Key FDA Decisions and Trial Results Expected in October

Health and Healthcare

Published: October 4, 2016 9:15 am

Last Updated: March 13, 2020 5:26 pm

It is well known that U.S. Food and Drug Administration (FDA) rulings, along with the results from clinical trials, can make or break companies in the biotech and pharmaceutical industries. The companies that subject themselves to the lengthy process of FDA approval or clinical research are taking on a fair amount of risk of failure. However, if a drug is approved or passes a clinical trial, there can be massive upside.

24/7 Wall St. has collected several big FDA decisions and mid-stage to late-stage trials that should be announced in October. We have added what to expect, as well as some color and the trading ranges and price targets.

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.

Shares of Exelixis closed most recently at $12.72, with a consensus price target of $12.67 and a 52-week trading range of $3.55 to $15.58.

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 $4.00, and the consensus price target is $8.00. The 52-week range is $2.96 to $18.62.

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 shares closed at $1.02 a share, with a 52-week range of $0.92 to $4.33 and a consensus price target of $3.67.

Medivation

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 most recently closed at $81.44, with a consensus price target of $77.79 and a 52-week range of $26.41 to $81.48.

Palatin Technologies

Palatin Technologies Inc. (NYSEMKT: PTN) is looking to release the results from its Phase 3 trial of bermelanotide for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, called the Reconnect Study. The company completed the last patient visits in its double blind portion of the study in the third quarter. The top-line results from this study are expected to be released in the early fourth quarter of 2016. Looking even further ahead, the company expects to submit an NDA to the FDA by mid-2017.

Shares of Palatin were last seen at $0.61, with a consensus analyst target of $4.67 and a 52-week range of $0.36 to $0.90.

Rexahn Pharmaceuticals

Rexahn Pharmaceuticals Inc. (NYSEMKT: RNN) announced the initiation of the Phase 1b/2a clinical trial with the novel oral anti-cancer agent RX-3117 in relapsed or refractory pancreatic cancer patients. The decision to proceed was based on satisfying the predefined criteria for preliminary efficacy for stage 1 of the trial.

RX-3117 was safe and well tolerated with preliminary efficacy seen in pancreatic cancer patients for whom three prior therapies had been ineffective. Results from stage 1 of the Phase 1b/2a clinical trial have been submitted for presentation at the ESMO taking place in mid-October.

Shares of Rexahn were at $0.21, with a consensus price target of $2.00 and a 52-week range of $0.20 to $0.52.

Anthera Pharmaceuticals

Anthera Pharmaceuticals Inc. (NASDAQ: ANTH) announced that the last patient in the Phase 3 CHABLIS-SC1 clinical study, evaluating blisibimod for the treatment of systemic lupus erythematosus, received their final study dose on July 27.

As described in the protocol, patients are followed for eight weeks after their last dose at which time the final safety data is 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 (11/11-16). It is very possible that these results could appear by the end of October ahead of the meeting to let the market digest the data.

Shares of Anthera were last seen at $3.20. The consensus price target is $9.75, and a 52-week range is $2.28 to $7.15.

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