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ADXS These guys never disappoint, they never release any good news. LOL
ESPR drug reduction of hsCRP is a positive, taking into account what is known in regards to prevention and management of cardiovascular disease. “Patients treated with bempedoic acid also achieved a significantly greater reduction of 33 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease”
ESPR has been climbing recently so possible a sell on news effect. The stock looks more de-risked now though
My understanding was that Omega 3 (EPA/DHA), increases levels of "good" cholesterol (HDL). Does it increase also the LDL?
Do you think is a possibility that AMGN steps in and buys ADXS at these low prices or Wouldn’t make sense for AMGN?
When are expected news on that front? (NEO program). Thanks
ADXS what a mess is this company. Being at multi years low mkt cap and diluting here...
TG Therapeutics, Inc. Announces Publication of Clinical Data from the Phase 1 First-in-Human Trial of Umbralisib in The Lancet Oncology $TGTX
But not for ADVM, they priced their offering at $6.75 and reached $7.75. Closed at $7.50, being my only green portfolio company on the day. Crazy
TGTX. So far, so good. When is Weiss going to partner?
BLCM. I remember going through that when holding JUNO. Stock went from $30 to $20 on a clinical hold because of 2 patients death. The stock recovered 7 months after the clinical hold. And as we all know, it got BO last week at $86. Not saying is exactly the same, plus that BLCM program on hold is not a "strict" CAR-T cell program. But, I think it will recover.
I have the impression thought that KITE and JUNO are loved and BLCM has no love in the stock Market (actually the 2 first have been taken already)
yes, i saw it too. Best part is the show seller fund manager, saying she shorts stocks because she want to unmask the companies that are scamming. LOL
ADXS – Announces publication of data from study evaluating ADXS11-001 in combination with chemoradiation as a treatment for high-risk, locally advanced anal cancer in the International Journal of Radiation Oncology.
The FDA approves Synergy Pharmaceuticals' (NASDAQ:SGYP) TRULANCE (plecanatide) for the once-daily treatment of adults with irritable bowel syndrome with constipation (IBS-C).
• TRULANCE was first approved in the U.S. a year ago for the treatment of chronic idiopathic constipation.
• Shares are up 16% premarket on average volume.
I am also holding some shares of BIVV, but wasn't following the company very close, I got the shares when I was holding BIIB and they gave BIVV shares as spin out.
I also hold JUNO shares, being a big supporter of them since IPO.
Today first day as an investor that two of my portfolio companies get BO in the same day.
Much bigger position in JUNO than BIVV though.
ARDM. I read the Adcom transcript. Looks like the question answered to the members was a problem as most say if question was frequency of exacerbation in stead of time to first exacerbation, the majority would have voted yes. I don't know if FDA would take this comments up for the decision which is on 24th of January.
M&A: Roche Buys RXDX to strength oncology pipeline. 74% premium
• Looking to broaden its oncology portfolio, Swiss healthcare firm Roche (OTCQX:RHHBY) is buying U.S. cancer drugmaker Ignyta (NASDAQ:RXDX) for $1.7B.
• Roche will pay $27 per share for Ignyta, representing a premium of about 74% to the stock's closing price on Thursday.
• The U.S. company has a suite of drugs in early stage development that use gene therapy to kill off underlying diseases that drive cancer tumor growth.
SGYP CEO replaced
APPOINTS TROY HAMILTON CHIEF EXECUTIVE OFFICER
DECEMBER 19, 2017
Co-Founder Gary S. Jacob, Ph.D., Named Executive Chairman
NEW YORK--(BUSINESS WIRE)-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today announced that Troy Hamilton, Pharm.D., previously Executive Vice President, Chief Commercial Officer, has been appointed Chief Executive Officer, effective immediately. Gary S. Jacob, Ph.D., previously President, CEO and Chairman, has assumed the position of Executive Chairman of the Board of Directors.
Do you have a price or time to exit ENTA?
ENTA. Congrats Dew. Your luck is my luck on this one. EOM
thank you. Do you think ONCS and possible competition is already priced in? consider that went from $150 to $95.
INCY
Thoughts on this one, touching 52 wl at $95? Has reached $150 at least two times before this low. Good time to add looking into 2018?
CPRX out 2/3 of position from my purchase of $0,99 in 2016
CPRX
and they have launched after the news, a 11M share stock offering.
Achillion Announces Pricing of Secondary Offering Of Common Stock
NEW HAVEN, Conn., Nov. 15, 2017 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. ("Achillion") (NASDAQ:ACHN) today announced the pricing of an underwritten public offering of 18,367,346 shares of its common stock by existing stockholder Johnson & Johnson Innovation-JJDC, Inc. ("JJDC"), which shares constitute all of JJDC's equity position in Achillion, at a public offering price of $2.75 per share. The offering is expected to close on November 20, 2017, subject to the satisfaction of customary closing conditions. Achillion will not sell any shares or receive any proceeds from the offering, and the total number of shares of its outstanding common stock will not change as a result of the offering.
NTLA price offering is $24 EOM
• MacroGenics (NASDAQ:MGNX) skyrockets in premarket trading after the company inks a licensing deal with Incyte (NASDAQ:INCY) covering its MGA012 antibody.
• Under the terms of the arrangement, Incyte pays MacroGenics an upfront payment of $150M and lands global development rights for MGA012.
• Shares of MGNX are up 35% premarket to $21.80.
The article was written before the FDA decision to accept the NDA and granted priority review, now $ 3.30 as has main risks have vanished. If FDA approves the drug, it will trade at least at $8. grifols is major owner and will be responsible for marketing.
ARDM
From amagenmus article on SA, answering your question:
On December 1, 2017, Aradigm completed two Phase 3 trials. One of the two trials in essence failed to meet statistical significance for both the primary endpoint of a median time-to-first-exacerbation versus placebo and the secondary endpoint of a frequency of pulmonary exacerbations over the 48-week treatment period versus placebo. The stock price fell from ~$5.24 to ~$2.17. It traded as low as $0.78 and is now trading at $1.43.
Interestingly, one of Aradigm's main competitors, the much bigger and better-funded Bayer, had a similar treatment failure in one of its two non-cystic fibrosis bronchiectasis trials, as reported on April 5, 2017. In this trial, the 14 day on/off trial succeeded, but the 28 day on/off trial failed.
Add to that 33% the last jump in price that occurred last week, probably leek as the company went up like 49% in two days last week. FDA decision end of January. GRifols will market the drug if approved
Thanks EOM
Do you know what is going on with ADXS? Yesterday 8% down and today also -17%. Any reason for that?
ACHN:
Why you didn't wait for J&J to drop their 18 million of shares? Or do you think they are going to unload after stoping the collaboration?
Do you guys remember when a year ago or so, in a GILD conf call, the CEO or CSO said when asked on M&As opportunities, that they had lost the train on CAR-T?
I expected a deal in oncology but not in CAR-T. I bet they think they can charge big for these drugs, even not for everybody
I would bet on JUNO, as CELG bought shares at double price of what they are now, just approx two years ago and they have a patent dispute with KITE
And JUNO in +15% EOM
CEMP merger with private co.
Cempra announces merger plans with privately-held antibiotic developer Melinta Therapeutics under which Melinta shareholders will own ~52% of the combined company. The deal should close in Q4.
• Melinta has one commercially available product, QIDP-tagged Baxdela (delafloxacin), approved by the FDA in June for the treatment of acute bacterial skin and skin structure infections ((ABSSSI)). A Phase 3 study in patients with community-acquired bacterial pneumonia (CABP) is in process.
• Other pipeline programs include radezolid, a second-generation oxazolidinone, macrolide and antibiotics to treat bacterial "super bugs."
• Shares are up 14% premarket on average volume.
ACHN +30% AH
Achillion Reports Proof-of-Concept With a First-in-Class, Oral Factor D Inhibitor
- Interim results demonstrate ability of ACH-4471 to reduce LDH and improve hemoglobin and fatigue scores in patients with untreated PNH -
- Global program expansion planned in PNH, C3G and IC-MPGN -
"Our focus in early clinical development with ACH-4471 has been on achieving proof-of-concept via factor D inhibition, and we are pleased to report that we believe we have achieved this goal. The emerging interim results from our phase 2 PNH trial have demonstrated a dose response to treatment with what we believe to be meaningful improvements in LDH, hemoglobin, fatigue score and other markers of response. To date, orally administered ACH-4471 has been well tolerated in this PNH clinical trial with four patients enrolled and treated with ACH-4471, two of whom have now received more than four months of dosing," commented Milind S. Deshpande, Ph.D., President and Chief Executive Officer of Achillion. "We believe that inhibition of factor D represents a highly innovative and differentiated mechanism of action with the potential to address multiple diseases of the alternative pathway, including PNH, C3G, IC-MPGN and geographic atrophy, an advanced form of dry age-related macular degeneration."
"I am very excited by the clinical performance of ACH-4471 in the first patients to receive treatment, particularly the improvements in hemoglobin and self reported well-being that have been observed in my patients," commented Peter Browett, M.D., Professor of Pathology, Haematologist, and principal investigator in the ACH-4471 phase 2 study. "The unique mechanism of action via factor D inhibition by ACH-4471 may also be able to control both intravascular breakdown of PNH red blood cells, as well as extravascular hemolysis, leading to improved patient outcomes."
My VRTX rocking.
• Vertex Pharmaceuticals (NASDAQ:VRTX) is up 24% after hours on robust volume on the heels of its announcement of positive mid-stage results from three different triple combination regimens in cystic fibrosis (CF) patients who have one F508del mutation and one minimal function mutation, a severe and difficult-to-treat type of the disease.
• Data from the Phase 2 trials showed mean absolute improvements in lung function of 9.7% and 12.0% as measured by percent predicted forced expiratory volume in one second (ppFEV1) in the regimens containing VX-152 and VX-440, respectively (in combination with tezacaftor and ivacaftor).
• Phase 1 results showed a 9.6% improvement in ppFEV1 in patients treated with VX-659 + tezacaftor + ivacaftor.
• In addition, preliminary data showed mean absolute improvements in ppFEV1 of 7.3% and 9.5% when VX-152 or VX-440 were added to tezacaftor and ivacaftor in CF patients with two copies of the F508del mutation.
• No significant safety signals were observed.
• Vertex has accelerated the development of Vx-445 and VX-659, both in Phase 2. Top-line data are expected in early 2018. Pivotal studies of at least one triple combo regimen will commence in H1 2018.
• The company will host a conference call today at 5:00 pm ET to discuss the results.