• Mon, Jan. 9, 12:47 PM
    Mon, Jan. 9, 12:47 PM | 22 Comments
  • Mon, Jan. 9, 11:38 AM
    • Incyte (INCY +6.7%) and Merck (MRK +0.4%) expand their collaboration investigating the combination of epacadostat and Keytruda (pembrolizumab) in solid tumors and blood cancers. The companies now plan to initiate pivotal studies in four additional tumor types: non-small cell lung cancer, renal cell carcinoma, bladder cancer and squamous cell carcinoma.
    • Epacadostat is a small molecule inhibitor of IDO1, an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation thereby allowing cancer cells to avoid detection by the immune system. Pembrolizumab helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
    • The good news has apparently spread to NewLink Genetics (NLNK +17.1%) who inked a development deal in October 2014 with Roche's (OTCQX:RHHBY) Genentech for IDO candidate GDC-0919.
    • #JPM17
    Mon, Jan. 9, 11:38 AM
  • Mon, Jan. 9, 11:03 AM
    Mon, Jan. 9, 11:03 AM | 10 Comments
  • Dec. 23, 2016, 11:56 AM
    • Thinly traded micro cap NewLink Genetics (NLNK +8%) perks up on increased volume in response to a Bloomberg report that its experimental Ebola vaccine, rVSV-ZEBOV, licensed to Merck (MRK +0.2%) in 2014, showed promising efficacy in an 11,000-person study in Guinea. The results were just published in The Lancet.
    • Of the people who received the vaccine (one shot) in the final stage of the trial, no cases of Ebola were recorded after a 10-day incubation period. An earlier study showed rVSV-ZEBOV to be 100% effective in people who were in close contact with Ebola patients in Guinea.
    • The vaccine candidate has Breakthrough Therapy status in the U.S. which is designed to accelerate the regulatory review process.
    • The Ebola outbreak from 2013 - 2016 in West Africa claimed 11,300 lives before exhausting itself.
    Dec. 23, 2016, 11:56 AM | 8 Comments
  • Nov. 1, 2016, 8:33 AM
    • NewLink Genetics (NLNK) Q3 results: Revenues: $15.3M (+7.7%); Operating Loss: ($16.9M) (-7.6%); Net Loss: ($15.5M) (+2.5%); Loss Per Share: ($0.54) (+1.8%); Quick Assets: $148.3M (-25.0%).
    • Financial Guidance: Cash and equivalents: ~$132M on December 31, 2016.
    Nov. 1, 2016, 8:33 AM
  • Nov. 1, 2016, 8:01 AM
    • NewLink Genetics (NASDAQ:NLNK): Q3 EPS of -$0.54 beats by $0.06.
    • Revenue of $15.35M (+8.0% Y/Y) beats by $11.52M.
    • Press Release
    Nov. 1, 2016, 8:01 AM | 1 Comment
  • Jul. 29, 2016, 8:02 AM
    • NewLink Genetics (NASDAQ:NLNK): Q2 EPS of -$1.12 misses by $0.35.
    • Revenue of $2.01M (-73.0% Y/Y) misses by $3.4M.
    Jul. 29, 2016, 8:02 AM | 1 Comment
  • Jul. 25, 2016, 9:43 AM
    • Merck (MRK -0.4%) announces that its experimental Ebola vaccine, V920 (rVSVdeltaG-ZEBOV-GP, live attenuation) has received accelerated review status in the U.S. and EU.
    • The FDA has tagged V920 a Breakthrough Therapy which provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
    • The European Medicines Agency (EMA) has granted PRIME status to V920 which provides early and proactive support from the regulator, including the appointment of a liaison called a rapporteur, with the aim of optimizing clinical trial design as well as accelerated review of the Marketing Authorization Application (MAA).
    • Merck licensed V920 from NewLink Genetics (NLNK +1.6%) in late 2014.
    Jul. 25, 2016, 9:43 AM | 1 Comment
  • Jun. 8, 2016, 11:00 AM
    Jun. 8, 2016, 11:00 AM
  • May 13, 2016, 11:51 AM
    • ConforMIS (CFMS -51%) downgraded to Neutral from Overweight by JP Morgan. Price target lowered to $8 (62% upside) from $18.
    • Johnson & Johnson (JNJ -0.5%) downgraded to Neutral from Buy by BTIG Research.
    • EPIRUS Biopharmaceuticals (EPRS +2.2%) downgraded to Neutral from Buy by BTIG Research.
    • BioDelivery Sciences (BDSI -1%) downgraded to Hold from Buy by Canto Fitzgerald. Price target lowered to $5 (150% upside) from $9.
    • NewLink Genetics (NLNK +7.6%) downgraded to Neutral from Buy by SunTrust Robinson Humphrey. Price target lowered to $12 (15% upside) from $59.
    • St. Jude Medical (STJ +0.3%) downgraded to Equal Weight from Overweight by Barclays. Price target raised to $80 (5% upside) from $74.
    • Zoetis (ZTS +0.3%) downgraded to Sell from Neutral by Goldman Sachs. Price target raised to $48 (4% upside) from $46.
    • Cogentix Medical (CGNT +9.1%) downgraded to Neutral from Buy by Roth Capital. Price target is $1.15 (25% upside).
    May 13, 2016, 11:51 AM | 9 Comments
  • May 10, 2016, 12:47 PM
    May 10, 2016, 12:47 PM
  • May 10, 2016, 9:16 AM
    May 10, 2016, 9:16 AM | 1 Comment
  • May 9, 2016, 6:43 PM
    • NewLink Genetics (NASDAQ:NLNK) -32.1% AH after announcing that its investigational immunotherapy for resected pancreatic cancer did not achieve its primary endpoint.
    • Patients in one part of the study received the investigational immunotherapy called algenpantucel L along with a standard-of-care treatment, compared with the traditional treatment alone; NLNK says there was no statistical difference between the two groups for overall survival time or for long-term survival.
    • Algenpantucel-L was NLNK’s most advanced clinical program using the company’s HyperAcute Cellular Immunotherapy platform.
    May 9, 2016, 6:43 PM | 10 Comments
  • May 9, 2016, 5:40 PM
    May 9, 2016, 5:40 PM | 3 Comments
  • Apr. 29, 2016, 10:00 AM
    • NewLink Genetics (NLNK +6.2%) Q1 results: Revenues: $5.7M (-85.5%); R&D Expense: $21.9M (+21.7%); SG&A: $9.2M (+9.5%); Operating Loss: ($25.4M) (-298.4%); Net Loss: ($23.7M) (-311.6%); Loss Per Share: ($0.82) (-334.3%); Quick Assets: $178M (-10.0%).
    • No guidance given.
    Apr. 29, 2016, 10:00 AM | 1 Comment
  • Apr. 29, 2016, 8:04 AM
    • NewLink Genetics (NASDAQ:NLNK): Q1 EPS of -$0.82 beats by $0.88.
    • Revenue of $5.71M (-85.4% Y/Y) beats by $3.63M.
    Apr. 29, 2016, 8:04 AM | 6 Comments