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Outlook Therapeutics® to Present at Eyecelerator @ AAO 2022
As part of the event, Russ Trenary, President and Chief Executive Officer will present as a part of the Retina Showcase, and Terry Dagnon, Chief Operations Officer will participate in a panel presentation. Details for the presentations are as follows:
Panel: Defining Clinically Relevant Endpoints in Approval Trials
Time: 11:45 AM – 12:30 PM ET
Discussion Topic: Government, academic, and industry experts offer perspectives on benchmarking practices that accurately characterize the effectiveness of treatments in clinical studies and meet regulatory requirements.
Company Participant: Terry Dagnon, Chief Operations Officer
Company Presentation: Retina Showcases
Time: 2:46 PM – 2:51 PM ET
Presenter: Russ Trenary, President and Chief Executive Officer
SOURCE:
https://ir.outlooktherapeutics.com/node/10616/pdf
OTLK - Outlook Therapeutics® and AmerisourceBergen Announce Strategic Commercialization Agreement for ONS-5010 for the Treatment of Wet AMD
AmerisourceBergen will provide third-party logistics (3PL) services and distribution, as well as medical information and pharmacovigilance services in the United States.
AmerisourceBergen’s commercialization support will expand to include additional services, such as patient services and field solutions.
A relationship with AmerisourceBergen for ONS-5010 is a critical step in the next phase of our pre-commercial strategy execution,” commented C. Russell Trenary, III, President and CEO of Outlook Therapeutics.
OTLK working with AmerisourceBergen will help to provide Outlook Therapeutics with an accelerated pathway to deliver a high-quality customer experience to retina specialists.
Outlook Therapeutics is also exploring a relationship with AmerisourceBergen to support the launch of ONS-5010 in international markets.
AmerisourceBergen expanded its global distribution capabilities in 2021 with the acquisition of Alliance Healthcare, a leading wholesaler of healthcare products in Europe.
SOURCE:
https://ir.outlooktherapeutics.com/node/10626/pdf
AmerisourceBergen / Strategic Commercialization Agreement for ONS-5010 for the Treatment of Wet AMD
OTLK is getting some commercial muscle once market approval is in:
OTLK - UPDATE: Chardan Capital analyst Daniil Gataulin initiates coverage on Outlook Therapeutics (NASDAQ:OTLK) with a Buy rating and announces Price Target of $10
Benzinga · 09/13/2022 06:06
SOURCE:
https://www.webull.com/news/7297859645928448
I got back in at $1.20 several weeks ago.
Bought another slice at $1.09! The MC is < $250M!!
I would believe the MC will largely exceed $250M post approval, a very likely event.
Best of luck with your investments!
$OTLK - The Outlook Therapeutics team will be attending the 22nd #Euretina Congress, September 1-4, in Hamburg, Germany.
See more information about OTLK at reddit.com/r/OTLK_Investors/
Thanks DavidW2
I must say they are an exception in the biotech world. They hit their target dates pretty much every time. And they exceeded expectations on this one.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-re-submits-biologics-license-application
It happens one month early!
Bought another slice at $1.14
September coming soon to a calendar near you.
Best of luck with your investments!
Expected Timeline
> On March 31st, 2022, the BLA was submitted.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us
> On May 31st, 2022, the Company announced the FDA decision wrt the BLA:
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-update-biologics-license
So we could reasonably expect something along those lines:
> Submittal September 30th
> News on BLA submittal approval or new rejection November 30th
That's when I expect to know if we are on sure footing for a PDUFA date without any more back and forth. I don't expect an AdCom as the product is 'already' used in effect. So I expect a straight PDUFA date with an up or down decision, probably Q3 2023, and very likely up, launch to follow Q4 2023.
Best of luck with your investments!
Keeping to September 2022 Resubmission
From the August 2022 presentation:
Johnny, you have lost a ton of money in pennystocks. You need to focus on truck-driving and the yappy Ukrainian who spends your money.
OTLK - The Outlook Therapeutics team will be attending ASRS (American Society of Retina Specialists), July 13-16, in New York City.
For more information on $OTLK's ONS-5010 ophthalmic bevacizumab, visit https://outlooktherapeutics.com
#ASRS2022
@asrsdocs
https://www.reddit.com/r/OTLK_Investors/
OTLK - CORPORATE PRESENTATIONS JULY 05, 2022
Good News:
U.S. FDA BLA submission targeted September 2022 with anticipated approval to follow 8-12 months later.
Sufficient capital for pre-launch activities and potentially through launch.
SOURCE:
https://ir.outlooktherapeutics.com/static-files/65b18fdb-77dd-4afb-8401-1169d0f9a743
OTLK - Outlook Therapeutics Announces Full Cash Pre-Payment of Convertible Promissory Note
July 5, 2022 ISELIN, N.J., July 05, 2022
(GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, announced today the full cash pre-payment of its unsecured convertible promissory note dated November 4, 2020, as amended November 16, 2021 (the “Note”).
All obligations under the Note have been repaid in cash and satisfied.
OTLK - Trenary C Russell III + Dagnon Terry they Bought OTLK Shares on June 21, 2022
TRENARY C RUSSELL III Bought 19,925 shares at $1.06 on June 21, 2022.
DAGNON TERRY Bought 10,000 shares at $1.05 on June 21, 2022.
(See more information about OTLK at r/OTLK_Investors)
SOURCE:
https://ir.outlooktherapeutics.com/static-files/64f27997-0f1c-4ce0-b050-9e7707370f17
https://ir.outlooktherapeutics.com/static-files/22b8fc54-60ef-49c4-a619-e8a2f6ef12eb
Approved earlier this year:
On February 7, 2022, FDA had approved Vabysmo (faricimab-svoa), an injectable therapy for those with wet age-relate macular degeneration (wAMD) and diabetic macular edema. This approval is especially interesting considering that it is the first drug of its kind to be approved for both wAMD and diabetic macular edema.
As I noted, this will be a premium priced product, no different than Eylea.
Hey Evan. Sorry I couldn’t private message a reply back to you. I haven’t used ihub much lately, but as to NISN, hedge fund Sabby has been the reason for the dip, but it has produced the buying opportunity moving forward. Recent announced 8 million share buyback.
Outlook Therapeutics is focused on developing and commercializing a commercially attractive monoclonal antibody for various ophthalmic indications
Outlook Therapeutics confirms BLA re-submission date for its ONS-5010 wet AMD treatment
Outlook Therapeutics submits BLA to FDA for its investigational therapy to treat wet AMD
About the company
Outlook Therapeutics Inc is a late clinical-stage biopharmaceutical company focused on developing and commercializing ONS-5010, a complex, technically challenging and commercially attractive monoclonal antibody, or mAb, for various ophthalmic indications. Its goal is to launch ONS-5010 as the first, and only, approved bevacizumab in the United States, Europe, Japan and other markets for the treatment of wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO).
Outlook Therapeutics (NASDAQ:OTLK) Inc has provided an update on its Biologics License Application (BLA) submission for ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
The pre-commercial biopharmaceutical company said it has confirmed the additional information necessary to re-submit the BLA for ONS-5010 by September 2022 following receipt of additional correspondence from the US Food and Drug Administration (FDA).
“The additional correspondence from the FDA confirms our commitment to our shareholders to re-submit a completed BLA to FDA by September of this year,” Outlook Therapeutics CEO Russell Trenary said in a statement.
“As stated previously, we believe the results from our clinical trials demonstrated safety and efficacy and we are on track to re-submit this BLA and, if approved, to deliver the first FDA-approved ophthalmic formulation of bevacizumab to the retina community,” Trenary added.
Outlook Therapeutics (NASDAQ:OTLK) Inc said it has voluntarily withdrawn the biologics license application (BLA) for its ophthalmic formulation of bevacizumab (ONS-5010 or Lytenava) after the US Food and Drug Administration (FDA) requested additional information.
The company added that it is actively working to respond to the FDA’s request and plans to resubmit a revised BLA by September. A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce.
Outlook Therapeutics (NASDAQ:OTLK) Inc ended its fiscal second quarter with $58.4 million in cash – enough to launch its lead drug ONS-5010 without raising significant additional capital, it said.
ONS-5010, which will be sold under the brand name Lytenava, is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.
Outlook Therapeutics (NASDAQ:OTLK) Inc CEO Russ Trenary tells Proactive it has submitted its Biologics License Application to the FDA for ONS-5010, an investigational therapy for the treatment of wet age-related macular degeneration (wet AMD).
If approved, the treatment will be branded as LYTENAVA (bevacizumab-vikg) and could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability.
Outlook to re-submit application for eye disorder drug in Sept. after FDA correspondence
Jun. 14, 2022 8:45 AM ET
Outlook Therapeutics, Inc. (OTLK)
By: Anuron Mitra, SA News Editor
AMD Abbreviation or acronym of age-related macular degeneration - eye problem in older persons. Word AMD is on foreground near eye model with stethoscope and visual acuity test on blurry background
Outlook Therapeutics (NASDAQ:OTLK) on Tuesday reiterated that it expects to re-submit its biologics license application (BLA) in Sept. for its ONS-5010 formulation for the treatment of wet age-related macular degeneration, a retinal disease.
The company reiterated the expectations for Sept. following the receipt of additional correspondence from the U.S. FDA.
OTLK stock had slumped on May 31 after the company voluntarily withdrew the BLA after the FDA's request for additional information.
Insiders have loaded a lot between $1.2-$1.5. Stock should return to $1.5 level soon.
Hi Swampboots,
Check out their corporate presentation:
https://ir.outlooktherapeutics.com/static-files/10b909de-a80a-45af-a98d-470ce9f068ef
Especially slide 9 and 10. They also have good videos.
Best of luck with your investments!
Is their remedy better than Avastin?
does this have a fast track status of any kind?... orphan or other???
September resubmission confirmed
The Company issued a PR reiterating the September resubmission timeframe:
Resubmitted today
OTLK - Corporate Presentation JUNE 2022
New on Slide 05
• Compelling pivotal data support U.S. FDA BLA submission targeted Sept. 2022
• Launch anticipated Q4 2023, if approved.
New on Slide 27
• Sufficient capital to support pre-launch activities for ONS-5010 and a pathway to potentially support launch if approved.
New on Slide 28
• U.S. FDA BLA submission targeted September 2022 with anticipated approval to follow 8-12 months later.
• Sufficient capital for pre-launch activities and potentially through launch.
(in May they said **"**Sufficient capital through the anticipated approval of the ONS-5010 BLA")
OTLK Did not give any explanation why they withdraw the BLA!
They only said they are "Compelling pivotal data support U.S. FDA BLA submission target Sept. 2022"
( See more information about OTLK at r/OTLK_Investors )
SOURCE:
https://ir.outlooktherapeutics.com/static-files/10b909de-a80a-45af-a98d-470ce9f068ef
I’m still here. I got a little lucky on this one, which doesn’t happen often, as I sold at a small loss after the PR about the BLA submission didn’t move the SP much. I had plans to get back in closer to FDA approval, and if a BO were to be announced prior, I was prepared to miss out on it. Now I just see this as a delayed entry point date. I can identify with those who are holding as I’ve been in NWBO for a very long time.
OTLK - HOLDING STRONG
I hope OTLK investors learn from these wise words from Great Investors who made huge fortunes on the stock market We need to Remember there words:
WARREN BUFFETT Quotes:
1) “The stock market is a device for transferring money from the impatient to the patient.”
2) “Time is the friend of the wonderful business, the enemy of the mediocre.”
3) "Short-term price fluctuations do not affect the long-term value."
4) "If you can control your emotions, you can control your money".
CHARLIE MUNG Quote:
"THE BIG MONEY IS NOT IN THE BUYING AND THE SELLING, BUT IN THE WAITING."
More information about OTLK at r/OTLK_Investors
How about pfe & thermo?
Nope, just digesting the info.
1) The Company did not provide a 'clean' submission to the FDA. I'm not super happy with that.
2) The Company has kept their timeline in the past, quite well actually. So their assessment of a September 2022 is a little reassuring.
I was expecting the FDA to provide a PDUFA date. Instead, it's back to the submission step. So not great, but the value is still there. The risk now is that the submission will be marred before even making it to PDUFA. I don't think that will be the case.
As for me, I did not sell any shares. I'm more in 'hold' mode at this point.
Best of luck with your investments!
Strange, where are all the people here? Everyone has sold all the shares and gone?
Glad I was right, stupid people sold at 68 cents? Take another three months company will resubmit. I guess this stock will return to $1.2-$1.3
Thermo, what do you think?
So surprise! Guess need to wait until Sept. after company resubmit BLA.
Fortunately I sold and took a small loss!:
8:27a ET 5/31/2022 - Dow Jones
Outlook Therapeutics Withdraws Wet AMD Treatment Application
Mentioned: OTLK
By Will Feuer
Outlook Therapeutics Inc. said it has voluntarily withdrawn its biologics license application for its experimental wet age-related macular degeneration treatment while it responds to the U.S. Food and Drug Administration's request for additional information.
The company said it plans to re-submit a revised application for its experimental treatment, called ONS-5010, or bevacizumab-vikg, by September.
"We are continuing to have productive discussions with the FDA and are committed to providing the additional information necessary to support the application," Chief Executive Russell Trenary said. "We look forward to a successful resubmission and ultimately the potential approval of ONS-5010 for the treatment of wet AMD."
Shares of Outlook Therapeutics tumbled almost 38% to $1.05 in premarket trading.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration and other retinal diseases, Outlook Therapeutics said.
Some 1.8 million Americans aged 40 years and older are affected by age-related macular degeneration, according to the U.S. Centers for Disease Control and Prevention. Age-related macular degeneration is the leading cause of permanent impairment of reading and fine or close-up vision among people aged 65 years and older, the agency says.
DIFFERENT STROKES for DIFFERENT FOLKS
As of today, OTLK BLA Acceptance by FDA can take place on any day.
If you want buy more OTLK Shares is better to do now, so you won't regret it later!
PDUFA date expected to be announced in June 2022
Source:
https://ir.outlooktherapeutics.com/static-files/3cdc129d-40e0-4c68-a436-f94352c65d12
My estimate will depend on whether they get a priority review. So, need to see that first.
What are your thoughts on “launch” timeline?
They're in a good position now but, if they pay off the debt, they are a little short of fully funded through launch. One has to make some assumptions re launch expenses.
Company has about $70M cash. Debt is about $22 M. Why not company just pay off debt in July? After that, company still have $48 M cash on hand. That should be enough until FDA approval in year 2023.
thank you very much for your thoughts. they are so much appreciated. wish you a nice weekend!
My primary thoughts currently are (a) PDUFA date, and whether OTLK will get priority review, (b) the Streeterville Debt that begins amortizing in July 2022.
Starting in July 2022, the Streeterville Debt is repayable in stock at a discount to the then current market. So, it's a form of toxic debt (e.g., the total shares issuable for repayment is variable) and, if excessive, can depress stock prices. The company can repay it until June. I'm considering ways to solve this problem but haven't come to any conclusions, nor made any proposals, yet.
any thoughts on the numbers?? thanks
Outlook Therapeutics GAAP EPS of -$0.09 misses by $0.03
May 13, 2022 8:06 AM ETOutlook Therapeutics, Inc. (OTLK)By: Deepa Sarvaiya, SA News Editor
Outlook Therapeutics press release (NASDAQ:OTLK): Q2 GAAP EPS of -$0.09 misses by $0.03.
At March 31, 2022, Outlook Therapeutics had cash and cash equivalents of $58.4 million, compared to $70.2 million at December 31, 2021.
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