Back In The Channel AgainMNKD is back in that Fib channel between the .5 and .382 levels. This was a previous channel earlier in the year. Now that the financing deal is done, will it finally see a prolonged uptrend without much interruption?
" However, with fresh capital in hand, the company aims at advancing its current pipeline. This includes a Phase 3 clinical trial of its Afrezza inhaled insulin product in pediatric subjects. MannKind also explained that it wants to further the development of product candidates in its pipeline. The company may also use a portion of the proceeds for acquisitions or strategic investments in complementary businesses or technologies.
Even with the pullback, analysts seem to remain bullish on the company. SVB Leerink most recently adjusted its price target on the stock. It had previously issued a $3 target but upped it to $5. The firm also carries an Outperform rating on the stock. "
Quote Source: Best Penny Stocks On Robinhood To Watch This Week If You Like Biotech
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SELB Back In High TrafficSELB is back in the upper area of its high-traffic support/resistance from several times prior. Most recently, it saw this act as support in February. But it wasn't able to sustain the level. Anyway, it's back at this but in this case, the level has acted as a potential resistance (for now). It's gonna be interesting to see what happens next.
Selecta seems to have benefited from a bullish outlook discussed by the company in its last corporate update.
“We are very pleased by the continued progress of our gene therapy program. In collaboration with AskBio, our lead program in methylmalonic acidemia, is on track to enter the clinic in the second quarter of this year, and we expect initial data by the end of the year,” said Carsten Brunn, Ph.D., president, and chief executive officer of Selecta.
“A key objective of 2021 will be to generate human data in our gene therapy programs and to continue to build our extensive pipeline in gene therapies, enzyme therapies–with an expected IND filing by the end of the year in IgA nephropathy–and autoimmune diseases, as we work to deliver on our mission to leverage our pioneering ImmTOR platform to improve the lives of patients and their families.”
Quote Source: Best Penny Stocks On Robinhood To Watch This Week If You Like Biotech
Is OPK Fibbin'?OPK back at the .236 fib line, which has been a clear area of support/resistance. The question is, will the speculation on its testing company end up giving the boost needed to push back above the $5 mark or is this truly a "fib" and OPK falls back down heading into the rest of March?
"Ongoing pressure from an activist investor to offload its BioReference unit has also become a source of speculation. This stemmed from recent M&A action within the diagnostics space earlier this month. Needless to say, the recent action in the stock has continued supporting some analysts’ bullish stances on the company. Most recently, Barrington Research boosted its price target to $8 from $7 and maintained its Outperform rating."
Quote Source: Best Penny Stocks On Robinhood To Watch This Week If You Like Biotech
Rubraca® Significantly Improves Progression-Free SurvivalClovis Oncology’s Rubraca® (rucaparib) Significantly Improves Progression-Free Survival versus Chemotherapy in Patients with Later-line Ovarian Cancer Associated with a BRCA Mutation
The ARIEL4 study met its primary endpoint, showing a statistically significant improvement in investigator-assessed progression-free survival (PFS) for Rubraca versus chemotherapy
The safety of Rubraca observed in the ARIEL4 study was highly consistent with both the U.S. and EU product labels.
$IMTX positive clinical data update from Phase 1 trialsImmatics Presents Data Update on Dose Escalation from Ongoing ACTengine® Cell Therapy Programs
·First anti-tumor activity observed in heavily pre-treated solid cancer patients during early phases of dose escalation
·Tumor shrinkage observed in 8 out of 10 patients including one partial response consistent with robust biological activity of infused T cell products
·Treatment-emergent adverse events were transient and manageable
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$ZCMD Zhongchao Renews Contract with China Association of HealthZhongchao Renews Contract with China Association of Health Promotion and Education and GlaxoSmithKline
Extending the Cooperation in Pulmonary Arterial Hypertension
$ZCMD yesterday announced the renewal of its partnership with the China Association for Health Promotion and Education and GlaxoSmithKline (China) Investment Limited to continue the medical education program "Pulmonary Arterial Hypertension Online Course – Connections with Famous Hospitals" ("PAH Project") in 2021.
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$CANF Signs $42.7 Million Out-Licensing Deal with EwopharmaCan-Fite Signs $42.7 Million Out-Licensing Deal with Ewopharma
Swiss Ewopharma to market Piclidenoson and Namodenoson in Central Eastern Europe (CEE)
$2.25 million upfront payment with an additional $40.45 million for regulatory & sales milestones and 17.5% royalties are included
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$RUBY Doubles on Progress in Early-Stage Cancer-Drug TrialRubius Therapeutics Reports Initial Clinical Data from Ongoing Phase 1/2 Trial of RTX-240 in Patients with Advanced Solid Tumors, Demonstrating Single-Agent Activity.
RTX-240 Generated Partial Responses in Metastatic Anal Cancer and Metastatic Uveal Melanoma Patients; No DLTs or Related Grade 3/4 Adverse Events
RTX-240 Promoted Trafficking of NK and T Cells into
Tumor Microenvironment
Initial Clinical Data Provide Evidence of Broad Potential of RED PLATFORM® Across Pipeline of Cancer and Autoimmune Programs
The initial data "demonstrate that RTX-240 has the potential to generate single-agent activity in patients with solid tumors, including a cold tumor such as metastatic uveal melanoma, where other treatments have failed to induce responses in patients," Christina Coughlin, an oncologist and immunologist who is chief medical officer at Rubius Therapeutics, said in a statement.
“The encouraging safety results, including a single event of Grade 1 liver toxicity, and preliminary efficacy data for RTX-240 to date give us the potential to realize the power of immune agonists for the treatment of cancer," Coughlin added.
The ongoing Phase 1/2 clinical trial of RTX-240 in patients with advanced solid tumors resulted in a 54% confirmed partial response rate in reducing the target lesions in a patient with metastatic anal cancer.
The adverse effects of the treatment included fatigue, chills, nausea, decreased appetite and arthralgia, which is pain in a joint.
Rubius is now planning a new Phase 1 study for the second half of 2021 to evaluate the combination of RTX-240 and another therapy.
It's also planning a Phase 2 expansion cohort for first-quarter 2022, according to its statement.
www.thestreet.com
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BIOL Back In The Channel AgainIt's almost exhausting watching BIOL do this every time...jump, fall, jump, fall, all right back to this channel. There's an interim gap to fill from a few weeks back but still many other levels to consider IF it can break back above and out of this channel. I think volume will be an indicator to watch in consideration of whether or not this can happen.
Because dental procedures have resumed to most of their pre-covid levels, many investors are bullish on the future of Biolase. While it is affected by the pandemic, the company is working to build new strategies. This goes hand in hand with its need to continue innovating and receiving new patents. With all of this in mind, is BIOL a penny stock to watch?
Quote Source: 5 Biotech Penny Stocks On Robinhood To Watch In March 2021
SYN Still Trying To Fill The GapThere's still a pretty big gap to fill from a few years ago but again, with a lot of biotech gaining recently, small caps could be back on the menu.
After Maxim Group upgraded SYN from a hold to a buy, shares of the biotech company dramatically increased. In addition to this, Maxim Group analysts gave a price target for SYN of $2.50. This represents a 10% or so gain from where it was before the rating. At the end of Friday, March 12th, SYN stock had shot up by over 29% to $0.92...CEO Steven Shallcross stated that “we are more encouraged than ever by this outlook for the business as we have made important progress during the fourth quarter advancing and demonstrating the significant value of our clinical development programs. With a number of upcoming catalysts later this year, we believe there is potential to continue to deliver significant value for our shareholders.”
Quote Source: 5 Biotech Penny Stocks On Robinhood To Watch In March 2021
Back At Historical S/R Level On ISRISR has been something of a sight in this market. Now, after pulling in and settling down a bit, it's back at the historic support/resistance level. With momentum acting as a tailwind in biotech stocks, overall, I'll be interested to see if it can get back above this level in more of a "calm fashion" haha.
While fewer surgeries occurred last year due to covid, IsoRay has managed to work around this, building its brachytherapy use cases along the way. CEO Lori Woods stated that “we are very pleased that we have been able to continue to make progress this quarter despite the ongoing challenges that the Covid-19 pandemic has presented. Amongst the highlights has been our continued success in expanding adoption of Celsium-131 in our core prostate market.”
Quote Source: 5 Biotech Penny Stocks On Robinhood To Watch In March 2021
$INVO Expands Amended U.S. Commercialization AgreementINVO Bioscience Expands Company-Owned Clinic Opportunity Under Amended U.S. Commercialization Agreement
$INVO today announced an amendment under its exclusive U.S. commercialization agreement with Ferring Pharmaceuticals. The amendment provides for an increase in the number of INVO company-owned clinics initially allowable under the agreement and removes certain geographical restrictions.
The amendment also adjusted the remaining annual 2020 minimum contractual product purchase requirement, whereby Ferring will place a $501,000 order, which will be recognized as revenue by INVO Bioscience in the first quarter of 2021.
BTIG buy recommendation with $14.00 price target- 360.5% upsideShares of $SEEL skyrocketed today after BTIG initiated coverage on the stock with a buy recommendation and a one-year price target nearly 4.7 times higher than Seelos' closing price on Thursday.
BTIG analyst Robert Hazlett likes the prospects for Seelos' pipeline. Last week, the biotech announced that it had completed enrollment in a pivotal proof-of-concept study evaluating SLS-002 in treating acute suicidal ideation and behavior in patients with major depressive disorder.
Seelos also has two other clinical-stage candidates. It's evaluating SLS-005 in phase 2 studies for three neurodegenerative disorders: amyotrophic lateral sclerosis (ALS), rare genetic disease Sanfilippo syndrome, and oculopharyngeal muscular dystrophy.
Seelos should report key data from its study of SLS-002 in the second quarter of this year.
Seelos also plans to advance SLS-005 into a pivotal phase 2b/3 clinical study targeting ALS in the first half of the year.
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seekingalpha.com
$ENTX Entera Bio Ltd Announces Positive Topline EB613 Phase 2Entera Bio Ltd Announces Positive Topline EB613 Phase 2 Biomarker Data
‒ Trial Met Primary Endpoint of Significant Increase in P1NP Based on Final Analysis of 3 Month Data
‒ Final Analysis of 6-Month Data, Including Change in Bone Mineral Density, Expected in Q2:21
‒ The trial’s primary endpoint was met - the complete 3-month results from the trial showed a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment (P <0.04) as compared to placebo.
‒ Similar to the increase in P1NP, a significant increase in Osteocalcin was also observed in the 2.5 mg group after 3 months (P <0.01).
‒ In line with a potential anabolic effect, a significant decrease in CTX was observed after 3 months of treatment (P <0.015). The decrease in CTX taken together with the increase in P1NP and Osteocalcin would indicate a potential positive impact on BMDand a reduced risk of fractures, which is the goal of an anabolic osteoporosis treatment.
‒ Entera intends to submit the full dataset for publication and/or presentation at an upcoming medical conference.
NLS Obtains License to Full Regulatory Data Package and know-howNLS Pharmaceutics Obtains License to Full Regulatory Data Package and Proprietary Know-How for Sanorex® (Mazindol)
Agreement provides exclusive rights to all available data included in the original new drug application ("NDA") for mazindol in the U.S.
$NLSP announces that it has entered into a License Agreement (the "Agreement") with Novartis Pharma AG, whereby the Company has obtained, on an exclusive basis in the United States, all of the available data referred to and included in the original NDA for Sanorex® (mazindol) submitted to the United States Food and Drug Administration in February 1972.
The Agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward.
Under the Agreement, NLS has obtained the same rights on an non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories.
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Why $EYES Skyrocketed 1233% in March?$EYES Receives FDA Approval for the Argus 2s Retinal Prosthesis System
$EYES today announced U.S. FDA has approved the Argus 2s Retinal Prosthesis System, a redesigned set of external hardware (glasses and video processing unit) initially for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP). The Company expects that the Argus 2s will be adapted to be the external system for the next generation Orion Visual Cortical Prosthesis System currently under development.
In addition to ergonomic improvements, the Argus 2s system offers significantly more processing power, potentially allowing for improved video processing.
A decision on when or if to begin production of the newly approved hardware is pending completion of Second Sight’s planned business combination with Pixium Vision, which currently is in progress. Should the business combination be completed, the new management team will then evaluate how best to proceed with the Argus 2s Retinal Prosthesis System, as well as all other products in development.
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Takeda Secures Global Rights from Ovid TherapeuticsTakeda Secures Global Rights from Ovid Therapeutics to Develop and Commercialize Soticlestat for the Treatment of Children and Adults with Dravet Syndrome and Lennox-Gastaut Syndrome.
Ovid eligible to receive up to $856M in payments, including a $196M upfront payment, regulatory and commercial milestone payments and tiered double-digit royalties on product sales
− Original 2017 collaboration between Ovid and Takeda to conclude; Ovid will have no further development or milestone obligations.
In addition, Ovid will receive tiered royalties beginning in the low double-digits and up to 20 percent on sales of soticlestat, if approved and commercialized.
Takeda intends to initiate Phase 3 studies of soticlestat in children and young adults with DS and LGS in calendar year Q2 2021.
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$KMPH Announces FDA Approval of AZSTARYS™KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD
Corium, Inc. will lead the commercialization of AZSTARYS per the definitive collaboration and license agreement.
Corium expects to make AZSTARYS commercially available in the U.S. as early as the second half of 2021.
Under the License Agreement, KemPharm may be eligible for up to $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S.
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Strong pan-coronavirus effectiveness of clinical drug candidatesPan-coronavirus Clinical Drug Candidates for the Treatment of COVID-19 Are Highly Effective in Pre-clinical Cell Culture Studies Performed in Preparation of FDA Pre-IND Application
$NNVC reported yesterday on the strong pan-coronavirus effectiveness of its two COVID-19 clinical drug candidates for which the Company is preparing a pre-IND application.
NV-CoV-2 is the Company's broad-spectrum anti-coronavirus clinical lead drug candidate for the treatment of COVID-19 patients based on its nanoviricides® platform.
$NNVC is also developing NV-CoV-2-R, a drug treatment that combines the power of both NV-CoV-2 and remdesivir in a single drug that encapsulates and protects remdesivir inside NV-CoV-2.
Both NV-CoV-2 and NV-CoV-2-R are expected to work against most, if not all , coronaviruses and their variants, based on the Company's findings on their pre-clinical effectiveness discussed below.
NV-CoV-2 and NV-CoV-2-R were found to be highly effective in comparison to remdesivir against two distinctly different coronaviruses in our new cell culture studies leading towards a pre-IND application and thereafter an IND submission for these COVID-19 drug candidates.
The Company intends to report on the results of these studies in its pre-IND application to the US FDA to obtain guidance regarding human clinical trials for treatment of COVID-19 patients. Additionally, the Company is actively seeking opportunities to engage appropriate sites for human clinical trials. Further, the Company is engaged in the preparation of clinical trial protocols and other activities that would be necessary for submitting an IND application to the US FDA.
The Company has developed NV-CoV-2 based on its platform nanoviricides® technology. This approach enables rapid development of new drugs against a number of different viruses.
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$MORF Reports Positive Interim Results from Phase 1Morphic Reports Positive Interim Results from Single Ascending Dose Phase 1 Clinical Trial of MORF-057
1. MORF-057 well tolerated in all dose cohorts.
2. MORF-057 achieved greater than 95% mean receptor occupancy of integrin at three highest dose levels; demonstrates ability to saturate receptor
3. Data provide early clinical proof of concept for MORF-057 as an oral, selective inhibitor.
4. Phase 1 multiple ascending dose and food effect trials ongoing
“We’re excited to present the totality of the Phase 1 trial data later this year and to leverage this emerging data set to inform the optimal study design for Phase 2 trials in ulcerative colitis and beyond.”
In the Phase 1 SAD trial, MORF-057 was well tolerated in all 5 cohorts receiving MORF-057 in single doses ranging from 25 mg to 400 mg with no serious adverse events (SAEs) and no significant lab abnormalities in any subject.
Morphic expects to present the full data set from the MORF-057 Phase 1 clinical trial at an appropriate medical meeting in mid-2021.
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Meanwhile, the company's long-standing partnership with pharma giant AbbVie is moving forward. Under the collaboration agreement between these two entities, which started more than two years ago, AbbVie initially paid $100 million up front to Morphic to acquire exclusive license options for some of Morphic's candidates.
Morphic Holding would be responsible for conducting research and development for these products up to the completion of investigational new drug enabling studies. AbbVie would then be able to exercise its license option for a fee to take up the development of these programs. Today, Morphic Holding announced that AbbVie paid a $20 million fee to assume the responsibility to develop and commercialize a couple of Morphic's pipeline candidates.
Lastly, Morphic has a partnership with Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), which focuses on developing integrin therapeutics for conditions for which there are few adequate therapy options. Morphic announced that it has expanded this partnership with the pharma company.
For a drugmaker with no products on the market, lucrative deals with well-established pharmaceutical companies are important. Morphic Holding will be able to use the funds it received from AbbVie to fund the clinical development of some of its other candidates, while its partnership with Janssen could bear fruit in the form of promising clinical compounds. These factors explain why investors are bidding up shares of Morphic Holding today.
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Why Lixte Biotechnology Soared heavily on friday?Why Lixte Biotechnology Soared heavily on friday?
It seems as though retail investors are banding behind this ultra-low float stock, lifting demand and therefore, lifting its price. the company hasn’t issued any news.
Nonetheless, it seems as though the retail crowd on Wall Street is banding behind the stock.
there is quite a bit of discussion about the stock on Wall Street Bets, StockTwits, and Twitter, suggesting that the retail crowd is interested.
At the moment, LIXT trades with a public float of just 4.5 million shares. That’s an incredibly low share supply. As the law of supply and demand tells us, when supplies of anything are very low and a flood of demand comes in, the price must increase.
With retail investors diving into LIXT, and such a tiny public float, it only makes sense that the stock is experiencing dramatic gains.
cnafinance.com
$JAN to Sell its Legacy Recycling Business for $25 MillionJanOne Announces Definitive Agreement to Sell its Legacy Recycling Business for $25 Million
Successful disposition will facilitate continued strategic focus on high-value late-stage biopharma asset JAN101 for the treatment of peripheral artery disease (PAD)
The transaction is expected to close on or before August 18, 2021
JanOne recently completed production of JAN101 under Current Good Manufacturing Practices (cGMP) for the anticipated Phase 2b PAD trials.
The Company plans to submit the Phase 2b protocol and related documents to the FDA under its Investigational New Drug Application (IND) for PAD in March 2021 .
finance.yahoo.com
Viracta Therapeutics Announces Closing of Merger with $SNSSViracta Therapeutics Announces Closing of Merger with Sunesis Pharmaceuticals and $65M Private Placement
Shares of Viracta to commence trading on the Nasdaq Global Select Market on February 25, 2021 under ticker symbol 'VIRX'
Cash and cash equivalents of over $120 million as of merger close
Registration trial for the treatment of relapsed/refractory EBV-positive lymphoma expected to begin in 1H2021, and a Phase 1b/2 trial in EBV-positive solid tumors in 2021.
The combined, publicly traded company will focus on the advancement and expansion of Viracta's clinical stage pipeline, including Viracta's lead program for the treatment of Epstein-Barr virus (EBV)-positive lymphoma.
Immediately prior to the closing of the merger, Viracta also closed the previously announced $65 million private placement of its common stock.
On February 24, 2021, and in connection with the closing of the merger, Sunesis effected a 1-for-3.5 reverse stock split . All issued and outstanding shares of common stock of Sunesis were subject to the reverse stock split.
Viracta has approximately 37.0 million shares of common stock outstanding , with pre-merger Viracta shareholders collectively owning approximately 86.05% of the combined company and pre-merger Sunesis shareholders collectively owning approximately 13.95% of the combined company.
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