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Dec. 22, 2015, 7:54 AM
- Noting significant short interest and recent selloffs, analyst Randall Stanicky makes INSY and SGNT his top "out of consensus" picks for 2016. INSY's short interest is 46% of the float and SGNT's is 4.4%.
- Though M&A will continue next year, there will be greater deal scrutiny and fewer targets, and Stanicky favors the targets vs. the accretive acquirers.
- Mylan (NASDAQ:MYL) and Impax Labs (NASDAQ:IPXL) are seen as most likely to pursue "transformative" deals, while Teva (NYSE:TEVA), Perrigo (NYSE:PRGO), Sagent, Eagle (NASDAQ:EGRX), Depomed (NASDAQ:DEPO), and Endo (NASDAQ:ENDP) are likely to pursue bolt-on purchases.
- Most likely targets: Akorn (NASDAQ:AKRX) and Flexion (NASDAQ:FLXN).
- Top large-cap picks: Endo and Teva.
- Related: 45% Upside For 2016's Top Takeover Target (Dec. 1)
Nov. 9, 2015, 4:08 PM
- Flexion Therapeutics (NASDAQ:FLXN): Q3 EPS of -$0.52 beats by $0.08.
Sep. 25, 2015, 12:44 PM
Sep. 9, 2015, 12:44 PM
Sep. 9, 2015, 9:17 AM
Sep. 8, 2015, 5:36 PM
Sep. 8, 2015, 4:56 PM
- A 310-subject Phase 2b study evaluating Flexion Therapeutics' (NASDAQ:FLXN) lead product candidate, FX006, for the treatment of moderate-to-severe osteoarthritis of the knee failed to achieve its primary endpoint of superiority of pain relief at week 12 compared to placebo (p=0.0821). A sensitivity analysis that addressed patient dropouts did show statistical significance at week 12 (p=0.042), however.
- FX006 demonstrated a statistically significant improvement in pain relief over weeks one through 12 (p=0.0012) and over weeks one through 24 (p=0.0209). At weekly time points, FX006 showed superiority to placebo at weeks one through 11 and at week 13 (p<0.05 at each time point).
- The 40 mg dose of FX006 performed better than the 20 mg dose with comparable treatment-related adverse events.
- Results from an ongoing Phase 3 study are expected in late Q1. The company intends to meet with the FDA to review all the data.
- FX006 is a novel, non-opioid, sustained release, intra-articular formulation of triamcinolone acetonide.
- The company will host a conference call tomorrow morning at 9:00 am ET to discuss the results.
- Shares are down 38% after hours on robust volume.
Sep. 1, 2015, 4:18 PM
- The FDA grants Fast Track status to Flexion Therapeutics' (NASDAQ:FLXN) lead product candidate, FX006, for the treatment of patients with osteoarthritis of the knee, a condition affecting over 4M Americans.
- Fast Track status provides for more interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
- FX006 is a novel, non-opioid, sustained release, intra-articular formulation of triamcinolone acetonide, a corticosteroid used to treat a variety of inflammatory conditions. Data from a Phase 3 study are expected in Q1 2016.
Aug. 6, 2015, 4:34 PM
- Flexion Therapeutics (NASDAQ:FLXN): Q2 EPS of -$0.58 misses by $0.04.
Aug. 4, 2015, 4:28 PM
- Flexion Therapeutics (NASDAQ:FLXN) establishes a senior secured term loan facility with MidCap Financial and Silicon Valley Bank that will allow it to borrow up to $30M at 6.25% with a maturity date of February 2020, subject to certain conditions.
- Flexion has already drawn down $15M. It intends use the funds to expand its manufacturing capacity with its contract manufacturers.
Jun. 8, 2015, 12:49 PM
May 7, 2015, 4:48 PM
- Flexion Therapeutics (NASDAQ:FLXN): Q1 EPS of -$0.43 beats by $0.13.
Mar. 24, 2015, 6:51 AM
- Flexion Therapeutics (FLXN -6.4%) FY14 results: Revenues: $0; R&D Expense: $17.9M (+61.3%); SG&A: $9.1M (+35.8%); Operating Loss: ($27M) (-51.7%); Net Loss: ($27.3M) (-50.0%); Loss Per Share: ($1.97) (+91.4%); Quick Assets: $151.6M (+824.4%).
- No guidance given.
Mar. 23, 2015, 4:19 PM
- Flexion Therapeutics (NASDAQ:FLXN): FY'14 EPS of -$1.97
- Cash & cash equivalents of $0.1M.
Feb. 11, 2015, 3:42 PM
- Anika Therapeutics (ANIK +0.9%) files a premarket approval application (PMA) with the FDA and an application seeking CE Mark clearance in the E.U. for approval to commercialize Cingal (sodium hyaluronate with triamcinolone hexatonide) for the single-injection treatment of osteoarthritis of the knee. The product utilizes the same hyaluronic acid as Monovisc plus a commonly used steroid.
- Related tickers: (FLXN -0.4%)(HZNP +0.8%)(OTCPK:NRIFF +4.6%)(AMPE +6.7%)(MNK -1.3%)(XENE -0.9%) (NASDAQ:CBYL)
Feb. 2, 2015, 4:27 PM
- The first patient has been dosed in a 450-patient Phase 3 clinical trial assessing Flexion Therapeutics' (NASDAQ:FLXN) lead product candidate, FX006, for the treatment of moderate-to-severe pain associated with osteoarthritis of the knee.
- FX006 is a novel, non-opioid, sustained release, intra-articular formulation of triamcinolone acetonide. The company expects top line data in 2016.
- The FDA lifted its clinical hold on the company's Phase 2b trial in early December after it concluded its investigation of a case of septic shock in one patient.
- Previously: Clinical hold lifted for Flexion's lead product (Dec. 1, 2014)
- OA-related tickers: (NASDAQ:HZNP) (OTCPK:NRIFF) (NASDAQ:XENE) (NYSEMKT:AMPE) (NASDAQ:ANIK) (NYSE:MNK) (NASDAQ:CBYL)
Flexion Therapeutics Inc is a development stage specialty pharmaceutical company. The Company is engaged in the development and commercialization of novel, long-acting, injectable pain therapies including; anti-inflammatory and analgesic therapies.
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