Search Results for: Clinical Roundup
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Clinic Roundup
Acadia Pharmaceuticals Inc., of San Diego, presented data at the International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia, from its Phase III program testing pimavanserin in Parkinson's disease psychosis (PDP), including data from the pivotal -020 study and related -015 open-label safety extension trial...Mei Pharma Inc., of San Diego, said the first patients were dosed in a Phase II trial of its lead candidate, HDAC inhibitor Pracinostat, in combination with Vidaza -
Conatus Pharma Seeks $69M for Liver Drug Emricasan
Filing its S-1 as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, the San Diego-based firm is seeking to raise up to $69 million to continue the clinical development of emricasan, a pan-caspase inhibitor...Meanwhile, Gary Burgess, senior vice president of clinical research and chief medical officer, joined Conatus in 2011 from Pfizer, where he oversaw the assimilation of Idun, including data integration, clinical oversight of ongoing Phase II studies, development -
Clinic Roundup
Hemaquest Pharmaceuticals Inc., of San Diego, has completed enrollment in a randomized, double-blind, placebo-controlled Phase IIb study of HQK-1001 in patients with sickle cell disease...The study, initiated in July 2012, enrolled a total of 77 patients in clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon -
ASCO Roundup
The following data were presented at the American Society of Clinical Oncology meeting in Chicago...Ambit Biosciences Corp., of San Diego, presented data from its Phase II ACE study of quizartinib (AC220), a FLT3 inhibitor, including data from 176 patients with either relapsed acute myeloid leukemia (AML) or AML that was refractory to second-line chemotherapy or hematopoietic stem cell transplantation (HSCT -
ASCO Roundup
Data from an ongoing Phase I/II study confirmed clinical evidence of the antitumor activity at multiple dose levels in patients with anaplastic lymphoma kinase-positive NSCLC, including brain metastases, and initial clinical evidence of antitumor activity in patients with EGFR receptor mutation NSCLC. (See BioWorld Today, Dec. 17, 2012...and the clinical benefit response rate was 82 percent -
Clinic Roundup
PharmAthene Inc., of Annapolis, Md., said the FDA lifted the clinical hold placed on a proposed Phase II study of SparVax, a next-generation recombinant anthrax vaccine...Prometheus Laboratories Inc., of San Diego, said PROCLIVITY02, a study comparing the sequence of Proleukin (high dose interleukin-2), followed by Yervoy (ipilimumab, Bristol-Myers Squibb Co.) to the converse order, as therapy in patients with metastatic melanoma, has investigational review board approval and anticipates enrolling -
Clinic Roundup
The company is exploring the best options for a new clinical study with higher doses of amitifadine in that population...La Jolla Pharmaceutical Co., of San Diego, said data from a Phase I (Part A) portion of the Phase I/II trial of GCS-100 in patients with chronic kidney disease (CKD) showed no serious adverse events, and there were no adverse changes in laboratory measures -
Clinic Roundup
Those results were presented at the New Clinical Drug Evaluation Unit meeting in Hollywood, Fla...Sorrento Therapeutics Inc., of San Diego, and Igdrasol Inc., of Irvine, Calif., reported data showing that five out of 16 patients (31.3 percent) treated with Cynviloq at 300 mg/m2 every three weeks in combination with gemcitabine as a first-line treatment in advanced pancreatic cancer had confirmed complete or partial responses -
Prosensa Leads More Biotechs into IPO Parade
Modest Offering 'Evokes' Public Market Access San Diego-based Evoke Pharma has stayed out of the limelight, advancing a single asset with just two full-time employees...Mast Therapeutics Inc., of San Diego, filed paperwork with the SEC, making known the company's plans to raise $30 million through a public offering -
Jennerex Plucks $21.6M Private Placement; Is IPO Up Next?
Apricus Biosciences Inc., of San Diego, priced an underwritten public offering of 6 million shares of common stock at $2.85 per share and warrants to purchase up to an aggregate of 3 million shares of common stock, for proceeds of $17.1 million...The company said proceeds will be used for general corporate purposes, including clinical trial expenses and additional regulatory efforts related to erectile dysfunction drug Vitaros (alprostadil 0.3 percent topical cream) and female sexual dysfunction -
Clinic Roundup
Ceregene Inc., of San Diego, reported additional efficacy data from a secondary analysis of its Phase IIb study of CERE-120 (AAV-neurturin), a gene therapy product designed to deliver the neurotrophic factor neurturin to treat Parkinson's disease...In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies -
Financings Roundup
Acadia Pharmaceuticals Inc., of San Diego, completed its public offering of 9.2 million shares, including 1.2 million shares sold to cover overallotments, priced at $12.50 per share, for gross proceeds of $115 million...and to fund linaclotide development opportunities to strengthen the clinical profile of Linzess and expand the product label for additional populations and indications -
Clinic Roundup
Elcelyx Therapeutics Inc., of San Diego, said it is enrolling patients with Type II diabetes in a Phase IIb trial of NewMet, a delayed-release formulation of generic metformin...Clinical improvements were seen in all patients with reductions in median stool frequency from 23 to 14 per week (p = 0.03) and an improvement in the median Bristol Stool Form Scale assessing stool type from 5.515 to 4.34 (p = 0.05...Tracon Pharmaceuticals Inc., of San Diego, said it initiated two randomized Phase IIb studies -
As Markets Fancy Biotech, PTC Therapeutics Joins IPO Queue
In addition to the trio of filings, one biotech IPO closed last week, as San Diego-based Ambit Biosciences Corp...A week earlier, Receptos Inc., also of San Diego, priced its IPO, raising $72.8 million by selling 5.2 million shares at $14 apiece -
Ambit Cuts Price, Ups Shares; $65M IPO to Fund Quizartinib
The San Diego-based biotech priced about 8.1 million shares at $8 apiece for gross proceeds of about $65 million...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories -
Tokai Adds $35.5M in Series E, Preps for Phase III CRPC Trials
Acadia Pharmaceuticals Inc., of San Diego, priced a $100 million public offering of 8 million shares of common stock at $12.50 apiece, a 3.5 percent discount to Tuesday's closing price...Receptos Inc., of San Diego, said it completed its initial public offering of 5.2 million shares priced at $14 apiece for proceeds of $72.8 million and granted underwriters Credit Suisse Securities LLC, Leerink Swann LLC, BMO Capital Markets and Wedbush PacGrow Life Sciences a 30-day option to purchase up to an -
Clinic Roundup
Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancer...Prometheus Laboratories Inc., of San Diego, said PROCLIVITY 01, a multicenter study of Proleukin (High Dose Interleukin-2 [HD IL-2])1 plus vemurafenib therapy in patients with BRAF V600 mutation-positive metastatic melanoma (mM) is enrolling patients -
Beyond Kalbitor: Dyax Adds $30M for HAE Prophylactic
is more than doubling its cash position with a $30 million registered direct offering, with proceeds to fund R&D activities, namely clinical development of DX-2930, a drug slated to start clinical development for prophylactic use in hereditary angioedema (HAE...MediciNova Inc., of San Diego, entered a securities purchase agreement, selling about 1.2 million shares of common stock priced at $3.15 apiece -
Receptos Prices Solid IPO, Raises $72.8M for Pipeline
Receptos Inc., of San Diego, priced its initial public offering (IPO) of 5.2 million shares of common stock at $14 per share, for a total raise of $72.8 million...The funds will support clinical work in multiple sclerosis (MS), inflammatory bowel disease (IBD) and allergic/immune-mediated disorders. (See BioWorld Today, April 8, 2013.) The pricing hits pretty close to the $86.3 million target set when the company filed for its offering only a month ago -
Lumena Large: $23M Series A Funds Phase II Cholestatic Bid
said Grey, formerly CEO of SGX Pharmaceuticals Inc., of San Diego, acquired in 2008 by Indianapolis-based Eli Lilly and Co...The drug has gone through 12 clinical trials in more than 1,400 subjects already, showing that it knocks down serum bile acid levels safely...Lumena plans to complete the Phase I clinical program of LUM002 in healthy volunteers later this year
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