$VRTX (Vertex Pharmaceuticals Incorporated)

$VRTX {{ '2016-02-05T18:32:07+0000' | timeago}} • Announcement

$VRTX said that the FDA has rejected its supplemental New Drug Application for the use of KALYDECO (ivacaftor) in people with cystic fibrosis ages two and older with one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator gene. $VRTX plans to meet with the FDA to determine an appropriate path forward.

$VRTX {{ '2018-01-10T15:15:09+0000' | timeago}} • Announcement

$VRTX said the European Commission has granted extension of the Marketing Authorization for ORKAMBI, intended for the treatment of cystic fibrosis (CF) in people with two copies of the F508del mutation, to include children ages 6 through 11. Existing reimbursement agreements in countries such as Ireland will enable rapid access to ORKAMBI.

$VRTX {{ '2017-12-12T14:48:16+0000' | timeago}} • Announcement

$VRTX and $CRSP will co-develop and co-commercialize CTX001, an investigational gene editing treatment, as part of a collaboration aimed at the development of new gene editing treatments that use the CRISPR/Cas9 technology. For CTX001, both companies will equally share all research and development costs and profits worldwide.

$VRTX {{ '2017-11-03T15:07:25+0000' | timeago}} • Announcement

$VRTX said results from two Phase 3 studies of the tezacaftor/ivacaftor combination treatment for cystic fibrosis in patients aged 12 and older, have been published. In both studies, the tezacaftor/ivacaftor combination demonstrated statistically significant and clinically meaningful improvements in lung function and other measures of disease.

$VRTX {{ '2017-10-27T15:51:51+0000' | timeago}} • Webcast

$VRTX believes the tezacaftor/ivacaftor treatment combination has the opportunity to grow the CF franchise. The company believes given its benefit/risk profile, it provides a tremendous new treatment option which is going to allow more patients to be treated with the CFTR modulator. This includes patients who have not been initiated on ORKAMBI.

$VRTX {{ '2017-10-27T15:51:33+0000' | timeago}} • Webcast

During 3Q17, strong growth in product revenues drove an expansion in $VRTX’s operating margin. Operating margins were 26% for 3Q17 compared to 16% for 3Q16. With the anticipated revenue growth, the company expects margins to continue to expand in the future.

$VRTX {{ '2017-10-27T15:51:19+0000' | timeago}} • Webcast

$VRTX announced Phase 3 results of ORKAMBI in children aged 2-5 years with cystic fibrosis who have two copies of the F508del mutation. The primary endpoint of the study was safety, and the result showed the treatment to be well-tolerated. Based on these results, $VRTX expects to submit for regulatory approval in the US and Europe in 1Q18.

$VRTX {{ '2017-10-25T22:13:31+0000' | timeago}} • Announcement

$VRTX expects total 2017 CF product revenues of $2.10-2.15Bil. The company expects that total 2017 combined GAAP R&D and SG&A expense will be in the range of $1.79-1.92Bil and combined non-GAAP R&D and SG&A expense will be in the range of $1.33-1.36Bil.

$VRTX {{ '2017-10-25T22:13:16+0000' | timeago}} • Announcement

For 3Q17, $VRTX posted total CF net product revenues of $549.6MM compared to $409.7MM for 3Q16. Net product revenues from ORKAMBI were $336.2MM versus $234MM for 3Q16. Net product revenues from KALYDECO were $213.5MM compared to $175.6MM in the prior-year quarter.

$VRTX {{ '2017-10-25T22:05:04+0000' | timeago}} • Announcement

$VRTX reported a net loss of $103MM or $0.41 per share for 3Q17 compared to a net loss of $38.8MM or $0.16 per share for 3Q16, primarily due to an upfront payment of $160MM related to the acquisition of VX-561 from Concert Pharmaceuticals. Adjusted net income was $136.4MM or $0.53 per share in 3Q17. Revenues totalled $578MM.

$VRTX {{ '2017-10-25T21:28:29+0000' | timeago}} • Infographic

$VRTX Vertex Pharmaceuticals Earnings AlphaGraphic: Q3 2017 Highlights

$VRTX {{ '2017-09-06T14:56:39+0000' | timeago}} • Announcement

$VRTX has announced the appointment of Tom Graney as SVP and CFO with effect from Sept 13, 2017.  He will report to EVP and COO Ian Smith.  Graney will be responsible for the development and execution of the financial strategies and operations of Vertex's business plans. He was the CFO and SVP of Finance and Corporate Strategy at $IRWD.

$VRTX {{ '2017-08-24T16:02:41+0000' | timeago}} • Announcement

Biotechnology firm $VRTX said the FDA and the European Medicines Agency have accepted its application for use of the tezacaftor/ivacaftor treatment in patients suffering from certain types of cystic fibrosis. Earlier, two phase-3 studies on the effectiveness of the drug combination had returned positive results.

$VRTX {{ '2017-08-01T19:57:27+0000' | timeago}} • Announcement

FDA approved $VRTX's Kalydeco for more than 600 people ages 2 and older with cystic fibrosis (CF) who have certain residual function mutations. After this, $VRTX lifted 2017 Kalydeco revenue guidance to $770-800MM from $740-770MM, and total CF product revenue outlook to $1.87-2.1Bil from $1.84-2.07Bil. This includes Orkambi guidance of $1.1-1.3Bil.

$VRTX {{ '2017-08-01T19:52:18+0000' | timeago}} • Announcement

$VRTX got FDA nod for cystic fibrosis (CF) drug Kalydeco for use in more than 600 people ages 2 and older with CF who have certain residual function mutations. This was based on phase 3 clinical data for Kalydeco in these mutations and follows the FDA's approval of the drug in May 2017 for 23 other residual function mutations.

$VRTX {{ '2017-07-26T20:38:11+0000' | timeago}} • Announcement

$VRTX also reviewed its recent progress toward treating all people with cystic fibrosis, including the completion of an asset purchase agreement with Concert Pharmaceuticals for worldwide development and commercialization rights to CTP-656 and other assets related to the treatment of cystic fibrosis.

$VRTX {{ '2017-07-26T20:36:21+0000' | timeago}} • Announcement

$VRTX lifted 2017 non-GAAP combined research & development and selling, general & administrative expenses outlook to $1.33-1.36Bil from $1.25-1.30Bil, and GAAP combined R&D and SG&A expenses estimate to $1.79-1.92 from $1.55-1.70. The updated forecast reflects the progression of the company's cystic fibrosis portfolio.

$VRTX {{ '2017-07-26T20:33:48+0000' | timeago}} • Announcement

$VRTX expects 2017 total cystic fibrosis product revenue of $1.84-2.07Bil, comprised of Orkambi and Kalydeco product revenues. $VRTX still expects 2017 product revenue for Orkambi of $1.1-1.3Bil and for Kalydeco of $740-770MM.

$VRTX {{ '2017-07-26T20:30:18+0000' | timeago}} • Announcement

$VRTX's net product revenues from cystic fibrosis therapy Orkambi for 2Q17 increased to $324.4MM from $245.5MM last year. This was primarily driven by the continued uptake in the medicine globally and additional uptake in people with cystic fibrosis ages 6 to 11 in the U.S., where approval was received in September 2016.

$VRTX {{ '2017-07-26T20:26:38+0000' | timeago}} • Announcement

$VRTX reported net income for 2Q17 of $31.17MM or $0.07 per share compared to a loss of $64.53MM or $0.26 per share last year. This swing in results was driven by higher revenue as well as a decline in interest expenses. Revenue grew to $544.14MM from $431.61MM. Non-GAAP EPS increased to $0.39 from $0.24.

$VRTX {{ '2017-07-25T21:51:58+0000' | timeago}} • Announcement

$VRTX and $CNCE completed an asset purchase agreement, under which $VRTX gained worldwide development and commercialization rights to CTP-656 and other assets related to the treatment of cystic fibrosis. $CNCE received $160MM in cash upon closing and is eligible to receive up to $90MM in additional milestones.

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