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Post by harryx1 on Dec 1, 2023 15:17:05 GMT -5
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Post by wyattdog on Dec 1, 2023 15:28:26 GMT -5
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Post by wyattdog on Dec 7, 2023 12:08:12 GMT -5
United Therapeutics Named by Newsweek as One of America’s Most Responsible Companies 2024 6:00 AM ET, 12/07/2023 - Business Wire SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Dec. 7, 2023--United Therapeutics (Nasdaq: UTHR), a public benefit corporation, today announced that the company has been named on Newsweek’s list of America’s Most Responsible Companies 2024. This award is presented by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider. The list of awards was announced on December 6, 2023, is available on Newsweek’s website, and recognizes the top 600 most responsible companies in the United States, spanning 14 industries.
America’s Most Responsible Companies were selected based on publicly available key performance indicators derived from Corporate Social Responsibility Reports and Sustainability Reports, as well as an independent survey asking U.S. residents about their perception of company activities related to corporate social responsibility. The key performance indicators focused on company performance in the environmental, social, and corporate governance areas, while the independent survey asked U.S. citizens about their perception of company activities related to corporate social responsibility.
United Therapeutics’ 2023 Corporate Responsibility and Public Benefit Report can be found at corporateresponsibility.unither.com.
“Maintaining the trust of all our stakeholders – our shareholders, patients, employees, and the communities in which we live and work – is core to our purpose and success,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics Corporation. “We are honored to be named among America’s Most Responsible Companies by Newsweek and Statista again this year, which reinforces our efforts as a public benefit corporation to operate responsibly and as a careful steward of all of our capital – human, natural, and financial.”
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. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
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Post by peppy on Dec 20, 2023 9:54:49 GMT -5
UTHR is being sold hard today, with volume. United Therapeutics Corporation $230.01. -4.27%. -10.25
That same volume took MNKD down from $3.995 to Volume: 755,944 DEC 20, 2023 9:59 AM ET....... 30 mins of trade.
$3.8599 -0.0501 (-1.28%)
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Post by wyattdog on Dec 20, 2023 17:09:39 GMT -5
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Post by Clement on Dec 21, 2023 7:15:13 GMT -5
This 8K gives us UTHR's perspective on the court decision of Dec. 20, 2023. It sounds to me like UTHR is not finished delaying Yutrepia, especially for PH-ILD. "On December 20, 2023, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) issued a decision regarding United Therapeutics Corporation’s (United Therapeutics or the Company) U.S. Patent No. 10,716,793 (the ’793 patent). The Federal Circuit affirmed the inter partes review (IPR) decision from the Patent Trials and Appeals Board that the claims of the ’793 patent should be canceled as invalid. Liquidia Technologies, Inc. (Liquidia) initiated the IPR. The '793 patent is listed in the Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations publication, also known as the Orange Book, for Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI® (treprostinil) Inhalation Powder, both of which are marketed by United Therapeutics. The Federal Circuit had earlier affirmed a separate decision by the U.S. District Court for the District of Delaware that Liquidia’s proposed Yutrepia™ product infringes the ’793 patent and that Liquidia had not proved invalidity of the ’793 patent. Thus, Liquidia is currently barred from obtaining final approval from FDA for launch of its proposed Yutrepia product until expiration of the ’793 patent. The Federal Circuit’s December 20th decision would allow Liquidia to launch its proposed Yutrepia product prior to the ’793 patent’s expiration unless the Federal Circuit’s decision is reversed. United Therapeutics has the right to seek rehearing of this decision by the Federal Circuit and/or seek review of this decision by the U.S. Supreme Court. The Company is currently evaluating its options. The claims of the ‘793 patent are not canceled until all appeals are exhausted. The FDA tentatively approved Liquidia’s new drug application (NDA) for Yutrepia to treat pulmonary arterial hypertension (PAH) on November 2021. In order to launch Yutrepia, (a) the District Court will need to lift its order barring FDA approval of the NDA, and (b) and FDA would need to grant final approval of the NDA. Further, in September 2023, Liquidia announced it had amended its NDA for Yutrepia to include the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), and that the FDA had set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024 to review Liquidia’s NDA. In September 2023, United Therapeutics filed a new lawsuit against Liquidia asserting that Liquidia’s proposed amended NDA infringes the ‘793 patent. In November 2023, United Therapeutics amended its complaint in this new litigation to add a claim for infringement of a newly-issued patent, U.S. Patent No. 11,826,327. This new patent expires in January 2042, and covers the use of inhaled treprostinil at specific dosages to improve exercise capacity in PH-ILD patients."
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Post by wyattdog on Dec 21, 2023 16:04:25 GMT -5
Oppenheimer Remains Bullish on United Therapeutics Despite Patent Setback 3:43 PM ET, 12/21/2023 - MT Newswires 03:43 PM EST, 12/21/2023 (MT Newswires) -- Oppenheimer said it remained bullish on United Therapeutics (UTHR) despite the recent patent setback involving Tyvaso.
In a note emailed Thursday, the firm noted that the negative stock reaction to United Therapeutics' failed attempt to revive a patent for Tyvaso discounted extreme scenarios and suggested that investors buy the stock during this dip.
On Wednesday, the US Court of Appeals for the Federal Circuit upheld the cancellation of a patent for Tyvaso, paving the way for rival Liquidia's (LQDA) Yutrepia to enter the market.
Noting that the court decision was expected, Oppenheimer said about 10% to 20% of Tyvaso sales were at risk in pulmonary arterial hypertension. However, the actual effect on the medicine's sales would be less as physicians rarely switch stable patients between treatments.
The firm maintained its outperform rating on the company's stock with a price target of $375.
Price: 218.50, Change: -7.01, Percent Change: -3.11
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Post by Clement on Dec 29, 2023 8:02:02 GMT -5
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C., December 29, 2023--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Dr. Martine Rothblatt, Chairperson and Chief Executive Officer, will provide an overview and update on the company’s business during a presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation will take place on Monday, January 8, 2024, from 11:15 a.m. to 11:55 a.m., Pacific Standard Time, and can be accessed via a live webcast on the United Therapeutics website at ir.unither.com/events-and-presentations.
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Post by wyattdog on Jan 23, 2024 10:48:36 GMT -5
Liquidia Technologies provides patent litigation update 7:36 AM ET, 01/23/2024 - Briefing.com As previously disclosed, United Therapeutics Corporation (UTHR) filed an amended complaint in the patent infringement action in the United States District Court for the District of Delaware (the "District Court") under the Drug Price Competition and Patent Term Restoration Act (the "Hatch-Waxman Act") alleging the infringement of U.S. Patent No. 10,716,793 (the "'793 Patent") and U.S. Patent No. 11,826,327 (the "'327 Patent") in response to the Company's amendment to add the pulmonary hypertension associated with interstitial lung disease ("PH-ILD") indication to the label for the tentatively approved New Drug Application ("NDA") for YUTREPIA (treprostinil) inhalation powder (the "New Hatch-Waxman Litigation"). On January 22, 2024, United Therapeutics filed a stipulation to dismiss all claims in the New Hatch-Waxman Litigation related to the '793 Patent. As a result of the dismissal of the claims related to the '793 Patent, only the claims related to the '327 Patent remain in the New Hatch-Waxman Litigation. As previously disclosed, because the '327 Patent was not issued prior to the filing of the original NDA for YUTREPIA or the filing of the amendment to the NDA for YUTREPIA to add the PH-ILD indication to the label, the Company does not believe that United Therapeutics is entitled to a statutory 30-month regulatory stay by statute. Section 505(c)(3)(C) of the Federal Food, Drug and Cosmetic Act, by its terms, provides for a 30-month stay only with respect to patents submitted for inclusion in the Orange Book prior to the filing of a given new drug application. As previously disclosed, the claims of the '327 patent relate solely to the PH-ILD indication. This stipulation of dismissal of the '793 Patent does not affect the injunction issued by District Court in the first Hatch-Waxman lawsuit filed by United Therapeutics in June 2020 (the "Original Hatch-Waxman Litigation"). As previously disclosed, the Company has requested that the District Court set aside the injunction issued in the Original Hatch-Waxman Litigation. Briefing on the Company's request will be completed today, after which the parties will await the District Court's decision. Disclosures
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Post by agedhippie on Jan 23, 2024 23:07:26 GMT -5
The summary is UTHR and LQDA have agreed to remove the '793 patent from the lawsuit and take PAH out of the equation leaving just the '327 patent and PH-ILD. LQDA claim that since they filed before the '327 patent was in the Orange book there should be no stay on the approval (I think they will be right).
UTHR still have the exclusivity period until March 2024 for the PH-ILD indication granted by the FDA that is entirely independent of the lawsuit.
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Post by uvula on Jan 30, 2024 8:43:39 GMT -5
Check out egenesis. A company that is using CRISPER to genetically modify pigs so that their organs can be transplanted into humans. UTHR is also involved in research to modify pigs organs for human implantation.
(Original post edited to avoid confusion.)
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Post by Clement on Jan 30, 2024 9:22:43 GMT -5
Check out egenesis. A company that is using CRISPER to genetically modify pigs so that their organs can be transplanted into humans. UTHR is using a different approach to accomplish the same thing. Are you claiming that UTHR is not using CRISPR as a laboratory tool in its genetic modifications?
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Post by uvula on Jan 30, 2024 10:06:21 GMT -5
Check out egenesis. A company that is using CRISPER to genetically modify pigs so that their organs can be transplanted into humans. UTHR is using a different approach to accomplish the same thing. Are you claiming that UTHR is not using CRISPR as a laboratory tool in its genetic modifications? I did not intend to make this claim. I edited my original post. Thank you.
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Post by Clement on Jan 31, 2024 9:29:31 GMT -5
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Post by Clement on Feb 9, 2024 9:35:22 GMT -5
4Q 2022 Earnings Call was on Feb. 23, 2023.
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