by DrKSSMDPhD | January 12, 2018 4:22 pm
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Source URL: https://www.stockgumshoe.com/2018/01/the-twelve-biotechs-of-christmas-2018-balthasar/
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We’re in Fort Lauderdale for NobleCon14, but didn’t get settled in til wee hours because of flight delay. I shared a flight down with Albion Fitzgerald, board chairman of CohBar and serial IT entrepreneur. We got into such an enthused conversation about CohBar and biotech in the airport that they boarded the plane in Newark and we’d not noticed. They screamed for us on the overhead, and we were the last two to get on.
Will begin posting under separate header on separate template here mid-morning.
Good morning! $CLRB fp – Cellectar Initiates DLBCL Cohort in Phase 2 Trial of CLR 131 in Refractory B-Cell Hematologic Cancers
http://investor.cellectar.com/releasedetail.cfm?ReleaseID=1055526
MADISON, Wis., Jan. 29, 2018 (GLOBE NEWSWIRE) — Cellectar Biosciences (Nasdaq:CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces that it has enrolled the first patient in the diffuse large B-cell lymphoma (DLBCL) cohort of its Phase 2 clinical trial of CLR 131, its lead radiotherapeutic Phospholipid Drug ConjugateTM (PDCTM). This group represents the fourth and final cohort of the company’s Phase 2 study for patients with relapsed or refractory B-cell hematologic cancers. The Company expects to enroll up to 10 patients with DLBCL into this cohort prior to conducting an interim analysis. If these interim data are positive, the DLBCL cohort could be expanded by an additional 10-20 patients.
“DLBCL is a rare hematologic cancer with few treatment options and the expansion of the Phase 2 trial provides the opportunity to further explore the broad treatment potential of CLR 131 in an area of significant unmet need. We are now exploring CLR 131 in six hematologic malignancies and we expect to initiate Phase 1 studies in head & neck cancer and pediatric tumors in 2018,” stated James Caruso, president and chief executive officer of Cellectar Biosciences. “Importantly, we are able to undertake our development plans with modest shareholder investment as our Phase 2 study is partially funded through a National Cancer Institute (NCI) Small Business Innovation Research grant. In addition, the Phase 1 head & neck study will be predominantly funded through a NCI Specialized Programs of Research Excellence grant and costs for the pediatric study will be shared with our partners at the University of Wisconsin.”
About the Phase 2 Study of CLR 131…
$BLPH long fp – Bellerophon Therapeutics Announces Enrollment Exceeds 100 Patients in Phase 3 INOvation-1 Study Evaluating INOpulse® for Treatment of Pulmonary Arterial Hypertension
WARREN, N.J., Jan. 29, 2018 (GLOBE NEWSWIRE) — Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced that enrollment in its Phase 3 INOvation-1 study evaluating INOpulse® in patients with pulmonary arterial hypertension (PAH) now exceeds 100 patients, representing more than half of the anticipated enrollment. As previously agreed with the U.S. Food and Drug Administration (FDA), an interim analysis of this trial will be performed by the Data Monitoring Committee when half of the subjects complete the 16-week blinded treatment phase. The interim analysis will determine if the study should be stopped early for efficacy or futility, continued as planned, or if the trial size should be increased. The Company anticipates the readout of the interim analysis in mid-2018, and the availability of top-line data from the full study toward the end of 2018.
http://investors.bellerophon.com/phoenix.zhtml?c=253899&p=irol-newsArticle&ID=2328865
$VTGN – ow and longer in pre-market
$ABEO 1/2p- http://phoenix.corporate-ir.net/phoenix.zhtml?c=63510&p=irol-newsArticle&ID=2328868
Abeona Receives FDA Regenerative Medicine Advanced Therapy Designation for EB-101 Gene Therapy in Epidermolysis Bullosa
First gene therapy RMAT designation for Epidermolysis Bullosa
Enables accelerated approval path and real world data usage
NEW YORK and CLEVELAND, Jan. 29, 2018 (GLOBE NEWSWIRE) — Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the US Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to EB-101, the Company’s gene-corrected autologous cell therapy product for patients with recessive dystrophic epidermolysis bullosa (RDEB).
“EB-101 is an autologous gene-corrected cell therapy approach that utilizes a patient’s own cells and genetically re-engineers them to produce the missing collagen protein, which helps hold skin on to the body. This reduces the number of painful blisters caused by injury and has demonstrated improved wound healing in our Phase 1/2 clinical trial for over 2 years,” said Timothy J. Miller, Ph.D., President and CEO of Abeona. “The receipt of the RMAT and Breakthrough designations, both over the last six months, reaffirms the significance of the EB-101 clinical trial results and the need to advance promising therapies in areas of considerable unmet medical need. We are pleased that the FDA granted the RMAT designation, which will help accelerate the development of EB-101, and look forward to continuing our collaborative discussions in defining the pathway forward for the Phase 3 trial set to begin later this year.”
Established under the 21st Century Cures Act, the RMAT designation is an expedited program for the advancement and approval of regenerative medicine products where preliminary clinical evidence indicates the potential to address unmet medical needs for life-threatening diseases or conditions. Similar to Breakthrough Therapy designation, the RMAT allows companies developing regenerative medicine therapies to work more closely and frequently with the FDA, and RMAT-designated products may be eligible for priority review and accelerated approval. In November 2017, the FDA expanded the RMAT designation for gene therapies. The sponsor of a RMAT therapy that is granted accelerated approval and is subject to post-approval requirements may, as appropriate, fulfill such requirements through submission of clinical evidence, clinical studies, patient registries, or other sources of real world data. For information on RMAT designation, visit the FDA website:
https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm …
$PIRS np
Pieris Pharmaceuticals to Host Key Opinion Leader Event on February 6th
BOSTON, MA–(Marketwired – January 29, 2018) – Pieris Pharmaceuticals, Inc. (PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, announced today that it will host a Key Opinion Leader (KOL) Event in New York on Tuesday, February 6th from 8-10:30 AM EDT.
The KOL event will feature world-class thought leaders in immuno-oncology and respiratory diseases, followed by a company presentation. The event will include presentations from:
Michael A. Curran, PhD, Assistant Professor in the Department of Immunology and Scientific Director of the Oncology Research for Biologics and Immunotherapy Translation (ORBIT) platform at MD Anderson Cancer Center.
David H. Ilson, MD PhD, Medical Oncologist and Attending Physician at Memorial Sloan Kettering Cancer Center and Professor at Weill Cornell Medical College.
Gary Anderson, PhD, FThorSoc, FERS, Professor in the Medical Faculty at the University of Melbourne and Director of the Centre for Lung Health Research.
Bruce Levy, MD, Parker B. Francis Professor of Medicine at Brigham and Women’s Hospital and the Chief of the Pulmonary and Critical Care Division.
DR. KSS LIVEBLOG: NOBLECON 14 #ThankYOU #ZKSS NEW!!!
https://www.stockgumshoe.com/2018/01/dr-kss-liveblog-noblecon-14/
It could be the exact bottom for GTBP GT Biopharma. I do charts. The chart looks great for a bottom right here. It moved up to the Nasdaq stock exchange. That’s the recent news.
$SNY $BIIV = crooks to pay fines… why don’t they ever go to jail?
Regulators at the SEC are sounding an alarm following suspicious trading activity that went down days before Sanofi’s $11.6 billion buyout of hemophilia drugmaker Bioverativ.
The agency has filed a lawsuit in the federal district court in Manhattan against one — or possibly many — unknown traders, alleging insider knowledge led to massive profits on the acquisition deal. The lawsuit seeks an order that would force Credit Suisse, the global bank that processed the trades through an account in Zurich, to disclose the names of the trader(s).
In the purchase that raised red flags for regulators, traders paid about $170,000 for options that earned them about $4.9 million after the acquisition announcement. That would be a 2,900% return in less than two weeks.
When Sanofi $SNY agreed to purchase Bioverativ $BIVV in the biggest biotech M&A deal so far in 2018, the smaller company’s stock price soared over 60% and its market cap climbed from $6.8 billion to over $11 billion.
Apparently, traders wanted to take advantage of those gains. The transactions in question were weird on a few levels. First, the traders bought call options that had a strike price between $65 and $70 per share. That’s an unusual move for a trader, because shares of Bioverativ had never closed about $64.12. Why buy call options at a premium?
The other strange thing about this move was that the call options had an expiration date of February 16, which means the buyers expected the share price to go up in a very short time. Last weird thing? The traders had never owned Bioverativ stock before.
Other than forcing Credit Suisse to cough up the defendants’ names, the SEC is seeking an order that would freeze the traders’ assets. They’re also asking that the traders hand over profits and pay fines.
My son and I had just this conversation over the weekend. He interned at the SEC while in college. The problem is that the transactions occur overseas. Could very well be US citizens but accounts are held in secret and banks can not release the names. Banks get a small penalty and clients get away with it. We talked about delaying payments but he said it has been moved up from 3 days to 2 to settle accounts. All it takes is to look at a chart and options before a catalyst and then after the event to find them. SEC sees much but can do little.
Except that they do know who did the buying and the fact they hadn’t bought before and they picked the price and the time — bets nobody would make without know inside information, The SEC knows enough that they can get these guys to write a check to pay a fine aka the cost of doing business.
Guess I lack reading comprehension skills. When I read – “against one — or possibly many — unknown traders”. Plus my sons inside knowledge of the SEC, finance, and international banking loop holes. And they might know that the accounts never traded the stock or options, but does not prove they have the traders names. But how foolish of me!
Thumb — not to be combative but I believe the traders are unknown to the writer of the article. I expect if a lawsuit is being filed it is against entities known by the SEC. Every trade leaves a paper trail. If you don;t believe it, try not paying your taxes on gains you’ve made on trades — and I trade on Canadian US and Euro markets and have had arguments with the tax over minutia such as 30 vs 31 days on wash sales on the LSE.
$PIRS ow – Six Form 4′ s filed Stock options acquired > One of them: https://ir.pieris.com/all-sec-filings/content/0001562180-18-000479/form4.html
All SEC filings for PIRS: https://ir.pieris.com/all-sec-filings #Best2ALL!
The Chart of the Day belongs to CRISPR Therapeutics (CRSP). I found the Biomedical stock by using Barchart to sort today’s Top Stocks to Own list first by the highest Weighted Alpha, then I used the Flipchart feature to review the charts for consistent price appreciation. Since the Trend Spotter signaled a buy in 12/18 the stock gained 122.62%.
CRISPR Therapeutics AG is a gene-editing company. It focused on the development of transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 gene-editing platform. CRISPR Therapeutics AG is headquartered in Basel, Switzerland.
https://www.barchart.com/stocks/quotes/CRSP/overview
$AKAO
— McPherson, Kansas facility compliance status amended to Voluntary Action Indicated (VAI)–
— VAI status provides the potential for the near-term FDA approval of Sandoz’s Glatopa 40 mg ANDA–
https://globenewswire.com/news-release/2018/01/30/1314256/0/en/Momenta-Pharmaceuticals-Announces-Positive-Outcome-for-Contracted-Glatopa-glatiramer-acetate-injection-Fill-Finish-Manufacturer.html
$AKAO long
Thanks danmcco. When I saw this, I wanted a little more information about VAI, and this is what I see on the FDA’s website:
“Clinical Investigator Inspection List (CIIL) Database Codes
SHARE
TWEET
LINKEDIN
PIN IT
EMAIL
PRINT
Database Code Definitions
CIIL Search Page
The following codes occur in the CLIIL database: Classification, Deficiency, and Inspection Type. Some codes are no longer being used, but they still appear in the database.
Classification Codes
MTF – Case closed with a Memo to File
NAI – No Action Indicated. No objectionable conditions or practices were found during the inspection.
VAI – Voluntary Action Indicated. Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily.
VAI1 – Correction made on site
VAI2 – No response requested
VAI2C – Consent problems found
VAI3 – Response requested
VAI3C – Case closed
VAI3F – Follow-up for cause inspection issued
VAI3R – Response received and accepted
VAIRC – 30-day response requested and case closed
VAIRR – 30-day response requested, received and accepted
VAIR – 30-day response requested
OAI – Official Action Indicated. Objectionable conditions were found and regulatory and/or administrative sanctions by FDA are indicated.
OAIC – Completed
OAIR – Response requested
OAIRR – Response requested and accepted
OAIW – Warning letter issued
CANC – Cancelled. The inspection assignment was canceled before the inspection was started.
WASH – Washout. An inspection was initiated but no meaningful information could be obtained.
REF – Reference ”
Not too much to go on, but perhaps sheds some light on the way forward for AKAO.
Here’s some good news and clarification from AKAO’s corporate website:Achaogen, Inc. (NASDAQ:AKAO), a late-stage
biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative
infections, today announced that the Food and Drug Administration (FDA) has classified the outcome of its fourth quarter
2017 reinspection of Pfizer’s McPherson facility as Voluntary Action Indicated (VAI). The Company’s New Drug Application
(NDA) for plazomicin is currently under regulatory review, and the change to VAI status provides a clear regulatory path for
approval for plazomicin out of the McPherson facility based on plazomicin’s PDUFA date of June 25, 2018.
“The upgraded VAI designation received by Pfizer’s McPherson facility is a positive outcome,” said Blake Wise, Achaogen’s
Chief Executive Officer. “Our PDUFA date is five months away and, with additional clarity around our manufacturing efforts,
we look forward to the potential marketing approval and launch of plazomicin.”
http://files.shareholder.com/downloads/AMDA-2JY46Z/5943159912x0x969935/6e3c08bd-7430-4899-abd7-85b2c260ae78/AKAO_News_2018_1_30_General_Releases.pdf
$BLCM – Huge drop on HOLD of stock here after three deaths that might be related to BPX-501.
https://www.biopharmcatalyst.com/news/2018/bellicum-blcm-shares-slide-on-clinical-hold
$BLPH
“Bellerophon Therapeutics Announces Enrollment Exceeds 100 Patients In Phase 3 INOvation-1 Study Evaluating INOpulse For Treatment Of Pulmonary Arterial Hypertension” (1/29/2018)
Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced that enrollment in its Phase 3 INOvation-1 study evaluating INOpulse® in patients with pulmonary arterial hypertension (PAH) now exceeds 100 patients, representing more than half of the anticipated enrollment. As previously agreed with the U.S. Food and Drug Administration (FDA), an interim analysis of this trial will be performed by the Data Monitoring Committee when half of the subjects complete the 16-week blinded treatment phase. The interim analysis will determine if the study should be stopped early for efficacy or futility, continued as planned, or if the trial size should be increased. The Company anticipates the readout of the interim analysis in mid-2018, and the availability of top-line data from the full study toward the end of 2018.[…]
https://www.clinicalleader.com/doc/bellerophon-therapeutics-announces-enrollment-exceeds-patients-0001
Very long Bellerophon.