Key FDA Decisions and Trial Results Coming in the Next 2 Months

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Vertex Pharmaceuticals

A Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) Phase 3 clinical study has been completed. It was conducted to support the potential approval of Orkambi for children with cystic fibrosis within the past year. The study enrolled 58 children ages 6 to 11 with two copies of the F508del mutation, and the primary endpoint of the study was safety. In May the FDA granted Vertex’s request for a PDUFA Priority Review of this supplemental New Drug Application (sNDA) by the end of September.

Vertex shares were last trading at $95.27. The 52-week range is $75.90 to $136.97, and the consensus price target is $110.32.


Exelixis Inc. (NASDAQ: EXEL) is scheduled to present data from its clinical trials of cabozantinib and cobimetinib, which will be subject to 15 presentations at the ESMO. Detailed results from the company’s CABOSUN trial will be presented at ESMO as a late-breaking abstract in the genitourinary tumors. Additional poster presentations will detail the investigation of cabozantinib in other cancer settings, including in combination with nivolumab in metastatic urothelial carcinoma and other genitourinary cancers, as well as the evaluation of cobimetinib in combination studies across multiple tumor types.

Shares of Exelixis closed most recently at $12.31, with a consensus price target of $10.67 and a 52-week range of $3.55 to $12.48.


In February, the FDA accepted Medivation Inc.’s (NASDAQ: MDVN) supplemental sNDA for Xtandi in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 Terrain and Strive Studies, to update the relevant clinical sections within the current indication. Xtandi is approved by the FDA for the treatment of patients with mCRPC. The FDA set the PDUFA goal date for Xtandi for October 22.

Shares of Medivation were recently trading up $80.96, with a consensus price target of $77.15 and a 52-week range of $26.41 to $81.04.

Celldex Therapeutics

Celldex Therapeutics Inc. (NASDAQ: CLDX) plans to present data from its glembatumumab vedotin study (glemba, or CDX-011) at the ESMO Congress as well. Enrollment for the program was completed and the primary endpoint was met in the Phase 2 single-agent study. The primary endpoint of the study, objective response rate, required a minimum of six responses in the first 52 patients to be deemed successful. Celldex is also evaluating glembatumumab vedotin in other cancers in which gpNMB is expressed.

Celldex shares were last seen at $3.58. The consensus price target is $8.00. The 52-week range is $2.96 to $18.62.

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Cerulean Pharma

Another company looking to present data at the ESMO is Cerulean Pharma Inc. (NASDAQ: CERU). Specifically, Cerulean will present data from the second group of patients from a Phase 1b/2 trial of CRLX101 in combination with weekly paclitaxel in platinum-resistant ovarian cancer. At the same time, the company will present data from an ongoing Phase 1 trial evaluating the weekly dosing of CRLX101.

Cerulean closed at $1.02 a share, with a 52-week range of $0.95 to $5.20 and a consensus price target of $3.29.