Regulus: Shares should double , maybe triple in the next six weeks !
by mmdwacjm | October 20, 2016 7:14 pm
It has seemed to have been an eternity since the FDA[1] placed rg-101 on a clinical hold. Regulus has stated they will provide a complete response letter to all of the questions and information requested by the FDA early in the fourth quarter 2016. The FDA then has thirty days to respond to the companies information provided. The FDA will either release the drug from clinical hold or request clarification of some of the information provided. That date I believe will be close to November 15th, 2016. It seems to me that based upon the scientific explanation provided by Dr. Kss, RGLS’s drug has nearly a 100% chance of the clinical hold being lifted on it. I can’t think of a better opportunity to take advantage of an almost certain thing. Certainly in the next six weeks there is no other stock in my portfolio that I think will double or even triple in value, unless maybe Akao is bought out or something else unusual happens. The only other potential news that could affect the stock price could be the releasing of the data from the trial of rg-101 with Gsk’s long acting drug NS5B. GSK holds out hope that the combination of these two drugs will cure the disease in a single office visit. Dr. Kss believes that this is doubtful as he believes a combination of three drugs combined is necessary. If the results are ineffective we could see another substantial drop in share price. However if the clinical hold is lifted a couple of weeks before the data with GSK comes out then Regulus’s shares should at least double. I plan in the next week to reduce almost all of my other stock positions and use the funds to buy RGLS stock. Long RGLS , AKAO . Wishing all gummies the best in the upcoming months as the year comes to a close.! Mark I would love to hear other peoples thoughts and ideas about this subject. In my heart I hope the GSK/RGLS combination achieves 100% cure rates and GILD and GSK get in a bidding war for RGLS!
- FDA: https://www.stockgumshoe.com/tag/fda/
Source URL: https://www.stockgumshoe.com/2016/10/microblog-regulus-shares-should-double-maybe-triple-in-the-next-six-weeks/
$RGLS long – Here is the link to Dr. KSS’s penned article: http://www.stockgumshoe.com/2016/07/the-state-of-things-ruction-at-regulus/
I have purchased some February $5 calls; real cheap now (assuming you believe the price will double or more), so I’m optimistic, too.
$RGLS long – Picked up some Feb $5 calls also. Thank you jcoulborn 🙂
Thank you Mark. No longer long ARTH?
CLEVELAND I have not sold a share since tax time and have even increased my position by 25%. There really hasn’t been anything to discuss as we are all waiting for the “publication of the recent clinical trial data” which is supposed to increase awareness of Arth and AC-5. Why it takes over two months for a tiny clinical trial to be published I have no idea! Regards Mark
Thanks Agree. We can always discuss Avtar Dhillion…… You have been following RGLS a long time. Wonder if Dr. KSS has any additional insight? Can one put any faith in FDA decisions presently….I am unsure.
“Thus far in 2016, 89 percent of FDA-submitted medical device applications have been pushed back by the FDA with a citation of at least one major deficiency.
That’s the highest in history.
The lowest was 40 percent in 2000.”
Dr KSS “I have a consulting conflict of interest pertaining to $RGLS that could bias me toward that stock.”
. LONG RGLS. Dr. Kss I believe has explained the science and why it was possible for the incidents of billirubin to occur. It was in the patient selection and not caused by the drug rg-101. Also the recent action in the stock, pushing the price lower and lower to shake out more shares from frustrated shareholders further convinces me that this drug will come off of clinical hold. I cannot believe that Regulus will mess this up. Mark
DR KSS main thread 10/27/16
Hi Joe: Just taking what’s in the public domain and going with that, I think we’ll see the RG-101 clinical hold lifted by December, good news in the Alport program, and a tripling of share price over 12 months. Gilead won’t buy them, but I’d not in any way be surprised if Gilead itself were taken over as a means of unlocking $50B in pent-up shareholder value. The system is screaming out in agony for a cheaper way to cure HCV, which puts Regulus in the holeshot position. Regulus would fit well with a rejuvvied GSK, and new CMO Timothy Wright really means Regulus is playing to win.
Mark What do you feel timing is for RGLS? Should I email you my comments on ARTH at your @mtsinai.on.ca email?
Cleveland — not Mark here, but here is my understanding. As Regulus detailed in its Nov. 1st Earnings Call (http://seekingalpha.com/article/4017940-regulus-therapeutics-rgls-ceo-paul-grint-q3-2016-results-earnings-call-transcript?part=single), the response to the clinical hold has been delayed by “several weeks.”
RGLS stated that it expects a response in 1st Quarter 2017.
When pressed, Grint stated that a response to the hold letter is expected to be spent to the FDA by the end of 2016. Since the FDA has 30 days to then respond, I would target late January for the lift of the hold — if the response addresses all of the FDA’s concerns. The FDA could also ask for additional information — further delaying things.
Long $RGLS
CLEVELAND Please send them to me at MMDWACJM@aol.com Thanks Mark
Copied from main board $RGLS
I just came across the Chardan analyst report. The analyst contends that “the efficacy barrier in HCV is now incredibly high, with the 95% sustained virologic response rate observed in the POLARIS-2 trial from Gilead”. He justifies the 58% cut in PT pointing to the delay in the clinical hold release for RG-101. Take it for what it’s worth. I’ve seen far better discussion of $RGLS here by Doc KSS.
Analyst Actions: Regulus Therapeutics’ Price Target Cut to $5 by Chardan on Clinical Delays; Buy Rating Kept
07:14 AM EST, 12/07/2016 (MT Newswires) — Regulus Therapeutics(RGLS) received a price-target cut Wednesday from Chardan Capital Markets, which said while the biopharmaceutical company’s new drug-development candidates unveiled Tuesday look promising, clinical delays for other drug candidates are adding to risks.
The new price target from Chardan is $5 per share, less than half the prior price target of $12. The price target is still well above the stock’s recent trading level; it closed Tuesday at $2.65, down 7% on the day. Chardan maintained its buy investment rating on the stock, saying “while we do feel there are significant risks for the Regulus pipeline, we still believe the risk-benefit profile is favorable in light of the significant underperformance of RGLS shares.” It noted the stock is down 70% for the year to date versus an 8.3% drop in the same period for the SPDR S&P Biotech exchange-traded fund (XBI).
At its inaugural research-and-development day Tuesday, Regulus revealed two new drug development candidates: RGLS5040 for the treatment of cholestatic diseases, and RGLS4326 for the treatment of autosomal dominant polycystic kidney disease. The company said it expects to file investigational new-drug applications with the Food & Drug Administration for both drug candidates in the second half of 2017. “While promising, these assets are quite early,” Chardan said in a note to clients, adding “we await additional preclinical results from these programs to increase our confidence moving forward.”
Meanwhile, the market is awaiting a response from the FDA regarding a clinical hold placed in late June on Regulus’s RG-101 treatment for the treatment of chronic hepatitis C virus (HCV) infection. In July, the company had said it was working to resolve issues outlined in a letter from the FDA, and anticipated filing the necessary information by early in the fourth quarter and getting a decision from the FDA within the quarter. However, when Regulus released its third-quarter earnings last month, it pushed the expected response back to the first quarter of 2017.
“Delays in clinical hold response and rising competitive pressures substantially increase the risk on RG-101,” Chardan said in its Wednesday note. It added: “Such delays, to us, create uncertainty about the program, as they suggest more significant issues with the safety profile of RG-101. More importantly…the efficacy barrier in HCV is now incredibly high, with the 95% sustained virologic response rate observed in the POLARIS-2 trial from Gilead…representing the new effective floor for phase III approval in the condition. Taken as a whole, we feel RG-101 faces significant regulatory and competitive challenges moving forward.”
In addition, Chardan highlighted delays for Regulus’s RG-012 drug candidate for Alport syndrome that were disclosed in the third-quarter earnings call. A phase II trial for the drug was delayed at the insistence of European regulators of the performance of a phase I multiple ascending dose study in healthy volunteers ahead of the phase II trial. This “raises issues with the ability of the company to rapidly and effectively move assets through clinical development,” the firm said Wednesday
RGLS, I am long myself on Regulus. I am pretty sure I read a post from one of the members that indicated Cantor Fitzgerald purchased 3.3 million shares of Regulus in addition to initiating coverage on it, but I cannot find it anywhere. Does anyone know if this the case, please respond.
OK Mark This has gotten my full attention. Have you given up? Hit $.94 low today on good volume and closed up at $ 1.10.
Market cap of $ 58 million Stock high of about $20 in 2015.
Posted this yesterday on main thread. http://www.stockgumshoe.com/2017/02/the-rest-of-the-12-biotechs-of-christmas/comment-page-6/#comment-4922113 with no interest which is good.
I checked today and sure enough employee stock options were awarded to top officers at $ 1.20 and Form 4’s filed yesterday. Insiders are very very good at picking spots to award themselves stock options.
A funeral march is afoot in main thread.
So I have downloaded about a 100 pages of material to go through this weekend.
The institutional interest in this is so amazing.
How long will the $ 91 million of cash last? If this is acquired what is potential market cap? Is this a 30-50 potential bagger?
Thanks
From Twitter Nice slide on some SMID cap cash and debt levels $IBB $OCRX $ITEK $MRNS $DRNA $CEMP $QURE $TTPH $RGLS pic.twitter.com/oFZfwOEZoN
https://twitter.com/tgtxdough/status/833721135716040706/photo/1