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Post by boytroy88 on Apr 19, 2021 5:06:13 GMT -5
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Post by kite on Apr 19, 2021 5:24:35 GMT -5
Mannkind and United Therapeutics Reach a Milestone in the Development of Tyvaso DPI™ With New Drug Application Submitted to the FDA
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-and-united-therapeutics-reach-milestone-developmentFollowing Afrezza®, Tyvaso DPI is the second compound formulated with Technosphere® technology to be reviewed by FDA WESTLAKE VILLAGE, Calif. and DANBURY, Conn., April 19, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) and United Therapeutics (Nasdaq: UTHR) reached a milestone today in the development of Tyvaso DPI™ as United Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA). “The NDA submitted today by United Therapeutics builds upon a drug master file previously submitted by MannKind,” said Michael Castagna, CEO of MannKind Corporation. “We are excited to see the second compound formulated with our technology complete a rigorous clinical development program. If approved by the FDA, Tyvaso DPI is expected to provide a major advancement in the delivery of inhaled treprostinil for PAH and PH-ILD patients.” MannKind and United Therapeutics entered into a worldwide exclusive licensing and collaboration agreement in September 2018 for the development and commercialization of Tyvaso DPI, a dry powder formulation of treprostinil, delivered via a small, portable dry powder inhaler. Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder, which was approved by the FDA in 2014. Tyvaso DPI, if approved, is expected to provide a convenient choice of inhaled administration for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). There are approximately 45,000 treated PAH patients in the U.S. and United Therapeutics estimates at least 30,000 treatable PH-ILD patients in the U.S. United Therapeutics has applied a priority review voucher to the NDA that could provide for an FDA decision by December 2021. The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act. MannKind and United Therapeutics are also developing BluHale®, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help the patient track information about inhaler use. Tyvaso DPI is an investigational therapy that is not approved for any use in any country or indication and the Tyvaso DPI tradename is pending final FDA review.
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Post by kite on Apr 19, 2021 5:26:33 GMT -5
UNITED THERAPEUTICS ANNOUNCES SUBMISSION OF TYVASO DPITM NEW DRUG APPLICATION TO FDA
ir.unither.com/news/press-releases/press-release-details/2021/United-Therapeutics-Announces-Submission-of-Tyvaso-DPI-New-Drug-Application-to-FDA/default.aspxNDA submission includes both pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease indications Priority review voucher applied to the NDA submission SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Monday, April 19, 2021: United Therapeutics Corporation (Nasdaq: UTHR) today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Tyvaso DPITM, a novel dry powder inhalation formulation of treprostinil, for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1 pulmonary hypertension) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3 pulmonary hypertension). There are approximately 45,000 treated PAH patients in the U.S. and United Therapeutics estimates at least 30,000 treatable PH-ILD patients in the U.S. The submission includes the results of the recently-completed BREEZE clinical study evaluating the use of Tyvaso DPI in PAH patients transitioning from Tyvaso® (treprostinil) Inhalation Solution, along with additional pharmacokinetic data from a study in healthy volunteers. “In the BREEZE and pharmacokinetic studies, Tyvaso DPI demonstrated safety, tolerability, and a comparable pharmacokinetic profile to nebulized Tyvaso Inhalation Solution,” said Leigh Peterson, Ph.D., Senior Vice President, Product Development at United Therapeutics. “If approved by the FDA, we expect Tyvaso DPI will provide an advancement in the delivery of inhaled treprostinil therapy.” “Since our founding, we’ve worked hard to ensure our patients have ample choices to deliver treprostinil in various ways to suit their individual needs,” said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. “If approved, Tyvaso DPI will enable patients to go about their day with just a small breath- actuated, dry powder inhaler that easily fits inside a pocket and requires no batteries or external power source to operate.” “We’re excited for the potential for Tyvaso DPI to be one of our next product launches, assuming a timely approval in December of this year,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “The patient choice afforded by Tyvaso DPI, if approved, will help us achieve our goal of doubling the number of patients on Tyvaso therapy by the end of 2022. We remain committed to investigating, innovating, and delivering multiple therapies and treatments designed to help our patients manage their conditions.” United Therapeutics has applied a priority review voucher to the NDA that could provide for an FDA decision by December 2021. The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act. Tyvaso DPI is an investigational therapy that is not approved for any use in any country or indication and the Tyvaso DPI tradename is pending final FDA review. United Therapeutics expects to present data from the BREEZE study and the pharmacokinetic study in healthy volunteers at upcoming medical conferences and in forthcoming scientific publications.
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Post by dh4mizzou on Apr 19, 2021 6:25:40 GMT -5
Forgive the question of ignorance. Is this the expedited review that's been discussed?
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Post by boca1girl on Apr 19, 2021 7:35:15 GMT -5
Forgive the question of ignorance. Is this the expedited review that's been discussed? Yes. |
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Post by hellodolly on Apr 19, 2021 7:44:36 GMT -5
Forgive the question of ignorance. Is this the expedited review that's been discussed? Yes, but now it's no longer just a discussion centered around when the NDA will be submitted rather the discussion will now focus on revenue...something WS likes. |
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Post by longliner on Apr 19, 2021 7:45:10 GMT -5
Mannkind and United Therapeutics Reach a Milestone in the Development of Tyvaso DPI™ With New Drug Application Submitted to the FDA
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-and-united-therapeutics-reach-milestone-developmentFollowing Afrezza®, Tyvaso DPI is the second compound formulated with Technosphere® technology to be reviewed by FDA WESTLAKE VILLAGE, Calif. and DANBURY, Conn., April 19, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) and United Therapeutics (Nasdaq: UTHR) reached a milestone today in the development of Tyvaso DPI™ as United Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA). “The NDA submitted today by United Therapeutics builds upon a drug master file previously submitted by MannKind,” said Michael Castagna, CEO of MannKind Corporation. “We are excited to see the second compound formulated with our technology complete a rigorous clinical development program. If approved by the FDA, Tyvaso DPI is expected to provide a major advancement in the delivery of inhaled treprostinil for PAH and PH-ILD patients.” MannKind and United Therapeutics entered into a worldwide exclusive licensing and collaboration agreement in September 2018 for the development and commercialization of Tyvaso DPI, a dry powder formulation of treprostinil, delivered via a small, portable dry powder inhaler. Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder, which was approved by the FDA in 2014. Tyvaso DPI, if approved, is expected to provide a convenient choice of inhaled administration for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). There are approximately 45,000 treated PAH patients in the U.S. and United Therapeutics estimates at least 30,000 treatable PH-ILD patients in the U.S. United Therapeutics has applied a priority review voucher to the NDA that could provide for an FDA decision by December 2021. The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act. MannKind and United Therapeutics are also developing BluHale®, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help the patient track information about inhaler use.Tyvaso DPI is an investigational therapy that is not approved for any use in any country or indication and the Tyvaso DPI tradename is pending final FDA review. This is the first time I've read that BluHale is being co-developed by MNKD / UTHR. |
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Post by hellodolly on Apr 19, 2021 7:45:27 GMT -5
This is the first time I've read that BluHale is being co-developed by MNKD / UTHR. Glad I'm not the only who didn't miss that. That's a big bonus. |
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Post by longliner on Apr 19, 2021 7:48:31 GMT -5
This is the first time I've read that BluHale is being co-developed by MNKD / UTHR. Glad I'm not the only who didn't miss that. That's a big bonus. It sounds like they just put the "big boy pants" on BluHale! |
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Post by otherottawaguy on Apr 19, 2021 8:13:42 GMT -5
My question is this going to be a sell the news event (i.e. already priced in) or is this going to be the start of something wonderful?
OOG
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Post by Clement on Apr 19, 2021 10:16:57 GMT -5
My question is this going to be a sell the news event (i.e. already priced in) or is this going to be the start of something wonderful? OOG It's solid. The PR indicates that Rothblatt's projection of timeline for Tyvaso DPI is on schedule. This submission is another step done. The PR confirms that the $105M PRV has now been applied irrevocably to this NDA for Tyvaso DPI. Confirmation.I think this gives investors, and especially institutions, more confidence in the stock. It could take a few days for the tutes to start loading up. |
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Post by buyitonsale on Apr 19, 2021 11:57:16 GMT -5
"The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act." I guess short sellers are going to try and milk it until FDA acceptance, which should happen by end of June. And after the acceptance they will try and milk it until approval. Sounds like a solid plan  |
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Post by longliner on Apr 19, 2021 12:18:44 GMT -5
"The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act." I guess short sellers are going to try and milk it until FDA acceptance, which should happen by end of June. And after the acceptance they will try and milk it until approval. Sounds like a solid plan I'll bet their little shorts are feeling a bit snug this morning.  |
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Post by Clement on Apr 19, 2021 12:31:19 GMT -5
"The FDA must first accept the application for review and issue a formal decision date in accordance with the Prescription Drug User Fee Act." I guess short sellers are going to try and milk it until FDA acceptance, which should happen by end of June.
And after the acceptance they will try and milk it until approval. Sounds like a solid plan Acceptance might be a little faster. I'm looking at Appendix A (slide 51) of the link below. "day 30 for priority" www.fda.gov/media/78941/download |
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Post by sportsrancho on Apr 19, 2021 15:58:35 GMT -5
My question is this going to be a sell the news event (i.e. already priced in) or is this going to be the start of something wonderful? OOG It's solid. The PR indicates that Rothblatt's projection of timeline for Tyvaso DPI is on schedule. This submission is another step done. The PR confirms that the $105M PRV has now been applied irrevocably to this NDA for Tyvaso DPI. Confirmation.I think this gives investors, and especially institutions, more confidence in the stock. It could take a few days for the tutes to start loading up. Agree... and this is not priced in IMO |
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