pending. United Therapeutics expects that the PTAB decision will not affect the district court’s order barring FDA from granting final approval for Yutrepia unless all claims Liquidia was found to infringe are found invalid following exhaustion of all appeals.

      United Therapeutics: Enabling Inspiration

      At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.

      You can learn more about what it means to be a PBC here: unither.com/PBC.

      Forward-looking Statements

      Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding ongoing patent litigation with Liquidia, the potential timing of FDA approval for Yutrepia, and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders and furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of July 24, 2023, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.

      TYVASO and TYVASO DPI are registered trademarks of United Therapeutics Corporation and/or its subsidiaries.

      YUTREPIA is a trademark of Liquidia Corporation.

      View source version on businesswire.com: https://www.businesswire.com/news/home/20230724981807/en/

      Contacts

      Dewey Steadman
      (202) 919-4097
      ir@unither.com
      MannKind | 4,350 $
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      schrieb am 22.06.23 12:14:21
      Beitrag Nr. 6.759 ()
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      MannKind startet Inhale-3-Studie, um den derzeit größten ungedeckten Bedarf bei Erwachsenen mit Typ-1-Diabetes (T1D) zu decken
      22.06.23
      PDF-Version
      Große Studie mit Erwachsenen zum Vergleich von HbA1c und der Kontrolle zu den Mahlzeiten beim Wechsel von injizierbarem Insulin oder Pumpen zu inhaliertem Insulin (Afrezza® ( Insulin Human) Inhalationspulver)
      Trotz der Fortschritte in der Diabetes-Technologie bleibt die Einhaltung der Zeitspanne während der Wachstunden eine Herausforderung
      Mangelnde Kontrolle der Essenszeit ist das zugrunde liegende Problem, das etwa 80 % (1) der T1D-Bevölkerung daran hindert, das HbA1c-Ziel zu erreichen
      DANBURY, Conn.UndWESTLAKE VILLAGE, Kalifornien.,22. Juni 2023 (GLOBE NEWSWIRE) --MannKind Corporation(Nasdaq: MNKD) , ein Unternehmen, das sich auf die Entwicklung und Vermarktung von inhalativen therapeutischen Produkten und Geräten für Patienten mit endokrinen und seltenen Lungenerkrankungen konzentriert, gab heute bekannt, dass es die INHALE-3-Studie startet, um den derzeit größten ungedeckten Bedarf bei Erwachsenen zu decken Leben mit T1D.

      „Diese große Studie ist geplant, um die Verbesserung der Blutzuckerkontrolle zu den Mahlzeiten zu bewerten, die für die Mehrheit der Menschen mit Typ-1-Diabetes weiterhin eine große Herausforderung darstellt“, sagte erMichael Castagna, PharmD, Chief Executive Officer vonMannKind Corporation. „INHALE-3 wird die Wirkung von Afrezza auf die Kontrolle der Essenszeit untersuchen, das ein Zeitwirkungsprofil aufweist, das dem von physiologischem Insulin in den ersten 120 Minuten nach einer Mahlzeit sehr ähnlich ist.“

      INHALE-3 ist eine 17-wöchige randomisierte kontrollierte Studie mit einer Verlängerung um 13 Wochen. Im Rahmen der Studie werden Teilnehmer über 18 Jahren mit Typ-1-Diabetes, die MDI, ein automatisiertes Insulinabgabesystem (AID) oder eine Pumpe ohne Automatisierung verwenden, nach dem Zufallsprinzip ausgewählt, um entweder ihre übliche Pflege fortzusetzen oder eine Insulinkur mit Basalinjektionen plus Afrezza einzuführen. In beiden Armen wird eine kontinuierliche Glukoseüberwachung zur Beurteilung der Mahlzeitenkontrolle und der A1c-Werte eingesetzt.

      „Menschen mit Diabetes verdienen Optionen und Innovationen, die Belastungen reduzieren und eine wirksame Glukosekontrolle ermöglichen können“, sagte Dr.Irl B. Hirsch, Professor für Medizin und Diabetesbehandlung und Lehrstuhlinhaber an derUniversität von Washington. „Als Protokollleiter der INHALE-3-Studie freue ich mich darauf, mit führenden klinischen Standorten im ganzen Land zusammenzuarbeiten, um aussagekräftige Daten zur Verwendung von inhaliertem Insulin zu sammeln.“

      Ungefähr 120 Patienten werden in der Studie, die in Zusammenarbeit mit dem durchgeführt wird, randomisiertJaeb-Zentrum für Gesundheitsforschungund 20 Standorte im ganzen Land, darunter dieJoslin Diabetes Center, DieBarbara Davis Center für Diabetes, DieDiabetes-Institut der Universität Washington,Nordwestliche Universität,Mayo-Klinik, UndDiabetes Care Center der University of North Carolina.

      Weitere Informationen zu INHALE-3 und die Liste der teilnehmenden Standorte finden Sie unter: https://clinicaltrials.gov/ct2/show/NCT05904743 .
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