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 an expansion of its program for H100, a non-invasive topical treatment for Peyronie's disease. H100 is designed to alleviate the inflammatory issues causing pain and irregularities in penile shape. Through an exclusive agreement with Hybrid Medical LLC, Petros aims to position H100 as the first approved non-invasive treatment for this condition. The company expresses optimism about H100's potential safety profile and expedited development timeline under a 505(b)(2) submission process.
Petros Pharmaceuticals (PTPI) has reported a remarkable 476% increase in STENDRA tablet sales year-over-year, attributed to its exclusive digital health marketing agreement with Hims & Hers Health. The partnership allows greater consumer access to STENDRA through Hims' telehealth platform, which now offers multiple dosages. Despite the growth, the company faces significant challenges, including reliance on a single product for revenue and the potential for market volatility. With only 25% of men with erectile dysfunction receiving treatment, the market opportunity remains substantial.
Petros Pharmaceuticals (Nasdaq: PTPI) announces participation in two upcoming Benzinga events. President Fady Boctor will be featured in a 20-minute interview at the Benzinga All Access Show on October 22, 2021, discussing corporate developments. Additionally, Boctor will present a corporate overview at the Benzinga Global Small Cap Conference on October 27, with one-on-one meetings available throughout the event. The company aims to lead in specialized men's health therapeutics.
Petros Pharmaceuticals (Nasdaq: PTPI) has closed a registered direct offering, raising approximately $5.7 million from its largest and other existing investors. The funds will support the expansion of its men's health platform and provide working capital. CEO Fady Boctor emphasized that this financing is vital for the continued development of its product STENDRA and other promising assets, particularly following STENDRA's strong market performance in recent quarters.
Petros Pharmaceuticals (Nasdaq: PTPI) announced a registered direct offering, agreeing to sell 3,323,616 shares of common stock at $1.715 per share, expected to generate around $5.7 million before expenses. The funds will be used to expand its men's health platform and for general corporate purposes. Closing is anticipated on or around October 18, 2021. Additionally, unregistered warrants for the same number of shares will be issued. The offering is part of compliance with SEC regulations and aims at enhancing shareholder value.
Petros Pharmaceuticals (Nasdaq: PTPI) announces its participation in the virtual Benzinga Healthcare Small Cap Conference from September 29-30, 2021. President and Chief Commercial Officer Fady Boctor will present on September 30 at 2:40 PM ET and will be available for one-on-one meetings throughout the event. The company is focused on becoming a leading men's health provider by developing innovative therapeutics for various issues, including erectile dysfunction and hormone health.
Petros Pharmaceuticals, a leader in men's health therapeutics, announces that President Fady Boctor will present at the H.C. Wainwright Global Investment Conference from September 13-15, 2021. The presentation will be accessible starting at 7:00 AM ET on September 13. Additionally, Mr. Boctor will hold one-on-one meetings throughout the event. Petros Pharmaceuticals aims to be a top specialized men's health company focusing on issues like erectile dysfunction, Peyronie's disease, and hormone health.
Petros Pharmaceuticals (PTPI) reported strong financial performance for Q2 2021, with net sales of $2.5 million, a 79% increase year-over-year. The growth was driven by a 123% rise in STENDRA net sales, contributing $1.7 million, and 28% growth in Medical Device sales. Gross margins reached 84%, up from 61% in Q2 2020. The company is pursuing over-the-counter status for STENDRA and expanding its labeling with FDA. However, cash reserves decreased to $11 million by June 30, 2021.
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.
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