Nov. 4, 2014, 5:35 PM
- ABTL, ACAS, ACLS, ALNY, ALSK, ANDE, AR, AREX, ASH, ATO, ATSG, AVG, AWK, BALT, BCOR, BIOS, BKD, BREW, BWC, CBS, CDE, CF, CLR, CODI, CPE, CSOD, CTL, CVG, CXO, DATA, DEPO, DK, DPM, DRYS, DVR, DYN, ECOL, ECYT, EFC, ENS, ENSG, ETE, ETP, EXAR, EXXI, FMI, FNV, G, GNW, GPOR, GSM, HOLX, HTCH, IL, INWK, IO, JCOM, KGC, KW, LBTYA, LHCG, LPSN, MBI, MCHX, MCP, MDR, MDWD, MED, MHLD, MIDD, MRIN, MTDR, MTRX, MUSA, MWE, NDLS, NLY, NVAX, NWSA, OILT, ORA, ORIG, OSUR, PAA, PLNR, PMT, PODD, POWR, PPO, PRGN, PRU, PTC, QCOM, QEP, QUAD, RGP, RNDY, RUTH, SB, SBY, SCTY, SD, SKUL, SLF, SSNI, SSRI, STMP, SUSP, SWIR, SWM, SXL, SYMC, SZYM, TCAP, TEAR, TEG, TERP, THOR, TNGO, TPC, TRAK, TROX, TRUE, TS, TSLA, TSRO, TTEC, TXTR, UHAL, VVUS, WBMD, WFM, WMC, WMGI, WR, WTI, WWWW, XPO, Z
Oct. 13, 2014, 12:46 PM
Oct. 13, 2014, 9:15 AM
Oct. 13, 2014, 8:38 AM
- In a Phase 2 open-label extension study, Alnylam's (NASDAQ:ALNY) investigational RNAi therapeutic, patisiran (ALN-TTR02), demonstrated effectiveness as a treatment for patients with familial amyloidotic polyneuropathy (FAP) who have transthyretin (TTR)-mediated amyloidosis.
- The mean decrease in modified Neuropathy Impairment Score (mNIS+7) at six months in 19 patients was 0.95 points. The compares favorably with a historical 7 - 10 point increase in untreated patients.
- Patients treated with patisiran achieved a sustained mean serum TTR knockdown at the 80% target level for over nine months and as high as 89.6% between doses.
- The ongoing open-label extension study is designed to evaluate the long-term safety and tolerability of patisiran administration.
- The mNIS+7 measurement is the primary endpoint of the company's Phase 3 trial of patisiran in FAP patients.
- Shares are up 13% premarket on good volume.
Sep. 15, 2014, 11:22 AM
- Alnylam (ALNY -2.3%) hires three new executives. It appoints Karen Anderson as SVP, Chief HR Officer. She joins the firm from Biogen where she was VP, HR for R&D and Corporate Development.
- It appoints Laurie Keating as SVP, General Counsel and Secretary. She joins the company from Millennium where she was SVP, General Counsel and Secretary.
- It appoints Marko Kozul, M.D. as VP, Strategy. He joins the firm from Leerink Partners where he was a senior biotech analyst.
Aug. 20, 2014, 10:41 AM
- The USPTO issues a Notice of Allowance to Alnylam Pharmaceuticals (ALNY -0.5%) for claims in the Tuschl et al. patent application 13/725,262. The 262 patent application includes claims directed to compositions that mediate RNAi and compromising a double-stranded molecule with up to 25 base pairs and at least one nucleotide analogue.
- The patent application broadly covers small interfering RNA (siRNA) molecules of various designs, including dicer substrate RNAi triggers and double-stranded RNAi-mediating molecules containing moieties that include unlocked nucleobase analogs among other naturally or non-naturally occurring nucleotide analogues.
Aug. 7, 2014, 5:43 PM
Aug. 7, 2014, 4:12 PM| Comment!
Aug. 7, 2014, 8:56 AM
Aug. 6, 2014, 5:35 PM
- AGO, AHT, AIRM, AL, ALIM, ALJ, ALNY, AMRN, AMRS, ANAC, ANET, ASYS, ATLS, AUQ, BCEI, BCOR, BIOL, BNFT, BNNY, BOFI, BPZ, CARA, CBS, CENT, CFN, CLNE, CLVS, CPST, CSC, CUBE, CVT, DAR, DIOD, DMD, DV, EAC, EBS, ECPG, ED, EGOV, ELX, ENOC, FF, FI, FRT, FWM, FXCM, GHDX, GST, GXP, HGR, HTGC, IRG, KTOS, LGF, MASI, MDVN, MED, MELI, MNST, NES, NFG, NOG, NVDA, NWSA, OLED, OPLK, PFMT, PODD, PRO, PSIX, QTWO, RATE, RBCN, RENT, RPTP, RRMS, SCTY, SEM, SFM, SHOR, SLXP, SPPI, SSTK, TEAR, TRNX, TRUE, TUMI, UBNT, UNXL, VOLC, VVUS, WIFI, XOMA, ZNGA,
Jul. 22, 2014, 8:43 AM
- The USPTO issues a notice of allowance to Alnylam's (NASDAQ:ALNY) patent application 13/693,478. The allowed patent broadly covers single- or double-stranded chemically modified RNA therapeutics conjugated with an N-acetylgalactosamine (GalNAc) ligand independent of length, sequence or disease target.
- GalNAc-siRNA conjugates enable durable silencing of liver-expressed disease genes with subcutaneous does administration and a wide therapeutic index. The delivery approach is part of the company's 5x15 genetic medicine strategy.
Jun. 19, 2014, 11:43 AM
- Alpha-1 Foundation philanthropy subsidiary The Alpha-1 Project (TAP) enters into a collaboration agreement with Alnylam Pharmaceuticals (ALNY -0.5%) for the continued advancement of RNAi therapeutic ALN-AAT for the treatment of alpha-1 antitrypsin (AAT) deficiency-associated liver disease.
- TAP's mission is to work with patients, academia, public health organizations and the private sector in the pursuit of cures and therapies for chronic obstructive pulmonary disease (COPD) and liver disease caused by AAT deficiency.
- Financial terms of the agreement are not disclosed.
- Related ticker: (ARWR -1.6%)
Jun. 13, 2014, 9:22 PM
- Arrowhead Research (ARWR -9.7%) says it is unencumbered in its efforts to develop its HBV drug candidate ARC-520. It has broad access to the IP necessary to develop the product and has no restrictions on its freedom to operate. The company signed a license agreement with Alnylam (ALNY) in January 2012 for HBV-related IP plus it owns other patents related to the drug's technology. It believes that ARC-520 does not infringe on any patents in Alnylam's McSwiggen patent estate.
- ARWR shares took it on the chin today due to the market's perception that ALNY's HBV patents may be a issue for ARWR.
Jun. 13, 2014, 11:41 AM
- Shares of Arrowhead Research (ARWR -16.1%) are down on heavy volume in response to the patent award to Alnylam Pharmaceuticals (ALNY -0.2%) expanding its McSwiggen patent estate for RNAi therapeutics. The just-awarded patent (no. 8,618,277) covers the development of RNAi therapeutics for HBV. One of Arrowhead's lead product candidates is ARC-520, an RNAi-based therapeutic for the treatment of chronic HBV infection.
Jun. 12, 2014, 10:13 AM
- The USPTO issues patent no. 8,618,277 to Alnylam (ALNY +1.3%) in its McSwiggen patent estate, which broadly describes chemical modifications of RNAi therapeutics needed to achieve drug-like properties in siRNA. The 277 patent includes important claims related to the development of RNAi therapeutics for the treatment of hepatitis B infection. It is exclusive to the company.
- The McSwiggen patent estate includes 23 granted patents around the world and is a core component of Alnylam's IP portfolio for the advancement of RNAi therapeutics. It obtained the estate via its acquisition of Sirna Therapeutics from Merck (MRK -1%).
May. 12, 2014, 9:26 AM
- Certain traders are apparently swinging from trees this morning as they pop shares of Alnylam (ALNY) 8% on modest volume in premarket action in response to its announcement of a significant reduction in HBV surface antigen in preclinical testing on four monkeys with its RNAi therapeutic ALN-HBV product candidate. The product reduced HBsAg as much as 2.3 log10 compared to 0.5 log10 which is the generally accepted minimum reduction indicating immunologic cure. While encouraging, a colossal amount of work and time remains before any such product will reach the market.
- Alnylam purchased the assets from Merck (MRK) in January for $175M ($25M cash + stock). Merck acquired the assets via its acquisition of Sirna Therapeutics in 2006 for $1.1B. Merck's exit at a significant loss is a clear signal that the road to commercialization will be long and arduous.
- Alnylam hopes to file an IND by the end of 2015.
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