$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.
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Biotehnology
$SLDB FDA Lifts Clinical Hold case studySolid Biosciences Announces FDA Lifts Clinical Hold on IGNITE DMD Phase I/II Clinical Trial
As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company’s response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions.
“We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021.”
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$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.
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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 $28 price target.
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$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
$IMNM Discovers Antibodies Capable of Neutralizing SARS-CoV-2Immunome Discovers Antibodies Capable of Neutralizing Multiple SARS-CoV-2 Variants, Including the South African Variant, in Pseudovirus Testing
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$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 $1.00 per share.
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$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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Topline data from the open-label, Phase 1b clinical trialDiffusion Pharmaceuticals Increases Previously Announced Bought Deal Offering of Common Stock to $30 Million, due to demand
announced today that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 29,268,294 shares of common stock of the Company at a price to the public of $1.025 per share, less underwriting discounts and commissions.
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Diffusion Pharmaceuticals Completes Phase 1b Study of TSC in Hospitalized COVID-19 Patients
No Dose Limiting Toxicities or Serious Adverse Events Observed in Dosing Regimen Previously Untested in Clinical Trial Setting.
completion and topline data from the open-label, Phase 1b clinical trial of its novel.
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Jefferies upgraded $PRTA to buy from neutral-100% upside1. Jefferies upgraded the stock to buy from neutral expecting a 100% upside to the stock.
Citing the ‘positive momentum and pipeline execution’ and rising investor attention, the analyst Michael Yee ups the price target to $30 from $15, nearly double its previous close.
Prothena’s pipeline has significantly expanded and improved.
The company’s early-stage candidates for Alzheimer’s disease ‘should start to garner more attention,’ Yee argues, projecting the three mid-to-late-stage assets to yield ‘a significant upside.’
Add more than $300M in cash and the partnerships with Bristol Myers and Roche, the stock ‘is primed to move up 100% towards $30+,’ concluded the analyst.
Out of Prothena's two candidates, PRX012 and multi-immunogen vaccine, targeting the Alzheimer’s disease, the former is on track for an IND filing in Q1 2022, the company disclosed in the recent R & D update.
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2. BTIG Research upgraded $PRTA from neutral to buy with price target $29.
seekingalpha.com
$ARTL surged 92% on buy rating from Ladenburg analystArtelo Biosciences surged 92% on buy initiation from Ladenburg
Shares of $ARTL Artelo Biosciences surged on friday after Ladenburg analyst Michael Higgins initiated the company with a buy rating.
They give the biopharma a $7 price target. It also represents a potential 329% upside over the stock’s closing price on Thursday.
Ladenburg analyst cites Artelo's focus on candidates targeting the endocannabinoid system.
Artelo Biosciences is a biopharma company focused on developing treatments that improve patients’ lives. That includes developing new therapies. The company’s pipeline includes ART27.13, which is designed to treat cancer patients suffering from anorexia. This treatment is currently undergoing a Phase 1 clinical trial.
seekingalpha.com
investorplace.com
Why $ANCN Anchiano Therapeutics Is Surging Today?Why $ANCN Anchiano Therapeutics Is Surging Today?
Thanks to some news in December in the biopharma space, $ANCN stock is racing higher. So what was that news? And what else do you need to know?
$ANCN Anchiano Therapeutics is captivating investors thanks to its Definitive Merger Agreement with Chemomab news in december.
The proposed merger will create a public company focused on advancing Chemomab’s lead product, CM-101, a first in class anti-CCL24 antibody into advanced clinical development for fibrosis-related diseases with significant unmet medical need
Concurrent PIPE financing to be used to fund clinical trials for CM-101 in fibrotic indications, focusing on two rare diseases and backed by leading healthcare-focused investors OrbiMed and Peter Thiel.
Concurrent with the merger, Chemomab seeks to complete a PIPE financing to advance CM-101 into Phase 2 clinical trials in rare fibrotic indications, as well as to further develop Chemomab’s earlier-stage pipeline.
We intend to hold a special meeting of Anchiano’s shareholders in the first quarter of 2021 to vote on this merger."
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$BPTH skyrockets on Received Third U.S. Patent GrantBio-Path Receives Third U.S. Patent Grant Related to Manufacture of Platform Technology
Provides Expanded Protection to Seminal Patents Related to DNAbilize
The new patent builds on earlier patents granted that protect the platform technology for DNAbilize®, the Company’s novel RNAi nanoparticle drugs.
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$KALV Reports Positive Results for KVD900 Phase 2$KALV KalVista Pharmaceuticals Reports Positive Results for KVD900 Phase 2 Demonstrating Statistically and Clinically Significant Responses Across All Endpoints as an Oral On-Demand Treatment for HAE Attacks
– Oral KVD900 Primary Endpoint Shows Only 15% Use of Rescue Medication in Patients with Hereditary Angioedema (HAE) –
– KVD900 Generally Safe and Well-Tolerated –
There were no serious adverse events reported in the trial and no patients withdrew due to adverse events.
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$ZOM Increases Bought Deal Offering of Common Shares to $173.5 MZomedica Corp. Increases Previously Announced Bought Deal Offering of Common Shares to $173.5 Million.
today announced that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 91,315,790 common shares of Zomedica, at a price to the public of $1.90 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about February 11, 2021, subject to satisfaction of customary closing conditions.
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$OPGN catalyst: FDA decision Acuitas AMR Gene PanelHyping on twitter: Added New position $OPGN primarily for the top catalyst FDA decision Acuitas AMR Gene Panel. In addition, pipeline includes Broad pathogen and Antimicrobial Resistance Marker coverage. 53 M market cap. Eyeing $3.3 breakout target towards $4 plus. Should spike on FDA decision.
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$OTLK Secures Funding to Support ONS-5010 / LYTENAVA™Outlook Therapeutics Increases Previously Announced Bought Deal Offering of Common Stock to $35.0 Million
announced today that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 35,000,000 shares of common stock of Outlook Therapeutics, at a price to the public of $1.00 per share, less underwriting discounts and commissions.
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Outlook Therapeutics Announces Closing of $35.0 Million Bought Deal
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Outlook Therapeutics’ Recent Financing Secures Funding to Support ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Through Planned BLA Submission
The combined net proceeds from these stock offerings are expected to provide sufficient capital to fund operations through the expected filing of the Biologics License Application (BLA) for ONS-5010 for wet age-related macular degeneration (wet AMD), which is planned for the end of calendar 2021 .
“Not only have we secured enough capital to significantly extend our cash runway through important upcoming milestones in 2021, but we have provided ourselves with more time to unlock the greatest value and potential for ONS-5010, the company, and our stockholders. We believe we are now in an improved position that will allow us to both maximize the value of this asset and to provide an FDA-approved ophthalmic formulation of bevacizumab to patients .”
Extensive market research indicates that ONS-5010, if approved, will be a significant therapy in the retinal anti-VEGF market, currently estimated to be in excess of $13 billion worldwide.
Clinical Progress of ONS-5010 On Track -
Therapeutics expects to report pivotal safety and efficacy data in the third calendar quarter of 2021.
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$OCGN Skyrockets On $23M Capital Raise Issued On 46% PremiumOcugen Inc. Announces $23 Million Registered Direct Offering of Common Stock Priced at a Premium to Market.
today announced that it has entered into definitive agreements with healthcare-focused institutional investors for the sale of an aggregate of 3,000,000 shares of its common stock at a purchase price of $7.65 per share in a registered direct offering. The offering is expected to close on or about February 10, 2021, subject to the satisfaction of customary closing conditions.
The gross proceeds of the offering are expected to be approximately $23 million, prior to deducting placement agent’s fees and other offering expenses payable by Ocugen. Ocugen intends to use the net proceeds from the offering for general corporate purposes, capital expenditures, working capital and general and administrative expenses.
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OCGN and Bharat Biote Announce Execution of Definitive AgreementOcugen and Bharat Biotech Announce Execution of Definitive Agreement for the Commercialization of COVAXIN™ in the US Market.
Definitive Agreement provides details of the previously announced intent to co-develop COVAXIN™ for the US market.
Ocugen and Bharat Biotech to share US commercialization profits.
Ocugen to receive initial supply of COVAXIN™ doses from Bharat Biotech upon authorization from US regulatory authorities while it ramps up manufacturing in the US.
COVAXIN™ received EUA (Emergency Use Authorization) in India in January and is currently in a fully enrolled Phase 3 clinical trial involving 25,800 patients.
COVAXIN™ (whole-virion inactivated COVID-19 vaccine candidate) effectively neutralizes UK variant of SARS-Cov-2 reducing the possibility of mutant virus escape.
today announced they have entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech’s COVAXIN™ , an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.
Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development , regulatory approval (including EUA) and commercialization for the US market .
B harat Biotech will supply initial dose s to be used in the US upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US . In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of COVAXIN™ in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.
In preparation for the development of COVAXIN™ in the US, Ocugen’s Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the U.S. Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application (BLA) approval in the US market for COVAXIN™. Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN™ to support its US immunization program.
H.C. Wainwright analyst Swayampakula Ramakanth raised his rating on Ocugen's stock on Thursday from neutral to buy and placed a $4.50 price forecast on its shares. Ramakanth cheered Ocugen's recent deal with India-based vaccine developer Bharat Biotech to potentially bring Covaxin, a COVID-19 vaccine candidate, to the U.S. market.
Ramakanth posits that Covaxin could induce broader immunity and better protection against new coronavirus strains than the COVID-19 vaccines that have received emergency use authorization in the U.S. He also highlighted Covaxin's potential logistical advantages, due to its less onerous temperature storage requirements.
Roth Capital analyst Zegbeh Jallah, meanwhile, believes Ocugen's share price could rise to as high as $8. Jallah applauded the structure of the deal, which gave Ocugen a 45% share of the potential profits from Covaxin's U.S. sales without requiring it to make an upfront payment to Bharat Biotech . Jallah's price target represents potential gains for investors of roughly 52% from Ocugen's closing price on Friday.
Much of Ocugen's future growth prospects now rest on its ability to obtain emergency use authorization for Covaxin in the U.S . Thus, investors should brace for volatility in Ocugen's stock price as it advances toward clinical trials.
granted EU Orphan Drug Designation for RintatolimodJUST GOT POSITIVE EU RECOMMENDATION
$AIM (old $HEB) granted EU Orphan Drug Designation for Rintatolimod for treatment of pancreatic cancer, Hemispherx Biopharma Europe.
Rintatolimod is Ampligen
This is going to trap shorts and when they PR this is going to explode!
www.ema.europa.eu
23andMe to Merge with Virgin Group's VG Acquisition Corp. SPAC23andMe to Merge with Virgin Group's VG Acquisition Corp. to Become Publicly-Traded Company Set to Revolutionize Personalized Healthcare and Therapeutic Development through Human Genetics.
- 23andMe is a leading consumer genetics and research company that offers a personalized health and wellness experience, and has built a premier genetic database to unlock insights leading to the rapid discovery of promising new targets for drug development
- Transaction will provide the capital to fund additional investment in key growth initiatives across 23andMe's consumer health and therapeutics businesses
- The transaction will value the outstanding shares of capital stock of 23andMe at an aggregate enterprise value of approximately $3.5 billion
- 23andMe CEO and Co-Founder Anne Wojcicki and Virgin Group's Sir Richard Branson are each investing $25 million into the $250 million PIPE and are joined by leading institutional investors including Fidelity Management & Research Company LLC, Altimeter Capital, Casdin Capital and Foresite Capital
- The pro forma cash balance of the combined company will exceed $900 million at closing
Completion of the transaction, estimated in the second calendar quarter of 2021.
23andMe is the only consumer genetic testing company with multiple FDA clearances for over-the-counter health and carrier status reports.
23andMe's existing equity holders will roll 100% of their equity into the combined company. Assuming no public shareholders of VG Acquisition Corp. exercise their redemption rights, 23andMe will be capitalized with up to $984 million in cash to fund operations and support new and existing growth initiatives.
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