REGN was knocked down by analyst stating they were losing 10% of Eylea sales per month to competition. Was knocked down all the way to $276, then we learn that Sanofi increased their stake and it's back up to $315 as takeover rumors persist. This bearish call is not justified and driven by an analyst agenda in my opinion.
Sentiment: Strong Buy
I think this MS Analyst has an agenda to drive the market valuation down to a potential acquirers liking. How can he value as he did when IMGN has a rare asset as one of the few true MAB manufactures, a successful ADC platform and all the top pharma names using their technology with a total of 17 shots on goal! Is Morgan Standley smarter than Roche, Novartis, Sanofi, Bayer, Amgen, Lilly and BioTest?
Sentiment: Strong Buy
IMGN is no penny stock, it's a real Biotech Company with great asset value. This MS Analyst has an agenda. You should have averaged down on IMGN, it will be back above your purchase price!
in July-August. This agency has improved their review process and has committed to approvals within1 year of filing. Century, Cardica's Japan distributor filed last August. So this should be any day now.
Sentiment: Strong Buy
Background: CoR is an anti-CD19 antibody maytansinoid conjugate. CD19 is expressed in the majority of B cell lymphomas. Phase I program showed clinical activity in pts with both indolent and aggressive lymphomas. Methods: Pts withCD19+ R/R DLBCL after at least one standard treatment including rituximab and not candidate for transplantation were eligible. Primary refractory pts were excluded. Biopsy was required at baseline. CoR 55 mg/m² was administered weekly for 4 weeks then bi-weekly until disease progression or other study discontinuation criteria. The primary objective was to demonstrate an overall response rate (ORR) of at least 20% following Cheson 2007 criteria. Tumor assessments were done every 12 weeks. Secondary objectives were: safety, pharmacokinetics (PK), duration of response (DOR), progression free and overall survival (PFS, OS). Assessment of correlation between biomarkers (BM) status and disease outcome was an exploratory objective. Results: 41 pts were evaluable. Median age was 71 (39:85), 53.7% were male; 92.7% had ECOG performance status 0-1. 31.7% had received ≥ 3 prior regimens for DLBCL. The ORR was 43.9% (90% CI: 30.6% to 57.9%, p-value 10%) all grades (gr) non-hematologic treatment-emergent adverse events (TEAEs) were nausea (23.0%), diarrhea (19.7%), fatigue and cough (18.0%), vomiting and decrease appetite (13.1%), asthenia, abdominal and back pain (11.5%). TEAEs led to treatment discontinuation in 4 pts. Only gr 1-2 eye disorders were reported, including 1 pt with unrelated gr 2 keratitis. Peripheral neuropathies were observed in 5 pts, all were gr 1-2. Hematological toxicity was moderate, with gr 3-4 neutropenia, thrombocytopenia and anemia in 26.4%, 9.9% and 6.6% pts respectively. PK assessment and investigations on BM expression are ongoing. Conclusions: CoR as single agent demonstrated significant activity in R/R DLBCL pts and reached its primary endpoint for ORR, with acceptable safety profile. Trial funded by Sanofi. Clinical trial information: NCT01472887.
Background: IMGN529 is a CD37-targeting ADC comprising a CD37-binding antibody conjugated to the maytansinoid anti-mitotic, DM1. CD37 is present on the surface of normal and malignant B lymphocytes. In preclinical studies, IMGN529 exhibits potent antitumor activity against NHL cells via direct inhibition, effector function and delivery of the maytansinoid payload. Methods: Study objectives are: determine the maximum tolerated dose/recommended phase 2 dose of IMGN529 in adult patients (pts) with relapsed or refractory NHL, and evaluate safety, pharmacokinetics, pharmacodynamics, and evidence of preliminary efficacy. IMGN529 is given intravenously on Day (d) 1 of each 21d cycle (C). Results: To date, 22 pts have been enrolled across four dose levels ranging from 0.1 to 0.8 mg/kg. NHL subtypes enrolled: 10 Follicular lymphoma (FL), 7 Diffuse large B-cell (DLBCL), 5 other. A reduction in lymphocyte count seen early after dosing (d 2) in the majority of pts suggests a CD37-mediated reduction in lymphocytes. One pt with DLBCL treated at 0.4 mg/kg, and 1 pt with FL treated at 0.2 mg/kg achieved partial remission in C 3 and C 5 respectively. Dose limiting toxicities (DLTs) consisted of grade (G) 4 neutropenia 7 days (1pt) and G2 peripheral neuropathy (1pt) at 0.8 mg/kg and G3 febrile neutropenia (2 pts) at 0.4 mg/kg. Adverse events (AEs) of G3 or higher occurred in 8 pts; those reported in more than 1 pt were: neutropenia (5 pts) and febrile neutropenia (2pts). Four of these pts experienced transient, early onset (C1d2-4) G3 neutropenia which may be a manifestation of cytokine release. The protocol was amended to provide peri-infusional steroids as a prophylactic regimen and dose re-escalation is ongoing; 3 patients treated at 0.4 mg/kg have completed C 1 with no DLTs. Clinical trial enrollment is ongoing with additional data expected. Preclinical studies to investigate the mechanism of the transient neutropenia are underway. Conclusions: IMGN529, a CD37-targeting ADC, has demonstrated early evidence of clinical activity and has the potential to be a novel therapeutic for B-cell lymphoproliferative malignancies. Clinical trial information: 01534715.
This may be Broadfin Capital Healthcare Master Fund. They now own 9.4% per the May 22nd 13G filing.
Sentiment: Strong Buy
This was the 191,474 share times 100 or 1.9M shares total. Each share of Series A preferred stock is convertible into 100 shares of our common stock at any time at the option of the holder, provided that the holder will be prohibited from converting Series A preferred stock into shares of our common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.98% of the total number of shares of our common stock then issued and outstanding, unless the holder gives us at least 61 days prior notice of an intent to convert into shares of common stock that would cause the holder to own more than 9.98% of the total number of shares of our common stock then issued and outstanding.
Sentiment: Strong Buy
Google "blue cross cardiovascular risk panel policy" you will see multiple state plans with this policy. I have a friend that had a risk panel by HDL labs in PA with BC Highmark as the Health Plan. It was denied as experimental. However, since HDL does not balance bill, he did not have to pay. He was confused as to whether this went against his out-of-network benefit since he did not pay an out of network deductible. Still waiting to see if he must pay. Confusing at the very least. Bottom line is the BC Medical Policy has denied payment to the laboratory.
Not only are the (2) GSK phase 3 failures a blow, but also the Blue Cross Health Plans now denying payment for CV Risk assessment panels by the Cardiovascular specialty labs like Health Diagnostic Labs and Atherotech. In reading their recent investor presentation, that's where all their growth is coming from. If these labs do not get reimbursed for running the test, they will drop selling it. Maybe they will get paid if the doctor orders it individually. This can fizzle just like Homocysteine did. Hope not!
Worst part about this 2nd phase 3 failure, is they removed stroke as and end point with a possible signal their was efficacy in coronary events. Stroke is where is where most of DDXS data is. Not good! Going to be hard to gain any reimbursement as a result of darapladib!
I'm sure more analyst ratings on the way.
I'm just as frustrated as you are, however, let's not pretend to be the only biotech that has been bear raided. How about celldex? From $38.82 to 11.02 on higher than average volume? IMGN has been down on below avg volume. Sangamo $24.69 to $11.71 or ECYT blowing up from $33.70 to 6.53? I think IMGN is doing better than most. It will come back next month during ASCO. Always does. These major dips don't last forever. Maybe the bears are trying to entice big pharma to acquire some of these assets. Lundbeck just bought Chelsea, Teva buying Cipla etc.
why not buy at 13.10? Because it's now 12.65 and hasn't found a bottom yet.
Oxford BioTherapeutics, an international biotechnology company focused on the development of innovative antibody-drug conjugates (ADCs) for the treatment of cancer, announced today that it has obtained the exclusive global rights to certain Xenomouse® antibodies generated by Amgen and to ImmunoGen's maytansinoid ADC technology for an undisclosed target. The rights were granted under the existing strategic collaboration between Oxford BioTherapeutics and Amgen. Oxford BioTherapeutics intends to use the antibodies and ADC technology to develop a novel ADC targeting a protein in HER2-negative breast cancer, initially focusing on triple negative breast cancer, and other cancers, where the target is expressed. The target was identified using the Company's OGAP® discovery technology.
ECYT has sent a chill through onco companies. This was all but a sure thing with a positive EU review. Many analysts said it was a de-risked asset only to have the DSMB shut it's phase 3 down. CLDX sports a 1.17 Billion dollar market cap. Scary place to enter when no one is guaranteed success. Given this valuation, I'd rather buy after a successful phase 3.
ECYT blowup didn't help! This is one many thought was de-risked and a sure thing after EU. Host of Biotech earnings PCYC, SGEN etc didn't impress either. This is the shorts driving down buying low and getting ready for ASCO next month.
Agree, anyone in the industry knows that hospitals consign medical devices and only pay after the devices have been used. 30 million would have to be a GPO national contact and that would be a price in exchange for volume commitment, not a lump sum payment. Ithe device is too new for such a contract. I can eventually see a children's hospital GPO contract, but not now.