BLA for Narsoplimab in HSCT-TMA Accepted for Priority Review Biologics License Application for Narsoplimab in HSCT-TMA Accepted for Priority Review by U.S. FDA
-- FDA sets PDUFA date of July 17, 2021 --
Biotech
YTEN 10/10First pullback , second pullback and now we are on the third pullback .
That is the actual situation after getting a +93.10% performance over the course of the week.
Right now biotechnological and medical stocks are rising because of the news, but be careful on getting
into this stock, it might be too late. Usually stocks do not bounce a fourth time after three pullbacks.
Even though, if we analyze the situation using Elliot waves, we could see a new uprising wave, but it is possible because of the volume showing on the candles that are slowing down the downtrend.
And the last tool used to analyze this market was the Fibonacci retracement. If prices go below the 38.2 mark, it would be very unusual to see a new high.
Have a great day!
Sorrento could surge 275% in 2021, Here is why...H.C. Wainwright analyst Ram Selvaraju rates SRNE a Buy along with a $30 price target, which implies a 275% upside from current levels.
Factors behind the optimistic outlook:
1. Sorrento has a stake in two cell-based immunotherapy companies that could “drive value in Sorrento shares over the coming months.”
2. the analyst highlights Sorrento’s “burgeoning portfolio of assets spanning three distinct therapeutic areas (non-opioid pain management, oncology and COVID-19).”.
3. two rapid COVID 19 detection tests; COVI-STIX, for which the company filed for Emergency Use Authorization (EUA) in the U.S. in December, and COVI-TRACE, which Selvaraju claims could come in handy at any mass gathering event.
“We believe that the incentive to facilitate the large-scale and indeed ubiquitous deployment of the COVI-TRACE test is extremely high and governments worldwide may seek to implement this in their respective regions,” the 5-star analyst opined.
4. Other Covid-19 candidates include COVIGUARD - a SARS-CoV-2 neutralizing antibody, COVI-AMG - an affinity-matured version of the COVIGUARD neutralizing antibody, a neutralizing antibody cocktail named COVI-SHIELD and COVIDTRAP, an ACE2 receptor decoy, intended to imitate the mammalian ACE2 receptor that acts as the primary portal for the SARS-CoV-2 virus to penetrate human cells.
finance.yahoo.com
Oppenheimer Analyst Says buy, following of some positive dataOppenheimer 5-star Analyst Says BioNano Genomics is ready to Execute in 2021.
the latest move was decidedly upbeat. In Wednesday’s session, the stock took off to the tune of 40% following the publication of some positive data.
article which made side-by-side comparisons between Bionano’s optical genome mapping platform Saphyr and PacBio's HiFi chemistry revealed that Saphyr had the upper hand on several metrics.
Across 32 different human genomes, PacBio technologies found only 72% of the large SVs (structural variants) that Bionano’s optical genome mapping (OGM) detected.
Saphyr was also found to be better at locating indels in regions correlated to neurodevelopment.
Additionally, Saphyr appears to be more cost effective. The platform’s estimated cost of $500 per genome coming in far below the $10,000-20,000 per genome when HiFi and SMRT sequencing are put into action.
Oppenheimer’s Kevin DeGeeter believes the data should help Saphyr make further inroads in the “large SV research market.” The analyst views 2021 “largely as an execution year.”
We expect the data to support broader adoption of Saphyr for de novo sequencing and research applications. the 5-star analyst said.
“Furthermore, we expect 2021 to be an important year for adoption of Saphyr for clinical cytogenetics market based on a series of positive recent publications... Based on our current assessment of the competitive landscape, we do not believe long-read sequencing technologies can replicate Saphyr's performance and cost structure for digital cytogenetics testing.”
Accordingly, DeGeeter reiterated an Outperform (i.e. Buy) on BNGO shares, along with a $1.5 price target. The implication for investors? Strong upside of 113% .
Two other analysts have thrown the hat in with a BNGO review recently, one saying Buy and the other recommending a Hold -- all add up to a Moderate Buy consensus rating. Meanwhile, the average price target stands at $1.42, implying gains of 101% could be in the cards over the next 12 months.
finance.yahoo.com
FDA identifies "Assay Kit" able to detect SARS-CoV-2 mutationsU.S. FDA Lists Applied DNA’s Linea™ COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)
(FDA) published a safety communication (the "Communication") that identifies the Company’s Linea™ COVID-19 Assay Kit (the "Assay Kit") as one of only two tests marketed under the FDA’s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). According to recent publications, the B.1.1.7 variant has been identified within the United States and may be associated with an increased risk of transmission of the virus that causes COVID-19.
Based on analysis conducted by the Company and FDA, one of the two S-gene targets (S1 and S2) of the Assay Kit has significantly reduced sensitivity in the presence of certain S-gene mutations, including a mutation found in the B.1.1.7 variant.
finance.yahoo.com
ATRA growth potentialAtara Biotherapeutics , Inc. (Nasdaq: ATRA ), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T- cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases
"Atara made significant progress in 2020 and is well-positioned for a strong 2021," said Pascal Touchon, President and Chief Executive Officer of Atara. "As the most advanced allogeneic T-cell therapy company, nearing initiation and subsequent completion of a rolling BLA for our lead product candidate tab-cel®, we are making key investments in commercial infrastructure to ensure delivery of this potentially transformative therapy to patients in dire need. Atara also anticipates significant progress throughout 2021 on ATA188 for progressive MS with multiple data read-outs and, after recent productive interactions with the FDA, is poised to expand enrollment in the RCT and conduct an interim analysis in H1 2022."
DBV Technologies rally on Positive FDA CommunicationDBV Technologies Spikes on Positive FDA Communication
DBV Technologies received positive responses from the U.S. Food and Drug Administration regarding its application for a peanut allergy treatment.
The U.S. FDA provided type A meeting requests to the questions the French company submitted in October following its receipt of a complete response letter in connection with its biologics license application (BLA) for Viaskin Peanut DBV712, its once-daily epicutaneous patch to treat peanut allergy in children ages four to 11.
"We are very encouraged by the positive feedback received from the FDA, and we appreciate the clarity provided," said Daniel Tassé, CEO of DBV Technologies. “We look forward to working with our investigators, clinical trial sites, and key stakeholders as we continue in our development of investigational Viaskin Peanut."
DBV says it will address details about a new human factor validation study and additional chemistry, manufacturing and controls data in subsequent communication with the FDA.
"We intend to advance a remediation plan for Viaskin Peanut and work closely with FDA to review protocols and re-file our BLA as soon as possible, so that we can bring Viaskin Peanut, if approved, to patients suffering from peanut allergies," Tassé said.
www.thestreet.com
finance.yahoo.com
Botanix: Strength to StrengthBotanix Pharmaceuticals Ltd (ASX:BOT) is a clinical stage cannabinoid therapeutics company. The company focus is the development of safe and effective topical treatments for serious skin conditions. It has an exclusive license to use a proprietary drug delivery system - Permetrex for direct skin delivery of active pharmaceuticals in all skin diseases. The company's product pipeline includes BTX1503 - Moderate to Severe Acne, BTX1308 - Plaque Psoriasis, BTX1204 - Atopic Dermatitis, and BTX 1701 - Mild Acne.
Bullish Outlook:
- Trending Bullish within Upward Channel
- Double Bottom off Support
- RSI not Overbought
- TB Fib Targets Achievable
- Positive news should see this continue trend
Trading.
"DISCLAIMER: NO ADVICE. The information presented here is general in nature and is for education purposes only. Nothing should be considered to be advice. You should consult with an appropriate professional for specific advice tailored to your situation."
$GILD ELLIOTWAVES$GILD is looking bullish going into 2021
We need a breakout of this downtrend channel for the impulsive waves to be valid, look for a break at the red trendline as well as a retest as support in wave 4
ObsEva, emerging company on verge of phase 3 completion
Hi Ya'll,
I hope you're having a Good Friday night. I came across this gem yesterday and I have to give it a shout out. ObsEva is a unique company, and has lots of potential. They have three drugs currently in pipelines. Its recently broken out and is channeling upward and moving very healthily. I have a price target of $10+. With a long term hold.
Yselty- Phase 3
Ebopripant - Phase 2
Nolasiban -Phase 1
www.obseva.com
Yselty is about to be finished testing. It looks positive and ready to be sold world wide. This product is very good for dealing with uterary fibroids which is very common and has no clear medication to use to solve it.
If y'all can post your own understanding of the significance of these drugs I would appreciate it. I do not fully understand what these drugs do but they seem to be a big deal.
Many analysts have set price targets ranging from $4.00-$28.00 a share.
I will link this.
www.tipranks.com
Please give the company corporate presentation a look, and please tell me if I missed anything crucial, like the executives, etc..
www.obseva.com
Thanks,
Benjamin
$MRK ELLIOTWAVESMy current waves on $MRK
would love some feedback, this catalyst and original chart was brought up originally by @tomikazi
It broke out of the downtrend channel and now is in wave 1.
Has a catalyst on Wednesday 1/20/21
PDUFA VII Decision for MRK's Vericiguat:
Merck Seeks Approval For Heart Failure Drug
Company: Merck & Co., Inc. (NYSE: MRK)
Type of Application: NDA
Candidate: vericiguat
Indication: heart failure
Positive ER expected :
Merck & Co., Inc.'s earnings, with the lowest EPS estimate coming in at $1.32 and the highest estimate coming in at $1.38. Merck & Co., Inc. reported
earnings of $1.16 per share during the same quarter last year, which indicates a positive year over year growth rate of 16.4%. The firm is scheduled to issue
its next quarterly earnings report before the market opens on Thursday, February 4th. -Marketbeat
LEXX -- Biotech play trading below just closed $5.25 financing$13.2M mkt cap, 3.5M float. Freshly uplisted to NASDAQ. Closed $11M oversubscribed financing at $5.25 on January 14th and trading at discount at $4.40. Oversold on the daily (RSI @ 28). Accum/Dist is evening out after 3 days of selloff. Gap at 6.41. Cash + assets exceed current market cap.
BLUE - Good Buying Opportunity With 3.42B Market Cap Bluebird Bio after four years again on good level to Buy, Profit Target Primary 70-80 and secondary is 100-140.
You can take this stock from short term to long term.
High probability swing short set up on CRSPHere is my short case on CRSP:
- at the top of trading channel started since Feb 2020
- over bought reading on RSI
- both PPO and RSI shows very clear divergence high
Starting building a position as it hits the top of the channel and scale in as it moves down. Impulsive break of the wedge should move it down to the support at $161. Reaction will be likely, consolidation or a minor bounce. Then, if it gets taken down, then moving down to the bottom of the channel which intersects with $145.80 horizontal support. If that breaks, it's going way lower since $110 and $131 area are pretty thin so the move will be probably pretty swift.
Full Commercial Launch of Tigereye(TM) Image-Guided CTO CrossingAvinger Initiates Full Commercial Launch of Tigereye(TM) Image-Guided CTO Crossing Catheter
With the initiation of full commercial launch, current and prospective accounts throughout the US and Germany are now able to order the Tigereye device.
During the fourth quarter of 2020, Avinger conducted a limited launch at 12 clinical centers in the U.S. and Germany. Approximately 50 CTO cases were successfully performed, showcasing Tigereye's advanced clinical capabilities and excellent product reliability in a variety of lesion types and settings.
The limited launch program demonstrated Tigereye's strong clinical results and efficiency across a wide range of PAD cases
"We believe full commercial availability of the Tigereye device will be an important contributor to expanding our revenue growth opportunities in 2021, both in terms of attracting new Avinger user sites and supporting higher utilization per site,"
finance.yahoo.com
FDA Emergency Use Authorization for SARS-CoV-2 N Protein AntigenQuanterix Receives FDA Emergency Use Authorization for SARS-CoV-2 N Protein Antigen Test
As case counts and positivity rates rise globally, the COVID-19 testing landscape is of critical importance
finance.yahoo.com
Sale of Manufacturing Operations and Global Supply AgreementAcorda Therapeutics Announces Agreement for Sale of Manufacturing Operations and Long-Term Global Supply Agreement for INBRIJA®, Corporate Restructuring, and Enters into "At The Market" Offering Agreement
$80 million up-front payment will substantially increase cash balance
Sale, restructuring and other operating expense reductions will reduce annual operating expenses by approximately $40 million
Total 2021 non-GAAP operating expense guidance expected to be $130-$140 million1
At The Market (ATM) offering allows the sale of common stock at aggregate value up to $15.25 million
Supply agreement will ensure uninterrupted supply of INBRIJA (levodopa inhalation powder) to people with Parkinson’s
finance.yahoo.com stock
Biomerica’s Covid-19 Antigen Rapid Test Receives CE MarkBiomerica’s Fast 15-Minute Simple to Use Covid-19 Antigen Rapid Test Receives CE Mark
Biomerica receives first orders and plans to ship tests in coming weeks
Clinical studies demonstrated an overall performance of 94.7% positive agreement (sensitivity) and 99.7% negative agreement (specificity) as compared to lab-based molecular PCR tests
The Company has already received its first European orders and plans to ship the first part of these orders in the coming weeks. The Company will now begin marketing this product broadly in Europe and other regions outside of the US.
merica’s new COVID-19 Antigen Rapid Test is highly portable, affordable, and provides results in 15 minutes with no equipment required to perform or read the test.
finance.yahoo.com
BIOLASE Announces Agreement With DSO Dental Care AllianceBIOLASE Announces Agreement With DSO Dental Care Alliance To Expand Laser Adoption In Dental Offices Across The United States
BIOL announced an agreement with Dental Care Alliance (DCA), one of the largest dental support organizations (DSO) in the United States with more than 330 affiliated practices in 20 states, to expand laser adoption and hands-on training programs in targeted geographies. The Company expects the agreement to lead to a rollout across all DCA offices in 2021.
finance.yahoo.com
This NCNA Penny Stock Could Surge Over 300%, Say AnalystThis NCNA Penny Stock Could Surge Over 300%, Say Analyst
NuCana uses a phosphoramidate chemistry technology called ProTide to create a class of drugs that will surmount the limitations of the existing nucleotide analogs behind many chemotherapy drugs. NuCana’s ProTides have already been used in Gilead’s antiviral drug Sovaldi.
In May of last year, NuCana announced the restart of its Phase III trial on Acelarin, the drug candidate furthest along the company’s pipeline, as a treatment for biliary tract cancers. The study encompasses over 800 patients in 6 countries and is currently ongoing. In November, the company published data described as ‘encouraging’ from the Phase Ib study of the same drug.
While Acelarin is the flagship drug in the pipeline, NuCana has two other prospects under development. NUC-3373 is in Phase I trial as a treatment for solid tumors and colorectal cancers, and NUC-7738 is a second pathway under investigation for applications to advanced solid tumors. Of these three, the colorectal study is the farthest advanced.
5-star analyst Robyn Karnauskas sees the pipeline as key to NuCana’s investor potential.
“We believe investors have overlooked the fact that NCNA is a platform Company that we believe is validated, as defined by the production of clinical products. We like that it has brought 3 products to the clinic, including one novel drug and two improved cornerstone chemos. The data suggest to us that the platform works and can produce better chemos While investors are mostly focused on Acelarin, we believe investors should also focus on NUC-3373, another core to our platform-based thesis that has data expected in 1H2021,” Karnauskas noted.
To this end, Karnauskas puts a $22 price target on NCNA, suggesting the stock has room for 384% growth ahead of it, along with a Buy rating.
finance.yahoo.com
This ACRX Penny Stock Could Surge Over 300%, Say AnalystsThis ACRX Penny Stock Could Surge Over 300%, Say Analysts
AcelRx is a pharmaceutical company dedicated to the creation of safer treatments for acute pain, developing synthetic opioid drugs for sublingual (under the tongue) dosing.
The company’s main product, Sufentanil, was approved by the FDA under the name Dsuvia in 2018, and by the EU as Dzuveo that same year. A second sublingual Sufentanil system, under the name Zalviso, has also been approved for use by the EU, and is in Phase 3 trial in the US.
In its most recent earning report, the company showed $1.4 million at the top line, driven by $1.3 million in product sales. The sales figure was up 433% sequentially, and the total revenue figure was up 133% year-over-year.
Cantor analyst Brandon Folkes is upbeat on Dsuvia’s prospects as an alternative to current opioid treatments, and he believes that potential will boost the company’s stock.
As ACRX launches a true alternative to IV opioids, we expect investors to begin to appreciate the value of the product.
In line with his bullish stance, Folkes rates ACRX a Buy, and his $9 price target implies room for a stunning 552% upside potential in the next 12 months.
finance.yahoo.com
T2SARS-CoV-2™ Panel can detect multiple variants of the SARS-CoVT2 Biosystems T2SARS-CoV-2™ Panel Proves Effective Amid Global Rise in Variants of the SARS-CoV-2 Virus
Panel can detect multiple variants of the SARS-CoV-2 virus, including those most recently identified in the United Kingdom, South Africa, and the U.S.
T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100 percent.
The T2SARS-CoV-2 Panel provides results in under two hours utilizing an upper respiratory swab sample. The test runs on the Company’s FDA-cleared and fully-automated T2Dx® Instrument, which is capable of performing seven tests simultaneously and up to sixty samples per day.
finance.yahoo.com
