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$CELG announced results from interim analysis of Magnify, a phase 3b, randomized, open-label, multicenter study of Revlimid (lenalidomide) plus rituximab combination therapy in patients with relapsed or refractory marginal zone lymphoma (MZL). Lymphoma a group of blood cell tumors that develop from lymphocytes (a type of white blood cell).
$CELG, which made two multi-billion dollar buyouts (Impact & $JUNO) in the beginning of 2018, swung to a loss in 4Q17, hit by the income tax charges. Celgene reported a loss of $81MM or $0.10 per share on a GAAP basis compared to a profit of $429MM or $0.53 per share, hurt by the impact of Tax Cuts and Jobs Act. Adjusted EPS rose 24% to $2.00.
$CELG Celgene Corp. Earnings AlphaGraphic: Q4 2017 Highlights. The increase in Revlimid and Otezla drug sales helped to boost Celgene's total revenue by 17% to $3.483Bil in the fourth quarter of 2017. Celgene swung to loss in the recently ended quarter on the impact of 2017 Tax Act.
Last week's rumor becomes reality. $CELG to acquire its strategic partner $JUNO for $9Bil. Juno Therapeutics, which had already skyrocketed nearly 50% in the last week, has increased more than 25% today in pre-market from Jan. 19th closing price of $67.81. Celgene expects that this deal will help it to boost the revenue generation beyond 2020.
$CELG agreed to acquire start-up firm Impact Biomedicines for an upfront payment of $1.1Bil. Under the deal terms, Celgene will further pay up to $1.25Bil on Impact's cancer drug Fedratinib getting FDA's approvals. If the global annual net sales of the drug exceed $5Bil, Celgene will pay a maximum of $4.5Bil. The deal is expected to close in 1Q18.
$CELG's cancer drug Revlimid fails to meet the endpoint in the first Phase 3 trial. Celgene said that additional analyses are ongoing and it would present the complete analyzed data in a future medical conference. Revlimid contributed 63% of Celgene's revenue in their recently ended third quarter.
$CELG and $JUNO report additional data from the TRANSCEND study. Celgene added that the results of this study show the potential for the CAR T therapy, a therapy to treat cancers. Application filing is expected to be completed in 2H18, with approval as early as the end of 2018. In June 2015, Celgene partnered with Juno Therapeutics by paying $1Bil.
$CELG and its partner $BLUE reported that FDA granted Breakthrough Therapy Designation, which will expedite the review of the plasma cell cancer treating therapy. This was based on the preliminary data from the ongoing phase 1 study of the therapy. In March 2013, Celgene and Bluebird Bio entered into a strategic alliance in the field of oncology.
In a confidential license agreement, $CELG and $LCI enter into a settlement related to Celgene's Thalomid drug, which is used to treat the plasma cell cancer. This agreement allows Lannett to manufacture and market a generic thalidomide product in the US from Aug. 1, 2019, or earlier under certain circumstances.
$CELG cut down its FY17 GAAP EPS outlook from $5.36-5.62 range to $4.78-5.19 range. For FY20, the drugmaker slashed its total net product sales target from the previous target of greater than $21Bil to $19-20Bil range and adjusted EPS target was reduced from the previous target of greater than $13 to greater than $12.50.
Despite higher profit and revenues in 3Q17, $CELG cut down its outlook for 2017 and 2020. Profit spiked nearly six times to $988MM or $1.21 per share, while revenue rose 10% to $3.29Bil. Product sales were up 11% to $3.28Bil, helped by the increase in sales of Revlimid, Pomalyst/Imnovid, Otezla and Abraxane drugs.
$CELG disclosed in an SEC filing that it expects to incur a pretax charge to earnings for 4Q17 in the range of $300-500MM ($0.27-0.45 per diluted share after tax) in connection with its decision to stop the two trials for Crohn's disease. Celgene also added that it would require to pay half of this charge in cash.
$CELG said that it will stop the two trials for treating the Crohn's disease (a chronic inflammatory bowel disease), following the recommendation of the Data Monitoring Committee. No safety signals were identified during a recent interim futility analysis. Celgene added that the third trial will not be initiated at this time.
After collaborating with $CELG for almost a decade, $XLRN amended its development and commercial agreement with Celgene for the investigational drug Sotatercept. Acceleron will develop and market Sotatercept in the pulmonary hypertension field. Celgene will be eligible to receive royalties on global net sales in that field.
$CELG to present data from multiple studies about the use of Abraxane to treat non-small lung cancer and pancreatic cancer. The data will be presented at the European Society of Medical Oncology (ESMO) 2017 Annual Meeting between Sept 8-12 in Madrid, Spain.
$CELG gets a pause from FDA as it partially holds the drugmaker's five clinical trials and one clinical trial fully. All of these trials involve cancer drug Durvalumab. Celgene added that patients enrolled in the partial hold trials may remain on the treatment and those who are on full clinical hold trial will be discontinued from the treatment.
$CELG and $AGIO said Idhifa (enasidenib) was granted approval from FDA for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 mutation. The approval was based on results from the Phase I/II study. AML is a cancer of blood and bone marrow marked by rapid disease progression.
For FY17, $CELG cut down its GAAP EPS outlook to $5.36-5.62 from its prior estimate of $5.95-6.29. However, Celgene lifted its non-GAAP EPS outlook to $7.25-7.35 from its previous estimate of $7.15-7.30. The company didn't alter its previous revenue outlook of $13.0-13.4Bil.