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Post by MnkdWASmyRtrmntPlan on Aug 4, 2022 10:51:38 GMT -5
I’m a bit surprised and confused by Martine’s comment on 50/50 split between DPI and nebulizer. My thoughts is maybe some later stage or those with an inability to use an inhaler properly for whatever reason (age, frail, can’t take a deep breath, etc) would benefit from the nebulizer where they don’t really have to do any work other than breath in the aerosol. Anyone have any better guesses? Martine went from 70% conversion to 50%, despite admitting it is more convenient and effective. Sorry Mango, I just took notes during the live broadcast and couldn't rewind to play-back, so I'm sure there are lots of mistakes and blanks there. I just thought I would get some info out until transcripts were made available. In particular, that was my mistake - I think it should have been 50/50 between PAH and ILD (not DPI and nebulizer). I guess my transcript was correct afterall. It was pointed out in another thread that it is actually 50/50 DPI/nebulizer.
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Post by neil36 on Aug 4, 2022 10:59:52 GMT -5
-Oppenheimer Adjusts United Therapeutics Price Target to $325 From $300, Maintains Outperform Rating 10:01 AM ET, 08/04/2022 - MT Newswires If anyone has access to the Oppenheimer report, it would be interesting what comments are made about DPI,the royalties and supply agreement with Mannkind
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Post by prcgorman2 on Aug 4, 2022 11:51:11 GMT -5
I’d like to know what version of Tyvaso they’re using for their TETON, etc., studies.
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Post by georgethenight2 on Aug 4, 2022 20:12:55 GMT -5
MY (VERY SKETCHY) NOTES FROM THE CALL: Martine: 30% growth rate year after year. We are now at 2 billion/year. 3 generations. 3 heats coming in the years ahead: 1. double our products, which will get us to a revenue doubling (esp tyvaso). 2 billion to 4.2. 2025 - approval of Teton study. Additional 4 billion in rev. 8 bill revenue half hypertension and half ild 3. ? YOY doubled tyvaso revenue. Tyvaso - 3 events 1st shipments started in june 2.will continue in qtr 3 3. strong second half Strong 2nd half particularly for tyvaso Opennheimer question: Jeffrey: trial in copd patients- why did you change the study protocol? - they modified the trial due to a preplanned & preapproved protocol design change at 2 or 3 different points. Changing from a cross-over to parallel design for highest probability of successful outcome. They will be completing phase 3 using parallel method. ?: missed question on tyvaso: Mike Bankowitz: penetration on the phild base - isa? phild & tyvaso. Increased subscriber base in second quarter. ?: how much increase in revenue will come from ILD, etc. - Martine: 50/50 between nebulized and tyvaso dpi. Wedbush: expand on DPI vs. nebulized. no real substance to comment (already been answered). what next for organ transplant - great progress in new facility. substantial completion of facility by 2023. continuing non-human primate studies. Martine: summary-growth from 2 to 4 billion including expansion of tyvaso and remodulin. Teton study - pulmonary fibrosis will be successful. That business will double from 4 to 8 billion. Finally, organ mfg will be able to monitize IT as they build from kidneys, lungs, liver transplants ... 3D printing. We should really focus on these numbers. Royalties alone might be triple or quadruple of Afrezza sales!! While I am not trying to get ahead of myself, the CEO herself has made her intention clear. They are growing their patient base, and while we the mix will be ONLY 50%, we are going to be making BANK! I really hope MC can find something similar to DPI. With adequate capital, MNKD will be a beast. I foretell all haters being sweep away with the tsunami of upgrades and FOLO buyers. This also brings me to UTHR, they are essentially looking to see sell an amount of drug, equal to their CURRENT market cap. This is amazing. If I had some more cash I would be a buyer. But, personally the real growth will be with Mannkind; worldwide approval, black box removed, pediatrics etc... need I go on?
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Post by mytakeonit on Aug 5, 2022 2:44:18 GMT -5
So ... BUY ALL THE CHEAP SHARES YOU CAN !!!
But, that's mytakeonit
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Post by Clement on Aug 24, 2022 8:07:38 GMT -5
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Post by kite on Sept 2, 2022 7:09:23 GMT -5
United Therapeutics Prevails in Dry Powder Inhaler Patent Litigation ir.unither.com/news/press-releases/press-release-details/2022/United-Therapeutics-Prevails-in-Dry-Powder-Inhaler-Patent-Litigation/default.aspxSILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States District Court for the District of Delaware issued an opinion in the pending litigation concerning United Therapeutics’ U.S. patents 9,593,066 (the ’066 patent) and 10,716,793 (the ’793 patent). This litigation concerns whether Liquidia Technologies, Inc.’s proposed treprostinil inhalation powder, YutrepiaTM, would infringe the ’066 and ’793 patents. The Court determined that Liquidia would induce infringement of various claims of the ’793 patent by marketing Yutrepia. The ‘793 patent relates to a method of administering treprostinil via inhalation. The Court also concluded that Liquidia failed to prove that any claim of the ’793 patent at issue is invalid. As a result of the Court’s decision, United Therapeutics expects the Court to enter an injunction barring the U.S. Food and Drug Administration from granting final approval for Yutrepia until expiration of the ’793 patent, May 14, 2027, as required by 35 U.S.C. § 271(e)(4)(A). The Court also determined that Yutrepiawould infringe several claims of the ’066 patent, but found those claims to be invalid. 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. Both parties have the right to appeal. United Therapeutics is evaluating the Court’s opinion and next steps, including the potential for appealing the Court’s decisions on the ’066 patent. “We’re pleased with the Court’s decision on the ’793 patent, and our legal team is evaluating options for the ’066 patent,” said Shaun Snader, Vice President and Associate General Counsel – IP and Litigation at United Therapeutics. “Today’s decision vindicates our claims that Yutrepia is an infringing product, and we will continue to vigorously defend our intellectual property.” The Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office recently issued a final written decision in an inter partes review (IPR) of the ’793 patent initiated by Liquidia. That final written decision held that the ’793 patent is invalid. United Therapeutics has requested rehearing regarding that decision, and if the PTAB does not reverse itself, the company will appeal. The ’793 patent remains valid during the pendency of all appeals. United Therapeutics expects any IPR appeal process will likely take at least a year. During that time, the company expects that the Court’s forthcoming injunction will remain in place and will not be lifted until such time, if ever, that the ’793 patent is held invalid or not infringed after all appeals have been exhausted.
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Post by Clement on Sept 7, 2022 9:03:53 GMT -5
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Post by Clement on Sept 7, 2022 11:45:25 GMT -5
"PERFECT" -- from a UT 2nd quarter press release on Aug. 3: "Tyvaso in PH-COPD — PERFECT. Enrollment is ongoing for the phase 3 PERFECT study evaluating Tyvaso for the treatment of WHO Group 3 pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). Recently, we decided to trigger a pre-specified transition and convert the PERFECT study from a crossover study into a single treatment period of 12 weeks. While this increased the size of the study from 136 patients to 314 patients, we believe this decision may increase site and subject participation with a simpler, shorter, and more traditional study design." So, during the 2nd quarter, UT decided to increase the number of patients significantly. It seems to me this puts any announcement or readout into the 4th quarter.
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Post by Clement on Sept 15, 2022 7:09:07 GMT -5
Now there's an update on clinicaltrials.gov which says, "Estimated Primary Completion Date : December 31, 2024"
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Post by lex8955 on Sept 15, 2022 7:30:00 GMT -5
VRNA drug for COPD is in Phase 3 and going to be submitted to FDA in 1qtr. 2023.
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Post by Clement on Sept 15, 2022 7:43:25 GMT -5
VRNA drug for COPD is in Phase 3 and going to be submitted to FDA in 1qtr. 2023. UT's trial is to treat "Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)". I agree that verona has drugs for COPD but I don't think they go head to head for this same exact indication. If you have found a Verona trial for "PH due to COPD", please post your source.
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Post by lex8955 on Sept 15, 2022 19:13:09 GMT -5
Thanks and you are right.
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Post by peppy on Sept 15, 2022 19:17:53 GMT -5
VRNA drug for COPD is in Phase 3 and going to be submitted to FDA in 1qtr. 2023. UT's trial is to treat "Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)". I agree that verona has drugs for COPD but I don't think they go head to head for this same exact indication. If you have found a Verona trial for "PH due to COPD", please post your source. I am thinking the Catch 22 is Abstract. Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD). Its presence is associated with shorter survival and worse clinical evolution. In COPD, pulmonary hypertension tends to be of moderate severity and progresses slowly. Plus COPD is an alveolar disease. Catch 22 most people with COPD will present with Pulmonary Hypertension.
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Post by neil36 on Sept 20, 2022 5:58:31 GMT -5
From Stocktwits (attributed to Bloomberg but I haven't found any other mention this morning):
On September 20, 2022, United Therapeutics Corporation (the Company) announced the termination of the PERFECT clinical study evaluating Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease. The Company terminated the study based upon a recommendation of the study’s independent Data Safety Monitoring Committee (DSMC), following a routine safety and efficacy analysis conducted by the DSMC. The Company will review the available data from the study and plans to share the results with the scientific community.
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