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 (Nasdaq:PTPI) announced a 1-for-10 reverse stock split effective at 4:05 p.m. on November 30, 2022. Following the split, shares will trade on a split-adjusted basis starting December 1, 2022. This decision was backed by stockholder approval at the annual meeting held on November 29, 2022. The move will decrease the total outstanding shares from approximately 20.7 million to 2.1 million, while maintaining each shareholder's percentage interest, with fractional shares rounded up.
Petros Pharmaceuticals (NASDAQ: PTPI) announced its Q3 2022 financial results, reporting net sales of negative $1.4 million, a decline from $2.1 million in the same quarter of 2021. This drop was driven by excessive returns due to expired product inventory. The company also recorded a net loss of $13.8 million, significantly up from a loss of $1.7 million year-over-year. Despite challenges, Petros highlighted FDA approval for an expanded STENDRA label and aims to achieve over-the-counter access for the product, which could enhance market reach. Total cash stood at $11.2 million as of September 30, 2022.
Petros Pharmaceuticals has expanded the FDA labeling of its erectile dysfunction drug STENDRA (avanafil) to include new clinical trial data. The study involved 286 men post-radical prostatectomy, demonstrating significant improvements in erectile function with doses of 100 mg and 200 mg. The company aims to enhance access to STENDRA, including potentially offering it over-the-counter. The label expansion reflects ongoing cooperation with the FDA to include previously unrepresented patient populations.
Petros Pharmaceuticals (NASDAQ:PTPI) announces that President Fady Boctor will participate in two significant conferences in October 2022. The first event is the LD Micro Main Event XV in Los Angeles on October 25, where he will present at 4:30 pm PT and be available for one-on-one meetings. The second event is the 23rd Annual Fall Scientific Meeting of SMSNA in Miami from October 27 to 30, where he will represent the company at Booth 102. Petros focuses on developing innovative therapeutics for various men's health issues.
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.
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