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March 28, 2014
07:29 EDTESPR, KBIO, OMER, ATNM, TGTX, HZNP, FPRX, DRNA, ZIOP, EBIO, RGDOBioCentury to hold a conference
Future Leaders in the Biotech Industry Conference is being held in New York on March 28.
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November 19, 2015
16:26 EDTFPRXFive Prime begins dose expansion in FPA144 Phase 1 trial
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15:14 EDTKBIOKaloBios KB003 product could receive FDA orphan stauts, Forbes says
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07:07 EDTZIOPZIOPHARM announces data highlighting Ad-RTS-hIL-12 activity in Glioma
ZIOPHARM Oncology announced that the company is presenting initial results from an ongoing Phase 1 dose-escalation study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma or grade III malignant glioma. The presentation, titled "Intratumoral Regulated Expression of IL-12 as a Gene Therapy Approach to Treatment of Glioma," will be delivered at 5:15 pm CT, Saturday, November 21, 2015 at the 20th Annual Society for Neuro-Oncology, or SNO, Annual Scientific Meeting in San Antonio, Texas. Ad-RTS-hIL-12 + the oral activator veledimex is a novel viral gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T-cell immune response. The ongoing multi-center Phase 1 trial of Ad-RTS-hIL-12 + veledimex examines a gene therapy strategy for recurrent high grade gliomas, with the goal of generating a localized anti-tumor immune response. The primary objective of the study is to determine the safety and tolerability of a single intra-tumoral Ad-RTS-hIL-12 injection activated upon dosing with oral veledimex. Secondary objectives are to determine the Ad-RTS-hIL-12 + veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 + veledimex, and assessment of biologic response. The study is expected to enroll up to 72 subjects. Preclinically, the effects of Ad-RTS-mIL-12 + veledimex were studied in orthotopic glioma animal models, demonstrating veledimex crossed the blood-brain-barrier. In a standard orthotopic glioma mouse model that evaluated dexamethasone, bevacizumab, temozolamide and a PD-1 inhibitor, Ad-RTS-mIL-12 + veledimex demonstrated a dramatic dose-related increase in survival, without significant adverse events, that was superior to all other treatments. In the current, on-going Phase 1 study, five patients are available for initial assessment, two with recurrent grade III malignant glioma and three with grade IV. Results show IL-12 was detectable in peripheral blood along with downstream IFNg, indicating that veledimex crossed the blood brain barrier activating IL-12 expression from intra-tumorally administered Ad-RTS-hIL-12. Ad-RTS-hIL-12 + veledimex was well tolerated with minimal neurologic toxicity. The most common adverse events were headache, fever, hyponatremia and nausea/vomiting. Related serious adverse events were aseptic meningitis, neutropenia, thrombocytopenia, leukopenia, with all toxicity to date consistent with the "on-target" effects of immunotherapy.
November 18, 2015
19:37 EDTKBIOKaloBios confirms communications with majority shareholder group
KaloBios Pharmaceuticals announced that it has been informed that an investor group comprised of Martin Shkreli and associates together have acquired more than 50% of the outstanding shares of KaloBios, and that the company is in discussions with Shkreli regarding possible direction for the company to continue in operation. Shkreli is the founder and CEO of Turing Pharmaceuticals, a privately held biopharmaceutical company. "We have received communications from Mr. Shkreli informing us of his group's ownership position, and a proposal to continue the company's operations," said Ronald Martell, executive chairman of KaloBios. "Our board of directors is prepared to entertain any constructive proposal, which we will act upon promptly. Addressing short-term cash needs is our first priority, and we continue to be open to further dialogue." KaloBios had previously announced that it would undertake a wind-down of the business.
19:15 EDTKBIOOn The Fly: After Hours Movers
UP AFTER EARNINGS: Keurig Green Mountain (GMCR), up 16.3%... (CRM), up 5.2%... SINA (SINA), up 2.3%... NetApp (NTAP), up marginally. ALSO HIGHER: KaloBios (KBIO), up 721.3% after the disclosure of purchases by Martin Shkreli and Anthion Partners... Vitae Pharmaceuticals (VTAE), up 23.3% after reporting top-line results from its Phase 1 trial of VTP-43742... DOWN AFTER EARNINGS: Semtech (SMTC), down 8.5% after reporting quarterly results. ALSO LOWER: Sunedison (SUNE), down 10.8% after Reuters reports that Blackstone is not interested in SunEdison investment.
19:04 EDTKBIOAnthion Partners acquires 714K shares of KaloBios
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16:57 EDTKBIOKaloBios jumps after Martin Shkreli buys shares
Shares of KaloBios are up over 400% after Martin Shkreli, the founder of Turing Pharmaceuticals, disclosed in a filing the purchase of 1.2M shares of KaloBios for an average price of $1.35 on November 16 and 17. Shares of KaloBios are up over 400% to $10.82 in after-hours trading.
09:22 EDTATNMOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Vipshop (VIPS), up 8%. ALSO HIGHER: Anavex Life Sciences (AVXL), up 27.5% after announcing preparation of regulatory filings based on guidance from FDA... Universal Insurance (UVE), up 7.7% after issuing a statement saying that Lakewood Capital Management's statement was misleading... Actinium Pharmaceuticals (ATNM), up 14.9% after submitting an Investigational New Drug application with the FDA for Iomab-B... Fairchild Semiconductor (FCS), up 8.8% after being acquired by ON Semiconductor (ON)... Norfolk Southern (NSC), up 5% after confirming a merger offer from Canadian Pacific (CP). DOWN AFTER EARNINGS: SouFun (SFUN), down 2.9%... Staples (SPLS), down marginally. ALSO LOWER: GoPro (GPRO), down 4.4% after price target lowered to $15 from $20 at Piper Jaffray... Citrix Systems (CTXS), down 3.5% after announcing operational review and the spin off of its GoTo family of products.
08:28 EDTFPRXLeerink to hold a bus tour
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November 17, 2015
18:01 EDTATNMActinium Pharmaceuticals submits Iomab-B IND application to FDA
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10:20 EDTHZNPOptions with increasing implied volatility
Options with increasing implied volatility: SGMS HZNP CSC ULTA RH BURL GME AEO BBRY TIF
November 16, 2015
11:06 EDTFPRXFive Prime management to meet with Leerink
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11:05 EDTFPRXFive Prime management to meet with Leerink
Meeting to be held in London on November 17 hosted by Leerink.
11:04 EDTFPRXFive Prime management to meet with Oppenheimer
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10:43 EDTHZNPOptions with increasing implied volatility
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09:19 EDTKBIOOn The Fly: Pre-market Movers
HIGHER: Nexvet Biopharma (NVET), up 16.8% after NV-01 study meets primary endpoint... Protalix BioTherapeutics (PLX), up 4.8% after announcing that it will conduct a Phase III clinical trial for PRX-102... Array Biopharma (ARRY), up 4.3% after announcing a commercialization collaboration with Pierre Fabre... Perrigo (PRGO), up 2.1% after being upgraded to Buy from Neutral at UBS. DOWN AFTER EARNINGS: Dillard's (DDS), down 11.7% after reporting quarterly results. ALSO LOWER: Clovis Oncology (CLVS), down 71.3% after the FDA requested additional clinical data for rociletinib... KaloBios Pharmaceuticals (KBIO), down 48.9% after announcing that it will wind down its operations... Starwood Hotels (HOT), down 6.3% after announcing that Marriott (MAR) will acquire the company... Marriott is down 2.4%... Five Below (FIVE), down 3.1% after being downgraded to Hold from Buy at Deutsche Bank.
November 13, 2015
16:45 EDTKBIOKaloBios to wind down operations
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14:06 EDTHZNPHorizon Pharma extends exchange offer to acquire Depomed
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10:50 EDTHZNPOptions with increasing implied volatility
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November 12, 2015
05:23 EDTHZNPStocks with implied volatility movement; HZNP ESRX
Stocks with implied volatility movement; Horizon Pharma (HZNP) 123, Express Scripts (ESRX) 32 according to iVolatility.
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