Verrica Pharmaceuticals Inc. - VRCA STOCK NEWS

Verrica Pharmaceuticals (Nasdaq: VRCA) has completed a Type A meeting with the FDA regarding its New Drug Application (NDA) resubmission for VP-102, aimed at treating molluscum contagiosum. The resubmission is expected in Q1 2021 following positive feedback from the FDA. In Q3 2020, Verrica reported a net loss of $10.5 million, an increase from $6.1 million the previous year. R&D expenses rose to $5 million, largely due to higher manufacturing costs. As of September 30, 2020, the company held $71.9 million in cash and equivalents, sufficient to sustain operations through Q4 2021.

Verrica Pharmaceuticals (Nasdaq: VRCA) announced the publication of positive results from its pivotal Phase III CAMP studies on VP-102 for treating molluscum contagiosum in the Journal of the American Medical Association (JAMA) Dermatology. The studies, involving over 500 participants, indicated that 46% in CAMP-1 and 54% in CAMP-2 achieved complete clearance of lesions with VP-102, compared to 18% and 13% respectively for the vehicle group (p<0.001). VP-102 was well tolerated, with no serious adverse events reported. The results may enhance the prospects of VP-102 as a safe FDA-approved treatment for a viral skin infection.

Verrica Pharmaceuticals (VRCA) announced that CEO Ted White will present a business overview at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 2:00 p.m. ET. The conference will be held virtually, and attendees can access the live webcast on Verrica's website. The company is developing VP-102, a potential first-in-class therapy for molluscum contagiosum, for which an NDA was submitted in September 2019. A Complete Response Letter from the FDA was received on July 13, 2020, regarding this NDA.

Verrica Pharmaceuticals (NASDAQ: VRCA) has secured an exclusive worldwide license from Lytix Biopharma for the development of LTX-315, targeting dermatologic oncology, particularly basal and squamous cell carcinomas. This oncolytic peptide shows promise in inducing immunogenic cell death in tumors. The deal could yield up to $113.5 million and tiered royalties. Clinical advancements aim for an IND submission in 2021. Verrica expects its financial position to support these activities through Q4 2021, reinforcing its commitment to innovative dermatologic treatments.

Verrica Pharmaceuticals (Nasdaq: VRCA) reported a net loss of $9.4 million for Q2 2020, up from $7.0 million in Q2 2019. The company aims to resubmit the NDA for VP-102 after receiving a Complete Response Letter from the FDA, which raised questions about the Chemistry, Manufacturing, and Controls process but noted no clinical safety or efficacy issues. Verrica plans a Type A meeting with the FDA in Q3 2020. The company also entered an Option Agreement with Torii Pharmaceutical for VP-102 in Japan, allowing for potential milestone payments totaling $69.5 million.

Verrica Pharmaceuticals (Nasdaq: VRCA) has announced Dr. Lawrence Eichenfield's appointment to its Board of Directors, effective August 1, 2020. He replaces Dr. Gary Goldenberg, who becomes Chief Medical Officer. Dr. Eichenfield, a leader in pediatric dermatology, is expected to significantly influence the development of VP-102, a treatment for molluscum contagiosum. The company has faced challenges with the FDA, receiving a Complete Response Letter for VP-102 on July 13, 2020, but remains optimistic about its product pipeline.

Verrica Pharmaceuticals (Nasdaq: VRCA) appointed Dr. Gary Goldenberg as Chief Medical Officer and Dr. Brad Catalone as Head of Drug Development, effective August 1, 2020. This leadership transition follows the resignation of Patrick Burnett, MD, who is pursuing other opportunities. Dr. Goldenberg's dermatology expertise will enhance clinical strategies while Dr. Catalone's background in CMC and regulatory affairs aims to support vital drug development efforts. These appointments are seen as pivotal for advancing Verrica's product pipeline, especially the NDA for VP-102, a treatment for molluscum contagiosum, submitted in September 2019.

Verrica Pharmaceuticals (Nasdaq: VRCA) announced on June 24, 2020, that it received a letter from the FDA highlighting deficiencies in its New Drug Application (NDA) for VP-102, a topical solution for molluscum contagiosum. While the FDA did not detail specific concerns, the company noted that requests focused on CMC aspects were hindered by COVID-19. Verrica aims to collaborate with the FDA to address these issues promptly. Despite the setbacks, positive results from two Phase 3 trials affirm the treatment's potential for FDA approval by the July 13, 2020 PDUFA date.

Verrica Pharmaceuticals presented new data from the Phase 3 CAMP trials for VP-102, its treatment for molluscum contagiosum. A pre-specified exploratory analysis showed statistically significant complete lesion clearance for all lesion count quartiles compared to vehicle (p<0.05). A post-hoc analysis indicated any patient meeting the protocol's baseline criteria could achieve complete clearance after up to four treatments. The findings were showcased at the American Academy of Dermatology 2020 Annual Meeting, enhancing VP-102's potential as a safe and effective option regardless of lesion count.