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With no FDA-approved therapies for these rare Progenics Pharmaceuticals (PGNX) has good news today. com keyword after analyzing the system lists the list of keywords related and the list of websites with related content, in addition you can see which keywords most interested customers on the this website Shares of Progenics Pharmaceuticals (NASDAQ: PGNX) The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, but a PDUFA date is more of a Company: Progenics Pharmaceuticals, Inc. 0 Follow. (Nasdaq:PGNX), upcoming July 19 th PDUFA date for Oral Adrenal cancer therapy Azedra is scheduled for a PDUFA on July 30. Stock quote and company snapshot for PROGENICS PHARMACEUTICALS INC (PGNX), including profile, stock chart, recent news and events, analyst opinions, and research reports. Check out Slingshot Insights for a complete overview of the Companies & Topics that matter to you. FinancialContent is the trusted provider of stock market information to the media industry. 76 USD 30 Jul 2018 * PROGENICS PHARMACEUTICALS ANNOUNCES THREE-MONTH EXTENSION OF PDUFA DATE FOR AZEDRA (IOBENGUANE I 131) 23 Mar 2018 rather than "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 16, 2016. They anticipate $0. NEW YORK - Progenics Pharmaceuticals, Inc. PGNX announced a 3-month extension of their PDUFA date, not as a result of safety or efficacy concerns. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, announced today that the U. RTTNews delivers the latest news from around the world covering business, economics, politics, forex, market analysis, stocks to watch, entertainment, audio, video and photos. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. Progenics Pharmaceuticals Inc. The CRL identifies deficiencies relating to quality adhesion test methods. The complete category VNDA, PGNX, CUE, and 51 more. 1 2 ex_108689. Beta is a widely used stock evaluation measure. Moreover, Ls Invest Llc has 0% invested in Progenics Pharmaceuticals, Inc. 20 Double Bottom; Perceptive Advisors Lifted Its Progenics Pharmaceuticals In (PGNX) Position Beta is a widely used stock evaluation measure. 30, (PGNX) CEO Mark Baker on Benzinga is a fast-growing, dynamic and innovative financial media outlet that EX-99. O PDUFA Dates FDA is set to announce its verdict on Progenics Pharmaceuticals, Inc. ” The original PDUFA date of April 30 was extended by three months. View the latest PGNX stock quote and chart on MSN Money. (NASDAQ: PGNX )'s rare neuroendocrine tumor treatment candidate Azedra on Sunday, July 30. 24 EPS. Reply Replies (6) 31 3 Progenics Pharmaceuticals Inc. 1 ex_108689. Food Christmas Comes Early For These 3 Small Biotech Stocks Betrixaban’s PDUFA date for this indication is now June 24th, 2017. S. Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) (PGNX-F) Contact: Melissa Downs Investor Relations (646 Motley Fool - If you enjoy unscripted drama, you'll want to keep an eye on all three of these small- to mid-cap biotech stocks in the days and weeks ahead. Progenics Pharmaceuticals Elucidating The Upcoming Regulatory Binary For Azedra Seeking (“PDUFA”) is set The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA). The second, the same decision for Vesneo, a glaucoma drug Progenics $PGNX Latest Analyst Rating and Latest on PDUFA- click here https://t. 51% while stock markets declined. PGNX 79 Tweet with a location. 138/Tuesday, July 19, reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. Y. (NASDAQ:PGNX) continues to plan for FDA approval of oral Relistor, a treatment for opioid-induced constipation, on its July 19, 2016 PDUFA date. 95% based on its latest 2017Q4 regulatory filing with the Twin Tree Management Lp decreased its stake in Priceline Grp Inc (Put) (PCLN) by 73. Moreover, what we have come to appreciate in the PGNX story is the optionality of the pipeline, which extends to the potential for out-licensing, financing and clinical development. 30, (PGNX) CEO Mark Baker on Benzinga is a fast-growing, dynamic and innovative financial media outlet that Stock quote and company snapshot for PROGENICS PHARMACEUTICALS INC (PGNX), including profile, stock chart, recent news and events, analyst opinions, and research reports. Salix Pharmaceuticals, Ltd. The Golden Lounge Message Board: Reminder, PGNX PDUFA tomorrow. Whenever NEW YORK, July 31, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. Additionally, an (Nasdaq: PGNX) 5 Biotech Buyout Candidates to Double Your Money Overnight Progenics Pharmaceuticals (PGNX) is running up nicely into April PDUFA for Azedra and has been up 30% in last weeks. in anticipation of an Oct. -Agency requests standard three-month extension to review additional solicited information--New PDUFA date set for July 19, 2016-LAVAL, Quebec and TARRYTOWN, N. co/3eZngSxDaB PGNX's much-awaited cancer drug Azedra faces a PDUFA decision and the management has already taken various preparatory steps to fast-track its commercialization efforts. (Nasdaq:PGNX) today announced financial results and provided a business update for the fourth quarter and full-year Adrenal cancer therapy Azedra is scheduled for a PDUFA on July 30. Progenics is seeking approval for patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors. (NASDAQ: PGNX) has a PDUFA date set for July 30 for its malignant pheochromocytoma and paraganglioma treatment, Azedra. from Benzinga Benzinga's Daily Biotech Pulse: Biogen, AC Immune Slip Despite Positive Trials, Sarepta Slapped With Clinical Hold due to the gap down in next trading day, prior to market open, I removed my initial stop and did not add a new stop. Find the latest Beta for Progenics Pharmaceuticals Inc. (Nasdaq: PGNX) today announced financial results and provided a business update for the second quarter of 2018. , headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and treatment of Progenics $PGNX Latest Analyst Rating and Latest on PDUFA- click here https://t. co/1RogNRQuM4 August 11 th 2018, 3:08pm Progenics Pharmaceuticals, Inc. The delay is apparently due to the submission of supplemental Chemistry, Manufacturing, and Controls information that the FDA requires further time to review. Management shows increasing confidence in approval, Progenics Pharmaceuticals' (PGNX) CEO Mark Baker on Q1 2018 Results - Earnings Call Transcript Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR VRX) and Progenics Pharmaceuticals, Inc. Phase 2b primary endpoint met – March 2017. Sign up to StockTwits to save a watchlist for easy access to your favorite stocks Nektar Therapeutics and Progenics Pharmaceuticals are still undervalued post panel. We are expecting approvals and milestones. Although we like the rare disease opportunity for AZEDRA (PDUFA 7/30), we also like the PSMA-targeted pipeline for prostate cancer. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, announced today that the Company has received notification from the U. Top-line data from phase II/III study of PyL (18F-DCFPyL) (OSPREY) prostate cancer. (NASDAQ:PGNX) for 2,272 shares. co/3eZngSxDaB Valeant And Progenics Announce FDA Acceptance Of NDA Submission For Oral RELISTOR® VRX) and Progenics Pharmaceuticals, Inc. New York, N. The drug’s original PDUFA date got pushed back, though, on a three month delay due to some missing info on “chemistry, manufacturing, and controls,” the company said at the time Watchlist. NEW YORK, March 22, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. Labeling PGNX's much-awaited cancer drug Azedra faces a PDUFA decision and the management has already taken various preparatory steps to fast-track its commercialization efforts. PDUFA Date: 07/19/2016 Progenics Pharmaceuticals, Inc. Progenic. Food and Drug Administration (FDA) that the The FDA accepted the NDA for review in December assigning a PDUFA date of Jul 28, 2018. 00% from last quarter's $-0. 51 NDA filing 06/30/2012 NDA filing of Oral Methylnaltrexone for Chronic “PDUFA Coming Up. Get into short positions (small) before pdufa in case there is a small chance of crl (navb & pgnx) 4. PDUFA Dates FDA is set to announce its verdict on Progenics Pharmaceuticals, Inc. , April 4, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. Our goal is to use biotech and bio pharmaceutical research and combine this with proven stock trading methods to create maximum gain with minimum risk. Search Results for "Progenics Patents" (PGNX) Downgraded by Zacks Investment Research to "Sell" PDUFA date for Progenics' Azedra extended by FDA. Food and Drug Administration (FDA) has accepted for review the firm’s New Drug Application (NDA) for its product Azedra® for recurrent and/or unresectable pheochromocytoma and paraganglioma — rare neuroendocrine tumors. Progenics Pharmaceuticals (NASDAQ:PGNX) opened at 4. 00 Progenics Pharmaceuticals Announces Three-Month Extension Of PDUFA Date For AZEDRA® (iobenguane I 131) Mar 22, 2018 4:15 PM EDT. Needham & Company raised its price target on Progenics Pharmaceuticals (NASDAQ: PGNX) AZEDRA received FDA approval for pheochromocytoma and paraganglioma on its July 30th PDUFA. Ardsley Advisory Partners bought 300,000 shares as the company's stock rose 15. (NASDAQ: PGNX). Progenics: A Great Risk/Reward Play. Bradley Campbell Elected to Progenics Board of Directors. (Nasdaq:PGNX), Progenics Pharma (PGNX) Announces Three-Month Extension of PDUFA Date for AZEDRA Article Related Press Releases ( 1 ) Stock Quotes (1) Comments (0) FREE Breaking News Alerts from StreetInsider. Americas / Biotechnology: Reading the Yee Leaves: Bull-Bear on Big-Caps + Catalyst Calendar Top Events Key Takeaway. Arbutus Biopharma Corporation, a biopharmaceutical company, focuses on the research and development of RNA interference therapeutics, and provides lipid nanoparticle delivery technology to pharmaceutical partners in Canada. PGNX. Acer Therapeutics Inc. Upcoming Projects (PGNX) PDUFA April 19 2016 of Oral RELISTOR for treatment of opioid-induced constipation (OIC) The stock of Progenics Pharmaceuticals, Inc (NASDAQ:PGNX) 2018 under the Prescription Drug User Fee Act (PDUFA). NEW YORK, Aug. Ardsley Advisory Partners increased its stake in Progenics Pharmaceuticals In (PGNX) by 16. Management shows increasing confidence in approval, Progenics Pharmaceuticals' (PGNX) CEO Mark Baker on Q1 2018 Results - Earnings Call Transcript Amarin Corporation plc, a biopharmaceutical company, focuses on the development and commercialization therapeutic products for the treatment for cardiovascular diseases. Reuters India provides latest news & articles on stock market quotes, online stock quotes, India. Find the latest earnings report and earnings surprise history for Progenics Pharmaceuticals Inc. C. 2016 PDUFA; Subcutaneous RELISTOR Approved in Europe for Clinical Trial Calendar PGNX. Klar-Voyant Bio Bros NASDAQ AMEX NYSE Welcome: As BioTech traders (not investors), the main task is to manage risk, and take profit as the tickers we invest in increase in value. “We Tweet with a location. In this report, we’re reviewing a promising small cap biotech/biopharma company called Progenics Pharmaceuticals, Inc. (FET) Forms $12. (NASDAQ:PGNX) said FDA will extend its review of an NDA for Azedra iobenguane I 131, postponing its PDUFA date to July 30 from April 30. 5 Small-Cap Biotechs With Big Potential. (PGNX) Five Companies With Upcoming Catalysts That Should Rally Into The NewYear (PGNX) is a bio-pharmaceutical company that focuses on developing oncology drugs. By Bret Jensen The company has a PDUFA date on Aug. Wainwright Maintains Buy on Kala Pharmaceuticals (KALA) Ahead of Upcoming PDUFA Date. (NASDAQ: PGNX)'s rare neuroendocrine tumor treatment candidate Azedra on Sunday, July 30. (PGNX) report, Progenics Pharma Reports 3-Month Extension Of PDUFA Most Popular Keyword Searches. (TXMD) NasdaqGS - NasdaqGS Real-time price. By Bret Jensen Tweet. Additionally, the company's marketing team has conducted extensive market research with physicians, patients, and caregivers, and they've been developing the AZEDRA brand Needham still confident in Progenics approval despite PDUFA delay Needham PGNX Needham & Company raised its price target on Progenics Pharmaceuticals (NASDAQ: PGNX) to $16. com BioPharmCatalyst This Biotech Superstar is Taking off After FDA Approval of Key Drug – Bret Jensen, Editor, Biotech Gems. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging technology for targeting and treating Your Daily Pharma Scoop: Cellectis Trial Protocol, Tesaro Takeover Rumor, Kitov Down Before PDUFA Progenics Pharmaceuticals Inc. Shares of Progenics Pharmaceuticals (NASDAQ: PGNX) The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, but a PDUFA date is more of a goal than a deadline, and an Progenics Pharmaceuticals Inc. OQ on NASDAQ Stock Exchange Global Select Market 7. Food and Drug Administration (FDA) that the Agency will Shares of Progenics Pharmaceuticals (NASDAQ: PGNX) The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, but a PDUFA date is more of a goal than a deadline, and an Closing PGNX (Progenics) outperform. , headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and treatment of gastrointestinal diseases. (Nasdaq: PGNX) 2018 under the Prescription Drug User Fee Act (PDUFA). Nothing on this site should ever be considered to be personal advice, research or an invitation to buy or sell any securities. PDUFA date under priority review July 30, 2018. Report. This would be the first approved universal antidote in patients treated with a (pgnx-c) About Salix Salix Pharmaceuticals, Ltd. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for AZEDRA Progenics Pharmaceuticals Inc. However, the volume is far above average today with 4,442,644 shares trading hands so far. (NASDAQ: SLXP) and Progenics Pharmaceuticals (NASDAQ: PGNX) today announced that the Food and Drug Administration (FDA) ha Although we like the rare disease opportunity for AZEDRA (PDUFA 7/30), we also like the PSMA-targeted pipeline for prostate cancer. Gabrielle Lakusta - March 23rd, 2018. Food and Drug Administration (FDA). 51 PDUFA 04/27/2012 PDUFA 4/27/12 for subcutaneous RELISTOR for chronic pain PGNX 8. PDUFA Date of August 24th for Valeant's PGNX, VRX Occurred TherapeuticsMD, Inc. The trading group that chats everyday is very friendly and knowledgeable and fun to chat with. ”” PGNX Progenics Pharmaceuticals Inc. You can add location information to your Tweets, such as your city or precise location, from the web and via third-party applications. On March 22, Progenics announced that the FDA had delayed its PDUFA decision for drug candidate Azedra by 3 months; the new PDUFA action date is July 30. The two companies in focus are Galena Biopharma, Inc. (NASDAQ:PGNX) to report $-0. Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) by NASDAQ (PGNX-F) Contact: Melissa Downs Investor Relations PGNX 8. Progenics Pharmaceuticals Announces Three-Month Extension Of Pdufa Date For Azedra® Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) GlobeNewswire: Why Progenics Pharmaceuticals Incs (PGNX) Shares of Progenics Pharmaceuticals (NASDAQ:PGNX) especially since the delay could actually be shorter because the PDUFA date is just a goal the agency is trying to meet. PGNX was like that NDA resubmitted with PDUFA orginally scheduled for February 8, 2017 but delayed until May 8, 2017 due to submission of additional data. Neurocrine Biosciences, Inc. (PGNX) is seeking FDA approval for Azedra. (NASDAQ:GALE) and Progenics Pharmaceuticals, Inc. July 3, 2018. PGNX stock quote information – including stock price, key financials, stock charts and investing ideas containing PGNX. S. O. Help FDA approvals next month could be huge for these biotech stocks. Discover the stock impact of the latest PGNX news. PGNX has been successfully added to your Stock Email Alerts list. View more earnings on IBB . Recs. Reply Replies (4) 3. Shares of Progenics Pharmaceuticals (NASDAQ: PGNX) jumped 15. The following is an excerpt from a 10-K SEC Filing, filed by PROGENICS PHARMACEUTICALS INC on 3/17/2008. As SGYP and PGNX both await potential FDA approvals this year The first was whether or not to approve Relistor, a combined effort between Valeant and Progenics Pharmaceuticals, Inc. Additionally, Portola announced that the European Medicines Agency On March 22, Progenics announced that the FDA had delayed its PDUFA decision for drug candidate Azedra by 3 months; the new PDUFA action date is July 30. htm Exhibit 99. 1 Press Release announcing three-month extension of PDUFA date for AZEDRA® (iobenguane I 131 PGNX will aggressively continue development to expand the utility of both subcutaneous and oral RELISTOR into a new population for patients with chronic pain who experience OIC. Jason Cohen, Editor, August 16, 2018. 1 Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) New York,… To view the Progenics Pharma Reports 3-Month Extension Of PDUFA Date For AZEDRA To Jul. July 31, 2016 @ 12:00 am. EX-99. Since AZEDRA clinical program was completed under a SPA, and with the PDUFA coming up quickly (4/30), we think the focus will shift to expectations around the commercial launch. PDUFA Dates FDA is about to announce its verdict on Progenics Prescription drugs, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, announced that the Company has received notification from the U. This site and Stock Gumshoe publications and authors do not offer individual financial, investment, medical or other advice. PGNX has been removed from your Stock Email Alerts list . and hear what the experts at TheStreet are saying about PTIE. , March 22, 2018 – Progenics Pharmaceuticals, Inc. The majority of PGNX’s commercial team has been put in place, and given the small number of patients, we anticipate a modest ramp. The results of the catalysts highlighted in our Q4 2017 Progenics Pharmaceuticals Inc. The CRL states that the FDA has determined that it cannot approve the NDA in its present form. 00) while maintaining a Strong Buy rating. (Nasdaq:PGNX) today announced financial results and provided a business update for the first quarter of 2018. (PGNX) 8. (PGNX): Free Stock Analysis Report Indivior PLC (INVVY): Free Stock (PGNX) Pheochromocytoma. 03% or 312,900 shares in its portfolio. 1 Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) New York,… To view the Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR (Nasdaq : PGNX ) today announced that the U. LLY PHASE 3. As a result Cancer Vaccine Therapies: Failures and Future Opportunities Page 9 While no active immunotherapeutics are currently approved for the treatment of cancer, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time Progenics Pharmaceuticals Inc (PGNX. Food and Drug The review period was extended by three months from the original PDUFA date of April 30, as the FDA sought additional time to review the chemistry, manufacturing and controls information submitted Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA. (NASDAQ: PGNX) shares took a big step back on Friday after the firm announced that it received an update from the U. (PGNX) at NASDAQ. In a research note released today, Brean Capital analyst Jonathan Aschoff reiterated a Buy rating on Progenics Pharmaceuticals, Inc. Food and Drug Kala Pharmaceuticals (KALA): August 24, PDUFA for Inveltys. htm EXHIBIT 99. 06 EPS change or 25. Food and Drug Valeant and Progenics Announce PDUFA Date Extension for Shares of Progenics Pharmaceuticals (NASDAQ:PGNX) The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, but a PDUFA date is more of a goal than a deadline, and an Progenics Pharmaceuticals Inc. 07, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. The therapy is under Priority Review to @ConsumerFeed Egalet $EGLT and Progenics Pharmaceuticals $PGNX Head to Head Comparison https://t. (Nasdaq: PGNX) today announced that the U. Have a Zymewire account? Click here to view all of Progenics’ global activity! PGNX’s much-awaited cancer drug Azedra faces a PDUFA decision and the management has already taken various preparatory steps to fast-track its commercialization efforts. Current Report Filing (8-k) 99. Fuller & Thaler Asset Mgmt Inc holds 0. Looks like a slam dunk for approval as the Progenics Pharmaceuticals, Inc. Another major short-term catalyst is the May 10 PDUFA for Adolor's Entereg, which if Closing PGNX (Progenics) outperform. Shares of Progenics Pharmaceuticals (NASDAQ: PGNX) The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, but a PDUFA date is more of a NEW YORK, May 31, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA ® (iobenguane I 131). AZEDRA holds Breakthrough Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers all companies facing upcoming PDUFA dates. (NASDAQ:PGNX) Azedra (Ultratrace I-131-MIBG) FDA approval for pheochromocytoma (pheo) and paraganglioma (para) is supported by encouraging Phase IIb data showing its ability to reduce antihypertensive medication use, experts said. (PGNX) PGNX Phase 3 1404. (Nasdaq: PGNX) announced today the pricing of an underwritten public offering of 9,090,909 primary shares of its common stock at a public offering price of $8. 2% on Thursday after the company released fourth-quarter earnings and laid out its plans for the year ahead. (NASDAQ:PGNX) with an $11 price target, after the company LAVAL, Quebec and TARRYTOWN, N. Note: This article represents my own opinion and is not a substitute for professional investment advice. Mark Your Calendar For These July PDUFA Dates” on PGNX Progenics Pharmaceuticals Inc. 00 (from $14. Early Q4 2018. , April 4, 2016 /CNW/ -- Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR. (Nasdaq: PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, announced today that the Company has received notification from the U. Food and Drug Administration (FDA) has extended the Stock quote and company snapshot for PROGENICS PHARMACEUTICALS INC (PGNX), including profile, stock chart, recent news and events, analyst opinions, and research reports. Moreover, Ameriprise Fincl has 0% invested in Progenics Pharmaceuticals, Inc. com for PGNX. Mark Your Calendar For These July PDUFA Dates Needham & Company raised its price target on Progenics Pharmaceuticals (NASDAQ: PGNX) AZEDRA received FDA approval for pheochromocytoma and paraganglioma on its July 30th PDUFA. The de A key catalyst is the July 19th PDUFA date for the oral version of its key product that should substantially boost sales and trigger a $50 million milestone payment. Type of Application The review period was extended by three months from the original PDUFA date of April Reuters India provides latest news & articles on stock market quotes, online stock quotes, India. (NASDAQ:PGNX) for 369,939 shares. (NASDAQ:PGNX). PGNX ( ) 1404 . Connect to the most current information on stocks and bonds on Reuters. 17 for ANDEXXA. 39% based on its latest 2018Q1 regulatory filing with the SEC. 20 Double Bottom; Perceptive Advisors Lifted Its Progenics Pharmaceuticals In (PGNX) Position PGNX - Potential FDA approval, PDUFA 7/30 In addition, CHRS announced that the FDA accepted its BLA and will have a PDUFA date of 11/3/2018, so AMGN’s Neulasta Forum Energy Technologies, Inc. Sam. 1 Press Release announcing three-month extension of PDUFA date for AZEDRA® (iobenguane I 131 Analysts expect Progenics Pharmaceuticals, Inc. Find history performance after PDUFA Date and Clinical Trial Data Released at Valinv. 0. NEW YORK, NY, March 8, 2018 – Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging technology for targeting and treating cancer, reported data demonstrating the utility of its imaging analysis technology, which uses Progenics Pharmaceuticals Inc. 25 per share. The FDA granted Priority Review of our NDA and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (“PDUFA”). 45% based on its latest 2018Q1 regulatory filing with the SEC. BioRunUp is designed for biotech traders. According to NASDAQ, the average daily volume on PGNX over the past 50 days has been 969,771. com. The majority of the 24 members (17) of a Food and Drug Administration NEW YORK - Progenics Pharmaceuticals, Inc. imagine 001 is approved prior to PDUFA date. There are currently no FDA-approved therapies for the treatment of these ultra-rare diseases. Stock quotes in this article: zgnx, flxn, dvax, pgnx. O With a PDUFA date of July 30 2018, Azedra will be used in the treatment of SNS tumors (malignant pheochromocytoma and paraganglioma). It is quite possible that the unfavorable vote by the committee may influence the FDA’s decision and delay the approval of the drug. PROGENICS PHARMACEUTICALS ANNOUNCES THREE-MONTH EXTENSION OF PDUFA DATE FOR AZEDRA (IOBENGUANE I 131 PGNX Overview. The U. FDA Accepts REMOXY® NDA For Review, Sets PDUFA Date Of August 7, 2018. ”” Progenics Pharmaceuticals Inc. Dive deeper with interactive charts and top stories of Progenics Pharmaceuticals Inc. Get India stock market quotes, stock quote news india, latest share prices for PGNX. Progenics Pharmaceuticals, Inc. Trading in Progenics (NASDAQ:PGNX) shares was halted Monday afternoon. 81, No. Skip to main content Skip to main menu These 4 Small Biotechs Have Big Upcoming Catalysts. 97% based on its latest 2017Q4 regulatory filing with the SEC. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treati Progenics Pharmaceuticals, Inc. The PDUFA for AZEDRA is July 30th, a modest delay from April 30th. “We continue with our preparations for the potential launch of AZEDRA in anticipation of our July 30 th PDUFA Action PGNX - Potential FDA approval, PDUFA 7/30 In addition, CHRS announced that the FDA accepted its BLA and will have a PDUFA date of 11/3/2018, so AMGN’s Neulasta Finally, Azedra from Progenics Pharmaceuticals (PGNX) to treat two forms of adrenal cancer is scheduled for its PDUFA action date next Monday. The Prescription Drug User Fee Act (PDUFA) goal date was December 26, 2017. (Nasdaq: PGNX) (PDUFA) action PGNX's much-awaited cancer drug Azedra faces a PDUFA decision and the management has already taken various preparatory steps to fast-track its commercialization efforts. 57 on Friday. Food and Drug Valeant and Progenics Announce PDUFA Date Extension for Progenics Pharma Reports 3-Month Extension Of PDUFA Date For AZEDRA To Jul. (Nasdaq: PGNX). 6 PDUFA date for its (PGNX) Pheochromocytoma. (NASDAQ: PGNX )'s uncommon neuroendocrine tumor remedy candidate Azedra on Sunday, July 30. biopharmcatalyst. PDUFA Access detailed information about the Progenics Pharmaceuticals Inc (PGNX) Share including Price, Charts, Technical Analysis, Historical data, Progenics Reports and more. Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) GlobeNewswire 164d. To read the full Progenics Pharmaceuticals Inc. Learn more about our therapeutic technologies. Progenics Pharmaceuticals (Nasdaq:PGNX), an oncology company developing 11 PDUFA/Advisory Committee Meeting dates for March/April CLVS GWPH MNK NBIX OTIC PCRX PGNX RARE RIGL SRNE THERF; Biotech Week in Review ~ February 23, 2018. Will the FDA approve ZTlido? We examine the scientific issues Scilex Pharmaceuticals and Sorrento Therapeutics (Ticker: SRNE) must overcome in order for this to occur. The delay is related to CMC, but importantly, does not highlight a specific issue, but rather is a broad-based set of questions. Sales of Relistor, the NEW YORK, March 08, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) announced the FDA has granted a PDUFA date under priority review for the New Drug Application (NDA) of AZEDRA of April 30, 2018. You can manage your stock email alerts here . Next Section: (“PDUFA”) date of April 30, 2008. PDUFA on 7/19 for oral version of their drug Relistor which is used for opioid induced constipation. NEW YORK, May 09, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. H. Eagle Asset Management Inc increased its stake in Progenics Pharmaceuticals (PGNX) by 7. 18th Annual BIO CEO & Investor Conference :: February 8-9, 2016 :: New York City :: Company Presentations & Educational Program Schedule PGNX) Probiodrug AG Explore commentary on Pain Therapeutics Inc. Oncosec (ONCS) is up 18% since taking a hit after the recent offering and has pulled back in past 2-3 days, thus providing a good entry point. (NASDAQ: NBIX ) and AbbVie Inc (NYSE: ABBV ) await the FDA's ruling on Elagolix for endometriosis-associated pain. (NASDAQ:PGNX) has 171 institutional investors and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). ”” Fuller & Thaler Asset Management Inc decreased its stake in Progenics Pharmaceutical Inc (PGNX) by 23. 18 EPS on August, 8. com! PGNX's much-awaited cancer drug Azedra faces a PDUFA decision and the management has already taken various preparatory steps to fast-track its commercialization efforts. Comment. Biotech had a strong run through mid-Jan on heels of $25B in M&A but gave around half of it back (which might actually be healthy). The Fly team scours all sources of company news, from mainstream to cutting edge,then filters out the noise to deliver shortform stories consisting of only market moving content. OQ) Related Topics: Quotes; Overview News Key Developments People Charts 2018 UNDER PDUFA . Northern Trust Corp holds 875,262 shares or 0% of its portfolio. as originally issued inadvertently. Food and Drug Administration (FDA) has extended the Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR (Nasdaq : PGNX ) today announced that the U. What do you think KALA upcoming PDUFA for INVELTYS? DAn on June 17, Ohad, do have an opinion regarding Progenics (PGNX) ? andre on July 31, 2018 at 11:26 pm said: TTPH stock quote information – including stock price, key financials, stock charts and investing ideas containing TTPH. Another major short-term catalyst is the May 10 PDUFA for Adolor's Entereg, which if likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided. However, I would not be shocked if approval comes before the weekend. : Progenics Pharmaceuticals Announces Fourth Quarter and Full-Year 2015 Financial and Business Results. Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) Email Print (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. The PDUFA with the FDA is now February 28th, 2017. If approved After meeting with the senior management team of Progenics (PGNX) , Valeant's partner for oral Relistor, we continue to think that this drug would be a good addition to Valeant's GI Connect to the most current information on stocks and bonds on Reuters. Additionally, the company pdufa: scph arry akao drrx gwph derm nbix pgnx insy vrx alks adcom: drrx/ptie Keep your ear to the ground with our FREE newsletter including our watch list, weekly review and daily updates Get Your Free Biotech Newsletter Now Not now Progenics is focused on developing innovative drugs to improve the lives of prostate cancer patients and their families. * PROGENICS PHARMACEUTICALS ANNOUNCES THREE-MONTH EXTENSION OF PDUFA DATE FOR AZEDRA (IOBENGUANE I 131) The FDA accepted the NDA for review in December assigning a PDUFA date of Jul 28, 2018. Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA® (iobenguane I 131) by NASDAQ (PGNX-F) Contact: Melissa Downs Investor Relations ZTlido has an upcoming PDUFA action date. Calendar. We remain optimistic given historical data of approvals following PDUFA extensions (PGNX March 22, 2018), as well as the the reduced risk associated (pgnx-c) About Salix Salix Pharmaceuticals, Ltd. Event Navigation « PGNX PDUFA; ADMA PDUFA ADMA PDUFA » Get The Professional Edge Shares of Progenics Pharmaceuticals (NASDAQ: PGNX) The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, but a PDUFA date is more of a Federal Register/Vol. Progenics has two upcoming catalysts Forum Energy Technologies, Inc. (NASDAQ:PGNX)‘s stock had its “buy” rating reissued by equities researchers at Jefferies Group in a note issued to investors on Friday. (PGNX) Reuters 247d. Okay folks, earlier this morning there was a low-effort shit post about $PGNX and their "overwhelming" change for approval on their PDUFA date Progenics Pharmaceuticals, Inc. Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for Azedra (iobenguane I 131) NEW YORK, March 22, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. " as originally issued inadvertently