Iveric Bio previously announced that GATHER1, the Company’s first Phase 3 clinical trial for Zimura (avacincaptad pegol) for GA, met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure. The Company expects topline data for GATHER2, the Company’s second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis. If 12-month results from GATHER2 are positive, the Company plans to submit applications with the FDA and the European Medicines Agency (EMA) for marketing approval of Zimura for GA. There are no FDA or EMA approved treatments available for patients with GA. From Iveric Bio
I think that’s what is expected in September. I took shares and sold CCs immediately.
How are you safe for this quarter if top line results from their phase 3 trial to be released in 2022 q3? Aka September at this rate. The IV is high for a reason guys……
Going to reiterate @kenbrellthompkins point. Results are set to be released in Q3 so they should be released any day now. I found an article stating that the topline data is set to be released in September. " IVERIC bio, Inc. (ISEE), a biopharmaceutical company developing treatments for retinal diseases, expects to announce topline data from its GATHER2 trial next month." - from an article published on August 25th of this year. So, your calls are very much not safe. If results are bad the stock could plunge 80-90% in the worst case scenario (Just look at what happened to HGEN which was another thetagang favorite).
I don’t mean to fear-monger but please do more research on this company including their financials and what other drugs they have in their pipeline. This way you can anticipate the price action if surprisingly bad results are reported. I would bet the options are priced fairly. When the IV is so high, there’s usually a damn good reason why.
I sold the 9/16 12.5 CC yesterday, which covered about 1/3 of my cost basis. Today that strike covers 1/2 cost basis. I’m perfectly happy if this gets called away at 12.5. It will be a very low effort ~$600 profit. My max loss is about the same. If it doesn’t work out, it’s tolerable for me.
If the shares don’t get called away, I decide whether to keep and do another CC or if I want to sell. Bio tech has been good for me. Nothing is safe or sure. We all have to evaluate what is reasonable risk and play what’s in front of us.
Holding is a weakness for me but has brought some of my best plays. For me this is a good opportunity to tone that holding muscle. For others it may not be good choice.
So looking over the trials, the gather2 trial design is not very different from gather1 trial design which had good results. The difference in gather1 trial vs gather2 seems to be more of a confirmation test and testing different dosage regiments. Not exactly a pharma guy but did also find this article at retinatoday.com that hints at data for gather2 (being released this month most likely) shouldn’t be to different from gather1 data Clinical Impact of the GATHER1 Trial for Geographic Atrophy - Retina Today
Anyone get assigned today? Still a no for me. Considering the gather2 data is the catalyst that drove up the IV and now we have application for fda approval that they hope to submit by q1 in 23, I may try to buy back the call if I can get it for around 3.00 and cont selling ccs. I doubt that will happen but considering the overall market and no other catalyst till q1 23, might be something to keep on the watch list at least. Thanks for bringing this to our attention sluzz