Why didn't IMGN mgmt say anything in their PR about what is bad and ugly about taxanes compared to Kadcyla? Alopecia, nausea, neutropenia, infections, .....
Why is superiority in PFS the primary objective, when FDA will approve Kadcyla's use for advance mBC if comparable efficacy is demonstrated? I guess Roche wants to be able to sell a proven superior product for first line use and easily justify Kadcyla's hefty price tag.
It looks like IMGN would have been better off doing their final equity offering when pps was at $13.
Someone knows that good news will be coming in Dec and they need to push pps down as low as they can so they can load up. I would say that this is a rare buying opportunity for a decent company with sure earnings and earnings potential
It was just the timing of the release of the ASH abstracts.
It is also ACHN's way of broadcasting to the world that they are experts in structure-based drug design, and they are also able to branch out into other lucrative indications with their in-house expertise.
Ninety-three percent of patients (14/15) achieved a negative PET scan after 2 cycles . All patients with disease bulk were PET-2 negative (10/10). Ninety-two percent of patients achieved a negative PET scan after 4 cycles of therapy.
The study treatment has been well-tolerated. No pulmonary toxicity has been observed. Serious adverse events have been documented in two patients: febrile neutropenia and grade 3 hypertension. One patient discontinued protocol treatment due to the development of grade 3 peripheral neuropathy after one treatment with BV+AVD.
Yet it was pushed down to 9.58. Government needs to do something about non-investing funds and manipulators to protect my investments.
Biotech sector is getting hit really badly. I'm now a pauper. Blame the manipulating hedgies. Funds should be required to invest in companies and not drive the roller coaster.
Amgen, Sanofi, Novartis, Pfizer are desperate to expand their onco pipeline. IMGN will either be snapped up, or will announce new partnerships. SGEN so far has no proof of concept in solid tumors with CLDX trial delay.
Gastric is huge in Japan/Asia.
I bought too soon at 8.36. I have another buy set at 7.11 in case they crash this down. Our Jan 10 options are gone unless at least 1 partnered product deliveries news or new partnership announcement with decent upfront.
Pomalidomide + dexamethasone . Nearly one-third of the patients in the pomalidomide group (95 of 302 patients) had their tumors shrink or showed other signs of achieving a partial response.
78% ORR. Biotest patients are probably even in a more advance stage than Poma subjects. 30% were Lenalomide-refractory.
Poma:After a median follow-up of 10.0 months, the researchers found, patients in the pomalidomide plus dexamethasone group had lived 4.0 months without the disease worsening, compared with just 1.9 months among the patients assigned to receive high-dose dexamethasone alone.
Biotest: maybe they will present prelim PFS during ASH.
Those invested in Celgene should sell some of their shares and buy more IMGN.
IMGN has to opt in and when it does, it will rake in more profits than SGEN. This is what we've been waiting for longs!
Great for mm patients, bad for the makers of earlier drugs. Amazing how technology has progressed. Chemo will be a thing of the past in a decade.
For relapsed MM (does not include len refractory), Patients treated with Kyprolis® (carfilzomib) for Injection in combination with Revlimid® (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared to patients treated with Revlimid and low-dose dexamethasone (Rd) (median 17.6 months). Overall survival was not improved.
Biotest drug should beat Kyprolis and Poma, then IMGN will soar past 20.
This is even better:
For r/r using kyprolis, the ORR was 22.9 percent (95 percent CI: 18.0, 28.5), consisting of 1 complete response, 13 very good partial responses, and 47 partial responses. The median response duration was 7.8 months. Patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of the completion of the last therapy. K got accelerated approval.
Boys and girls, I'm tempted to add more today below $11! Biotest drug should be approved based on PhaseII results.
If you know your ADCs, as well as your ABCs, and 123s, this is an opportune time to load up on IMGN. Still more than $100M in revenue with a robust partnered pipeline.
No PFS difference, but AEs from taxanes, early and long term, are terrible. Most patients would rather be on Kadcyla than lose their hair on taxane chemo.
Up to 60% grade 3 neutropenia on paclitaxel. It's not only about hair loss.
Roche statement only mentioned that "adverse events observed in the two experimental arms of the study were generally consistent with those seen in previous studies of Kadcyla and/or Perjeta1". That refers to Kadcyla and K + P. Roche seems to have deliberately avoided mention of comparing adverse events of K vs H+T.
529 DLT of neutropenia can be controlled with steroids and GCSF and new DLT has not been reached with the new protocol, yet efficacy is already seen at 1mg/kg.
The overall response rate (ORR) is 78%; including 1 stringent complete response, 2 complete responses, 10 very good partial responses, and 15 partial responses. Two patients achieved a minor response and 6 patients disease stabilization, resulting in a clinical benefit in 100% of the evaluable patients. The ORR was 83% among the 30 evaluable patients receiving the RPTD. Interestingly, the ORR was 70% among the 23 patients with prior exposure to Len and bortezomib, and among 10 patients refractory to prior treatment with Len.
Docetaxel treatment (alopecia, asthenia, nausea, diarrhea, peripheral edema, vomiting, neuropathy, and neutropenia. None of that with Kadcyla. Two patients treated with docetaxel alone died due to septic events and multi-organ failure.
Paclitaxel discontinued in 15% of patients because of peripheral neuropathy in 5, onycholysis in 1, and a chest wall infection in 1.