Fri, Jul. 29, 8:02 AM
Mon, Jul. 25, 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.
Wed, Jun. 8, 11:00 AM
Fri, May 13, 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).
Tue, May 10, 12:47 PM
Tue, May 10, 9:16 AM
Mon, May 9, 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.
Mon, May 9, 5:40 PM
Fri, Apr. 29, 10:00 AM| Fri, Apr. 29, 10:00 AM | 1 Comment
Fri, Apr. 29, 8:04 AM
Mon, Apr. 25, 10:33 AM
- The U.S. Department of Health and Human Services' (HHS) Biomedical Advanced Research and Development Authority (BARDA) exercises its option to continue funding the development of NewLink Genetics' (NLNK +0.7%) Ebola vaccine candidate, rVSV-ZEBOV-GP. Its decision frees up an additional $21.6M to support clinical bridging studies to further assess the vaccine's safety and immunogenicity in different populations from the original testing region.
- To date, NewLink has received ~$53M in BARDA funding. The option exercise extends the performance period until October 11, 2017.
Mon, Feb. 29, 10:05 AM
- NewLink Genetics (NLNK +5.5%) Q4 results: Revenues: $7.7M (-95.4%); R&D Expense: $14.8M (+24.4%); SG&A: $7.7M (-7.2%); Operating Loss: ($14.8M) (-109.9%); Net Loss: ($21.6M) (-118.0%); Loss Per Share: ($0.75) (-119.6%).
- FY2015 results: Revenues: $68.5M (-60.3%); R&D Expense: $71.4M (+100.0%); SG&A: $30.7M (+59.1%); Operating Loss: ($33.6M) (-128.6%); Net Loss: ($40.4M) (-142.1%); Loss Per Share: ($1.41) (-145.6%); Quick Assets: $197.8M (-2.5%).
- No guidance given.
Mon, Feb. 29, 8:04 AM
- NewLink Genetics (NASDAQ:NLNK): Q4 EPS of -$0.75 beats by $0.17.
- Revenue of $6.06M (+83.6% Y/Y) beats by $1.17M.
- Shares +4.95% PM.
Wed, Feb. 17, 10:07 AM
- Micro cap Inovio Pharmaceuticals (INO +4%) is up in early trading on increased volume in response to its announcement of positive preclinical data for its Zika virus vaccine candidate. In the study, DNA constructs, synthetically generated with the company's SynCon vaccine technology, targeting multiple Zika virus antigens and administered using its CELLECTRA electroporation delivery technology induced robust and durable immune responses. Phase 1 testing is expected to commence before year end.
- Investors seeking to profit from a Zika-stoked up move need to be patient. Regulatory clearance for a vaccine, even with accelerated review, is probably two years away. Drugs to treat infection are further away still.
- Intrexon (XON +6.4%) has seen some recent bullish action (shares doubled from mid-January to early February) in apparent anticipation of the revenue potential of its genetically modified sterile male mosquitoes, OX513A, that produced a 95% reduction in the Aedes aegypti population, the type of mosquito that transmits Zika and Dengue, in a small study in northeast Brazil. Here, again, sobriety is key. The beneficial effects are only temporary (unless the sterile guys are repeatedly released over a wide area, a tall order since mosquitoes only travel ~200 yards so covering a large area would require substantial human and physical resources). Intrexon's pricing leverage will also be constrained because irradiated sterile mosquitoes perform just as effectively and they will be available free-of-charge. Both techniques have similar cost structures, about $400/1M mosquitoes.
- Zika Index: (XON +6.4%)(INO +5.9%)(CERS +1%)(SNY +0.8%)(NLNK -1.8%)
Wed, Feb. 3, 2:24 AM
- The first known case of Zika virus transmission in the U.S. has been reported by the Centers for Disease Control and Prevention, which confirmed it was contracted through sex and not a mosquito bite.
- Zika had been thought to be spread only by mosquitoes of the Aedes genus, so sexual contact as a mode of transmission would be a potentially alarming development.
- Sanofi (NYSE:SNY) and NewLink Genetics (NASDAQ:NLNK) have both recently announced project launches to develop a vaccine against the disease.
- Previously: WHO declares Zika virus a public health emergency (Feb. 02 2016)
- Update: The New York Times reports that there have been only three reports related to possible sexual transmission: one in 2008, one in 2013 and one recently. The first two cases were men who had genital pain and blood in their semen, pointing to possible infection in the testes or prostate. Details about the third case were not available. The CDC has issued tentative guidelines suggesting pregnant women avoid contact with semen from men who have been in Zika-associated areas and men to wear condoms. Very little is known about this potential route of Zika transmission. Also, the cases of microcephaly in babies born to Zika-infected mothers may be due to other factors. The evidence at present is circumstantial.
Fri, Jan. 22, 4:49 PM
- Results from a Phase 1b/2 clinical trial assessing NewLink Genetics' (NASDAQ:NLNK) indoximod plus gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer showed encouraging durable responses with a delayed pattern and a 42% objective response rate (ORR), including one complete response. The data will be presented today at the 2016 Gastrointestinal Cancers Symposium in San Francisco.
- The results were generated from 12 evaluable patients out of 50 enrolled to date. The target enrollment in the Phase 2 portion is 80. The ORR was 42% (n=5/12) with one complete responder. The small n notwithstanding, this handily beat the 23% ORR in the IMPACT study which established gemcitabine/nab-paclitaxel as the standard of care for metastatic pancreatic cancer.
- Indoximod is an orally available small molecule that inhibits an enzyme called indoleamine 2,3-dioxygenase (IDO), a central regulator of local and systemic immunosuppression that allows tumors to avoid the body's immune response.
- Pancreatic cancer is one of the most resistant to treatment. The one-year survival rate is only 20%, falling to 6% at five years.
- Shares are up 3% after hours on modest volume.
NewLink Genetics Corp. is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Its portfolio includes biologic and small molecule immunotherapy product candidates... More
Country: United States