Healthcare Business

Key FDA Decisions and Trial Results Expected in October

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 closed most recently trading at $3.66. The consensus price target is $8.00, and the 52-week range is $2.96 to $18.62.

Palatin Technologies

Palatin Technologies Inc. (NYSEMKT: PTN) has completed its last patient visits for its late-stage reconnect studies, which consist of two pivotal Phase 3 clinical trials of bremelanotide for the treatment of female hypoactive sexual desire disorder. Management noted that patient enrollment and last patient out of the studies were concluded on time. It is now looking forward to data verification and database lock, which it anticipates will occur in late September. The top-line results should follow shortly after, which is expected to be in October.

Shares of Palatin were last seen at $0.51, within a 52-week range of $0.36 to $0.94. The consensus price target is $4.00.

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 $1.04. The consensus price target is $3.29. The 52-week range is $0.95 to $5.20.

Anthera Pharmaceuticals

The last patient in the Anthera Pharmaceuticals Inc. (NASDAQ: ANTH) Phase 3 CHABLIS-SC1 clinical study received a final study dose in late July. In this study, patients are followed for eight weeks after their last dose, at which time the final safety data was collected. Due to timing of this final visit, the company expects top-line efficacy and safety data will be available prior to the annual American College of Rheumatology Annual Meeting in November.

Anthera shares last traded at $2.98, in a 52-week range of $2.28 to $10.00. The consensus price target is $10.60.

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