ISR has received FDA 510(k) clearanceC4 Imaging Announces Sirius Positive Signal MRI Marker Given FDA 510(k) Clearance for Use with Isoray’s Cesium-131 Brachytherapy Seeds to Treat Prostate Cancer
ISR has received FDA 510(k) clearance for the use of C4 Imaging’s Sirius® positive-signal MRI (Magnetic Resonance Imaging) Markers with Isoray’s Cesium-131, brachytherapy seeds.
Sirius MRI Markers will enable Isoray’s customers to fully utilize the benefits of MRI seed localization.
Brachytherapy, or internal radiation therapy, is a leading, cost-effective option for the treatment of prostate cancer. Isoray is the world’s only producer of Cesium-131, commercially known as Cesium Blu™, brachytherapy seeds. Cesium-131 is a radioactive isotope that delivers a minimally invasive and highly targeted treatment to the site of the cancer preserving healthy tissue and organs. Patients benefit from the rapid resolution of their side effects allowing them to return to their normal lives quickly.
finance.yahoo.com
Biotechnology
“Strong Buy” Penny Stock That Could Deliver Massive Returnis engaged in the development of gene therapies for rare, frequently terminal, diseases, including neurometabolic disorders, primary immune deficiencies, and blood disorders. The gene therapy approach uses blood stem cells to deliver corrected genetic information directly into the patient’s body.
Orchard’s pipeline demonstrates the diversity of disorders amenable to gene therapy – the company has no less than 12 drug candidates in development. Among these candidates, Libmeldy (OTL-200) stands out.
Libmeldy is in commercialization stages as a treatment for MLD (metachromatic leukodystrophy), a rare, mutation-based genetic disorder of the nervous system, received its approval for medical use in the EU in December 2020.
“We look forward to the company’s commercial execution in the EU and an eventual 2022 approval in the US. Last month ORTX received IND clearance from the FDA for the program paving the way for discussions with the US regulators to decide a suitable path forward toward a BLA filing.”
with possibly two gene therapies approved in the next 12-18 months and a pivotal study beginning in a third (MPS-I), we think ORTX shares are undervalued at these levels," the analyst concluded.
Wedbush analyst David Nierengarten rates ORTX as Outperform (i.e. Buy), and his $15 price target indicates a potential for 241% growth in the year ahead.
Only Buy ratings, 3, in fact, have been issued in the last three months. Therefore, ORTX gets a Strong Buy consensus rating. At $15, the average price target indicates shares could appreciate by 241% in the year ahead.
finance.yahoo.com
“Strong Buy” Penny Stock That Could Deliver Massive Returns“Strong Buy” Penny Stock That Could Deliver Massive Returns
The 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.
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.
finance.yahoo.com
positive prelim data from a Phase 1 study-leukemia treatmentCuris Announces Positive Preliminary Data from Ongoing Phase 1 Study of CA-4948 Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes.
Key findings include:
- Marrow blast reductions observed in all evaluable patients (6 patients).
- 6 of 7 patients enrolled remain on study.
- Patients enrolled experienced a median of 3 prior lines of treatment (range 1-4).
- Two patients experienced a marrow complete response, one with blast count going from 23% pretreatment to 1% on treatment, and the other going from 11% pretreatment to 2% on treatment.
- No DLTs observed in 7 DLT-evaluable patients in the 200 mg BID and 300 mg BID cohorts.
- Enrollment has begun in the 400 mg BID cohort.
Curis said its CA-4948 monotherapy in adult patients was well tolerated, has demonstrated signs of biologic activity in the ongoing study and is capable of achieving "relevant levels of drug exposure."
finance.yahoo.com
I have a strong feeling... (EDSA)Hello everybody and happy new year! ❤
Major retest of breaking 6-7 years of channel Resistance. The retest after a very strong impulsive move out of the channel is forming a falling wedge with very tight price consolidation. Another plus about this stock is that it has a very low float. I like accumulation here, maybe one more chance at 3.56
I'm extremely bullish on this and see a lot of correlation with a lot of other low float biotech / pharmaceutical stocks.
My thoughts on a very long term swing trade,
See you at the top 🚀
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
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
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
Could vrtx fill the gap?VRTX has been inching closer to breaking out of its range state. With Biotech making new highs the stock should have flow tailwinds and any suppression of volatility in the market should be a positive.
]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
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
BCRX - keep trading the pullbackNote from BoA Global Research: "BCRX announced a royalty purchase agreement with RPRX and a credit loan agreement with Athyrium. BCRX will receive an upfront $125mn cash from RPRX, in exchange for 8.75% sales-based royalties up to $350mn annual sales, 2.75% royalties between $350mn-$550mn and tiered revenues outside of key territories for the recently-approved Orladeyo in preventing hereditary angioedema (HAE) attacks. The agreement also grants RPRX 1% sales royalty on its oral Factor D inhibitor BCX9930 that’s currently being evaluated in treating paroxysmal nocturnal hemoglobinuria (PNH). BCRX will also draw $125mn from the $200mn credit facility with Athyrium to repay outstanding ~$44mn debt with MidCap Fin. Trust and support its ongoing launch of Orladeyo and R&D development. We positively view today’s updates, as the agreements strengthen the company’s balance sheet and remove the near term need for dilutive financing. It also extends its cash runway meaningfully and allows the company to focus on advancing the early-stage BCX9930 program."
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Ascending Triangle breakout for TRIL?It appears as though TRIL is breaking the horizontal resistance of the ascending triangle, only modestly at the time being.
The two green lines are the shoulders of an Inverted Head & Shoulders, and the blue head is obviously the head of the pattern.
On the RSI there's a bullish flag or descending triangle forming, I guess we will see if there's enough momentum to break through the downward sloping resistance, and possibly back test turning into support like I have drawn hypothetically in green.
A bearish cross already happened on the KST, it looks like a bullish cross is on the horizon.
Clearly a divergence between the price rising and the RSI moving moderately sideways.
