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Yesterday, 6:47 AM
- Celgene (NASDAQ:CELG) expands its clinical trial data management technology relationship with Medidata (NASDAQ:MDSO). A user of its Rave product (electronic data capture, management and reporting) since 2008, it will now transition to its Clinical Cloud which includes Designer (study and protocol design), Grants Manager (site budgeting and planning), CTMS (clinical trial management), SQM (site quality management) and Patient Cloud ePRO (electronic patient-reporting outcomes).
- Celgene will also incorporate Insights, which provides advanced metrics, visualizations and a powerful set of industry data and benchmarks.
- Financial terms are not disclosed.
Fri, Jan. 29, 8:44 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion backing approval of Empliciti (elotuzumab), an immunostimulatory antibody, for the treatment of multiple myeloma (MM). The approval, if granted, will be as combination therapy with Celgene's (NASDAQ:CELG) REVLIMID (lenalidomide) and dexamethasone in MM patients who have received at least one prior therapy. A final decision by the European Commission usually takes ~60 days.
- The FDA cleared elotuzumab in November. It was co-developed by the two companies. BMY is solely responsible for commercialization.
- Previously: FDA clears Bristol-Myers and AbbVie's elotuzumab for type of blood cancer (Nov. 30, 2015)
Thu, Jan. 28, 7:54 AM
- Celgene (NASDAQ:CELG) Q4 results ($M): Total Revenues: 2,563.3 (+22.9%); Net Product Sales: 2,539.2 (+23.6%).
- Net Income: 561.0 (-8.6%); EPS: 0.69 (-6.8%); Non-GAAP EPS: 1.18 (+16.8%).
- Key Product Sales: REVLIMID: 1,560.7 (+18.0%); ABRAXANE: 270.0 (+14.5%); POMALYST/IMNOVID: 293.8 (+45.4%); VIDAZA: 147.4 (-4.1%); OTEZLA: 183.0 (+284.5%).
- 2016 Guidance: Net Product Sales: $10.5B - 11.0B; REVLIMID Sales: $6.6B - 6.7B; EPS: $4.26 - 4.64; Non-GAAP EPS: $5.50 - 5.70.
- Q1 Guidance: EPS: $0.98 - 1.05; Non-GAAP EPS: $1.27 - 1.30.
- Shares are down 2% premarket on light volume.
Thu, Jan. 28, 7:32 AM
Wed, Jan. 27, 5:30 PM
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Wed, Jan. 27, 3:30 PM
- As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
- Only Biogen and Abbott have bucked the trend.
- Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
- ETFs: BIB, BIS, CNCR
Wed, Jan. 27, 1:13 PM
- Tomorrow is a busy day for healthcare large caps with six firms reporting Q4 results. Companies and consensus views are:
- Premarket: Eli Lilly (LLY +1.1%): EPS of $0.78 on revenues of $5.3B; Zimmer Biomet Holdings (ZBH +1.1%): EPS of $2.04 on revenues of $2.0B; Abbott Laboratories (ABT +2.3%): EPS of $0.61 on revenues of $5.3B; Celgene (CELG -1%): EPS of $1.22 on revenues of $2.5B and Bristol-Myers Squibb (BMY -0.5%): EPS of $0.28 on revenues of $4.1B.
- After the close: Amgen (AMGN): EPS of $2.29 on revenues of $5.5B.
Fri, Jan. 22, 8:23 AM
- Credit Suisse analysts have been very busy lately with a long list of initiations: Acceleron Pharma (NASDAQ:XLRN) Outperform with $50 (47% upside) price target; BioMarin Pharmaceutical (NASDAQ:BMRN) Outperform with $110 (36% upside) price target; Amgen (NASDAQ:AMGN) Outperform with $205 (34% upside) price target.
- Celgene (NASDAQ:CELG) Outperform with $149 (41% upside) price target; Coherus Biosciences (NASDAQ:CHRS) Outperform with $25 (79% upside) price target; Gilead Sciences (NASDAQ:GILD) Outperform with $125 (40% upside) price target.
- Regeneron Pharmaceuticals (NASDAQ:REGN) Neutral with $552 (19% upside) price target; Vertex Pharmaceuticals (NASDAQ:VRTX) Outperform with $151 (59% upside) price target; Alnylam Pharmaceuticals (NASDAQ:ALNY) Outperform with $154 (117% upside) price target.
- Alexion Pharmaceuticals (NASDAQ:ALXN) Neutral rating with $201 (29% upside) price target; Biogen (NASDAQ:BIIB) Neutral with $322 (23% upside) price target; XenoPort (NASDAQ:XNPT) Underperform with $4 (16% downside risk) price target.
- PTC Therapeutics (NASDAQ:PTCT) Outperform with $36 (33% upside) price target; Mesoblast Limited (NASDAQ:MESO) Outperform with $10 (92% upside) price target and Incyte (NASDAQ:INCY) Outperform with $110 (49% upside) price target.
Wed, Jan. 20, 1:47 PM
Wed, Jan. 20, 11:36 AM
- To point out the obvious, the biotech sector has been unable to fight off the widespread selling. The iShares Nasdaq Biotech Index Fund (IBB -1.8%) is down again, albeit on modestly higher volume. It's down over 21% since late December.
- Representative tickers: (GILD -1.7%)(CELG +0.7%)(BIIB -2.7%)(AMGN -0.6%)(ALXN -2.8%)
Mon, Jan. 11, 12:24 PM
- Celgene (CELG -5.9%) slumps on double normal volume after it released its 2016 guidance of non-GAAP EPS of $5.50 - 5.70 (+19%) on revenues of $10.5B - 11.0B (+17%), both below the growth rates for 2015. GAAP EPS is expected to be $4.26 - 4.64. REVLIMID forecast: $6.6B - 6.7B.
- Preliminary 2015 results: total revenues: $9.16B (+21%); non-GAAP EPS: ~$4.71 (+27%); GAAP EPS: $1.89 - 1.99; Product sales: REVLIMID: $5.8B (+16%), ABRAXANE: $967M (+14%), POMALYST/IMNOVID: $983M (+45%) and OTEZLA: $472M.
- Preliminary Q4 results: non-GAAP EPS: ~$1.18; GAAP EPS: $0.63 - 0.73.
- Concurrently, the company announces changes to its senior management team effective March 1. Chairman & CEO Bob Hugin will transition to Executive Chairman, President & COO Mark Alles will be promoted to CEO, President, Global Hematology and Oncology Jacqualyn Fouse, Ph.D., will be promoted to President & COO and Scott Smith, President Immunology & Inflammation will assume an expanded leadership role.
Tue, Jan. 5, 9:23 AM
- OncoMed Pharmaceuticals (NASDAQ:OMED) earns two milestone payments from collaboration partner Celgene (NASDAQ:CELG), $70M for successful safety data from a Phase 1b study of demcizumab in patients with pancreatic, non-small cell lung and ovarian cancers and $2.5M for the designation of a clinical candidate for an undisclosed immuno-oncology program.
- Results from the Phase 1b trial showed no demcizumab-related Grade 3 or higher cardio-pulmonary toxicities among 155 patients treated with truncated dosing. 68 patients from the group have received at least two cycles of demcizumab at the Phase 2 dose or higher and have been followed for at least 100 days.
- Including the milestones, the company ended 2015 with $227.2M in pro forma cash. Operating expenses should total ~$110M, consistent with prior guidance.
- According to the company, over the next three years it can potentially earn more than $168M in opt-in payments from Celgene, $60M in opt-in and milestone payments from Bayer (OTCPK:BAYRY) and $43M in opt-in payments from GlaxoSmithKline (NYSE:GSK). It is eligible to receive more than $5B in total milestone and option payments from the three firms.
- Previously: OncoMed soars on demcizumab deal with Celgene (Dec. 3, 2013)
Dec. 23, 2015, 9:12 AM
Dec. 22, 2015, 6:41 PM
- Celgene (NASDAQ:CELG) is up 6.9% after hours following a patent settlement concerning its top-selling drug, Revlimid.
- The drugmaker's deal with India's Natco Pharma and its U.S. partner Arrow International (part of AGN) means Natco and Arrow get a license to make an unlimited quantity of generic Revlimid starting Jan. 31, 2026 -- more than a year before patents on the drug expire (April 2027).
- Natco will also get a limited license to sell the multiple myeloma drug -- which made up 63% of Celgene's $2.3B in revenues last quarter -- in the U.S. starting March 2022.
- Jefferies on the deal: "Though this represents a compromise, overall we view the settlement as a positive, removing a major overhang on shares and enabling a clearer road towards lower-risk long-term growth."
Dec. 22, 2015, 5:39 PM
Dec. 21, 2015, 11:03 AM
- Norwegian biotech Bionor Pharma ASA (OTCPK:BNRPF)(OTCPK:BNRQY) announces successful results from a mid-stage study, REDUC, assessing the combination of its therapeutic vaccine Vacc-4x and Celgene's (CELG +0.5%) HDAC inhibitor Istodax (romidepsin) in controlling reactivated HIV and reducing latent viral reservoir in 17 HIV-infected subjects undergoing antiretroviral therapy.
- Latent HIV reservoir was reduced by 40% while viral load remained below the level of detection in almost 65% of patients (n=11/17) despite reservoir reactivation.
- According to the company, the results justify further advancement of Vacc-4x as a core component in a functional cure for HIV. Resistance of the latent reservoir of HIV to combination antiretroviral therapy (cART) is the main barrier to eradicating the virus from the body. The feasibility of a functional cure (the virus is controlled at a low enough level to prevent disease progression and transmission) is supported by the clinical evidence of some HIV-infected individuals who are able to control their infection in the absence of cART. These "elite controllers" are characterized by low viral reservoirs.
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