The Tellurian cornerstone project is Driftwood LNG, a proposed ~27.6 mtpa liquefaction export facility that will be located near Lake Charles, Louisiana. Driftwood is shovel ready having secured all necessaryFERC approvalsfor construction and operation, and has a $15.5 billion lump-sum turn key engineering, procurement and construction contract with Bechtel that guarantees cost, performance and schedule. Bechtel built Cheniere's facilities on time and on budget and has done so with many others around the world. A crucial point -having the approvals - also for the pipeline - is a crucial point for the building of this project but that also gives TELL a competitive advantage. In some other states, pipelines cannot get permitting and whole LNG export projects have been stopped; one of those was Pembina's Jordon Cove project in Oregon. The Kitimat project in Vancouver, BC, has been long delayed. Both those would have had the added advantage of lower cost shipping to customers in Asia direct from the west coast. --> Tellurian repays 2019 term loan in full; shares rally Mar. 15, 2021 8:22 AM ETTellurian Inc. (TELL) Tellurian(NASDAQ:TELL) +5%pre-market after saying itfully repaid its 2019 term loanafter making a voluntary $38M prepayment using cashon hand. As a result of the prepayment, Tellurian lowered its outstanding debt balance to $21M, which it says it plans to pay off in the coming months from upstream generated cash flows and cash on hand. $2.79
XPeng attracts investment from local government Mar. 15, 2021 8:02 AM ETXPeng Inc. (XPEV) XPeng(NYSE:XPEV)is higher in early trading after landing a $76.8M investment from the provincial government in Guangdong to accelerate the company's business expansion. The Chinese automaker is based in Guangzhou, the capital of Guangdong province, and has two manufacturing plants there. Shares of XPeng areup 3.56%premarket to $36.40 XPeng plans to list shares in Hong Kong this year and possible Shanghai.
Here comes the Stoney 8:30 Monday morning stock blitz. This is where we get 20 stocks and Stoney pays no attention to anything else. OK STONEY... You have to look at this one. Dementia has a huge market. This company also has about 25% of its float shorted. BTAI Its up pre-market on this news: BioXcel Therapeutics Receives FDA Breakthrough Therapy Designation for BXCL501 for the Acute Treatment of Agitation Associated with Dementia Download as PDF March 15, 2021 Designation offers the potential for expedited development and review, highlighting the urgent need for new treatment options for dementia related agitation NEW HAVEN, Conn., March 15, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that BXCL501, the Company's investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine ("Dex"), has been granted Breakthrough Therapy designation from the U.S. Food and Drug Administration ("FDA") for the acute treatment of agitation associated with dementia. The Breakthrough Therapy designation is intended to expedite the development and review of certain product candidates designed to treat serious or life-threatening diseases or conditions, and the designation includes increased interaction and guidance from the FDA. “Managing dementia related agitation, specifically in elderly patients, represents a significant challenge for physicians and caregivers, as there are currently no FDA-approved therapies and off-label drugs come with black box warnings," stated Vimal Mehta, Chief Executive Officer of BioXcel. "The FDA's decision to grant Breakthrough Therapy designation further underscores the significant unmet need for a new treatment for this underserved patient population, as well as highlights BXCL501’s potential in becoming the first therapeutic option, if approved, to address this debilitating medical condition. We look forward to working closely with the FDA to advance BXCL501 into a pivotal dementia program, in hopes of quickly bringing this therapy to the millions of patients across treatment settings that lack alternative options.” The Breakthrough Therapy designation for BXCL501 was supported by the positive topline data from the Phase 1b/2 TRANQUILITY study for the acute treatment of agitation associated with dementia, including Alzheimer's disease. BXCL501 demonstrated statistically significant reductions in agitation measures at 2 hours post-dose with both the 30 and 60 mcg doses as measured by multiple scales. The dose dependent response observed has the potential to support the Company’s plans to evaluate BXCL501 for use across the full range of dementia care settings. About FDA Breakthrough Therapy Designation Breakthrough Therapy designation is an FDA program intended to expedite the development and regulatory review of investigational therapies that are designed to address serious or life-threatening conditions. The criteria for Breakthrough Therapy designation requires preliminary clinical evidence that indicates that the candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. This designation provides the Company with more intensive FDA guidance on an efficient drug development program, and eligibility for other actions to expedite the FDA review, such as a rolling review of a New Drug Application (“NDA”), where the FDA may review sections of the NDA before the complete application is submitted. An NDA for a product candidate receiving breakthrough designation may also be eligible for priority review if the relevant criteria are met. Breakthrough Therapy designation does not change the standards for approval. For more information, please visit the FDA website at www.fda.gov. About Dementia Related Agitation Dementia is a neurocognitive condition caused by damage to brain cells that leads to a decline in cognitive abilities and independent function. It affects approximately 6 million individuals in the United States, with Alzheimer's disease accounting for up to 80% of these cases. During the course of the disease, patients with dementia often suffer from psychological and behavioral symptoms, such as agitation, which has been reported in up to 70% of patients. Agitation associated with dementia can negatively affect both the patient and caregiver's quality of life. Caregiver burden can contribute significantly to burnout, which can result in premature institutionalization of the patient. Treating agitation associated with dementia has been a challenge for providers as there are currently no FDA-approved therapies for the treatment of dementia-related agitation, and off-label therapies have black box warnings associated with their use. About BXCL501 BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 potentially targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of agitation in patients with schizophrenia, bipolar disorders, and dementia. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. This product candidate is also currently being evaluated in a Phase 1b/2 trial (RELEASE) for the treatment of opioid withdrawal symptoms and in a Phase 2 trial (PLACIDITY) for the treatment of delirium related agitation. BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel's drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BioXcel's two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.
Clinical Pipeline BXCL501 BXCL501 is an investigational, proprietary, orally dissolving, sublingual or buccal thin film formulation of dexmedetomidine (Dex), a selective alpha-2a receptor agonist for the treatment of agitation and substance abuse withdrawal symptoms. BXCL501 is our most advanced neuroscience clinical program, being developed initially for the acute treatment of agitation in patients with schizophrenia and bipolar disorders. A selective adrenergic agent with a sublingual or buccal route of administration, BXCL501 is designed to be easy to administer and has shown a rapid onset of action in clinical studies. It is designed to generate a calming effect without producing excessive sedation. We believe it is highly differentiated from antipsychotics currently used as standard of care, which produce unwanted symptoms such as tremors, neutropenia and extra-pyramidal motor effects. Managing patient agitation in neuropsychiatric and neurodegenerative disorders represents a significant challenge for physicians and caregivers, and we believe BXCL501 has the potential to address these challenges while providing an efficient treatment regimen for patients. In July 2020, we announced positive topline results from the SERENITY I and II pivotal trials for the acute treatment of agitation in patients with schizophrenia and bipolar disorders. BXCL501 consistently showed statistical superiority over placebo for the primary, secondary, and all exploratory endpoints. Both patient populations responded quickly to BXCL501, demonstrating statistically significant and clinically meaningful improvement in agitation beginning as early as 20 minutes in patients with bipolar disorders at both dose levels (120 mcg and 180 mcg), and as early as 20 minutes in patients with schizophrenia for the 180 mcg dose level. In addition, the duration of response lasted for at least four hours after treatment. Based on the data from the two Phase 3 trials, we plan to submit the Company’s first NDA in Q1 2021. In addition, we are continuing our development of BXCL501, exploring this candidate as a potential treatment for agitation across neuropsychiatric disorders. The Company is currently conducting the TRANQUILITY trial, a Phase 1b/2 trial of BXCL501 for the acute treatment of agitation associated with dementia, and the RELEASE trial, a Phase 1b/2 study of BXCL501 for the treatment of opioid withdrawal symptoms. BTI expects to initiate a Phase 2 trial in patients with agitation associated with dementia, including COVID-19 patients, within the next several months. BXCL701 BXCL701 is an investigational orally-available systemic innate immunity activator with dual mechanisms of action. Designed to stimulate both the innate and acquired immune systems, BXCL701 has the potential to inhibit dipeptidyl peptidase (DPP) 8/9 and block immune evasion by targeting Fibroblast Activation Protein (FAP). BXCL701, is currently being developed for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. BXCL701 currently has two ongoing combination therapy clinical trials: The Company is currently conducting a Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab) for advanced prostate cancer (tNEPC and CRPC). The Phase 1b safety assessment of BXCL701 indicated that a split dose totaling 0.6 mg per day is the recommended dose when used in combination with KEYTRUDA. BTI has entered into the Phase 2 efficacy portion of this trial, with an additional efficacy update planned for the near future. The MD Anderson-led Phase 2 open-label basket trial was designed to evaluate the response rate of orally administered BXCL701, combined with KEYTRUDA, in two arms: Arm A is enrolling checkpoint naïve patients (where checkpoint therapy is indicated: “hot tumors”); and arm B is enrolling patients who have progressed following checkpoint therapy alone. The efficacy bar has already been met for both arms, allowing the trial to advance to completion.
Blackstone so smart.. Extended Stay to be acquired by Blackstone, Starwood in deal valued at $6B If you really want to kick yourself look at a chart of BX during the huge Pandemic drop off that we all experienced in everything-- steady as a rock! Van once said sell everything and buy PLTR but the truth is you really could sell everything and just hold BX.
About Dementia Related Agitation Agitation associated with dementia can negatively affect both the patient and caregiver's quality of life. Caregiver burden can contribute significantly to burnout, which can result in premature institutionalization of the patient. Treating agitation associated with dementia has been a challenge for providers as there are currently no FDA-approved therapies for the treatment of dementia-related agitation, and off-label therapies have black box warnings associated with their use. <Van last night I woke up to go to the bathroom and the slide door to the deck is WIDE OPEN!! Our bathroom leads out to a deck that has to be redone!!! And once before two bats flew in while we were sleeping and that was one of the scariest events in my life and they came in with the door just six inches open- flew in sideways-- Try getting that out of your bedroom at midnight!!! But this time the freakin' door is W-I-D-E open, ten feet open, a bear could of walked in!! And it's ZERO degrees out with a wind of 50 MPH! All the hot hair was sucked out. It's freezing inside And WHERE IS MY WIFE! I look and she's not out there I look back in the bed and there she is sleeping... Dementia or the bottle of white wine she drank by herself....-- I got agitated! I had Dementia caused agitation last night!!!!>
Will this buy of Extended Stay America Kick off our stk pick! Hilton Grand vacations or BlueGreen? OR SOMEONE ELSE..... WAIT I GOT IT!!! WAIT I GOT IT! YES JANES YOU WANT TRAVEL...... I GIVE YOU NOT ONLY THAT BUT LEISURE AS WELL..... YES! TRAVEL AND LEISURE WHAT WE ALL WANT!!! YES TNL IS YOUR GUMMY OF THE DAY!-- Travel + Leisure price target raised to $71 from $66 at JPMorgan 07:42 TNL JPMorgan analyst Joseph Greff raised the firm's price target on Travel + Leisure to $71 from $66 and keeps an Overweight rating on the shares. The analyst says the tone at the firm's gaming, lodging and leisure conference last week was optimistic. Management teams expressed optimism that the U.S. consumer should spend more and travel more given U.S. fiscal stimulus programs and relatively high savings rates, Greff tells investors in a research note. The analyst generally shares these views and appreciates "these positive trends with more acceleration to come." Show Related Items >>
TNL-$62 Travel + Leisure price target raised to $74 from $62 at Truist 03/05 TNL Truist analyst C. Patrick Scholes raised the firm's price target on Travel + Leisure to $74 from $62 and keeps a Buy rating on the shares as part of a broader research note on Timeshares. The analyst is positive on the sector amid "green shoots" being observed in Leisure travel along with rapid improvement in companies' balance sheets. Scholes adds that valuations in this group do not look "stretched" relative to historical levels.
Travel + Leisure price target raised to $69 from $63 at Deutsche Bank 02/25 TNL Deutsche Bank analyst Chris Woronka raised the firm's price target on Travel + Leisure to $69 from $63 and keeps a Buy rating on the shares. The company's decision to focus on growing its brand umbrella via travel sub-sectors that are adjacent to the core timeshare business is "wise" and should ultimately enhance margins as membership/subscription-based revenue streams become a larger part of the overall EBITDA mix, Woronka tells investors in a research note. The analyst says Travel + Leisure is one of the few leisure plays where multiple expansion "still makes sense."