Flexion Therapeutics (FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel, long-acting, injectable pain therapies. FLXN is In Phase 2 clinical trials.
Seven other companies are scheduled for the week of
The manager and joint managers are
FLXN scheduled a
Pfizer (PFE) ,
Flexion Therapeutics (FLXN)
The rating on FLXN is neutral.
FLXN has big shareholders, Pfizer and Nova A/S, with a large addressable market, and is in Phase 2 clinical trials. FLXN is priced at 2.7 times book, with a relatively moderate cash burn rate - the P/E ratio is -13.3, 'moderate' is above -11. An higher absolute number indicates lower cash burn rate.
FLXN is a specialty pharmaceutical company focused on the development and commercialization of novel, long-acting, injectable pain therapies.
FLXN is targeting anti-inflammatory and analgesic therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis, referred to as OA. FLXN's broad and diversified portfolio of product candidates addresses the OA pain treatment spectrum, from moderate to severe pain, and provides FLXN with multiple unique opportunities to achieve its goal of commercializing novel, patient-focused pain therapies.
FLXN's pipeline consists of three proprietary product candidates: FX006, a sustained-release, intra-articular steroid; FX007, a TrkA receptor antagonist for post-operative pain; and FX005, a sustained-release intra-articular p38
FLXN's lead product candidate, FX006, is a first-in-class injectable intra-articular, meaning "in the joint," sustained-release treatment for patients with moderate to severe OA pain. FX006 combines a commonly administered steroid, triamcinolone acetonide, with poly lactic-co-glycolic acid to provide sustained therapeutic concentrations in the joint and persistent analgesic effect.
In a completed Phase 2b dose-ranging clinical trial, FX006 has demonstrated clinically meaningful and significantly better pain relief compared to the current injectable standard of care.
Before pursuing Phase 3 clinical development, FLXN expects to initiate a confirmatory Phase 2b clinical trial in the second quarter of 2014 to further identify a safe and well-tolerated dose of FX006 that demonstrates superior pain relief to placebo.
FLXN is also currently conducting a synovial fluid pharmacokinetic clinical trial to measure the duration that FX006 remains in the joint, which will inform us on the dosing regimen for a planned repeat dose safety clinical trial to assess when repeat dosing of FX006 can be safely administered.
Two additional product candidates
FLXN is developing two additional product candidates, FX007 for post-operative pain and FX005 to treat end-stage OA patients.
FX007 is a locally administered TrkA receptor antagonist for persistent relief of post-operative pain, including in patients who have received total joint replacement, also referred to as total joint arthroplasty, or TJA.
FLXN plans to file an Investigational New Drug application for FX007 in the first half of 2014. FX005 is an intra-articular, sustained-release p38 MAP kinase inhibitor which has both analgesic and anti-inflammatory effects, and has successfully completed a placebo-controlled Phase 2a proof of concept clinical trial demonstrating significant pain relief in OA patients.
FLXN has worldwide commercialization rights to all of its product candidates.
FLXN intends to market products in
FLXN was incorporated in
FLXN is a development stage company and do not have any products approved for sale and have not generated any revenue from product sales.
From its inception through
There is one issued U.S. patent covering the TrkA antagonist compound, FX007, which is owned by
FLXN's industry is highly competitive and subject to rapid and significant technological change. The large size and expanding scope of the pain market makes it an attractive therapeutic area for biopharmaceutical businesses.
FLXN's potential competitors include pharmaceutical, biotechnology and specialty pharmaceutical companies. Several of these companies have robust drug pipelines, readily available capital, and established research and development organizations.
Sofinnova Capital VI FCPR 19.24%
Novo A/S 11.19%
Use of proceeds
FLXN expects to net
the remainder for working capital and other general corporate purposes.