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Ultragenyx's rhGUS Gets FDA Nod for Rare Genetic Disease

15h zacks
Ultragenyx Pharmaceutical Inc. (RARE - Free Report) announced that the FDA has approved its genetic disorder drug, vestronidase alfa or rhGUS, for treatment of children and adults with mucopolysaccharidosis VII (MPS VII, also known as Sly syndrome). It is approved under the trade name, MEPSEVII. (43-0)

Alnylam Starts Rolling NDA Submission for RNAi Candidate

20h zacks
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has initiated submission of a rolling New Drug Application (NDA) to the FDA for lead candidate patisiran. The candidate is an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis.  The rolling submission allows completed portions of an NDA to be reviewed by the FDA on an ongoing basis. (49-0)

Your Daily Pharma Scoop: A Look At Sanofi, Ultragenyx Gets FDA Nod, Capricor Tumbles

2017-11-16 seekingalpha
This abridged “Daily Scoop” is published by Avisol Capital Partners, which runs the physician-managed Total Pharma Tracker healthcare investment research service on Seeking Alpha Marketplace. (381-1)

Valeant (VRX) Announces Pricing of Senior Secured Notes

2017-11-15 zacks
Valeant Pharmaceuticals International, Inc. (VRX - Free Report) announced that it has priced its previously announced offering of $750,000,000 aggregate principal amount of 5.500% senior secured notes due 2025. These will be additional notes and form part of the same series as the existing 5.500% senior secured notes due 2025.Valeant will sell the notes at a price of 100.0% of the principal amount thereof plus accrued interest from Oct 17, 2017. (201-0)

Pacira's Exparel sNDA to be Reviewed by FDA Advisory Committee

2017-11-15 zacks
Shares of Pacira Pharmaceuticals, Inc. (PCRX - Free Report) declined about 6.6% on Nov 14. This followed the FDA’s notice stating that the company’s supplemental New Drug Application (sNDA) for  label expansion of Exparel (bupivacaine liposome injectable suspension) in the nerve block setting will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (“AADPAC”) before a final decision. (49-0)

Ligand Pharmaceuticals' (LGND) Presents at Analyst Day (Transcript)

2017-11-15 seekingalpha
Welcome. Thank you, everyone, for joining us. Ligand's end-of-the-year Analyst Day 2018 and beyond. We appreciate the turnout. We got a nice group on the audience today. The attendees on the webcast that continue to add and we really do appreciate your attention here at the end of day and close to the end of the year. My name is John Higgins, I'm the CEO of Ligand. I'm joined by several of our colleagues. (115-0)

Theravance (TBPH) Submits NDA for COPD Candidate Revefenacin

2017-11-14 zacks
Theravance Biopharma, Inc. (TBPH - Free Report) and partner Mylan (MYL - Free Report) announced that the new drug application for the combined entity’s key pipeline candidate, revefenacin (TD-4208), has been submitted to the FDA for treatment of adults with chronic obstructive pulmonary disease (“COPD”). (74-0)

Merck (MRK) Gets CHMP Nod for Infection Candidate Prevymis

2017-11-14 zacks
Merck & Co., Inc. (MRK - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending marketing approval of Prevymis (letermovir). (41-0)

Alnylam RNAi Drug Gets Accelerated Assessment Grant From EMA

2017-11-14 zacks
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has granted an accelerated assessment for patisiran. (72-0)

Shire Gets Positive CHMP Opinion for Hemophilia A Drug

2017-11-14 zacks
Shire plc (SHPG - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has issued a positive opinion recommending approval  of Adynovi [Antihemophilic Factor (Recombinant), PEGylated]. (73-0)

Seattle Genetics' Adcetris Gets FDA Nod for Label Expansion

2017-11-13 zacks
Seattle Genetics, Inc. (SGEN - Free Report) announced the FDA approved an expanded indication for its lymphoma drug, Adcetris (brentuximab vedotin). (105-0)

Arena (ARNA) Completes Enrolment in Etrasimod Phase II Study

2017-11-13 zacks
Arena Pharmaceuticals, Inc. (ARNA - Free Report) announced that it has completed full enrollment with 157 patients in a phase II study evaluating its pipeline candidate etrasimod in ulcerative colitis (UC). Etrasimod (APD334) is an orally available next-generation sphingosine 1-phosphate (S1P) receptor modulator. (100-0)

Vertex Gets CHMP Recommendation for Orkambi Label Expansion

2017-11-13 zacks
Vertex Pharmaceuticals Inc. (VRTX - Free Report) announced that the Committee for Medicinal Products for Human Use ("CHMP") has recommended approval of a label expansion for Orkambi in Europe. The company is seeking extension of its marketing authorization for Orkambi to include use in children with cystic fibrosis ("CF") who are aged between 6 and 11 years and have two copies of the F508del mutation. (63-1)

AstraZeneca Gets Positive CHMP Opinion for Asthma Candidate

2017-11-13 zacks
AstraZeneca, plc (AZN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending marketing approval of its respiratory disease candidate, benralizumab. AstraZeneca is looking to get benralizumab approved as an add-on maintenance treatment for severe eosinophilic asthma in adults. (56-0)

BRIEF-Ligand Pharmaceuticals says signed license and supply agreement via subsidiary with Meridian Laboratories​

2017-11-13 reuters
* Ligand Pharmaceuticals Inc - ‍on Nov. 10, 2017, co signed a license agreement and a supply agreement via a subsidiary with Meridian Laboratories Inc​ (3-0)

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