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   Biotech / MedicalImmunomedics (IMMU) - moderated


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To: erickerickson who wrote (52459)9/11/2019 7:51:38 PM
From: allatwwk
2 Recommendations   of 57211
 
erick -- I think you misunderstood my comment. The closing of a deal, AFTER announcement, is subject to a bunch of things. This includes items like anti-trust considerations and shareholder approval. These things take time. My original comment wasn't about how long it takes to agree to a deal, but how long it takes to close one AFTER its been announced. This takes quarters, not weeks.

You can imagine no exec will make a deal which closes right around the time of a big data reveal. Because if the data doesn't do what they hope, heads would roll all over the place. This isn't an 'IMMU only' scenario, any company where the valuation is locked into a binary event (like the ASCENT data) has this issue.

Once the ASCENT data becomes available (whether publicly or via confidential disclosures to potential suitors), IMMU will be in play again.

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From: diaperdaddy9/11/2019 8:07:22 PM
3 Recommendations   of 57211
 
Just curious?

Is IMMU an execution story?

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To: Fitzhughlaw who wrote (52460)9/11/2019 8:15:30 PM
From: idahoranch1
7 Recommendations   of 57211
 
I had this conversation with Chau a couple of months ago. He said that until EV had full approval with their phase lll trial, irrespective of AA, 132 has a clear runway to AA. Once getting AA, it doesn’t matter if EV gets full phase lll approval, 132, buy virtue of AA, would get it’s review out of the phase lll trial and could be approved by meeting it’s primary endpoints. BTD simply greases the path somewhat, but has no bearing on approvals.

If EV got full approval through the phase lll trial before 132 got AA, then 132’s trial end points for AA or approval wouldn’t be valid.

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To: diaperdaddy who wrote (52462)9/11/2019 8:16:41 PM
From: idahoranch1
3 Recommendations   of 57211
 
Another CRL and it likely could be for a few husbands............

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To: Fitzhughlaw who wrote (52460)9/11/2019 8:42:38 PM
From: stockdoc77
4 Recommendations   of 57211
 
I think what you and later Idaho are saying is correct. SGEN may not necessarily block us from a path for BTD and possible AA, depending on our timeline and their P3 result. Like I said, I am going to be very interested in the bladder cancer data, not just the response rate, but whether we have a large enough sample to file for BTD (though not sure how big that sample needs to be).

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From: stockdoc779/11/2019 8:56:34 PM
9 Recommendations   of 57211
 
Stock up 4 dollars or 30% in the last week. The market is fundamentally revaluing us higher. Not sure where this will peak, I'm surprised by the strength of the move. Leads to the obvious question, what has changed in the last 7 days? I see four factors, the most important likely was the Daiichi data showing that their trop 2 ADC appears to have significant toxicity issues, and that progress on that product is going to be much slower than an all-out sprint which was possible given its initial excellent results. Second, Behzad reiterated we will be filing early fourth quarter. Given that is now 30 days away, it is unlikely that any significant material issues need to be fixed, it should be mostly getting the paperwork in order. Third, getting the late breaker poster for bladder cancer, which also put the possibility of BTD and potentially even AA back in play for bladder. Finally, we got more clarity on the timeline for ASCENT, and Behzad seems to reassure us that the FDA will not use an imminent ASCENT readout as a reason to not act on AA.
Once we file for BLA in October, and we get acceptance of the application 30 days later, we will be back to where we were last summer when the stock hit 27. The difference is that this time we no longer have risk of failure of AA on efficacy issues, and we have had 9 months to fix our CMC, which should in any normal world, be fixed. This is the execution factor, and I have been skeptical of B on the execution side over the summer. Given the other risks that were hanging over us, I advocated selling the company (at roughly 25-30 PPS). Given the events of the last week, I think we have derisked significantly, and I am now comfortable holding into January. If the bladder data allows us to get BTD, that would derisk us even more.
Given that we are better positioned now than we were last August (assuming BLA is filed and accepted), then shouldnt the stock price reflect that? Would that not argue for us getting a PPS over 30 after the BLA is accepted? The analysts remain rather bulllish with price targets of 20-40 dollars, and as the Twins keep pointing out, institutions have remained invested (although Fidelity has come and gone and come and gone at various times). The biotech sector as a whole though sold off last year and has never really recovered, at least on the spec company side of things, and that may hold us back. But it is conceivable the stock price could react similar to last summer once we get acceptance of our BLA.

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To: allatwwk who wrote (52461)9/11/2019 9:06:46 PM
From: erickerickson
   of 57211
 
I stand corrected...

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To: Fitzhughlaw who wrote (52460)9/11/2019 9:29:08 PM
From: weatherproof
13 Recommendations   of 57211
 
As to IMMU-132 vs. EV:

1. As Idaho indicated, as long as SGEN hasn't moved past AA and received full approval on their ph IV confirmatory trial, IMMU-132 is still eligible for AA, and then full approval of 132.

2. In the case of DS, the approach involves a similar mechanism of action as that of IMMU-132, targeting the same target, TROP-2, This is not the case with EV, so there is room for both EV and 132, which is further supported by the notion that there appears to be no overlapping toxicities with those therapeutic approaches.

3. Most patients dealing with bladder cancer are older and drug safety is going to be important in terms of keeping these patients on the drug. It appears IMMU's safety profile is favorable as compared to EV. This safety advantage is significant in terms of the biologic's use in early lines of treatment and in combination applications.

4. The exclusion for neuropathies for EV is particularly noteworthy as that is a lingering side effect for platinum-based therapies which will precede use of SGEN's EV for platinum-eligible patients.

On another note, we not only see the toxicity associated with Daiichi Sankyo's DS-1062, but we see suspension of Pfizer's TROP-2 ADC, as mentioned by Behzad in his recent fireside chat. This reinforces the importance of discovering the right balance of antibody, linker and drug conjugate which has escaped many companies with much larger R&D budgets.

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To: idahoranch1 who wrote (52464)9/11/2019 9:43:27 PM
From: Karuna1
   of 57211
 
:-) :-) good one!!

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To: stockdoc77 who wrote (52466)9/11/2019 10:29:30 PM
From: li3511
1 Recommendation   of 57211
 
Don’t overthink this. Three spec biotechs that I own all went up by 15% in one day, 2-3 days ago. A big part of the move is sector rotation, perhaps triggered by recent conferences.

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