Company Overview and News

 
Catalyst Enrolls First Patient in Phase III Firdapse Study

21h zacks
Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) , enroled the first patient in its phase III clinical trial (MSK-002) to evaluate the efficacy and safety of Firdapse (amifampridine phosphate) in patients with MuSK antibody positive Myasthenia Gravis (MuSK-MG).
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Bristol-Myers' Opdivo Gets Priority Review for Lung Cancer

2018-04-19 zacks
Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has accepted and granted a priority review designation to the supplemental Biologics License Application (sBLA) for the label expansion of Opdivo (nivolumab) to treat patients with small cell lung cancer (“SCLC”) whose disease has progressed after two or more prior lines of therapy. The FDA set an action date of Aug 16, 2018.
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Calithera's Kidney Cancer Candidate Gets Fast Track Status

2018-04-19 zacks
Calithera Biosciences, Inc. (CALA - Free Report) announced that the FDA has granted Fast Track designation to its lead candidate, CB-839. The candidate is being developed in combination with Exelixis, Inc.’s (EXEL - Free Report) Cabometyx (cabozantinib) for the treatment of metastatic kidney cancer.
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Bayer to Divest 3.6% Stake to Singapore Company Temasek

2018-04-18 zacks
Bayer AG (BAYRY - Free Report) will divest its 3.6% stake to Singapore's state investment company Temasekfor total gross proceeds of €3 billion. Along with its existing holding in Bayer, Temasek will own about 4% in Bayer after the transaction. Bayer has announced the deal toward its planned $66 billion takeover of Monsanto (MON - Free Report) .
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Agios' Leukemia Drug Bodes Well for Growth & Strong Pipeline

2018-04-18 zacks
On Apr 17, 2018, we issued an updated report on Agios Pharmaceuticals, Inc. (AGIO - Free Report) , a development-stage biopharmaceutical company focused on development of treatments for cancer and rare genetic metabolic disorders (RGD), a subset of orphan genetic metabolic diseases.
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Alkermes Rallies as FDA Accepts NDA for Depression Drug

2018-04-17 zacks
Shares of Alkermes plc (ALKS - Free Report) jumped about 4.5% when the FDA accepted for review the new drug application (NDA) for ALKS 5461 for the treatment of major depressive disorder (“MDD”). The FDA had initially issued a Refusal to File letter on Mar 30 for the candidate stating that the NDA did not have enough evidence for the oral medication to work.
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Alnylam (ALNY) Reports Positive Data for RNAi Candidate

2018-04-17 zacks
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced positive results from phase I and phase I/II open-label extension (OLE) studies of givosiran, which is being evaluated for the treatment of acute hepatic porphyrias (AHPs).
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Merck's Keytruda Betters Survival in Lung Cancer Combo Study

2018-04-17 zacks
Merck’s (MRK - Free Report) shares increased 2.59% on Apr 16 after it presented full data from the pivotal phase III KEYNOTE-189 study. Data from the same showed that Keytruda combined with Eli Lilly’s (LLY - Free Report) Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) significantly improved overall survival, thereby reducing the death risk by half (51%) compared with chemotherapy alone.
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Intercept Reports Phase III Sub-Study Liver Biopsy Data

2018-04-16 zacks
Intercept Pharmaceuticals (ICPT - Free Report) announced encouraging data from the POISE biopsy sub-study. Results from the study confirmed that long-term treatment with obeticholic acid (“OCA”) leads to the reversal or stabilization of fibrosis/cirrhosis in patients with primary biliary cholangitis (“PBC”) who have had an incomplete response to ursodeoxycholic acid (UDCA).
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Rigel Pharmaceuticals' (RIGL) Stock Gains 16%: Here's Why

2018-04-13 zacks
Shares of Rigel Pharmaceuticals (RIGL - Free Report) moved up by 16% as it awaits FDA’s decision on its lead pipeline candidate Tavalisse (fostamatinib) on Apr 17. The jump in share price could also be because the company’s website described tavalisse (fostamatinib) as "the company's first FDA approved product”. However, this was actually not the case and the company issued a statement clarifying that due to an error of the external host of its investor relations website, inaccurate information was displayed.
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FDA Lifts Clinical Hold on Bellicum's (BLCM) T Cell Therapy

2018-04-12 zacks
Bellicum Pharmaceuticals, Inc.’s (BLCM - Free Report) announced that FDA has lifted clinical hold on studies conducted in the United States evaluating its T cell therapy, BPX-501. The company consulted with regulatory body and agreed to make amendments to the study protocols, which include guidance on monitoring and management of neurologic adverse events.
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Epizyme (EPZM) Publishes Tazemetostat Phase I Data, Stock Up

2018-04-11 zacks
Shares of Epizyme Inc. (EPZM - Free Report) rose almost 10% after the company announced the publication of tazemetostat phase I clinical data in The Lancet Oncology. The study demonstrated favorable safety findings and anti-tumor activity and established recommended dose for the phase II expansion study.
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Karyopharm's Myeloma Candidate Gets Fast Track Designation

2018-04-11 zacks
Karyopharm Therapeutics Inc.'s (KPTI - Free Report) shares increased more than 6% on Apr 10 after the company announced that its oral selective inhibitor of nuclear export (SINE) compound, selinexor (KPT-330), has been granted a fast track designation by the FDA.
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FDA Prolongs Review Date for AbbVie Endometriosis Candidate

2018-04-11 zacks
AbbVie Inc. (ABBV - Free Report) and partner Neurocrine Biosciences announced that the FDA has extended the review period of marketing application for the companies’ pipeline candidate, elagolix, by three months. As a result, the regulatory body will now announce its decision by the third quarter of 2018 instead of the previously anticipated second-quarter 2018 timeline.
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