reports
Lumos Pharma Appoints Joseph S. McCracken, DVM, MS to Board of Directo...
Lumos Pharma Appoints Joseph S. McCracken, DVM, MS to Board of Directors Rick Hawkins, CEO, appointed Chairman of the Board AUSTIN, Texas, March 30, 2020 (GLOBE NEWSWIRE) -- (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, has announced the appointment of Joseph S. McCracken, DVM, MS to the company's Board of Directors, effective March 23, 2020. Dr. McCracken has extensive experience in the pharmaceutical and biotechnology industry, with prominent roles in business development, commercial development, and positions as board member for s...
NewLink Genetics Stockholders Approve Merger with Lumos Pharma
NewLink Genetics Stockholders Approve Merger with Lumos Pharma - Combined company, Lumos Pharma, Inc., to trade on Nasdaq under the stock symbol “LUMO” - Phase 2b trial expected to be initiated mid-2020 evaluating oral therapeutic candidate LUM-201 (ibutamoren) in Pediatric Growth Hormone Deficiency (PGHD) - Projected combined cash on March 31, 2020 in excess of $80 million expected to be sufficient to fund company through Phase 2b trial in PGHD data read-out AUSTIN, Texas and AMES, Iowa, March 18, 2020 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (Lumos Pharma) and NewLink Genetics Corpora...
NewLink Genetics Reports Fourth Quarter and Full Year 2019 Financial R...
NewLink Genetics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update Special Meeting of Stockholders set for March 17, 2020 for vote on proposed merger of NewLink Genetics and Lumos Pharma AMES, Iowa, Feb. 28, 2020 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced financial results for the fourth quarter and full year ended December 31, 2019, and provided an update on corporate activities. “We continue to focus our work toward the anticipated completion of our proposed merger with Lumos Pharma,” stated Carl Langren, Chief Financial Officer, and me...
NEWLINK GENETICS CORP. suffers a double requalification, which weighs ...
The independent financial analyst theScreener just downgraded the general evaluation of NEWLINK GENETICS CORP. (US), active in the Biotechnology industry. As regards its fundamental valuation, the title loses a star(s) and now shows 0 out of 4 stars. Its market behaviour is also negatively reassessed and may be considered as risky. theScreener believes that this double requalification keeps the title under pressure and justifies an overall rating downgrade to Negative. As of the analysis date Ja...
NewLink Genetics Announces Exclusive Worldwide License Agreement with ...
NewLink Genetics Announces Exclusive Worldwide License Agreement with Ellipses Pharma for Development of and Rights to Commercialization of NLG207 AMES, Iowa, Dec. 23, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) announced today that the company has entered into an exclusive worldwide license agreement with Ellipses Pharma Limited (Ellipses) for the development of and rights to commercialize NLG207 (formerly CRLX101), a nanoparticle formulation of the topoisomerase 1 inhibitor camptothecin. This license agreement signed by NewLink Genetics and Ellipses is effective as of December 17, 2019. Und...
NewLink Genetics Announces FDA Approval of Ebola Vaccine V920 (ERVEBOÂ...
NewLink Genetics Announces FDA Approval of Ebola Vaccine V920 (ERVEBO®) AMES, Iowa, Dec. 20, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) announced today that, after priority review, the , or Zaire Ebola virus vaccine V920 (rVSV∆G-ZEBOV-GP), as confirmed by our partner, (NYSE:MRK), known as MSD outside the US and Canada. This represents the first vaccine approved by the FDA for the Ebola virus and follows the November 11th grant by the European Commission (EC) of a across 31 European countries. Yesterday’s approval comes almost three months prior to the Prescription Drug User Fee Act (PDUF...
NewLink Genetics Responds to Proposal from Evercel
NewLink Genetics Responds to Proposal from Evercel Board Continues to Believe that Planned Lumos Merger Agreement is in the Best Interests of NewLink Stockholders AMES, Iowa, Dec. 16, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) (“NewLink” or the “Company”) today publicly announced its rejection of the unsolicited acquisition proposal received on November 5, 2019 from Evercel, Inc. (“Evercel”) (OTC:EVRC), a holding company with a primary operating business selling line matrix printers and accessories. The NewLink Board of Directors (the “Board”), consistent with its fiduciary duties and in ...
NewLink Genetics Announces European Commission Grant of Conditional Ma...
NewLink Genetics Announces European Commission Grant of Conditional Marketing Approval for Ebola Vaccine V920 (ERVEBO®) AMES, Iowa, Nov. 12, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) announced that Monday, November 11th, the European Commission (EC) granted , as confirmed by our partner, (NYSE:MRK), known as MSD outside the US and Canada. With this approval, the EC will grant a centralized marketing authorization for the vaccine with unified labeling that is valid in 31 European countries. The granting of this approval by the EC follows the September 17th announcement by the FDA that it ....
NewLink Genetics Reports Third Quarter 2019 Financial Results and Prov...
NewLink Genetics Reports Third Quarter 2019 Financial Results and Provides Corporate Update Management to host conference call today at 8:30 a.m. ET AMES, Iowa, Nov. 06, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced financial results for the third quarter ended September 30, 2019 and provided an update on corporate activities. “We are excited about the proposed merger with Lumos Pharma that we announced at the close of the third quarter and continue to advance the process required to close the transaction,” commented Brad Powers, General Counsel and member of NewLink’s Office...
NewLink Genetics to Host Its Third Quarter 2019 Conference Call on Nov...
NewLink Genetics to Host Its Third Quarter 2019 Conference Call on November 6, 2019 AMES, Iowa, Oct. 30, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced it will host its third quarter 2019 conference call and webcast at 8:30 AM ET on Wednesday, November 6, 2019, to discuss its third quarter financial results and provide an update on corporate activities. There will also be a question and answer session following the prepared remarks. Investors and the general public are invited to listen to a live audio webcast of the conference call, which can be accessed five minutes prio...
NewLink Genetics Announces EU Regulatory Committee (CHMP) Recommendati...
NewLink Genetics Announces EU Regulatory Committee (CHMP) Recommendation for Conditional Marketing Authorization for Ebola Vaccine V920 (ERVEBO®) AMES, Iowa, Oct. 21, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) announced today that Friday, October 18th, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use , as confirmed by our partner, (NYSE:MRK). This Committee recommendation will now be reviewed by the European Commission (EC) which, if it chooses to affirm the CHMP’s recommendation, will grant a centralized marketing authorization of the vaccine (brand name E...
NewLink Genetics and Lumos Pharma Enter into Merger Agreement to Form ...
NewLink Genetics and Lumos Pharma Enter into Merger Agreement to Form Biopharmaceutical Company Focused on Developing Therapies to Treat Rare Diseases -- Combined company to assume the name, Lumos Pharma, Inc. and is expected to be led by Richard J. Hawkins, current CEO of Lumos Pharma -- -- Lumos asset, LUM-201, represents first oral therapeutic candidate for pediatric growth hormone deficiency (PGHD) with planned Phase 2b expected to begin in mid-2020 -- -- Lumos Pharma stockholders, including Deerfield Management, a fund managed by Blackstone Life Sciences, Roche Venture Fund, New Ente...
NewLink Genetics Announces FDA Accepts Partnered Biologics License App...
NewLink Genetics Announces FDA Accepts Partnered Biologics License Application (BLA) and Grants Priority Review for Ebola Vaccine V920 (rVSV∆G-ZEBOV-GP) AMES, Iowa, Sept. 17, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced that the U.S. Food and Drug Administration (FDA) for the prevention of disease caused by the Ebola Zaire virus. Merck’s rolling submission was made pursuant to the FDA’s Breakthrough Therapy Designation for V920, a designation awarded to our partner, Merck, in July 2016. The Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 202...
NewLink Genetics Provides Corporate Update and Reports Second Quarter ...
NewLink Genetics Provides Corporate Update and Reports Second Quarter 2019 Financial Results Announces management transition; Charles J. Link Jr, M.D. to retire as CEO and Chairman of the Board AMES, Iowa, July 30, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) (“NewLink Genetics” or the “Company”) today announced financial results for the second quarter ended June 30, 2019 and provided an update on clinical and corporate developments, including a transition of management. Charles J. Link, Jr, M.D. has chosen to retire from his posts as Chairman, Chief Executive Officer and Chief Scientific Of...
NewLink Genetics Presents Updated NLG802 Results at the Immuno-Oncolog...
NewLink Genetics Presents Updated NLG802 Results at the Immuno-Oncology 2019 World Congress NLG802, a prodrug of indoximod, produced significantly higher pharmacokinetic (PK) exposure in patients compared to molar equivalent of indoximod while maintaining encouraging safety profileNotable response in 5th line pancreatic cancer patient re-challenged with chemotherapy after NLG802 treatment ended AMES, Iowa, May 23, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced the , “A Phase 1 Clinical Trial of NLG802, a Prodrug of Indoximod with Enhanced Pharmacokinetic Properties,” was presen...
NewLink Genetics Reports First Quarter 2019 Financial Results and Prov...
NewLink Genetics Reports First Quarter 2019 Financial Results and Provides Clinical Activities Update - Management to host conference call today at 4:30 p.m. ET AMES, Iowa, May 08, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced financial results for the first quarter ended March 31, 2019 and provided an update on clinical activities. “We continued to make progress across our clinical programs this year. We look forward to presenting additional encouraging data later this month on NLG802. We were also pleased to present Phase 2 results for NLG207 in combination with weekly p...
NewLink Genetics to Participate in Upcoming Investor and Medical Confe...
NewLink Genetics to Participate in Upcoming Investor and Medical Conferences AMES, Iowa, May 06, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) announced today that the company will participate in the following investor and medical conferences: Bank of America Merrill Lynch Global Health Care Conference 2019 on May 14-16 in Las Vegas Management will present on Thursday, May 16 at 8:40 AM PT / 11:40 AM ET Immuno-Oncology 2019 World Congress on May 23-24 in Barcelona, Spain Poster presentation of Abstract #188 entitled, “A Phase 1 Clinical Trial of NLG802, a Prodrug of Indoximod with Enhance...
NewLink Genetics to Host Its First Quarter 2019 Conference Call on May...
NewLink Genetics to Host Its First Quarter 2019 Conference Call on May 8, 2019 AMES, Iowa, April 24, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced it will host its first quarter 2019 conference call and webcast at 4:30 PM ET on Wednesday, May 8, 2019, to discuss its first quarter financial results and provide an update of its clinical development activities. There will also be a question and answer session following the prepared remarks. Investors and the general public are invited to listen to a live audio webcast of the conference call, which can be accessed five minutes prio...
NewLink Genetics Presents Encouraging Phase 2 Results for NLG207 in Ov...
NewLink Genetics Presents Encouraging Phase 2 Results for NLG207 in Ovarian Cancer at AACR 2019 AMES, Iowa, April 02, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced results from a Phase 2 study of NLG207, a nanoparticle formulation of the topoisomerase 1 inhibitor camptothecin, conducted in conjunction with The GOG Foundation, Inc. (GOG-3008), in patients with refractory ovarian cancer. The data were presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2019 in Atlanta, Georgia. "We are encouraged by the responses observed in this P...
NewLink Genetics Announces Clinical Trial Abstract Presentation at AAC...
NewLink Genetics Announces Clinical Trial Abstract Presentation at AACR Annual Meeting AMES, Iowa, Feb. 27, 2019 (GLOBE NEWSWIRE) -- (NASDAQ:NLNK) today announced that a late-breaking abstract reporting results from a Phase 2 study of NLG207, a nanoparticle formulation of the topoisomerase 1 inhibitor, camptothecin, has been accepted for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019 being held at the Georgia World Congress Center, March 29 - April 3, in Atlanta, Georgia. Abstract 7933 (Poster 17) entitled, A phase II study of NLG207 (form...
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