Vertex Pharmaceuticals IncorporatedNASDAQ
Yesterday, 9:02 AM
Tue, Nov. 29, 3:28 PM
- Barclays' Geoff Meacham has downgraded BioMarin Pharmaceutical (BMRN -1.4%), Johnson & Johnson (JNJ -0.5%), Seattle Genetics (SGEN -0.2%), United Therapeutics (UTHR -4.1%) and Vertex Pharmaceuticals (VRTX -0.9%) to Equal Weight from Overweight.
- He trimmed BMRN's price target to $105 (21% upside) from $125 citing "moderating growth and an overall lack of catalysts in 2017."
- J&J's price target was sliced to $125 (11% upside) from $130 due to a "less compelling risk/reward profile."
- SGEN's fair value target was lowered to $53 (21% downside risk) from $70 due to valuation.
- UTHR's price target was revised to $100 (21% downside risk) from $115 citing the likely impact of Uptravi on Orenitram uptake.
- He lowered Vertex's price target to $90 (5% upside) from $100 citing the lack of upside for Kalydeco and Orkambi.
Tue, Nov. 29, 7:44 AM
- Galapagos N.V. (NASDAQ:GLPG) initiates a Phase 1 clinical trial in the Netherlands assessing a novel C2 corrector drug for the treatment of cystic fibrosis (CF) called GLPG2737. The aim of the trial is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of GLPG2737 in 64 healthy volunteers. Top-line results should be available in Q2 2017. The action triggers a $10M milestone payment from collaboration partner AbbVie (NYSE:ABBV).
- The companies are developing a portfolio of candidates that address three complementary components of CF. GLPG2737, the first of multiple C2 correctors under development, is the final component in a planned triple combination therapy. Potentiators GLPG1837 and GLPG2451 and C1 corrector GLPG2222 are already being evaluated in the clinic.
- In preclinical testing, triple combinations of the compounds have restored healthy activity levels in human bronchial epithelial (HBE) cells of CF patients with the F508del mutation. In addition, they have demonstrated an increase in chloride transport compared to Vertex Pharmaceuticals' (NASDAQ:VRTX) ORKAMBI (lumacaftor/ivacaftor) in HBE cells with homozygous F508del (two copies of the mutation).
- The company says it expects to start testing a triple combination therapy in humans by mid-2017.
Mon, Nov. 28, 5:08 PM
- Thinly traded nano cap Nivalis Therapeutics (NASDAQ:NVLS) craters 55% after hours on robust volume in response to its announcement of a failed Phase 2 clinical trial assessing cavosonstat in adult cystic fibrosis (CF) patients who have two copies of the F508del-CFTR mutation and were being treated with Vertex Pharmaceuticals' (NASDAQ:VRTX) ORKAMBI (lumacaftor/ivacaftor).
- Results failed to show a treatment benefit compared to placebo with either a 200 mg or 400 mg dose (twice daily) as measured by percent predicted FEV1, the primary endpoint, or in sweat chloride reduction at week 12, a secondary endpoint.
- CEO Jon Congleton says, "While we are disappointed in the outcome of this trial, we plan to continue to investigate the therapeutic potential of cavosonstat and our S-nitrosoglutathione reductase (GSNOR) inhibitor portfolio to determine next steps."
- Orally administered cavosonstat (N91115) stabilizes the CFTR protein by inhibiting GSNOR, a potential therapeutic approach to treat asthma as well.
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.
Wed, Nov. 9, 8:08 AM
- Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
- Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN) +3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
Mon, Nov. 7, 9:02 AM
- Vertex Pharmaceuticals (NASDAQ:VRTX) is up 3% premarket, albeit on only 600 shares, in response to its announcement of positive results from a Phase 3 clinical trial assessing ORKAMBI (lumacaftor/ivacaftor) in children ages 6 - 11 with cystic fibrosis who have two copies of the F508del mutation.
- ORKAMBI was approved in the U.S. in late September for this patient population, but the additional late-stage study will support a marketing application in Europe because the EMA specified a different primary endpoint: the absolute change in lung clearance index through 24 weeks of treatment versus placebo. The company plans to file its application to expand ORKAMBI's label in the EU as soon as feasible.
- ORKAMBI was originally approved for the treatment of CF children at least 12 years old with two copies of the mutation.
Fri, Oct. 28, 1:02 PM
- United Therapeutics (NASDAQ:UTHR) upgraded to Buy from Neutral by Ladenburg Thalmann. Price target raised to $138 (18% upside) from $128.
- NeoGenomics (NASDAQ:NEO) upgraded to Buy from Neutral with a $10 (25% upside) price target by BTIG Research.
- Pacira Pharmaceuticals (NASDAQ:PCRX) upgraded to Market Perform from Underperform by BMO Capital. Price target raised to $36 (8% upside) from $35.
- Alkermes (NASDAQ:ALKS) upgraded to Overweight from Neutral by JPMorgan. Price target raised to $78 (53% upside) from $51.
- McKesson (NYSE:MCK) downgraded to Neutral from Outperform by Baird. Price target lowered to $164 (34% upside) from $200. Also downgraded by Standpoint Research, Deutsche Bank and Leerink Swann.
- Community Health Systems (NYSE:CYH) downgraded to Underperform from Neutral by Baird. Price target lowered to $8 (47% upside) from $12.
- TeamHealth Holdings (NYSE:TMH) downgraded to Market Perform from Outperform by Leerink Swann. Price target raised to $43 (17% upside) from $40..
- ARIAD Pharmaceuticals (NASDAQ:ARIA) downgraded to Market Perform from Market Outperform by JMP Securities. Price target raised to $9.37 (7% upside) from $4.37.
- Vertex Pharmaceuticals (NASDAQ:VRTX) downgraded to Neutral from Buy by H.C. Wainwright. Price target lowered to $85 (8% upside) from $155.
- Teva Pharmaceutical Industries (NASDAQ:TEVA) downgraded to Neutral from Buy by Mizuho. Price target lowered to $45 (7% upside) from $64.
Tue, Oct. 25, 7:07 PM
- Vertex Pharmaceuticals (NASDAQ:VRTX) is up 6% after hours on robust volume. Q3 revenues were up nicely, yes, but also stoking buying is its announcement of two new Phase 2 studies assessing next-generation correctors for the treatment of cystic fibrosis (CF). Both should commence by year end.
- One Phase 2 will assess the safety and efficacy of a four-week dosing regimen of VX-440, in combination with tezacaftor (VX-661) and KALYDECO (ivacaftor), in ~40 CF patients who have one F508del mutation and one minimal function mutation and ~25 CF patients with two copies of the F508del mutation. Top-line data are expected in H2 2017 and will support the advancement into Phase 3 development.
- The other Phase 2 will evaluate two weeks of triple combination dosing with VX-152 in ~35 CF patients with one F508del mutation and one minimal function mutation and ~25 CF patients with two copies of F508del. Top-line data are also expected in H2 2017 and will support the advancement into a longer-term Phase 2b study or registration program.
- The company has also plans to initiate a Phase 1 study of VX-659 by year end with a Phase 2 trial on tap for H2 2017.
Tue, Oct. 25, 5:37 PM
Tue, Oct. 25, 4:43 PM
- Vertex Pharmaceuticals (NASDAQ:VRTX) Q3 results ($M): Total Revenues: 413.8 (+33.6%); Product Revenues: 409.7 (+35.4%).
- Net Income: (41.8) (+56.0%); Non-GAAP Net Income: 40.1 (+225.7%); EPS: (0.17) (+56.4%); Non-GAAP EPS: 0.16 (+223.1%).
- Key Product Sales: ORKAMBI: 234.0 (+78.6%); KALYDECO: 175.6 (+5.8%).
- 2016 Guidance: ORKAMBI Sales: $950M - 990M (unchanged from September update but lower than previous outlook of $1.0B - 1.1B); KALYDECO Sales: $685M - 705M (unch).
Tue, Oct. 25, 4:04 PM
Mon, Oct. 24, 5:35 PM
- AAPL, ABAX, AIZ, AKAM, AKR, AMP, BCR, BLDP, BXMT, BXP, CB, CEB, CHRW, CINF, CLI, CMG, CNI, COF, CSL, CSV, CVA, DFS, DGI, EQR, ESRX, ETH, EW, FSP, FUEL, HIW, HT, HTA, IRBT, JNPR, LOGI, MDR, MRCY, NBR, NCR, NUVA, OI, P, PNRA, PSB, QTS, RMD, RNG, ROIC, RRC, RSYS, SKT, TMK, TRMK, TSS, UDR, UIS, UMBF, USNA, VRTX, WFT, WRB, WSBC, ZIXI
Tue, Oct. 18, 10:29 AM
- Biotech industry offers "attractive buying opportunities" given pre-election weakness, Jefferies says.
- Valuation multiples are near-historic lows; policy concerns are likely overstated.
- Firm recommends using weak sentiment to buy attractive names. Likes: Gilead (NASDAQ:GILD) and Celgene (NASDAQ:CELG) in large-caps, The Medicines Co. (NASDAQ:MDCO), Alkermes (NASDAQ:ALKS) and Vertex (NASDAQ:VRTX) in mid-caps. Alder Biopharmaceuticals (NASDAQ:ALDR), Cempra (NASDAQ:CEMP), Ultragenyx (NASDAQ:RARE) and Immunomedics (NASDAQ:IMMU) in small-caps.
Fri, Oct. 14, 8:34 AM
- Vertex Pharmaceuticals (NASDAQ:VRTX) announces that it has updated and expanded its 2004 Research, Development and Commercialization Agreement with Cystic Fibrosis Foundation Therapeutics (CFFT), the Cystic Fibrosis Foundation's nonprofit drug discovery and development affiliate.
- Under the new contract, Vertex will receive an upfront payment of $75M plus up to $6M per year for development funding. For compounds first synthesized/tested between March 1, 2014 and August 31, 2016, Vertex will pay CFFT low-to-mid-single-digit royalties. For compounds first synthesized/tested before February 28, 2014, Vertex will continue to pay single-digit-to-sub-teen royalties.
- In addition, sales of combination products will be allocated equally to each of the active pharmaceutical ingredients in the combo product consistent with the way ORKAMBI is handled.
- Separately, Vertex has inked a data license agreement with the Cystic Fibrosis Foundation under which it will pay for continued access to its patient registry.
Thu, Oct. 6, 3:32 PM
- Biotech investors are sitting on the sell button today. The iShares Nasdaq Biotechnology ETF (IBB -2.4%) is down on increased volume. Shares have retraced over 5% since the recent close of 300 on September 22.
- Alnylam (ALNY -48%) is leading the rout after it announced that it was dropping development of RNAi candidate revusiran.
- Representative tickers: (AMGN -0.3%)(BIIB -1.3%)(GILD -1.9%)(CELG -1.4%)(BMY)(MRK -0.7%)(PFE -1.2%)(VRTX -3%)(ALXN -2.2%)