Evofem To Launch On-Demand Contraceptive
Today we're GonNa talk about a company that is trying to commercialize a female contraceptive and the company's called Yvo FEM and their product is called sexy and it's going to be launched actually in the next few days. So I wanNA talk about them as the main story, and then we're going to start with some updates from Gilead O'Donnell as well as bio Merrin and actually we got some news from Amarin today that I'm GonNa touch on just very very briefly because I haven't. Totally incorporated it into my portfolio yet, but we did see some dramatic news from them. So with that, let's get going and the first thing I want to talk about is the Gilead, news that we heard and what we found out is that they were issued a complete response letter for the approval of Phil God's Nib, which was their treatment for rheumatoid arthritis. So, this is a bit of a surprise I would say and Phil God was going to be something that replaces revenue streams that are slowly starting to fall off a patent for Gilliat and they're gonNA start to feel that in the form of loss of revenue and forgotten it was kind of shoe into get approved by the FDA issued them this complete response letter saying that they will not approve the drug unless certain conditions are met and usually when companies receive Sierra L. either it's unconditional in the sense that they don't have any recourse or it has conditions on it and hear what we. Found out that the FDA wanted more data from their face, three Manta and Manta Ray studies before completing its reviewed, the NBA and they're specifically concerned about issues in male sex organs. So Gilead is going to have to provide this data, the FDA before they will approve it, and it looks like from what I looked very briefly on the clinical trials dot Gov site is that the primary completion date isn't until early twenty, twenty one where they final completion date of twenty, twenty four. Now Juliette is pre savvy. So I feel like they'll be able to eventually overcome these hurdles once they provide some data. So I. don't see it being long long-term hindrance of the company, but we've seen the stock get hammered pretty hard since the glory days of remedy severe and in general has been kind of slow to adopt new therapies to their pipeline in order to maintain that growth that people expect. So hopefully, with the approval of Fil gone, they'll be able to replace those drugs that are falling off of patent and be able to maintain their value that way. But personally no position for me from Gilead but I thought it was interesting to point this APP. Nasr Company. I WanNa talk about is by Merrin, and they are trading at a fourteen billion dollar market cap now, and they were also issued a complete response letter for Rock Avian and this was their hemophilia, a gene therapy and I've touched on Hemophilia A and. A number of different videos but I haven't touched the topic in a while. I did notice the CRO though and it's interesting because the conditions that the FDA wanted in order to approve the drug was evidence from two years of data for its ongoing phase three trial to support the durability of the gene therapy. So this is obviously kind of rough for the company because the bar is rarely set this high for other companies that two year window of therapy is going to be maintained. This has me questioning the gene therapy space as a whole that you know other companies that have invested in say route Jenex bio if they're going to have to show two years of data to show that it is a Gerbil effect, this obviously plays into the models and delays the time at which it's GonNa take for them to get revenue. So kind of. makes. Me Nervous about the gene therapy space but you know different diseases seem to have different thresholds for what the FDA wants and it's tough to predict. So thought it was worth bringing up and just for those who are actually following by man, their last phase three patient will complete two years of follow up in November twenty, twenty, one, serve you're expecting revenue from this drug. Now you're GonNa have to wait until twenty, twenty two proudly see any revenue. So that's a disappointment even though the drug does help us significant number of patients. All right. Moving on I WANNA touch on otani therapeutics ticker symbol od T, and they're trading now at around five hundred, seventy, four, million dollar market cap for those that don't remember I, touched on this a while ago they were short candidate that I had once I seemed like they had a run up in the stock for no obvious reason, and then I sold it off in anticipation of run up to this event that we just saw news to, and they're commercializing a tax seen that is given orally. So right now has to be given IV in a lot of complications surrounding that a lot of hurdles that patients he'd go through to get this. Treatment and it's Kinda tedious. So if he can come up with an oral version, it would be much better for patients and that's what Oh Donald Trump do here. So what we heard is that their face three contessa trial achieved primary endpoint and what they were looking at is test attacks will their drug plus bean compared to just capital being alone, and the results showed that the progression free survival was significantly better in the tax will plus Kapustin group rather than just cap aside to being alone nine point eight months versus six point nine months with a hazard ratio of zero point seven to just pretty good and value point zero, zero three.