ObsEva SA (OBSV)

[Frankestin]

According to the U.S. National Institutes of Health (NIH), 20-25% of women of reproductive age have fibroids.
https://www.health.ny.gov/community/adults/women/uterine_fibroids/
Yselty is indicated for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Assuming 10/20% have moderate to severe symptoms of uterine fibroids ... the numbers are staggering!
it seems that patience is needed!

[Frankestin]

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/yselty

[Frankestin]

https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-yselty_en.pdf

[Frankestin]

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-april-2022

[Frankestin]

3.6. Initial applications in the decision-making phase
3.6.1. linzagolix choline - EMEA/H/C/005442
for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids Scope: Revised opinion
Action: For adoption
List of Questions adopted on 24.02.2022. Opinion adopted on 16.12.2021. List of Outstanding Issues adopted on 11.11.2021, 16.09.2021. List of Questions adopted on 22.04.2021.
https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-19-22-april-2022-meeting_en.pdf#page16

[Pan_O_War]

$OBSV ObsEva CEO: «We are planning ObsEva 2.0»
~ Will need to use Google Translate from German > ENglish ~

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https://www.fuw.ch/article/obseva-ceo-wir-planen-obseva-2-0

[Frankestin]

https://www.obseva.com/wp-content/uploads/2022/03/ObsEva-Annual-Report-2021.pdf
Looking forward to 2022:
Thanks to the significant progress last year, we enter 2022 stronger and well-positioned for anticipated approvals. Looking ahead, we expect multiple catalysts, including:
? Yselty® for uterine fibroids:
– PUDFA target action date of September 13, 2022, as set by the FDA
– European Commission approval expected following December 2021 positive CHMP opinion
– Preparing for commercial launch
? Yselty® for endometriosis:
– Additional data from the post-treatment follow-up of the Phase 3 EDELWEISS 3 trial are
expected in 2Q 2022 and from the post-treatment follow-up of the extension study in 4Q 2022
? Ebopiprant:
– Discussing US clinical development with the FDA
? New opportunities:
– Exploring new indications, partnerships, and other strategic opportunities that enhance
ObsEva’s value and further our mission of bringing to market novel therapies that improve women’s health
? Financing: Furthering ongoing efforts to strengthen the balance sheet

[Frankestin]

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/yselty

[Frankestin]

Elizabeth Garner, MD, MPH, Chief Medical Officer of ObsEva, commented, "We are pleased with these additional EDELWEISS study results, which demonstrate the rapid onset of treatment effect, impact on quality of life and intentions for surgery, and continue to support the promising clinical profile of linzagolix in the treatment of women with moderate-to-severe endometriosis-associated pain. We look forward to advancing the endometriosis program for linzagolix, which will include exploration of a non-add back therapy option, consistent with our strategy to address the individual treatment needs and preferences of all women."

[Pan_O_War]

ObsEva Announces Additional Efficacy Results for Linzagolix 200 mg with Add-Back Therapy (ABT) and Linzagolix 75 mg without ABT in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain



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https://www.obseva.com/pressrelease-detail/?pr=4921

[Pan_O_War]

ObsEva Announces Year End 2021 Financial Results and Provides Corporate Update
[url]
https://www.globenewswire.com/news-release/2022/03/10/2400482/0/en/ObsEva-Announces-Year-End-2021-Financial-Results-and-Provides-Corporate-Update.html[/url][tag]insert-text-here[/tag]


https://www.globenewswire.com/news-release/2022/03/10/2400482/0/en/ObsEva-Announces-Year-End-2021-Financial-Results-and-Provides-Corporate-Update.html

[Frankestin]

Additional data from the 6-month analysis are expected in 1Q:22.
It’s NOW
Additional data from the post-treatment follow-up of the Phase 3 EDELWEISS 3 trial are expected in 2Q:22 and from the post-treatment follow-up of the extension study in 4Q:22.

[Frankestin]

ObsEva is working with the EMA toward approval, and is in dialogue with the regulatory agency to address questions on the marketing authorization application (MMA), which is expected to be discussed at the April CHMP plenary meeting. On February 10, 2022, ObsEva announced a strategic licensing agreement with Theramex to support the commercialization and market introduction of linzagolix across global markets outside of the U.S., Canada and Asia, and EU launch preparations are advancing. In the United States, the New Drug Application (NDA) has been accepted for review by the FDA, with a PDUFA target action date of September 13, 2022. In October 2021, ObsEva announced a commercial sales agreement with Syneos Health to commercialize linzagolix within the United States.

[Pan_O_War]

Article 8 is specific or just general.

Not sure what area you are specifically referring to.

[Frankestin]

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021
https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-yselty_en.pdf

https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-21-24-february-2022-meeting_en.pdf
OBSEVA IS IN DIALOGUE WITH EMA TO UNDERSTAND AREAS THAT MAY REQUIRE FURTHER CLARIFICATION
IMO very large area!

Article 8
1. In order to obtain an authorization to place a medicinal
product on the market regardless of the procedure established
by Regulation (EEC) No 2309/93, an application shall be made
to the competent authority of the Member State concerned.
2. A marketing authorization may only be granted to an
applicant established in the Community.
3. The application shall be accompanied by the following
particulars and documents, submitted in accordance with
Annex I:
(a) Name or corporate name and permanent address of the
applicant and, where applicable, of the manufacturer.
(b) Name of the medicinal product.
(c) Qualitative and quantitative particulars of all the
constituents of the medicinal product in usual terminology,
but excluding empirical chemical formulae, with mention
of the international non-proprietary name recommended
by the World Health Organization where such name exists.
(d) Description of the manufacturing method.
(e) Therapeutic indications, contra-indications and adverse
reactions.
(f) Posology, pharmaceutical form, method and route of
administration and expected shelf life.
(g) If applicable, reasons for any precautionary and safety
measures to be taken for the storage of the medicinal
product, its administration to patients and for the disposal
of waste products, together with an indication of any
potential risks presented by the medicinal product for the
environment.
(h) Description of the control methods employed by the
manufacturer (qualitative and quantitative analysis of the
constituents and of the finished product, special tests, e.g.
sterility tests, tests for the presence of pyrogenic
substances, the presence of heavy metals, stability tests,
biological and toxicity tests, controls carried out at an
intermediate stage of the manufacturing process).
(i) Results of:
physico-chemical, biological or microbiological tests,
toxicological and pharmacological tests, clinical trials.
(j) A summary, in accordance with Article 11, of the product characteristics, one or more specimens or mock-ups of the
outer packaging and the immediate packaging of the
medicinal product, together with a package leaflet.
(k) A document showing that the manufacturer is authorised
in his own country to produce medicinal products.
(l) Copies of any authorisation obtained in another Member
State or in a third country to place the medicinal product
on the market, together with a list of those Member States
in which an application for authorisation submitted in
accordance with this Directive is under examination.
Copies of the summary of the product characteristics
proposed by the applicant in accordance with Article 11
or approved by the competent authorities of the Member
State in accordance with Article 21. Copies of the package
leaflet proposed in accordance with Article 59 or approved
by the competent authorities of the Member State in
accordance with Article 61. Details of any decision to
refuse authorization, whether in the Community or in a
third country, and the reasons for such a decision.
This information shall be updated on a regular basis.

[Frankestin]

They are small but They are the right one!
https://www.theramex.com/our-history/

[Pan_O_War]

ObsEva Enters into Licensing Agreement with Theramex for the Commercialization of Linzagolix

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https://www.obseva.com/pressrelease-detail/?pr=4862

[Pan_O_War]

+50,000 Shares Insider buying

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https://www.ser-ag.com/de/resources/notifications-market-participants/management-transactions.html?issuedBy=OBSEVA#/

[Pan_O_War]

Let's go!

[Frankestin]

I think now they will make it go up!
Go to 3

[Frankestin]

Feb. 01, 2022 (GLOBE NEWSWIRE) -- ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced the appointment of Katja Buhrer as Chief Strategy Officer and member of the company’s Executive Committee, effective February 1, 2022. Ms. Buhrer will oversee a range of operational areas including corporate strategy, investor relations and public relations, and will contribute in other areas such as business development and alliance management.

“We are thrilled to welcome Katja to ObsEva at this important time in the company’s growth,” said Brian O’Callaghan, Chief Executive Officer of ObsEva. “Katja is an accomplished corporate development executive whose track record managing strategic transactions, partnerships, and investor relations programs strengthens our leadership team as we prepare to transition to a commercial-stage company. We further look forward to her leadership as we explore new indications, partnerships, and other strategic opportunities that enhance ObsEva’s value.”

Ms. Buhrer commented, “I am delighted to join ObsEva and collaborate with the executive team to address large, underserved indications that compromise women’s reproductive health. ObsEva’s regulatory, clinical, and strategic advances in the past year, coupled with upcoming catalysts as the company pursues multiple approvals in 2022, make this a compelling opportunity. I look forward to working towards real change in women’s health while enhancing value for our shareholders.”

[Pan_O_War]

Obseva: In January, the Geneva-based biotech company saw three share purchases by one or more board members totaling almost half a million Swiss francs. The remarkable thing is that these are the first share purchases by company executives since December 2020. Last Friday, four days after the last of the three purchases, Obseva announced a capital increase, which sent the stock plunging as much as 16 percent at times on Monday.

Obseva shares have lost nearly 60 percent of their value over the past year and are currently trading at record lows. The company, whose market value is still just under 100 million francs, is being traded as a takeover candidate. A commitment is only suitable for extremely risk-capable investors.

source cash.ch

[Pan_O_War]

XBI ETF is a massive current and gives an additional layer of context on the story of OBSV's price - outside of any issues/merits of the company itself.

[Pan_O_War]

Insider Buying 1.24.2022 + 50,000 Shares

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https://www.ser-ag.com/de/resources/notifications-market-participants/management-transactions.html?issuedBy=OBSEVA#/

[Pan_O_War]

Not sure if my below post is accurate - but cannot delete!

[Pan_O_War]

Looks like on the CHMP agenda for decision this week (w/o 1.24)

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https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-24-27-january-2022-meeting_en.pdf

[Pan_O_War]

Amplifying Scientific Innovation®: JPM22 Health Equity, Dr. Elizabeth Garner, CMO, ObsEva


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[FLY HIGH NOW]

https://finance.yahoo.com/news/obseva-announces-positive-topline-results-120000442.html

[Frankestin]

I was expecting some news for this:
Ebopiprant for Treatment of Preterm Labor: Preparations are ongoing to initiate a Phase 2b clinical study in Q4:21. The Phase 2b dose ranging study will build on the recently announced PROLONG Phase 2a proof-of-concept study, which demonstrated early clinical efficacy and safety in pregnant women with spontaneous preterm labor. Given ebopiprant is currently the only known product in development for this indication and based on its innovative mechanism of action and positive topline data, the Company plans to discuss with European regulators a possible accelerated registration program based on a Phase 2b/3 adaptive design. In parallel with development of ebopiprant in Europe and Asia, the Company is also actively evaluating the regulatory strategy for ebopiprant development in the United States, where there are currently no FDA-approved tocolytic medications available for treatment of preterm labor.

likely something changed after this:
https://www.organon.com/news/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/

[Pan_O_War]

Insider buying? (not sure whom):

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https://www.ser-ag.com/de/resources/notifications-market-participants/management-transactions.html?issuedBy=OBSEVA#/

[Pan_O_War]

$21.00 Price Target

[FLY HIGH NOW]

https://www.tipranks.com/experts/analysts/liana-moussatos

[Pan_O_War]

Endometriosis Drug Shows Promise in Preliminary Phase 3 Trial Results


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https://www.sciencealert.com/drug-company-announces-topline-results-for-endometriosis-pain-research

[Pan_O_War]

Heavily shorted atm w/about 5 days to cover. Perhaps this is what is suppressing the price?

[Pan_O_War]

NEW 2022 Corporate Presentation here:


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https://www.obseva.com/wp-content/uploads/2021/02/ObsEva_Corporate-Deck_Latest.pdf?doing_wp_cron=1641543229.7086830139160156250000

[Pan_O_War]

ObsEva Announces Positive Topline Results for Linzagolix 200 mg with Add-Back Therapy in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

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https://www.obseva.com/pressrelease-detail/?pr=4786

[Frankestin]

https://www.obseva.com/pressrelease-detail/?pr=4786

Once daily linzagolix 200 mg with ABT met both co-primary efficacy objectives, demonstrating reductions in dysmenorrhea and non-menstrual pelvic pain versus placebo at 3 months; showed statistically significant and clinically meaningful improvements versus placebo in ranked secondary endpoints of dysmenorrhea, non-menstrual pelvic pain, dyschezia, overall pelvic pain, and ability to perform daily activities at 6 months-

Ongoing for up to an additional 6 months
https://clinicaltrials.gov/ct2/show/NCT04335591

Where will they decide to take it?

[Pan_O_War]

ObsEva to Present at the H.C. Wainwright BioConnect 2022 Conference

[url]https://www.globenewswire.com/news-release/2022/01/03/2359807/0/en/ObsEva-to-Present-at-the-H-C-Wainwright-BioConnect-2022-Conference.html
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https://www.globenewswire.com/news-release/2022/01/03/2359807/0/en/ObsEva-to-Present-at-the-H-C-Wainwright-BioConnect-2022-Conference.html

[Frankestin]

https://www.globenewswire.com/news-release/2022/01/03/2359807/0/en/ObsEva-to-Present-at-the-H-C-Wainwright-BioConnect-2022-Conference.html
Oh good!
They want appropriate showcase to comment on the data!
IMO

[Pan_O_War]

7 of the Best Penny Stocks Under $3 for 2022 to Buy Now (OBSV #1):

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https://investorplace.com/2021/12/7-of-the-best-penny-stocks-under-3-for-2022-to-buy-now/

[Pan_O_War]

Yeah - that's the last piece for this year!

[Frankestin]

Good!
waiting for
https://www.biospace.com/article/releases/obseva-announces-enrollment-completion-of-linzagolix-phase-3-edelweiss-3-trial-for-patients-with-moderate-to-severe-endometriosis-associated-pain-/
https://www.clinicaltrialsarena.com/comment/obseva-yselty-edelweiss-endpoint-data/
https://seekingalpha.com/news/3781226-obseva-on-track-for-european-approval-of-uterine-fibroids-therapy

[Pan_O_War]

ObsEva Added to the NASDAQ Biotechnology Index ObsEva SA

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https://www.stonkmoon.com/news/OBSV/02af91d89eee259cc5db807cb18e918d

[Pan_O_War]

Wedbush Reaffirms Their Buy Rating on ObsEva SA (OBSV) $21.00
[url]
https://www.analystratings.com/articles/wedbush-reaffirms-their-buy-rating-on-obseva-sa-obsv/[/url][tag]insert-text-here[/tag]

https://www.analystratings.com/articles/wedbush-reaffirms-their-buy-rating-on-obseva-sa-obsv/

[Pan_O_War]

[FLY HIGH NOW]

https://finance.yahoo.com/news/obseva-announces-positive-chmp-opinion-120000531.html


Very positive news for FDA approval and EU accepted

[Pan_O_War]

Looking good!

[Frankestin]

it's not over
Next in Q4:
Phase 3 Endometriosis results.

Ebopiprant for treatment of preterm labor: Phase 2b dose ranging study initiation in EU/Asia (Q4:21)
Company plans to discuss with European regulators a possible accelerated registration program based on a Phase 2b/3 adaptive design.

[Frankestin]

the strong results on the full suppression dose (200 mg) with ABT showed that linzagolix could potentially offer best-in-class efficacy.”
A final marketing authorization decision from the EC is anticipated within two months. The CHMP’s positive opinion follows the recent FDA acceptance for review of the uterine fibroids New Drug Application (NDA) (PDUFA date of September 13, 2022).

[Frankestin]

ObsEva Announces Positive CHMP Opinion for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

-European Commission Decision Anticipated in Q1 2022-

-CHMP recommendation follows the recent acceptance of the linzagolix uterine fibroids NDA by the U.S. Food and Drug Administration-