PLx Pharma initiated with an Outperform at Oppenheimer » 08:1004/0904/09/21
Oppenheimer analyst Leland Gershell initiated coverage of PLx Pharma with an Outperform rating and $20 price target. Led by a commercially savvy team and now armed with its first approval, PLx is well-positioned to compete for consumer, provider, and channel attention in the ~$10B U.S. secondary cardiovascular prevention retail market, Gershell tells investors in a research note.
PLx Pharma initiated with an Outperform at Oppenheimer » 06:4704/0904/09/21
Oppenheimer analyst Leland Gershell initiated coverage of PLx Pharma with an Outperform rating and $20 price target.
|Over a week ago|
new option listings on March 17th » 08:3003/1703/17/21
ABCL, AFIN, AONE, CCCC, CPNG, DEN, DRIO, ELVT, ESTE, FLL, FMTX, GBIO, HTOO, IRIX, JMP, LGHL, LTRN, NRIX, PCVX, PLXP, PMVP, RSVA, SY, USIO, WYY
New option listings for…
New option listings for March 17th include AbCellera Biologics Inc (ABCL), American Financial Trust Inc (Class A Stock) (AFIN), one (Class A Stock) (AONE), C4 Therapeutics Inc (CCCC), Coupang Inc (Class A Stock) (CPNG), Denbury Inc (DEN), DarioHealth (DRIO), Elevate (ELVT), Earthstone Energy (ESTE), Full House Resorts (FLL), Forma Therapeutics Holdings Inc (FMTX), Generation Bio Company (GBIO), Fusion Fuel Green PLC (Class A Stock) (HTOO), IRIDEX (IRIX), JMP Group (JMP), Lion Group Holding Ltd (ADS) (LGHL), Lantern Pharma Inc (LTRN), Nurix Therapeutics Inc (NRIX), Vaxcyte Inc (PCVX), PLx Pharma (PLXP), PMV Pharmaceuticals Inc (PMVP), Rodgers Silicon Valley Acquisition Corporation (RSVA), So Young International (SY), Usio Inc (USIO), and WidePoint (WYY).
PLx Pharma reports Q4 EPS (87c) with items, consensus (29c) » 06:5603/1203/12/21
The fourth quarter of…
The fourth quarter of 2020 included a non-cash loss of $4.2M, or (44c) per share, related to the change in fair value of warrant liability and $0.5M, or (5c) per share, of Series A and Series B convertible preferred stock dividends.
|Over a month ago|
PLx Pharma 7.88M share Spot Secondary priced at $8.00 » 08:5903/0303/03/21
The deal priced below the…
The deal priced below the last closing price of $9.14. Raymond James and Oppenheimer are acting as joint book running managers for the offering.
PLx Pharma files to sell common stock, no amount given » 16:0603/0203/02/21
PLx intends to use the…
PLx intends to use the net proceeds from this offering for general corporate purposes. General corporate purposes may include additions to working capital and capital expenditures. Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as the joint book-running managers for the public offering.
PLx Pharma price target raised to $12 from $9 at JMP Securities » 11:2903/0103/01/21
JMP Securities analyst…
JMP Securities analyst Jason Butler raised the firm's price target on PLx Pharma to $12 from $9 and keeps an Outperform rating on the shares after the company announced that the FDA has approved the sNDAs for both the 81mg and 325mg doses of Vazalore. He believes the company is well positioned for "a strong targeted launch" of its PLxGuard formulation of aspirin, the analyst tells investors following the approval news.
PLx Pharma receives FDA approval of sNDAs for VAZALORE 325 mg, 81 mg » 06:5203/0103/01/21
PLx Pharma announced that…
PLx Pharma announced that the U.S. FDA approved supplemental new drug applications for its lead products, VAZALORE 325 mg and VAZALORE 81 mg, the first ever novel, liquid-filled aspirin capsule. "We are delighted that the FDA approved both sNDAs for VAZALORE, and we are eager to implement our commercial launch plans later this year," stated Natasha Giordano, President and CEO of PLx.
|Over a quarter ago|
PLx Pharma files to sell 9.99M shares of common stock for holders 17:1812/2112/21/20
PLx Pharma submits sNDAs for Vazalore 325 and 81 mg to FDA » 16:0811/1611/16/20
PLx Pharma announcedthat…
PLx Pharma announcedthat two chemistry and manufacturing control, CMC, supplemental New Drug Applications , one for VAZALORE 325 mg and one for VAZALORE 81 mg dose (referred to together as, were submitted to the U.S. Food and Drug Administrationin October for regulatory approval. The 325 mg sNDA provided information on a change in formulation and a new manufacturing site for the currently approved VAZALORE and also contains a bioequivalence clinical study report with the required data and analyses from the recently completed BE study. The submission for the 81 mg dose provided for a new product strength of VAZALORE and builds off the information in the original approved NDA and the recent sNDA submitted for VAZALORE 325 mg. The Company received acknowledgement letters from the FDA, officially confirming the receipt of the submissions and setting the estimated completion date for its reviews for VAZALORE 325 mg and VAZALORE 81 mg for the end of February 2021. If approved, the Company plans to bring both doses of VAZALORE to market in the third quarter of 2021. "We are delighted to have achieved this major milestone for the submissions of our two sNDAs to the FDA earlier than previously announced. This is a significant step for PLx and the millions of patients with vascular disease who can benefit from a novel aspirin therapy. We are highly confident our submissions are supported by strong and compelling data that FDA requires for CMC submissions and we look forward to their review," stated Natasha Giordano, President and Chief Executive Officer of PLx. "I'd also like to thank our teams and our partners for their extraordinary efforts preparing these filings and our shareholders for their support in advancing VAZALORE to regulatory review," concluded Giordano.