Wed, Nov. 30, 9:19 AM
- An open-label, dose-escalation Phase 1/2 study is underway assessing Incyte's (NASDAQ:INCY) INCAGN1949 in patients with advanced/metastatic solid tumors. The first stage will evaluate safety and tolerability while the second stage will assess the recommended dose.
- According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is December 2018. The estimated study completion date is February 2019.
- INCAGN1949 is a monoclonal antibody that binds to an immune checkpoint receptor called OX40, also known as CD134 or TNFRSF4. It is a co-stimulatory receptor found on activated T cells. Targeting OX40 stimulates the immune response to promote the killing of cancer cells and inhibits the activity of regulatory T cells that mediate immune suppression.
- The product candidate is being co-developed with Agenus (NASDAQ:AGEN).
Fri, Nov. 18, 11:13 AM
- Barron's Ben Levisohn reports that Gilead Sciences (GILD -1.3%) has a range of attractive candidates should it decide to spend some its $32B cash hoard on an acquisition, a virtual certainty after the recent momelotinib disappointment.
- Considering the company's stated interest in oncology, obvious choices are Incyte (INCY -1.1%) and TESARO (TSRO -3%).
- Venturing out into the rare disease space, Alexion Pharmaceuticals (ALXN -1.6%), Vertex Pharmaceuticals (VRTX -1.6%) and BioMarin Pharmaceutical (BMRN -1.1%) are attractive fare.
- None of these companies are a surprise to biotech followers. All have been noted as buyout targets for some time now.
Thu, Nov. 17, 3:07 PM
- Echoing Piper's Josh Schimmer, Leerink's Michael Schmidt also believes Gilead's (GILD -0.8%) stumble with momelotinib makes Incyte (INCY +4.9%) an attractive acquisition target since Gilead's candidate is no longer a potential risk to Jakafi sales, Incyte's top seller. He has an Outperform rating on the stock and has raised the price target to $115 (9% upside) from $101.
Thu, Nov. 17, 9:20 AM
- Gainers: RLOG +121%. SINO +99%. GSL +94%. DCIX +32%. NMM +32%. ESEA +24%. TOPS +22%. WNR +22%. NM +22%. NAO +19%. SB +18%. ANW +17%. PANL +16%. SHIP +12%. NTAP +12%. HAIN +11%. GLBS +11%. UAM +11%. GURE +10%. PLCE +8%. NNA 8%. BBY 8%. INCY 6%. RCON 6%. PLUG 6%. GNK 6%. ENDP 6%.
- Losers: LEI -26%. VUZI -18%. SPP -18%. NVTA -14%. FSLR -12%. ZX -10%. TEGP -10%. SSI -9%. STEM -8%. FOXF -8%. TTMI -7%. PFGC -6%.
Thu, Nov. 17, 8:35 AM
- Leerink Partners analyst Geoffrey Porges believes Incyte (NASDAQ:INCY) is, again, on Gilead Sciences' (NASDAQ:GILD) short list of acquisition targets after momelotinib failed to beat Jakafi in a late-stage study. Gilead is widely known to be looking for an acquisition to boost growth.
- Mr. Porges says the combined company would still overlap in filgotinib and baricitinib but Incyte's passive role in the development and commercialization of baricitinib should not affect filgotinib's prospects very much.
- INCY is up 5% premarket.
Thu, Nov. 17, 8:27 AM| Thu, Nov. 17, 8:27 AM | 5 Comments
Wed, Nov. 16, 4:48 PM
- Two Phase 3 clinical trials, SIMPLIFY-1 and SIMPLIFY-2, assessing Gilead Sciences' (NASDAQ:GILD) Janus kinase (JAK) inhibitor momelotinib compared to ruxolitinib [Incyte's (NASDAQ:INCY) Jakafi] or best alternative therapy (BAT) in patients with myelofibrosis produced different outcomes.
- SIMPLIFY-1 met its primary endpoint of non-inferiority to ruxolitinib for splenic response rate at week 24 (SRR24) defined as the percentage of patients achieving at least a 35% reduction in spleen volume (momelotinib: 26.5%; ruxolitinib: 29.0%; p=0.011).
- SIMPLIFY-2 failed to meet its primary endpoint of superiority compared to BAT in patients previously treated with ruxolitinib as measured by SRR24 (momelotinib: 6.7%; BAT: 5.8%; p=0.90). 88% of the patients randomized to the BAT arm continued to receive ruxolitinib while the remainder received chemo, interferon, corticosteroids, other therapies or a combination thereof.
- Detailed results will be presented at a future scientific conference.
- Shares are down a fraction after hours.
Tue, Nov. 1, 7:44 AM
Tue, Nov. 1, 7:02 AM
Mon, Oct. 31, 5:30 PM
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Fri, Oct. 7, 8:37 AM
- Incyte (NASDAQ:INCY) is up 3% premarket, albeit on only 530 shares, in response to its announcement of updated results from the Phase 1 portion of a Phase 1/2 clinical trial, ECHO-202, assessing the combination of epacadostat and Merck's (NYSE:MRK) Keytruda (pembrolizumab) in treatment-naive advanced/metastatic melanoma patients. The data are being presented at the European Society for Medical Oncology 2016 Congress in Copenhagen.
- The rates of progression-free survival (PFS) in 19 patients treated with the combination were 74% (n=14/19) at Month 6 and 57% (n=11/19) at Month 12. Median PFS has not been reached. The complete response rate (CR) was 26% (n=5/19) while the objective response rate (ORR) and disease control rate (DCR) were 58% (n=11/19) and 74% (n=14/19), respectively. Median follow-up was 56+ weeks (range: 46 - 90+).
- In the total Phase 1 population (n=62), grade 3 (severe) and above treatment-related adverse events (TRAEs) were observed in 19% (n=12/62), the most common being rash (8%) and increased lipase (5%). Five patients (8%) discontinued treatment due to TRAEs. The most common (at least 15%) all-grade TRAEs were fatigue, rash, joint pain, itchy skin, diarrhea and nausea.
- 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.
- Enrollment in the Phase 2 portion is ongoing.
Fri, Sep. 30, 8:05 AM
- Resmed (NYSE:RMD) upgraded to Buy from Neutral by Bank of America. Price target raised to $89.00 (39% upside) from $71.50.
- Incyte (NASDAQ:INCY) upgraded to Outperform from Market Perform by Raymond James.
- Eli Lilly (NYSE:LLY) upgraded to Buy from Neutral by Goldman Sachs. Price target raised to $95 (19% upside) from $89.
- Impax Laboratories (NASDAQ:IPXL) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $26 (10% upside) from $25.
- Hologic (NASDAQ:HOLX) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $44 (15% upside) from $42.
- BioDelivery Sciences International (NASDAQ:BDSI) upgraded to Buy from Neutral by Janney Montgomery Scott. Price target raised to $4.00 (47% upside) from $2.45.
- Galectin Therapeutics (NASDAQ:GALT) downgraded to Neutral from Buy by H.C. Wainwright. Price target lowered to $1.50 (23% upside) from $8.00. Downgraded to Sell from Buy by Roth Capital. Price target lowered to $0.75 (39% downside risk) from $3.00.
- Gilead Sciences (NASDAQ:GILD) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $94 (21% upside) from $112.
- Mirna Therapeutics (NASDAQ:MIRN) downgraded to Neutral from Buy by H.C. Wainwright. Price target lowered to $2 (4% upside) from $6.
Fri, Aug. 12, 7:06 AM
- Ocular Therapeutix (NASDAQ:OCUL) initiated with Outperform rating with a $21 (233% upside) price target by JMP Securities.
- Nevro (NYSE:NVRO) initiated with Buy rating and $100 price target (3% upside) by Bank of America Merrill Lynch.
- Incyte (NASDAQ:INCY) initiated with Buy rating and $105 (29% upside) price target by SunTrust Robinson Humphrey.
Tue, Aug. 9, 10:31 AM
- Incyte (INCY) Q2 results: Revenues: $246.3M (+51.1%); R&D Expense: $120.3M (+7.0%); SG&A: $66.8M (+29.2%); Operating Income: $44.6M; Net Income: $34.4M (+269.9%); EPS: $0.18 (+260.0%); Quick Assets: $629.2M (-11.1%).
- 2016 Guidance: Jakafi Sales: $825M - 835M from $815M - 830M; Iclusig net product revenues: $25M - 30M (unch).
Tue, Aug. 9, 7:02 AM
Mon, Aug. 8, 5:30 PM
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