Mon, Jun. 29, 4:40 PM
- Juno Therapeutics (NASDAQ:JUNO) jumps 53% after hours on robust volume in response to its announcement of a 10-year collaboration with Celgene (NASDAQ:CELG) to develop and commercialize novel immunotherapies for the treatment of cancer and autoimmune diseases.
- Under the terms of the agreement, Celgene will make an upfront payment of ~$1B which includes an equity investment of ~$850M (9.1M shares at $93 per share). Celgene has the option of being Juno's commercialization partner for oncology and cell therapy autoimmune product candidates, including its CD19- and CD22-directed CAR-T product candidates, exclusive of B-Cell Maturation Antigen.
- Juno will be responsible for R&D in North America and will retain commercialization rights in these territories. Celgene will be responsible for development and commercialization in the rest of the world and will pay Juno royalties on net sales. Celgene has the right to select two programs, exclusive of CD19 and CD22, whereby the two firms will share equally in costs and profits in all territories except China. Under certain circumstances, Celgene may select a third program.
- Juno has the option of co-developing and co-commercializing certain Celgene-originated product candidates that target T cells. Costs and profits will be shared with Celgene on a 70/30 basis (70% - Celgene).
- The upfront payment consists of $150M in cash plus the purchase of 9,137,672 shares of Juno common stock at $93 per share. Under certain circumstances, Celgene could acquire up to a 30% stake in Juno.
- The companies will host a conference call at 5 pm ET today to discuss the deal.
Wed, Jun. 17, 7:44 AM
Mon, Jun. 15, 5:34 PM
- Preliminary results from a Phase 2 clinical trial assessing Acceleron Pharma's (NASDAQ:XLRN) luspatercept in patients with lower risk myelodysplastic syndromes (MDS) show that three month's treatment with luspatercept increased hemoglobin levels and achieved transfusion independence in lower MDS patients. Longer term treatment produced sustained benefit for six months, possibly longer. The data were presented at the 20th Congress of the European Hematology Association in Vienna, Austria.
- Results from the 12-month extension study show that low transfusion burden patients (n=9) experienced a mean hemoglobin increase of ~2 g/dL (normal range: 13.5-17.5 g/dL for men and 12.0-15.5 g/dL for women) at one month which increased as high as 3.0 g/dL and was maintained for the six-month period for which data are available. In transfused patients, 43% achieved transfusion independence with several maintaining independence for more than six months.
- Also on a preliminary basis, data from a Phase 2 trial in beta thalassemia showed that 38% of patients treated with luspatercept experienced a mean increase in hemoglobin of at least 1.5 g/dL for at least nine weeks. In non-transfusion dependent patients who had iron overload (n=12), eight (67%) experienced reduced liver iron concentrations of 1-4.6 mg/g dry weight over a 16-week period. In transfusion dependent patients, 100% (n=10/10) who received luspatercept had more than a 40% reduction in transfusion burden while two of three with iron overload showed reduced liver iron concentration by 1.96 and 4.7 mg/g dry weight, respectively (reference value = ~1.8 mg/g dry weight).
- Luspatercept, being co-developed with Celgene (NASDAQ:CELG) is a protein therapeutic called a ligand trap. It promotes red blood cell formation by inhibiting members of the transforming growth factor beta superfamily, proteins that induce programmed cell death (apoptosis).
Wed, Jun. 10, 5:03 PM
- The FDA designates Agios Pharmaceuticals' (NASDAQ:AGIO) AG-120 an Orphan Drug for the treatment of acute myelogenous leukemia.
- AG-120, currently in Phase 1 development, is an inhibitor of the mutated form of the metabolic enzyme IDH1 (isocitrate dehydrogenase 1), present in a wide range of cancers. Normally, IDH enzymes help break down nutrients and generate energy for cells. When mutated, however, IDH creates a molecule that alters cells' genetic programming by which they remain in a primitive state and proliferate quickly. The company believes that inhibiting the mutated proteins may lead to clinical benefit for the subset of cancer patients whose tumors carry them.
- Agios retains the development and commercialization rights to AG-120 in the U.S. while Celgene (NASDAQ:CELG) owns the rights ex-U.S.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Tue, Jun. 9, 9:05 AM
- Acceleron Pharma (NASDAQ:XLRN) will host a conference call and live webcast on June 15 at 10:00 am ET to review the highlights of two oral presentations on the luspatercept Phase 2 clinical trials in myelodysplastic syndromes and beta thalassemia given at the 20th Congress of the European Hematology Association.
- Fast Track-designated Luspatercept, being co-developed with Celgene (NASDAQ:CELG), is a protein therapeutic called a ligand trap. It promotes red blood cell formation by inhibiting members of the transforming growth factor beta (TGF-beta) superfamily, proteins that induce programmed cell death or apoptosis.
Wed, Jun. 3, 4:58 PM
- The collaboration between Celgene (NASDAQ:CELG) and bluebird bio (NASDAQ:BLUE) that began in March 2013 to develop and commercialize CAR-T therapies has a new focus. The companies will now direct their efforts on developing product candidates targeting B-cell maturation antigen (BCMA) for the next three years. BCMA is a cell surface protein that is expressed in normal plasma cells and in most myeloma cells, but is absent in other normal tissues.
- The companies will work together on the initial anti-BCMA candidate, known as bb2121, as well as next-generation anti-BCMA product candidates. A Phase 1 study of bb2121 will commence in early 2016.
- The rights to all other CAR-T programs developed by bluebird under the collaboration will remain with bluebird.
- Under the terms of the amended collaboration, bluebird will receive an upfront payment of $25M to fund the development of the lead anti-BCMA candidate through a Phase 1 study and the development of next-generation anti-BCMA candidates through Phase 1 trials. Celgene will have the option to develop and commercialize each product candidate worldwide and bluebird has the option to share equally in the development and commercialization of each candidate in the U.S. Celgene will pay bluebird development and regulatory milestone payments as well as royalties on net sales.
- BLUE is down 2% after hours on average volume. CELG is unchanged.
Thu, May 21, 9:30 AM
- Alongside Goldman's list of 50 stocks appearing most as top holdings at hedge funds is its list of the 50 top shorts.
- New additions this quarter: Baxter Intl (NYSE:BAX), UPS, Marriott (NASDAQ:MAR), NextEra (NYSE:NEE), Ford (NYSE:F), National Oilwell Varco (NYSE:NOV), McDonald's (NYSE:MCD), M&T Bank (NYSE:MTB), CenturyLink (NYSE:CTL), Amgen (NASDAQ:AMGN), Pioneer Natural (NYSE:PXD), Duke Energy (NYSE:DUK), Seagate (NASDAQ:STX), AbbVie (NYSE:ABBV), Cisco (NASDAQ:CSCO).
- The full list (in order of $ value of short interest): AT&T (NYSE:T), Disney (NYSE:DIS), IBM, Verizon (NYSE:VZ), Intel (NASDAQ:INTC), Kinder Morgan (NYSE:KMI), Exxon (NYSE:XOM), Pfizer (NYSE:PFE), J&J (NYSE:JNJ), Deere (NYSE:DE), Caterpillar (NYSE:CAT), Exelon (NYSE:EXC), GE, Boeing (NYSE:BA), Halliburton (NYSE:HAL), Fox (NASDAQ:FOXA), Comcast (NASDAQ:CMCSA), UTX, Regeneron (NASDAQ:REGN), Merck (NYSE:MRK), salesforce.com (NYSE:CRM), AbbVie (ABBV), Conoco (NYSE:COP), Wal-Mart (NYSE:WMT), Eli Lilly (NYSE:LLY), Celgene (NASDAQ:CELG), Schlumberger (NYSE:SLB), AutoZone (NYSE:AZO), Wells Fargo (NYSE:WFC), Emerson (NYSE:EMR), McDonald's (MCD), Reynolds (NYSE:RAI), Target (NYSE:TGT), Accenture (NYSE:ACN), Coca-Cola (NYSE:KO).
Mon, May 18, 9:53 AM
- The FDA designates luspatercept for Fast Track review for the treatment of patients with transfusion-dependent and non-transfusion-dependent beta thalassemia.
- Beta thalassemia is genetic disorder caused by mutations in the HBB gene, which provides instructions for making beta-globulin, a protein subunit of hemoglobin. Sufferers are anemic and have increased risk of developing abnormal blood clots.
- Luspatercept is a protein therapeutic called a ligand trap. It promotes red blood cell formation by inhibiting members of the transforming growth factor beta (TGF-beta) superfamily, proteins that induce programmed cell death or apoptosis. It is being co-developed by Acceleron Pharma (XLRN +1.1%) and Celgene (CELG). A Phase 2 trial in beta-thalassemia is in process.
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
Fri, May 15, 10:59 AM
- NantWorks LLC member company NantPharma acquires the rights to Sorrento Therapeutics' (SRNE +16.8%) Cynviloq (paclitaxel polymeric micelle for injection) through its takeover of Sorrento subsidiary Igdrasol. Under the terms of agreement, Sorrento will receive an upfront payment of $90M, more than $600M in regulatory milestones, $600M in sales-based milestones and additional transfer payments from total unit sales.
- Cynviloq is going after Celgene's (CELG +0.3%) Abraxane (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) which generated almost $900M in sales over the past four quarters.
- NantWorks LLC, founded by Abraxane inventor Dr. Patrick Soon-Shiong, has a close relationship with Sorrento. They announced a joint venture, Nantibody LLC, in December to develop immunotherapies for cancer and autoimmune diseases. Under the terms of the JV, Nantibody established a 19.9% equity stake in Sorento with warrants to purchase over 1.7M additional shares.
- Sorrento entered into a collaboration with another NantWorks company, NantCell LLC, in March also focused on cancer immunotherapies.
- Previously: Sorrento Therapeutics inks second collaboration deal with Nantworks (March 16)
- Previously: Sorrento up on news of collaboration with Abraxane inventor (Dec. 15, 2014)
Tue, May 5, 6:54 PM
- An interim analysis of a Phase 2 trial evaluating luspatercept in patients with lower risk myelodysplastic syndromes (MDS) show that treatment with luspatercept increased hemoglobin levels and enabled many patients to become transfusion independent.
- Data from 44 of 58 patients were available for analysis. In the higher dose groups (0.75 to 1.75 mg/kg subcutaneously every three weeks) 54% (n=24/44) showed increased hemoglobin. 36% of patients who received red blood cell transfusions during the eight weeks prior to treatment in the study achieved transfusion independence for at least eight weeks during the study.
- In patients considered positive for ring sideroblasts (abnormal red blood cell precursor cells in the bone marrow), 63% showed increased hemoglobin and 39% achieved transfusion independence. RS-positive patients, representing ~30% of all MDS sufferers, are more resistant to treatment.
- Luspatercept is a protein therapeutic called a ligand trap. It promotes red blood cell formation by inhibiting members of the transforming growth factor beta (TGF-beta) superfamily, proteins that induce apoptosis (cell death). It is being co-developed by Acceleron Pharma (NASDAQ:XLRN) and Celgene (NASDAQ:CELG).
- The data were presented at the 13th International Symposium on Myelodysplastic Syndromes in Washington, DC.
- Previously: Celgene and Acceleron Pharma to start Phase 3 study to assess luspatercept in blood disorders (April 30)
Thu, Apr. 30, 12:58 PM
- Acceleron Pharma (XLRN -5.2%) and collaboration partner Celgene (CELG -3.7%) plan to initiate a Phase 3 study by year-end to evaluate Acceleron's luspatercept for the treatment of myelodysplastic syndromes (MDS) and beta thalassemia.
- Luspatercept is a protein therapeutic called a ligand trap. It promotes red blood cell formation by inhibiting members of the transforming growth factor beta (TGF-beta) superfamily, proteins that induce apoptosis (cell death).
- Preliminary data from an ongoing Phase 2 trial of luspatercept in MDS will be presented on May 2 at the 13th International Symposium on Myelodysplastic Syndromes in Washington, DC.
- Myelodysplastic syndromes are a group of cancers in which immature blood cells in the bone marrow fail to mature. The abnormally low level of circulating blood cells leads to anemia and its associated problems. Beta thalassemia is a blood disorder caused by mutations in the HBB gene that results in insufficient production of hemoglobin. These patients are also anemic.
- The companies established their collaboration in 2008 to develop and commercialize sotatercept (ACE-011) for the treatment of anemia in rare blood diseases. They added luspatercept (ACE-536) in 2011. Sotatercept is also a TGF-beta-targeting protein therapeutic, but with a different mechanism of action.
Thu, Apr. 30, 8:34 AM
- Celgene (NASDAQ:CELG) Q1 results ($M): Total Revenues: 2,080.8 (+20.3); Net Product Sales: 2.055.2 (+20.4%); Net Income: 718.9 (+157.0%); EPS: 0.86 (+30.3%); CF Ops: 858 (+54.0%).
- Key product sales: Revlimid: 1,342.9 (+17.4%); Abraxane: 223.4 (+20.9%); Pomalyst/Imnovid: 198.5 (+46.4%); Vidaza: 143.6 (-3.2%).
- 2015 Guidance: Net product sales: $9.0B - 9.5B (unch); Revlimid: $5.6B - 5.7B (unch); Abraxane: $1.00B - 1.25B (unch); non-GAAP EPS: $4.60 - 4.75 (unch); GAAP EPS: $2.97 - 3.19 from $3.68 - 3.92.
- Shares down 2% premarket on modest volume.
Thu, Apr. 30, 7:32 AM
Wed, Apr. 29, 5:30 PM
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Wed, Apr. 29, 3:34 PM
- Before the open (consensus views):
- Sanofi (SNY -1%), Revenues of $39B.
- Celgene (CELG -0.1%), EPS of $1.06 on revenues of $2.1B.
- AmerisourceBergen (ABC -1.2%), EPS of $1.19 on revenues of $32.3B.
- Teva Pharmaceutical Ind. (TEVA +1.1%), EPS of $1.25 on revenues of $4.8B.
- Shire plc (SHPG -0.6%), EPS of $2.59 on revenues of $1.5B.
- After the close:
- Gilead Sciences (GILD -1.3%), EPS of $2.32 on revenues of $6.9B.
- Biomarin Pharmaceuticals (BMRN -0.2%), loss per share of ($0.53) on revenues of $203M.
Mon, Apr. 27, 8:17 AM
- Celgene (NASDAQ:CELG) acquires privately-held San Francisco, CA-based Quanticel Pharmaceuticals for $100M in cash and up to $385M in various R&D and regulatory milestones. Celgene expects the transaction to be neutral to 2015 non-GAAP EPS guidance.
- Quanticel, which as been a strategic alliance partner to Celgene since 2011, is a cancer-focused drug discovery firm based on a proprietary single-cell genomic analysis platform.
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