$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.
twitter.com
Biotechs
$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.
finance.yahoo.com
Outlook Therapeutics Announces Closing of $35.0 Million Bought Deal
finance.yahoo.com
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.
finance.yahoo.com
$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.
finance.yahoo.com
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.
finance.yahoo.com
Sympathy playSympathy play
Anavex stock gained after favorable data from Cassava Sciences in Alzheimer’s! With a rise yesterday, Cassava Sciences extended its gains after announcement of favorable data from an open-label study in Alzheimer’s disease!
The shares have been on a bullish mode for the last several days, reaching an all-time high, on encouraging data for its differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders such as Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system diseases.
“Strong Buy” Penny Stock With Over 200% Upside on the Horizon“Strong Buy” Penny Stock With Over 200% Upside on the Horizon
a biotechnology company with a focus on the treatment of glioblastomas, a class of aggressive tumors that attack the braid and spinal cord. These cancers, while rare, are almost always terminal, and CNS is working a new therapy designed to more effectively cross the blood-brain barrier to attack glioblastoma.
Berubicin, CNS’s flagship drug candidate, is an anthracycline, a potent class of chemotherapy drugs derived from the Streptomyces bacteria strains, and used in the treatment of a wide variety of cancers. Berubicin is the first drug in this class to show promise against glioblastoma cancers.
The drug candidate has completed its Phase 1 clinical trial, in which 44% of patients showed a clinical response. This number included one patient who showed a ‘Durable Complete Response,’ defined as a demonstrated lack of detectable cancer.
Following the success of the Phase 1 study, CNS applied for, and received, FDA approval of its Investigational New Drug application. This gives the company the go-ahead to conduct a Phase 2 study on adult patients, an important next step in the development of the drug. CNS plans to start the mid-stage trial in 1Q21.
Based on the potential of the company’s asset in glioblastoma, and with its share price at $2.22, several analysts believe that now is the time to buy.
Among the bulls is Brookline’s 5-star analyst Kumaraguru Raja who takes a bullish stance on CNSP shares.
Berubicin is the first anthracycline to cross the blood-brain barrier in adults and access brain tumors… Berubicin has promising clinical data in a Phase 1 trial in recurrent glioblastoma (rGBM) and has Orphan drug designation for treatment of malignant gliomas from the FDA. We model approval of Berubicin for treatment of recurrent glioblastoma in 2025 based on the Phase 2 data with 55% probability of success for approval. We model peak sales of $533 million in 2032,” Raja opined.
“CNS pipeline also includes WP1244 (novel DNA binding agent) that is 500x more potent than daunorubicin in inhibiting tumor cell proliferation is expected to enter the clinic in 2021… In vivo testing in orthotopic models of brain cancer showed high uptake of WP1244 by brain and subsequent antitumor activity,” the analyst added.
finance.yahoo.com
Lexaria Provides Guidance on Upcoming R&DLexaria Bioscience Corp. Announces Uplisting to Nasdaq Capital Market and Pricing of $9.6 Million Upsized Public Offering
Lexaria also announced the pricing of an underwritten public offering (the "Offering") of 1,828,571 units, each unit consisting of one share of common stock and one warrant to purchase one share of common stock at a public offering price of $5.25 per unit (all prices in US$).
The shares of common stock and warrants comprising the units are immediately separable and will be issued separately, but will be purchased together. The warrants have an exercise price of $6.58 per share, are immediately exercisable and will expire five years following the date of issuance.
The Company has granted the underwriter a 30-day option to purchase up to an additional 274,285 shares of common stock and/or warrants to purchase up to 274,285 shares of common stock.
finance.yahoo.com
Lexaria Provides Guidance on Upcoming R&D
Lexaria recently closed an oversubscribed financing of US$11 million that has greatly enhanced the Company's ability to conduct applied R&D designed to evidence effectiveness of its patented DehydraTECHTM drug delivery technology across multiple classes of bioactive substances or drugs. In the weeks to come, Lexaria expects to announce many new studies designed to provide initial evidence expected to support further study and commercial exploitation. All studies referenced within this press release are fully funded from existing Company resources.
finance.yahoo.com
Why SELLAS Life Sciences Is Surging Premarket?Why SELLAS Life Sciences Is Surging Premarket?
SELLAS Life Sciences is captivating investors thanks to its late-stage cancer vaccine
Thanks to some news in December in the biopharma space, SLS stock is racing higher. So what was that news? And what else do you need to know?
its leading candidate Galinpepimut-S is making its way through Phase 3.
This immunotherapy targets the Wilms Tumor 1, which is the leading cancer antigen. Essentially, the company believes that this therapy, which is given via vaccine, reduces the immune response in a patient and has the ability to delay the relapse of cancer. Although SELLAS Life Sciences is testing it for a variety of cancers, it is currently in Phase 3 trials for acute myeloid leukemia.
This lead candidate is where the massive move in SLS stock comes from.
Importantly, SELLAS Life Sciences had some big news of its own in december. While its leading immunotherapy candidate remains in clinical trials, it entered a license agreement with China-based 3D Medicines. Through this deal, 3D Medicines will handle developing and commercializing Galinpepimut-S in mainland China, Hong Kong, Taiwan and Macau. According to a company press release, this could net $202 million in license fees for SELLAS. It also could bring an upfront payment of $7.5 million sometime this quarter.
it looks like another company is responsible for the move in SLS stock.
What do I mean? Well, in december we saw a major rally in Greenwich LifeSciences (NASDAQ:GLSI). Ahead of a conference, the company shared promising Phase 2b data on its breast cancer immunotherapy. Importantly, Greenwich LifeSciences is evaluating GP2 as a therapy for patients who have already undergone surgery for breast cancer. And according to the report yesterday, GP2 has reduced the recurrence rate of cancer in trial participants to 0%.
How does this tie into SELLAS Life Sciences? Well, GP2 and Galinpepimut-S are both unique immunotherapies that rely on vaccination as a delivery method. Essentially, both treatments are cancer vaccines. Both treatments are also quite innovative, representing potential advancements in the realm of cancer care. This means that with a more than 2,000% rally from GLSI stock, many investors may be rooting for the same with SLS.
Remember though, this is a tiny company that must continue to navigate clinical trials. Keep an eye on SLS stock, but proceed with caution.
100% Survival Achieved in Osteosarcoma Lung MetastasesMoleculin Announces 100% Survival Achieved in Osteosarcoma Lung Metastases Animal Model
a preclinical study in animals demonstrated a potentially significant therapeutic benefit of Annamycin against metastatic osteosarcoma.
Computerized tomography (CT) scans demonstrated that animals treated with Annamycin exhibited significant suppression of tumor growth and not a single death was observed in the treated animals, whereas significant tumor burden contributed to the rapid death of 90% of untreated animals. While the study continues, as of day 130, the survival rate for animals treated with Annamycin was 100%, compared with only 10% for untreated animals.
Annamycin is a "next generation" anthracycline that has recently been shown in animal models to accumulate in the lungs at up to 34 times the level of doxorubicin, which may account for the 100% survival rate attained in this most recent osteosarcoma lung metastases study.
Moleculin recently announced that the FDA has allowed the Company's request for investigational new drug (IND) status in order to study Annamycin for the treatment of soft tissue sarcoma metastasized to the lungs. In addition, the FDA granted Orphan Drug Designation for Annamycin for the treatment of soft tissue sarcomas.
"We expect that one, and potentially two, clinical trials in sarcoma lung metastases should be up and running this year."
finance.yahoo.com
ANVS401 Improves Cognitive and Functional Outcomes in StrokeAnnovis Bio's Lead Candidate ANVS401 Improves Cognitive and Functional Outcomes in Stroke Mice Study
data showing that a combination treatment using the Company's lead candidate ANVS401 and pifithrin after stroke improved mice locomotor activity and cognitive function more so than treatment with just one or the other agent.
While both treatments yielded improvements in locomotor and cognitive function, the combined ANVS401/PFT- treatment proved able to enhance stroke-induced endogenous neurogenesis and improve the functional recovery in stroke animals. The combined treatment also significantly improved cognitive function more than the single treatment with PFT- alone.
finance.yahoo.com
Simufilam Improves Cognition and Behavior in Alzheimer’s DiseaseCassava Sciences’ Simufilam Improves Cognition and Behavior in Alzheimer’s Disease in Interim Analysis of Open-label Study
- Patients’ Cognition Improved 1.6 Points on ADAS-Cog11 -a 10% mean improvement from baseline to month 6.
- Patients’ Behavior Improved 1.3 Points on NPI, a 29% mean improvement from baseline to month 6.
- Improvements Maintained at 6 Months -
- Results Support Advancing Simufilam into Phase 3 Clinical Program
Next Steps:
Cassava Sciences believes today’s data and prior clinical results support advancing simufilam into a Phase 3 clinical program in Alzheimer’s disease. Initiation of a Phase 3 trial remains on schedule for 2nd half 2021.
Cassava Sciences and the U.S. FDA recently concluded a successful end-of-phase 2 (EOP2) meeting for the simufilam drug development program. Details of the EOP2 meeting will be announced Q1 2021 after official FDA meeting minutes are finalized.
finance.yahoo.com
This Penny Stock NMTR Could soar 462% in 2021The company’s development pipeline features drug candidates under investigation as treatments for short bowel syndrome (SBS) and celiac disease (CeD), two conditions that are both dangerous and difficult to treat.
9 Meters’ flagship product, Larazotide, is in Phase 3 development for the treatment of CeD. CeD affects about 1% of the population, yet there are no approved therapies. Top-line data from the study is expected in the second half of 2021.
Furthermore, this past December, the company announced that it had entered an agreement with EBRIS, the European Biomedical Research Institute of Salerno, to investigate Larazotide as a potential treatment for respiratory complications due to COVID-19.
The other major drug in the company’s pipeline is NM-002, for SBS. The company has recently announced positive Phase 1b/2a results, with a measurable impact on disease symptoms from a compound that was well-tolerated by patients.
ne of these NMTR bulls is Truist’s Srikripa Devarakonda. Citing Larazotide as a key component of his bullish thesis, the analyst noted, “We acknowledge investors are likely to see a pivotal trial in a tough-to-crack Celiac disease program as high risk despite encouraging Ph2b data. We model $705M/$353M in peak unadjusted/adjusted sales and see potential upside of 400% - 1650% from positive Ph3 readout.”
finance.yahoo.com
COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 TrialNovavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants
Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK).
Novavax also announced successful results of its Phase 2b study conducted in South Africa.
Significant progress on PREVENT-19 Clinical Trial in US and Mexico
finance.yahoo.com
Acquisition of Quellis Biosciences Inc.+private placementCatabasis Pharmaceuticals Announces Acquisition of Quellis Biosciences Inc.
Acquisition Includes QLS-215, a Potential Best-in-Class Monoclonal Antibody Inhibitor of Plasma Kallikrein in Preclinical Development for the Treatment of Hereditary Angioedema
Concurrent with the acquisition of Quellis, Catabasis entered into a definitive agreement for the sale of Series X convertible preferred stock (the "Series X preferred stock") in a private placement to a group of institutional accredited investors.
Catabasis expects to use the proceeds from the private placement primarily to enable the completion of IND-enabling studies, Phase 1a, and Phase 1b/2 clinical trials for the lead program QLS-215 in hereditary angioedema (HAE), a rare, debilitating and potentially life-threatening disease.
Catabasis expects to file an Investigational New Drug application for QLS-215 in the first half of 2022 and plans to initiate a Phase 1 clinical trial with initial results anticipated by the end of 2022. Subsequently, Catabasis expects to initiate a Phase 1b/2 trial in patients affected by HAE in 2023 with initial results anticipated by the end of 2023.
About the Transactions
finance.yahoo.com
EDSA to Study Investigational Drug as Potential Rescue TheraphyEdesa Biotech to Study Its Investigational Drug as Potential Rescue Therapy
EDSA has received regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada to add a sub-study to its ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases.
This sub-study will allow us to potentially expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure," Dr. Nijhawan said.
finance.yahoo.com
Significant and Rapid Reduction in Hepatitis B Surface AntigenInitial Data from Ongoing Phase 1 Trial of VIR-3434 for Chronic Hepatitis B Virus Infection Demonstrates Significant and Rapid Reduction in Hepatitis B Surface Antigen
Data from the first blinded cohort of eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434, showed that six of eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients.
Additional data will be submitted for presentation at an upcoming medical conference. A Phase 2 trial combining VIR-3434 with Vir’s HBV-targeting siRNA, VIR-2218, is expected to commence in the second half of this year.
finance.yahoo.com
the world's first Phase 3 oral insulin studyOramed Doses Patients Across Multiple Sites in Phase 3 Oral Insulin Study
Randomization of patients in the world's first Phase 3 oral insulin study conducted under FDA approved protocol
Announced today that randomization of patients in its first Phase 3 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D) is under way. The study is being conducted in accordance with U.S. Food and Drug Administration (FDA) approved protocols.
Efficacy data will become available after all patients have completed the first 6-month treatment period.
finance.yahoo.com
SYMJEPI Products Now Available in the WalgreensSYMJEPI Products Now Available in the Walgreens Prescription Savings Club, with the Lowest Prices for Epinephrine Products
ADMP) today announced that its SYMJEPI® (epinephrine) Injection products are now available to members of the Walgreens Prescription Savings Club program, for a discounted price of $99.99 for a two-pack, the lowest price offered for epinephrine products through the Walgreens Prescriptions Savings Club, and the lowest price for epinephrine devices on the market1.
finance.yahoo.com
AzurRx BioPharma Announces First Two Patients DosedAzurRx BioPharma Announces First Two Patients Dosed in Phase 2b OPTION 2 Extension Study of MS1819 in Cystic Fibrosis Patients
Due to enrollment in the initial crossover trial being ahead of schedule, we are given an opportunity to thoroughly explore optimal doses and capsule types that will help guide our future development plans for MS1819 in a Phase 3 program. In the meantime, we will continue our preparation for a successful FDA meeting later this year.”
Topline data results for this study are anticipated in Q1 2021, as enrollment remains strong.
finance.yahoo.com
AditxtScore™ Immune Monitoring Service Operational on February 1AditxtScore™ Immune Monitoring Service Will be Operational on February 1st
Company Plans to Offer Service through Channel Partners
The initial application of the platform will be AditxtScore™ for COVID-19 which has been designed to provide a more complete assessment of an individual’s infection and immunity status with respect to the SARS-CoV-2 virus.
We’re currently in discussions with labs, hospitals and other channel partners around the world interested in incorporating AditxtScore™ into their offerings.
finance.yahoo.com
Obalon Therapeutics Surges On News Of Merger With ReShape LifeObalon Therapeutics Surges 75% On News Of Merger With ReShape Lifesciences
ReShape Lifesciences Inc. to Merge With Obalon Therapeutics, Inc. to Expand Weight Loss Product Offering
ReShape Lifesciences, a weight-loss solutions company, entered into a merger agreement with Obalon Therapeutics, under which ReShape and Obalon will combine in an all-stock transaction.
Under the agreement, which has been unanimously approved by the boards of both companies, existing ReShape stockholders will have majority ownership of the combined company.
Obalon will be renamed ReShape Lifesciences Inc. and will trade under the NASDAQ ticker symbol "RSLS."
The current directors and officers of ReShape will comprise the board of directors and executive management of the combined company.
www.nasdaq.com
finance.yahoo.com
