SA News • Mon, Nov. 24
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Mon, Nov. 24, 12:15 PM
- The FDA designates privately-held Catabasis Pharmaceuticals' investigational NF-kB inhibitor, CAT-1004, an Orphan Drug for the treatment of Duchenne muscular dystrophy (DMD).
- NF-kB is a key mediator of cellular injury. Evidence suggests that activated NF-kB contributes to the underlying pathology of DMD.
- In a Phase 1 trial, CAT-1004 was well-tolerated and demonstrated a significant reduction of activated NF-kB. The company plans to proceed to Phase 2 development in 1H 2015.
- Among the benefits of Orphan Drug designation is a seven-year period of market exclusivity if approved.
- DMD-related tickers: (SRPT +7.6%)(RNA +63.3%)(BMRN +1.7%)(PTCT +3.4%)(OTCQB:MRNA -3.3%)(ROSG +0.8%)
Mon, Nov. 24, 8:58 AM
- Sarepta Therapeutics (NASDAQ:SRPT) is up 14% premarket on robust volume in response to BioMarin Pharmaceuticals' (NASDAQ:BMRN) announced acquisition of Prosensa Holding N.V. (NASDAQ:RNA) for $680M.
- Some observers believe Sarepta's Duchenne muscular dystrophy drug eteplirsen is better than Prosensa's drisapersen which makes it a more attractive acquisition target.
- Previously: BioMarin buys Prosensa
- Previously: Sarepta +11.2% following FDA statement
Mon, Nov. 24, 7:28 AM
- BioMarin Pharmaceuticals (NASDAQ:BMRN) acquires Prosensa Holding N.V. (NASDAQ:RNA) for $17.75 per share (~$680M) plus ~$80M in milestones related to the regulatory approvals of drisapersen in the U.S. no later than May 15, 2016 and in Europe no later than February 15, 2017.
- The FDA is currently assessing the drisapersen NDA under a rolling review process. The Duchenne muscular dystrophy drug has Orphan Drug, Fast Track and Breakthrough Therapy designations.
- In addition to the terms of the acquisition agreement cited above, BioMarin will purchase a $50M convertible note from Prosensa within five days of signing the contract. If the transaction fails to close for any reason, the note will automatically convert into 4,395,914 shares of RNA stock.
- RNA is up 65% premarket to $18.87 on light volume.
Thu, Oct. 23, 5:15 PM
- BioMarin Pharmaceuticals (BMRN +0.9%) Q3 results ($M): Revenues: 176.8 (29.1%); Cost of Sales: 29.9 (+6.4%); Operating Expenses: 200.3 (+33.6%); Operating Income: 11.2 (+122.1%); Net Income: 7.4 (+114.0%); EPS: 0.05 (+113.2%); Quick Assets: 666.4 (-15.1%).
- Product Sales: Vimizim: 25.2; Naglazyme: 67.5 (+6.8%); Kuvan: 53.4 (+22.5%); Aldruazyme: 22.6 (-3.4%); Firdapse: 4.7 (+14.6%).
- 2014 Guidance: Total Revenues: $700M - 710M from $680M - 700M; Naglazyme sales: $305M - 320M (unch); Kuvan sales: $190M - 200M from 180M - 200M; Vimizim sales: $65M - 70M from $60M - 70M; GAAP net loss: ($160M - 175M) from ($180M - 195M); non-GAAP net loss: ($50M - 65M) from ($60M - 80M).
Thu, Oct. 23, 4:10 PM| Comment!
Wed, Oct. 22, 5:35 PM
- ADES, ALGN, ALTR, AMZN, BAS, BJRI, BLDR, BMRN, CB, CBI, CERN, CLMS, CLNE, CNMD, CPWR, CTCT, CYN, DECK, DLB, DV, ECHO, ELY, EW, FET, FII, FLS, FSL, GHL, GIMO, HBHC, HUBG, HWAY, IM, INFA, JNPR, KLAC, LOGM, LSCC, MSFT, MTSN, MXIM, MXWL, N, NCR, NTGR, OLN, P, PACB, PCCC, PDFS, PEB, PFG, PFPT, POL, QLIK, RMD, RUBI, RVBD, SHOR, SIVB, SPNC, SRCL, SWFT, SWN, SYNA, VMI, VRSN, WOOF, WRB, WRE, WRI
Wed, Oct. 8, 8:12 AM
Wed, Jul. 30, 6:16 PM
- Biomarin Pharmaceutical (BMRN +0.1%) Q2 results: Total Revenues: $191.8M (+40.2%); Operating Expenses: $210.7M (+34.3%); Operating Loss: ($18.9M) (+6.0%); Net Loss: ($33.5M) (-55.8%); Loss Per Share: ($0.23) (-43.8%); Quick Assets: $836.6M (+6.6%).
- 2014 Guidance: Total revenues: $745M - 765M from $650M - 680M, Nagalzyme revenue: $305M - 320M from $290M - 310M, Kuvan revenue: $180M - 200M (unch), Vimizim revenue: $60M - 70M (unch); cost of sales: 16.5 - 17.5% from 17.5 - 18.5%; GAAP net loss: ($180M - 195M) from ($255M - 285M); non-GAAP loss: ($60M - 80M) from ($100M - 130M).
Wed, Jul. 30, 4:32 PM| Comment!
Tue, Jul. 29, 5:35 PM
- ABX, AEL, AEM, AKAM, ALB, ALL, ALLE, AMC, ANIK, ARII, ASGN, ATEN, ATW, AUY, AVG, BALT, BGC, BMRN, CATM, CAVM, CBT, CENX, CHDN, CJES, CLUB, CMO, CNL, CNW, CODE, COHR, CTRP, CW, CWT, DDR, DRE, DRIV, EGN, EHTH, ELGX, ENTR, EQIX, EQY, ESRT, ESV, EXL, EXR, FBHS, FEIC, FISH, FMC, FNF, FOE, FORM, FORR, GLUU, HIG, HK, HOLX, HOS, HR, HTH, INT, IPI, ISIL, KBR, KEX, KGC, KRFT, KS, LGCY, LNC, LOCK, LPSN, LRCX, MAA, MANT, MDAS, MEOH, MET, MOBL, MOH, MTGE, MTW, MUR, NANO, NE, NEWP, NOW, OI, OTEX, PDM, PEIX, PGTI, PPC, PVA, QUIK, RKUS, ROVI, RRTS, SAM, SBRA, SCI, SFLY, SIMG, SPN, SPRT, SSS, STAA, STAG, STMP, STR, SU, SZYM, TCO, TGB, TGI, TS, TSO, TTEK, TTMI, TWTC, UNM, VGR, VPRT, WDC, WFM, WLL, WMB, WPZ, WSTL, WTW, YELP
Mon, Jul. 7, 9:18 AM| Comment!
Thu, May. 1, 5:18 PM
- Total revenues: $151.5M (+18.5%): Vimizim: $0.9M, Naglazyme: $80.1M (+15.4%), Kuvan: $45.2M (+20.2%), Aldurazyme Product: $18.1M (+8.4%), Aldureazyme royalties: $21.9M (+13.5%), Firdapse: $4.7M (+30.6%).
- Quick assets (ex-A/R) at quarter end: $1.14B (+156%).
- 2014 guidance unchanged:
- Total revenues: $650M - $680M: Naglazyme: $290M - $310M, Kuvan: $180M - $200M, Vimizim: $60M - $70M.
- COGS: 17.5% - 18.5%.
- Net loss: $255M - $285M.
- (BMRN +3.6%)
Thu, May. 1, 4:28 PM
Wed, Apr. 30, 5:35 PM
- ABFS, ABTL, ACGL, ADNC, ADUS, AEM, AFFX, AHS, AIV, AKAM, ALDW, ALJ, AVD, BAGL, BBG, BCOR, BJRI, BKH, BMRN, BYI, CALD, CERS, CHGG, CPSI, CSOD, CTCT, CTRL, CUBE, CVD, DCT, DGI, DRC, DVA, DXCM, EGO, EHTH, ELLI, ENTR, EPAY, EXEL, EXPE, FI, FLR, FLT, GERN, HCI, HME, HT, HTCH, HTGC, IMMR, IMPV, INVN, IPXL, ITMN, KEYW, KOG, KRFT, LAYN, LNKD, LNT, LRE, MCRS, MHK, MITK, MODN, MOH, MRC, MTW, MTZ, MXWL, NGVC, NTRI, NU, OIS, OMCL, ONNN, ONTY, OPEN, OUTR, PCCC, PKT, PMCS, PSA, QLGC, RBCN, SBAC, SEM, SGEN, SKUL, SNAK, SPF, SQNM, SREV, SSNC, SWIR, SWN, TEG, TPX, TS, TSYS, VRTX, WU, WWWW, WYNN, XL, XPO.
Mon, Apr. 28, 11:48 AM
- The European Commission approves BioMarin Pharmaceuticals' (BMRN +0.2%) Vimizim (elosulfase alfa) for Mucopolysaccharidosis type IVA (Morquio A syndrome) in patients of all ages.
- The enzyme replacement therapy has orphan drug status in the EU and has 10 years' market exclusivity.
- Morquio A syndrome results from the under-activity of an enzyme involved in glycosaminoglycan metabolism.
- 85% of Morquio A patients live outside of the U.S. It affects ~3,000 people in the developed world.
- The U.S. FDA approved the drug on February 14, 2014.
Wed, Feb. 26, 4:40 PM
BMRN vs. ETF Alternatives
Biomarin Pharmaceutical Inc develops and commercializes pharmaceuticals for serious diseases and medical conditions. Its product portfolio is comprised of five product candidates Naglazyme, Kuvan, Aldurazyme, VIMIZIM and Firdapse.
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