MACK
Merrimack PharmaceuticalsNASDAQ
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  • Wed, Nov. 9, 5:36 PM
    | Wed, Nov. 9, 5:36 PM | 2 Comments
  • Wed, Nov. 9, 4:06 PM
    • Merrimack Pharmaceuticals (NASDAQ:MACK): Q3 EPS of -$0.23 beats by $0.04.
    • Revenue of $28.1M (+70.9% Y/Y) misses by $11.1M.
    • Shares +2.7%.
    • Press Release
    | Wed, Nov. 9, 4:06 PM | 7 Comments
  • Tue, Nov. 8, 5:35 PM
  • Mon, Oct. 31, 8:39 AM
    • The FDA accepts for review Actavis' (NASDAQ:TEVA) Abbreviated New Drug Application (ANDA) seeing approval of a generic form of doxorubicin hydrochloride liposome injection, marketed under the brand name DOXIL by Janssen (NYSE:JNJ).
    • Merrimack Pharmaceuticals (NASDAQ:MACK) is responsible for the development and commercial supply of the bulk product while Actavis is responsible for fill/finish activities, regulatory approvals and commercialization in the U.S.
    • DOXIL generates ~$600M a year in global sales.
    | Mon, Oct. 31, 8:39 AM | 1 Comment
  • Tue, Oct. 18, 5:35 PM
    | Tue, Oct. 18, 5:35 PM | 2 Comments
  • Tue, Oct. 18, 9:16 AM
    | Tue, Oct. 18, 9:16 AM
  • Tue, Oct. 18, 6:52 AM
    • The European Commission approves Shire plc's (NASDAQ:SHPG) Marketing Authorization Application (MAA) seeking approval of ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate), in combination with chemotherapy agents 5-fluorouracil (5-FU) and leucovorin (LV), for the treatment of adult patients with metastatic adenocarcinoma of the pancreas who have progressed after gemcitabine-based therapy. The approval follows a positive CHMP opinion in July.
    • The data supporting the application was generated in the Phase 3 NAPOLI-1 study which showed treatment with the combination extended overall survival, progression-free survival and objective response rate compared to 5-FU/LV alone.
    • ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
    • Shire has global development and commercialization rights to ONIVYDE except in the U.S. and Taiwan which is the responsibility of Merrimack Pharmaceuticals (NASDAQ:MACK).
    • MACK is up 8% premarket on average volume. SHPG is 2% on light volume.
    | Tue, Oct. 18, 6:52 AM | 38 Comments
  • Tue, Oct. 11, 9:18 AM
    | Tue, Oct. 11, 9:18 AM
  • Tue, Oct. 11, 8:56 AM
    • Merrimack Pharmaceuticals (NASDAQ:MACK) is ahead 8% premarket on higher-than-average volume in response to its announcement of final results from the Phase 3 NAPOLI-1 study assessing ONIVYDE (irinotecan liposome injection), in combination with standard-of-care fluorouracil (5-FU) and leucovorin, for the treatment of patients with metastatic pancreatic ductal adenocarcinoma following gemcitabine-based therapy. The data were presented at the European Society for Medical Oncology 2016 Annual Meeting in Copenhagen.
    • Overall survival favored the combination over standard-of-care, 6.2 months versus 4.2 months (p=0.039) with a 25% lower risk of death or cancer progression (hazard ratio = 0.75). One in four patients in the ONIVYDE cohort survived at least one year. The disease control rate (responders + those with stable disease) also favored the ONIVYDE combo regimen, 52% vs. 24%.
    • The product was approved in the U.S. and Taiwan in October 2015. It was given a thumbs up by the Advisory Committee in Europe in July.
    • ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
    • Previously: Merrimack posts increased survival rate in Oivyde trial (Jan. 19)
    | Tue, Oct. 11, 8:56 AM | 11 Comments
  • Fri, Oct. 7, 11:57 AM
    • Ionis Pharmaceuticals (NASDAQ:IONS) upgraded to Outperform from Market Perform by BMO Capital. Price target raised to $48 (42% upside) from $42.
    • Catalyst Pharmaceuticals (NASDAQ:CPRX) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $4 (199% upside) from $1.
    • AmerisourceBergen (NYSE:ABC) upgraded to Market Outperform from Market Perform by Avondale Partners.
    • Alnylam Pharmaceuticals (NASDAQ:ALNY) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $40 (14% upside) from $107. Downgraded to Equal Weight from Overweight by Barclays. Price target lowered to $50 (42% upside) from $85. Downgraded to Neutral from Overweight by JPMorgan. Downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $36 (3% upside) from $38.
    • Merrimack Pharmaceuticals (NASDAQ:MACK) downgraded to Neutral from Overweight with a $5.75 (2% upside) price target by JPMorgan.
    • Iradimed (NASDAQ:IRMD) downgraded to Neutral from Buy by Roth Capital. Price target lowered to $11.50 (11% upside) from $28.
    • Trinity Biotech (NASDAQ:TRIB) downgraded to Equal Weight from Overweight by Stephens & Co.
    • Depomed (NASDAQ:DEPO) downgraded to Neutral from Buy by Mizuho Securities.
    • Align Technology (NASDAQ:ALGN) downgraded to Neutral from Overweight with a $96 (8% upside) price target by Baird.
    | Fri, Oct. 7, 11:57 AM | 16 Comments
  • Mon, Oct. 3, 9:22 AM
    | Mon, Oct. 3, 9:22 AM
  • Mon, Oct. 3, 7:41 AM
    • With the aim of beefing up its cash runway as it focuses its R&D efforts on a set of systems biology-derived oncology candidates, Merrimack Pharmaceuticals (NASDAQ:MACK) eliminates 22% of its headcount, including President & CEO Robert Mulroy who has resigned effective immediately. The company says it expects to save more than $200M in operating costs over the next two years and will have sufficient cash to fund operations for at least 12 months.
    • Merrimack will record a one-time charge of $4.5M - 5.0M in severance-related costs.
    • Chairman Gary Crocker will take over as interim President & CEO until a permanent leader is appointed.
    • The reduction will not impact the company's commercial organization or the execution of the ONIVYDE launch and label expansion.
    • Update: Shares are down 9% premarket on light volume.
    | Mon, Oct. 3, 7:41 AM | 23 Comments
  • Fri, Aug. 26, 7:15 AM
    • Actinium Pharmaceuticals (NYSEMKT:ATNM) initiated with Buy rating and $5 (194% upside) price target by Roth Capital.
    • Jazz Pharmaceuticals (NASDAQ:JAZZ) initiated with Neutral rating by Janney Montgomery Scott.
    • Cantel Medical (NYSE:CMN) initiated with Hold rating by Needham.
    • Patheon NV (Pending:PTHN) initiated with Outperform rating by William Blair.
    • Caladrius Biosciences (NASDAQ:CLBS) initiated with Buy rating and $6.50 (31% upside) price target by Chardan Capital.
    • HTG Molecular Diagnostics (NASDAQ:HTGM) initiated with Buy rating and $5 (92% upside) price target by Rodman & Renshaw.
    • Rockwell Medical (NASDAQ:RMTI) initiated with Buy rating and $12 (72% upside) price target by BTIG Research.
    • Agios Pharmaceuticals (NASDAQ:AGIO) initiated with Neutral rating by BTIG Research.
    • TRACON Pharmaceuticals (NASDAQ:TCON) initiated with Buy rating and $15 (137% upside) price target by BTIG Research.
    • Ophthotech (NASDAQ:OPHT) initiated with Buy rating and $92 (76% upside) price target by BTIG Research.
    • Merrimack Pharmaceuticals (NASDAQ:MACK) initiated with Neutral rating by BTIG Research.
    • Acceleron Pharma (NASDAQ:XLRN) initiated with Buy rating and $46 (55% upside) price target by BTIG Research.
    | Fri, Aug. 26, 7:15 AM | 15 Comments
  • Thu, Aug. 4, 4:11 PM
    • Merrimack Pharmaceuticals (NASDAQ:MACK): Q2 EPS of -$0.40 misses by $0.07.
    • Revenue of $33.68M (-7.9% Y/Y) beats by $2.71M.
    • Shares +3.04%.
    • Press Release
    | Thu, Aug. 4, 4:11 PM | 7 Comments
  • Wed, Aug. 3, 5:35 PM
  • Mon, Jul. 25, 7:08 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Merrimack Pharmaceuticals (NASDAQ:MACK) and commercialization partner Shire plc's (NASDAQ:SHPG) ONIVYDE (irinotecan liposome injection), in combination with the chemo  agents fluorouracil (5-FU) and leucovorin, for the treatment of patients with metastatic pancreatic adenocarcinoma  who have progressed after gemcitabine-based therapy.
    • The positive opinion was based on the Phase 3 NAPOLI-1 study that showed pancreatic cancer patients treated with ONIVYDE plus 5-FU and leucovorin achieved overall survival of 6.1 months compared to 4.2 months for those receiving 5-FU and leucovorin alone (p=0.012) with a 33% reduction in the risk of death (hazard ratio: 0.67). One in four patients treated with the ONIVYDE regimen survived at least one year.
    • ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
    • Shire has global development and commercialization rights to ONIVYDE except the U.S. and Taiwan.
    • The FDA approved ONIVYDE for this indication in October 2015.
    • A final decision from the European Commission usually takes ~60 days.
    | Mon, Jul. 25, 7:08 AM | 2 Comments