Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Sep. 24, 2014, 12:46 PM
Sep. 24, 2014, 10:01 AM
- Alkermes plc (ALKS +0.4%), through its subsidiary Alkermes, Inc., will reap some financial benefits from Acorda's (ACOR +17.3%) $525M acquisition of Civitas. It will receive $30M for the sale of certain commercial-scale pulmonary manufacturing equipment used by Civitas and ~$29M for its ~6% stake in the privately-held firm.
- The payments will not impact Alkermes' non-GAAP net income.
Sep. 24, 2014, 9:20 AM
Sep. 24, 2014, 8:51 AM
Sep. 24, 2014, 8:08 AM
- Acorda Therapeutics (NASDAQ:ACOR) acquires privately-held Chelsea, MA-based Civitas Therapeutics for $525M in cash. The transaction enables Acorda to obtain worldwide rights to CVT-301 (inhaled L-dopa), a Phase 3 product candidate for the treatment of OFF episodes in patients with Parkinson's disease. Estimated U.S. sales of CVT-301 are expected to be at least $500M.
- Acorda will hold a conference call this morning at 8:30 am ET to discuss the transaction.
Jul. 31, 2014, 8:40 AM
Jul. 31, 2014, 6:13 AM
Jul. 30, 2014, 5:30 PM
- AAWW, ABMD, ACIW, ACOR, ADP, AGI, ALKS, ALU, AMRC, APA, ASEI, ATK, AVP, AYR, AZN, BDX, BG, BGCP, BKCC, BLL, BUD, BWA, BZH, CCJ, CDW, CEVA, CHTR, CI, CL, CME, CNSL, COMM, COP, COT, CRCM, CRR, CTCM, CVI, CVRR, DDD, DISCA, DLPH, DTV, ENDP, EPD, EXC, FCH, FCN, FIG, FLY, FRM, GEL, GG, GIL, GLOP, GMT, GNRC, GTLS, H, HGG, HL, HP, HST, IDA, IMN, INCY, IRDM, IRM, ITT, IVZ, K, KMT, LKQ, LLL, LM, MA, MCK, MD, MDP, MNTA, MOD, MOS, MPC, MPLX, MSCI, MTOR, MWIV, NGD, NI, NJR, NWL, OAK, OCN, ODFL, OXY, PCG, PCRX, PES, PNR, PNW, PPL, PRFT, PWR, Q, RFP, RYL, SBH, SC, SCG, SFY, SHOO, SNAK, SNMX, STC, STRA, STRZA, SUP, SWC, TE, TEVA, TKR, TRP, TWC, UAN, UPL, USAK, VG, VICL, VNTV, VRX, WLT, WWE, XEL, XOM, XRAY
Jun. 26, 2014, 7:11 AM
- Actavis (ACT) files an ANDA for a generic version of Acorda Therapeutics' (ACOR) MS drug Ampyra (dalfampridine) Extended Release Tablets, 10 mg. The company intends to vigorously defend its IP rights and will initiate a patent infringement lawsuit against ACT within the 45-day response period. This will trigger an automatic stay of a potential FDA decision for 30 months.
- Four of Ampyra's five patents are valid until at least 2025. It's Orphan Drug status extends until January 2017.
Jun. 18, 2014, 7:59 AM| Comment!
Jun. 17, 2014, 12:50 PM
Jun. 16, 2014, 6:11 PM
- Acorda Therapeutics (ACOR +0.5%) plans to offer $300M aggregate principal amount of convertible senior notes due 2021 pursuant to a shelf registration filed today with the SEC. Underwriters over-allotment is $45M aggregate principal amount. Net proceeds will be used for general corporate purposes including funding possible acquisitions and investing in complimentary businesses, products and technologies.
May 6, 2014, 8:30 AM
- Acorda Therapeutics (ACOR) total revenues: $80.5M (+12%); product revenues: $74.5M (+16.2%); Ampyra net revenue: $72.5M (+16.4%); operating income: $3.4M vs ($2.5M); net income: $703K vs ($1.1M); EPS: $0.02 vs ($0.03); quick assets (ex-A/R): $372.2M (+1.4%).
- 2014 guidance: Ampyra net revenue: $328M - 335M, R&D and SG&A forecasts remain the same.
May 6, 2014, 6:03 AM| Comment!
May 5, 2014, 5:30 PM
- ACM, ACOR, AER, AKRX, AME, ARCC, ARCO, ARW, BCE, BCS, CBOE, CNK, COCO, CRTO, CRZO, CYNO, DISCA, DNR, DTV, DWRE, EMR, EXH, EXLP, FE, GDP, GLDD, HCP, HFC, HPT, HSH, HSIC, HTH, IFF, ISIS, KWK, MMP, MNTA, MONT, MOS, MPW, MSO, MVIS, MWIV, NRG, [[NTi]], NUS, ODP, OXF, PDCE, PQ, PRIM, RDC, RHP, RTI, RTRX, STWD, TDG, TGH, TPH, TW, UBS, VMC, VSH, VTG, WCG, WNR, XRAY, ZBRA, ZTS.
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