Acceleron Pharma Inc.'s (XLRN) collaboration partner, Celgene Corp. (CELG) is scheduled to present interim data from an ongoing phase 2a study of Sotatercept in patients with end stage renal disease on hemodialysis at the National Kidney Foundation 2014 Spring Clinical Meeting. The meeting will take place on April 22-26, 2014.
XLRN closed Monday's trading 6.08% lower at $42.50.
Alphatec Holdings Inc. (ATEC) said that its consolidated net revenues for full year 2013 rose to $204.7 million from $196.3 million in 2012. Looking ahead to 2014, the company anticipates annual revenues of $208 million to $215 million, representing approximately 1.6% to 5% growth over 2013.
The company also noted that it has settled the OrthoTec vs. Surgiview litigation. Under the terms of the settlement, Alphatec has agreed to pay OrthoTec $49 million over the next 7 years in cash, with an initial cash payment of $17.5 million.
ATEC closed Monday's trading 15.11% higher at $1.60. In after-hours, the stock gained another 4.37% to $1.67.
Amgen Inc. (AMGN) announced that a phase III trial evaluating its investigational drug Evolocumab has met its primary endpoint of low-density lipoprotein cholesterol reduction in patients with homozygous familial hypercholesterolemia.
In the trial, dubbed TESLA, Evolocumab demonstrated clinically meaningful and statistically significant percent reduction in LDL-C, or "bad" cholesterol from baseline at week 12.
AMGN closed Monday's trading 1.08% higher at $123.86.
Five Prime Therapeutics Inc. (FPRX) touched a new high of $23.08 on Monday before closing the day's trading at $22.99, following a collaboration deal with Bristol-Myers Squibb Co. (BMY) to discover novel immuno-oncology therapies for 2 immune checkpoint pathways.
Under the terms of the agreement, Bristol-Myers will obtain exclusive, worldwide rights to develop and commercialize products directed toward certain protein targets identified by Five Prime prior to and during the collaboration.
Five Prime will receive an upfront payment of $20 million and up to $9.5 million in research funding over the course of the research term from Bristol-Myers.
Additionally, Bristol-Myers Squibb will make a payment of approximately $21 million to acquire 4.9% of Five Prime's outstanding common stock purchased at approximately a 30% premium. Five Prime will be eligible to receive up to $300 million in future development, regulatory and sales based milestone payments per collaboration target and tiered mid-single-digit rising to low-double-digit royalty payments on net sales of each product commercialized by Bristol-Myers.
Five Prime went public last September, offering its shares at $13 each.
The Data Safety Monitoring Board has recommended that NeoStem Inc.'s (NBS) phase II study of AMR-001 for the preservation of heart function after a severe heart attack be continued, following a fourth interim data and safety review.
The trial, dubbed PreSERVE, has completed full enrollment and data will be available in the second half of 2014.
NBS closed Monday's trading at $7.53, up 0.53%.
Prosensa Holding N.V. (RNA) rose more than 30 percent to $8.80 in extended trading on Monday, following encouraging 48-week data from its U.S.-based, phase II placebo-controlled study of its lead compound, Drisapersen for the treatment of Duchenne Muscular Dystrophy.
Duchenne Muscular Dystrophy, or DMD, the most common form of muscular dystrophy, is a genetic disorder caused by a mutation in a gene that can code for a protein in the muscles called dystrophin. DMD, which is characterized by muscle weakness and calf enlargement, affects mostly boys - with 1 in every 3,500 boys worldwide being born with this disease.
In the phase II study, dubbed DEMAND V, boys in the higher-dose Drisapersen group of 6 mg/kg once weekly experienced stabilization and even improvements in their muscle function and physical activity as measured by the six-minute walk test (6MWT) for the 24-week treatment phase and maintained this improvement during the 24-week follow-up period, according to the company.
Last September, the company announced that a phase III placebo-controlled study of Drisapersen at a dose of 6mg/kg/week over 48 weeks in patients with Duchenne Muscular Dystrophy did not meet the primary endpoint of a statistically significant improvement in the 6 Minute Walking Distance (6MWD) test compared to placebo. The news sent the stock nose-diving to a low of $5.67 on Sep.20, 2013 from the previous day's close of $24.
Repros Therapeutics Inc. (RPRX) has been given the go-ahead by FDA to conduct phase 1 and 2 studies of oral Proellex under two separate INDs for endometriosis and uterine fibroids, while remaining on partial clinical hold. The highest allowed dose of oral Proellex for testing will be 12 mg daily.
Proellex was placed on full clinical hold by FDA in August 2009 due to findings of serious adverse events associated with liver toxicity, and its then-ongoing Proellex studies were suspended. The full clinical hold on Proellex was lifted in June 2010, and the company was allowed to run a single study under partial clinical hold status.
In October 2012, the FDA agreed to reclassify the full clinical hold on further oral Proellex studies to a partial clinical hold to allow the company to conduct a phase II study of low dose oral Proellex in the treatment of endometriosis.
Repros is currently conducting a phase II study for the use of Proellex in severe endometriosis and plans to submit a phase II protocol for the treatment of symptomatic fibroids.
STAAR Surgical Co. (STAA) touched a new high of $19.50 on Monday before closing at $17.70 as investors cheered the favorable voting of FDA panel for the company's Visian Toric Implantable Collamer Lens.
The Visian Toric ICL, a first-of-a kind product in the U.S., is a refractive phakic implant placed in the posterior chamber of the eye between the iris and the natural crystalline lens.
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