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
Biotech
CYCC Announces at-the-market $7 Million Strategic InvestmentCyclacel Pharmaceuticals Announces at-the-market $7 Million Strategic Investment by Fundamental Investor Acorn Bioventures
Cyclacel Pharmaceuticals has entered into a definitive securities purchase agreement with Acorn Bioventures, LP, a biotech-focused fundamental investor.
- Strategic investment from single biotech-focused institutional investor -
- Enables clinical development of both fadraciclib and CYC140 in hematological malignancies and solid tumors -
Acorn Bioventures has agreed to purchase in a registered direct offering 485,912 shares of common stock and 237,745 shares of newly designated Series B Preferred Stock (convertible into shares of common stock at a ratio of 1:5), and in a concurrent private placement, warrants to purchase 669,854 shares of common stock, for aggregate gross proceeds of approximately $7 million.
The warrants will be exercisable beginning twelve months following the date of issuance, will expire on the five-year anniversary of the date of issuance, and have an exercise price of $4.13 per share.
finance.yahoo.com
ILMN Stocks for 2021 Looking to Illumina price now that earnings are knocking at the door, as you can see we are in a kind of Rangin Zones for ILMN price, anyway his Fundamental for a long term stil realy valuable in my opinion, We traced some of the most importants keys levels as support and resistence adding just the last trendline we are looking for a breakout or a confirm as a support. Biotechnologys industries are supposed to grow but we always recommend to investors for attention because this market is getting bigger day by day and competitors could be able to take a slice from this Big Profitable Pie.
JAGX Signs Second Agreement for $6 Mil Non-dilutive FinanciningJaguar Health Signs Second Agreement for $6 Million Non-dilutive Financing Transaction Involving the Sale of Royalty Rights Related to Future Mytesi (Crofelemer) and Lechlemer Revenue Stream
Jaguar Health, Inc. has signed an agreement (the "Agreement") with a secured lender (the "Lender") for a non-dilutive royalty financing transaction, pursuant to which Jaguar would sell to the Lender for an aggregate purchase price of $6 million (the "Royalty Purchase Price") a royalty interest entitling the Lender to receive 2.0x the Royalty Purchase Price of future royalties of Mytesi® (crofelemer) and lechlemer and certain up-front license fees and milestone payments from licensees and/or distributors as well as any interest, fees, and charges in accordance with the terms set forth in the Agreement (the "Royalty Repayment Amount"), and to pay interest on the Royalty Repayment Amount at the rate of ten percent per annum until the same is paid in full.
No royalty payments due for 18-24 months
Jaguar intends to use the proceeds to support regulatory activities associated with the Company's development pipeline
This $6 million royalty financing transaction follows an earlier $6 million royalty transaction consummated in October 2020 with an affiliate of the Lender.
We may consider entering into similar agreements in the future and of course business development relationships as additional sources of non-dilutive funding."
finance.yahoo.com
SRNE - Beginning of the big move.Currently shorts are controlling the stock. Seems that it found it's support and we might see a short squeeze in the upcoming 1-3 weeks.
#Ultimovacs $ULTI announce FOURTH randomized phase 2 trial FOCUSNote that information about the third study is still expected before year end.
Ultimovacs ASA – Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab
Oslo, 22 December 2020: Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced the initiation of FOCUS, a Phase II randomized clinical trial that will evaluate the Company’s proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany, who is a renowned oncology clinician and researcher specializing in the analysis of immuno-oncology treatments and their interaction with tumor tissues. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.
“We continue to strategically expand our clinical development program for our proprietary cancer vaccine, not only by testing UV1 in additional cancer indications with critical need, such as head and neck cancer, but also by collaborating with clinicians like Professor Binder who can provide us with unique insights,” stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. “Professor Binder and her team are well-recognized experts who will increase our understanding of UV1’s mechanism of action and contribute data on anti-tumor activity induced by UV1 vaccination.”
The FOCUS (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study) Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma across 10 clinical sites in Germany. The trial will evaluate the addition of UV1 to a standard of care treatment with PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab monotherapy. A total of 75 patients indicated for treatment with pembrolizumab will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint of the study is the progression-free survival rate at 6 months, and planned readout of topline results is expected in 2023. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council and will not require Ultimovacs to secure additional financing at this stage.
“This clinical trial is the extension of an earlier collaboration with Ultimovacs that introduced me to the therapeutic potential of the UV1 approach,” commented Professor Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle. “I am excited to apply my own insights as well as my team’s expertise to this trial with the goal of potentially providing head and neck cancer patients with better treatment options.”
“We have continued to build momentum in our broad clinical development program with the start of the FOCUS study, representing the important opportunity to test UV1 in combination with pembrolizumab in a randomized setting for the first time,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs. “We welcome the funding provided by the Norwegian Research Council, which supports our ability as a small biotechnology company to conduct four Phase II trials in parallel and evaluate UV1 in different indications with more than 450 patients and as part of various treatment combinations.”
Dr. de Sousa added: “Although we have signed our agreement with the lead investigator for our previously announced third Phase II clinical trial, we will need to wait for the investigator and the pharmaceutical partner to finalize the signature process for their agreement before we can provide full details, which we expect to do before year end.”
]ImmunityBio and NantKwest to MergeImmunityBio and NantKwest to Merge, Creating a Leading Immunotherapy and Cell Therapy Company (agreement to merge in a stock-for-stock transaction.)
Merged entity brings together 11 Phase II / III clinical trials across oncology and infectious disease that use combined immunotherapy platforms
Together, ImmunityBio and NantKwest will have a broad, clinical-stage pipeline – including 13 assets in clinical trials and 11 in Phase II to III – as well as a robust early stage pipeline to address other difficult to treat cancers.
Broad late-stage pipeline for solid tumors including bladder, lung, breast, and pancreatic in addition to infectious disease programs for HIV and COVID-19
Transaction Details
The transaction is structured as a tax-free 100% stock-for-stock merger, with ImmunityBio to reverse merge with NantKwest. Under the terms of the agreement, ImmunityBio shareholders will receive a fixed exchange ratio of 0.8190 shares of NantKwest for each share of ImmunityBio owned. Upon completion of the transaction, on a fully diluted basis, ImmunityBio shareholders will own approximately 72% of the combined company and NantKwest shareholders will own approximately 28% of the combined company, on a fully diluted basis.
The transaction, which is expected to close in the first half of 2021. Following the closing of the transaction, the combined company will assume the ImmunityBio name and continue to be listed on the NASDAQ exchange. However, the combined company ticker symbol is expected to be changed to IBRX.
finance.yahoo.com
ImmunityBio Announces Primary Endpoint Met of Phase 2/3 Trial for BCG Unresponsive Non-Muscle Invasive Bladder Cancer CIS with 72% Complete Response Rate
QUILT 3.032 study completes planned enrollment of BCG unresponsive non-muscle invasive bladder cancer CIS cohort with 59% probability of patients maintaining complete response for at least 12 months
Over 85% of patients in this study have avoided a cystectomy to date
Breakthrough status for ImmunityBio’s superagonist Anktiva N-803 in this indication
Biologics License Application filing anticipated in second half of 2021
finance.yahoo.com
Lilly to acquire Prevail for $22.50 per share in cash Lilly to acquire Prevail for $22.50 per share in cash (or an aggregate of approximately $880 million) payable at closing plus one non-tradable contingent value right ("CVR") worth up to $4.00 per share in cash (or an aggregate of approximately $160 million), for a total consideration of up to $26.50 per share in cash (or an aggregate of approximately $1.040 billion).
Acquisition will establish a gene therapy program at Lilly, anchored by Prevail's portfolio of neuroscience assets, and will broaden Lilly's commitment to use novel modalities to attempt to address otherwise fatal genetic forms of neurodegenerative disease.
Gene therapy is a promising approach with the potential to deliver transformative treatments for patients with neurodegenerative diseases such as Parkinson's, Gaucher and dementia
The acquisition of Prevail will bring critical technology and highly skilled teams to complement our existing expertise at Lilly, as we build a new gene therapy program anchored by well-researched assets. We look forward to completing the proposed acquisition and working with Prevail to advance their groundbreaking work through clinical development."
finance.yahoo.com
Easy 10%er upcoming Consolidation at LQDA in range of their all time low after FDA issued the biotech company a CRL due to COVID restrictions. After speaking with regulators at the FDA, The company expressed this CRL had nothing to do with the underlying data. Options activity has been healthy. I believe price will increase from here, which is why I have started a position and continue to add on any meaningful dips (eg yesterday, the company issued PR for $200 mln mixed securities shelf offering) causing week hands to sell. Stop loss under previous low, friends. let’s go!!
Disclaimer: this is not recommendation to buy or sell, this information is to be used for educational purposes only. Trade at your own risk.
BioCardia Anticipates DSMB Feedback on Interim Data1. BioCardia Anticipates DSMB Feedback on Interim Data From Pivotal Phase 3 CardiAMP Heart Failure Trial
BCDA today announces that it anticipates data safety monitoring board (DSMB) verbal feedback by the end of December 15, 2020 on interim data from the Company’s pivotal Phase 3 CardiAMP Heart Failure Trial that is currently enrolling nationwide for infusion of BioCardia’s CardiAMP™ autologous cell therapy to the myocardium. The DSMB is then anticipated to provide its written feedback approximately 24 hours later. BioCardia plans to provide an announcement pre-market on December 17 , 2020 summnarizing the feedback and outlining the next resulting steps.
The CardiAMP Heart Failure study has been approved by the FDA to enroll up to 260 patients at up to 40 centers. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy in the treatment of patients with ischemic heart failure . The FDA has said that the trial qualifies as a pivotal trial to produce the primary data to support market registration for the CardiAMP cell therapy for this significant unmet clinical need.
www.globenewswire.com
2. BioCardia, Inc. Announces $8.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
today announced it has entered into definitive agreements with investors for the purchase and sale of 1,789,474 shares of its common stock at a purchase price of $4.75 per share in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about December 16, 2020, subject to the satisfaction of customary closing conditions.
finance.yahoo.com
Arvinas Nearly Doubles on Promising Cancer Drug ResultsArvinas Nearly Doubles on Promising Cancer Drug Results
The test results show the Arvinas drugs' potential for treating breast and prostate cancer, Cantor said.
Arvinas (ARVN) - Get Report shares blasted off Monday as Cantor Fitzgerald offered bullish comments on the biopharmaceutical company after it reported positive news on its breast and prostate cancer treatments.
“For ARV-471, interim Phase 1 data show potential for best-in-class safety and tolerability, estrogen receptor (ER) degradation superior to that previously reported for the current standard of care agent (fulvestrant), and robust efficacy signals in heavily pretreated patients with locally advanced or metastatic ER positive / HER2 negative (ER+/HER2-) breast cancer,” the company said in a statement.
The test results show ARV-471’s potential as the best-in-class potential estrogen receptor degrader, Cantor analyst Alethia Young wrote in a commentary cited by Bloomberg. The results are “very encouraging and demonstrated ARV-471 was active,” Young wrote. She has an overweight rating and a $66 price target on Arvinas.
“The efficacy signals include one Response Evaluation Criteria in Solid Tumors (RECIST) confirmed partial response (PR), two additional patients with unconfirmed PRs, and a clinical benefit rate (CBR) of 42%,” Young said.
Separately, Cantor said that “for ARV-110, the ongoing dose escalation portion of the Phase 1/2 trial in men with metastatic castration-resistant prostate cancer (mCRPC) has provided additional evidence of anti-tumor activity and patient benefit, including a prostate specific antigen reduction of more than 50% (PSA50) rate of 40% in a molecularly defined patient population.”
Further, “Arvinas has initiated a Phase 2 dose expansion to explore a two-pronged development strategy, including the potential for accelerated approval in molecularly defined, late-line patients, and broader development in less-heavily pretreated mCRPC patients with fewer androgen receptor (AR)-independent mechanisms of tumor resistance,” Young said.
Oppenheimer Upgrades Arvinas Inc. (ARVN) to Outperform, Following Clinical Update
www.thestreet.com
www.streetinsider.com
Solid Biosciences Announces $90 Million Private PlacementSolid Biosciences Announces $90 Million Private Placement
Solid Biosciences has entered into a securities purchase agreement with a select group of institutional investors and accredited investors for a $90 million private placement, which is expected to close on or about December 15, 2020, subject to the satisfaction of customary closing conditions.
The private placement includes new investors Suvretta Capital Management, LLC and Aspire Capital Fund, LLC and existing investors, including RA Capital Management, Perceptive Advisors, LLC, Bain Capital Life Sciences, EcoR1 Capital, LLC, Boxer Capital, and Ikarian Capital, LLC, as well as certain board members and executive officers.
In this private placement, the Company is selling 24,324,320 shares of common stock at a price of $3.70 per share.
The Company expects to use net proceeds from the private placement to fund research and development expenses, including the advancement of SGT-001, and for working capital and other general corporate purposes.
finance.yahoo.com
And just like that, Sangamo $SGMO is back at ATH market capSangamo Therapeutics is committed to translating ground-breaking science into genomic medicines with the potential to transform patients’ lives using gene therapy, ex vivo gene-edited cell therapy, and in vivo genome editing and genome regulation.
Still holding on!We entered CGEN last week hoping for a rise to 15. The biotech sector (IBB) was breaking out and our model was picking up a potential reversal signal. So far the trade has been flat to down. We will be stopped out on any close below 12 but for now we are holding strong.
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Vaccibody $VACC leaping to ATH after releasing #Covid19 Data Vaccibody reports promising preclinical data with a second-generation COVID-19 vaccine and announces its infectious disease strategy
● Vaccibody demonstrates promising pre-clinical data with its second-generation COVID-19 vaccine candidate, VB10.COV2
● VB10.COV2 induces rapid, strong and long-lasting neutralizing antibodies and multifunctional, dominant CD8+ T cell and Th1 CD4+ T cell responses in mice after a single dose
● Vaccibody will present the pre-clinical data and its broader infectious disease strategy during a webcast on Friday December 11 at 10 am CET