Aastrom (3/27/13) – ASTM Restructures to Focus on Orphan Drug Indication, Lowering BUY and TARGET PRICE – Aastrom dropped a bomb premarket today when new CEO, Dominick Colangelo, announced that the company is shelving their Phase III CLI program and cutting half their workforce after completing a comprehensive strategic review. ASTM will now focus on[…]
Category: Company Updates
Pharmacyclics Update (3-06-13)
Janssen (JNJ) Begins Ibrutinib Long-Term Extension Study. Pharmacyclicsâ partner Janssen has filed to begin a Phase 3b study, enrolling 200 patients who have participated in ibrutinib studies. This is a long-term follow-up study to give patients ibrutinib for up to 3 years, a logical trial to continue to monitor the long-term safety and efficacy of[…]
Coronado Update (2-25-13)
Coronado announced the initiation of an investigator-sponsored pilot study to evaluate CNDO-201 (TSO) for the treatment of moderate-to-severe psoriasis. This is first new TSO study since Harlan Weisman joined the Company as CEO in early January. As a reminder, Weisman led the development of Remicade, JNJ’s best-selling product and approved for several of the same indications[…]
BioMarin Update (2-22-13)
The Orphan Drugs Leader. With 2012 exceeding $500 million, BioMarin has vaulted itself into an elite group of the top-tier biotech companies. Naglazyme ($257 million, +14% Y/Y) and Kuvan ($143 million, +23%) each had solid years and royalties from Aldurazyme ($80 million, +6%) continue to deliver strong cash flow. With a truly impressive pipeline filled[…]
Pharmacyclics Update (3-25-13)
Pharmacyclics (3/25/13) â BEAR RAID GIVES US OPPORTUNITY, PCYC BACK UNDER BUY LIMIT â Last week, Pharmacyclics shares dropped precipitously on the heels of several items â none of which were directly related to ibrutinibâs clinical trials, approval timeline and, hence, commercial potential. First, both ARIAâs Iclusig and ONXXâ Krypolis â two of the most[…]
Pacira Update (3-01-13)
Pacira posts Phase 3 nerve block study; completes EXPAREL pilot hernia study. Pacira has posted the design and is about to begin a Phase III nerve block study with EXPAREL in patients undergoing thoracic surgery. The trial will enroll 180 patients and data collection is due by August. Nerve block is the next major market for[…]
ImmunoGen Update (2-22-13)
Roche received FDA approval for IMGN’s T-DM1 (Kadcyla) for the treatment of late-stage metastatic breast cancer patients who fail to respond to Herceptin and taxol. While this was a widely expected approval, it represents a significant milestone for IMGN as this is their first drug approval. The company will receive a $10.5 million milestone payment[…]
Pharmacyclics Update (2-21-13)
Abbott To Develop Diagnostic for p17 del Gene in High-Risk CLL for PCYC/JNJ â Abbott Labs announced that it would collaborate with PCYC and JNJ to develop a companion diagnostic test using their FISH technology to identify patients with high-risk CLL patients that present with a deletion of the p17 chromosome. As a reminder, ibrutinib[…]
Incyte Update (3-18-13)
Incyte’s stock is down this morning after disclosing that a UK patient taking Jakafi has died from a rare brain infection, progressive multifocal leukoencephalopathy (PML). It is unclear whether Jakafi caused the infection and that it is the only reported case among nearly 10,000 patients who have taken the drug. A review of the clinical[…]
Isis Update (2-26-13)
ISIS Starts Phase II Study for ISIS-CRP. ISIS also initiated Phase II trials with ISIS-CRP, which targets C-reactive protein (CRP), which is elevated in many inflammatory diseases, in patients with atrial fibrillation (AF). The goal is to reduce the frequency of AF episodes and provide proof-of-principle for CRP as a drug development target. In addition, ISIS[…]
Coronado Update (2-22-13)
CNDO signed an R&D, joint ownership and exclusive license agreement with Freie Universität Berlin for the identification and evaluation of secretory proteins from Trichuris suis. By collaborating with Dr. Susanne Hartman, one of the world leaders in parasitology, the deal extends Coronadoâs research into TSO (Trichuris suis ova or CNDO-201). Preclinical models will further explore the[…]
Celgene Update (2-21-13)
“Celgene Announces Accelerated $600 Million Share Repurchase Program” In a clear sign of optimism about its corporate outlook, CELG today announced it would accelerated share repurchases of $600 million of the companyâs common stock, representing approximately 1.4% of shares outstanding. The long-awaited PFS data for the Revlimid MM-020 trial is due end-Q2/early Q3. With renewed growth[…]