In an update announced last month, ObsEva reported that, pursuant to Phase 3 results, the European Medicines Agency ( ) had validated for review the company's Marketing Authorization Application ( MAA ) for Yselty (100mg and 200mg). Potential MAA approval is anticipated in Q4:21. The drug is also slated to be the subject of a New Drug Application ( NDA ) that is due to be submitted to the FDA in Q2.
Wedbush analyst Liana Moussatos said that Linzagolix has the potential to achieve best-in class oral GnRH receptor antagonist status based on a flexible dosing regimen either with or without the add-back hormone therapy ( ABT )—a key differentiator from other GnRH receptor antagonists… Based on the positive PRIMROSE 1 and PRIMROSE 2 primary endpoint results for YSELTY®/UF and additional follow-up data, we project annual sales of more than $750 million in 2027 for Linzagolix/UF,” Moussatos opined.
To this end, Moussatos rates OBSV a Buy along with a $28 price target.
With the change in market sentiments, keeping itself as women's health oriented, or making itself into reproductive health oriented, is a big deal.
Continuing on, their board and SAB (scientific advisory board), makes me happy too. I know none of these people. It could be simply because its in Switzerland, and I am in Boston, but most biotherapeutics try to put a few of the big boys from Harvard/MIT on their board for looks. This SAB looks focused on women's health, not "medicine and science".
I can see this company really taking off. This is, in some ways, a love letter to my vision of the future of the company, not to the company itself. As things change, such as market movements and clinical trials, things could go very well or very poor for this company. But I see this having way more upside than down. This is in no way financial advise, just my personal sentiments and research that could be flawed.
The fundamentals look great on the company, its got great image and everything to go right for it. The pipeline is amazing, it is sticking to one area which makes me interested in the philosophy of the leadership team, but that one direction also gives me some positive feelings. They aren't doing single class, single molecule therapies, they seem to really be tackling, or targeting female reproductive health, and rather orphan diseases at that. Most of these issues have been treated with hormones because that was the only thing anyone could think of, and this second wave of women health science is amazing to see from the business and science side.
The benefits of going after women's health are insane. They are walking around with a name your own price tool. While it is estimated they could have 750 mil$ per year from Linzagolix by 2027, I am wondering where they are getting these numbers from with women treated and cost per treatment cycle. Current treatments for Endometrioisis and Uterine Fibroids are lacking, either in efficacy or delicacy. How many women have mild symptoms and elect to avoid treatment due to lack of treatments. Did the analyst do a proper research deep dive, or did they look at current treatments for Uterine Fibroids and valued it as taking a portion of the existing market.
Furthermore, from a scientific point of view, the GnRH antagonist is beneficial in endometriosis and uterine fibroids, without doing any research in other ovarian health states, conditions or cancers, how much does GnRH receptor play a role in various disease states?
After doing a cursory search on pubmed for GnRH receptor, and nothing to do with disease or cancer, in the first 20 papers, there were published reports discussing GnRH receptor and its axis in gonadic deficiency and prostate cancer. Furthermore, it is reported to have a signaling pathway connected to ERK, an extremely prominent pathway in cancer therapy development. I guarantee you that they are using their drug in every possible cancer assay and disease assay to find something new to treat with it. And it's passing phase 3's in women, I doubt they will do so in men if they find the right diseases.
Looking further down their pipeline is what gives me the greatest joy. This is going to be 2-4 years down the line, but they have 2 drugs in their pipeline that deal with pre-term labour (could easily turn into an abilify where any woman with traits or symptoms that correlate with pre-term pregnancy is given this), and increasing IVF rates. WHAT!?!? These are both huge markets, and this company is aligning itself to be the premier pharmaceutical company for women's health. With the change in market sentiments, where feeling and brand really matters (hello Tesla and Gamestop, AMC, "meme stocks").