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, a leader in men's health therapeutics, will have President Fady Boctor presenting at two virtual conferences. The Q3 Investor Summit is scheduled for August 17-18, 2021, with Boctor's presentation at 12:30 pm ET on August 17. The SNN Network Summer Virtual Event will follow on August 17-19, 2021, featuring his talk on August 18 at 4:00 pm ET. One-on-one meetings will be available throughout both conferences. Investors can register for these events via the provided links.
Petros Pharmaceuticals (Nasdaq: PTPI) received approval for a meeting with the FDA scheduled for September 2021 to discuss potential labeling changes for its erectile dysfunction medication, STENDRA® (avanafil). Proposed modifications include adjustments to the nitrate contraindication, allowing for twice-daily dosing under certain conditions, inclusion of clinical study results for patients post-radical prostatectomy, and updates on endothelial function effects. The aim is to enhance STENDRA's profile and accessibility, especially as over 30 million men in the U.S. suffer from erectile dysfunction, but many remain untreated.
Petros Pharmaceuticals (Nasdaq: PTPI) announces the completion of a pilot study aimed at achieving over-the-counter (OTC) status for its erectile dysfunction medication, Stendra, from the FDA. The initial study showed promising results, with over 90% of participants understanding key label messages. A Phase 2 study has been initiated to further support the OTC designation. Currently, no prescription ED therapies are approved for OTC status in the U.S. Achieving this milestone could enhance accessibility for the 30 million U.S. men suffering from ED.
Petros Pharmaceuticals (Nasdaq: PTPI) has announced that its President and Chief Commercial Officer, Fady Boctor, will present at the Access to Giving Virtual Investor Conference from July 13 to 15, 2021. Boctor's presentation is scheduled for July 14 at 3:30pm ET. Interested parties can register for the event through a provided link or request one-on-one meetings via email. The company aims to be a leader in men's health by developing innovative therapies for various conditions including erectile dysfunction and hormone health.
Petros Pharmaceuticals (Nasdaq: PTPI) announced that President Fady Boctor will present a corporate overview at the LD Micro Virtual Invitational Conference from June 8 to 10, 2021. Boctor's presentation is scheduled for June 10 at 4:00pm ET, Track 1. Investors can register to watch the presentation here. The company focuses on developing innovative therapeutics for men's health issues, including erectile dysfunction and Peyronie's disease.
Petros Pharmaceuticals (PTPI) reported a strong Q1 2021, with net sales reaching $4.1 million, up 300% from Q1 2020. The increase was driven by a 23% rise in STENDRA® prescriptions, achieving an all-time high. Gross margins expanded to 84% from 56% in the previous year. The company posted a net income of $3.0 million, improving from a net loss of $6.1 million. Operating expenses decreased by 22% to $3.9 million. The robust performance reflects effective sales initiatives and a favorable post-COVID environment.
Petros Pharmaceuticals (Nasdaq: PTPI) announced its participation at the Investor Summit Conference on May 18, 2021. President and Chief Commercial Officer Fady Boctor will present at 9:30am ET. Investors can also arrange one-on-one meetings with Mr. Boctor after the conference. The company aims to lead in men's health therapeutics, focusing on issues like erectile dysfunction and Peyronie's disease. Interested investors can register for the conference here.
Petros Pharmaceuticals (Nasdaq: PTPI) will present at the Benzinga Global Small Cap Conference on May 13, 2021. Fady Boctor, President and Chief Commercial Officer, is set to deliver his corporate presentation at 10:50am ET. Investors interested in a one-on-one meeting can request arrangements after the event. Petros Pharmaceuticals aims to lead in specialized men's health by developing innovative therapeutics addressing issues such as erectile dysfunction, Peyronie's disease, and hormone health.
Petros Pharmaceuticals (NASDAQ: PTPI) announced preliminary research on Stendra® (avanafil) for enhancing endothelial function in men with erectile dysfunction (ED), aiming for FDA discussions to expand its labeling. The peer-reviewed study, involving 140 participants, indicated significant improvements in nitric oxide and erectile function with daily avanafil compared to placebo. Stendra, FDA-approved since 2013, has previously been recognized for its rapid onset of action. However, the study had limitations, including a small sample size and short follow-up, necessitating further research.
Petros Pharmaceuticals (NASDAQ: PTPI) announced the appointment of Dr. Mohit Khera to its steering committee to enhance patient access for STENDRA® (avanafil), a treatment for erectile dysfunction (ED). Dr. Khera, a Urology Professor at Baylor College of Medicine, aims to explore potential over-the-counter availability for STENDRA® in the U.S., reflecting on successful non-prescription models in other countries. This initiative is part of Petros's strategy to bolster the relaunch of STENDRA®, which generated approximately $30 million in revenue in 2019.
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