ObsEva SA (OBSV)

[Pan_O_War]

[Pan_O_War]

ObsEva Q&A: addressing unmet needs in women’s health

[url]https://www.pharmaceutical-technology.com/features/obseva-unmet-needs-womens-health/
[/url][tag]insert-text-here[/tag]

https://www.pharmaceutical-technology.com/features/obseva-unmet-needs-womens-health/

[Pan_O_War]

ObsEva Q&A: addressing unmet needs in women’s health

[url]https://www.pharmaceutical-technology.com/features/obseva-unmet-needs-womens-health/
[/url][tag]insert-text-here[/tag]

https://www.pharmaceutical-technology.com/features/obseva-unmet-needs-womens-health/

[Pan_O_War]

Dilution over?

[Pan_O_War]

Milestones:

-Linzagolix (Yselty®) for uterine fibroids: US New Drug Application filing planned in Q3:21; European marketing approval recommendation anticipated in Q4:21-

-Linzagolix for endometriosis: Readout from Phase 3 EDELWEISS 3 study
expected in Q4:21-

-Ebopiprant: Global License Agreement completed with Organon -

-Actively pursuing new indications and partnerships to maximize value of pipeline candidates-

As of June 30, 2021, ObsEva had cash and cash equivalents of $58.9 million, compared with $31.2 million as of December 31, 2020.

[Pan_O_War]

Earnings: insert-text-here

https://www.obseva.com/pressrelease-detail/?pr=4468

[Pan_O_War]

ObsEva Announces Two Cornerstone Publications Describing Clinical Trials of Nolasiban for Improving Pregnancy and Live Birth Outcomes Following IVF

insert-text-here

https://www.obseva.com/pressrelease-detail/?pr=4434

[Pan_O_War]

There isn't much volume - just the odd super massive volume spikes!

[robsdaman]

Don’t like how the volume dried up today, not a good sign at all

[GolfFishSurf]

With good news this stock still goes down. Look at that 1-month chart..... this should be back to around $4+ already, but just keeps sinking.

[Theo]

"What if Goldman Sachs was like - let's algo walk the price down, seal the deal and scoop up a shit ton at low prices?"

I suppose anything is possible...

The price action yesterday left me extremely frustrated however. That was not a controlled selling into the market- the company simply dumped en mass. If you have news that will move markets, then why not simply feed in at higher prices? Yesterday's float rollover and yet all for relatively zero gain suggests to me that they were/are at a point of getting desperate for cash- and that scares me more as the then attitude becomes sell into the market and we'll R/S later when we get too bloated.

It may very well climb somewhat from here (I hope so for those that still hold) but I don't see significant moves to the upside from here, which is what I was looking for the past few months now that the company porked us good yesterday...

[Pan_O_War]

The majority of the accumulation occurred btn 10:30-11:30 a.m. at prices $3 and above.

After that the price really just drifted lower on lower volume.

[Pan_O_War]

Unless of course all the secondary offering shares have been or are close to being absorbed.

What if Goldman Sachs was like - let's algo walk the price down, seal the deal and scoop up a shit ton at low prices?

Share offering done + further good news (on Yselty) and BOOM!

[Theo]

Was good news, 68 million shares traded, (float rolled over) and yet the stock is flat for the month and down for the year? I'm out- something is definitely amiss here...

GLTA!

[Pan_O_War]

Hopefully this is absorbing any remaining shares from secondary offerings.

[make it happen]

News was already released... T1. Halt - News Pending. Trading is halted pending the release of material news.

[Frankestin]

a halt for t1 will be epic

[Pan_O_War]

And to think the NDA Submission still to come this quarter - it's GO TIME!

[Frankestin]

ObsEva is entitled to receive tiered double-digit royalties on commercial sales as well as up to $500 million in upfront and milestone payments including $25 million to be paid at signing, up to $90 million in development and regulatory milestones and up to $385 million sales based milestones. Goldman Sachs acted as exclusive financial advisor to ObsEva.

how much is the MC?

oh now the NDA for Yselty

[Pan_O_War]

Organon and ObsEva Enter Global License Agreement to Develop and Commercialize Ebopiprant (OBE022), an Investigational Agent Being Evaluated as a First-in-Class Treatment for Preterm Labor

insert-text-here

https://www.obseva.com/pressrelease-detail/?pr=4394&doing_wp_cron=1627370494.5277700424194335937500

[Pan_O_War]

Check this recap out form the Frugal Norwegian:

insert-text-here

https://frugalnorwegian.com/obsv/?playlist=eb6d908&video=293733f

[MyFiveCents]

I am new to this company.

What is the expected market size for the company drugs?

I see analysts have high price targets!

Thanks

[Pan_O_War]

Thank you.

[Theo]

Just to further elaborate, OBSV will present:

Session Date: Wednesday, July 7, 2021

Session Time: 4:00-5:30 p.m. ET

😎

[Pan_O_War]

ObsEva to Present Ebopiprant (OBE022) Data at the Society for Reproductive Investigation 68th Annual Meeting (7.6-9)

insert-text-here

https://www.obseva.com/pressrelease-detail/?pr=4382&doing_wp_cron=1625218329.0887610912322998046875

[Pan_O_War]

ObsEva Presents Clinical Data on Open-Label Pilot Study of Yselty® (linzagolix) for the Treatment of Severe Adenomyosis at ESHRE Virtual 37th Annual Meeting

insert-text-here


https://www.obseva.com/pressrelease-detail/?pr=4377

[Pan_O_War]

Agreed. I mean - I think OBSV will tick all the boxes and get everything.

Just time...

[GolfFishSurf]

I think we will get the European approval, but we are a long ways off in the U.S.

[Pan_O_War]

Will have to see how the market reacts.

Is the NDA significant, or only the FDA Approval?

I would think it would count for something - and hopefully a shift in the price floor upwards.


The other big parts are commercialization and European Marketing Approval (Q4).

[GolfFishSurf]

And with that, do we have a chance to get back to where we were in February?

[Frankestin]

it will be today or Wednesday... usually the Swiss are on time!

[Theo]

👍 👍 🍺 🍺

[Pan_O_War]

Q3 starts next week: NDA Submission imminent.

[Pan_O_War]

ObsEva To Present Data on Two Clinical Development Programs at ESHRE Virtual 37th Annual Meeting

insert-text-here

https://www.obseva.com/pressrelease-detail/?pr=4368

[Pan_O_War]

ObsEva Presents PROLONG Phase 2a Proof-of-Concept Data on Ebopiprant (OBE022) for the Treatment of Spontaneous Preterm Labor at the RCOG Virtual World Congress 2021


insert-text-here

https://www.obseva.com/pressrelease-detail/?pr=4358

[Frankestin]

Come on, only you are missing!
I would like to add a little something!


Yselty® for uterine fibroids:
– Submitting an NDA (New Drug Application) to the US Food & Drug Administration (Q2)
– Securing European marketing approval (Q4)
– Preparing for commercial launch
• Yselty® for endometriosis:
– Yielding topline data from the EDELWEISS 3 Phase 3 study (Q4)
• Ebopiprant:
– Initiating a Phase 2b dose ranging study (EU and Asia) (Q4)
– Discussing US clinical development with the FDA
• New opportunities:
– Exploring new indications, including the potential development of linzagolix in prostate
cancer treatment
– Seeking suitable strategic partnerships or other commercialization arrangements that
properly balance the current development needs with our retention of product value

[Pan_O_War]

ObsEva Announces Oral Presentation at the RCOG Virtual World Congress 2021

insert-text-here

https://www.obseva.com/pressrelease-detail/?pr=4332

[Theo]

ObsEva Annual General Meeting 2021 held Friday May 28, 2021

[criqsus]

To treat Uterine Fibroids its a combo of Ibuprophen and hormone treatments.
I dont see a drug that targets that specific condition
https://www.webmd.com/women/uterine-fibroids/understanding-uterine-fibroids-treatment

[criqsus]

Great page, a good effort once again. Durgs.com lists approx 76 drugs for endometriosis https://www.drugs.com/condition/endometriosis.html. As stated there is strong competition but if OBSV is strongly differentiated, they will have a good edge over the field of opponents.

[Theo]

Laid out nicely

[Pan_O_War]

Excellent coverage!

[frugalNorwegian]

I am now covering this company on my FrugalNorwegian site. I initially had good prospects about this company, but the competition for UF and Endometriosis will be fierce. I would appreciate any feedback on my OBSV page. Thanks!

https://frugalnorwegian.com/obsv/

[Pan_O_War]

Key Catalysts:

Commercialization Partner?
Q3 NDA Submission Q3
Q4 European Marketing Approval

[Pan_O_War]

On track for Q3 NDA Submission!

[Pan_O_War]

PR: ObsEva Announces Final Results from the Phase 3 PRIMROSE Program of Yselty® (linzagolix) for the Treatment of Uterine Fibroids

insert-text-here

https://www.obseva.com/pressrelease-detail/?pr=4275&doing_wp_cron=1621504935.4309470653533935546875

"Our EU MAA review is ongoing and we continue to prepare for our US NDA submission in Q3 2021."

[Theo]

$OBSV What's with the sudden splurge in pre-market volume about? I can't find any chatter anywhere...yet anywayz.

[Pan_O_War]

Yeah me too - good luck!

[Theo]

"The truth is - we just don't have full information."

Yep, and until circumstances change or otherwise dictate, I'll remain invested hanging on to Q3 and Q4 impact events.

[Pan_O_War]

I hear you - it's also a bit of head game when announcements like these happen.

Going thru a similar situation in another company/position.

The truth is - we just don't have full information.

But the bottom line bet is on Yselty UF - and that I think is a very solid BULLISH Bet.