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Sep. 17, 2014, 9:15 AM
Sep. 17, 2014, 8:29 AM
Sep. 16, 2014, 5:32 PM| Sep. 16, 2014, 5:32 PM | 2 Comments
Sep. 16, 2014, 12:33 PM
- On Thursday, September 18, the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet to discuss privately-held Clarus Therapeutics' New Drug Application for Rextoro, an orally-available testosterone for patients with hypogonadism.
- Briefing docs
- Tomorrow, the two committees will jointly meet to discuss the appropriate population for testosterone therapy and the potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
- Related tickers: (ABBV +0.7%) (LLY +0.9%) (AUXL -1.6%) (TEVA +1.8%)
Sep. 15, 2014, 4:08 PM
- The Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet on Wednesday, September 17 to discuss the appropriate population for testosterone replacement therapy (TRT) and the potential for adverse cardiovascular outcomes associated with TRT.
- Briefing docs
- Related tickers: (ABBV +0.1%) (LLY -0.1%) (AUXL -2.9%) (TEVA -1.4%)
Sep. 9, 2014, 6:38 PM
- Auxilium Pharma (NASDAQ:AUXL) +3% AH after announcing a corporate restructuring designed to "streamline operations, maximize cash flow, and drive sustainable earnings growth."
- AUXL plans include a ~30% workforce reduction, realigning the organization into two sales forces from three, and focusing R&D efforts on efficient development of near-term value programs cellulite and Frozen Shoulder Syndrome, changes the company says will achieve at least $75M/year in cost savings.
- AUXL expects to record restructuring related charges totaling up to $20M.
Aug. 21, 2014, 9:25 AM
- Auxilium Pharmaceuticals (NASDAQ:AUXL) announces the results from a Phase 2a clinical trial evaluating the safety and efficacy of injections of collagenase clostridium histolyticum (CCH) for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Three doses (low-0.06mg; mid-0.48mg; high-0.84mg) of CCH showed an improvement in the appearance of cellulite as measured by investigator- and patient-generated scores on the Global Aesthetic Improvement Scale (GAIS).
- The mid and high dose groups demonstrated a statistically significant improvement in the appearance of cellulite (measured by GAIS scores) with a p-value of <0.05. In these two groups, 68% of patients rated themselves "satisfied" or "very satisfied" with the results compared to 34% in the placebo cohort.
- Dulling the veneer of the results is the fact that the trial is based on subjective observational data, as evidenced by the 34% satisfied/very satisfied proportion of the control group. The results would be more robust if the reduction in cellulite was independently quantified. Also, the p-value, ideally, would be <0.01 or less.
Aug. 11, 2014, 8:38 AM
- Auxilium Pharmaceuticals (NASDAQ:AUXL) appoints Andrew Saik as CFO effective August 18, 2014. He joins the firm from Endo Health Solutions where he was SVP, Finance and Treasurer.
Aug. 7, 2014, 8:05 AM
- Auxilium Pharmaceuticals (AUXL +2.6%) Q2 results: Revenues: $83.0M (-17.4%); Operating Expenses: $110.2M (-14.5%); Operating Loss: ($27.2M) (+3.2%); Net Loss: ($36.5M) (-185.5%); Loss Per Share: ($0.73) (-184.9%); Quick Assets: not disclosed.
- 2014 Guidance: Revenues: $380M - 420M (unch); non-GAAP net income: $0M - 15M (unch); gross margin: 76 - 77%; SG&A expenses: $245M - 250M from $255M - 260M; R&D expenses: $40M - 45M (unch).
Aug. 7, 2014, 6:05 AM
- Auxilium Pharmaceuticals (NASDAQ:AUXL): Q2 EPS of -$0.44 misses by $0.23.
- Revenue of $83M (-17.4% Y/Y) misses by $5.52M.
Aug. 6, 2014, 5:30 PM
- AAON, AES, AFSI, AINV, AMCX, ATHM, AUXL, BCE, BDBD, BPI, BR, CBB, CCOI, CECE, CECO, CNQ, CQB, CRIS, CTB, DUK, EAT, FUR, FWLT, GBDC, GDP, GLP, GOLD, GTN, HAR, HII, HIMX, HRC, HSC, HSNI, HZNP, ICE, IDCC, IRC, KERX, LAMR, LEAF, LG, LINE, LMIA, LNCE, LPI, LQDT, LXP, LXRX, MFC, MMS, MNK, MONT, MPEL, MPW, MYL, NCT, NRF, NRG, NVO, NXST, NXTM, OGE, ONE, OWW, PBH, PHMD, POZN, PRIM, QIWI, RDN, RGLD, RSTI, RTK, SABR, SATS, SFUN, SGM, SNI, SPH, SRE, SRPT, SSYS, SUNE, TDC, TGH, THS, TICC, TK, TPH, VNDA, WEN, WIN, WMC, WWAV, ZEUS
Jul. 16, 2014, 7:30 PM
- The Obama administration is proposing a ban on “inversion deals,” retroactive to May 2014, in which U.S. companies buy foreign ones and move corporate headquarters abroad to escape U.S. tax laws.
- Inversion deals are more common among drug and manufacturing companies that earn much of their income overseas or have assets such as patents that are held offshore; shares of companies with pending deals who fell today on the proposal included Shire (NASDAQ:SHPG), AbbVie (NYSE:ABBV), Auxilium Pharma (NASDAQ:AUXL) and QLT (NASDAQ:QLTI).
- In an unprecedented move for a U.S. retailer, Walgreen (NYSE:WAG) also is weighing leaving U.S. shores, a move that could help lower its U.S. tax bill and save the company hundreds of millions of dollars per year.
- With the pace of inversions picking up, many in Washington are critical of the practice but they disagree on what to do about the trend: stop the deals cold via a one-off bill or pass a broad tax overhaul that would lower the 35% corporate tax rate.
Jun. 26, 2014, 9:22 AM
- BioSpecifics Technologies (BSTC) reports that Swedish Orphan Biovitrium AB (SOBI) has filed for a label expansion for XIAPEX (collagenase clostridium histolyticum) for Peyronie's Disease. XIAPEX is currently approved for the treatment of Dupuytren's contracture in adult patients with a palpable cord.
- BioSpecifics' development partner Auxilium Pharmaceuticals (AUXL) partnered with SOBI in 2013 for the marketing of XIAPEX in 71 Eurasian and African countries.
- XIAPEX is marketed as XIAFLEX in the U.S. The FDA approved its indication for Peyronie's Disease in December 2013.
Jun. 26, 2014, 9:17 AM
Jun. 26, 2014, 8:22 AM
- Auxilium Pharmaceuticals (AUXL) and Canadian biotech QLT Inc. enter into a definitive agreement to merge. Under the terms of the agreement, QLT will remain incorporated in British Columbia and will be renamed "New Auxilium." Current AUXL shareholders will be receive 3.1359 QLT shares for each AUXL share. AUXL shareholders will own ~76% of the combined entity and QLT shareholders will own ~24%.
- Auxilium's current management team will lead the new company. Shares will trade on NASDAQ under "AUXL" and QLT will be delisted from the Toronto Stock Exchange.
- AUXL shares are up 17% premarket on robust volume.
Jun. 11, 2014, 9:13 AM
Auxilium Pharmaceuticals, Inc., is a specialty biopharmaceutical company, which develops and markets products to urologists, endocrinologists, orthopedists and select primary care physicians and plastic surgeons who focus on the hand, and rheumatologists.
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