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$1.63 A.H trading
LOL yup. The volume tailed off here. Maybe News in the AM? I doubt it lmao
NEWS
Atara Biotherapeutics Announces Closing of Expanded Global Tab-cel® Partnership with Pierre Fabre Laboratories
THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel® or EBVALLOTM). Building on the earlier partnership announced in October 2021 to commercialize tab-cel in Europe, this transaction provides Pierre Fabre Laboratories with the development, manufacturing, and commercialization rights for tab-cel in the United States and all remaining markets.
“We are pleased to announce the closing of the transaction with Pierre Fabre Laboratories who are committed to expanding the reach of tab-cel to patients in the U.S. and across the globe,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Atara’s priority is to now submit the tab-cel BLA filing package, while initiating our first clinical study with ATA3219, a potential best-in-class allogeneic off-the-shelf CD19 CAR T with unique features.”
With the closing of the transaction, Atara will receive approximately USD 27 million in cash upfront and initial inventory purchase. Under the agreement, Atara has the potential to receive up to a total of USD 640 million and significant double-digit tiered royalties on net sales, including up to USD 100 million in potential regulatory milestones through BLA approval. In addition, Pierre Fabre Laboratories will reimburse Atara for expected tab-cel global development costs through the Biologics License Application (BLA) transfer, and purchase future tab-cel inventory through the manufacturing transfer date.
Substantially all tab-cel manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer.
Atara plans to submit the BLA to the U.S. Food and Drug Administration (FDA) for tab-cel for the treatment of post-transplant lymphoproliferative disease (PTLD) in the second quarter of 2024.
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions, that can be rapidly delivered to patients within days. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile Epstein-Barr virus (EBV) T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of non-EBV-associated liquid and solid tumors. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X (formerly known as Twitter) and LinkedIn.
Forward-Looking Statements
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel®, including a potential BLA, the potential characteristics and benefits of tab-cel®, and the progress and results of, prospects for, and closing of the expanded global partnership with Pierre Fabre Laboratories involving tab-cel®, and the potential financial benefits to Atara as a result of the expanded global partnership with Pierre Fabre Laboratories; (2) the development, t
Soaring on no news or at least I didn't find any.
I'm going on a 20-minute break. I will find you somewhere if not here LOL
She put the oxygen mask on me.:)
Anytime bro! :)
Luckily she picked up those new smelling salts or I would be in a coma!
$10 and congrats to you!
Well,2024 just might be the year all the shorts end up working at a car wash!
This war is over when I say its over :)
GOOD! Those scumbags deserve it
https://www.polished.com/ Think I will replace my kitchen cabinets and give them some much-needed business
Yes, and that was the price just when I ran out of smelling salts. But don't be concerned my Nurse went out and bought me more
a pack of hungry lions chasing her and just got halted at $5.51 = HOD up 419%
EXACTLY! Man, it's all a scam! no if's and but's
Hey brother, the end of the World is coming! My recommendation is not to think about it and just make $$$ by trading these scams :)
As of November 17, 2023, there were 2,109,347 shares of the registrant’s common stock issued and outstanding.
If you believe that I have a Bridge in Brooklyn for sale at a steep discount!
$11.17 BURN THOSE SHORTS
I feel he is on the money. HYSR has been under strong accumulation all month. Just gotta wait on her. Buy and hold MHO
Never holds its gains so you are spot on!
Never holds its gains so you are spot on!
Concerned shareholder of Polished.com, Inc. urges investor collaboration
Jerald Hammann, a Polished.com shareholder, urges shareholders concerned about their investment in Polished.com to collaborate to increase the effectiveness of their actions.
Individual shareholders often lack the voting power to effect meaningful change at shareholder meetings. However, through collaboration, the opportunity exists for shareholders to discuss their investment objectives and assert a proactive posture in addressing board nominations and corporate governance proposals.
If you are interested in discussing your investment objectives relative to Polished.com or in discussing its 2024 annual shareholder meeting, please contact Jerald Hammann at investoradvocacy411 @rkhiii.
Disclaimers
This is not a solicitation of authority to vote your proxy. Please DO NOT send the author your proxy card. The author is not able to vote your proxy, nor does this communication contemplate such an event.
This is not an offer to enter into any agreement to act together with any shareholder for the purpose of acquiring, holding, voting, or disposing of equity securities. The author has no present intent to enter into a group pursuant to 17 CFR § 240.13d-5(b)(1).
The views expressed are those of the author as of the date referenced and are subject to change at any time based on market or other conditions. These views are not intended to be a forecast of future events or a guarantee of future results. These views may not be relied upon as investment advice. The information provided in this material should not be considered a recommendation to buy or sell any of the securities mentioned. It should not be assumed that investments in such securities have been or will be profitable. This communication should not be construed as a research report.
Sweet close $10.65. Hoping the pussies keep buying back at a loss. Ass Wipes
It's a rocket ship!!!!!! WOW
This is where we fight!
This is where we will fight
Back over $10.00, these cock suckers getting their shorts burned! Good! bastards
Thank you, good sir. I just read the news. I'm not impressed
Thank you, good sir. I just read the news. I'm not impressed
I saw that brother! Gotta make Coffee this is gonna be an interesting day
No telling how high she can go.
Could go insane! LOL
Direct Digital Holdings to Participate in the 2024 ICR Conference
HOUSTON, Dec. 18, 2023 /PRNewswire/ -- Direct Digital Holdings, Inc. (Nasdaq: DRCT) ("Direct Digital Holdings" or the "Company"), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC ("Colossus SSP"), Huddled Masses LLC ("Huddled Masses") and Orange142, LLC ("Orange142"), today announced that management will participate in the 2024 ICR Conference on January 8-10, 2024 at the Grande Lakes Resort in Orlando, FL.
Mark D. Walker, Chairman and Chief Executive Officer of Direct Digital Holdings, will participate in a fireside chat on Tuesday, January 9, 2024 at 8:00 AM ET. Management will also be available for meetings the same day.
For more information, or to schedule a meeting with management, please contact ICR.
NFOBIRD CO., LTD ANNOUNCES NEW BUSINESS COOPERATION IN INFORMATION TECHNOLOGY SYSTEM SOFTWARE DEVELOPMENT
HONG KONG, Dec. 18, 2023 /PRNewswire/ -- Infobird Co., Ltd (NASDAQ: IFBD) ("Infobird" or the "Company"), a software-as-a-service provider of AI-powered customer engagement solutions in China, today announced that a new business cooperation in software development of information technology system has been signed.
Recently, Infobird Technologies Limited (hereinafter referred to as "Infobird HK") and a company signed a new business contract, aiming to cooperate in software and IT system development, with a total value of US$1.8 million. The principal business of counterparty is Gig Economy Platform of localized life services. Henceforth, Infobird will intensify the investment in research and development of SaaS systems and software technologies and commit to explore more SaaS technologies applicable scenarios to help clients with business expansion.
Infobird will expand its business to the SaaS segmented scenarios, to penetrate the call centre SaaS business into specific scenes and seek better opportunities. Company has already identified new business models and obtained R&D achievements in several sectors, and prefers to focus on high margin market segmentation with more competitive advantage and positive cash flow generation.
About Infobird Co., Ltd
Infobird, headquartered in Hong Kong, is a software-as-a-service provider of innovative AI-powered, or artificial intelligence enabled, customer engagement solutions. For more information, visit Infobird's website at www.Infobird.com.
Forward-Looking Statements
Looking good in pre-markets doctor. I think $1.00 before the end of year:)))))
She has a low float. My feeling is it pops over $2.00
Over 80% of gastric cancers are attributed to H. pylori bacterial infection
Gastric cancer is the third most common cause of cancer related death in the world
H. pylori infection is also a major cause of peptic ulcers
IRVINE, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic products, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Hp Detect™ Stool Antigen ELISA test (K232892), a new product that is designed to detect the presence of the H. pylori bacteria, which infects approximately 35% of the U.S. population. H. pylori infection is a disease which affects half the population of the world.
The Biomerica Hp Detect™ test detects the presence of the H. pylori bacteria which infects approximately 35% of the U.S. population. Over 80% of gastric cancers are attributed to H. pylori infection, and gastric cancer is the third most common cause of cancer-related death worldwide. Physicians and medical centers will be able use the results from the Hp Detect™ Stool Antigen test to diagnose the presence of H. pylori and assess H. pylori infection status after treatment.
Dr. William Chey, an expert in the management of H. pylori infection and Chief, Division of GI and Hepatology, Michigan Medicine, stated, “Testing for H. pylori eradication to assess status after treatment is crucial, especially in the context of increasing antibiotic resistance.”?
Biomerica’s Chief Executive Officer Zack Irani stated, “This FDA clearance is a milestone in our commitment to bringing a diagnostic solution for over 115 million people suffering from H. pylori infection across the U.S. We are particularly excited about this product as it has been shown to be highly accurate and has several key advantages for laboratories, physicians and patients. We have also created an efficient, low-cost manufacturing process that should enable high gross margins on this product.”
FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of the body, including hair-bearing areas, with no limitations on duration of use
ZORYVE foam provides rapid disease clearance and significant reduction in itch, one of the most burdensome symptoms of seborrheic dermatitis
First drug approved for seborrheic dermatitis with a new mechanism of action in over two decades
Seborrheic dermatitis affects more than 10 million people in the United States
Commercial product expected to be available by end of January
Management will host conference call on Monday, December 18 at 8:30 a.m. EST
WESTLAKE VILLAGE, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. ZORYVE foam provides rapid disease clearance and significant reduction in itch, with nearly 80% of individuals achieving the primary efficacy endpoint of IGA Success and just over 50% of individuals reaching complete clearance at Week 8 in the STRATUM trial. ZORYVE is a once-daily steroid-free foam and the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades.
“We know from dermatology clinicians and those living with seborrheic dermatitis that there has been a real struggle with disease clearance and treatment adherence due to lack of efficacy, difficulty treating certain body areas, inconvenient treatment regimens, and concerns about safety with long-term use,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “ZORYVE foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hair-bearing areas, with no limitation on duration of use. We are proud to deliver meaningful innovation through this approval of ZORYVE foam, and to offer a new topical treatment that effectively clears and controls the disease and can simplify its management for the millions of adults and adolescents living with seborrheic dermatitis.”
Seborrheic dermatitis affects more than 10 million people in the United States, and is a common, chronic, and recurrent inflammatory skin disease that causes red patches covered with large, greasy, flaking yellow-gray scales, and persistent itch. In individuals with darker skin tones, inflamed areas may not appear red, but instead can appear pink, slightly purple, or lighter in color than the surrounding skin. It occurs most often in areas of the body with oil-producing (sebaceous) glands, including the scalp, face (especially on the nose, eyebrows, ears, and eyelids), upper chest, and back. Hair-bearing areas make applying topicals like creams, gels, and ointments difficult.
“In the STRATUM trial, ZORYVE foam provided rapid disease clearance as early as Week 2 and significant itch relief in as little as 48 hours. In addition, almost 80% of patients achieved treatment success at Week 8. While multiple factors contribute to seborrheic dermatitis, inflammation and skin barrier dysfunction play key roles. ZORYVE has been shown to effectively reduce the signs of inflammation, redness, and scaling in patients with seborrheic dermatitis, and with its unique formulation, ZORYVE foam effectively delivers the drug without disrupting the skin barrier and has been shown to be safe and tolerable. ZORYVE foam is thus ideally formulated, having the potential to become the new standard of care for seborrheic dermatitis treatment,” said Andrew Blauvelt, MD, MBA, clinical investigator at Oregon Medical Research Center, and investigator on the STRATUM trial.
Beyond the appearance and irritation of physical symptoms, seborrheic dermatitis is associated with a decrease in quality of life and may negatively affect emotional well-being, self-esteem, and day-to-day life, including sleep and work. People with seborrheic dermatitis, and especially adolescents and school-age children, may suffer from social stigma, negative self-image, and low self-esteem associated with very visible skin diseases like seborrheic dermatitis.
“Approximately 10 million people in the United States have seborrheic dermatitis, but until today, there have been limited treatment options. We are thrilled with this FDA approval and are excited to bring to market a new, highly effective steroid-free topical formulation that can be used anywhere on the body,” said Frank Watanabe, president and CEO of Arcutis. “Our commercial team is ready and poised to launch ZORYVE foam very soon, and we are committed to ensuring affordable access to ZORYVE foam to those who may benefit from this novel treatment.”
Arcutis intends to make ZORYVE foam widely available via key wholesaler and dermatology pharmacy channels as a new treatment option by the end of January 2024. The Company is dedicated to responsible pricing and affordable access to therapy. The ZORYVE® Direct Program helps patients access their prescribed Arcutis medication. For patients with seborrheic dermatitis who have been prescribed ZORYVE, this patient support program helps patients navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients.† Arcutis will also continue to offer the Arcutis CaresTM patient assistance program (PAP) that provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.‡
Management will host a conference call on Monday, December 18 at 8:30 a.m. EST. A live webcast of the call and presentation material will be available on the “Events” section of the Company's Investor website. An archived version of the webcast will be available on the Arcutis website after the call.
ZORYVE Foam Clinical Data
The approval is supported by positive results from Arcutis’ Phase 2 and pivotal Phase 3 trials in seborrheic dermatitis. The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) and the Phase 2 (Trial 203) were parallel group, double-blind, vehicle-controlled studies evaluating the safety and efficacy of ZORYVE foam 0.3% in seborrheic dermatitis. Together the two studies enrolled 683 adults and adolescents ages 9 years and older.
The STRATUM study met its primary endpoint, with nearly 80% of ZORYVE foam treated individuals reaching Investigator Global Assessment (IGA) Success rate at Week 8 (79.5% ZORYVE foam vs 58.0% vehicle; P<0.0001). In Trial 203, 73% of individuals treated with ZORYVE foam achieved IGA Success (73.1% ZORYVE foam vs 40.8% vehicle; P<0.0001.) IGA Success was defined as an IGA score of “Clear” (0) or “Almost Clear” (1), plus a 2-grade IGA score improvement from baseline at Week 8.
Improvement with ZORYVE foam was seen early, with roflumilast demonstrating a statistically significant improvement compared to vehicle on IGA Success at Week 2, the first timepoint assessed in STRATUM. In addition, 50.6% of individuals in the ZORYVE foam treated arm reached complete clearance (IGA=0) at Week 8.
The STRATUM study also demonstrated statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling, and erythema (redness). More than 60% of individuals achieved a ≥4-point reduction in itch at Week 8 as measured by Worst Itch-Numerical Rating Score (62.8% roflumilast foam vs 40.6% vehicle; P=0.0001), and significant improvements in itch were also reported at Week 2 and Week 4. Individuals treated with ZORYVE foam reported a 28% improvement in itch from baseline in 48 hours (compared to 13% on vehicle nominal P=0.0024).
In addition, more than 50% of individuals treated with ZORYVE foam achieved an erythema (redness) score of 0, and more than 50% achieved a scaling score of 0, at Week 8. Treatment with ZORYVE foam demonstrated a significantly larger improvement in patient reported outcomes as early as Week 2 as measured through Dermatology Life Quality Index (DLQI), with improvements maintained through Week 8.
ZORYVE foam was well-tolerated with a favorable safety and tolerability profile during up to 52 weeks of treatment. Incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs). Overall, the most common adverse reactions occurring in ≥1% of subjects in the combined Phase 2 and Phase 3 study populations were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
A Media Snippet accompanying this announcement is available by clicking on this link.
About ZORYVE®
ZORYVE (roflumilast) topical foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. Another formulation of ZORYVE, roflumilast cream 0.3%, is approved by the FDA for the topical treatment of plaque psoriasis in individuals 6 years of age and older. Both ZORYVE foam and cream are topical formulations of roflumilast, a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. It is an established target in dermatology.
INDICATIONS
ZORYVE cream is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.
ZORYVE foam, 0.3%, is indicated for treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.
The most common adverse reactions (≥1%) for ZORYVE cream include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).
The most common adverse reactions (≥1%) for ZORYVE foam include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.
ZORYVE is for topical use only and not for ophthalmic, oral, or intervaginal use.
About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and X.
Forward-Looking Statements