Molluscum contagiosum

Ligand Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Wednesday, February 22, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Health Technology, Pachyonychia congenita, Coronavirus, Nevoid basal-cell carcinoma syndrome, RNA-dependent RNA polymerase, Maintenance, IND, Immunoglobulin A, MC, Focal segmental glomerulosclerosis, NDA, COPD, Jazz Pharmaceuticals, Basal-cell carcinoma, COVID-19, NMPA, SB206, Infection, Therapy, Pelican, Retirement, Syndrome, Marketing, Patient, Pneumonia, File, SARS-CoV-2, Telecanthus, Travers Smith, Kidney, Research, GAAP, Investment, RASP, Growth, Income tax, MLM, Total, NASH, FSGS, RNA, Acute myeloid leukemia, Telephone, IM, Depreciation, Forecasting, Quality of life, Microcystic lymphatic malformation, Verona, Molluscum contagiosum, BLA, Risk, FDA, EPS, Element, EMA, Communication, IV, Cryptocurrency, Pharmaceutical industry, Video game, Ligand, IgA nephropathy

Total revenues for the fourth quarter of 2022 were $50.4 million, compared with $56.4 million for the same period in 2021.

Key Points: 
  • Total revenues for the fourth quarter of 2022 were $50.4 million, compared with $56.4 million for the same period in 2021.
  • Core Captisol sales were $3.3 million for the fourth quarter of 2022, compared with $7.1 million for the same period in 2021.
  • Captisol sales related to COVID-19 were $23.5 million for the fourth quarter of 2022, compared with $28.3 million for the same period in 2021.
  • Contract revenue was $1.5 million for the fourth quarter of 2022, compared with $3.5 million for the same period in 2021.

Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum

Retrieved on: 
Tuesday, January 24, 2023
Food, Patient, New Drug Application, Endpoint security, Dermatology, Therapy, Skin, NDA, Molluscum contagiosum, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Prevalence, Pharmaceutical industry

WEST CHESTER, Pa., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Prevalence of Over 6 Million Molluscum Contagiosum Patients in the U.S. Alone
    WEST CHESTER, Pa., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA).
  • “We are pleased with the hard work and commitment from the entire Verrica team that has allowed us to resubmit the NDA for VP-102 for molluscum,” said Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals.
  • “We believe the successful tech transfer of our bulk solution manufacturing addresses the only deficiency in our previous filing that resulted in our Complete Response Letter last year.
  • We look forward to working with the FDA through the review process, and if approved, bringing VP-102 to patients as the first FDA-approved treatment option for molluscum.”

Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum

Retrieved on: 
Friday, January 6, 2023
Molluscum contagiosum, Food, SB206, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, File, NDA, Nitric oxide, FDA, New Drug Application, Pharmaceutical industry

DURHAM, N.C., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), announced today that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum contagiosum (“molluscum”). Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval.

Key Points: 
  • Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval.
  • “Today marks a significant milestone for Novan and the culmination of substantial efforts of the entire Novan team – the Company’s first NDA submission.
  • Berdazimer gel, 10.3% is poised to be a first-in-class topical treatment for molluscum.
  • I think caregivers and patients with molluscum would welcome berdazimer gel as a breakthrough in treatment.

Verrica Pharmaceuticals Announces the Successful Technology Transfer of Bulk Solution Manufacturing of VP-102 to Piramal Pharma Solutions

Retrieved on: 
Wednesday, January 4, 2023
Skin, Molluscum contagiosum, NDA, Disease, Technology transfer, Patient, Piramal, FDA, Therapy, Dermatology, Fine chemical

WEST CHESTER, Pa., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced the successful completion of the technology transfer of bulk solution manufacturing to Piramal Pharma Solutions. The technology transfer includes the completion of the registration batch material, which has been placed on stability, and the manufacture of three process validation batches of bulk solution.

Key Points: 
  • WEST CHESTER, Pa., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced the successful completion of the technology transfer of bulk solution manufacturing to Piramal Pharma Solutions.
  • The technology transfer includes the completion of the registration batch material, which has been placed on stability, and the manufacture of three process validation batches of bulk solution.
  • “We are pleased to have completed the technology transfer of bulk solution manufacturing for VP-102 to Piramal Pharma Solutions,” said Ted White, Verrica’s President and Chief Executive Officer.
  • We would like to thank Piramal Pharma Solutions, and their entire staff at the Sellersville, PA location, who have been true partners in this tech transfer process.

Ligand’s Partner Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum

Retrieved on: 
Friday, January 6, 2023
FDA, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Novin, Molluscum contagiosum, Food, SB206, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, File, NDA, Nitric oxide, Trial of the century, Medicine, Investment, FDA, Pharmaceutical industry, Ligand

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Novan, Inc. (Nasdaq: NOVN) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum contagiosum (molluscum).

Key Points: 
  • Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Novan, Inc. (Nasdaq: NOVN) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum contagiosum (molluscum).
  • Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval.
  • “In 2019 Ligand provided funding to Novan for the clinical development of berdazimer gel in exchange for milestones and royalties.
  • If approved, berdazimer gel, 10.3% would be the first topical treatment indicated for molluscum with the convenience of self-application.

Ligand Provides Highlights from its Investor and Analyst Day Event

Retrieved on: 
Tuesday, December 13, 2022
Professional Services, Health, FDA, Finance, Clinical Trials, Pharmaceutical, Biotechnology, Water, Baxter International, Gilead Sciences, Security (finance), Molluscum contagiosum, NDA, Immunoglobulin A, EPS, Drug discovery, Partnership, EMA, ESG, Amgen, Element, Economics, FDA, Solubility, Pachyonychia congenita, Investment, Gilead, LBL, COVID-19, GAAP, Nevoid basal-cell carcinoma syndrome, News, Vaccine, IgA nephropathy, COPD, Social Security Government Pension Offset, MLM, Merck, Marketing, Forecasting, Social, Risk management, Fine chemical, Renewable energy, Pharmaceutical industry, Pfizer, COVID, Takeda, Ligand

Highlights of todays event held in-person in New York City and virtually included the following:

Key Points: 
  • Highlights of todays event held in-person in New York City and virtually included the following:
    Management reviewed Ligands business model and the ongoing diversification of its partnership portfolio.
  • Ligand shares in the promise of the biopharmaceutical industry through royalty economics earned from providing development capital and access to its platform technologies.
  • Today Ligand has economic rights to more than 100 programs being developed or commercialized by nearly 100 different partners.
  • Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release.

EPI Health, a Novan Company, Executes a $15.0 Million Financing Agreement

Retrieved on: 
Friday, December 2, 2022
Bay View, Pharmacy, Rosacea, Novin, EPI, Skin, Psoriasis, Commerce, Molluscum contagiosum, Acne, Marketing, Security (finance), Patient, Acquisition, Heritage Bank, SB206, Health, Annual report, Risk management

DURHAM, N.C., Dec. 02, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that EPI Health, LLC, a fully consolidated subsidiary of the Company, has signed an accounts receivable-backed factoring agreement, to support its operations, with Bay View Funding, a wholly owned subsidiary of Heritage Bank of Commerce (Nasdaq: HTBK).

Key Points: 
  • The new $15.0 million factoring facility will provide capital in an amount that is up to 70% of EPI Health's gross eligible receivables.
  • We are excited to work with the commercial team at EPI Health and the corporate team at Novan.
  • Novan, Inc. is a medical dermatology company primarily focused on researching, developing, and commercializing innovative therapeutic products for skin diseases.
  • Novan also has a pipeline of potential product candidates using our proprietary nitric oxide-based technology platform, NITRICIL, to generate new treatments for multiple indications.

Novan to Participate in the Cantor Fitzgerald Medical & Aesthetic Dermatology, Ophthalmology & Medtech Conference

Retrieved on: 
Thursday, December 1, 2022
Cantor, Marketing, Molluscum contagiosum, SB206, Health, Acne, Skin, Conference, Acquisition, Patient, Rosacea, Pharmacy, Ophthalmology, Psoriasis, Pharmaceutical industry

DURHAM, N.C., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that Paula Brown Stafford, President and Chief Executive Officer of Novan, will participate in a panel discussion titled, “Distraction or Destruction?: What’s New/Next in the Industry,” at the Cantor Fitzgerald Medical & Aesthetic Dermatology, Ophthalmology & Medtech Conference on Thursday, December 8, 2022 at 11:00 AM ET.

Key Points: 
  • : Whats New/Next in the Industry, at the Cantor Fitzgerald Medical & Aesthetic Dermatology, Ophthalmology & Medtech Conference on Thursday, December 8, 2022 at 11:00 AM ET.
  • The panel discussion will highlight medical and aesthetic dermatology companies and their innovative platform therapies and provide opportunity to discuss upcoming milestones and anticipated findings from data in the next 12-18 months.
  • Novan, Inc. is a medical dermatology company primarily focused on researching, developing, and commercializing innovative therapeutic products for skin diseases.
  • Novan also has a pipeline of potential product candidates using our proprietary nitric oxide-based technology platform, NITRICIL, to generate new treatments for multiple indications.

Novan Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 14, 2022
FDA, Marketing, Molluscum contagiosum, Food and Drug Administration, Health, Rosacea, Psoriasis, Failure, EPI, Novin, Skin, Webcast, Conference, Dermatology, JAMA Dermatology, NDA, Annual report, Pharmacy, Acquisition, Satō, Safety, Security (finance), SB206, Documentation, Development, Growth, COVID-19, Research, Acne, Risk, Research and development, Patient, Risk management, Renewable energy, Pharmaceutical industry, Lithium, Video game

DURHAM, N.C., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced its financial and operating results for the third quarter ended September 30, 2022 and provided a corporate update. The Company will host a conference call and webcast, today, November 14, 2022, at 8:30 a.m. ET (details below).

Key Points: 
  • ET
    DURHAM, N.C., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (the Company or Novan) (Nasdaq: NOVN), today announced its financial and operating results for the third quarter ended September 30, 2022 and provided a corporate update.
  • Total prescription activity for third quarter 2022:
    37% growth in third quarter year-to-date compared to same period in 2021;
    31% growth in third quarter compared to third quarter 2021; and
    7% decrease in third quarter compared to second quarter 2022.
  • 216% growth in third quarter compared to third quarter 2021, based in part to timing of product launch in the United States; and 14% decrease in third quarter compared to second quarter 2022.
  • 59% growth in third quarter year-to-date compared to same period in 2021;
    78% growth in third quarter compared to third quarter 2021; and
    23% growth in third quarter compared to second quarter 2022.

Verrica Pharmaceuticals Reports Third Quarter 2022 Financial Results

Retrieved on: 
Monday, November 7, 2022
Exercise, Skin, Company, CMC, CRL, Genetically modified bacteria, Dermatology, Collaboration, Squamous cell carcinoma, Fomite, U.S. Securities and Exchange Commission, Pharmacokinetics, Inflammation, Research, GAAP, Patient, Private Securities Litigation Reform Act, Wart, Itch, Mission statement, Achievement, United, Clinical trial, Social stigma, Physician, Sibling, Table, Molluscum contagiosum, NDA, FDA, Caregiver, Income, GLOBE, Cantharidin, Technology transfer, Safety, Disease, Pain, Therapy, Pharmaceutical industry, Reinsurance, Air cargo, Torii, Piramal, Chemistry

WEST CHESTER, Pa., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the third quarter ended September 30, 2022.

Key Points: 
  • WEST CHESTER, Pa., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the third quarter ended September 30, 2022.
  • Research and development expenses were $2.9million in the third quarter of 2022, compared to $3.8 million for the same period in 2021.
  • General and administrative expenses were $3.9million in the third quarter of 2022, compared to $8.0 million for the same period in 2021.
  • As of September 30, 2022, Verrica had aggregate cash, cash equivalents, marketable securities and restricted cash of $39.5million.