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AbbVie Announces Positive Topline Results from Phase 3 Trial Evaluating VENCLEXTAâ„¢/VENCLYXTOâ„¢ (Venetoclax) Tablets in Combination with Rituxan® (rituximab) for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
http://www.prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-phase-3-trial-evaluating-venclextavenclyxto-venetoclax-tablets-in-combination-with-rituxan-rituximab-for-the-treatment-of-patients-with-relapsedrefractory-chronic-lymphocytic-300520916.html
Shares rocket up as Nabriva Therapeutics touts a PhIII win for antibiotic
https://endpts.com/nabriva-results-colin-broom-lefamulin
NBRV +103% /PM on LEAP 1 ph3 topline data
http://www.conferencecalltranscripts.org/8/summary2/?id=4151359
The Nuclear Tech Breakthrough That Could Make Oil Obsolete
- Nuclear fusion is on the brink of a major milestone, but the field faces a chronic lack of funding.
https://www.bloomberg.com/news/articles/2017-08-22/the-nuclear-tech-breakthrough-that-could-make-oil-obsolete
We hear a lot about the approaching end of the fossil fuel era. But as various companies work on wind and solar, there's a group of scientists quietly working on another method of generating electricity, in the lab that once created the atomic bomb. This week, Bloomberg Technology's Jing Cao visits the researchers who are smashing hydrogen atoms together in a process called nuclear fusion. They say they're on the brink of a major milestone, but they face an age-old problem: not enough funding.
Reached $4.20 PM with almost 500k shares traded. Looks like people were just waiting for the raise to be over with. Will be interesting as this heads to catch up with SAGE with a drug that's theoretically 6x more effective. Sage did great in PPD phase 2. Upcoming p2 PPD for MRNS should be a slam dunk, IMO.
ARRY sells 20,930,232 shares of its common stock at a public offering price of $10.75 per share.
http://www.prnewswire.com/news-releases/array-biopharma-announces-pricing-of-public-offering-of-common-stock-300520176.html
Array also granted the underwriters a 30-day option to purchase up to 3,139,534 additional shares of common stock.
I believe the OP of the tweet was referring to SAGE-547 for PPD which is administered intravenously.
Amgen wins FDA nod for its biosimilar of Avastin, Roche's $3B seller
http://www.fiercepharma.com/pharma/amgen-wins-fda-nod-for-its-avastin-biosimilar-putting-target-roche-s-3b-seller
https://twitter.com/sgottliebfda/status/908377656831496192
SAGE, MRNS and oral bioavailability
Reminder: $MRNS cmpd has 6X the oral bioavailability of SAGE-547 and 2X half-life of SAGE-217 according to $SAGE: https://t.co/Nv228bE9L7 pic.twitter.com/2QKd8aVifw
— Jesse brodkin (@jesse_brodkin) September 14, 2017
Any significant deals coming from the TAP deals would be great as well. That would mean MRK won't be able to lowball PD if they sit at the negotiating table next year.
More than those TAP deals, I see a deal of this magnitude coming from MRK post positive registration trial data in mid-2018 (maybe post AA). And it's likely going to be a buyout rather than a development deal. Just my opinion of course.
Hoping to see a similar deal with another San Diego company next year.
http://www.biospace.com/news_story.aspx?StoryID=469261&full=1&utm_source=dlvr.it&utm_medium=twitter
An FYI on the competition...
T-VEC+pembrolizumab clinical data just published in cell..shows impressive responses & increases in CD8+ cells https://t.co/g9dtbfG0VH pic.twitter.com/BcNKPW7bmW
— Robert Coffin (@robertcoffin3) September 8, 2017
THC +13% on report that company may seek sale
https://www.cnbc.com/amp/2017/09/13/tenet-healthcare-shares-jump-13-percent-on-report-that-company-may-seek-sale.html
Scott Gottlieb is closing a big loophole in the orphan drug law
https://endpts.com/scott-gottlieb-is-closing-a-big-loophole-in-the-orphan-drug-law
ARRY $175M offering, $EPZM $120M (eom)
The Way We Get Electricity Is About to Change Forever
- Superior batteries are on the way, and they could disrupt power markets within the next decade—Sooner Than You Think.
https://www.bloomberg.com/amp/news/articles/2017-09-13/the-way-we-get-electricity-is-about-to-change-forever
Batteries are everywhere these days: in our iPhones, toothbrushes, vacuum cleaners, and electric cars. But batteries—really big batteries—are just getting started.
The idea is that grid-sized versions might be used to store excess wind and solar power, smoothing out the peaks and valleys of the electricity supply. There’s just one problem: Batteries are still way too expensive when stacked up against cheap coal and natural gas. Today, less than one-tenth of one percent of the world’s electricity spends any time in a storage battery.
The question is: How far will battery prices tumble, and will it all happen in time to help wipe fossil fuels off the grid? That’s the subject of the latest installment of Bloomberg’s animated web series, Sooner Than You Think, which examines some of the biggest transformations in human history that haven’t happened quite yet.
As we build more electric cars and electricity storage, the cost of batteries plummets. Prices have dropped by half just since 2014. If this learning curve continues, a widespread transformation of power grids could begin within this decade. Cheap solar and wind power will spread ever faster—now backed by batteries.
The timing of new technologies is difficult to predict, but it may not be long before the battery revolution becomes impossible to ignore.
That would be nice chickpea598. Let's hope there were some late conversions to PR or CRs.
A slide from the R&R presentation mentions they will be presenting at SITC this year. Curious to know what data they will be presenting. The interim data from registration trial will be available only in mid 2018 per the same presentation.
Sage Dives On Seizure Trial, But Could Double On Depression Drugs http://www.investors.com/news/technology/sage-dives-on-seizure-trial-but-could-double-on-depression-drugs/
Leerink analyst Paul Matteis cautioned against interpreting the results of the seizure trial as a proxy for Sage's entire central nervous system program. It's hard to see a read-through on Sage's drugs in depression, which could be major catalysts for the stock.
Sage's postpartum depression drug, known as SAGE-547, has placebo-controlled data, better understood natural history and placebo effects, and breakthrough designation therapy, Matteis wrote in a note to clients.
"It's worth noting that status epilepticus, unlike postpartum depression, is a byproduct of a handful of different co-morbidities/etiologies, many of which have little to do with the brain itself," he wrote.
Upcoming data in postpartum depression and major depressive disorder "will likely go far into shaping the Street's view" on Sage, Matteis said. Studies in both are more than 90% enrolled and both will be "high-profile events."
With the stock down hard Tuesday, the potential upside for postpartum depression results has increased, Matteis said. It's possible a major depressive disorder could be the next big catalyst, but the drug known as SAGE-217 in the disorder is "undeniably riskier."
"The stock has now become much more binary, with the potential to double on positive postpartum depression and major depressive disorder data, or the potential to trade near cash if the postpartum depression data came first and were negative," he said.
My guess is it's just scientific nomenclature like Pembrolizumab for Keytruda and Nivolumab for Opdivo. IL-12 is used by many so I'm guessing ONCS wants to uniquely identify the product.
Now with PPD being their only lifeline, how justified is the multi $B valuation gap between them and MRNS? MRNS ph2 PPD data is due in Q4. Will be interesting.
Thanks for your input xavierprivas. For the PPD trial, do you think them using Captisol-enabled Ganaxalone this time will not make much of a difference? Captisol seems to be used with 7 FDA approved drugs already.
Btw I'm very much intrigued by Ecor1 taking that big of a position in MRNS at this time, being early investors in SAGE. Doesn't seem like they have low confidence in MRNS. Currently MRNS market cap is only 3% that of SAGE.
FWIW, EcoR1 Capital, a venture capital investor in SAGE, declared an 11.1% stake in MRNS on 8/8/17.
It is interesting that EcoR1 Capital, which took an 11.1% stake in $MRNS on 8/8/17, is also a VC investor in $SAGE. https://t.co/Qy37z0N6ri pic.twitter.com/ClYUfahoWt
— Titan V (@titan_v16) September 11, 2017
$MRNS PPD trail using Captisol this time, use of which has led $SAGE to achieve higher efficacy but also enabled 7 FDA approvals for pharmas pic.twitter.com/564sjR1MPl
— Titan V (@titan_v16) September 10, 2017
Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma
http://www.incyte.com/ir/press-releases.aspx
INSY - Drug company faked cancer patients to sell drug
http://cnn.it/2xQ8NLf
Based on what I see on Twitter and StockTwits, a lot of day/swing traders are playing a technical bounce. Seen many such alerts on ONCS today. On the bright side, if we close over $1, we reset the delisting timer of 30 days IMO. Nonetheless with many eyes on the stock, investors or traders, each upcoming PR should have some kind of positive effect on the PPS.
Oncosec Appoints Industry Veteran Annalisa Jenkins Mbbs, Frcp To Board Of Directors
- Former Head of Global Research and Development for Merck Serono and Head of Global Medical Affairs of Bristol-Myers Squibb brings biopharma drug development, fundraising and M&A experience to OncoSec
http://www.conferencecalltranscripts.org/8/summary2/?id=4116915
Cellectis Reports Clinical Hold of UCART123 Studies
http://www.businesswire.com/news/home/20170904005410/en/
Cellectis (Paris:ALCLS) (NASDAQ:CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today having received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold was placed on both UCART123 ongoing Phase 1 studies, respectively in acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Cellectis is working closely with the investigators and the FDA in order to resume the trials with an amended protocol including a lowered dosing of UCART123.
The clinical hold was initiated after Cellectis reported one fatality in the BPDCN clinical trial (ABC study). This was the first patient treated in the BPDCN study, a 78-year-old male treated with one prior therapy, who presented with relapsed/refractory BPDCN with 30% blasts in his bone marrow and cutaneous lesions (biopsy-proven BPDCN) at baseline prior to conditioning regimen. He received 30mg/m2/day fludarabine for 4 days and 1g/m2/day cyclophosphamide for 3 days, as a preconditioning regimen. On August 16, 2017 (Day 0), he received 6.25x105 UCART123 cells per kilogram, the first dose level explored in the protocol, without complication. At Day 5, the patient experienced a grade 2 Cytokine Release Syndrome (CRS)1, and a grade 3 lung infection, which quickly improved after a first dose of tocilizumab and institution of anti-infective therapy (broad spectrum intravenous antibiotics). He then experienced at Day 8 a grade 5 CRS, together with a grade 4 Capillary Leak Syndrome2. Despite a treatment in keeping with CRS management including administration of corticosteroids and tociluzumab x 2 as well as intensive care unit support, the patient died on Day 9.
The first patient treated in the AML study was a 58-year-old woman, with 84% blasts in her bone marrow at baseline prior to conditioning regimen. On June 27, 2017 (Day 0), the patient received the same preconditioning regimen and the same dose of UCART123 as the BPDCN patient, without complication. She experienced an initial grade 2 CRS at Day 8, worsening to a grade 3 at Day 9 and resolving at Day 11 with treatment management in intensive care unit. She also experienced a grade 4 Capillary Leak Syndrome at Day 9, resolved at Day 12.
No GvHD3 was reported for any of these patients.
The DSMB (Data Safety Monitoring Board) met on August 28 and recommended lowering the dose to 6.25x104 UCART123 cells per kilogram in both studies and capping cyclophosphamide to a total dose of 4g over 3 days.
Pembrolizumab Falls Short in Phase III Head and Neck Cancer Trial
https://shar.es/1SEY2E
Early Keytruda combo data paint Incyte’s epacadostat as a threat to Bristol-Myers’ I-O melanoma franchise
http://www.fiercebiotech.com/biotech/early-keytruda-combo-data-paint-incyte-s-epacadostat-as-a-threat-to-bristol-myers-i-o
What to look for tonight when Incyte, Merck disclose new skin cancer immunotherapy study results
https://www.statnews.com/2017/08/30/incyte-merck-melanoma-esmo/
(Unrelated to ONCS but may impact ONCS)
(MRNS) Frontiers in Cellular Neuroscience - Ganaxolone: A New Treatment for Neonatal Seizures
http://journal.frontiersin.org/article/10.3389/fncel.2017.00246/full
Frontiers in Cellular Neuroscience - Ganaxolone: A New Treatment for Neonatal Seizures
http://journal.frontiersin.org/article/10.3389/fncel.2017.00246/full
I'm guessing they didn't have any PRs that converted to CRs and hence no updates on the UCSF trial. In a way I think it's right not to present on that dataset again. Remember in February when the market was already saying that the data set was an old one (though only half true) from November 2016. Hence presenting it again even with some additional data could be viewed negatively IMO. All eyes will be on the registration trial data now, whenever that may arrive.
Amazon has no fear about entering the health business, say former leaders at the company
https://www.cnbc.com/2017/08/24/amazon-has-no-fear-about-health-business-say-former-amazon-leaders.html
It is an open label trial and they can in fact release data whenever they choose. The only question is how long will it take to have some interim data. Keep in mind the treatment cycle is 24 weeks. If they are starting recruitment from September, the treatment cycle won't be complete until Jan/Feb 2018. Also how many patients will enroll by September? Will it be a good number of patients for the interim dataset such that the market does not ignore the ORR due to sample size? For them to provide a 3 month update, a good number of patients will need to show CR/PR half way within their treatment cycles. While not impossible, I wouldn't count on it. I think we won't have meaningful interim results until late H1 2018 or early H2. They could be released earlier if some sites already began recruitment in June/July, which I don't believe is the case. So we will have to wait a little longer than previously expected IMO. Still bullish on the data nonetheless.
They can get up to a total of 12 months to get back to $1 after a delisting notice (6 months if notice was triggered due to SP < $1 and not due to a major deficiency + another 6 months' extension). If they are confident they can produce the 30% ORR from the registration trial, they will probably not need another reverse split.
Enrollment by year end means interim data most likely in 2H 2018. I hope there will be something in the meantime to move it over a dollar and keep it there.
Valuable insights. Thanks for sharing xavierprivas.