Health and Healthcare
Key FDA Decisions and Trial Results Expected in October
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Biotech and pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair to a great amount of risk involved, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.
The U.S. Food and Drug Administration (FDA) rulings and results from clinical trials can make or break these companies, as proven time and again.
24/7 Wall St. has collected several big FDA decisions and mid-to-late-stage trials that should be coming up in October and added some color, along with the trading range and price target.
For the month of October, perhaps the biggest headliner is the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen between October 7 and 11.
Outside of the ESMO, there are no assurances that the dates will remain static. Some date changes are positive developments, and some can be disasters, if a company is not deeply financed.
As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
Exelixis
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.
Michael M. Morrissey, Ph.D., president and CEO of Exelixis, commented on the ESMO:
This year’s ESMO Congress provides Exelixis and our partners with the opportunity to present data across a broad spectrum of cancers and potential treatment combinations. We look forward to the first presentation of the CABOSUN data, which will provide more detail about the statistically significant and clinically meaningful improvement in progression-free survival for cabozantinib in patients with advanced renal cell carcinoma in the front-line setting. Our focus remains on further examining the potential of our therapies and moving these medicines through clinical development so they are available to patients and physicians as quickly as possible.
Exelixis was last trading at $11.92, with a consensus analyst price target of $10.67 and a 52-week trading range of $3.55 to $12.22.
Medivation
In February, the FDA accepted Medivation Inc.’s (NASDAQ: MDVN) supplemental New Drug Application (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 last seen at $80.97, with a consensus price target of $77.15 and a 52-week range of $26.41 to $80.99.
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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