Nutrix Therapeutics ( NRIX) has momentum for earnings LONGNRIX , on the 15 minute chart is experiencing increase volatility and volume now two
days out from its earnings report. It printed a "big ass" green engulfing candle to finish the
week. The MACD with zero lag shows a bullish inflection in the lines
On the daily chart, price fell about 25% in 2023. earnings have been both line beats but
the negative cash flow remains as a challenge. The volume and volatility show both are
heightened in the pre-earnings run- up. . This is a risky earnings
play, NRIX does not yet make money like many other young biotechnology companies trying to
grow However, because it lost less than forecasted, buyer interest has increased. There is
an absence of any options volume and so illiquidity prevents consideration of options
trading. I suspect a long trade in shares may gain to $14 targeting the pivot highs of
April 23 and November 22 for projected gain upside of about 65% ( stop loss of 2.5%)
If earnings disappoint trader expectations and price fades I will stop out with a loss of about
2.5% This makes this long swing trade a projected 2.5 /65 a R:r of 25 which validates it as
a conservative trade if taking only 5% or less of buyer power applied to the risk. Biotechnology
is expected to be one of the hottest subsectors of 2024. This could be one of them.
Biotehnology
Recognized R&D Pioneers in Anti-Inflammatory TherapeuticsThe founding team members at 180 Life Sciences Corp. (NASDAQ: ATNF) are the recognized pioneers of research and development in anti-inflammatory therapeutics.
180 Life Sciences is a clinical-stage biotechnology company that brings together the expertise of world-renowned scientists to develop and test novel treatments for inflammation and is currently working in both preclinical and clinical studies.
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$OI to join S&P SmallCap 600 on March 30Neurocrine Biosciences Inc. (NASD:NBIX) will replace O-I Glass Inc. (NYSE:OI) in the S&P MidCap 400, and O-I Glass will replace HMS Holdings Corp (NASD:HMSY) in the S&P SmallCap 600 effective prior to the opening of trading on Tuesday, March 30.
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$APOP and Quoin Pharmaceuticals Announce Strategic MergerCellect Biotechnology and Quoin Pharmaceuticals Announce Strategic Merger
Up to $25 million of funding at $75 million pre-money valuation to be available to the combined company concurrently with the merger
Cellect shareholders to retain 25% of the combined Company pre-funding
Quoin has secured $25 million in committed equity funding from Altium Capital, a highly regarded institutional healthcare investor.
Quoin has also negotiated an $18.5 million venture loan from a leading U.S. commercial bank.
Completion of the merger is subject to approval of the Cellect and Quoin shareholders and certain other conditions and is expected to close by the end of the second quarter of 2021.
Why $IMMP soared in December case studyFirst time an antigen presenting cell (APC) activator has shown an Overall Survival (OS) benefit in a randomised setting in metastatic breast cancer patients known to be insensitive to immune checkpoint inhibitor therapy
Promising and improving overall trend in OS in total population (based on approx. 60% of events): median survival benefit of +2.7 months from efti plus chemotherapy, compared to chemotherapy plus placebo.
Statistically significant OS benefit in efti group observed in pre-defined patient groups:
+7.1 months survival benefit (median of 21.9 vs. 14.8 months, nearly 50% longer) from efti with chemotherapy for patients under 65 years of age
+9.4 months survival benefit (median of 22.4 vs. 12.9 months, 74% longer) from efti with chemotherapy for patients with a low starting monocyte count
Statistically significant increase in CD8 T cells in patients treated with efti plus chemotherapy, correlated with prolonged OS, indicating pharmacodynamic activity and proof of concept of efti’s mode of action
Collection of OS data ongoing, with final data expected to be reported mid 2021
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$PRQR Announces Positive Results from Clinical Trial of QR-421aProQR Announces Positive Results from Clinical Trial of QR-421a in Usher Syndrome and Plans to Start Pivotal Trials.
QR-421a demonstrated a concordant benefit in multiple measures of vision, including best corrected visual activity (BCVA), static perimetry, and retinal imaging (OCT)
QR-421a observed to be well tolerated with no serious adverse events reported
Two pivotal Phase 2/3 trials are expected to start by the end of 2021
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$HOTH Announces Positive Data from Animal TestingVoltron Therapeutics, Inc. Announces Positive Data from Animal Testing of Self-Assembling Vaccine in the Fight Against COVID-19
today announced positive data from its second set of preclinical animal testing of its HaloVax™ Self-Assembling Vaccine (SAV) against COVID-19.
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$bntc Skyrocket as Morgan Stanley Takes StakeBenitec Shares Skyrocket as Morgan Stanley Takes Stake
$BNTC shares blasted higher Tuesday after disclosing in a regulatory filing that Morgan Stanley has a 5.2% stake in the genetic drug company.
The stake amounts to 249,174 shares, or about $1.51 million.
Benitec‘s “proprietary platform, called DNA-directed RNA interference, or ddRNAi, combines RNA interference, or RNAi, with gene therapy to create medicines that facilitate sustained silencing of disease-causing genes following a single administration,” the company said.
“The company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including Oculopharyngeal Muscular Dystrophy (OPMD), and Chronic Hepatitis B.”
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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 $40.45 million for regulatory & sales milestones and 17.5% royalties are included
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$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 $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S.
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$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 $20 million fee to assume the responsibility to develop and commercialize a couple of Morphic's pipeline candidates.
Lastly, Morphic has a partnership with Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), which focuses on developing integrin therapeutics for conditions for which there are few adequate therapy options. Morphic announced that it has expanded this partnership with the pharma company.
For a drugmaker with no products on the market, lucrative deals with well-established pharmaceutical companies are important. Morphic Holding will be able to use the funds it received from AbbVie to fund the clinical development of some of its other candidates, while its partnership with Janssen could bear fruit in the form of promising clinical compounds. These factors explain why investors are bidding up shares of Morphic Holding today.
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Why Lixte Biotechnology Soared heavily on friday?Why Lixte Biotechnology Soared heavily on friday?
It seems as though retail investors are banding behind this ultra-low float stock, lifting demand and therefore, lifting its price. the company hasn’t issued any news.
Nonetheless, it seems as though the retail crowd on Wall Street is banding behind the stock.
there is quite a bit of discussion about the stock on Wall Street Bets, StockTwits, and Twitter, suggesting that the retail crowd is interested.
At the moment, LIXT trades with a public float of just 4.5 million shares. That’s an incredibly low share supply. As the law of supply and demand tells us, when supplies of anything are very low and a flood of demand comes in, the price must increase.
With retail investors diving into LIXT, and such a tiny public float, it only makes sense that the stock is experiencing dramatic gains.
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$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 .
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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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