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ZEN
Are you?
BB
Thanks, but you did not answer the question.
It is nice that crypto is eligible to purchase them.
But how many bikes or taxis have been sold, generating
how much revenue.
They have gone silent.
Bottom Bounce
Nice article from June 2021.
I have not been able to find any news or info on any of the sales.
Would you know how many bikes and or taxis they have sold and what revenues were produced from these?
Thanks in advance
Jon Cohen and Michael Hansen Join Talkspace's Board of Directors
4:05 pm ET September 15, 2022 (Globe Newswire) Print
EQNX::TICKER_START (NASDAQ:TALK),(NASDAQ:OPK), EQNX::TICKER_END Shareholders ofTalkspace, Inc. (Nasdaq: TALK) today elected Jon Cohen, M.D., to the virtual behavioral healthcare company's board of directors and approved all other shareholder proposals during the company's first Annual Meeting of Stockholders.
Dr. Cohen is prior Executive Chairman and Chief Executive Officer of BioReference Laboratories and Senior Vice President of OPKO Health (NASDAQ: OPK). Dr. Cohen brings 30 years of healthcare industry strategy and operating experience to Talkspace's board of directors. He succeeds Jeffrey Crowe as an independent Class I Director with a term expiring in 2025.
Additionally, the Company's board appointed Cengage Group Chief Executive Officer Michael Hansen to complete Charles Berg's term as a Class II director expiring in 2023. Mr. Hansen, a digital transformation expert, previously served as partner and Chairman at the Boston Consulting Group's digital convergence practice. He's been named one of Fast Company's Most Creative People in Business and twice been recognized as a top CEO by Glassdoor.
Finally, Talkspace shareholders approved the following proposals, all of which were supported by the Board:
About Talkspace
Talkspace (NASDAQ: TALK) is a leading virtual behavioral healthcare company committed to helping people lead healthier, happier lives through access to high-quality mental healthcare. At Talkspace, we believe that mental healthcare is core to overall healthcare and should be available to everyone.
Talkspace pioneered the ability to text with a licensed therapist from anywhere and now offers a comprehensive suite of mental health services from self-guided products to individual, couples and family therapy, in addition to psychiatric treatment and medication management. With Talkspace's core psychotherapy offering, members are matched with one of thousands of licensed providers across all 50 states and can choose from a variety of subscription plans including video, text or audio chat sessions and/or unlimited text messaging.
All care offered at Talkspace is delivered through an easy-to-use, fully-encrypted web and mobile platform that meets HIPAA, federal, and state regulatory requirements. Talkspace covered approximately 77 million lives at June 30, 2022, through our partnerships with employers, health plans, and paid benefits programs.
For more information, visit www.talkspace.com.
Contacts
â?For Investors:
Mike Lovell, Senior Director Investor Relations
515-771-1585
Mike.Lovell@Talkspace.com
For Media:
SKDK
John Kim
310-997-5963
jkim@skdknick.com
Thanks for getting back to me.
I noticed that the 85 cent premium was as high as $1.04 on Monday 8/22 when share price dropped to 1.69. Now that it is back up to $1.85 premium is at 95 cents.
My personal feeling is that the share price is on the right upward path and we will see
$3 or more by Jan as sales increase.
I wish they would advertise on TV like the others are doing. I live in a retirement community and I try to tell people about our CGM all the time. No one has heard of it.
Anyway, thanks for your help. GLTA
Haven't been on the board in awhile.
Just curious what you think of selling Jan 20, 2023 2.5 Puts at 80/85 cents?
Or do you think a different strike price would be a better play?
And just confirming what I think I know.....
If it closes above the strike price on that date, I keep the premium
If it closes below the strike price on that date, I own the stock unless I buy puts back
at whatever price.
What if it closes AT the strike price?
Thanks in advance....
Why stock-market volatility may rise Friday due to Russell rebalancing
Today 2:56 PM ET (MarketWatch)Print
By Christine Idzelis
About $12 trillion in investor assets are benchmarked to the Russell U.S. indexes
Investors are bracing for a heavy day of trading Friday due to the rebalancing of the Russell U.S. equity indexes, an annual reconstitution that comes amid elevated volatility in the stock market.
Global index provider FTSE Russell kicked off the rebalancing process on May 6, or so-called rank day, to ensure the indexes accurately reflect the U.S. stock market. The reconstitution, scheduled to take place after the market's close on Friday, tends to be among the biggest trading days of the year, Steven DeSanctis, an equity strategist at Jefferies, told MarketWatch last month as the process was getting underway.
See:'You don't want to be shocked': It's 'rank day' and here's what that means for U.S. stocks
About $12 trillion in investor assets are benchmarked to the Russell U.S. indexes, according to a FTSE Russell statement in early June. The larger trading volume tied to the rebalancing could exacerbate stock market volatility, which has been running high as investors cope with soaring inflation, rising interest rates and concerns over a slowing U.S. economy.
Volume will likely surge heading toward the closing bell Friday, according to Jay Woods, chief market strategist at DriveWealth, a broker-dealer on the floor of the New York Stock Exchange.
"It's all about the close," Woods said by phone Wednesday. "That closing trade is the most important trade for all these mutual funds and ETFs" ahead of the rebalancing as it serves as a gauge of their performance, he said.
The CBOE Volatility Index was trading around 29 Wednesday afternoon, well above its 200-day moving average of 23.5, according to FactSet data, at last check.
The U.S. stock market opened lower Wednesday, but the Dow Jones Industrial Average , the S&P 500 and Nasdaq Composite were showing gains in afternoon trading, according to FactSet data.
Meanwhile, the Russell 2000 Index , which consists of small-cap stocks in the U.S., was up modestly Wednesday afternoon, FactSet data show, at last check. The index has slumped more than 24% this year through Tuesday.
Read:Why stock-market investors are 'nervous' that an earnings recession may be looming
Also see:Stock market is not fully pricing in a looming recession, warns Morgan Stanley's Mike Wilson
Under the Russell reshuffling, a "good chunk" of Facebook parent Meta Platforms Inc.'s (META) shares are set to move to the Russell 1000 Value Index from the Russell 1000 Growth Index, according to a Jefferies note dated June 5. Meta's shares have dropped around 53% in the 12 months through Tuesday, FactSet data show.
Growth stocks have been pummeled in 2022. The Russell 1000 Growth Index has plunged almost 29% this year through Tuesday, with its losses exceeding the Russell 1000 Value Index's 14% drop, according to FactSet.
Read:Meta Platforms poised to become 'value' stock in Russell reshuffling this month, says Jefferies
As part of the rebalancing, several energy companies were slated to move up to the large-cap-focused Russell 1000 Index from the small-cap-focused Russell 2000 Index, according to the preliminary results highlighted in FTSE Russell's June 3 statement. They included Antero Resources Corp. (AR), Chesapeake Energy Corp. (CHK), Ovintiv Inc. (OVV), PDC Energy Inc. (PDCE), Range Resources Corp. (RRC) and Southwestern Energy Co. (SWN).
In its June 5 report, Jefferies pointed to "big sector shifts" in the Russell 2000 Value Index, where energy is expected to see its weighting drop while becoming a larger part of the Russell 2000 Growth index. The shift comes as energy stocks skyrocketed this year, though the sector has sold off this month.
For example, the S&P 500's energy sector has jumped more than 33% in 2022, but has fallen around 14% so far in June, according to FactSet data based on Wednesday afternoon trading.
"With the recent selloff in energy, the cyclicals are the laggards in June," said DeSanctis, in a Jefferies research note dated June 20. "The sector is seeing selling pressure come from the ETFs, and maybe even value managers, as the group's weight falls significantly in their indexes due to FTSE Russell rebalancing."
-Christine Idzelis
(END) Dow Jones Newswires
June 22, 2022 14:56 ET (18:56 GMT)
absolutely correct.
Rio Tinto is in 35 countries worldwide.
So basically Rio Tinto is funding the purchase of Johnson Matthey
thanks
what is the time frame for approval and receipt of the loan?
Could we expect to see the funds within the month?
Oshkosh Bags $2.9B Order From USPS For Next Generation Delivery Vehicles
Today 3:05 PM ET (Benzinga)Print
The U.S. Postal Service (USPS) has placed an order of Next Generation Delivery Vehicles (NGDV) with Oshkosh Defense, a subsidiary of Oshkosh Corp (NYSE: OSK).
The initial order is for 50,000 NGDVs and is valued at $2.98 billion. The first order will include a minimum of 10,019 BEVs.
Oshkosh won the competitively awarded NGDV contract in February 2021.
Oshkosh Defense will manufacture zero-emission battery electric vehicles (BEV) and fuel-efficient low-emission internal combustion engine vehicles (ICE) for the USPS in their Spartanburg, South Carolina factory.
The company expects to begin production of the NGDVs in 2023.
Price Action: OSK shares traded higher by 1.17% at $107.39 on the last check Thursday.
A lot of activity in the May 20th $3 calls and $3 puts. Over 10500 of each.
Calls last price 7 cents
Puts last price $1.42
Is that a certain type of play?
What do you think of just selling those puts?
As always, thanks in advance
thanks for responding.
What you say makes a lot of sense.
I'm just feeling my way with PUTS, as I have not written too many.
I usually sell covered calls and have enjoyed much success.
But my reasoning for going out so long, is I believe SENS will do well in 6-9 months. So if they put the stock to me at $1.50 then I am using my money for other ventures. I like the company very much,
but their guidance IMO, tells me we need to be patient.
So, my next question to you regards what happens to the put if there is a buyout at say 5 or 6 dollars +/- ? Does the price drop accordingly and gives me the chance to buy it back at much cheaper price, or do they put it to me at $1.50?
Much thanks for your input and education.
thanks for the update.
I have been mulling over writing some Jan 20, 2023 $1.50 puts.
Friday they closed at 54 cents.
Any thoughts?
TIA
Saol Therapeutics and GeneDx, Inc. Collaborate to Detect Patients with Rare Mitochondrial Disease
Program Supports Access to A Pivotal Phase 3 Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency (DCA/PDCD trial; NCT02616484)
News provided by
Saol Therapeutics
Mar 01, 2022, 06:00 ET
Share this article
ROSWELL, Ga., March 1, 2022 /PRNewswire/ -- Saol Therapeutics, a company researching new treatments for rare diseases, is pleased to announce a collaboration with GeneDx, Inc. a leader in genomic analysis, a wholly owned subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), to assist in identifying patients diagnosed with a rare mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD) who may be eligible to participate in a Phase 3 clinical trial. PDCD affects less than 300 children in the United States annually and lacks any FDA-approved treatment.
This pivotal phase 3 trial administers the investigational drug dichloroacetate (DCA) to young children who have a deficiency of the pyruvate dehydrogenase complex (PDC). PDC deficiency is the most common cause of congenital lactic acidosis and is frequently a fatal metabolic disease of childhood. DCA has Orphan Product designation from the FDA for congenital lactic acidosis (CLA), including patients with PDCD.
GeneDx, in collaboration with Saol, will help make clinicians who treat PDCD aware of this pivotal trial.
GeneDx's advanced genetic testing provides diagnostic information on disease-causing genetic changes thanks to expert gene variant interpretation built on the combination of an unparalleled dataset and deep clinical knowledge. Through the program, GeneDx, in collaboration with Saol, will help make clinicians who treat PDCD aware of this pivotal trial in an effort to possibly accelerate patient recruitment among this highly targeted patient population.
Dr. Peter Stacpoole, Principal Investigator of the DCA/PDCD trial and Prof. of Medicine at the University of Florida, notes, "There are currently no FDA-approved treatments for patients with PDCD. Despite this, finding and recruiting children appropriate for participation in clinical trials is not easy. With the help of GeneDx, we hope to complete trial recruitment this year."
Dave Penake, CEO of Saol Therapeutics, is excited about the collaboration with GeneDx. "Individualized genetic screening offers physicians and families the insights needed to avoid years of misdiagnosis. With their help, we are better able to identify mitochondrial diseases early. Without this technology, recruitment for a disease like PDCD could take many years to complete."
About Saol Therapeutics
Saol Therapeutics (pronounced "Sail") is a privately held, biopharmaceutical company with operations in Roswell, GA, Dublin, Ireland and Hamilton, Bermuda. Saol is focused on clinical development activity in rare diseases, with a focus on mitochondrial disorders, as well as central nervous system disorders such as spasticity and pain management. Saol is one of the collaborators on a Phase 3 trial studying the first potential treatment for pyruvate dehydrogenase complex deficiency (PDCD). More information on the clinical trial can be found at Phase 3 PDCD Trial. More information about Saol can be found at https://saolrx.com/.
About GeneDx
GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Originally founded by scientists from the National Institutes of Health, GeneDx offers a world-renowned clinical genomics program with particular expertise in rare and ultra-rare genetic disorders. In addition to its market-leading exome sequencing service, GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics, and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit https://www.genedx.com/.
SOURCE Saol Therapeutics
Selling Genedx to Sema4 (SMFR)
OPK gets $150 million and 80 million shares of SMFR
I dont think it is diagnosing anything.
I believe they wrote claros off a few qtrs back.
No problem.
However, OPK is in the process of selling this to Sema4.
Thanks again.
I dipped into 3 of those puts at .32 each.
I may go back for 2 more tomorrow at .36 or so.
I believe in the company and think it will rebound. I believe I will make money on these either way, as I wont mind buying them if I have to.
The Jan calls I have I sold 10 at average 75 cents each. So I have a pretty good profit.
Thinking of buying them back and then waiting for spike in price and sell something greater in value but lower in strike price.
Your strategy sounds pretty good and I hope to use it again in some other positions.
GLTA
Thanks for the explanation. Sounds like a win, win.
Heretofore I have only sold covered calls. But writing (selling) a put at this price level sounds pretty good to me. I envision the share price going back up near term, and long term I think we will be richly rewarded.
Always appreciate reading your ideas.
Thanks
I still have my Jan 23 $10 calls. Whats our advice there.
TIA
Senseonics Holdings, Inc. Schedules Fourth Quarter and Full Year 2021 Earnings Release and Conference Call for March 1, 2022, at 4:30 p.m. Eastern Time
February 15, 2022
GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced that it plans to release its fourth quarter and full year 2021 financial results after market close on Tuesday, March 1, 2022.
Management will hold a conference call to review the Company’s fourth quarter and full year 2021 performance starting at 4:30 p.m. (Eastern Time) on the same day. The conference call will be concurrently webcast. The link to the webcast will be available on Senseonics Holdings, Inc. website at www.senseonics.com by navigating to “Investor Relations,” and then “Events & Publications,” and will be archived there for future reference. To listen to the conference call, please dial 1-888-317-6003 (US/Canada) or 1-412-317-6061 (International), passcode 2775821, approximately ten to five minutes prior to start time.
About Senseonics
Senseonics Holdings, Inc. is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems, Eversense®, Eversense® XL and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220215006052/en/
Senseonics Investor Contact
Lynn Lewis or Philip Taylor
Investor Relations
415-937-5406
investors@senseonics.com
Source: Senseonics Holdings, Inc.
<< Back to 2022 News Releases
Pfizer, OPKO Get EU OK for NGENLA Injection for Pediatric Growth-Hormone Deficiency
11:25 am ET February 15, 2022 (Dow Jones)
Pfizer Inc. and OPKO Health Inc. on Tuesday said the European Commission has approved NGENLA, their once-weekly injection for children ages three and older with growth-hormone deficiency.
The companies said the approval of the drug, also known as somatrogon, reduces the frequency of required injections from once daily.
New York drug maker and OPKO, a Miami healthcare-services company, signed a worldwide agreement in 2014 to develop and commercialize somatrogon for growth-hormone deficiency.
The U.S. Food and Drug Administration last month turned away the application seeking approval of somatrogon. Pfizer at the time said it would evaluate the FDA's comments and work with the agency to determine the path forward.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 15, 2022 11:25 ET (16:25 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Ascensia issues positive PR
ASCENSIA DIABETES CARE ANNOUNCES FDA APPROVAL OF THE EVERSENSE E3 CONTINUOUS GLUCOSE MONITORING SYSTEM FOR USE FOR UP TO 6 MONTHS
February 14 2022 - 07:00AM
PR Newswire (US)
PARSIPPANY, N.J., Feb. 14, 2022 /PRNewswire/ -- Ascensia Diabetes Care, a global diabetes care company, announces that its partner Senseonics Holdings, Inc. (NYSE American: SENS) has received approval from the U.S. Food and Drug Administration (FDA) for the next-generation Eversense® E3 Continuous Glucose Monitoring (CGM) System. Ascensia plans to make the Eversense E3 sensor, which can be used for up to 6 months, available to patients in the U.S. during the second quarter of 2022.
Ascensia Diabetes Care logo
Robert Schumm, President at Ascensia Diabetes Care, said, "As the world's first and only long-term CGM System, Eversense is truly innovative and the prospect of using a single sensor for 6 months is a huge step forward for people with diabetes. Ensuring that as many people as possible have access to Eversense E3 is key for us and we'll be introducing a program to help users experience Eversense affordably as we work closely with payers on coverage. We look forward to rolling out this next-generation system through our dedicated CGM commercial team in the U.S. in the coming months, as we strive to improve the lives of people with diabetes everywhere."
Developed by Senseonics and brought to people with diabetes by Ascensia, the newly approved Eversense E3 CGM System, which includes a sacrificial boronic acid (SBA) design modification to enhance sensor survival, offers patients:
The longest lasting CGM available, with 6-month sensor wear duration and essentially two sensor insertion and removal procedures per year
Exceptional accuracy, with a mean absolute relative difference (MARD) of 8.5% demonstrated in the PROMISE Study1 for the duration of sensor wear
A fully implantable fluorescence-based sensor, with a removable smart transmitter* that provides discreet on-body vibratory alerts and transmits data to a mobile app
Fewer calibrations, with primarily one calibration required per day after day 21 of use
"This next generation system delivers on the patient's desire for a CGM sensor that is both long-lasting and highly accurate," said Elaine Anderson, Head of Eversense CGM Business Unit at Ascensia Diabetes Care. "Its unique features and benefits offer people with diabetes unparalleled flexibility, convenience and accuracy. Our partner Senseonics has designed Eversense E3 with the user in mind and we are excited to bring the system to people in the U.S. in the second quarter."
To be among the first to know when Eversense E3 is commercially available, patients who are interested in getting started with Eversense now can sign up at www.eversensediabetes.com/get-started-today. Physicians, nurse practitioners and physician assistants who are interested in offering the Eversense CGM System can sign up at www.ascensiadiabetes.com/eversense/become-a-provider/register/. Alternatively, contact 844-SENSE4U (844-736-7348) to learn more about the first and only long-term implantable CGM system.
* There is no glucose data generated when the transmitter is removed.
1 Garg S. et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study. Diabetes Technology & Therapeutics 2021; 24(2): 1-9.DOI: 10.1089/dia.2021.0182
View original content:https://www.prnewswire.com/news-releases/ascensia-diabetes-care-announces-fda-approval-of-the-eversense-e3-continuous-glucose-monitoring-system-for-use-for-up-to-6-months-301481042.html
SOURCE Ascensia Diabetes Care
Copyright 2022 PR Newswire
taken from another board...
88 Energy Ltd@88EnergyLtd
We have successfully completed an oversubscribed share placement raising A$32 million gross proceeds. Placement will ensure that we are well funded to undertake appraisal activities at Merlin-2 well, due to spud in March 2022. https://clients3.weblink.com.au/pdf/88E/02486237.pdf
Thanks for your input.
Decided to hold my 10s.
However bot and sold some feb 2.5s and 3s.
Just bot some feb 3.5s at .26 looking to double.
Sold some mar 5s and 5.5s
I think approval is coming soon. Hopefully today
GLTA
https://www.drugdeliverybusiness.com/senseonics-fda-clearance-180-day-cgm-whats-next-fran-kaufman/
With FDA clearance ‘imminent’ for Senseonics 180-day CGM, what’s next?
January 31, 2022 By Sean Whooley
Eversense CGM Senseonics The Eversense CGM [Image courtesy of Senseonics] When Dr. Fran Kaufman began her career in the late 1970s, diabetes management consisted of urine testing and animal insulin.
At that point, it had not been proven that managing glucose actually mattered, according to Kaufman, and proof didn’t come until 1992 with the conclusion of the DCCT study.
“I’ve seen a lot of innovation,” said Kaufman, chief medical officer at continuous glucose monitoring technology developer Senseonics (NYSE:SENS).
She’s been involved in innovation as well, the latest being the 180-day Senseonics Eversense continuous glucose monitor (CGM), for which FDA approval could be coming very soon.
Data presented in 2021 demonstrated strong accuracy with the 180-day sensor, as the next-generation Eversense matched performance levels compared to the current 90-day sensor available in the U.S., but with calibration reduced to essentially once per day.
In early January, the Germantown, Maryland-based company said it expected approval “in the coming weeks.”
“That approval, like everything, has been delayed and we’re so appreciative of what these agencies have done, being able to bring forth such innovation to combat [COVID-19], so we’re willing to step aside as we all have to be able to get a handle on this pandemic,” Kaufman told Drug Delivery Business News. “So, we’re waiting and we do think it should be imminent.”
An earlier version of the 180-day sensor is already available in Europe, with the same next-generation version nearing FDA clearance also under review in the EU. By doubling the duration of the current offering in the U.S., it halves the number of insertion and removal procedures while also reducing the calibration frequency after day 21 through a new calibration scheme.
Kaufman said that one of the sensor’s tests produced a mean absolute relative difference (MARD) of 8.5%, representing high accuracy.
She pointed to ease-of-use among other innovations that encompass the patient-centric efforts Senseonics has made to improve the CGM system.
“There are innovations with the reduction in calibration scheme as well as improvement in some of the user interaction and chemistry improvement,” Kaufman said. “There are all kind of things that we’re excited about.”
Once Senseonics wins FDA approval, its marketing partnership with Ascensia Diabetes Care comes into play.
“They bring forth a huge presence in the field and in marketing and commercialization,” she said. “It enables us to really focus on what we do best.”
The U.S. rollout for the 180-day Eversense CGM will show the benefits of the partnership, Kaufman said, with commercialization responsibilities falling on Ascensia and product development belonging to Senseonics, which began as an R&D company. The partnership allows Senseonics to keep future innovations within a “robust pipeline” at the forefront of its efforts, Kaufman said.
In a November report, BTIG analysts acknowledged the large market opportunity for Eversense — which, at that time, was expected to win FDA approval by the end of 2021 — but said a premium valuation wasn’t warranted “given the company’s past challenges in commercializing the product and the remaining risks related to commercial execution with its new partner.”
Next steps for Senseonics and Eversense include extending durability to one year, a mark that could be reached with the help of chemistry modifications and fundamental changes in the sensing surface itself.
The company also has plans for pushing the calibration frequency to once per week and adding a battery center that won’t increase the diameter but will marginally increase the length, allowing for the transmitter to be taken off and the device to be used as an intermittent scanning device with devices such as a smartphone.
Kaufman said the potential changes in the pipeline at Senseonics are meant to serve the entire spectrum of people managing their diabetes.
“I still think that we’ll need CGM to be sure things are working well and to understand part of our physiology better,” Kaufman said. “What better device for that in the future than an implantable one that could last a year that you could query when you want to? And when you don’t, you don’t have to get that information. I’m just excited that we’ll have something that will be meaningful through this next evolution of how we manage diabetes.”
Filed Under: Auto-injectors, Big Data, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance Tagged With: Diabetes, Eversense, FDA, Senseonics
leemalone2k3 covered calls strategy
Just read your post and like your ideas. Curious did you buy back the Jan 23 10's and if so what price? What are you looking to sell them again at? (if you care to share, I would much appreciate your assistance). You got a great price in April. I sold 10 of those also, but in Sept, and my average price received was .73.
Thinking of buying some Jan 23 2.50s at a dollar. What do you think?
Not adverse to risk as I just bought 5 each Feb 2 1/2s (.23) and 5 Feb 3's.(.12)
I know its speculation, but upon FDA approval (hopefully this week), do you think we will hit 5, or maybe 6 realistically?
Thanks in advance....
Pfizer, OPKO Health Report FDA Issued Complete Response Letter For Biologics License Application For Their Somatrogon
4:30 pm ET January 21, 2022 (Benzinga) Print
Pfizer Inc. (NYSE:PFE) and OPKO Health, Inc. (NASDAQ:OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220121005474/en/
“We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world,” said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. “We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric growth hormone deficiency patients and their families.”
Regulatory applications for somatrogon have been submitted to several countries around the world for review. Earlier this week, Japan’s Ministry of Health, Labour and Welfare approved NGENLA® (somatrogon) Inj. 24 mg Pens and 60mg Pens, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. In 2021, Health Canada approved NGENLA® for the long-term treatment of pediatric patients who have GHD, and Australia’s Therapeutic Goods Administration (TGA) approved NGENLA® for the long-term treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone. Furthermore, in December 2021, the Committee for Medicinal Products for Human Use (CHMP) of EMA issued a positive opinion recommending somatrogon for marketing authorization in the EU, to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. A decision from the European Commission (EC) is expected in early 2022.
In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Senseonics Holdings Shares Spike Higher; Co Reiterates FY21 Guidance; Sees FY21 Global Net Revenue To Be In Middle Of Guidance Range Of $12M-$15M
4:48 pm ET January 4, 2022 (Benzinga) Print
Senseonics Announces Business Updates
Senseonics Holdings, Inc. (NYSE:SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced operational and financial business updates.
Operational and Financial Updates
Substantive review with the FDA for the PMA supplement for the next generation Eversense 180-day CGM system is nearing completion, all queries raised have been answered and a decision regarding approval is expected in the coming weeks
Designing plans with Ascensia Diabetes Care for a smooth transition to the 180-day system in the U.S., pending FDA approval, including:
Marketing campaigns to highlight the availability of system upgrade programs for patients and to increase overall patient awareness
Payor engagement regarding reimbursement and coverage transitions
These plans are being designed with a goal of minimizing the impact to patients, providers and sales, taking into account the expected use of existing inventory in Q1 2022 and initiating transition to the new product in Q2 2022
Reiterating 2021 financial outlook expectation for full year 2021 global net revenue to be in the middle of the revenue guidance range of $12.0 million to $15.0 million
"We understand that the FDA is at full capacity managing the backlog of COVID-19 related filings creating longer than expected review timelines. We are confident a decision regarding approval of the 180-day system will be made in the coming weeks as the FDA continues to clear out the backlog," said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. "In 2021 we integrated operations and coordination activities with our commercial collaborator Ascensia Diabetes Care. A thoughtful go-to-market strategy is being designed to target a smooth transition to the 180-day system while providing uninterrupted service for patients, providers and payors. We are excited to advance long-term solutions for people with diabetes as we continue to aim to make the new 180-day system available in the U.S.."
About Senseonics
Senseonics Holdings, Inc. is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about Senseonics' expected net revenue for the full year of 2021 and the full year of 2022, the timing and outcome of the potential decision on the 180-day Eversense system from the FDA, the timing, effectiveness and readiness for launch of the 180-day Eversense system, the ability to collaborate with Ascensia Diabetes Care, the ability to smoothly transition patients, physicians and payors, the impact of existing inventory and transition timing on financial results, the ability to manage such impact, and other statements containing the words "believe," "expect," "intend," "may," "projects," "will," "planned," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties in the regulatory approval process, uncertainties inherent in the commercial launch and commercial expansion of the product, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, and such other factors as are set forth in the risk factors detailed in Senseonics' Annual Report on Form 10-K for the year ended December 31, 2020, Senseonics' Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and Senseonics' other filings with the SEC under the heading "Risk Factors." In addition, the forward-looking statements included in this press release represent Senseonics' views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics' views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics' views as of any date subsequent to the date hereof.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220104006026/en/
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Is this investment a line of credit or a secondary offering...
The letter says:
Dear Shareholders:
I am pleased to share with you today that iQSTEL has for some time now been in strategic negotiations with a notable investment firm to structure terms for a substantial investment that will both contribute to iQSTEL's qualification for up-listing to a national exchange in addition to giving us access to funds that can significantly accelerate our growth over the next three years.
iQSTEL is in receipt of an investment proposal for funding that in total exceeds $50 million. Our independent Board of Directors (BOD) has approved the general terms of the proposal and outlined conditions for management to proceed with executing an agreement with the investment firm.
Even as far along as we are in the negotiations, there is no guarantee the investment agreement will come to fruition. My confidence level in finalizing the deal is high, and I currently anticipate executing the agreement before the end of the year, but again, no deal is final until it is final.
Thanks for your reply.
Much appreciated.
I just wish the company was a little more transparent in their explanations and would limit the rhetoric to exact info instead of "potential this and possibly that". Maybe tomorrow will be different.
New bikes look great.
Questions...Who is buying these machines and how much are they paying?
How much is profit to ALYI?
How many different models are there and what market place are they going to?
Seeking Alpha Article
iQSTEL's Third Quarter Positioned The Company Very Near To Profitability
Nov. 18, 2021 8:07 PM ETiQSTEL Inc. (IQST)7 Comments1 Like
Summary
iQSTEL Q3 results met expectations with gross margins improved by every division, and overall.
iQSTEL’s heavy focus on technology is not receiving consideration in the market.
I see iQSTEL as a speculative buy that is trading under its fair current value.
iQSTEL (OTCQB:IQST) is a microcap holding company that I have covered here at Seeking Alpha. Historically, iQSTEL’s revenues are mostly derived from its operation as a small telecom service provider. The company also has several new technology products such as Blockchain, Electric Vehicle (EV), EV batteries, Fintech, and Internet of Things (IoT) smart devices. Some of these new products may already be generating revenue as of the current quarter, and others are set to bring revenue in early 2022. I have rated iQSTEL as a “Speculative Buy” and I see that rating even more applicable with the latest filing of their quarterly report.
Source for Image and Information: iQSTEL
Q3 2021 Report
iQSTEL delivered solid results for the third quarter and they pretty much met my expectations on almost all counts. I had hoped some of the new revenue streams would begin to show in the third quarter, but I stated that it was more likely to occur in Q4 or in early 2022. Also, it might have created more of a “Wow!” factor if the company had achieved profitability in Q3, but they did come very close, and apparently without the help of new revenue streams. Importantly though, the company did maintain a clear progression toward becoming profitable, and it looks very plausible that the shift will occur in Q4, if it has not already happened in Q4.
Source: Created by author with iQSTEL SEC filing data
Shareholders' equity held well in that it dropped just a bit less than the small amount of negative net income. The company maintained a positive balance of total assets to total liabilities.
Source: Created by author with iQSTEL SEC filing data
Cash decreased by about 66% during the quarter to approximately $1.2 million, likely in part due to the small negative net income. The current cash position appears to provide enough to finish out the year, even if the company’s net income were to not improve. iQSTEL has not sold any shares since March of 2021; and with this cash position and potential for profitability, if they do sell shares, it seems more likely it would be primarily for M&A activity.
iQSTEL decreased its general and administrative expenses slightly year-over-year and continues to see the benefit of becoming “debt-free” of toxic debts such as convertible notes and warrants. Interest expenses were less than 1% of last year’s Q3 at $6,802 for Q3 21 vs. $913,592 for Q3 20.
I mentioned some concern about telecom gross margins in my last writing, since Q2 data was a little weak. But telecom gross margins did improve in Q3 21, and the margins improved in each telecom division as well as overall, looking at the first full 9 months of data.
Source: Created by author with iQSTEL SEC filing data
The company needs to continue to improve its telecom gross margins. Currently, its largest revenue generating division has the lowest gross margins, but this division also represents some of the newest business. If we can expect the new business to achieve margins comparable to the other divisions, then it could add substantially to iQSTEL’s profitability. The guidance we have is that the company’s merger of all its telecom divisions is underway, and they expect to begin seeing the cost benefits with the current (4th) quarter. Also worth noting is that this consolidation will provide for cross-selling of telecom services, and thus may lead to opportunities to increase revenue.
All year this year, iQSTEL predicted revenues of $60.5 million for 2021. Recent guidance suggests that the company will reach this goal, and potentially surpass it.
Source: Created by author with iQSTEL SEC filing data
In most every metric, iQSTEL is demonstrating a guided transformation from a struggling business to stability. Perhaps that is most evidenced by its quick advances up the ladder of OTC tiers as they moved to OTCQB, then very quickly after that they graduated to the OTCQX level. OTCQX is the highest level available in the OTC, and it is only available to companies that meet their financial requirements. iQSTEL continues to state its goal to become listed on the Nasdaq, and it may be that reaching the minimum share price requirement is the only remaining criteria that still needs met.
Valuation
According to Aswath Damodaran, the average telecom gross margin is 19.06%. This margin is already in the range of some of iQSTEL’s more established telecom business such as Swisslink. The newer business should mature, and the telecom reorganization should cut costs. Then, if we can expect iQSTEL’s telecom services to achieve a margin of 19.06% or near it, I could easily see a fair market price for iQSTEL above $1.00 at a telecom average P/E of 22.99. That alone could take the stock to about twice the current market value, if not more. And to be clear, those calculations do not even consider further contributions for any other of iQSTEL’s products or services.
Source: CSI Market
The current telecom price to sales ratio is 1.66. Using the forecasted 60.5 million in revenue times the ratio, you could see a market cap of $100,430,000 and you could expect to see a market price of about $.71 for the stock. Until or unless the company improves telecom margins, I would ordinarily call $.71 as the fair market value for the stock. But then, I would need to add value for all its other new products and services. So maybe we start by saying the company stock’s fair value is $.71 “+”. In any case, that is significantly higher than the current share price of around $.53, at this writing.
Source: CSI Market
What is iQSTEL?
The question I asked in my last article is even more relevant today. Is iQSTEL a small emerging telecom, or a technology company? If you do a few searches, you may often see that iQSTEL is described as a technology company. And it matters a lot for a fair valuation, because technology companies on average command a larger P/E and a much larger Price to Sales ratio.
Source: CSI Market
Source: CSI Market
You can rightly say that most all the historic revenue is based on telecom services, and that is simple enough. But the company is feverishly working on its technology product and services. It is hard to predict revenue with no more than what we know today, but we do know that all the new products and services entail much improved gross margins, perhaps more in the 35% range more or less.
While the historic revenue may be telecom, the company is actively manufacturing EV motorcycles as of this week and they expect a first batch ready to sell by the end of the year. IoT Smart Tank devices were or are still being installed, MNPA is being made commercially available in Q4, and Fintech services should begin to materialize by early 2022. On top of all that, they have finalized designs and are currently negotiating terms with an EV battery customer. What do you call a company that uses all its core resources as a springboard to its technology options?
Would you call Amazon a bookstore when it clearly had vision way beyond that? Maybe not to compare really, but iQSTEL certainly has much bigger plans than just telecom. Maybe some will need to see technology revenues begin to show in financials, but at some point, it may become appropriate to call iQSTEL a technology company. For some, that point may be now.
Once new revenue streams are more apparent, we can observe the P/E and see how the market reacts. But if you want to find a current fair market value for now, I believe it is greater than $.71, and up to at least $3.13 ($60.5m x 7.33 p/s, divided by 141,657,358 shares) depending on how much you value their potential.
Looking back at historic results has its merits, but the company is well on its way to reporting its new, higher margin revenue streams soon, and they can no longer be considered as just a telecom provider. It does not appear to me that the market has factored that in, based on typical and common available valuation methods.
Source: iQSTEL (iQSTEL “EVOSS” EV motorcycle designed for Latin American style preferences)
Risks
I am restating the risks I saw from my original article in case you missed it. All these risks are still relevant, and I also recommend reading the full list of risks as shown in the company's SEC filings.
A major risk I see would be if some or all the core telecom businesses were to be lost before they can reach the diversification they are working on. This could come in the form of a loss of one or more carrier customers or changes in technology. For example, there is some industry shift away from SMS to RCS. This has been slow to adopt, but it is in progress. It could certainly become an issue, but SMS is still widely used and in some cases is being used more than ever as companies are increasing the use of SMS for identity verification. Also, iQSTEL is working to shift with changing technologies, including RCS.
Other risks I see would be a failure to improve margins over time, any overspending, unnecessary dilution eroding shareholder confidence, or a failure to execute and loss of capital due to failure.
The planned new initiatives raise the question of increased costs. Much of the plans come from subsidiaries acquired in the prior year, and I think it is safe to assume products like MNPA will not require a lot of new capital expenditure. IoT device expenses such as Smart Tank, likely would be covered by contract. Fintech, and certainly electric vehicles, could present capital expenditures to recover, although iQSTEL should have a lot of the R&D part of it behind them at this point. iQSTEL will need a measured approach to all costs as would be prudent.
I would reevaluate my investment thesis for iQSTEL if there was significant loss of business, failure to achieve profitability in a reasonable time frame and failure to achieve good margins. I would also reevaluate my thesis if I saw significant dilution occurring that does not bring in equal or better value to the company. For an investment in iQSTEL, I expect shareholder equity to continue to improve over time.
Final Thoughts
I am invested in iQSTEL with a substantial position. Most of this was purchased below today’s share price. Perhaps what I like most with iQSTEL is their vision to combine a mix of seemingly unrelated products and services to their advantage. Telecom customers may become Fintech customers, who may purchase an EV product. They work on a base of Latin America, but they are branching their services globally and, in fact, they have a presence in 15 countries now.
With all the new products and services, iQSTEL continues to promote its telecom business. They recently attended a show in Spain, and this week, they attended a show in the Mideast, to grow their presence in telecom. I would not be surprised if these efforts brought in new business. In addition, the company has just announced plans to acquire 51% of an existing telecom company that is expected to bring in another $15 million in annual revenue, even before any cross-selling of iQSTEL's other services. The deal is expected to close in early January 2022.
Source: iQSTEL
The full range of catalysts coming for the end of 2021 and early 2022 is very extensive including the acquisition, potential telecom margin improvements, EV and IoT device products, and Blockchain [MNPA] and Fintech services. Also, I expect the fair market value to reflect that iQSTEL is a lot more than just a telecom company, as the catalysts become apparent in the financials.
This article was written by
Dwight Baker profile picture
Dwight Baker
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I am an individual investor with over 30 years experience trading stocks and ETF's. I have researched stock...
Growth, Income, Long-Term Horizon, Medium-Term Horizon
Contributor Since 2014
I am an individual investor with over 30 years experience trading stocks and ETF's. I have researched stocks in a wide range of areas such as telecoms, REIT's, manufacturing, and energy to name a few. I expect to supplement my retirement with income derived from stock trading and dividends. My current focus is steady dividend income balanced with high growth opportunities. Anything I write may be considered a first step toward due diligence but it is my personal opinion only. I strongly recommend consulting an experienced, registered and qualified investment advisor before making all investment decisions.
Disclosure: I/we have a beneficial long position in the shares of IQST either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: Please note that I am not a financial advisor. The article should not be considered as a suggestion to buy or sell this or any other stocks. Consider this one source of a full range of due diligence you should undertake but is entirely my personal opinions. It is strongly recommended that you consult an experienced, qualified, and registered investment advisor before trading.
AGTC Clinical Trial Investigators to Present Data from Ongoing XLRP and Achromatopsia Phase 1/2 Trials at the Fourteenth International Symposium on Retinal Degeneration
8:00 am ET September 28, 2021 (Globe Newswire) Print
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare inherited retinal diseases, today announced a presentation of the Company's ongoing clinical trials in achromatopsia (ACHM) and X-linked retinitis pigmentosa (XLRP) at the Fourteenth International Symposium on Retinal Degeneration (RD2021).
Rachel Huckfeldt, MD, PhD, Assistant Professor of Ophthalmology at Harvard Medical School will present Twelve-month Findings from Two Phase 1/2 Clinical Trials of Subretinal Gene Therapy for Achromatopsia in adults and low-dose pediatrics on September 29, 2021, at 9:35 AM ET.
Paul Yang, MD, PhD, Assistant Professor of Ophthalmology at the Casey Eye Institute, Oregon Health & Science University in Portland, will present Twelve-Month Analysis of Macular Structure using Optical Coherence Tomography (OCT) from a Phase 1/2 Clinical Study of Subretinal Gene Therapy Drug AGTC-501 for X-Linked Retinitis Pigmentosa, on September 29, 2021, at 10:35 AM ET.
"We look forward to our investigators having the opportunity to share analysis of these results with members of the eye health community," said Sue Washer, President and CEO of AGTC. "We believe the data provide important validation for the broad application of our AAV technology platform, including the best-in-class potential for our XLRP therapy candidate and further clinical investigation of our therapy to treat ACHM."
"ACHM is an inherited condition caused by mutations in one of several genes, including the CNGB3 or CNGA3 genes, resulting in nonfunctioning "cone" photoreceptors responsible for color vision, and is associated with poor visual acuity, extreme light sensitivity leading to daytime blindness, and partial or complete loss of color discrimination," said Dr. Huckfeldt. "These results are very encouraging, and I look forward to sharing them with my fellow retinal specialists."
"Patients with XLRP experience damage to photoreceptors in the retina (both rods and cones) leading to declining vision in dim light conditions and progressive peripheral vision loss that can eventually result in legal blindness," said Dr. Yang. "The sustained durability of improved visual function over 12 months is compelling evidence of biological activity for this XLRP gene therapy."
AGTC plans to advance its ACHM program to the next stage of clinical development and is moving forward on an End-of-Phase 2 (EOP2) briefing packet to submit to the U.S. Food and Drug Administration, developing assays for pivotal ready testing, and planning production of clinical trial material. Along with the 12-month results in XLRP and other key XLRP data previously released by the company, AGTC is currently executing the Skyline and Vista Phase 2/3 trials that will expand safety and efficacy analyses, including microperimetry and luminance mobility maze outcomes.
Learn more and register here for the virtual/digital event to attend these important presentations: https://bit.ly/3z9uHre.
About AGTC
AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. AGTC's most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHMB3 and ACHMA3). Its preclinical programs build on the Company's industry leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders. In recent years AGTC has entered into strategic partnerships with companies including Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, and Bionic Sight, LLC, an innovator in the emerging field of optogenetics and retinal coding.
Forward-Looking Statements
This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs, including statements about the potential of the Company's late-stage development programs in X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM). Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic, including the impact on its ability to obtain the raw materials necessary to conduct its clinical trials. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in our most recent annual report on Form 10-K and subsequent periodic reports filed with theâ?¯SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
PR Contact:
Bryan Blatstein
Spectrum Science Communications
T: (212) 468-5379 or (917) 714-2609
bblatstein@spectrumscience.com
Corporate Contact:
Stephen Potter
Chief Business Officer
Applied Genetic Technologies Corporation
T: (617) 413-2754
spotter@agtc.com
https://ml.globenewswire.com/media/542616ce-01ae-469d-b4ff-5285f7e0584e/small/applied-genetic-technologies-logo.jpg
Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency
Today 4:24 PM ET (Benzinga)Print
Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for somatrogon, a once-weekly long-acting recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD) in pediatric patients. The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to January 2022, as a result of Pfizer's submission of additional data to the original BLA.
In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.
GeneDx announces sequencing over 300,000 Patient Exomes
GeneDx Announces the Sequencing of More Than 300,000 Clinical Patient Exomes
Today 2:30 PM ET (PR NewsWire)Print
GeneDx, Inc., a leader in genomic analysis, a wholly owned subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced it has completed clinical genetic exome sequencing for more than 300,000 patients, making the company's dataset the largest of its kind in the world. Supported by matching phenotypes, the company's market-leading genomic analysis and interpretation capabilities have created a diagnosis and discovery engine advancing genetic medicine worldwide.
https://mma.prnewswire.com/media/1631016/GeneDx_logo.jpg
GeneDx today announced it has completed clinical genetic exome sequencing for more than 300,000 patients.
"The transition to widespread use of exome and ultimately whole genome sequencing rather than multi-gene panels promises to radically simplify the use of genomic information in healthcare. The rapid acceleration in demand for our exome testing, including nearly 100,000 exomes completed in the last year alone, shows this transition is well underway," said Katherine Stueland, president and CEO of GeneDx. "Often our patients are infants in the neonatal intensive care unit whose parents are facing a daunting process to figure out what's wrong with their child. Going immediately to sequencing the genomes of baby and parents dramatically curtails that quest, enabling the care team to have the right answer on what's wrong so they can intervene quickly."
With the volume of clinical exome sequencing accelerating more than 40 percent annually, GeneDx has played a pivotal role in supporting rare disease diagnosis for hundreds of thousands of patients while also expanding understanding of gene-disease relationships that improve diagnosis and treatment for patients worldwide. The company's extensive experience with exome sequencing results in a definitive diagnosis in 20% more cases with 27% fewer variants of unknown significance compared to public datasets.1 The variant interpretation framework that supports the company's exome service also underlies its rapid whole genome sequencing service, which provides a complete genetic picture of a patient in seven days or less.
In addition to best-in-class interpretation and classification, GeneDx's interpretation capabilities and dataset have been an important discovery engine. Nearly a quarter of cases diagnosed today include gene-disease relationships originally identified by GeneDx, and each year company researchers collaborate on dozens of publications of new gene-disease relationships, significantly expanding medical understanding of the genetic underpinnings of developmental delay, intellectual disability and other genetic diseases.
Exome and whole genome sequencing are genetic tests designed to provide a comprehensive look at an individual's DNA. The broadest test, whole genome sequencing, analyzes the full genetic sequence of an individual, allowing clinicians to assess any variants that may be associated with health concerns. Exome sequencing concentrates on a subset of the genome, analyzing the roughly 20,000 protein-coding genes that are the source of most genetically-linked health issues. Each type of testing provides more complete information compared to the targeted multi-gene panels clinicians typically use to look for genetic underpinnings of health conditions. The American College of Medical Genetics and Genomics recently published guidelines strongly recommending exome or genome sequencing as a first or second-line test in children with intellectual disability, developmental delay or multiple congenital abnormalities.2
About GeneDxGeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Originally founded by scientists from the National Institutes of Health, GeneDx offers a world-renowned clinical genomics program with particular expertise in rare and ultra-rare genetic disorders. In addition to its market-leading exome sequencing service, GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics, and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit http://www.genedx.com.
About OPKO HealthOPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding GeneDx's test offerings, the adoption and widespread use of exome and whole genome sequencing, the utility and accuracy of exome and whole genome sequencing, the ability to provide rapid whole genome interpretation within seven days or less, whether GeneDx's interpretation capabilities and dataset will be an important discovery engine, whether healthcare providers will be able to properly treat conditions based on the results of exome and whole genome sequencing, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
References:
-- Data on file
-- Manickam, K., McClain, M.R., Demmer, L.A. et al. Exome and genome sequencing for pediatric patients with congenital anomalies or intellectual disability: an evidence-based clinical guideline of the American College of Medical Genetics and Genomics (ACMG). Genet Med (2021). https://doi.org/10.1038/s41436-021-01242-6
Contacts:Julie McKeoughjmckeough@genedx.com
Hillary Titushtitus@bioreference.com
https://c212.net/c/img/favicon.png?sn=NY14115&sd=2021-09-21
View original content to download multimedia:https://www.prnewswire.com/news-releases/genedx-announces-the-sequencing-of-more-than-300-000-clinical-patient-exomes-301381900.html
SOURCE GeneDx, Inc.
Thanks for the link...
However the IR page lists the latest and only press release from
Mar 7, 2018.
It doesn't list the PR detailing when Driveline ELD was submitted for approval.
Does anyone have that PR? I'd like to review it.
no trading in past five minutes.
Have we been halted pending news?
OPKO Health Completes Enrollment in Phase 2 Trial Evaluating RAYALDEE as a Treatment for Symptomatic COVID-19 Outpatients
August 30, 2021
MIAMI, Aug. 30, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) announces the completion of enrollment in its Phase 2 trial with RAYALDEE® as a treatment for mild-to-moderate COVID-19. The U.S. trial, “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue),” was expected to enroll approximately 160 subjects, including some with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness. Final enrollment reached 171 subjects and topline data are expected later this year.
The REsCue trial randomized symptomatic COVID-19 outpatients in a 1:1 ratio to 4 weeks of treatment with RAYALDEE or placebo and a 2-week follow-up. Dosing with RAYALDEE begins with 300 mcg per day on Days 1, 2 and 3 followed by 60 mcg per day on Days 4 through 27. This dosing regimen is modelled to raise serum total 25-hydroxyvitamin D (25D) within the range of 50-100 ng/mL. The trial’s primary efficacy endpoints are attainment of the targeted 25D level and time to resolution of COVID-19 symptoms. Secondary endpoints include incidence of emergency room or urgent care visits, oxygen saturation below 94%, need for and duration of hospitalization, requirement for mechanical ventilation, mortality rate and severity and duration of illness evidenced by quality-of-life and biochemical measures. More information about this trial is available on ClinicalTrials.gov.
About RAYALDEE
RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). RAYALDEE, approved to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 CKD and vitamin D insufficiency, was launched in the U.S. in November 2016.
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," “could,” "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including the expected benefits of RAYALDEE, whether and when we will complete the clinical study contemplated for RAYALDEE and whether final study data will be positive, our ability to commercialize RAYALDEE for COVID-19 patients, whether RAYALDEE is capable of treating patients with COVID-19 including whether RAYALDEE could impact the SARS-CoV-2 virus or cytokine storm, or have any impact on the severity of the disease or that it will effectively raise and maintain serum total 25D consistently at or above 50ng/mL, as well as other non-historical statements about our expectations, beliefs or intentions regarding our technologies and products, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as the risks that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward- looking statements. We intend that all forward-looking statements be subject to the safe- harbor provisions of the PSLRA.
Contacts:
LHA Investor Relations
Yvonne Briggs, 310-691-7100
ybriggs@lhai.com
or
Bruce Voss, 310-691-7100