Wed, Sep. 7, 5:08 PM
- La Jolla Pharmaceuticals (NASDAQ:LJPC) perks up 4% after hours, albeit on light volume, in response to its announcement that it has reached agreement with the European Medicines Agency on the design of a pivotal study assessing LJPC-401, a novel formulation of the iron regulator hepcidin, for the treatment of beta thalassemia (BT) patients suffering from iron overload. BT is an inherited disorder that reduces the production of hemoglobin.
- The primary endpoint of the study, expected to commence in mid-2017, will be a clinically relevant measurement directly related to iron overload.
- Management will host a conference call tomorrow morning at 9:00 am ET to discuss its plans.
Mon, Aug. 8, 5:10 PM
Fri, May 6, 9:20 AM
Fri, May 6, 9:07 AM
Thu, Feb. 25, 5:14 PM
- La Jolla Pharmaceutical (NASDAQ:LJPC): Q4 EPS of -$0.69 beats by $0.03.
- Revenue of $0.41M
Nov. 6, 2015, 10:26 AM
- La Jolla Pharmaceutical (LJPC -4.5%) Q3 results: Revenues: $0.6M; R&D Expense: $7.8M (+200.0%); SG&A: $3.4M (+41.7%); Net Loss: ($10.4M) (-103.9%); Loss Per Share: ($0.70) (-89.2%); Quick Assets: $135.1M (+178.0%).
- No guidance given.
Nov. 6, 2015, 8:32 AM
- La Jolla Pharmaceutical (NASDAQ:LJPC): Q3 EPS of -$0.70 beats by $0.01.
- Revenue of $0.65M
Sep. 11, 2015, 9:08 AM
- The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) adopts a positive opinion recommending La Jolla Pharmaceutical's (NASDAQ:LJPC) LJPC-401 an orphan drug for the treatment of chronic iron overload requiring chelation therapy. Chelating agents bind to and help clear excessive iron from the body, but they are toxic. La Jolla's LJPC-401 is a novel formulation of hepcidin, a naturally occurring peptide hormone that prevents the accumulation of iron in organs.
- Abnormal iron accumulation occurs in disorders such as sickle cell disease, beta thalassemia and hereditary hemochromatosis.
- Orphan drug status in the EU provides for a 10-year period of market exclusivity for the indication, if approved.
Sep. 10, 2015, 9:11 AM
Sep. 9, 2015, 4:37 PM
- La Jolla Pharmaceutical (NASDAQ:LJPC) commences a public offering of common stock. Price, volume and terms have yet to be announced.
Sep. 8, 2015, 3:58 PM| Sep. 8, 2015, 3:58 PM | 11 Comments
Sep. 8, 2015, 12:41 PM
Aug. 21, 2015, 1:12 PM
- Thinly traded La Jolla Pharmaceutical (LJPC +18.8%) shrugs off the index and sector sellers, albeit on average turnover of only 273K shares. No particular news accounts for the move. On Tuesday, two of the company's product candidates were designated Orphan Drugs by the FDA.
- Previously: Two La Jolla Pharma compounds tagged Orphan Drugs for rare connective tissue disorder (Aug. 18)
Aug. 21, 2015, 12:45 PM
Aug. 18, 2015, 8:57 AM
- The FDA designates two novel compounds from La Jolla Pharmaceutical (NASDAQ:LJPC) Orphan Drugs for the treatment of fibrodysplasia ossificans progressiva (FOP), an extremely rare genetic disorder in which the body's repair mechanism causes fibrous tissue (muscle, tendon, ligament) to be ossified spontaneously or when damaged. The disorder is sometimes called "stone man syndrome" because sufferers are slowly imprisoned by their own skeletons. There are no effective treatments for the condition.
- The compounds, licensed from Vanderbilt University, are small molecule kinase inhibitors designed to selectively block a specific member of the bone morphogenetic protein ((BMP)) type-1 receptor family called ALK2. The improper activation of these receptor pathways (ALK 1-7) is responsible for a wide range of disorders. FOP is caused by mutations in ALK2.
- FOP affects less than 200 Americans and less than 1,000 people worldwide.
- Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
Aug. 11, 2015, 9:01 AM
- The FDA accepts the Investigational New Drug Application (IND) from La Jolla Pharmaceutical (NASDAQ:LJPC) for LJPC-401, its novel formulation of hepcidin under development for the treatment of iron overload. Preliminary results from a Phase 1 trial are expected by the end of the year.
- Hepcidin is a naturally occurring regulator of iron adsorption and distribution. Excess iron is a characteristic of certain diseases such as hereditary hemochromatosis (genetic deficiency of hepcidin) and beta thalassemia. If untreated, excess iron can damage organs and eventually lead to death.