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Based in New Haven, CT, Alexion Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of life-transforming drugs, for the treatment of patients with ultra-rare disorders. The company’s complement franchise consists of key growth driver, Soliris, which is approved for the treatment of two severe and ultra-rare disorders resulting from chronic uncontrolled activation of the complement component of the immune system — paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Soliris is also approved for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. The FDA also approved its long-acting C5 complement inhibitor, Ultomiris, for the treatment of adult patients with PNH, to be administered every eight weeks. In October 2019, the FDA approved the use of Ultomiris as a treatment for adult and pediatric (one month of age or older) patients with aHUS to inhibit complement-mediated TMA.
Novartis Poised to Grow on Oncology Portfolio & Biosimilars
by Zacks Equity Research
Novartis expects the next growth phase to begin in 2018 driven by Cosentyx Entresto, Kisqali and Kymriah.
ProQR's Genetic Disorder Candidate Gets Orphan Drug Status
by Zacks Equity Research
ProQR Therapeutics (PRQR) announced that its investigational dystrophic epidermolysis bullosa candidate, QR-313, was granted orphan drug designation by the FDA.
Teva/Nuvelution to Speed Up Development of Austedo in US
by Zacks Equity Research
Teva Pharma (TEVA) and Nuvelution inked a deal to accelerate the development of Austedo (deutetrabenazine) tablets for the treatment of tics associated with Tourette syndrome.
Epizyme (EPZM) Looks Good: Stock Adds 7.8% in Session
by Zacks Equity Research
Epizyme (EPZM) was a big mover last session, as the company saw its shares rise nearly 8% on the day amid huge volumes.
Alkermes' ARISTADA Shows Better Results to Treat Schizophrenia
by Zacks Equity Research
Alkermes (ALKS) announced encouraging results from a phase IV study of ARISTADA for the treatment of schizophrenia.
Pluristem's Ischemia Candidate Gets Fast Track Designation
by Zacks Equity Research
Pluristem Therapeutics' (PSTI) phase III study of PLX-PAD cells in patients with critical limb ischemia granted Fast Track designation by the FDA.
Clovis Oncology (CLVS) in Focus: Stock Moves 10.5% Higher
by Zacks Equity Research
Clovis Oncology (CLVS) was a big mover last session, as the company saw its shares rise nearly 11% on the day amid huge volumes.
Axovant Sciences Ltd. (AXON) Jumps: Stock Rises 7.2%
by Zacks Equity Research
Axovant Sciences Ltd. (AXON) was a big mover last session, as the company saw its shares rise over 7% on the day.
Glaxo's Triple Therapy COPD Inhaler Gets CHMP Nod in the EU
by Zacks Equity Research
Glaxo's (GSK) single inhaler triple therapy for the treatment of COPD in patients who are already being treated with a ICS/LAMA combination received a positive opinion from the CHMP in the EU.
J&J's (JNJ) Psoriasis Drug Guselkumab Gets CHMP Nod in EU
by Zacks Equity Research
J&J's (JNJ) pipeline candidate, guselkumab for the treatment of moderate-to-severe plaque psoriasis received a positive opinion from the CHMP in the EU.
Why Alexion Pharmaceuticals (ALXN) Could Beat Earnings Estimates Again
by Zacks Equity Research
Alexion Pharmaceuticals (ALXN) boasts a favorable Zacks Rank and a positive Earnings ESP, which is a great sign of a coming earnings beat.
Intercept Pharmaceuticals (ICPT) in Focus: Stock Moves 8.6% Higher
by Zacks Equity Research
Intercept Pharmaceuticals, Inc. (ICPT) was a big mover last session, as the company saw its shares rise nearly 9% on the day.
Keryx Biopharmaceuticals, Inc. (KERX) Catches Eye: Stock Jumps 5.9%
by Zacks Equity Research
Keryx Biopharmaceuticals, Inc. (KERX) was a big mover last session, as the company saw its shares rise nearly 6% on the day
Abeona Therapeutics (ABEO) Surges: Stock Moves 22.9% Higher
by Zacks Equity Research
Abeona Therapeutics (ABEO) shares rose nearly 23% in the last trading session, amid huge volumes.
Synthetic Biologics (SYN) in Focus: Stock Moves 7.7% Higher
by Zacks Equity Research
Synthetic Biologics (SYN) was a big mover last session, as the company saw its shares rise nearly 8% on Friday amid huge volumes.
Pfizer Xtandi Succeeds in Early Stage Prostate Cancer Study
by Zacks Equity Research
Pfizer's (PFE) prostate cancer drug Xtandi met the primary endpoint in a late-stage study, which can expand the label of the drug to include early-stage patients.
Strength Seen in Halozyme Therapeutics (HALO): Stock Soars 21.2%
by Zacks Equity Research
Halozyme Therapeutics (HALO) was a big mover last session, as the company saw its shares rise more than 21% on the day amid huge volumes.
4 Biotech Stocks That Show Promise on Sustainable Growth
by Zacks Equity Research
Biotech sector is performing well in 2017 due to an increase in FDA approvals, new product sales ramp up, R&D success and innovation, strong clinical study results and continued strong performance of legacy products.
Glaxo's Shingles Candidate Gets Positive FDA Committee Vote
by Zacks Equity Research
Glaxo (GSK) declared that an FDA advisory panel has unanimously voted recommending approval for its shingles vaccine candidate, Shingrix, in older patients.
Alexion (ALXN) Reports Interim Results for Soliris Study
by Zacks Equity Research
Alexion (ALXN) announced results from an interim analysis of an ongoing phase III REGAIN study of Soliris. The study showed sustained treatment benefits of Soliris treatment for patients with refractory generalized myasthenia gravis.
Roche (RHHBY) Announces Data on Respiratory Drug Esbriet
by Zacks Equity Research
Roche Holdings AG (RHHBY) announced results from a six-month study combining idiopathic pulmonary fibrosis (IPF) drug Esbriet (pirfenidone) and Ofev.
Alexion to Restructure Operations, to Lower Headcount by 20%
by Zacks Equity Research
Alexion Pharmaceuticals, Inc. (ALXN) announced that it will undertake a restructuring plan to re-align the global organization and cut workforce.
Biotech Stock Roundup: Alexion to Cut Jobs, Streamline Operations, Kura Up on Cancer Data
by Arpita Dutt
Key highlights include Alexion's (ALXN) restructuring plans and promising data from Kura Oncology on its lead pipeline candidate.
Achillion's HCV Partnership with J&J Terminated, Stock Falls
by Zacks Equity Research
Achillion Pharmaceuticals (ACHN) suffered a setback as Janssen terminated their worldwide license and collaboration arrangement on hepatitis C.
AstraZeneca's Asthma Candidate Shows Promising Results
by Zacks Equity Research
AstraZeneca's asthma candidate, benralizumab, showed promising results in patients who experience more frequent exacerbations despite being on standard-of-care medicines.