GBA Presents: THE GREEN MARKET

And another - It has not been a good week.

Cabaret Voltaire's Richard H Kirk dies aged 65
_120638873_kirk_gettyimages-82213768.jpg
 
It's weird the way my life seeps into these investments. I have a real problem with water. It surfaces in many ways but right now my right sink in the bathroom is shut offf by the master valve and the left sink is dripping non stop. It drives me crazy.I t cannot be fixed we have tried twice because I have sunk these sinks into an old chest of drawers creating a unique big mess. It was a good idea 30 years ago.

Oppenheimer bullish on Zurn Water Solutions following spinoff 07:38 ZWS

 
stonedinvestor said:
Getting close to a re buy point-

Confluent, Inc. (CFLT)- I wrote down $53 as a buy target willing to wiggle.... $55?
NasdaqGS - NasdaqGS Real Time Price. Currency in USD

59.07-4.49 (-7.06%)
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Danger of waiting-!

Confluent, Inc. (CFLT)

62.90+3.76 (+6.36%)
At close: October 6 4:00PM EDT
64.00+1.10 (+1.75%)
Pre-Market:06:18AM EDT
 
Cytokinetics outlines go-to-market strategy, provides update on pipeline 07:37 CYTK Cytokinetics plans to outline the company's go-to-market strategy for omecamtiv mecarbil in the United States, and present updates on the company's advancing cardiovascular pipeline and strategies. The company also plans to present the clinical trial design for SEQUOIA-HCM, the Phase 3 clinical trial of aficamten in patients with obstructive hypertrophic cardiomyopathy. "Cytokinetics is approaching an inflection point after more than two decades of research and development pioneering the field of muscle biology and advancing the pharmacology of myosin modulators," said Robert Blum, Cytokinetics' President and Chief Executive Officer. "As aficamten advances into Phase 3 with SEQUOIA-HCM, expected to begin this year, our company is well positioned to deliver on the promise of potential medicines for patients with cardiovascular diseases of impaired muscle function and weakness." Go to market; Cytokinetics leadership will outline the go-to-market strategy for omecamtiv mecarbil in the U.S., which will be guided by a build of core capabilities to ensure success based on de-risking milestones leading up to the potential launch of omecamtiv mecarbil. The four pillars of the strategy include first, establishing a deep understanding of patients with worsening heart failure and the healthcare providers and associated institutions who treat this subset of patients. Second, engaging and educating cardiologists who treat these patients and the importance of appropriate treatment. Third, working with payers to ensure affordable access to omecamtiv mecarbil. Finally, supporting patients and caregivers through education, co-pay assistance, and innovative models for patient support. SEQUOIA-HCM: Phase 3 Clinical Trial of Aficamten. Cytokinetics is also presenting the design of SEQUOIA-HCM. SEQUOIA-HCM is a Phase 3l trial designed to evaluate aficamten in patients with symptomatic oHCM on background medical therapy for 24 weeks. The primary objective is to assess the effect of aficamten on change in peak oxygen uptake measured by cardiopulmonary exercise testing from baseline to week 24. Secondary objectives include change in Kansas City Cardiomyopathy Questionnaire score from baseline to week 12 and week 24, the proportion of patients with greater than or equal to1 class improvement in New York Heart Association functional class from baseline to week 12 and week 24, change in post-Valsalva left ventricular outflow tract gradient to week 12 and week 24, the proportion of patients with post-Valsalva LVOT-G less than30 mmHg, and change in total workload during CPET to week 24. SEQUOIA-HCM is planned to enroll 270 patients, randomized on a 1:1 basis to receive aficamten or placebo in addition to standard-of-care treatment. Each patient will receive up to four escalating doses of aficamten or placebo based on echocardiographic guidance alone. Cytokinetics expects to begin SEQUOIA-HCM in Q4 2021.
 
stonedinvestor said:
Amicus spin-out and profit potential makes it takeout target, says Cowen 09:00 FOLD


Shares of Amicus Therapeutics Inc.FOLD,-5.11%were up 5.6% in premarket trading on Thursday, the day after the company announced a deal to sell its gene therapy business to ARYA Sciences Acquisition Corp IVARYD,+0.90%,a special purpose acquisition company sponsored by Perceptive Advisors. Amicus will have a 36% stake in the new company, which will be called Caritas Therapeutics Inc. It will retain commercialization rights to the Fabry and Pompe gene therapy programs. Amicus chair and CEO John Crowley will become chair and CEO of the new company, while Bradley Campbell, Amicus' president and COO, will become CEO of Amicus. The deal is expected to allow Amicus, which also announced a $200 million investment from private investors, to become profitable in 2023. The transaction will close by early next year. Amicus' stock is down 58.1% so far this year, while the S&P 500SPX,+0.16%is up 15.5%.
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I've dipped a toe in here plan to add more today:

Amicus Therapeutics, Inc. (FOLD)-Plant FOLD In GArden

10.93+0.83 (+8.22%)
At close: October 6 4:00PM EDT
 
stonedinvestor said:
BDSI--

If you are going to have an analyst day it's good to have something to talk about. This interests me--

Investor Dayon October 14, 2021

RALEIGH, N.C., Sept. 09, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, announced today that it has completed the acquisition of U.S. and Canadian rights to ELYXYB™ (celecoxib oral solution) from Dr. Reddy’s Laboratories Limited.

ELYXYB is the first and only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. BDSI intends to launch ELYXYB in the first quarter of 2022. Additionally, BDSI plans to conduct an ELYXYB pediatric study, which will have the potential to address the significant unmet needs of pediatric and adolescent patients suffering from migraine attacks.

Migraine is a debilitating condition for almost 40 million people in the U.S. Many acute migraine sufferers are searching for treatments that provide relief quickly and conveniently.

“The availability of ELYXYB represents a significant therapeutic development for the acute treatment of migraine,” stated Richard Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine, Director of the Montefiore Headache Center, and one of the clinical investigators for the ELYXYB studies. “With rapid onset of action delivered in a unique, ready-to-use oral solution, ELYXYB provides a convenient, quick relief treatment option to help patients return to functioning in their everyday lives.”

ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption1. This allows for the administration of a lower dose of drug to achieve therapeutic effect relative to a conventional oral solid dosage form. For adult patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options. ELYXYB’s unit-dose oral solution makes it convenient for patients to take it immediately upon emergence of acute migraine attacks.

“ELYXYB’s pivotal studies showed that the percentage of patients achieving Most Bothersome Symptom (MBS) freedom at two hours post-dose was significantly greater for those patients receiving ELYXYB versus those receiving placebo. Study 2 demonstrated that the percentage of patients reaching headache pain freedom two hours post-dose was significantly greater for those receiving ELYXYB versus those receiving placebo. The data also showed meaningful speed of onset with Tmaxachieved in approximately 60 minutes,” said Thomas Smith, MD, Chief Medical Officer at BDSI, and a former thought leader in the migraine space. “BDSI looks forward to expanding our impact in Migraine and to deepening our commitment to our patients-first philosophy.”

<< What is significantly better? We will find out today. 52%? language a little wishy washy >>

“The acquisition of ELYXYB represents a critical step to building our presence in Neurology which is an excellent strategic adjacency to our pain franchise,” said Jeff Bailey, CEO of BDSI.

“We are confident that ELYXYB will contribute to BDSI’s revenue growth and profitability over time, with patent protection until 2036. Our extensive commercial expertise, robust corporate infrastructure, and strong financial position will allow us to successfully commercialize ELYXYB and continue to pursue additional value-enhancing business development opportunities,” Bailey indicated.

BDSI will host an Investor Day on October 14, 2021, to discuss ELYXYB in further detail.
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BDSI- Strongly Considering) ) )


BioDelivery Sciences International, Inc. (BDSI)

3.7700+0.0700 (+1.89%)
At close: October 6 4:00PM EDT
 
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