Myovant Sciences Ltd (MYOV)

[Cosa]

Sorry about that! I think it was my frustration waking up negative 20% lol. Bought a chunk and lowered my average down to 12.91. Underwater but still have hopium. Good luck!

[DewDiligence]

Got it. I wasn't sure what you meant b/c what I posted was a company press release.

[Cosa]

It was the article you posted. But let me make a correction in my statement. It is not FUD. It is material information of an FDA review in which they found errors. In my opinion there was an over reaction causing the SP to fall. We will not know the results of the sNDA until a future date. This could be a great buying opportunity. I added shares today.

Good luck
MYOV!

[DewDiligence]

Which article are you referring to?

[Cosa]

Article look like FUD to me. I bought more.

[Paullee]

sounds like another buying op

[DewDiligence]

MYOV/PFE—Myfembree sNDA in endometriosis hits undisclosed snag:

https://www.globenewswire.com/news-release/2022/04/12/2420541/0/en/Myovant-Sciences-and-Pfizer-Provide-Update-on-Supplemental-New-Drug-Application-for-MYFEMBREE-for-the-Management-of-Moderate-to-Severe-Pain-Associated-with-Endometriosis.html

In accordance with the ongoing review of the application, on April 6, 2022, the U.S. Food and Drug Administration (FDA) provided notice to the companies that the agency identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.

The FDA did not provide additional detail. The FDA noted that the letter does not reflect a final decision on the pending sNDA and that the application is still under review. Myovant and Pfizer will continue to work with the FDA to determine next steps with the application.

The PDUFA date is 5/6/22.

[Cosa]

Need to break through $15

[Cosa]

Double bottom and consolidating. Hopefully we continue to move up slowly back to $20.

[Cosa]

When you think it's cheap and it keeps going down (Face Palm Emoji)

[DewDiligence]

MYOV—CHMP approves Orgovyx for HSPC:

https://www.globenewswire.com/news-release/2022/02/25/2392377/0/en/Myovant-Sciences-Receives-Positive-CHMP-Opinion-for-ORGOVYX-relugolix-for-the-Treatment-of-Advanced-Prostate-Cancer.html

MYOV is still seeking a partner for the European rights to Orgovyx. The PR says MYOV expects to have a deal in the next two months or so.

[Cosa]

Added more shares today at $12.80. So cheap!

MYOV

[DewDiligence]

Correction: FY3Q21. (FY2021 ends 3/31/22.)

[DewDiligence]

MYOV FY3Q22 results…

PR:
https://www.globenewswire.com/news-release/2022/01/26/2373340/0/en/Myovant-Sciences-Announces-Financial-Results-for-Third-Quarter-of-Fiscal-Year-2021-and-Corporate-Updates.html

CC slides:
https://investors.myovant.com/static-files/dd5fd544-5f29-4ab7-9089-13a416dde95b

[Cosa]

Bought more shares this morning.

MYOV!

[Cosa]

Added more this morning, it's so beaten down. And for what?...

[Paullee]

good move

[Cosa]

Added more under $14

[Cosa]

just bought more today on this nice dip!

MYOV!

[Cosa]

Added more today under $14!

Go MYOV!

[Cosa]

Added some today, didn't have powder last week Friday.

[Cosa]

New 52 week low, my bio's are getting crushed! Good time to start grabbing more.

[Optionsrbest4u]

Failed to participate in yesterday's rally -

Resting on 1-year support.

Wouldn't mind at all acquiring shares at around $15

[Cosa]

Wow, when was the last time it was down this far...

[Archivoid]

Yeah but there are other BPs looking to buy. Waiting on sumi. I was busy buying today.

[DewDiligence]

The stock is down because of PFE's decision to not opt in:

#msg-166513002

[Archivoid]

Surprised this board is silent today. Thinking we might see red to green here soon. Love to see the beat on earnings.

[Cosa]

MYOV! moving on up. again..

[Cosa]

Creeping back up

[DewDiligence]

MYOV/PFE think Myfembree has a significant convenience edge relative to ABBV’s Oriahnn. Myfembree is one pill qD, while Oriahnn requires one pill in the morning and a different pill (Elagolix alone, without the two hormone drugs) in the evening.

Myfembree’s US list price will be the same as Oriahnn’s.

[DewDiligence]

MYOV/PFE CC slides on Myfembree launch:

https://investors.myovant.com/static-files/f4ae5146-2ff5-4d90-a654-1afadfd401cd

[DewDiligence]

The FDA simply completed the review before the PDUFA date. This happens sometimes when the BLA/NDA is a slam dunk.

[Paullee]

Guess the PUDUFA date was moved up

[MDizzle]

Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE

the first once-daily treatment for heavy menstrual bleeding associated with uterine fibroids


In the Phase 3 LIBERTY 1 and LIBERTY 2 studies, MYFEMBREE demonstrated 72.1% and 71.2% response rates in menstrual blood loss (MBL) at Week 24, with MBL reductions of 82.0% and 84.3% from baseline. Myovant and Pfizer will jointly commercialize MYFEMBREE, with product availability expected in June.

[Paullee]

they were not real sales. They were made to pay the taxes on their "free"
shares that vested.

[Cosa]

Insiders selling, last sale was 30,000 shares last week.

[DewDiligence]

Brief comments on today's news: #msg-162759644.

[MDizzle]

Myovant, Pfizer See Positive Data From Uterine Fibroids Therapy Study


By Chris Wack


Myovant Sciences Ltd. and Pfizer Inc. said Wednesday they saw positive data from the Phase 3 study of relugolix combination therapy in women with uterine fibroids.

The companies said this study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.

The study met its primary endpoint, with 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate of menstrual blood loss of less than 80 mL through week 76, compared with 15.1% of women who discontinued treatment and initiated placebo at week 52, the companies said.

All three key secondary endpoints were also achieved, including sustained responder rate at two years, time to relapse of heavy menstrual bleeding, and amenorrhea rate.

Through two years, 69.8% of women who continued on relugolix combination therapy remained responders, the companies said. And 88.3% of women who discontinued treatment at Week 52 relapsed with heavy menstrual bleeding, with a median time of return to heavy menstrual bleeding of 5.9 weeks.

The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed. The most commonly reported adverse event in at least 10% of women treated with relugolix combination therapy was nasopharyngitis.

Relugolix combination tablet is under review by the U.S. Food and Drug Administration for the treatment of women with uterine fibroids, with a decision expected by the June 1, 2021, target action date.

[Paullee]

yes, one of the non events that G S spoke of, ha!

[MDizzle]

Myovant Sciences, Pfizer Report Positive Results From Relugolix Trial






Myovant Sciences and Pfizer Inc. reported positive results from a Phase 3 long-term extension study of the investigational once-daily relugolix combination.

The companies said the therapy in women with endometriosis showed clinically meaningful reductions in dysmenorrhea and nonmenstrual pelvic pain over one year with minimal and stable bone mineral density loss. The data were consistent with the efficacy and safety profile observed through 24 weeks in the previous Phase 3 studies.

These results will be included in the new drug application to the U.S. Food and Drug Administration for relugolix combination tablet for the treatment of women with endometriosis, which the companies intend to submit in the first half of 2021, they said.

In the long-term extension study, 84.8% and 73.3% of women receiving relugolix combination therapy over one year achieved clinically meaningful pain reductions in dysmenorrhea and nonmenstrual pelvic pain, respectively. Bone mineral density remained stable through Week 52 in women treated with relugolix combination therapy after minimal, nonclinically meaningful bone loss through Week 24, the companies said.

In December, Myovant and Pfizer entered into a collaboration for the development and commercialization of relugolix in oncology and women's health in the U.S. and Canada. Myovant and Pfizer will jointly develop and commercialize Orgovyx relugolix in advanced prostate cancer and, if approved, relugolix combination tablet in uterine fibroids and endometriosis, they said.

[Cosa]

Added some shares today.

[DewDiligence]

MYOV hires new CEO:

https://www.globenewswire.com/news-release/2021/01/04/2152496/0/en/Myovant-Sciences-Appoints-Industry-Veteran-David-Marek-as-Chief-Executive-Officer.html

Mr. Marek is a veteran biopharmaceutical executive with over 30 years of experience in the industry. He brings to Myovant the commercial expertise of a seasoned pharmaceutical executive, the strategic prowess from leading one of the world’s most successful healthcare advertising agencies, as well as the consumer and digital marketing know-how from one of the most popular health information portals, WebMD. Mr. Marek joins Myovant from Axsome Therapeutics where he was chief commercial officer responsible for building out commercial capabilities in preparation for multiple expected launches.

The PR praises outgoing CEO, Lynn Seeley, but it says nothing about her reason for leaving or where she is going.

[MDizzle]

I think it will hit it.

[Cosa]

Lol. Hopefully not till 2022. $650 mill should last the year right...

[Paullee]

Evercore reiterates it's 55 target

[SurgeGuy2.0]

When will the new Offering/Dilution for 2021 be announced?

[Cosa]

Amazing how this went down on FDA approval and went up on Pfizer collaboration. Got me scratching my head.

[Cosa]

I think this has more upside potential. What do you guys think? $45...wait it out?

[BottomBounce]

$MYOV & $GEVO https://www.prnewswire.com/news-releases/thinking-about-buying-stock-in-ocugen-marathon-phunware-myovant-sciences-or-gevo-301198613.html

[MDizzle]

Myovant Sciences, Pfizer to Develop, Commercialize Relugolix



7:03 AM ET 12/28/20 | Dow Jones

By Colin Kellaher


Myovant Sciences Ltd. on Monday said it would collaborate with Pfizer Inc. to develop and commercialize relugolix in oncology and women's health in the U.S. and Canada in a deal potentially worth more than $4 billion to Myovant.

The companies plan to jointly develop and commercialize Orgovxy (relugolix) in advanced prostate cancer and, if approved, a relugolix combination tablet for women's health in the U.S. and Canada.

Myovant and Pfizer would equally share profits and certain expenses for Orgovxy and the relugolix combination tablet, with Myovant recording revenue, the company said.

Myovant said it would receive up to $4.2 billion under the deal, including an upfront payment of $650 million, $200 million in potential regulatory milestones for U.S. Food and Drug Administration approvals for the relugolix combination tablet, and tiered sales milestones.

Myovant said it would receive $50 million and be entitled to double-digit royalties on sales if Pfizer exercises an option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries.