alive and kicking
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I do think w a full approval especially for paxlovid soon there are ethical hurdles to running a trial against placebo in high risk patients. I also think given the evolution of the pandemic you may not see as high an efficacy signal even w a similarly or more effective drug given different variants and buildup of population immunity. so a non inferiority to pax is best, knowing in particular that you don't need superiority to get to the front of the line bc anything similar without all the DDIs would be a winner
If anything when there is an acute event like this and everyone is still trying to wrap their heads around the data is where you increase the odds of such a discrepancy between you and the market because of the reflexive nature of price gyrations (especially in biotech) before the dust settles. And the more I look at the ENTA data the more I like it. Enstrelvir totally whiffed on the TSS. When they narrowed down to respiratory symptoms plus fever they saw about a 1 point difference to placebo in 2 days. ENTA hit on many time points on the TSS, and when they similarly narrowed down to a comparable group of symptoms that are more prominent w the current variant they showed a much larger effect especially at the 400mg dose (more than double) at 24-48 hours. Paxlovid was a fail here totally
Co-Primary Efficacy Endpoint: Total Scores for 12 COVID-19 Symptoms
The mean total scores of the predefined 12 COVID-19 symptoms are depicted in Supplementary Figure 1. There was no significant difference in the time-weighted average change from baseline up to 120 hours in the total score of the 12 COVID-19 symptoms between the ensitrelvir 125-mg or 250-mg groups and the placebo group (Table 2), irrespective of COVID-19 vaccination history (Supplementary Table 4).
Shionogi Pfizer and gilead all have trials underway. Are they all wrong and there is no path to approval? Let’s see if paxlovid sales go to zero if there is no need for antivirals now. There is a bear case to be made but you are not making it
RVNC down 9% to $34.15 after hours per Yahoo
When there isn't any human trial data all that can be assessed is preclinical data, you know, data from cell lines, animal models and biochemical tests. Where is the preclinical data for the new PFE "wonder" drug?
Dewophile made great post on the Biotech values board that fits with my thinking. I will add in that the phase I data for EDP-323 in RSV should be out in a month or so. It is worth the read.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171872796
That is interesting, but it doesn't tell me why I would want to invest at current prices. Tell me why I would want to get involved with this name. How long until they can partner, how much they have to give up to partner, how long to run trial(s), get approval. Chance of success. Realistic price target. Other questions.
Why do I want to get involved?
Why not down
Why not down
A biotech company with ambitions to compete with Pfizer’s blockbuster Covid-19 pill announced mixed results from a study of its experimental antiviral therapy and won’t carry forward with development of the drug on its own.
Investing in biotech can be risky so you have to have some diversity, and I do and also advise others who ask me to do the same. I made more than >3x as much on IMGN as I lost on ENTA this morning, RVNC has also been doing well and SGEN is getting bought out at a big premiums, so April and May and 2023 have been very good to me.
Back to ENTA, the fact remains that EDP-235 showed a statistically significant reduction in Covid symptoms in a healthy young population, something Paxlovid failed to do in a trial several fold larger that the SPRINT. This was even though the population in the SPRINT trial ENTA just ran.
One question that was asked in the CC was the market for anti-Covid drugs now that Covid is essentially endemic. The market fro such drugs are ~$10 billion in 2023. PFE estimated $8 billion for 2023 but reported $4 billion for Q1. The market is still quite big and will remain so for quite some time.
There is no hiding that is it painful to see an investment drop as much as ENTA did today. I did buy more ENTA this morning at $24.15. I will probably keep buying over the next few days. In a month or two I will likely sell some as I need a tax loss to reduced my capital gains from the SGEN buyout. Still, my goal is to have more shares of ENTA than I did before the SPRINT trial data was released. I am not telling everyone they should do this. That is my plan and you have to weigh what to do yourself.
Good luck to you and other ENTA investors as we move through this challenging time.
Apparently we have a sensitive little fellow on this board who likes to talk smack but can't handle a little himself.
The after hours trades means lots of pain tomorrow. However, there is also opportunity possible. I have made some nice cash picking up shares after a drop, as long as you think the drop is unwarranted.
I listened to the CC and the key points, at least to me were.
Enough cash to take ENTA into 2026. This doesn’t model ENTA running their own phase 3 and they aren’t looking to do so. The goal is now and has always been to partner. Looking for partnership for phase 3 as their plan has never been to run their own phase 3. Mentioned phase 2 for long Covid but that will likely be self-funded and run but nothing is set right now.
FDA doesn’t approve Covid drugs aren’t based on viral load changes. It is symptom relief, reduction of hospitalizations and deaths.
Why would symptoms improve with EDP-235 but not really viral load? They speculated that EDP-235 has a higher tissue distribution levels (EC50 & EC90) than Paxlovid but measurements only in the nasal cavity. Effect of EDP-235 on different viral compartments, lung, heat etc could explain systemic symptoms improved with EDP-235 without showing better viral clearance in nasal swabs. It would be difficult to assess these other compartments. Also talked about the much more rapid viral clearance in the nasal swabs in placebo. Nasal swabs only measure viral RNA levels, not active virus that can trigger inflammation.
Question about viral rebound. The analyses haven’t been completed.
Question about EDP-514. looking at other data sets, external assets. No mention of another internal drug.
EDP-323 polymerase inhibitor for RSV. Phase I data safety, tolerability and pharmacokinetics due next month. Challenge study would be next assuming positive data.
Based on AH trading ENTA is going to take it on the chin most likely, but let's see if they can get a big pharma to buy in here the clinical data is unprecedented versus paxlovid and even ensitrelvir
My agenda is to speak the truth.
Well, you deny that your bullish thesis was incorrect and grossly overstated.
You denied that the placebo arm reality was significant.
Without the benefit of having heard the cc yet or looking back at paxlovid and other protease data in development I would say if I had to pick one - either efficacy hits on VL or symptoms I would pick the latter as that is the approvable endpoint and enta has a chance at a successful phase 3 in lower risk patients now too
Now you deny.
Wow. Buying more shares… for what exactly?
You’re going to lose all of your money.
Now trading at $24. I suppose your opinion was incorrect “Vin”
EDP-235 met the primary endpoint of the trial and was generally safe and well-tolerated. A dose-dependent improvement in symptoms was observed with EDP-235 treatment compared to placebo, which achieved statistical significance (p<0.05) in the 400mg treatment group at multiple time points, starting as early as one day after the first dose. In a prespecified population consisting of patients enrolled within 3 days of symptom onset, a statistically significant improvement was observed with EDP-235 at 400mg at all time points.
I thought paxlovid did see a benefit in VL but it may not have been stat stig and obviously it was in high risk patients who are going to clear virus far slower
To see any clinical improvement in a low risk population is a win I think - this definitely warrants progressing to a phase 3 non-inferiority trial in high risk patients vs paxlovid IMO
It too late to buy this going to short down to 6-9 incoming days
RVNC—Some posters on iHub are making too big a fuss over the 1Q23 sales numbers (to be reported tomorrow),
It too late to buy this going to short down to 6-9 incoming days
Was gonna pull the trigger on IMGN on May 1st, but thought I could wait for FED update as the management indicated the trial result would be out EARLY May. Have to say May 2nd is indeed EARLY :) congrats on the big gain.
I don't think is it too late for people to buy into IMGN or to increase their shares, but it comes at a cost as you have to pay for the information gained from MIRASOL. Not only is Elahere in more trials, this time for PSOC (Platinum sensitive Ovarian cancer), they have other ADCs including an updated and improved follow up to Elahere, called IMGN151. The pre-clinical data presented so far sure makes IMGN151 look impressive and better than Elahere, as it shows efficacy against low, medium and high alpha foliate expression and has a longer lasting ADC linker. However, these improvements in IMGN151 could affect toxicity so obviously clinical trial data is the key. The phase I trial of IMGN151 is already in progress and its estimated primary completion date is Sept 30, 2023 so is a ways off.
Here is the IMGN151 pre-clinical data.
https://aacrjournals.org/cancerres/article/80/16_Supplement/2890/642251/Abstract-2890-IMGN151-A-next-generation-folate
Here is the IMGN151 phase I trial.
https://clinicaltrials.gov/ct2/show/NCT05527184
Skankapus is exactly that lol
Why this up on offering lol
As you probably know I'm also invested in NWBO. Their vaccine, DCVax-L, has been extensively tested in GBM, the survival advantage is spectacular when combined with other drugs, like Keytruda, which failed in GBM prior to being combined with DCVax-L. By itself DCVax-L raised 5 year survival by a factor of nearly 3 from 5% to about 14%, but add the other therapeutics and 50% or more are likely to live 5 years. The vaccine is made from the patients tumor and white cells. Like Elahere in other platinum resistant cases, DCVax-L has anecdotal evidence that it's effective in other solid cancers. I certainly don't know for certain that off label either will work, but the odds are actually pretty good that in at least some applications both of them will work.
Wow, I initially guessed the offering would be at $10/share, then after thinking about it more I said that guess might be a bit low. Selling at $12.50 and almost 30 million shares just blows me away. The stock price is going to go up, up and up from here!!
Congratulations to all longs. I guess the uninformed shorts are feeling even more unhappy tonight. Good, it makes me laugh!
Wow, I initially guessed the offering would be at $10/share, then after thinking about it more I said that guess might be a bit low. Selling at $12.50 and almost 30 million shares just blows me away. The stock price is going to go up, up and up from here!!
Congratulations to all longs. I guess the uninformed shorts are feeling even more unhappy tonight. Good, it makes me laugh!
IMGN sells 29.9M* shares @$12.50—a 2% premium to yesterday’s close:
Net proceeds after underwriting fees from this upsized offering will about $350M*.
I don't believe that Drs. will wait for further approvals to use Elahere with platinum resistant patients with other cancers off label if other therapeutics aren't benefitting their patients.
Seems like the shorts are learning a painful lesson, that ignorance can really hurt you, and I am enjoying it. They will continue to lie and distort about the new share offering, either out of ignorance or desperation.
IMGN won't try to rapidly sell the entire batch of new shares to garner $200 million they mentioned. IMGN will almost certainly one end up selling only a tranche of shares and then wait. IMGN has plenty of cash on hand so it isn't like they need an immediate influx of cash to maintain operations. IMGN hasn't even announced the price for the new shares, likely because they are waiting to see when the price stabilizes then they will offer the tranche of news shares for a few dollars below that price. My initial guess was $10/share but that is probably too low given the stock price is now in the mid $13s. Time will tell.
IMGN needs to get Elahere full FDA approval in Europe, both of which are coming.
Definitely will get bought out. Im thinking 30-40 and up to as high as 80’s with bidding wars.
https://www.immunogen.com/wp-content/uploads/2019/09/ESMO_2019_FORWARD-I-Oral_Final.pdf
Looks like about half the patients in forward 1 were FR high. That’s probably representative of the FR positive population on the whole.
As far as I can tell, the MIRASOL trial included only high FR-alpha expressers. IMGN’s previous phase-3 FORWARD-1 trial that failed in 2019 included high and moderate FR-alpha expressers (https://www.businesswire.com/news/home/20190301005092/en/ImmunoGen-Announces-Top-Line-Results-Phase-3-Study ), and showed promising results in the high-expresser subgroup.
We are offering $200,000,000 of shares of our common stock. Our common stock is listed on The Nasdaq Global Select Market under the symbol “IMGN.” On May 2, 2023, the last reported sale price of our common stock on The Nasdaq Global Select Market was $5.20 per share.
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that it intends to offer and sell, subject to market and other conditions, $200 million of shares of its common stock in an underwritten public offering. ImmunoGen also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the number of shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
The short who knows NOTHING about either IMGN or ovarian cancer and who only shows up AFTER the price spike of IMGN assures you that he came here out of the goodness of his heart, knows what is best for you and only wants the best for you. Funny how if you see where he posts you can see that he is short who knows nothing about Biotech. It is so pathetic and predictable it is laughable. When I buy or sell I post at the time I make the transaction. My record is good and transparent.
No need to read what the shankman wrote wrote but my comment to him and his ilk is an old adage "The dogs bark, but the caravan moves on". The IMGN rocket ship is just beginning its ride. Enjoy!!
Two questions: What proportion of ovarian cancers are folate-receptor-alpha positive? Is this biomarker of value in other kinds of cancer?
A number of important characteristics contribute to its attractiveness as a candidate for therapeutic intervention in EOC. FRa is a tumor-associated antigen in this malignancy, with over 80% of ovarian carcinomas constitutively expressing the receptor and elevated FRa expression is often associated with more poorly differentiated, aggressive tumors. In contrast, FRa shows a highly restricted distribution pattern in normal tissues, with expression limited to a variety of polarized epithelia, such as those found in the choroid plexus, kidney, lung, and placenta
Moreover, studies have shown that FRa expression is retained in recurrent and metastatic tumors and is not significantly altered in response to chemotherapy [4], [5], providing further support for targeting this receptor in the treatment of EOC, whether newly diagnosed or at the time of recurrence.