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   Biotech / MedicalImmunomedics (IMMU) - moderated


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To: idahoranch1 who wrote (52464)9/11/2019 9:43:27 PM
From: Karuna1
   of 57518
 
:-) :-) good one!!

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To: stockdoc77 who wrote (52466)9/11/2019 10:29:30 PM
From: li3511
1 Recommendation   of 57518
 
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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To: li3511 who wrote (52470)9/11/2019 10:51:05 PM
From: idahoranch1
1 Recommendation   of 57518
 
Did they follow through the next day? Not that it proves anything, but I kind of expected to give a little back today. It WOULD be nice for the sector to recover during a good news period for us.

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From: Fitzhughlaw9/12/2019 8:54:59 AM
15 Recommendations   of 57518
 
ESMO "Investor Event" presentation scheduled for this coming Saturday from Barcelona (12:30 p.m. EST), and some of the big hitters in oncology for this indication (Tagawa) and in an interesting but not to be overlooked development, breast cancer (Rugo), are participating:

Immunomedics to Host Investor Event and Webcast on September 28, 2019 During ESMO Congress

MORRIS PLAINS, N.J., Sept. 12, 2019 (GLOBE NEWSWIRE) -- Immunomedics, Inc. ( IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that it will host an Investor Event on Saturday, September 28, 2019 at 6:30 p.m. Central European Summer Time in Barcelona, Spain, during the Congress 2019.

The event will feature presentations by key opinion leaders including Scott Tagawa, M.D., MS, Richard A. Stratton Associate Professor in Hematology & Oncology, Associate Professor of Medicine & Urology, Weill Cornell Medicine, and Associate Attending Physician, NewYork-Presbyterian – Weill Cornell Medical Center, who will present the interim results from TROPHY-U-01 at the Congress. Cora N. Sternberg, M.D., FACP, Clinical Director, Englander Institute for Precision Medicine and Professor of Medicine in Hematology & Oncology, Weill Cornell Medicine and NewYork-Presbyterian will discuss the implications of these data in an evolving metastatic urothelial cancer landscape.

In addition, Hope S. Rugo, M.D., FACP, Professor of Medicine; and Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, will lead the discussion on the Company’s breast cancer programs. Members of Immunomedics leadership team will also be present to provide a corporate update.

For additional information and/or to RSVP for the event, please contact Dr. Chau Cheng at ccheng@immunomedics.com. The investor event will be webcast live via the Investors page on the Company’s website at https://immunomedics.com/investors/. Approximately two hours following the live event, a replay of the webcast will be available for approximately 30 days.

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To: Fitzhughlaw who wrote (52460)9/12/2019 9:48:03 AM
From: JohnBeach
8 Recommendations   of 57518
 
In addition to what you quoted of the FDA's guidance, it continues to say that one of the ways to demonstrate substantial improvement is:

"The new drug has an important safety advantage that relates to serious adverse reactions (e.g., those that may result in treatment interruption) compared with available therapies and has similar efficacy."

That would appear to be 132's path to BTD.

FWIW, statistically the chance is not great: In the first 3 quarters of the federal fiscal year beginning Oct 1 2018, the FDA received 118 BTD requests. 36 were granted, 46 denied, and the rest are pending. On the other hand, in mUC, 9 drugs since 2014 have received BTD.

Considering the way things are moving toward targeted therapies, I think targeting Trop2 in mUC would guarantee 132's chance at BTD and position it better vs EV. Trop2 is expressed in 83% of mUC. Eliminating those 17% of patients that wont respond will elevate the ORR on par with EV. And it would be better for patients. I wonder if they collected tissue samples for a post hoc look (they are doing that in the prostate study).

Then again, what company schedules an investor event if the data isn't impressive?

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To: idahoranch1 who wrote (52471)9/12/2019 10:00:36 AM
From: li3511
   of 57518
 
Yes.

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To: li3511 who wrote (52470)9/12/2019 10:12:29 AM
From: JohnBeach
   of 57518
 
IMMU had it's best day in almost 2 years. And then followed through. Add to that several analysts made positive comments about the competitive landscape on the Daiichi news. It may have helped that the sector was up some, but this wasn't sector rotation. The 1062 news was meaningful.

IMMU is a mid cap. How many mid caps bios made 15% moves in a day?

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From: bnutman9/12/2019 10:22:30 AM
2 Recommendations   of 57518
 
Hope Rugo is a great addition to the presentation. I remember her making a succinct summary of SG at a previous conference.

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To: bnutman who wrote (52476)9/12/2019 10:36:55 AM
From: Fitzhughlaw
4 Recommendations   of 57518
 
It was at the ASCO 2018 presentation given by the company: immunomedics.com. See pages 27-42 ("Sacituzumab Govitecan –Phase 1/2 Results in HR+/HER2–Metastatic Breast Cancer").

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To: Fitzhughlaw who wrote (52477)9/12/2019 4:42:35 PM
From: ladyPI
1 Recommendation   of 57518
 
Don’t think she would be traveling across the pond to give mediocre data. I did not know we were getting more BC info at this conference but why else would she be there ?

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