- SESN needs three (3) years to gather data for resubmission and approval.
- It'll be a long way until CLVS FAP-2286 development matures ADGI is a good stock to keep an eye on.
- Refiling is the best option for ICPT’s obeticholic acid (OCA).
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Without further ado, let’s start with the latest news on SESN for which they have announced an anticipated regulatory path forward for Vicineum.
George.mani Dec 9, 2021, 10:20 PM
What is the view on the latest news on SESN? How long will the new test and approval process take?
biosci.capital.partners Dec 9, 2021, 10:54 PM
george.mani Let me take a look into it for you, Mr. Mani.
george.mani It'll likely be three years. The trial is going to take roughly 2 years long + roughly one year for data gathering and resubmission and approval.
Flamman Dec 9, 2021, 10:24 PM
biosci.capital.partners Dec 9, 2021, 10:58 PM
flamman FAP-2286 seems quite promising. This technology works. The key is that it'll take a while for them to advance it through trial b/c it's quite early.
flamman What are your thoughts, Mr. Flamman? Thanks.
Flamman Dec 10, 2021, 1:47 AM
I like the new Radiology treatment but they have a long way to go. I am not expecting much from CLVS. I am hoping for the unexpected. Like a nice revenue increase on new sales. Or 1st line ovarian cancer maintenance. It is not where I am putting in new money. I think we have better options.
Biosci.capital.partners Dec 10, 2021, 4:31 AM
flamman Congrats on your solid strategy, Mr. Flamman. 1st line ovarian cancer Rx would be very nice. It'll be a long way until FAP-2286 development matures.
Biosci.capital.partners Dec 9, 2021, 11:06 PM
all Dear, IBI members. Keep your eyes on ADGI. After a HUGE rally to the moon, ADGI cooled off, and momentum is now building again.
It seems like a good COVID play because their drugs have good chances of working against Omicron as well as other variants.
By focusing on the conservative region of the virus that does not evolve much, they can ensure much longer efficacy as well as hitting nearly all variants. Of course, that's theoretically, we'll have to wait for the full data. Thus far, I like ADGI.
Flamman Dec 9, 2021, 11:23 PM
SESN path is filled with thorns!!
Biosci.capital.partners Dec 9, 2021, 11:28 PM
flamman We had a small prior discussion on this one, Mr. Flamman. As you and I and other IBI members expected, SESN will have to run a new trial. So the question now is how long would it take for the whole process until approval.
Biosci.capital.partners Dec 9, 2021, 11:47 PM
It's a "downmarket" today as biotech is hit again. I'll continue to keep my eyes on the market to cue you in on the best time to initiate more purchases.
Jw221 Dec 10, 2021 12:02 AM
Biosci.capital.partners Dec 10, 2021, 1:15 AM
jw221 Biotech companies are being hit quite hard lately. ADCOM usually makes the right decision. If they voted no, the drug will unlikely get through the FDA.
jw221 What are your thoughts on strategies for RETA? Thanks.
Biosci.capital.partners Dec 10, 2021, 8:14 AM
kevinjohnston Does the TA indicate any upcoming recovery? Thanks, Kevin.
jw221 Dec 10, 2021 7:06 PM
I initially wanted to open an option position to capture the premium but hesitated. RETA is currently trading around MCAP of 1b, they have 700m cash in hand.
If Bardo does not receive approval, what are your thoughts on their other pipeline (Oma)?
Kevinjohnston Dec 11, 2021, 12:50 AM
I would avoid RETA for now. It's recovery is weak and has no support or bottom confirmed. I recommend watching it from the sidelines.
Alina17 Dec 10, 2021 12:18 AM
ICPT. Intercept Pharma to pull marketing application for NASH candidate in Europe
Intercept Pharmaceuticals (NASDAQ:ICPT) has lost ~9.3% in the pre-market after the company announced that it notified the European drug regulator of its decision to withdraw the Marketing Authorization Application (MAA) for obeticholic acid (OCA). With the MAA submitted to the European Medicines Agency (EMA), Intercept (ICPT) had sought the approval for OCA in liver fibrosis due to nonalcoholic steatohepatitis (NASH).
While the MAA was based on the data from the ongoing pivotal Phase 3 REGENERATE study, plans are in progress to generate additional data from the trial. However, the timeline for MAA could not be further extended to incorporate these data, anticipated in 2022.
Meanwhile, in its review, based on the data submitted so far, EMA’s Committee for Medicinal Products for Human Use (OTC:CHMP) was not able to establish “a positive benefit-risk” for the drug, the company said in elaborating its reason to withdraw the application.
OCA, indicated in U.S. with ursodeoxycholic acid (UDCA) for primary biliary cholangitis netted $92.8M in sales for Intercept (ICPT) in Q3 2021 indicating ~17% YoY growth.
Flamman Dec 10, 2021, 12:27 AM
I would have thought this was obvious that it was likely they would have to refile. They do not have the data they need ready yet, but will have it soon and the EMA said they cant extend time further they have to refile.
They also have to refile with the FDA. So I am not sure why this is big news. Any negative sends the stock lower. Doesn't matter if we all know this info.
Alina17 Dec 10, 2021, 12:59 AM
Thanks for your comment flamman
Biosci.capital.partners Dec 10, 2021 1:17 AM
flamman Alina17 You're correct. They don't have the necessary data but EMA won't extend the timeline. As such, refiling is their best option.
Biosci.capital.partners Dec 10, 2021 8:14 AM
kevinjohnston How's the TA looking for ICPT, Kevin? Thanks.
Kevinjohnston Dec 11, 2021 12:41 AM
biosci.capital.partners It is very close to a bottom. An entry here is interesting. It has a strong support at 12.83 and is holding pretty well at 14.32 If it collaspe I would sell however, as the base is not solid yet.
Biosci.capital.partners Dec 11, 2021 1:22 AM
kevinjohnston Excellent insight, Kevin!
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To your success,
Dr. Harvey Tran and IBI Portfolio Manager
Analyst's Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours.
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