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Baker Bros Advisors LLC. added to their position.
you can see all their positions at
www.j3sg.com.
where it says "institutions" type in Baker Bros.
you can see when they open a new position, increase, decrease and close positions. i began following them in 2012.
they are well known in the biotech world since most of there 24 billion in holdings are new or established biotech!! companies.
Cheers!
Otonomy Announces Top-Line Results for the Phase 3 Clinical Trial of OTIVIDEX® in Patients with Ménière's Disease
February 22 2021 - 07:00AM
GlobeNewswire Inc.
*Otonomy shares are trading lower after the comapny announced that its Phase 3 clinical trials of OTIVIDEX in patients with Meniere's disease did not meet its primary endpoint.
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that the Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. This analysis did achieve statistical significance for the per protocol (PP) population (n = 136; p value = 0.031). These results were similar using the Generalized Poisson model (p value = 0.340 for ITT and p value = 0.030 for PP).
“We are disappointed by the top-line results for the primary intent-to-treat population and are undertaking an assessment to understand the difference observed with the per protocol analysis. We thank the many patients, clinical investigators and study site staff who supported this effort,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Our focus turns to the strong pipeline we have built as recently highlighted by the successful clinical trial results for OTO-313 in tinnitus and OTO-413 in hearing loss. OTO-313 and OTO-413 each address a large patient population with significant unmet need and no approved drug therapy. These programs provide an attractive opportunity for the company with clinical readouts anticipated in mid-2022. We expect that our existing cash balance will permit us to achieve these clinical readouts as well as advance our preclinical hearing loss programs including OTO-825, a gene therapy for congenital hearing loss."
The company previously reported a cash balance including cash, cash equivalents, and short-term investments totaling $86.3 million as of December 31, 2020, GAAP operating expenses for full year 2020 of $42.6 million and non-GAAP operating expenses, which exclude stock-based compensation, for full year 2020 of $36.5 million.
I reduced my holdings a few months ago. Of course, I’m kicking myself for doing that. But still have some skin in the game.
Yea still holding and will be for a long long time. Glad to see it finally cracked 5. Be nice if could get to 8 or 9 before 313 readout.
Sadie, are you still holding $OTIC? Any thoughts on the recent price action and news releases? Hopefully they will finally receive approval soon for one of their products. Some big investments coming in affecting the stock price. Some terrific price action on Friday wouldn’t you say?
Billionaire Steven Cohen Pulls the Trigger on These 3 Penny Stocks
Maya Sasson
August 17, 2020, 12:30 PM
https://www.tipranks.com/news/article/billionaire-steven-cohen-pulls-the-trigger-on-these-3-penny-stocks/
First up we have Otonomy, which is focused on providing new treatment options for patients living with the debilitating impacts of disorders of the ear. Its strong pipeline and $3.51 share price have scored it substantial praise from the pros on Wall Street.
This is the stance taken by Cohen. Increasing its stake in the company by a whopping 388%, Point72 snapped up 774,259 shares in Q2. With the total size of the holding now landing at 974,259 shares, the position is valued at $3,527,000.
5-star analyst Charles Duncan, of Cantor, also counts himself as a fan. The analyst believes there are numerous clinical catalysts on the horizon that should be significant value drivers for the stock if successful.
“In addition to the positive topline data for OTO-313 in tinnitus that was PR’d in early 3Q20, we anticipate additional data reads over the next ~9 months. These potential value creation milestones include topline data from the pivotal P3 OTIVIDEX study, which we believe may lead to an NDA filing in 2021E, as well as data from the signal-seeking P1/2 study of OTO-413 in hearing loss(4Q20E). We believe these readouts could re-affirm Otonomy’s leadership position in the emerging field of high unmet need neuro-otology, as well as reinvigorate investor interest,” Duncan opined.
That said, Duncan remains focused on the Phase 3 study of OTIVIDEX in Ménière’s disease, the enrollment for which should wrap up in Q3 2020. The analyst is “encouraged that despite the challenges to trial conduct during this time, the company has noted that patient compliance remains high for reporting vertigo symptoms and that the integrity of efficacy data being collected via a daily telephone diary is intact.”
To this end, the top analyst rates OTIC an Overweight (i.e. Buy) along with an $11 price target. This target implies shares could climb 212% higher in the next twelve months. (To watch Duncan’s track record, click here)
It’s not often that the analysts all agree on a stock, so when it does happen, take note. OTIC’s Strong Buy consensus rating is based on a unanimous 5 Buys. The stock’s $9.40 average price target suggests a 167% upside from current levels. (See Otonomy stock analysis on TipRanks)
OTIC 3.92 Otonomy Inc
https://finance.yahoo.com/news/otonomy-reports-positive-top-line-200410183.html
Lifetime high is $32.00
Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus. Saw a 43% cure rate vs 13% placebo; Which was significantly different.
Unfortunately, there are no FDA approved drug treatments for tinnitus and existing approaches rely on coping strategies. Therefore, I am very encouraged by the treatment response observed with OTO-313 in this trial as well as the consistency of the improvement for OTO-313 responders across all four tinnitus endpoints examined in this trial, and I look forward to participating in future clinical studies.”
Projected to be a a 100+ billion dollar industry with Tinnitus affects an estimated 32 percent of the U.S. population and nearly 40% globally. With a current marker cap of 92 million there is A LOT of room for growth.
Pretty impressive run happening. Hope it continues. Does anyone know the reason?
$2.72 now, wow
yeah nice volume
Much easier. Drugs already approved just a different use. The FDA has already unofficially approved it last year just need to make it official.
this is an sNDA right? if so, any1 know any data that says its harder/easier for sNDA vs. normal NDAs to get approval?
Appears that Blackrock distributed its $OTIC stock holdings among its fund subsidiaries. What is the purpose of this?
Hi. Is FDA approval imminent? Is price target by March... $20+ a share possible? What about a potential Buy Out soon after, possible?
well $OTIC tomorrow 6 good for me 2 $$$$$$$$$$
Well going over $6...today? I hope so....
Now back to enjoy my rest of Christmas vaca.....
Man I like my $OTIC & $NOG
Next one will be $ONCI for a wild ride
GLTYA
Hang in there @sadie115. I have a feeling you will be rewarded in many ways.
Once in a wile I will check in and out....still great entry and still holding $OTIC
Well it didn't get as high as I hoped it would this last week but that's OK. Now that the euphoria has died down it will probably be several months before it even gets to 7 if then. Heck, I have been holding since Sept. of 2016 since I was accepted into the phase 3 study so no big deal. To use a gamblers phrase I'll just let it ride. But there is always the possibility Otividex could be approved for use much earlier in Europe and Asia, due to they move much quicker than the FDA. If that happens, well, you know. And finally, thank you to all for your kind thoughts for me as well as for everyone who has this damn disease. I don't think I would wish it on my worst enemy. Cheers, and GLTA.
$OTIC back on track....glad I didn't sold
$OTIC Looks like its holding sort off from close yesterday....now some sideways move for the next leg would be just fine for me
GLTYA
I did not sell because of my job...overworked yesterday...no time. So imo I have to sell lower or hold....
That was from Sept 2 months late but correct!
l2 hunter Member Level Friday, 09/08/17 10:41:28 AM
Re: None
Post #
240
of 335 Go
OTIC STRONG CHART SETTING NOW FOR MASSIVE BOUNCE NEXT WEEK... RADAR FOR POSSIBLE 100% 200% NEXT WEEK
NOW IS PAY TIME... $10 TEST NEXT?
GL covering ahead. Better do it during market hours she could gap up another couple bucks tomorrow.
Given I shorted in premarket good luck. Just been adding to my short throughout the day. Can't even break 6 in normal trading. No way this is worth $6-7+ they still have a lot of money to spend before they're worth anything. Prob an offering with a price of $3 or something silly like that coming here.
GL shorting OTIC you will get crushed! Institutions are loading big today it is very obvious! Institutions already own 79% of the OS so the float from that 30 million shares is low! Analyst reports ahead of the reports yesterday had a $12.00 average PPS target. You can bet that will go up now!
I agree. OTIC should be back at least at $7.50 on the afterhours reports that hit yesterday and it did run there afterhours yesterday as you stated and to about $7.00 this AM. I think OTIC will see $7.50 short term hopefully we see at least $6.50 by the close then $20.00 ahead longer term. I am fully loaded. Todays overall markets are not helping. The days ahead should be much more green.
OTIC hit $7.50 during after hours trading last night. Hell, it was trading in the $20 range in the past 90 days, I believe it is headed back there in the near term.
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This stock has over 30 million shares outstanding and plenty of shares available to short. It's not one of those low floaters you're used to. The matket cap of this company isn't justified at those levels with only phase 2 trials completed.
I'd watch out for an announcement of a share offering to raise funds for the extra trials to come.
OTIC hit $7.50 during after hours trading last night. Hell, it was trading in the $20 range in the past 90 days, I believe it is headed back there in the near term.
OTIC was at almost $7.00 premarket she should run over $6.00 easy if not today then tomorrow looking for $6.50 to $7.00. Also within the last 3 months OTIC was over $20.00.
Back Home... loaded and ready for 7,50+
We go up now!! The beast is roaring!!
OTIC
This is a beast right now.
Hey I'm just back from a meeting at work. I will sell maby at end of day...just for close. Don't have much time to look. So hope it will end around hod
Just 30 minutes into the trading day and OTIC traded over 50% of it's float at 80% gains for the day.
OTIC is going back up to $20 Bucks.
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