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February 14, 2013
11:51 EDTPGNXProgenics presents data from Phase 1 study of PSMA ADC
Progenics Pharmaceuticals reported positive clinical data from a completed phase 1 study of PSMA ADC, an antibody-drug conjugate designed to selectively deliver chemotherapy to cells that express prostate-specific membrane antigen. PSMA ADC was generally well tolerated in patients at doses up to and including 2.5 mg/kg, the maximum tolerated dose. Findings were presented at the 2013 Genitourinary Cancers Symposium, a meeting co-sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology. Fifty-two patients with metastatic castration-resistant prostate cancer were dosed at nine dose levels. Significant antitumor activity was observed across doses ranging from 1.8 mg/kg to 2.8 mg/kg. Dose limiting toxicities, primarily neutropenia, were seen at 2.8 mg/kg. The most commonly reported adverse events were anorexia and fatigue. Progenics opened enrollment in a subsequent phase 2 study of PSMA ADC in September 2012. This ongoing trial is an open-label, multicenter study assessing the anti-tumor activity and tolerability of PSMA ADC in up to 75 subjects with mCRPC. Patients are receiving a total of eight doses of drug at 2.5 mg/kg. The study endpoints evaluate responses in prostate specific antigen; circulating tumor cells; pain; and change in tumor size as measured under RECIST criteria. Safety also is being evaluated.
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July 14, 2014
09:16 EDTPGNXOn The Fly: Pre-market Movers
HIGHER: Citigroup (C), up 3.6% after reporting better than expected Q2 results, announcing $7B settlement with DOJ and FDIC... Apple (AAPL), up 0.7% after Barclays upgrades stock to Overweight, Morgan Stanley raises Apple estimates above consensus... Shire (SHPG), up 1.6% after receiving revised proposal from AbbVie (ABBV) of GPB 53.20 per share, which it says it would be willing to recommend to Shire shareholders. AbbVie is down 2.8% after the news... Mylan (MYL), up 4% after acquiring Abbott's (ABT) non-U.S. developed markets specialty and branded generics business in all-stock transaction valued at about $5.3B. Abbott up 1.6% after the news... Progenics (PGNX), up 13% after FDA says RELISTOR can be approved on data submitted in sNDA... Exelixis (EXEL), up 13% after announcing coBRIM Phase 3 trial met primary endpoint... URS (URS) up 8% after acquired by AECOM Technology (ACM) for $56.31 per share. AECOM shares alos up 2% after deal announcement... Whiting Petroleum (WLL), up 4.5% after agreeing to acquire Kodiak Oil & Gas (KOG) in a $6B transaction. Kodiak Oil & Gas up 3%... Kandi Technologies (KNDI), up 11% after announcing JV's sale of 4,114 EVs in Q2. LOWER: Riverbed (RVBD), down 4.5% after saying it sees its Q2 adjusted EPS at low end of 26c-28c range... Harmonic (HLIT), down 13% after reporting preliminary Q2 earnings results.. EBay (EBAY), down 0.5% after downgraded at Pacific Crest, confirming partnership plans with Sotheby's (BID).
08:06 EDTPGNXProgenics to host conference call
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07:07 EDTPGNXFDA says RELISTOR can be approved on data submitted in sNDA
Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the Food and Drug Administration has informed Salix that RELISTOR can be approved on the data submitted in the sNDA. The FDA Office of Drug Evaluation III responded to the company’s formal appeal filed in response to the Complete Response Letter of July 27, 2012 to the supplemental NDA ) for RELISTOR. The Agency’s letter stated that, “Salix’s request that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain based on the submitted data is granted.” This request for a proposal for a post-marketing observational study is in accordance with recommendations of the June 11-12, 2014 meeting of the Anesthetic and Analgesic Drug Product Advisory Committee. Salix will work with the DGIEP in an effort to provide information to the division that will enable the division to approve RELISTOR for use by patients with chronic non-cancer pain and experiencing OIC.
06:55 EDTPGNXProgenics trading halted, pending news
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