Vical Incorporated (NASDAQ:VICL) Candidate Awarded Limited Use Indication

Vical Incorporated (NASDAQ:VICL)

Vical Incorporated (NASDAQ:VICL)

Vical Incorporated (NASDAQ:VICL) gained 7.03% after the U.S. Food and Drug Administration said its investigational antifungal VL-2397candidate drug would be eligible for a Limited Use Indication, pending Phase 2 trial outcome.

Vical Incorporated (NASDAQ:VICL)

Vical Investors Reaction

Vical Incorporated (NASDAQ:VICL) recorded a new 52-week high of $3.70 after the FDA approved the Limited Use of its candidate drug. However, the stock fell to end Tuesday’s trading session and ended at $2.74 a share. The stock is up by more than 5% for the year and traders are waiting to see if it will rise even further on the new designation.

The Limited Use Indication designation is an important milestone. It will allow Vical Incorporated (NASDAQ:VICL) to develop and commercialize VL-2397 on an accelerated basis.

“The preclinical and clinical data to date for VL-2397 supports the profile of an ideal antifungal agent which must be fast acting, have minimal drug interactions, and a low risk for toxicity,” said Dr. Haran Schlamm, MD, Vical’s infectious disease consultant.

Vical Incorporated (NASDAQ:VICL) is in the process of initiating Phase 3 trial of VL-23497 for the treatment of invasive aspergillosis (IA) in acute leukemia patients. The trial will be a non-inferiority study that will seek to compare the candidate drug to the standard of care treatment for IA.

The biopharmaceutical company plans to enroll approximately 300 acute leukemia patients. The primary end for the trial will be “all cause mortality” (ACM) at 4 weeks with the secondary endpoint being ACM at 6 weeks. Vical Incorporated (NASDAQ:VICL) has already partnered Mycoses Study Group Education and Research Consortium for the design and preparation of the proposed trial.

Vical Pipeline

In addition to VL-2397, Vical Incorporated (NASDAQ:VICL) is working on ASP0113, a potential first in class investigational DNA vaccine for the prevention of latent cytomegalovirus. The vaccine is currently in multinational Phase 3 registration trial in HCT patients. Data from the trials is expected in the first quarter of next year.

Vical Incorporated (NASDAQ:VICL) is also developing an HSV-3 therapeutic vaccine, VCL-HBO1 for the reduction of lesion recurrences in patients with symptomatic genital herpes infection. The vaccine is currently being evaluated in Phase 2 study of healthy adult subjects.

Separately, the biopharmaceutical company reported a net loss of (-$3.3) million for its second quarter, up from a net loss of (-$1.3) million reported last year. Revenues in the quarter totaled $3.4 million compared to $4.1 million reported last year. Vical Incorporated (NASDAQ:VICL) had cash and investments of $37.3 million as of June 30, 2017.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

Author: James Marion

James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

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