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Petros Pharmaceuticals, Inc. - PTPI STOCK NEWS

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.

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Petros Pharmaceuticals announces initiation of self-selection study for potential OTC version of STENDRA, an erectile dysfunction medication
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Petros Pharmaceuticals completes pivotal label comprehension study for potential non-prescription version of STENDRA, indicating positive results and paving the way for further development and collaboration with FDA.
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Petros Pharmaceuticals (PTPI) announces Fady Boctor to present corporate overview at LD Micro Main Event XVI on October 4, 2023.
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Petros Pharmaceuticals shifts focus to non-prescription access for lead product, utilizing new FDA rules. Exploring partnerships for technology development. Experienced management in marketing former Rx products to OTC arena.
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Petros Pharmaceuticals, Inc. announces corporate overview presentation at H.C. Wainwright 25th Annual Global Investment Conference
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Petros Pharmaceuticals announces a $15 million private placement financing to support the development of its erectile dysfunction drug, STENDRA, as an over the counter (OTC) medication. The funds raised, combined with the company's cash on hand, will provide a strong financial position through 2024.
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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of Petros Pharmaceuticals (PTPI)?

The current stock price of Petros Pharmaceuticals (PTPI) is $0.2944 as of December 20, 2024.

What is the market cap of Petros Pharmaceuticals (PTPI)?

The market cap of Petros Pharmaceuticals (PTPI) is approximately 3.0M.

What is Petros Pharmaceuticals' main product?

Petros Pharmaceuticals' main product is STENDRA® (avanafil), an oral PDE5 inhibitor for the treatment of erectile dysfunction.

What are the primary segments of Petros Pharmaceuticals?

The primary segments are Prescription Medications and Medical Devices, with the latter being the main revenue generator.

What recent advancements has Petros Pharmaceuticals made?

Petros has integrated AI technologies for patient self-screening, received FDA feedback, and formed strategic partnerships to enhance access to STENDRA.

What is the significance of Petros Pharmaceuticals' AI integration?

The AI integration aims to optimize the self-screening and safe administration of STENDRA, facilitating its transition to over-the-counter availability.

How is Petros Pharmaceuticals expanding STENDRA's accessibility?

Through partnerships like the one with Lemonaid Health, Petros is expanding STENDRA's distribution via telehealth platforms.

What is the role of the Advisory Committee at Petros Pharmaceuticals?

The Advisory Committee, comprising former FDA officials and key opinion leaders, guides the Rx-to-OTC switch for STENDRA.

What are the key regulatory steps for STENDRA's OTC switch?

The key steps include designing a Drug Facts Label, conducting Label Comprehension Studies, Self-Selection Studies, and an Actual Use Trial to demonstrate safe and appropriate use.

What partnerships has Petros Pharmaceuticals recently formed?

Petros has formed partnerships with a leading AI software provider and Lemonaid Health to enhance STENDRA's accessibility and distribution.

What are the safety considerations for STENDRA?

STENDRA should not be used with organic nitrates or in patients with certain cardiovascular conditions. It should also be used cautiously with alpha-blockers, other antihypertensives, or substantial alcohol intake.

How is Petros Pharmaceuticals addressing unmet medical needs?

By driving innovations in the self-care market and expanding access to key prescription pharmaceuticals as OTC options, Petros aims to meet significant unmet medical needs.

Petros Pharmaceuticals, Inc.

Nasdaq:PTPI

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PTPI Stock Data

3.05M
9.36M
8.1%
2.29%
1.99%
Drug Manufacturers - Specialty & Generic
Pharmaceutical Preparations
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