Outlook Therapeutics Inc (OTLK) News

Outlook Therapeutics® Announces Presentation of Efficacy and Safety Results from NORSE EIGHT Clinical Trial Evaluating ONS-5010 for the Treatment of Wet AMD

GlobeNewswire - 9:05 AM ET 1/23/2025 Investment News

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Data presented at Hawaiian Eye and Retina 2025 Meeting
Results confirmed that intravitreal ONS-5010 provided early and sustained anatomic improvements, with steady gains in BCVA and reliable, consistent safety
ONS-5010 demonstrated to be non-inferior to Lucentis at 4 and 12 weeks
Company on track for anticipated BLA resubmission in calendar Q1 2025

ISELIN, N.J., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. ( OTLK ) , a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the presentation of data from NORSE EIGHT at the Hawaiian Eye and Retina 2025 Meeting being held January 18-24, 2025 in Kauai, HI.

As part of the meeting, Baruch D. Kuppermann, MD, PhD, of Gavin Herbert Eye Institute, University of California, Irvine, CA presented the abstract titled, “ONS-5010 (bevacizumab-vikg) versus Ranibizumab for Neovascular Age-related Macular Degeneration: Results from the NORSE-EIGHT Noninferiority Randomized Trial,” highlighting the Company’s recently announced 12-week safety and efficacy results for the NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients.

Image: none

The NORSE EIGHT clinical trial was a randomized, controlled, parallel-group, masked, non-inferiority study of newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects received injections at day 0 (randomization), week 4, and week 8 visits, and returned for a final study visit at week 12. The primary endpoint was mean change in BCVA from baseline to week 8.

“The NORSE EIGHT results provide additional evidence to the retina community that ONS-5010 meets the expectations for an ophthalmic formulation of bevacizumab, without the challenges that can arise from using repackaged, off-label formulations available today. The reductions in central retinal thickness observed in the trial confirmed that ONS-5010 reduced fluid in the retina on par with ranibizumab, and I’ve been encouraged with the consistency of this treatment across all NORSE clinical studies,” said Dr. Kuppermann.

Key Highlights

Mean BCVA at baseline was 58.8 ETDRS letters for the ONS-5010 group and 59.9 letters for the ranibizumab group.
ONS-5010 demonstrated mean BCVA improvements of +3.3, +4.2 and +5.5 letters at Months 1, 2, and 3 respectively.
The difference in mean BCVA between ONS-5010 and ranibizumab was -1.009 letters (95% confidence interval, -2.865, 0.848), meeting the noninferiority margin at Month 3 (p=0.0043) (applying the statistical parameters from the week 8 primary endpoint with the lower bound of the non-inferiority margin at -3.5 with a 95% confidence interval).
As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment with the U.S. Food and Drug Administration (FDA).
Anatomical response was similar between treatments, with a reduction in central retinal thickness of -123.9 microns for ONS-5010 treated eyes and -127.3 microns for the ranibizumab group.
ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab, with no cases of retinal vasculitis reported in either study arm. The most commonly reported adverse event (AE) was conjunctival hemorrhage, which occurred in 5 (2.5%) participants in each group.
Safety results demonstrated across the full duration of NORSE EIGHT are consistent with previously reported safety results from the NORSE ONE, NORSE TWO, and NORSE THREE clinical trials.

“Based on the data seen to date, we continue to be encouraged by the potential of ONS-5010 for the treatment of wet AMD. We believe that the complete data set from all of our NORSE clinical trials supports the resubmission of our BLA in the United States for the treatment of wet AMD, which we remain on track to complete this quarter,” added Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics ( OTLK ).

Based on the completed analysis of the 12-week results, Outlook Therapeutics ( OTLK ) plans to resubmit the Biologics License Application (BLA) application for ONS-5010 in the first quarter of calendar 2025.

For more information about the NORSE EIGHT study, visit clinicaltrials.gov and reference identifier NCT06190093.

In the EU and the UK, ONS-5010/LYTENAVA™ (bevacizumab gamma) has already been granted Marketing Authorization. Outlook Therapeutics ( OTLK ) intends to continue efforts to begin launching in Europe in the first half of calendar 2025.

About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the European Union (EU) and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the treatment of wet AMD.

In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational.

Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

About Outlook Therapeutics, Inc. ( OTLK )

Outlook Therapeutics ( OTLK ) is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics ( OTLK ) is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “plan,” “potential,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, Outlook Therapeutics’ plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, as well as the potential to launch with a partner, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, plans to resubmit the BLA for ONS-5010 and the timing thereof, Outlook Therapeutics’ commercialization strategy, expectations concerning decisions of regulatory bodies and the timing thereof, ONS-5010/LYTENAVA™’s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com
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Baruch D. Kuppermann, MD, PhD
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Baruch D. Kuppermann, MD, PhD
Source: Outlook Therapeutics, Inc. ( OTLK )

This is getting interesting!

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-complete-twelve-week-efficacy



ONS-5010 demonstrated to be non-inferior to Lucentis at 12 weeks

BLA resubmission on track for calendar Q1 2025

Entered into agreements for warrant inducement transaction expected to result in up to $20.4 million in gross proceeds

ISELIN, N.J., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Outlook Therapeutics, or the Company) (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients. ONS-5010 demonstrated noninferiority to ranibizumab at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025.

Julia A. Haller, MD, Ophthalmologist-in-Chief at Wills Eye Hospital and an Outlook Therapeutics Board member, commented, “The 3-month data from NORSE EIGHT provides additional evidence to confirm what retina specialists expected. The clinical trial continues to demonstrate that ONS-5010 injections result in immediate and sustained anatomic efficacy, with steady gains in visual acuity and reliable, consistent safety.”

The difference in the mean between ONS-5010 and ranibizumab was -1.009 best corrected visual acuity (BCVA) letters with a 95% confidence interval of (-2.865, 0.848) in the NORSE EIGHT trial. Applying the statistical parameters from the week 8 primary endpoint with the lower bound of the non-inferiority margin at -3.5 with a 95% confidence interval, the noninferiority margin was met at week 12 (p=0.0043), indicating that the two study arms are not different at this timepoint. In the intent-to-treat (ITT) population, NORSE EIGHT demonstrated a mean 5.5 letter improvement in BCVA in the ONS-5010 arm and 6.5 letter improvement in BCVA in the ranibizumab arm.

Mean change in BCVA at week 12 Non-Inferiority
ONS-5010 1.25 mg +5.5 letters 95%CI: (-2.865, 0.848)
P-value: 0.0043

Ranibizumab 0.5mg +6.5 letters

Additionally, the change in central retinal thickness, a measure of anatomical response, was similar in both study arms at all three study timepoints.

Mean change in central retinal thickness
Week 4 Week 8 Week 12
ONS-5010 1.25 mg -106.6 microns -117.7 microns -123.9 microns
Ranibizumab 0.5mg -108.4 microns -120.9 microns -127.3microns

As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA). However, BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity. Overall, in NORSE EIGHT, ONS-5010 demonstrated mean visual acuity improvements of +3.3 letters at week 4, +4.2 letters at week 8, and +5.5 letters at week 12.

Additionally, in NORSE EIGHT, ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab. The safety results demonstrated across the full duration of NORSE EIGHT are consistent with previously reported safety results from the NORSE ONE, NORSE TWO, and NORSE THREE clinical trials, with no cases of retinal vasculitis reported in either study arm.

“We believe that the statistically significant 12-week results for ONS-5010 in NORSE EIGHT, combined with the complete NORSE EIGHT data set, confirms our successful NORSE TWO pivotal study and will support the resubmission of our BLA in the United States for the treatment of wet AMD,” added Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. “Our team continues the necessary work for the planned resubmission of our BLA in the first quarter of calendar 2025. We remain confident in the potential of ONS-5010/LYTENAVA™ to provide an important therapy for the treatment of wet AMD in place of off-label repackaged bevacizumab that has not received regulatory approval for use in retinal diseases here in the United States.”

In the European Union and the United Kingdom, ONS-5010/LYTENAVA™ (bevacizumab gamma) has already been granted Marketing Authorization. Outlook Therapeutics intends to begin launching in Europe in the first half of calendar 2025.

Best of luck with your investments!

Certainly agree that showing non-inferiority at 12 wks was good. It doesn't erase the 8-wk primary end point miss but, if the FDA wants to approve, it gives them cover. It's far from a certainty but the market would be better off with this drug approved.

Also, many participants in the announced transaction will likely sell the common and hold the warrants. I estimate about 4 million shares for sale from the deal, so there will be some pressure on the stock for a while.

Great news!! I knew the 8 week preliminary was a fake news share grab. Looks like I have to average down some more due to additional dilution, but my bet is FDA is good to go

Lil Kippy. I'm still wagging my tail, buddy!

The only Dump is Life's Dump on you lil dog..

"Navid dump. I meant Navid dump"

OTLK SVP, Head of Europe, Jedd Comiskey talk on

https://vimeo.com/1040850052/9b4970a560

Taking over the investment talk from Russ Trenary. The message is pretty much the same as it's been for a while now.

Best of luck with your investments!

Pula In his defense, he did say Mercedes 580 S!

OTLK broke a key resistant level at $2.42 could see a run here.

Seems to be a problem w humanity when were comparing allowing people to see properly to luxury vehicles.

Healthcare systems everywhere have a cost problem. The reality we don't all get to drive Mercedes S-580s.

I fail to understand what the csuite has been doing 5 days a week on salaries in the hundreds of thousands and the eu uk partnership hasnt been fully explored. Everything shouldve been fully explored after crl. But instead you had a ceo that thought the fda wanted animal studies and instead of doing a proper catt study they do 8 week endpoint horseshit so none of this comes as a surprise. This company needs to close. It needs to close and bevacizumab needs to stop being used becausw every opthalmologist on the western world knows faricimab or eylea is what they would always inject in their parents eyes. This has been a big fing game and these thieves have profitted from it. Trenary getting any severance is criminal. He has no soul to even accept a penny

And that is exactly why the FDA will approve. There is too much pressure on them not to. Doctors and payors already use it roughly 60% of the time for new patients. It’s proven effective and safe. The market needs an approved version.

Europe seems to have value, particularly for a company with an established Euro salesforce. That's stating the obvious, I know. I believe there are a few partners that seems like good fits but, as everyone was focused on USA, the partnership opportunity hasn't been fully explored. Even now, the focus is on capital I would assume.

Good points Thermo. What are your thoughts on Europe approval, the revenue it will generate and/or price tag if OTLK sells it off?

I'm time traveling... "this month" meant January 2025. But you all know the data schedule. Sorry for the sloppy writing.

This month, we’ll see the 12 week data for Norse 8. It may look better than the pre-specified 8 week endpoint, or not…

If it does look better, the company will likely file the BLA and there’s a chance it gets approved. But it is impossible to have high conviction of a US approval, regardless of the data.

Which means the first problem is the capital necessary to get to a BLA decision. I see raising the necessary capital as very challenging. Institutions don’t like coin flips.

The company may either fail to raise the capital, leading to its closure, or secure funding under highly dilutive terms. Remember there is about $30M of debt outstanding, and terms will need to be amended.

The FDA has a problem too. If they decline to approve the LYTENAVA BLA, what happens to the 50% of the market that uses off-label Avastin now? If the FDA doesn’t believe LYTENAVA is safe and effective, how can they allow a similar (though inferior in several ways) product to remain in on the market? But, taking it off the market will cause significant disruption.

otlk.............................https://stockcharts.com/h-sc/ui?s=otlk&p=W&b=5&g=0&id=p86431144783

Resubmittal to the FDA

This is quite uncertain, given the current results of N.8. The Company says:

Previously, the Company reported that in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA).

However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010. Analysis of the data is ongoing as the month 3 data from NORSE EIGHT is being collected, which is expected to be available in January 2025. Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-fiscal-year-2024

Best of luck with your investments!

Upcoming anticipated milestones:



* Final efficacy data from NORSE EIGHT expected in January 2025;

* Resubmission of the ONS-5010 BLA targeted for Q1 CY2025;

* Initial commercial launches in Europe planned to commence in first half of CY2025; and

* Potential for US FDA approval of ONS-5010 in second half of CY2025.

See: https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-fiscal-year-2024

Best of luck with your investments!

You know what would be a great Christmas present, seeing insiders buying. That would speak volumes. 

OTLK, under $2

I’m definitely a sick individual

A friend

LOL - Foolish EX says after pumping it non-stop. EX - The Paid manipulator trying his best to make a living....

Karmic law, if not human law, in effect.........

Anybody who says that it is impossible for FDA not to approve after a failed trial is nuts.

I will grant some chance of approval. No way to estimate w/o a better feel for both the trial data and the FDA view of what exactly was needed given they already had a positive P3.

And there is certainly significant value in the EU/UK market.

But to pump that FDA approval is a certainty just makes the board look foolish.

Every online forum has become an echo chamber for britbox clammporing otlk nonsense. He reposts the same nonsense on yahoo reddit here and twits. This is either a very sick individual, or someone in the company or employed by the company.

OG who are you quoting?

This sums it up perfectly.
“I am really convinced that N8 in addition to N1, N2, N3 + the three academic studies on ophatalmic bevacizumab provided to the FDA + confirmation of Safety + resolution of manufacturing issues + EU/UK approval + difficulties of supplies by the 2 remaining off label compounders + lobbying from doctors + patient safety and needs make it absolutely impossible for the FDA not to approve Lytenava”

So I’ve had a couple theories. In Norse 2 the patients were treatment naive, and so they would naturally show much better vision improvement. Is it possible FDA wanted Norse 8 to test with non treatment naive patients to see the difference in the drugs efficacy between the types of patients so Dr’s would have a better understanding of who to use what drug for ? Meaning, Dr’s and payors would all agree they can start new patients on ONS, but as they progress or have already started treatment, use something else for better results?
Another is that the trial was actually a stability test for the FDA to know how fast the drug loses potency, for expiration dates, as someone stated they heard Russ mention he was using older product they had for the trial.
Another is that once all data is processed it’ll show much better results, perhaps even meeting goals or close enough. Another is that it’s irrelevant, as a non inferiority trial only needs to show it’s not significantly worse than another drug, which it has and will show. We don’t know what the FDA’s margin is for that here, but if the other issues that caused the CRL have been resolved I believe it will be approved. The FDA knows it’s being used off label roughly 60% of the time for new patients already. So it works well enough, and the price is right, for Dr’s to start with. The FDA wants to replace it with a safer version that’s an approved. I believe the packaging and safety of the product is what’s the cornerstone issue for them here.

They still have a commercially approved product. That should care some weight, no? Yea the European market isn't as big but it's still (with the NICE rec) potential for positive cash flow. Guess everyone is skeptical of super dilution 

Along with 23% of the rest of the employees.

https://ir.outlooktherapeutics.com/node/11891/pdf

Russ Trenary is out!

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-executive-leadership-transition/



ISELIN, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company’s President and Chief Executive Officer (CEO), effective immediately. Lawrence Kenyon, Executive Vice President, Chief Financial Officer and member of the board of directors, has been appointed Interim CEO.

“On behalf of our management team and board, I would like to thank Russ for his dedication and many contributions to the Company and wish him the best in his future endeavors,” commented Randy Thurman, the Company’s Executive Chairman. “We are pleased to have Larry lead Outlook Therapeutics during this transition period. We remain committed to our plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025 and to begin sales of LYTENAVA™ in Europe in the first half of calendar 2025.”

Mr. Kenyon has served as the Company’s Chief Financial Officer and Secretary since September 2015. He has been a member of Outlook Therapeutics’ board of directors since August 2018 and also served as the Company’s President and CEO from August 2018 to July 2021.

The Company has engaged an executive search firm to work with the board of directors to identify a permanent CEO.

I had completely missed that news. No wonder the PPS is not recovering. Two bad news in a row.

Ouch.

Best of luck with your investments!

That is excellent news. So how much revenue would the company generate from European sales? 

NICE was right on time :) ! They kept to their schedule

Best of luck with your investments!

And OTLK's PR

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-nice-recommendation-lytenavatm
“We are very pleased to receive the NICE recommendation of LYTENAVA™ (bevacizumab gamma) for patients with wet AMD. As the first positive reimbursement decision worldwide, this builds on our momentum and bolsters our commercialization strategy moving forward,” commented Jedd Comiskey, Senior Vice President, Head of Europe, of Outlook Therapeutics. “We remain committed to providing the UK health system with a cost effective treatment option for treating wet AMD. Looking ahead, our team continues preparations for commercial launch in the UK anticipated in 2025 and continues to work through the pricing and reimbursement processes for EU countries, with launches in the EU anticipated to follow.”

Best of luck with your investments!

NICE and Price of Lytenava vs. other treatments:

Use the least expensive option of the available treatments (including bevacizumab gamma, aflibercept, faricimab and faricimab ).

* bevacizumab gamma == Lytenava
* aflibercept == Eyela
* faricimab == Vabysmo
* faricimab == Lucentis

Lytenava is likely to be better priced overall.

Best of luck with your investments.

Great find someconcerns Here is the NICE page

https://www.nice.org.uk/guidance/TA1022/chapter/1-Recommendations

Use the least expensive option of the available treatments (including bevacizumab gamma, aflibercept, faricimab and ranibizumab). Take account of administration costs, dosages, price per dose and commercial arrangements. If the least expensive option is unsuitable, people with the condition and their healthcare professional should discuss the advantages and disadvantages of other treatments.


Only continue bevacizumab gamma treatment if an adequate response is maintained. Criteria for stopping should include persistent deterioration in visual acuity and anatomical changes in the retina.

And yes, bevacizumab gamma is Lytenava / ONS-5010

Evidence-based recommendations on bevacizumab gamma (Lytenava) for treating wet age-related macular degeneration in adults.

Best of luck with your investments!

BRIEF-Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

Reuters - 5 minutes ago Investment News

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Dec 4 (Reuters) - Outlook Therapeutics Inc ( OTLK ):

* OUTLOOK THERAPEUTICS® ANNOUNCES NICE RECOMMENDATION OF LYTENAVA™ (BEVACIZUMAB GAMMA) FOR THE TREATMENT OF WET AMD

* OUTLOOK THERAPEUTICS INC ( OTLK ) - FIRST POSITIVE REIMBURSEMENT DECISION WORLDWIDE FOR LYTENAVA™; FIRST LAUNCH ANTICIPATED IN H1 2025

* OUTLOOK THERAPEUTICS INC ( OTLK ) - ENTERS STRATEGIC COLLABORATION WITH CENCORA Source text: Further company coverage:

Thermo, can you explain the $9-$53 target after faille trail?? Ask your body EX for clarification if you have too..

SMH....

OTLK.............................................https://stockcharts.com/h-sc/ui?s=OTLK&p=W&b=5&g=0&id=p86431144783

And the $30-$50 range is for what? Please Explain....

I've seen numbers in the $30-50 range 

Has anyone modeled out what the company would be worth per share if dilution was not needed, and Europe sales were at the lower end of the range of projections.

OTLK................https://stockcharts.com/h-sc/ui?s=OTLK
&p=W&b=5&g=0&id=p86431144783

The so-called Analyst put a target of $30 on SP prior to the trial complete Failure & he...

then maintains a target of $30 after the complete failure???

How could that be??? SMH

Unfortunately guys, the story is almost over, the active ingredient is the same, dosage is twice as large, effectivness is less, why a doctor should prescribe less efficient drug? I hold position, will survive failure, it doesn't significantly matter if I sell now or wait for FDA possible rejecton due lack of effectivness compared to offlabel.  Still waiting for OTLK disclosure of their financial strategy. 
Best of luck for you 

The entry point was around 1-1.10 on Wednesday. 

If you sell now you deserve to be poor right? Youve averaged down so many times you must own half the company by now

Great place to jump in or average down !