NOVN Novan Inc.

0.56
+0.07  (+14%)
Previous Close 0.49
Open 0.52
52 Week Low 0.215
52 Week High 3.72
Market Cap $45,248,532
Shares 80,786,380
Float 79,666,604
Enterprise Value $23,882,011
Volume 18,684,187
Av. Daily Volume 16,013,855
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Upcoming Catalysts

Drug Stage Catalyst Date
SB206
Molluscum
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
SB414
Atopic Dermatitis
Phase 1b
Phase 1b
Phase 2 trial to be initiated 4Q 2019.
SB206
Human papillomavirus (HPV)
Phase 2
Phase 2
Phase 2 data released November 29, 2016. Primary endpoint met.
SB204
Acne vulgaris
Phase 3
Phase 3
Phase 3 top-line data released January 27, 2017. Met one of three co-primary endpoints in NI-AC301 trial. Met all endpoints in NI-AC302 trial. Additional Phase 3 trial required.
SB208
Fungal infections
Phase 2
Phase 2
Phase 2 data released April 12, 2017. Primary endpoint met.

Latest News

  1. MORRISVILLE, N.C., June 25, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company anticipates that its current cash position will be sufficient to fund costs associated with conducting an additional Phase 3 pivotal trial for SB206 as a treatment for molluscum, or B-SIMPLE4 (Berdazimer Sodium In Molluscum Patients with Lesions). Since June 1, 2020, the Company has secured approximately $16.9 million in capital from the use of common stock purchase agreements with Aspire Capital Fund, LLC and the exercise of common stock warrants sold in its March 2020 public offering.

    The Company is targeting enrolling the first patient for B-SIMPLE4 in September 2020 and, if the trial is initiated on…

    MORRISVILLE, N.C., June 25, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company anticipates that its current cash position will be sufficient to fund costs associated with conducting an additional Phase 3 pivotal trial for SB206 as a treatment for molluscum, or B-SIMPLE4 (Berdazimer Sodium In Molluscum Patients with Lesions). Since June 1, 2020, the Company has secured approximately $16.9 million in capital from the use of common stock purchase agreements with Aspire Capital Fund, LLC and the exercise of common stock warrants sold in its March 2020 public offering.

    The Company is targeting enrolling the first patient for B-SIMPLE4 in September 2020 and, if the trial is initiated on this timetable and not further impacted by the COVID-19 pandemic, top-line efficacy results would be targeted for late in the second quarter of 2021.

    "We are delighted to be in a position to proceed with the B-SIMPLE4 study," commented Paula Brown Stafford, Novan's President and Chief Executive Officer. "An unmet need remains for molluscum patients and their caregivers, and we look forward to advancing the SB206 program."

    Currently there are no U.S. Food and Drug Administration-approved therapies for the treatment of molluscum. Treatment choices for patients, the majority of whom are below the age of 10, include in-office and often painful, physician-administered scraping, freezing, burning and blistering treatments. The only other choices appear to be off-label prescriptions and over-the-counter products with no clinical data that support a molluscum indication and therefore have no proven clinical efficacy and an unknown safety profile. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum.

    About Novan

    Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide's naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women's health and gastrointestinal diseases.

    Forward-Looking Statements

    This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing for the B-SIMPLE4 Phase 3 trial and anticipated top-line results, and the sufficiency of our cash position. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, the risk that we may not be able to begin enrollment as planned or that enrollment in or the conduct of the B-SIMPLE4 Phase 3 trial may be delayed or otherwise impacted as a result of the COVID-19 pandemic or other factors; the risk that results from the B-SIMPLE4 Phase 3 trial will not be received timely or will not achieve significance sufficient to support a new drug application; the risk that the cost of the B-SIMPLE4 Phase 3 trial or other operational costs will exceed our expectations; our ability to obtain any additional funding that may become necessary to continue our business and the further development of our product candidates, including SB206 for molluscum; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; the risk that disruptions at the FDA or other agencies could cause such agencies to cancel or postpone meetings or otherwise impact the ability of such agencies to provide regulatory guidance or feedback or timely review and process our regulatory submissions, all of which could have a material adverse effect on our business; risks related to the manufacture of clinical trial materials; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 Phase 3 trial; and other risks and uncertainties described in our annual report filed with the Securities and Exchange Commission on Form 10-K/A for the twelve months ended December 31, 2019, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

    CONTACT:

    (Investors & Media)

    Cole Ikkala

    Director, Investor Relations, Communications & Business Development

    Primary Logo

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  2. MORRISVILLE, N.C., June 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that Paula Brown Stafford, the Company's President and Chief Executive Officer, will present a corporate overview at the Life Sciences Investor Forum on Thursday, June 25, 2020 at 2:00 p.m. Eastern.

    This will be a live, interactive online event where investors are invited to ask the company questions in real-time. The presentation and Q&A session will be webcast live and can be accessed through the Events page of the For Investors section of the Company's website at https://novan.gcs-web.com/events or at www.lifesciencesinvestorforum.com.

    If attendees are not able to join the event live on the day of the conference, an…

    MORRISVILLE, N.C., June 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that Paula Brown Stafford, the Company's President and Chief Executive Officer, will present a corporate overview at the Life Sciences Investor Forum on Thursday, June 25, 2020 at 2:00 p.m. Eastern.

    This will be a live, interactive online event where investors are invited to ask the company questions in real-time. The presentation and Q&A session will be webcast live and can be accessed through the Events page of the For Investors section of the Company's website at https://novan.gcs-web.com/events or at www.lifesciencesinvestorforum.com.

    If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event. It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates.

    About Novan

    Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide's naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women's health and gastrointestinal diseases.

    About Life Sciences Investor Forum

    Life Sciences Investor Forum is the leading proprietary investor conference series that provides an interactive forum for Life Sciences companies to meet with and present directly to investors. A real-time solution for investor engagement, Life Sciences Investor Forum is powered by Intrado Digital Media and specifically designed for more efficient investor access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combines leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

    CONTACT:

    (Investors & Media)

    Cole Ikkala

    Director, Investor Relations, Communications & Business Development

    Primary Logo

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    • Enrollment of first patient targeted for September 2020
    • Top line results expected late in the second quarter of 2021 based on anticipated timeline

    MORRISVILLE, N.C., April 30, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding SB206 for the treatment of molluscum contagiosum ("molluscum"). Based on guidance the Company received during the meeting and subsequently contained within the meeting minutes, Novan is preparing to conduct one additional pivotal trial ("B-SIMPLE4"), which, if successful, could be supported by the previously completed B-SIMPLE2 trial…

    • Enrollment of first patient targeted for September 2020
    • Top line results expected late in the second quarter of 2021 based on anticipated timeline

    MORRISVILLE, N.C., April 30, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding SB206 for the treatment of molluscum contagiosum ("molluscum"). Based on guidance the Company received during the meeting and subsequently contained within the meeting minutes, Novan is preparing to conduct one additional pivotal trial ("B-SIMPLE4"), which, if successful, could be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application ("NDA"). In addition, the FDA provided guidance with regard to the study design for B-SIMPLE4 and expectations for a future NDA submission, which has been incorporated in the B-SIMPLE4 preliminary trial design characteristics:

    • Number of patients: approximately 750 (1:1 randomization)
    • Stratification: investigator type, subjects per household and inflammation of molluscum lesions as measured by BOTE1 (beginning of the end)
    • Primary endpoint: proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or "ITT" population, where the analysis assumes that patients with missing data at Week 12 are assessed as treatment failures)
    • Visits: Screening/Baseline, Week 2, Week 4, Week 8, Week 12 and safety follow-up at Week 24
    • Implementation of additional patient and caregiver training and retention efforts
    • Use of decentralized visit capabilities for conduct during COVID-19 pandemic

    Novan plans to send the proposed protocol to the FDA in the near term. The Company has begun the planning and start-up phase for B-SIMPLE4. Novan is targeting enrolling the first patient for B-SIMPLE4 in September 2020, and if the trial is initiated on this timetable, the Company would expect top-line efficacy results late in the second quarter of 2021. The initiation and execution of B-SIMPLE4, beyond the start-up phase, is subject to additional funding or strategic partnering and may be further impacted by the COVID-19 pandemic.

    "We believe the totality of the clinical data for SB206 is positive and the B-SIMPLE4 protocol incorporates both the input from the FDA and our learnings from B-SIMPLE1 and B-SIMPLE2," commented Paula Brown Stafford, Novan's President and Chief Executive Officer. Ms. Stafford further commented, "We also believe that the time between now and first-patient-in, which we anticipate in September, provides a window of opportunity to explore and evaluate potential value-creating strategic and other relationships in order to advance this important program."

    As announced on April 20, 2020, the Company has engaged H.C. Wainwright & Co., LLC to assist the Company in exploring and evaluating a range of strategic and financial alternatives. This evaluation is on-going. The Company has not stated a definitive timeline for completion of the evaluation process and there can be no assurance that the evaluation process will result in the Company pursuing any strategic or financial alternatives, or that a strategic or financial alternative, if any, would be completed successfully or at all.

    1. Butala, N., et al. "Molluscum BOTE Sign: A Predictor of Imminent Resolution." Pediatrics, vol. 131, no. 5, 2013, doi:10.1542/peds.2012-2933.

    About Novan

    Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide's naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women's health and gastrointestinal diseases.

    Forward-Looking Statements

    This press release contains forward-looking statements including, but not limited to, statements related to potential strategic or financial transactions involving the Company, pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing for the B-SIMPLE4 Phase 3 trial and anticipated top-line results, the timing of potential regulatory submissions, and our needs for funding. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, the risk that we may not be able to begin enrollment as planned or that enrollment in or the conduct of the B-SIMPLE4 Phase 3 trial may be delayed or otherwise impacted as a result of the COVID-19 pandemic or other factors, the risk that results from the B-SIMPLE4 Phase 3 trial will not be received timely or will not achieve significance sufficient to support an NDA; our ability to complete any strategic alternatives and/or obtain additional funding necessary to continue our business and the further development of our product candidates, including to enable or complete the B-SIMPLE4 trial, on a timely basis, or at all; risks and uncertainties as to the terms, timing, structure, value, benefits and costs of any strategic or financial transaction, and our ability to complete one at all; our ability to reduce cash expenditures; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; the risk that disruptions at the FDA and other agencies could cause such agencies to cancel or postpone meetings or otherwise impact the ability of such agencies to provide regulatory guidance or feedback or timely review and process our regulatory submissions, all of which could have a material adverse effect on our business; risks related to the manufacture of clinical trial materials; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to our evaluation of strategic alternatives or the conduct of the B-SIMPLE4 trial; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

    CONTACT:

    (Investors & Media)
    Cole Ikkala
    Director, Investor Relations, Communications & Business Development

    Primary Logo

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    • Engages H.C. Wainwright & Co. as strategic and financial advisor
    • NITRICIL™ nitric oxide technology platform has enabled multiple early and late-stage pipeline opportunities in dermatology, women's health and GI disorders

    MORRISVILLE, N.C., April 20, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it has engaged H.C. Wainwright & Co., LLC ("H.C. Wainwright & Co.") to assist the Company in exploring and evaluating a range of strategic and financial alternatives, intended to maximize shareholder value.

    The Company has advanced several late stage development programs in the field of dermatology, including the Company's lead product candidate, SB206, that is in Phase 3 clinical trials for molluscum…

    • Engages H.C. Wainwright & Co. as strategic and financial advisor
    • NITRICIL™ nitric oxide technology platform has enabled multiple early and late-stage pipeline opportunities in dermatology, women's health and GI disorders

    MORRISVILLE, N.C., April 20, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it has engaged H.C. Wainwright & Co., LLC ("H.C. Wainwright & Co.") to assist the Company in exploring and evaluating a range of strategic and financial alternatives, intended to maximize shareholder value.

    The Company has advanced several late stage development programs in the field of dermatology, including the Company's lead product candidate, SB206, that is in Phase 3 clinical trials for molluscum contagiosum ("molluscum"), a primarily pediatric contagious skin infection. In addition, Novan has initiated several early stage programs in women's health and gastrointestinal ("GI") disorders. Novan's development programs were created from the Company's proprietary NITRICIL™ technology platform. This proprietary technology has been utilized in more than 3,400 subjects and patients, providing the Company with clinical efficacy and safety data, demonstrating anti-viral, bacterial, fungal and inflammatory properties.

    The Company believes that its clinical and preclinical data, technology platform and market potential, will provide for a range of opportunities in order to maximize shareholder value:

    • SB206 (molluscum): April 1, 2020 verbal guidance provided from the U.S. Food and Drug Administration ("FDA") indicating that the FDA will consider one additional pivotal trial ("B-SIMPLE4"), that, if successful, can be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application ("NDA"). Management remains focused on SB206, Novan's lead product candidate for the treatment of molluscum, as a key value driver for the Company.
       
    • SB206 (external genital warts): positioned to initiate Phase 3 pivotal trials following positive Phase 2 results in the fourth quarter of 2016, and an end of Phase 2 meeting with the FDA in the second quarter of 2017.
       
    • SB204 (acne vulgaris): positioned to initiate one additional pivotal Phase 3 trial in moderate-to-severe acne patients. In the first quarter of 2017, announced statistically significant results compared to vehicle on all three co-primary endpoints in NI-AC302.
       
    • SB414 (atopic dermatitis): positioned to initiate a Phase 2 clinical program given the successful downregulation of key biomarkers, favorable tolerability and lack of systemic exposure in a Phase 1b study with SB414 2%, announced in the third quarter of 2018.
       
    • SB208 (tinea pedis and onychomycosis): positioned to initiate a Phase 2 trial in onychomycosis following positive results in a Phase 2 study of tinea pedis and a Phase 1 study in nail growth, announced in the second quarter of 2017 and the second quarter of 2018, respectively.
       
    • WH504 and WH602 (high-risk HPV, cervical intraepithelial neoplasia): since August 2019, awarded a total of $2.3 million in grants from the National Institutes of Health ("NIH") and U.S. Department of Defense's ("DoD") Congressionally Directed Medical Research Programs ("CDMRP") in order to advance formulation development of nitric oxide-containing intravaginal gel (WH602) and non-gel (WH504) product candidates.
       
    • GI disorders: berdazimer sodium demonstrated statistically significant improvements in disease activity (i.e., reduced disease activity index scores), as compared to vehicle in a dextran sulfate sodium (DSS)-induced acute colitis mouse model during the fourth quarter of 2019.
       
    • Coronaviridae family: initiated a work order in March 2020 to complete in vitro assessment of the Company's NITRICIL™ technology, berdazimer sodium, against species within the Coronaviridae family, including SARS-CoV-2, the virus that causes COVID-19.
       
    • New Chemical Entity ("NCE") development: the Company has the ability to rapidly generate NCEs and drug delivery capabilities, utilizing our NITRICIL™ nitric oxide technology platform, for discovery, research and development across segments such as animal health and ophthalmology, among additional therapeutic areas.

    Given the opportunities enabled by Novan's NITRCIL™ technology platform, the Company believes that in conjunction with H.C. Wainwright & Co. it is well-positioned to advance a strategic and financial review process intended to maximize shareholder value.

    "Despite the challenging business environment, our team has worked diligently, over the past sixty-days to gain FDA regulatory clarity regarding a path forward for SB206 in the molluscum indication and secure additional capital from the equity markets," commented Paula Brown Stafford, Novan's President and Chief Executive Officer. Ms. Stafford further commented, "With these milestones accomplished and the broader opportunities enabled by Novan's NITRCIL™ technology platform, the Board of Directors and senior management are now committed to working closely with H.C. Wainwright & Co. in order to explore Novan's strategic and financial alternatives, with the goal to advance our nitric-oxide based technology platform for the benefit of patients and maximize value for our shareholders and other stakeholders of our Company."

    The Company has not stated a definitive timeline for completion of the evaluation process and there can be no assurance that the evaluation process will result in Novan pursuing any strategic or financial alternatives, or that a strategic of financial alternative, if any, would be completed successfully or at all. Novan does not intend to discuss or disclose developments with respect to this process until the evaluation process has been completed, or the Novan Board of Directors has concluded that disclosure is appropriate or required.

    About Novan

    Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide's naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women's health and gastrointestinal diseases.

    Forward-Looking Statements

    This press release contains forward-looking statements including, but not limited to, statements related to potential strategic or financial transactions involving the Company, pharmaceutical development of our nitric oxide-releasing product candidates and our intention to advance development of certain product candidates and the timing and contents of potential regulatory submissions. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, risks and uncertainties related to our ability to complete any strategic alternatives and/or obtain additional funding necessary to continue our business and the further development of our product candidates, including to enable or complete the B-SIMPLE4 trial, on a timely basis, or at all; risks and uncertainties as to the terms, timing, structure, value, benefits and costs of any strategic or financial transaction, and our ability to complete one at all; risks and uncertainties related to the impact of this announcement on the Company's securities, its employees and its third-party partners; risks and uncertainties in our ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of our product candidates; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; the risk that disruptions at the FDA and other agencies could cause such agencies to cancel or postpone meetings or otherwise impact the ability of such agencies to provide regulatory guidance or feedback or timely review and process our regulatory submissions, all of which could have a material adverse effect on our business; the risk that the B-SIMPLE4 Phase 3 trial will be delayed or postponed and that results will not be received timely or will not achieve significance sufficient to support an NDA; risks related to the manufacture of clinical trial materials; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to our evaluation of strategic alternatives or the conduct of the B-SIMPLE4 trial; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

    CONTACT:

    (Investors & Media)
    Cole Ikkala
    Director, Investor Relations, Communications & Business Development

    Primary Logo

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    • Per verbal guidance, FDA to consider one additional pivotal trial
    • FDA-generated minutes expected on or before May 1, 2020
    • Sato Pharmaceutical to begin start-up of Phase 1 trial in Japan

    MORRISVILLE, N.C., April 03, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has conducted its Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding SB206 for the treatment of molluscum. The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application ("NDA").

    Based on guidance received during the meeting, the Company understands the FDA will consider one additional…

    • Per verbal guidance, FDA to consider one additional pivotal trial
    • FDA-generated minutes expected on or before May 1, 2020
    • Sato Pharmaceutical to begin start-up of Phase 1 trial in Japan

    MORRISVILLE, N.C., April 03, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has conducted its Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding SB206 for the treatment of molluscum. The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application ("NDA").

    Based on guidance received during the meeting, the Company understands the FDA will consider one additional pivotal trial ("B-SIMPLE4"), if successful, to be supported by the previously completed B-SIMPLE2 trial. In addition, the FDA provided guidance with regard to both the study design for B-SIMPLE4 and expectations for a future NDA submission. FDA-generated minutes, expected on or before May 1, 2020, will serve as the meeting's official record.

    "We are pleased with the promising dialogue that we had with the FDA and the clarity provided for a path forward for SB206," commented Paula Brown Stafford, Novan's President and Chief Executive Officer. Ms. Stafford further commented, "Our team is working diligently to incorporate the agency's suggestions and feedback into the B-SIMPLE4 study design as we seek to optimize execution success and minimize regulatory risk."

    Novan's Japanese development and commercialization partner, Sato Pharmaceutical Co., Ltd. ("Sato"), has also informed the Company of Sato's intention to progress the SB206 development program in Japan with a Phase 1 clinical trial given the observed treatment benefit and favorable safety profile in the B-SIMPLE program.

    "Upon review of the totality of the efficacy and safety data from the B-SIMPLE program, Novan and Sato share optimism for the continued progression of SB206 for molluscum in both the US and Japan," commented Ms. Stafford. "Sato is a tremendously valuable business and development partner and we look forward to continued collaboration to progress the program."

    About Novan

    Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide's naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women's health and gastrointestinal diseases.

    Forward-Looking Statements

    This press release contains forward-looking statements including, but not limited to, pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, the expected timing and contents of meeting minutes from the FDA from our April 1, 2020 meeting regarding our B-SIMPLE program, the timing for the B-SIMPLE4 Phase 3 trial, Sato's progress of the clinical development program for SB206 in Japan and the timing of potential regulatory submissions. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; the risk that disruptions at the FDA and other agencies could cause such agencies to cancel or postpone meetings or otherwise impact the ability of such agencies to provide regulatory guidance or feedback or timely review and process our regulatory submissions, all of which could have a material adverse effect on our business; the risk that the B-SIMPLE4 Phase 3 trial will be delayed or postponed and that results will not be received timely or will not achieve significance sufficient to support an NDA; risks and uncertainties related to our ability to obtain funding or enter into strategic relationships on a timely basis, or at all, to enable or complete the B-SIMPLE4 Phase 3 trial and to continue operations; our ability to reduce cash expenditures; risks related to the manufacture of clinical trial materials; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 trial; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

    CONTACT:

    (Investors & Media)
    Cole Ikkala
    Director, Investor Relations, Communications & Business Development

    Primary Logo

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