Jun. 9, 2014, 1:54 PM
- Orexigen Therapeutics' (OREX +0.9%) long wait for marketing clearance for its weight loss drug Contrave (naltrexone) should be over by Wednesday's PDUFA date. The company had to resubmit its NDA after conducting a study to assess Contrave's cardiovascular risk after the FDA sent the company a CRL in January 2011. Based on an interim analysis of the 8,900-patient Light Study, the data show that there was no excessive cardiovascular risk with the use of Contrave versus placebo in overweight and obese patients.
- Marketing partner Takeda Pharmaceuticals U.S.A. will launch Contrave with its 900-strong sales force. With this amount of heft it should give Vivus (VVUS -0.9%) and Arena (ARNA -1.3%) a run for their money.
Jun. 6, 2014, 2:36 PM
- Arena Pharmaceuticals (ARNA -2.4%) is a strong sell on multiple red flags, says SA contributor The Pump Stopper.
- Among these is the company's failure to disclose an SEC investigation, heavy insider selling, Belviq sales roughly 80% below expectations, and a new formidable competitor OREX awaiting what could be imminent FDA approval of its own product.
- Price target: $1.25, or about 80% below the current level.
May. 12, 2014, 4:51 PM
- Arena Pharmaceuticals (ARNA -4.9%) total revenues: $6.8M (+183.3%); Belviq revenues: $2.9M; operating expenses: $30.4M (+29.9%); GAAP loss/share: ($0.12) (-33.3%); quick assets (ex-A/R): $255.6M (+15.2%).
- Belviq prescriptions: 77K (+31%) per IMS Health.
- 60% of insured lives in the U.S. have access to Belviq.
- Distribution partner Eisai files for Belviq marketing authorization in Brazil triggering a $0.5M milestone payment.
May. 12, 2014, 4:05 PM| 5 Comments
May. 11, 2014, 5:35 PM
Feb. 27, 2014, 5:19 PM
- Arena (ARNA) expects 2014 upfront payments from existing collaborations are to total $9M, development/patent reimbursements from Eisai $7M, and Siegfried manufacturing services $1M.
- 2014 spending guidance: R&D of $90M-$98M, G&A of $30M-$36M, capex of $9M-$10M. 2013 R&D and G&A spend amounted to $66.5M and $31.7M, respectively.
- Belviq product revenue totaled $2.4M in Q4, and partner Eisai has "doubled the size of the sales force detailing BELVIQ to approximately 400 representatives."
- Cash/equivalents amounted to $221.9M at the end of 2013.
- Q4 results, PR
Feb. 27, 2014, 4:24 PM
Feb. 27, 2014, 12:10 AM
- ACAD, AHT, AIRM, AL, ALIM, AMRN, APEI, ARNA, ATLS, AVD, BAGL, BCEI, BID, BIO, CEMP, CHUY, CLNE, CRM, DCO, DECK, ELGX, EPR, EVC, GPS, HALO, HTGC, KBR, KOG, LINE, MDVN, MELI, MENT, MNST, MTZ, NGD, NMBL, NOG, OLED, OVTI, PKT, PODD, REGI, ROST, SD, SFM, SLXP, SPLK, SPNC, SQNM, SWN, TESO, TUMI, UHS, WES, WG, WTR, XTEX, YOKU
Feb. 26, 2014, 5:35 PM
- AHT, AIRM, AL, ALIM, AMRN, APEI, ARNA, ATLS, AVD, BAGL, BCEI, BID, BIO, CEMP, CHUY, CLNE, CRM, DCO, DECK, ELGX, EPR, EVC, GPS, HALO, HTGC, KBR, KOG, LINE, MDVN, MELI, MENT, MNST, MTZ, NGD, NMBL, NOG, OLED, OVTI, PKT, PODD, REGI, ROST, SD, SFM, SLXP, SPLK, SPNC, SQNM, SWN, TESO, TUMI, UHS, WES, WG, WTR, XTEX, YOKU
Feb. 10, 2014, 2:19 PM
- Arena Pharmaceuticals (ARNA +4.9%) and Japanese partner say their Belviq weight loss drug will be available to more people thanks to an agreement with pharmacy benefits manager CVS Caremark (CVS +0.6%), which means more than half of all Americans with insurance should now have access to the drug.
- Aetna (AET) recently announced it would offer Belviq as a preferred brand to eligible patients as part of its pilot program to self-insured plan sponsors.
- Belviq is approved for use in adults who are obese or who are overweight and have at least one serious medical condition, such as diabetes or high cholesterol.
Feb. 3, 2014, 7:44 AM
Jan. 27, 2014, 10:52 AM
- A little bit more air comes out of the previously scorching small-cap biotech names today. Among them: CytRx (CYTR -4.8%), Dyax (DYAX -5.2%), Galena (GALE -9.6%), Novavax (NVAX -9%), Arena (ARNA -6.3%), Synta (SNTA -10.8%), Zogenix (ZGNX -3.5%), Tonix (TNXP -8.4%).
- Biotech ETFs: IBB, XBI, BIB, BBH, FBT, PBE, BIS
Dec. 26, 2013, 10:57 AM
- Shares of Arena Pharmaceuticals (ARNA +5.7%) are notably higher in morning trading.
- Perhaps helping the cause is SA contributor EnhydrisPECorp, who thinks "the tide is starting to turn" for the company and says the Street's generally bearish take on the shares may be the result of analysts "drinking too much egg nog."
- Also mentioned in the article (and also sharply higher) are shares of Inovio Pharmaceuticals (INO +13.4%) which the author says may "double from current levels." The piece cites insider and institutional buying.
Nov. 27, 2013, 1:08 PM
- JPMorgan maintains an Overweight rating and $12 price target on Orexigen (OREX +4.1%) following the company's positive Contrave announcement earlier in the week.
- In a note dated November 25th, analyst Cory Kasimov commented, "While details are expectedly sparse at this point, the press release notes that the interim analysis 'clearly achieved' its goal in ruling out excessive CV risk associated with the product. With an imminent NDA resubmission anticipated, we believe Contrave is well on its way to being approved in the US by mid 2014 and potentially in Europe later that year. In our opinion, [this] development should finally trigger a substantial narrowing of the still meaningful valuation gap that exists between OREX and the other two pure play obesity companies, Arena (ARNA +0.6%) and Vivus (VVUS -0.4%)."
- For good measure, some color on Empatic: This Phase 3 ready product also includes buproprion as one of its two components, similar to Contrave. By demonstrating a lack of CV risk in LIGHT, we believe that the value and future probability of success of Empatic ... also increases.
Nov. 15, 2013, 8:38 AM| 4 Comments
Nov. 11, 2013, 9:15 AM
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