Welcome to our dedicated page for Petros Pharmaceuticals news (Ticker: PTPI), a resource for investors and traders seeking the latest updates and insights on Petros Pharmaceuticals stock.
Petros Pharmaceuticals, Inc. (NASDAQ: PTPI) is a pioneering men's health pharmaceutical company dedicated to advancing therapeutics that enhance medication adherence, tolerability, and preservation of male organic function. The company operates through two main segments: Prescription Medications and Medical Devices. Its cornerstone product, STENDRA® (avanafil), is an oral phosphodiesterase 5 (PDE5) inhibitor designed specifically for the treatment of erectile dysfunction. Currently, Petros is actively pursuing increased access to STENDRA through potential over-the-counter (OTC) designation, making it the first prescription-grade ED therapy to achieve this status.
The Medical Devices segment is the primary revenue generator, focusing on vacuum erection devices marketed both domestically and internationally. The Prescription Medications segment involves operations related to these devices and ongoing efforts to transition STENDRA to OTC availability. Recently, Petros has integrated advanced artificial intelligence (AI) technologies to enhance patient self-screening and ensure safe administration of STENDRA without the need for a prescription.
Recent Achievements and Partnerships:
- Successful collaboration with a leading AI software provider to develop a self-screening tool for STENDRA, enhancing the self-selection process under FDA guidance.
- Launch of a Human Factors Study incorporating the AI tool, aimed at optimizing the safe administration of STENDRA for OTC use.
- Positive feedback from the FDA on the AI technology's efficacy in addressing key concerns for OTC availability, especially for nitrate-using patients.
- Partnership with Lemonaid Health to expand the distribution of prescription STENDRA through their telehealth platform, improving accessibility for ED patients nationwide.
- Formation of an Advisory Committee comprising former FDA officials and key clinical and regulatory opinion leaders to guide the Rx-to-OTC switch process.
Petros Pharmaceuticals is committed to innovation in the self-care market, driving expanded access to essential prescription pharmaceuticals as OTC treatment options. Through strategic partnerships and technological advancements, the company aims to meet significant unmet medical needs and enhance the quality of life for men worldwide.
Petros Pharmaceuticals has announced new data published in the International Journal of Urology, revealing positive results for its erectile dysfunction treatment, STENDRA (avanafil), in a study comparing it to sildenafil (Viagra). The trial demonstrated STENDRA's rapid onset of action, with 84.8% of patients achieving an erection within 15 minutes. After 12 weeks, 64.8% of STENDRA users reported normal erectile function vs. 36.9% for sildenafil. Despite the small sample size and other limitations, the findings support STENDRA's therapeutic value and potential for OTC status.
Petros Pharmaceuticals (NASDAQ:PTPI) reported Q2 2022 net sales of $4.2 million, a significant increase from $2.5 million in Q2 2021. The company achieved its first positive Adjusted EBITDA of $200,000, reflecting improved operational efficiency. Key progress includes successful OTC label comprehension for STENDRA® and a research agreement with Massachusetts General Hospital. Total gross profit was $3.5 million, with gross margins steady at 84%. Cash reserves totaled $13.3 million as of June 30, 2022.
Petros Pharmaceuticals, Inc. (Nasdaq: PTPI) has confirmed that a July 28, 2022, press release announcing an acquisition was fraudulent. The company clarified that it is not involved in any acquisition and has reported this fraudulent activity to Nasdaq. Petros aims to be a leading provider of men's health therapeutics, focusing on conditions such as erectile dysfunction and Peyronie’s disease.
The company remains committed to its business strategy and continues to prioritize the development of innovative solutions for men's health issues.
Petros Pharmaceuticals (Nasdaq: PTPI) has collaborated with Dr. Drew Pinsky to raise awareness about men's health issues, particularly erectile dysfunction (ED) and STENDRA (avanafil). Dr. Drew's involvement aims to destigmatize these sensitive topics and educate the public on treatment options. The partnership underscores Petros's efforts to pursue Over The Counter (OTC) designation for STENDRA. Currently, an estimated 30 million men in the U.S. suffer from ED, with 75% remaining untreated. This initiative seeks to enhance visibility and accessibility of Petros's offerings in the men's health landscape.
Petros Pharmaceuticals (PTPI) reported Q1 2022 financial results, with net sales of $2.5 million, down from $4.1 million in Q1 2021. The decline was primarily due to a severe supply shortage of STENDRA, leading to a 52% decrease in prescription medicine sales. Gross profit fell to $2 million, with gross margins at 81%. R&D expenses rose to $405,000, influenced by the development of new products. The net loss for Q1 2022 was $174,000, a stark contrast to a $3 million profit the previous year. Cash reserves declined to $17.7 million, from $23.9 million at the end of 2021.
Petros Pharmaceuticals is pursuing the 505(b)(2) pathway for its investigational agent H-100, potentially the first FDA-approved non-invasive topical treatment for Peyronie’s disease, affecting over 10% of men in the US. Developed using nanotechnology, H-100 aims to enhance medication permeation and tackle the disease's inflammatory cascade. The 505(b)(2) pathway offers an efficient development route by leveraging existing FDA data. Petros aims to provide a much-needed alternative to current invasive treatment options.
Petros Pharmaceuticals (Nasdaq: PTPI) announces its President and Chief Commercial Officer, Fady Boctor, will present at the Planet MicroCap Showcase 2022. The event takes place from May 3-5, 2022, at Bally’s Hotel & Casino, Las Vegas, NV, with Boctor's presentation scheduled for May 4 at 10:00 AM PT. He will also be available for one-on-one meetings during the conference. Petros focuses on innovative therapies for men’s health, targeting issues like erectile dysfunction and hormone health.
Petros Pharmaceuticals has announced a new partnership with the Wellman Center at Massachusetts General Hospital to explore a tissue-specific oxygenation sensor aimed at improving Erectile Device Therapy. This Sponsored Research Agreement includes an option for an exclusive license of the sensor technology, which could enhance the efficacy of at-home treatments for erectile dysfunction. The new technology promises real-time feedback for patients and practitioners, potentially marking a significant advancement in men's health therapies.
Petros Pharmaceuticals (PTPI) has reported positive results from its OTC label comprehension study for STENDRA (avanafil), an erectile dysfunction drug. The results indicate over 95% comprehension of key messages among participants, including those with lower health literacy. This success supports the company's plans to submit an OTC application to the FDA, potentially making STENDRA the first prescription-grade ED medication available over-the-counter in the U.S. The company emphasizes the importance of expanding access for the estimated 30 million men suffering from ED.
Petros Pharmaceuticals (PTPI) reported significant financial improvements for the fiscal year ending December 31, 2021. Net sales reached $7.8 million, though down from $9.6 million in 2020, attributed to competitive market conditions. Gross profit increased by 13% to $6.2 million, driven by reduced inventory write-offs and lower fulfillment costs. The net loss narrowed by 56% to $9.0 million, reflecting efficient operations and decreased derivative liabilities. The company is collaborating with Dr. Drew Pinsky to enhance awareness of men's health and is pursuing FDA approval for over-the-counter status for STENDRA®, aiming to broaden its market.
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