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“WF - SGMO: Hem A Update, Emerging Best-In-Class (Outperform PT 34)
We are reiterating our OUTPERFORM rating on shares of Sangamo
Therapeutics (SGMO) following data update for its hemophilia A gene
therapy, SB-525, with partner Pfizer (PFE). Overall data suggest
stable Factor VIII activity in the normal range between weeks 19-24
for the highest dose cohort and well above the 68% level mean level
from competitor Biomarin (BMRN) at 24 weeks. With Biomarin data
suggesting waning efficacy from 64% to 36% between 12 months
and 24 months, additional follow up will be important but at this
stage data appear best-in-class, in our view, and supportive of
significant upside potential given Pfizer investment in late stage
development and manufacturing.
? Sangamo Therapeutics (SGMO) and partner Pfizer (PFE) reported
over the weekend updated data from the phase 1/2 Alta study of
their gene therapy product candidate SB-525 in hemophilia A at the
International Society on Thrombosis and Haemostasis (ISTH)
meeting, and also announced that FDA has granted SB-525 the
RMAT (regenerative medicine advanced therapy) designation.
? The Alta study treated 10 patients at four dose levels (9E11, 2E12,
1E13, and 3E13 vg/kg). The highest dose cohort has treated 4
patients, including 2 patients (P7 and P8) for whom initial data were
reported in April 2019, and two new patients (P9 and P10). The
factor VIII (FVIII) levels in P7 and P8 remained in normal range
(measured by a chromogenic assay) at 24 and 19 weeks of follow-
up, respectively. The two new patients, P9 and P10, had 6 and 4
weeks of follow-up, respectively, and they demonstrated rapid FVIII
increase kinetics that appear consistent with P7 and P8 at similar
time points (though with slightly lower starting levels). SGMO noted
that, after the data cut-off for the ISTH presentation, P9 reached
normal FVIII levels at week 7. Overall, it was noted that patients in
the highest dose cohort reached normal FVIII levels (50-150%)
within 5-7 weeks of treatment, with sustained FVIII levels and no
bleeding episodes and no factor replacement use. SGMO also
reported that the two patients treated in the second highest dose
cohort (1E13 vg/kg) have demonstrated durability of FVIII levels
through weeks 52 and 32, respectively.
? SB-525 was described as generally well tolerated. Patients in the
Alta study were not treated with prophylactic steroids. There was
one case of treatment-related SAE as previously reported
(hypotension and fever 6 hours after SB-525 infusion), and no
similar hypotension event was observed in the three subsequent
patients dosed. ALT and AST elevation occurred in 30% and 10% of
patients, respectively, though no patients experienced ALT elevation
associated with loss of FVIII expression. In the highest dose cohort,
2 patients experienced Grade 1 ALT elevation (above 1.5x baseline)
managed with a tapering course of oral steroids.
? SGMO expects to treat the 5th patient (P11) in the 3E13 vg/kg dose cohort soon, and SGMO and PFE are working on plans to advance SB-525 to a registrational study. PFE is to assume responsibility for SB-525 late-stage development and manufacturing, and transfer of the SB-525 manufacturing process from SGMO to PFE has been initiated.
? SGMO announced that, based on data from the Alta study, the FDA has granted RMAT designation for SB-525 to treat severe hemophilia A. RMAT designation, granted to regenerative medicine therapies with preliminary clinical evidence indicating the potential to address an unmet medical need with a serious condition, includes all the benefits of fast track and breakthrough therapy designation programs, including early interactions with FDA.”
“BREAKING NEWS - Sangamo (SGMO) - SB-525 Looks Highly Competitive At ISTH; FDA Grants RMAT & Pfizer Planning Registration Trials - With the updated ALTA study presented at ISTH, Sangamo has firmly made its case for SB-525 as a leading hemophilia A gene therapy treatment. The FDA appears to agree - it has granted the Company RMAT status - the first one given for a hem A gene therapy. Partner Pfizer (included in the press release headline) will be taking over the program as it heads into Phase III clinical trials. REITERATE BUY........
Efficacy - Fast Acting, Consistent & Durable Responses To Date - The two original 3E13 patients have been treated for 19 and 24 weeks, respectively (as of 5/30/19). Two more patients have since been treated at the higher dose (as per the extension cohort) and are showing the same rapid response in Factor VIII activity to SB-525 as the first two - hence 4 subjects have now been treated at the “3e13” dose. Since the cutoff date, one of those two (subject 9) has also since attained normal Factor VIII levels by week 7. As the chart above shows, Factor VIII levels of the first two have stayed well in the “normal” range with no diminution, while the other two appear on their way, too. As a comparison, it took ~16 weeks for BMRN’s ValRox subjects to reach normal FVIII levels versus 7 weeks for SB-525. And the ValRox normal levels reached were below that of SB-525, too.
No Spontaneous Bleeds - In two additional tables below, at the high dose there has been no bleeding episodes in any of the 4 patients after 3 weeks post-treatment (the fourth had yet to reach the >3 weeks period at the cutoff).
No Need For FVIII Infusions - Prophylactic Factor VIII usage in the 3e13 dose, also went to zero after the >3 week treatment period. The prophylactic FVIII regimen of the four subject prior to SB-525 treatment was an infusion either every other day, every 3 days or every 4 days.........
Safety - Pretty Clean - SB-525 was generally well tolerated. Unlike other gene therapies for hem A, patients in the Alta study were not treated with prophylactic steroids. One treatment-related serious adverse event (SAE) was reported. This patient experienced hypotension and fever six hours after completion of SB-525 infusion and this fully resolved with treatment and the patient was discharged as planned within 24 hours. No similar hypotension event was observed in the three subsequent patients dosed. Adverse events observed in 10% (n=1) or more patients included: increased alanine aminotransferase (30%) and aspartate aminotransferase (10%), pyrexia (30%), fatigue (10%), hypotension (10%), myalgia (10%), and tachycardia (10%). No patients treated with SB-525 have experienced an alanine aminotransferase (ALT) elevation associated with a loss of Factor VIII expression. In the 3e13 vg/kg cohort, two subjects experienced a transient grade 1 ALT elevation (>1.5 x baseline) managed with a tapering course of oral steroids. This safety profile suggests that SB-525 could be the cleanest of the three (ValRox, SPK-800, SB-525).....
FDA Grants SB-525 RMAT Status - Based on the accumulating results from the Alta study, the FDA has granted regenerative medicine advanced therapy (RMAT) designation for SB-525 gene therapy to treat severe hemophilia A. RMAT designation is granted to regenerative medicine therapies intended to treat, modify, reverse, or cure a serious condition, for which preliminary clinical evidence indicates that the medicine has the potential to address an unmet medical need. The RMAT designation includes all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with FDA. In our view, the RMAT designation will accelerate the clinical and approval timelines for SB-525.
PFE Is About To Take Over - Seng Cheng, Senior Vice President and Chief Scientific Officer of Pfizer’s Rare Diseases Research Unit said, “We are encouraged by the initial clinical data suggesting safety, tolerability, and efficacy of SB-525 and are beginning preparations, including manufacturing, to potentially advance into a registrational study. We are also encouraged by our interactions with regulators and by the FDA’s recent RMAT designation. If FVIII levels are sustained, and patients continue to have no bleeding episodes and remain off factor replacement therapy, we believe that this gene therapy may potentially represent a transformative treatment paradigm for severe hemophilia A.” The PR also mentions that Pfizer will soon assume responsibility for SB-525 late-stage development and manufacturing.Transfer of the SB-525 manufacturing process from Sangamo to Pfizer has been initiated.
SGMO - Now A Bonafide HEM A GT Player - Before ISTH, SGMO was off of investors’ radar screens for hem A gene therapy. While the number of patients is small and time on SB-525 is still relatively short compared with BMRN and ONCE (acquired by Roche recently for $5 billion), the new updated data, along with the RMAT designation and PFE’s increased participation in the program has no doubt placed the Company among the leaders in the race for blockbuster hemophilia A gene therapy treatments.
SMGO is a BUY under 20 with a TARGET PRICE of 30”
DJ, Mickelson, Scott, Kaymer, Spieth. 275
Great...thanks. EOM
A little help please on correcting a board.
Ticker ATOM is for the company, Atomera. http://atomera.com/
But iHub seems to think it is for something called Atomic Burrito. Lol.
Well, for now.....Koepka, Fowler, Woods, Day, Garcia 278
Thanks!
McIlroy, Fowler, Adam Scott, Mickelson, Kutcher. 279
Thanks!
Bettor Places $85K on Tiger Woods to Win Masters at 14-1 Odds; Would Win $1.19M
https://bleacherreport.com/articles/2830454-bettor-places-85k-on-tiger-woods-to-win-masters-at-14-1-odds-would-win-119m
RICHMOND, Calif., April 3, 2019 /PRNewswire/ -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO) today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares are being offered by Sangamo. In addition, Sangamo expects to grant the underwriters of the offering a 30-day option to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering will be completed, or as to the actual size or terms of the offering.
Sangamo anticipates using the net proceeds from the offering for working capital and other general corporate purposes, including support for its own and its partnered gene therapy, genome editing, cell therapy and gene regulation product candidates and research programs, its manufacturing facilities and other business development activities.
https://investor.sangamo.com/news-releases/news-release-details/sangamo-therapeutics-announces-proposed-public-offering-common-1
Sangamo price target raised to $34 from $24 at Wells Fargo. Wells Fargo analyst Jim Birchenough raised his price target for Sangamo Therapeutics to $34 from $24 following this morning's clinical update on the company's gene therapy, gene editing and cell therapy pipeline. The stock in morning trading is up 35%, or $3.35, to $12.88. The update was better than expected, particularly for hemophilia gene therapy and beta thalassemia ex vivo gene editing, Birchenough tells investors in a research note. The analyst is "encouraged" by Sangamo's progress against the higher technical hurdle of in vivo genome editing. He believes direct evidence of genome editing, "strong" fetal hemoglobin response and early signs of transfusion independence bode well for ultimate success and should translate into improved likelihood of success in the larger opportunity of sickle cell disease. The analyst reiterates an Outperform rating on Sangamo Therapeutics.
Read more at:
https://thefly.com/landingPageNews.php?id=2887507
“After getting slammed two months ago after rolling out the first in vivohuman data available from a rare disease study using its gene editing tech, the players at Sangamo have earned some hard won respect on Wall Street today after posting a snapshot of promising, though very early stage, results for their hemophilia A gene therapy, partnered with Pfizer.
Focusing on the high-dose cohort — with only 2 patients getting a 3e13 vg/kg dose of SB-525 — researchers spotlighted FVIII activity of 140% and 94%, or 93% and 65% of normal, depending on which assay they used. That’s very competitive in a field dominated up to now by BioMarin $BMRN and Spark, now being acquired by Roche, so long as it holds up.
One ex vivo gene editing program also gathered some initial responses in beta thalassemia and Sangamo outlined plans to beef up its AAV manufacturing operations with a new contract signed with Brammer Bio while its own facility is under construction.
Sangamo’s shares $SGMO slowly swelled in pre-market trading as the positive message sunk in. Then it soared. Its stock was up more than 50% before the bell......”
https://www.investorvillage.com/smbd.asp?mb=1933&mn=124063&pt=msg&mid=19300692
Brooks Koepka
Rory McIlroy
Adam Scott
Henrik Stenson
Tommy Fleetwood
279
From my Favorites screen, if I click on a Ticker symbol on far left, when that screen loads it is fine momentarily but then some gigantic marijuana ad appears behind it. The screen I want to see shrinks in size to accommodate the graphic/advertisement behind it. Doesn't my iHub membership level keep this stuff away, or do I need an adblocker?
Under.....Rams 27, Pats 17.
Thanks!
NO- u. KC-u
Thanks!
Sent you a PM with a link to get to the other site for VHC discussion.
http://ir.virnetx.com/news-releases/news-release-details/virnetxs-judgement-against-apple-affirmed-united-states-court
Press Release
January 15, 2019 at 12:03 PM EST
VirnetX's Judgement Against Apple Affirmed by the United States Court of Appeals for the Federal Circuit
$439.8 Million Affirmed Judgement Includes Jury Verdict, Willful Infringement, Interest, Costs and Attorney Fees
ZEPHYR COVE, Nev., Jan. 15, 2019 /PRNewswire/ -- VirnetX™ Holding Corporation (NYSE AMERICAN: VHC), an Internet security software and technology company, announced today that the United States Court of Appeals for the Federal Circuit entered a unanimous Rule 36 order in the Federal Circuit case 2018-1197 titled "Appeal from the United States District Court for the Eastern District of Texas in No. 6:10-cv-00417-RWS, Judge Robert Schroeder, III" affirming the judgement issued by the United States District Court for the Eastern District of Texas in this case. The original District court judgement awarded the Company a total of $439.8 million including jury verdict, willful infringement, interest, costs and attorney fees, following the previously disclosed jury trial and verdict in the amount of $302.4 million.
About VirnetX
VirnetX Holding Corporation is an Internet security software and technology company with patented technology for secure communications including 4G LTE security. The Company's software and technology solutions, including its secure domain name registry and Gabriel Connection Technology™, are designed to facilitate secure communications and to create a secure environment for real-time communication applications such as instant messaging, VoIP, smart phones, eReaders and video conferencing. The Company's patent portfolio includes over 115 U.S. and international patents and over 50 pending applications. For more information, please visit www.virnetx.com
KC over, LAR over, LAC under, NO under
HOU-O, SEA-U, BAL-U, CHI-O
Here’s a dog getting the cat so they can pose for a picture. Lol.
Eli, please switch my loser pick from PIT to DET.
Thanks.
DAL to win. PIT to lose.
Thanks!
TEN to win. NYG to lose.
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ATL to win. GB to lose.
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NE to win. BAL to lose.
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SEA to win. OAK to lose
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BAL to win. MIA to lose.
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NO to win. PHI to lose
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Aww, shoot. Just checking in now. Can I pick Monday night game?
GB to win. ARI to lose.
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CHI to win. CLE to lose
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PIT to win. DEN to lose.
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KC to win. CIN to lose.
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MIN to win. SF to lose
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CAR to win. WAS to lose.
Thanks,
LAC to win JETS to lose.
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JAX to win. BUF to lose.
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LAR to win. IND to lose.
Hopefully.
Not so sure.
I think I am “most people” and I will not ever buy a nike item again.