SA News • Dec. 1, 2014
Dec. 1, 2014, 5:06 PM
- The FDA lifts the clinical hold on Flexion Therapeutics' (NASDAQ:FLXN) lead product, FX006, based on the successful completion of the testing and investigation requested by the agency after the report of a single case of septic arthritis of the knee, as reported at that time.
- The company intends to immediately resume patient recruitment in its pivotal Phase 2b study of FX006 and to initiate a Phase 3 in early 2015.
- FX006 is an investigational sustained release intra-articular steroid treatment for patients with moderate-to-severe osteoarthritis pain.
Nov. 13, 2014, 4:33 PM
Oct. 7, 2014, 11:57 AM
- BC, Canada-based Xenon Pharmaceuticals (XENE) is set for its IPO of 4M shares at $10 -12.
- The clinical-stage biopharmaceutical firm discovers and develops differentiated therapeutics for orphan indications based on its Extreme Genetics platform. It focuses its discovery efforts on rare human diseases with extreme traits, including diseases caused by mutations in ion channels.
- The Extreme Genetics platform yielded the first gene therapy product approved in the EU, uniQure's (QURE +1.5%) Glybera (alipogene tiparvovec) for the treatment of adult patients with familial lipoprotein lipase deficiency.
- Its pharma partners include (TEVA -0.3%), Genentech (OTCQX:RHHBY -2.5%) and Merck (MRK -1.2%). Collaborations have generated over $140M in revenue to Xenon so far. Future milestone payments could potentially surpass $1B.
- The company's lead product is TV-45070 for the treatment of osteoarthritis of the knee. A 300-patient Phase 2b clinical trail run by Teva subsidiary Ivax International GmbH is underway.
- A second product candidate, GDC-0276, for the treatment of pain is being developed in collaboration with Genentech. A Phase 1 study commenced in September 2014.
- Osteoarthritis of the knee-related tickers: (AMPE +0.3%)(FLXN -4.6%)(ANIK -1.2%)(ZMH -0.7%)
Sep. 17, 2014, 5:37 PM
Aug. 8, 2014, 10:39 AM
Aug. 7, 2014, 6:36 PM
Jun. 17, 2014, 5:03 PM
- In a Phase 2a clinical trial, Flexion Therapeutics' (FLXN -1.2%) lead compound FX006 demonstrated sustained therapeutic concentrations of triamcinolone acetonide (TCA) for 12 weeks in knee joints with a single intra-articular injection. The company is developing the non-opioid product for the treatment of osteoarthritis of the knee. Its sustained release qualities may prevent the negative side effects associated with immediate-release steroids.
- FX006 showed a six-fold increase in the duration of joint residency compared to immediate-release TCA, the current standard of care injectable therapy. In an earlier pharmacokinetic study, peak plasma concentration of TCA in the hours following injection decreased 40-fold versus immediate-release TCA.
- Flexion plans to present more data at an upcoming scientific meeting. It expects to receive top-line data from the Phase 2b confirmatory trial in 1H 2015. A Phase 3 will follow based on the Phase 2b results.
Mar. 10, 2014, 11:34 AM
- Wells Fargo initiates coverage of Flexion Theapeutics (FLXN) with an Outperform rating with a price target of $24 - $26 citing positive Phase 2 trial results of its lead product, FX006, a sustained-release injectable steroid for osteoarthritis pain.
- Needham & Co. initiates coverage with a Buy rating and $26 price target.
- The stock debuted on February 12.
- Shares currently exchange hands at $19.
Mar. 10, 2014, 8:46 AM
Feb. 28, 2014, 12:46 PM
Feb. 12, 2014, 9:10 AM
- Flexion Therapeutics (FLXN) has raised $65M in its Nasdaq IPO by selling 5M shares at $13, within the range of $12-14.
- Flexion, which develops osteoarthritis drugs, has a market cap of $192M.
- There's also a greenshoe option of 750,000 shares.
- Flexion's shares are due to start trading today.
- IPO Previews: Don Dion, IPOdesktop
- ETF: IPO
FLXN vs. ETF Alternatives
Flexion Therapeutics Inc is a development stage specialty pharmaceutical company. The Company is engaged on the development and commercialization of novel, long-acting, injectable pain therapies including; anti-inflammatory and analgesic therapies.
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