What's your position on ?
Why are you ish?
You voted ish on Vote again
Posts appear on the My Feed page of subscribers to this ticker
Tue, Jan. 19, 7:28 PM
- Merrimack Pharmaceuticals (MACK -3.1%) says updated data on its Phase 3 NAPOLI-1 study of an Onivyde combination regimen shows a one-year survival rate increased by 63% in patients with metastatic pancreatic cancer.
- That's for Onivyde combined with fluorouracil and leucovorin, when compared to fluorouracil and leucovorin alone. The new data will be presented at this week's Gastrointestinal Cancers Symposium in San Francisco.
- No new safety or tolerability concerns were noted in the update.
- After hours: MACK +1%.
Thu, Jan. 7, 8:03 AM
- Health Canada grants Priority Review status for Baxalta's (NYSE:BXLT) New Drug Submission for irinotecan liposome injection (nal-IRI) for the treatment patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The review should be completed in the second half of the year.
- Under a licensing deal with Merrimack Pharmaceuticals (NASDAQ:MACK), Baxalta is responsible for the development and commercialization of nal-IRI outside of the U.S. and Taiwan.
- The FDA cleared nal-IRI, branded as Onivyde, in October 2015.
- Previously: Baxter and Merrimack collaborate on cancer drug (Sept. 24, 2014)
Dec. 22, 2015, 5:05 PM
- Merrimack Pharmaceuticals (NASDAQ:MACK) submits an amendment to its ongoing Phase 2 clinical trial assessing MM-121 in patients with heregulin-positive non-small cell lung cancer (NSCLC) to the FDA requesting a change in the primary endpoint to overall survival (OS). If approved, it will accelerate the development process by providing the data to support a New Drug Application (NDA).
- Under the amendment, the company expects to enroll ~280 heregulin-positive NSCLC patients who will be randomized to receive MM-121 plus the investigator's choice of docetaxel or pemetrexed or docetaxel or pemetrexed alone. Eligible patients must have failed no more than three prior lines of therapy for locally advanced or metastatic disease and, where applicable, prior PDL1 therapy.
- MM-121 is a fully human monoclonal antibody that binds to a receptor on tumor cells called ErbB3, which is activated by the growth factor heregulin. ErbB3 signaling is thought to play a key role in tumor growth and resistance to cytotoxic and anti-endocrine therapies. MM-121 blocks ErbB3 signaling which enhances the anti-tumor effect of the combination drug.
- Sanofi (NYSE:SNY) returned the rights to MM-121 to the company in June of last year.
- Separately, Merrimack closed a $175M debt offering via private placement that will fund the further development of MM-121, among other priorities. The senior secured notes bear interest of 11.5% and mature on December 15, 2022.
- Previously: Sanofi pulls the plug on Merrimack mAb for cancer (June 20, 2014)
Nov. 10, 2015, 5:40 PM
Nov. 9, 2015, 4:04 PM
- Merrimack Pharmaceuticals (NASDAQ:MACK): Q3 EPS of -$0.38 beats by $0.02.
- Revenue of $16.4M (-41.4% Y/Y) beats by $2.36M.
Oct. 23, 2015, 9:14 AM
Oct. 23, 2015, 8:02 AM
- Merrimack Pharmaceuticals (NASDAQ:MACK) is up 6% premarket on light volume. Yesterday, the FDA approved Onivyde (irinotecan liposome injection) for the second-line treatment of pancreatic cancer.
- Previously: Trading in Merrimack Pharma halted pending news; PDUFA date Saturday for MM-398 for pancreatic cancer; FDA approves (Oct. 22)
Oct. 22, 2015, 11:28 AM
- Nasdaq halts trading in Merrimack Pharmaceuticals (MACK -1.6%) pending news. The FDA's action date for its Priority Review of the company's MM-398 NDA for the treatment of metastatic adenocarcinoma of the pancreas in patients previously treated with gemcitabine is October 24. Since this is Saturday, the FDA should announce its decision no later than tomorrow. The NDA was filed last November.
- Update: The FDA clears MM-398, branded as Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. Onivyde was designated an Orphan Drug for pancreatic cancer so it is eligible for a seven-year period of market exclusivity for the indication.
Aug. 24, 2015, 9:19 AM
- Gainers: GAS +29%.
- Losers: VTL -79%. ACI -31%. BZUN -25%. WBAI -23%. JMEI -20%. BTU -17%. MDR -17%. CSIQ -17%. VIPS -16%. FIT -16%. SFUN -15%. LC -15%. PLUG -15%. EXXI -15%. QIHU -14%. MACK -14%. ACHN -14%. KNDI -13%. CYBR -13%. OHGI -13%. Z -13%. TCK -13%. JKS -13%. AVEO -12%. OAS -12%. WLL -12%. MCUR -12%.
Aug. 11, 2015, 9:50 AM
- Merrimack Pharmaceuticals (MACK +13.3%) Q2 results: Revenues: $36.6M (+31.7%); R&D Expense: $42.8M (+26.6%); SG&A: $12.3M (+55.7%); Operating Loss: ($18.6M) (-33.8%); Net Loss: ($22.8M) (-26.0%); Loss Per Share: ($0.21) (-23.5%); Quick Assets: $67.7M (-45.4%).
- No guiidance given.
Aug. 10, 2015, 4:06 PM
- Merrimack Pharmaceuticals (NASDAQ:MACK): Q2 EPS of -$0.21 beats by $0.10.
- Revenue of $36.6M (+31.6% Y/Y) beats by $19.03M.
- Shares -0.4%.
Jun. 18, 2015, 5:36 PM
May 15, 2015, 11:46 AM
- Five Prime Therapeutics (FPRX -0.7%) initiated with Outperform rating and $45 (114% upside) price target by Oppenheimer.
- Trillium Therapeutics (TRIL +9%) initiated with Outperform rating and $32 (60% upside) price target by Oppenheimer.
- Paratek Pharmaceuticals (PRTK +1.5%) initiated with Outperform rating and $43 (54% upside) price target by Leerink Swann and a Buy rating with $35 (25% upside) price target by Cantor Fitzgerald.
- Advaxis (ADXS +2.2%) initiated with Buy rating and $26 (37% upside) price target by Janney Capital.
- SAGE Therapeutics (SAGE +1.1%) initiated with Buy rating and $80 (36% upside) price target by Goldman Sachs.
- Bristol-Myers Squibb (BMY) initiated with Hold rating and $70 (3% upside) price target by Berenberg.
- Akebia Therapeutics (AKBA +2.3%) initiated with Buy rating and $18 (125% upside) price target by Brean Capital.
- Merrimack Pharmaceuticals (MACK +1.8%) initiated with Buy rating and $15 (20% upside) price target by Guggenheim Securities.
- Tokai Pharmaceuticals (TKAI +0.4%) initiated with Outperform rating and $38 (217% upside) price target by Oppenheimer.
May 7, 2015, 5:20 PM
- Merrimack Pharmaceuticals (NASDAQ:MACK): Q1 EPS of -$0.32 misses by $0.03.
- Revenue of $14.8M (+13.8% Y/Y) beats by $0.82M.
May 4, 2015, 10:12 AM
- Baxter International (BAX +0.6%) files a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) seeking clearance for MM-398 (irinotecan liposome injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. Merrimack Pharmaceuticals (MACK +3.5%), the original developer of MM-398, filed a New Drug Application (NDA) with the FDA in November.
- The companies inked an exclusive development and commercialization deal for MM-398 for ex-U.S. territories in September 2014. PharmaEngine has the rights in Taiwan.
- MM-398 is a nanotherapeutic consisting of the chemo agent irinotecan encapsulated in a liposomal sphere. It is being evaluated as a treatment of chemo-resistant tumors across multiple types of cancer.
- Previously: Merrimack pancreatic cancer product candidate Fast Track'd (Nov. 20, 2014)
May 1, 2015, 5:36 PM
Other News & PR