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.
finance.yahoo.com
Biotechstocks
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.
finance.yahoo.com
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.
www.fool.com
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.
finance.yahoo.com
ASLAN Pharmaceuticals Announces $18 Million Private PlacementASLAN Pharmaceuticals Announces $18 Million Private Placement
ASLAN today announced that it has entered into a securities purchase agreement to raise gross proceeds of approximately $18 million resulting from the sale of its ordinary shares through a private placement to new institutional investors, Vivo Capital and Surveyor Capital (a Citadel company).
the Company will issue an aggregate of 25,568,180 ordinary shares (equivalent to 5,113,636 American Depositary Shares (“ADSs”)) at an equivalent price of $3.52 per ADS, equal to the last closing price of the Company’s ADSs. The Company intends to use the net proceeds from the private placement primarily to advance clinical development of ASLAN004, as well as for general corporate purposes.
“These additional resources position us well as we look forward to unblinding the interim data from our ongoing study of ASLAN004 in atopic dermatitis in early March and look towards initiating our phase 2b program later in 2021.”
finance.yahoo.com
NMTR: an explosive biotech microcapNMTR had an incredible run over the past month. But it appears that it has been rejected at resistance, and will retrace fib levels back toward $1.00 before exiting this wedge.
A defined risk strategy here is to buy the $1.00 puts, continue rolling them out, and then within the next month add the $1 calls to form a long straddle. Be careful as liquidity is low.
DOCT.C -- Cup & Handle breakout!Under the radar biotech play. Confirmed Cup & Handle breakout. Bullish MACD cross is a technical buy signal. Technical price target .30+.
Reversal Setup #stocksPotential reversal to the upside off of range lows
Reward/Risk: 3.68/1
Entry: 81.94 or at a lower price
Stop: 76.00
Target: 102.00
Options Play: April 16 85/90 Call Vertical
$ONCY initiated with a Buy at H.C. Wainwright -302.14% potentialOncolytics initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Patrick Trucchio initiated coverage of Oncolytics Biotech with a Buy rating and $15 price target. The company is "on the cusp of demonstrating potential to upend the treatment paradigms of several cancers," Trucchio tells investors in a research note. He believes Oncolytics is well positioned for the "oncolytic virus trend."
The price target was set to $ 15.00. At a current price of $ 3.73 there is upside potential of 302.14%.
$SNSS Definitive Merger Agreement CASE STUDYSunesis Pharmaceuticals and Viracta Therapeutics Announce Definitive Merger Agreement
Merger to create Nasdaq-listed company focused on developing Viracta’s precision oncology pipeline targeting virus-associated malignancies
Leading institutional investors committed a total of $105 million in private financings with Viracta
Combined company expected to have approximately $120 million cash balance following the close of the merger
intends to be listed on the Nasdaq Global Market under the ticker symbol “VIRX.”
Viracta plans to initiate a registration trial for the treatment of EBV-positive lymphoma in the first half of 2021, and also plans to initiate a Phase 1b/2 trial in EBV-positive solid tumors in 2021.
The transaction is expected to close in the first quarter of 2021.
finance.yahoo.com
$SLDB FDA Lifts Clinical Hold case studySolid Biosciences Announces FDA Lifts Clinical Hold on IGNITE DMD Phase I/II Clinical Trial
As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company’s response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions.
“We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021.”
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$CLSN received Fast Track designation from the FDA$CLSN today announced that it has received Fast Track designation from the U.S. FDA for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer.
Fast Track designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need.
Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market,” said Michael H. Tardugno
Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical trial design.
finance.yahoo.com
This penny stock $OBSV could skyrocket 100% in 2021The company’s lead drug candidate, linzagolix (branded as Yselty), is an orally administered GnRH receptor antagonist that has completed two Phase 3 studies, PRIMROSE 1 in the US and PRIMROSE 2 in both the US and Europe. The clinical trials enrolled 574 and 535 patients, respectively, and used doses of 100mg or 200mg to treat heavy menstrual bleeding associated with uterine fibroids. The results from both studies were positive, supporting Linzagolix's favorable safety and efficacy profile.
In an update announced last month, ObsEva reported that, pursuant to Phase 3 results, the European Medicines Agency (EMA) had validated for review the company's Marketing Authorization Application (MAA) for Yselty (100mg and 200mg). Potential MAA approval is anticipated in Q4:21. The drug is also slated to be the subject of a New Drug Application (NDA) that is due to be submitted to the FDA in Q2.
Wedbush analyst Liana Moussatos said that Linzagolix has the potential to achieve best-in class oral GnRH receptor antagonist status based on a flexible dosing regimen either with or without the add-back hormone therapy (ABT)—a key differentiator from other GnRH receptor antagonists… Based on the positive PRIMROSE 1 and PRIMROSE 2 primary endpoint results for YSELTY®/UF and additional follow-up data, we project annual sales of more than $750 million in 2027 for Linzagolix/UF,” Moussatos opined.
To this end, Moussatos rates OBSV a Buy along with a $28 price target.
finance.yahoo.com
$EOLS skyrocketed after end of Intellectual Property LitigationAbbVie, Evolus, and Medytox Announce Resolution of Intellectual Property Litigation
AbbVie (NYSE: ABBV), Evolus (NASDAQ: EOLS) and Medytox announce settlement agreements to fully resolve all outstanding litigation, including the United States International Trade Commission (ITC) case regarding the sale of Jeuveau®, between the companies. A California court case filed by Medytox against Evolus will be dismissed.
Under the terms of the settlement agreements, AbbVie and Medytox will release all claims against Evolus related to the alleged misappropriation of Medytox's trade secrets and grant a license to Evolus to continue to commercialize Jeuveau® in the United States and Nuceiva™ in all other territories in which Evolus has licensing rights. AbbVie and Medytox will receive milestone and royalty payments from Evolus. In addition, Evolus will issue common stock to Medytox.
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$VCNX skyrockets on Deals with Two Pharma CompaniesVaccinex Announces Signing of Two Multi-Project Deals with Leading Pharmaceutical Companies Focused on Leveraging Its ActivMAb® Platform
Partnerships will use Vaccinex’s ActivMAb® platform for viral display of complex antigens to enable antibody discovery
www.globenewswire.com
Jefferies $PRTA buy recommendation with price target of $6Why VistaGen Therapeutics Stock Soared yesterday
The big jump came after Jefferies analyst Andrew Tsai initiated coverage on the stock with a buy recommendation. Tsai also set a one-year price target of $6, nearly three times the price of VistaGen's shares at the market close on Wednesday.
Why bullish?
Tsai really likes the potential for VistaGen's lead pipeline candidate PH94B . It's a nasal spray that VistaGen is evaluating in phase 2 studies targeting multiple neurological disorders. The company has already reported positive data from one of those studies, with PH94B showing promise in treating acute social anxiety disorder .
There are still plenty of risks for PH94B and VistaGen's two other pipeline candidates.
www.fool.com
$IMNM Discovers Antibodies Capable of Neutralizing SARS-CoV-2Immunome Discovers Antibodies Capable of Neutralizing Multiple SARS-CoV-2 Variants, Including the South African Variant, in Pseudovirus Testing
finance.yahoo.com
$ONTX Closing of $28.75 Million Public Offering of Common StockOnconova Therapeutics to Present Corporate Update at the 2021 BIO CEO & Investor Digital Conference-February 16-18, 2021
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Onconova Therapeutics, Inc. Announces Closing of $28.75 Million Public Offering of Common Stock Including Full Exercise of the Over-Allotment Option.
A total of 28,750,000 shares of its common stock were sold, including 3,750,000 shares of common stock following the exercise by the underwriters of their over-allotment option, at a public offering price of $1.00 per share.
finance.yahoo.com
$NVCN Regains Compliance with Nasdaq Minimum Bid Price RuleNeovasc Regains Compliance with Nasdaq Minimum Bid Price Rule
Currently, the Company is still not in compliance with the minimum market value requirement set forth in Nasdaq Rules for continued listing on the Nasdaq. Nasdaq Listing Rule 5550(b)(2) requires companies to maintain a minimum market value of US$35 million; the Company has until June 8, 2021 to regain such compliance.
The Company is also listed on the Toronto Stock Exchange and regaining compliance on the Nasdaq does not affect the Company’s compliance status with such listing.
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