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PLx Pharma Inc. (NASDAQ: PLXP) announced a private placement raising $18 million, led by White Rock Capital Management. The company has submitted supplemental New Drug Applications (sNDAs) for VAZALORE 325 mg and 81 mg to the FDA, targeting a commercial launch in Q3 2021. Financially, PLx reported no revenue for Q3 2020, down from $41,106 in Q3 2019, and a net loss of $3.6 million, compared to a profit of $1.4 million in Q3 2019. For the nine months ending Sept 2020, revenue decreased to $30,430 from $541,571 in 2019, with a net loss of $8.5 million.
PLx Pharma Inc. (NASDAQ: PLXP) announced the submission of two supplemental New Drug Applications (sNDAs) for its VAZALORE product to the FDA. The sNDAs, submitted in October 2020, are for VAZALORE 325 mg and 81 mg doses, aimed at improving patient outcomes with aspirin therapy. The FDA has set the estimated review completion date for the end of February 2021, with plans for a potential product launch in Q3 2021. The company is optimistic about the supportive data backing its submissions, emphasizing the need for safer aspirin therapies for patients with vascular disease.
PLx Pharma Inc. (NASDAQ: PLXP) has announced the rescheduling of its 2020 third quarter financial results call to November 16, 2020. The call will be led by President and CEO Natasha Giordano and CFO Rita O’Connor at 4:30 p.m. ET. The event will provide insights into the Company’s performance and updates on its VAZALORE™ products, including the FDA-approved liquid-filled aspirin capsule designed to improve platelet inhibition and lower stomach-related risks. A replay will be available for two weeks post-call.
PLx Pharma Inc. (NASDAQ: PLXP) announced it will release its 2020 Q3 financial results on November 13, 2020, before U.S. markets open. The conference call, hosted by CEO Natasha Giordano and CFO Rita O’Connor, will take place at 8:30 a.m. ET. VAZALORE™, its FDA-approved liquid-filled aspirin capsule, aims to offer faster platelet inhibition and lower gastrointestinal risks compared to traditional aspirin. The company is also preparing data for a supplemental NDA filing to support the approval of VAZALORE 81 mg.
PLx Pharma Inc. (NASDAQ: PLXP) announced that CEO Natasha Giordano and CFO Rita O’Connor will present virtually at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2020, at 11:40 AM ET. The presentation will be available via live webcast and archived for 30 days on the company’s website. PLx is focused on its VAZALORE™ delivery system, which includes the FDA-approved aspirin capsules designed for improved safety and effectiveness. The company is also working on post-approval data collection for VAZALORE 325 mg and potential approval for VAZALORE 81 mg.
PLx Pharma Inc. (NASDAQ: PLXP) reported a net loss of $6.0 million for Q2 2020, improving from a $9.6 million loss in Q2 2019. Revenue dropped to $27,907 from $182,905 year-over-year due to the conclusion of a NIH grant. The bioequivalence study for VAZALORE 325 mg is on track, and the company plans to submit supplemental New Drug Applications for VAZALORE 325 mg and 81 mg by mid-November 2020. Aiming for a launch in Q3 2021, the company completed $8 million in Series B financing. Cash and equivalents as of June 30, 2020, were $13.3 million.
PLx Pharma Inc. (NASDAQ: PLXP) announced it will release its 2020 second quarter financial results on August 14, 2020, before U.S. markets open. CEO Natasha Giordano and CFO Rita O’Connor will host a conference call at 8:30 a.m. ET to discuss the results. VAZALORE, the company’s FDA-approved liquid-filled aspirin capsule, aims to provide faster platelet inhibition and reduce stomach risks. The focus is on data collection for a sNDA filing for VAZALORE 325 mg and to support the approval of VAZALORE 81 mg.
PLx Pharma Inc. (NASDAQ: PLXP) announced that stockholders approved the issuance of over 20% of common stock during a special meeting on May 15, 2020. This approval facilitates a $8 million convertible preferred stock financing, backed by Park West Asset Management and MSD Partners. The funds will support the final regulatory steps for VAZALORE™, a new aspirin therapy. Natasha Giordano, CEO, expressed optimism about the financing's impact on VAZALORE's market launch as they aim for FDA approval of its new dosage forms.
PLx Pharma (NASDAQ: PLXP) reported a net income of $1.2 million for Q1 2020, reversing a loss of $23.7 million in Q1 2019. The results included a non-cash gain of $4.6 million, compared to a loss of $7.7 million a year earlier. The company engaged in discussions with the FDA regarding a bioequivalence study for VAZALORE 325 mg and plans to submit supplemental New Drug Applications (sNDAs) by year-end 2020. An $8 million financing is expected to support operations until Q2 2021. Revenue for Q1 2020 was $2,523, significantly down from $317,560 in the prior year, mainly due to the conclusion of a federal grant.
