Get started

Biotechstocks

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
NASDAQ:APDN
by AlenCiken
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
NASDAQ:DBVT
by AlenCiken
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
NASDAQ:AVGR
by AlenCiken
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
A
by AlenCiken
1
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
NASDAQ:BMRA
by AlenCiken
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
B
by AlenCiken
1
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
NASDAQ:NCNA
by AlenCiken
5
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
A
by AlenCiken
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
NASDAQ:TTOO
by AlenCiken
Exclusive Licensing Agreement for GIAPREZA and XERAVA in EuropeLa Jolla Pharmaceutical Company Announces Exclusive Licensing Agreement for GIAPREZA™ (Angiotensin II) and XERAVA™ (Eravacycline) in Europe La Jolla to receive upfront cash payment of $22.5 million plus potential commercial milestone payments of up to $109.5 million and double-digit tiered royalty payments Under the terms of the exclusive licensing agreement, La Jolla will be entitled to receive: (i) an upfront cash payment of $22.5 million; (ii) potential commercial milestone payments of up to $109.5 million; and (iii) double-digit tiered royalty payments based on net sales of GIAPREZA and XERAVA. In exchange, La Jolla granted PAION an exclusive license to commercialize GIAPREZA and XERAVA in the Territories. finance.yahoo.com
L
by AlenCiken
Day Traders Lighting Up Reddit Spur Rally in ZomedicaDay Traders Lighting Up Reddit Spur Rally in Tiny Health Stock Zomedica Such outsized moves in small-caps are becoming par for the course these days. Surging at the open on the back of mentions in Reddit forums was Zomedica Corp., a company that develops medicines for pets. The stock jumped as much as 98% on Monday and is up almost four-fold from the start or the year. The penny stock garnered a mention in several Reddit forums over the past few days finance.yahoo.com
AMEX:ZOM
by AlenCiken
2
Day Traders Lighting Up Reddit Spur Rally in TransEnterixDay Traders Lighting Up Reddit Spur Rally in Tiny Health Stock TRXC The stock has surged about 180% since the start of the new year. Today’s trading volume was more than 13 times normal. The penny stock garnered a mention in several Reddit forums over the past few days, with one user comparing it with the roughly $95 billion market-cap leader in surgical robotics, Intuitive Surgical Inc. TransEnterix markets the Senhance surgical system, cleared by the U.S. Food and Drug Administration in 2017. According to the device-maker in an update last week, 10 of the systems were installed in 2020. The Morrisville, North Carolina-based company said it ended 2020 with $17.5 million in cash and equivalents, enough to keep the company afloat into the third quarter. finance.yahoo.com
T
by AlenCiken
3
GeoVax Awarded NIH Grant to Advance COVID-19 Vaccine DevelopmentGeoVax Awarded NIH Grant to Advance COVID-19 Vaccine Development announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a Small Business Innovative Research (SBIR) grant in support of its development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The Phase 1 grant, titled, “Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19,” will support the ongoing design, construction and preclinical testing of GeoVax’s vaccine candidates in preparation for human clinical trials. The efficacy testing will be performed in collaboration with the University of Texas Medical Branch (UTMB). Vaccines using the GV-MVA-VLP platform developed for other pathogens have proven to be efficacious with a single dose, having strong durability which would be a significant advantage for SARS-CoV-2 global vaccination campaigns.” We are pleased to receive this Phase 1 SBIR funding award, which will supplement the internal resources allocated to our COVID-19 vaccine program and accelerate our progress toward human clinical trials. finance.yahoo.com
NASDAQ:GOVX
by AlenCiken
Reduction in Heart Attacks, Strokes and Cardiac DeathSingle Dose of Rexlemestrocel-L Provides Substantial and Durable Reduction in Heart Attacks, Strokes and Cardiac Death in Patients With Chronic Heart Failure results from the landmark DREAM-HF randomized controlled Phase 3 trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L (REVASCOR®) or control sham. A single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes, and cardiac deaths. The incidence of heart attacks and strokes were reduced by 60% over a median follow-up period of 30 months following a single dose of rexlemestrocel-L in the population of 537 patients with New York Heart Association (NYHA) class II or III chronic heart failure (5% vs 13%, p=0.002). The incidence of death from cardiovascular causes was reduced by 60% following a single dose of rexlemestrocel-L in the 206 patients with NYHA class II disease (8% vs 20%, p=0.037) finance.yahoo.com
NASDAQ:MESO
by AlenCiken
1
ISR has received FDA 510(k) clearanceC4 Imaging Announces Sirius Positive Signal MRI Marker Given FDA 510(k) Clearance for Use with Isoray’s Cesium-131 Brachytherapy Seeds to Treat Prostate Cancer ISR has received FDA 510(k) clearance for the use of C4 Imaging’s Sirius® positive-signal MRI (Magnetic Resonance Imaging) Markers with Isoray’s Cesium-131, brachytherapy seeds. Sirius MRI Markers will enable Isoray’s customers to fully utilize the benefits of MRI seed localization. Brachytherapy, or internal radiation therapy, is a leading, cost-effective option for the treatment of prostate cancer. Isoray is the world’s only producer of Cesium-131, commercially known as Cesium Blu™, brachytherapy seeds. Cesium-131 is a radioactive isotope that delivers a minimally invasive and highly targeted treatment to the site of the cancer preserving healthy tissue and organs. Patients benefit from the rapid resolution of their side effects allowing them to return to their normal lives quickly. finance.yahoo.com
I
by AlenCiken
2
“Strong Buy” Penny Stock That Could Deliver Massive Returnis engaged in the development of gene therapies for rare, frequently terminal, diseases, including neurometabolic disorders, primary immune deficiencies, and blood disorders. The gene therapy approach uses blood stem cells to deliver corrected genetic information directly into the patient’s body. Orchard’s pipeline demonstrates the diversity of disorders amenable to gene therapy – the company has no less than 12 drug candidates in development. Among these candidates, Libmeldy (OTL-200) stands out. Libmeldy is in commercialization stages as a treatment for MLD (metachromatic leukodystrophy), a rare, mutation-based genetic disorder of the nervous system, received its approval for medical use in the EU in December 2020. “We look forward to the company’s commercial execution in the EU and an eventual 2022 approval in the US. Last month ORTX received IND clearance from the FDA for the program paving the way for discussions with the US regulators to decide a suitable path forward toward a BLA filing.” with possibly two gene therapies approved in the next 12-18 months and a pivotal study beginning in a third (MPS-I), we think ORTX shares are undervalued at these levels," the analyst concluded. Wedbush analyst David Nierengarten rates ORTX as Outperform (i.e. Buy), and his $15 price target indicates a potential for 241% growth in the year ahead. Only Buy ratings, 3, in fact, have been issued in the last three months. Therefore, ORTX gets a Strong Buy consensus rating. At $15, the average price target indicates shares could appreciate by 241% in the year ahead. finance.yahoo.com
O
by AlenCiken
“Strong Buy” Penny Stock That Could Deliver Massive Returns“Strong Buy” Penny Stock That Could Deliver Massive Returns The company’s development pipeline features drug candidates under investigation as treatments for short bowel syndrome (SBS) and celiac disease (CeD), two conditions that are both dangerous and difficult to treat. 9 Meters’ flagship product, Larazotide, is in Phase 3 development for the treatment of CeD. CeD affects about 1% of the population, yet there are no approved therapies. Top-line data from the study is expected in the second half of 2021. this past December, the company announced that it had entered an agreement with EBRIS, the European Biomedical Research Institute of Salerno, to investigate Larazotide as a potential treatment for respiratory complications due to COVID-19. The other major drug in the company’s pipeline is NM-002, for SBS. The company has recently announced positive Phase 1b/2a results, with a measurable impact on disease symptoms from a compound that was well-tolerated by patients. finance.yahoo.com
N
by AlenCiken
positive prelim data from a Phase 1 study-leukemia treatmentCuris Announces Positive Preliminary Data from Ongoing Phase 1 Study of CA-4948 Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes. Key findings include: - Marrow blast reductions observed in all evaluable patients (6 patients). - 6 of 7 patients enrolled remain on study. - Patients enrolled experienced a median of 3 prior lines of treatment (range 1-4). - Two patients experienced a marrow complete response, one with blast count going from 23% pretreatment to 1% on treatment, and the other going from 11% pretreatment to 2% on treatment. - No DLTs observed in 7 DLT-evaluable patients in the 200 mg BID and 300 mg BID cohorts. - Enrollment has begun in the 400 mg BID cohort. Curis said its CA-4948 monotherapy in adult patients was well tolerated, has demonstrated signs of biologic activity in the ongoing study and is capable of achieving "relevant levels of drug exposure." finance.yahoo.com
NASDAQ:CRIS
by AlenCiken
ONTX Back At Previous Support Now Resistance?"Shares of this cheap stock managed to make a move from just $0.26 on November 30th to highs of over $0.55 this week. Volume has also become a focus recently too as the second half of December saw some of the highest daily trading volumes of the 3rd and 4th quarters. What has been going on with ONTX? Last month, Onconova received permission from the FDA to study its drug, ON 123300. This is used for treating certain types of cancer. What’s important to note is what the company’s CEO said and the milestones he gave. Specifically, Steven Fruchtman said, “We are advancing the process to secure institutional review board approval, and affirm our expectation that the first patient will be enrolled during the first half of 2021.” Interested to see if there's enough momo to get it above this level Source: Top Penny Stocks To Buy Under $1 On Robinhood This Week
O
by PennyStocks101
Big Rock Partners Acquisition Corp Announces Merger with NeuroRxBig Rock Partners Acquisition Corp. Announces Merger with NeuroRx, Inc. Combined Company to Have an Estimated Post-Transaction Equity Value in Excess Of $500 Million (Excluding Potential Earnout Payments), Assuming A Share Price Of At Least $10.00 Per Share NeuroRx, Inc. is a clinical stage, small molecule pharmaceutical company which develops novel therapeutics for the treatment of COVID-19 (RLF-100 or "ZYESAMI™ (aviptadil)") and Bipolar Depression (NRX-100, 101) The transaction is expected to occur in the first or second quarter of 2021. Under the terms of the transaction, Big Rock will issue to NeuroRx's current equity holders an aggregate of 50 million shares of Big Rock common stock for their interests in NeuroRx ubject to certain conditions, an aggregate of 25 million additional shares of Big Rock common stock will be issued to NeuroRx pre-merger equity holders if, prior to December 31, 2022, (1) RLF-100 receives emergency use authorization by the FDA and (2) the FDA accepts the Company's filing of its application to approve RLF-100. In addition, subject to certain conditions, a $100 million cash earnout may be payable to NeuroRx pre-merger equity holders if, prior to December 31, 2022, either (1) FDA approval of the Company's COVID-19 Drug is obtained and the Company's COVID-19 Drug is listed in the FDA's "Orange Book" or (2) FDA approval of the Company's Antidepressant Drug Regimen is obtained and the Company's Antidepressant Drug Regimen is listed in the FDA's "Orange Book". finance.yahoo.com
B
by AlenCiken
2