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Post by Clement on Jul 24, 2023 12:18:33 GMT -5
Yutrepia can be marketed in March, 2027 or sooner if "all claims Liquidia was found to infringe are found invalid following exhaustion of all appeals."
Exhaustion of all appeals sounds like it could take a while. This is good news for UTHR and comes one week before the Q2 earnings call.
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Post by jkendra on Jul 24, 2023 12:41:58 GMT -5
Looks like this document was updated Jul 20th, 2023. This is in relation to United Therapeutic's trade secret lawsuit in which United claims former employee Robert Roscigno stole documents for Liquidia's benefit. If I remember correctly United was asking for a halt of Liquidia being able to release a product competing with Tyvaso. www.nccourts.gov/assets/documents/orders-of-significance/2023%20NCBC%20Order%2036.pdf?VersionId=CG5YCn5OABqzAvkEDj7vrSWWh4VDVa51STATE OF NORTH CAROLINA DURHAM COUNTY IN THE GENERAL COURT OF JUSTICE SUPERIOR COURT DIVISION 21 CVS 4094 UNITED THERAPEUTICS CORPORATION, Plaintiff, v. LIQUIDIA TECHNOLOGIES, INC. and ROBERT ROSCIGNO
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Post by agedhippie on Jul 24, 2023 13:26:24 GMT -5
The court result was highly predictable. Realistically there was no way the court would grant LQDA's appeal while UTHR's appeal against the rejection pf the '793 patent was outstanding. While UTHR is almost certain to lose the appeal the court couldn't put the genie back in the bottle if somehow UTHR won - they have to let UTHR's appeal run it's course before they allow LQDA to start selling.
On LQDA's part this appeal was never going to succeed for the reasons above, but they had to try because it would have taken 6 months off the launch time line as it currently stands (they could launch late 2023 rather than mid 2024). The drop in the LQDA price is people pulling out money for a few months and investing it elsewhere before coming back nearer the launch date (there's little point in leaving money tied up going nowhere for 6 months.)
The bottom line is that the launch remains on target for mid-2024.
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Post by hellodolly on Jul 24, 2023 14:43:14 GMT -5
The court result was highly predictable. Realistically there was no way the court would grant LQDA's appeal while UTHR's appeal against the rejection pf the '793 patent was outstanding. While UTHR is almost certain to lose the appeal the court couldn't put the genie back in the bottle if somehow UTHR won - they have to let UTHR's appeal run it's course before they allow LQDA to start selling. On LQDA's part this appeal was never going to succeed for the reasons above, but they had to try because it would have taken 6 months off the launch time line as it currently stands (they could launch late 2023 rather than mid 2024). The drop in the LQDA price is people pulling out money for a few months and investing it elsewhere before coming back nearer the launch date (there's little point in leaving money tied up going nowhere for 6 months.) The bottom line is that the launch remains on target for mid-2024. 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.
1. What are those circumstances as it relates to the moratorium? The ‘793 patent relates to a method of administering treprostinil via inhalation. 2. 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. Reads to me like once all appeals by UTHR are decided, the FDA approval for Yutrepia will be locked out until 2027 or, it comes down to the Federal decision. By then, seems all UTHR appeals will be exhausted. Right now, today is a victory for UTHR.
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Post by agedhippie on Jul 24, 2023 15:49:29 GMT -5
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.
1. What are those circumstances as it relates to the moratorium? The ‘793 patent relates to a method of administering treprostinil via inhalation. 2. 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. Reads to me like once all appeals by UTHR are decided, the FDA approval for Yutrepia will be locked out until 2027 or, it comes down to the Federal decision. By then, seems all UTHR appeals will be exhausted. Right now, today is a victory for UTHR. If and only if UTHR win their appeal against the invalidation of the '793 patent will LQDA have to wait until 2027. Right now the PTAB have ruled that the patent is invalid, the review ruled it invalid, and so UTHR appealed the review (which they will lose.) When UTHR loses that final appeal the patent is struck and the 2027 date becomes irrelevant since there is no-longer a patent to infringe. That's the source of the mid-2024 timeline - it's when judgement on the final appeal is delivered.
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Post by harryx1 on Jul 25, 2023 9:31:31 GMT -5
As you and Gregonius (on Stocktwits) speak in definitive terms regarding LQDA 100% winning all the appeals and launching in 2024, I hope people take caution. Not only is it not a certainty that LQDA will prevail, but if they do, it could still take years to go through the appeal process. The other item that I have brought up to Gregonius that he seems to ignore (and you probably will as well) is that the District Courts are not bound by PTAB decisions. The DC ruled that the patent was not invalid. The case is not black & white as you and Gregonius want people to believe, a lot can happen in courts that aren't expected. I've followed other companies that have been in patent disputes where it looked like one side had an iron clad case and end up losing. Again the District Court can supersede the Patent Death Squad aka PTAB and cases can be extended many, many years beyond the averages. Itzafugazi and I have both provided evidence of what I have stated above, so I hope people do their own DD. IMO, UTHR will at the very least do everything they can to drag the cases out to beyond the 2027 patent expiration. What happens when a district court and the PTAB disagree over the validity of a patent?
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Post by wyattdog on Jul 25, 2023 10:14:40 GMT -5
Update: United Therapeutics Says it Wins Patent Litigation Against Liquidia Over Yutrepia Inhaler 9:23 AM ET, 07/25/2023 - MT Newswires 09:23 AM EDT, 07/25/2023 (MT Newswires) -- (Updates with Liquidia Corp.'s response in the fifth and sixth paragraphs and the latest stock movement in the last paragraph.)
United Therapeutics (UTHR) said Monday that the US Court of Appeals for the Federal Circuit has affirmed a District Court decision that Liquidia Corp.'s (LQDA) proposed Yutrepia product infringes its patent.
As a result, the US Food and Drug Administration cannot provide final approval for Yutrepia until United's patent expires on May 14, 2027, the company said.
The appeals court affirmed that Liquidia would "induce infringement" of multiple claims of United's patent by marketing Yutrepia and failed to prove any claim of that patent was invalid, the company said.
Yutrepia (treprostinil) inhalation powder is indicated for the treatment of pulmonary arterial hypertension.
"With today's decision, only one of the three patents asserted against Liquidia stands in the way of seeking final approval for YUTREPIA. We remain confident that this single patent will no longer be at issue upon conclusion of the on-going appeal of the '793 IPR decision, which invalidated all claims in the patent," Liquidia Chief Executive Roger Jeffs said on the company's website Monday.
"It's been a long process, but as the record shows, there are no valid or infringed patent claims when you look at the full scope. This is a timing issue tied to legal process as UTHR tries to delay the final approval of YUTREPIA which in our opinion is the preferred product profile to meet patients' needs," a Liquidia spokesperson told MT Newswires in an emailed comment.
United Therapeutics shares slipped 0.3% in recent premarket activity Tuesday, while Liquidia shares were up 2.5%.
Price: 245, Change: -0.73, Percent Change: -0.3
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Post by Clement on Jul 26, 2023 6:45:21 GMT -5
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Post by wyattdog on Jul 31, 2023 14:19:02 GMT -5
United Therapeutics Corp expected to post earnings of $4.51 a share- Earnings Preview 07/31/2023 02:34 * United Therapeutics Corp is expected to show a rise in quarterly revenue when it reports results on August 2. * The Silver Spring Maryland-based company is expected to report a 12.3% increase in revenue to $524.171 million from $466.9 million a year ago, according to the mean estimate from 10 analysts, based on Refinitiv data. * ?Refinitiv's mean analyst estimate for United Therapeutics Corp is for earnings of $4.51 per share. * The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 9 "strong buy" or "buy," 1 "hold" and 2 "sell" or "strong sell." * The mean earnings estimate of analysts was unchanged in the last three months. ? * Wall Street's median 12-month price target for United Therapeutics Corp is $302.5?, above? its last closing price of $245.17. Previous quarterly performance (using preferred earnings measure in US dollars). ? QUARTER STARMINESM REFINITIV ACTUAL BEAT, SURPRI ENDING ARTESTIMAT IBES MET, SE % E? ESTIMATE MISSED Mar. 31 2023 4.41 4.52 4.86 Beat 7.4 Dec. 31 2023 4.54 4.51 2.67 Missed -40.8 Sep. 30 2022 4.00 3.89 4.91 Beat 26.1? Jun. 30 2022 4.02 4.13 2.41 Missed -41.7 ??Mar. 3.30 3.35 5.03 Beat 50.4 31 2022 Dec. 31 2021 3.68 3.72 2.35 Missed -36.8? Sep. 30 2021 3.58 3.59 3.42 Missed -4.8 Jun. 30 2021 3.01 3.02 3.65 Beat 20.9 This summary was machine generated July 31 at 18:34 GMT. All figures in US dollars unless otherwise stated
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Post by uvula on Jul 31, 2023 15:24:13 GMT -5
Refinitiv.com
Did refinitiv provide the data that were used by 10 analysts, or did refinitiv take the earnings estimates by 10 analysts and average them to come up with the numbers used in the article?
Either way, I don't think the numbers in the article have any more merit than numbers already guessed my our proboards members.
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Post by porkini on Jul 31, 2023 17:46:36 GMT -5
Refinitiv.com Did refinitiv provide the data that were used by 10 analysts, or did refinitiv take the earnings estimates by 10 analysts and average them to come up with the numbers used in the article? Either way, I don't think the numbers in the article have any more merit than numbers already guessed my our proboards members. Maybe you should contact your brokerage to see if they subscribe to this or similar service. I see the info through my Fidelity account, there is a very detailed PDF document that I cannot repost here as it is only available through my Fidelity logon. My brief look at that document quickly led me to believe a simple average is not used. (document name: Equity_Summary_Score_Methodology.pdf)
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Post by wyattdog on Aug 3, 2023 9:00:21 GMT -5
-Wedbush Lifts United Therapeutics' Price Target to $307 From $305 After 'Strong' Q2 Results, Keeps Outperform Rating 7:04 AM ET, 08/03/2023 - MT Newswires
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Post by wyattdog on Aug 3, 2023 11:51:05 GMT -5
Morgan Stanley Adjusts Price Target on United Therapeutics to $318 From $316, Maintains Overweight Rating 11:54 AM ET, 08/03/2023 - MT Newswires 11:54 AM EDT, 08/03/2023 (MT Newswires) -- (MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: www.mtnewswires.com/contact-us)Price: 234.18, Change: -6.68, Percent Change: -2.77 --Ladenburg Thalmann Adjusts Price Target on United Therapeutics to $268 From $256, Maintains Buy Rating 10:20 AM ET, 08/03/2023 - MT Newswires 10:20 AM EDT, 08/03/2023 (MT Newswires) -- (MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: www.mtnewswires.com/contact-us)Price: 231.87, Change: -8.99, Percent Change: -3.73
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Post by sr71 on Aug 3, 2023 13:40:31 GMT -5
Morgan Stanley Adjusts Price Target on United Therapeutics to $318 From $316, Maintains Overweight Rating 11:54 AM ET, 08/03/2023 - MT Newswires 11:54 AM EDT, 08/03/2023 (MT Newswires) -- (MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: www.mtnewswires.com/contact-us)Price: 234.18, Change: -6.68, Percent Change: -2.77 --Ladenburg Thalmann Adjusts Price Target on United Therapeutics to $268 From $256, Maintains Buy Rating 10:20 AM ET, 08/03/2023 - MT Newswires 10:20 AM EDT, 08/03/2023 (MT Newswires) -- (MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: www.mtnewswires.com/contact-us)Price: 231.87, Change: -8.99, Percent Change: -3.73 Perhaps mytakeonit could correct UTHR's pricing with a little of his own spare change?
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Post by boca1girl on Aug 6, 2023 14:25:12 GMT -5
UTHRs closing price on Friday was up, $4.50 to close at $236.37 on high volume. A one day drop after earnings. MNKD had similar price action.
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