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Novan, Inc. is a clinical-stage biotechnology company pioneering the use of nitric oxide’s natural antiviral and immunomodulatory properties to develop treatments for dermatological and oncovirus-mediated diseases. By harnessing the unique potential of nitric oxide in a solid form that can be conveniently deployed on demand in localized formulations, Novan aims to significantly enhance patient outcomes in various disease areas.
Novan's innovative approach allows it to address unmet medical needs by focusing on dermatological conditions and oncovirus-mediated diseases. The company's pipeline includes therapeutic candidates designed to treat conditions such as acne, psoriasis, and antiviral applications.
Recently, Novan announced the sale of substantially all its assets for $15 million in cash, subject to approval by the Bankruptcy Court. This transaction will include the repayment of the DIP credit facility, with the remaining cash paid at closing. The sale process is governed by the APA and includes procedures for higher or better offers, ensuring compliance with court-approved bidding procedures.
Novan's strategic partnerships and collaborations with leading pharmaceutical companies reflect its commitment to advancing its clinical programs and expanding its therapeutic portfolio. Despite financial challenges, Novan continues to pursue its mission of improving patient care through groundbreaking biotechnological innovations.
Novan, Inc. (NASDAQ: NOVN) announced positive results from the B-SIMPLE4 Phase 3 study of SB206 for treating molluscum contagiosum. The trial involved 891 patients and achieved statistically significant clearance of lesions at Week 12. The safety profile remained consistent with prior studies, with mild to moderate treatment-emergent adverse events primarily at the application site. A pre-NDA meeting with the FDA is planned for the first half of 2022, with a potential NDA submission targeted for Q3 2022, positioning SB206 as a promising at-home treatment alternative in dermatology.
Novan, Inc. (Nasdaq: NOVN) announced that Paula Brown Stafford, President and CEO, will participate in a fireside chat at the Cantor Fitzgerald Virtual Global Healthcare Conference on September 28, 2021, at 8:00 AM ET. The event is hosted by Jennifer Kim, VP of Equity Research.
The company’s management will also engage in virtual one-on-one meetings with qualified investors. A webcast of the chat will be available on Novan's website for 90 days post-event. Novan is focused on developing nitric oxide-based therapies for dermatology and anti-infective treatments using its proprietary platform, NITRICIL™.
Novan, Inc. (NASDAQ: NOVN) outlines strategic priorities with plans for three New Drug Application (NDA) filings in three years. The first, for SB206 targeting molluscum contagiosum, is set for Q3 2022. Additionally, SB204 for acne vulgaris has been selected for a pivotal Phase 3 study, while the SB019 program for SARS-CoV-2 progresses to Phase 1 in healthy volunteers by mid-2022. The B-SIMPLE4 study of SB206 showed statistically significant results with a p-value <0.0001 for lesion clearance, affirming the potential of Novan's proprietary NITRICIL™ platform.
Novan, Inc. (NASDAQ: NOVN) has chosen Syneos Health (NASDAQ: SYNH) as its commercial solutions provider for SB206, aimed at treating molluscum contagiosum. This collaboration seeks to facilitate the prelaunch strategy and future sales, pending FDA approval. The pivotal Phase 3 B-SIMPLE4 trial reported promising results, achieving complete clearance in over 32% of patients at week 12. An NDA submission for SB206 is targeted for Q3 2022, offering potential first-in-class treatment for molluscum with significant unmet needs in dermatology.
Novan, Inc. (NASDAQ: NOVN) announced that CEO Paula Brown Stafford will participate in a fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021.
Management will also hold virtual one-on-one meetings with registered investors. The fireside chat will be available on-demand starting September 13 at 7:00 AM ET for 90 days via Novan's website. Novan focuses on nitric oxide technology to develop treatments for various conditions, with their lead product, SB206, aimed at molluscum.
Novan, Inc. (Nasdaq: NOVN) will host a corporate update conference call on September 9, 2021, at 8:30 a.m. ET, led by CEO Paula Brown Stafford and her management team. Participants can join via phone or the company's website, where the webcast will also be archived for 90 days. Novan focuses on developing nitric oxide-based therapies for various medical conditions, with its lead candidate, SB206, a topical antiviral gel aimed at treating molluscum, addressing a significant unmet need in dermatology.
Novan, Inc. (NASDAQ: NOVN) has appointed Dr. Tomoko Maeda-Chubachi as Chief Medical Officer, advancing from her previous role as Senior Vice President, Medical. Dr. Maeda-Chubachi played a crucial role in the SB206 Phase 3 trial, which yielded positive efficacy and safety results. Her publication in JID Innovations reinforces SB206's potential to reduce the duration of molluscum contagiosum. The company emphasizes its commitment to leveraging the NITRICIL™ platform for further development of its product pipeline.
Novan reported positive progress in its pipeline, highlighting successful data from its NITRICIL™ technology across three development programs. Key updates include the preparation for a New Drug Application (NDA) filing for SB206, which showed statistically significant efficacy in treating molluscum contagiosum in a pivotal Phase 3 trial. The company also raised $40 million in a public offering, ending Q2 2021 with $65.8 million in cash. Net loss for Q2 2021 was $6 million, a decrease from Q2 2020. Novan continues to explore pipeline expansion and strategic partnerships.
Novan, Inc. (Nasdaq: NOVN) will report its Q2 2021 financial results on August 12, 2021, at 8:30 a.m. ET. A conference call hosted by President and CEO Paula Brown Stafford will provide insights into the company's operational and financial performance. The call can be accessed by calling (844) 707-0661 (domestic) or (703) 318-2240 (international) with conference ID 6686508. Novan focuses on nitric oxide-based treatments, with its lead candidate SB206 targeting molluscum, aiming to meet significant medical needs.
Novan, Inc. (Nasdaq: NOVN) announced the completion of the Week-24 follow-up visits in the pivotal B-SIMPLE4 Phase 3 study for SB206, a topical gel aimed at treating molluscum contagiosum. The study randomized 891 patients and showed positive topline results, achieving statistical significance for the primary endpoint with a p-value below 0.0001. Novan plans to submit its New Drug Application (NDA) by Q3 2022. Currently, there are no FDA-approved therapies for molluscum, highlighting a significant market opportunity for SB206.
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