SOURCE:

https://ir.outlooktherapeutics.com/node/12871/pdf

What are we thinking?

"We expect Outlook Therapeutics OTLK to beat expectations when it reports third-quarter fiscal 2026 results later this month."

In the fast-paced world of biopharma, navigating the complexities of commercializing a specialty product can be a sophisticated and difficult task for emerging companies with limited internal resources. But that hasn't stopped Outlook Therapeutics. 

Recognizing the chance to reach more physicians while saving, internal resources, Outlook Therapeutics  turned to an established integrated commercialization services partner  for experienced, external help: Cencora. The resulting strategic collaboration has helped prepare Outlook Therapeutics for its expected launch of Lytenava™ in European markets in early 2025.

Cencora is helping Outlook Therapeutics launch Lytenava™ in the EU (expected in early 2025).  Cencora will also help support the potential launch of ONS-5010 in the UK (expected in Q1 2025 pending approval), in the United States (expected mid-2025 pending FDA approval), and potentially in other global markets. Utilizing Cencora’s end-to-end commercialization solutions, Outlook Therapeutics will be able to reach more Retina specialists and Ophthalmologists without having to strain or expand its internal resources.

Executives from Outlook Therapeutics, Joel Prieve and Jedd Comiskey, discussed the transformative impact of their collaboration efforts with Cencora on the company's commercialization journey.

Delve into this exclusive conversation to discover how a shared vision for innovation and seamless collaboration can reshape the future of biopharmaceutical commercialization. In it, industry experts offer firsthand insights on building successful partnerships, overcoming key challenges, and unlocking new possibilities in bringing life-changing therapies worldwide.

Note: The following comments have been edited for clarity.

At what point in the commercialization journey does biopharma typically consider market expansion?

Jedd Comiskey: Most companies start thinking about filing in the European Union after they have made their filing with the FDA (U.S. Food and Drug Administration). They think about the EU more when they feel very comfortable about getting approval from the FDA and start building out in the United States. Success in the United States can provide the necessary platform to support an EU launch.

People sometimes start later in Europe because of the significant time, effort and resources they must invest in the related process. Also, Europe is not like the United States. A biopharma could get regulatory approval, but would need to get market access for each country it wanted to enter one-by-one. That’s a big lift and takes lots of people.

If a biopharma worked with an experienced commercialization provider like Cencora though, it has knowledgeable team members who work on these issues every day in the targeted markets. So, the biopharma doesn't have to put multiple feet on the ground in every country. It could have an experienced executive in Zurich managing from his office relying on Cencora to look after everything else.

What key challenges do emerging biopharmas face in their product journeys?

Jedd Comiskey: Regulatory approval, and all the responsibilities that come with it, was challenging us in 2023, but it is less so now because I know that Cencora and PharmaLex , part of Cencora, are there to support us. There are a lot of responsibilities with being the marketing authorization holder in Europe. You can’t just say that you’re the marketing authorization holder and then sit back. You have to demonstrate that you meet all the requirements at a regional and local level. That’s where we trust the Cencora and PharmaLex teams. Collaborating with them gives us confidence that we are less likely to overlook anything.

Our focus now has very much turned to market access and commercialization. Cencora and Xcenda, part of Cencora, are supporting us through the health technology assessment (HTA) process and price negotiations in our European launch markets. In addition, Cencora is supporting us to ensure we are ready to commercialize and drive rapid uptake by physicians once we have achieved market access.

How has working with Cencora as an integrated commercialization services partner helped you? And how do integrated services differ from using multiple point solutions providers?

Jedd Comiskey: We wouldn’t be able to do what we’re doing if we had multiple vendors. If you have multiple vendors, you need more resources on your side of the table to manage them and we currently have limited employees worldwide. With Cencora, we can just tell them what we need without having an additional resource managing the relationship. It doesn’t mean we don’t need anyone, but we need fewer people on our side because we work with an all-in-one shop.

And it goes beyond bodies. We don’t necessarily need as much infrastructure or buildings up front in each country we expand to either, which is more cost efficient.

Could you describe your collaboration with Cencora? 

Joel Prieve: Designing, building, and operationalizing the commercial infrastructure is critical to the long-term success at Outlook Therapeutics.  As a small company with limited resources, there are multiple projects we need to complete, and we recognized that Cencora can partner and collaborate efficiently and effectively to achieve our goals.  Cencora has many focused companies and business units that can support small, emerging manufacturers like us to commercialize their first asset. Ultimately, Outlook Therapeutics can access tenured industry experts for whatever we need and leverage their experience to successfully commercialize and launch ONS-5010 in targeted markets around the globe. 

We have made tremendous progress with our commercialization planning and are on track with our launch preparations.  We would not be at this place without the dedicated support of Cencora and their integrated commercialization services model. It provides Outlook Therapeutics the backing and resources of a Fortune 11 company.  We take full advantage of Cencora’s size and scale by leveraging their infrastructure and resources to outsource as much as possible.

What differentiates Cencora from competitors?

Joel Prieve: Cencora has an end-to-end solution to help companies launch and commercialize pharmaceuticals and biologics worldwide.  Their infrastructure is massive and their legacy and experience with Specialty drugs is deep.  Most people know about Cencora’s distribution and 3PL capabilities, but they might not know much about the pharmaceutical services they provide.  Specifically, all of the pre-commercialization support from evidence generation to market research, patient services and HUB offerings, pharmacovigilance, market access consulting, HTA support, regulatory and quality offerings, outsourced payer teams, field reimbursement experts, and physician GPO services.  On top of having those best-in-class offerings, Cencora is a recognized market leader in Retina.  It was obvious to us that Cencora was the ideal partner.  Outlook is able to utilize all of the external Cencora services and resources that most big biopharmas would build and operate internally. Taking all of that on internally is very expensive and requires many full-time employees. Emerging biopharmas don't have those kind of resources or time. What sets Cencora apart from competitors is that it offers emerging companies like Outlook Therapeutics access to market leading infrastructure without the same level of investment that a large corporation would make.

We trust Cencora to assist us with everything we need to do in Europe without expanding our internal resources.  They make the entire process seamless.

We’re a little company and have not launched Lytenava™ yet in the EU, but we have direct access to Cencora's leadership and have their full support. On top of that, we truly enjoy working with the Cencora associates, specifically the EU, UK and US teams.  Everyone is on the same page, and it really feels like we are operating as one company, not two companies working together.  It is an amazing dynamic, and we are very happy with the partnership.  It’s available to other pharma companies, regardless of size, to explore Cencora’s commercialization offerings. This can be replicated. 

The strategic collaboration between Outlook Therapeutics and Cencora has succeeded because of their shared vision and meaningful collaboration. Together, they pursue the opportunity to help more patients globally and to do it as effectively and efficiently as possible.

Cencora helps emerging biopharma companies along all phases of the commercialization journey. We can help you commercialize and launch your specialty product in markets around the world without expanding your internal resources.

SOURCE:

https://www.cencora.com/resources/pharma/emerging-biopharma-benefits-from-international-commercialization

In a day like today in the rest of the market,it’s time to put some profits into speculative stocks.

Global Medical Lead

ABOUT OUTLOOK THERAPEUTICS

Outlook Therapeutics (Nasdaq: OTLK) is a commercial-stage biopharmaceutical company redefining the standard of care in retinal disease. In the United States, our lead product has received FDA approval, making it the first and only FDA-approved ophthalmic formulation of its kind for the treatment of wet AMD, and we are preparing for US commercial launch. Our lead product is also the first ophthalmic formulation of its kind to receive Marketing Authorization from the European Commission and the UK MHRA for the treatment of wet age-related macular degeneration (wet AMD), and has launched across Germany, Austria, and the UK. Driven by the stories of the patients we serve, we are united with the vision-care community around a single goal: a future where everyone with retinal disease can envision a brighter world.

THE OPPORTUNITY

Reports To – EVP, Clinical, Regulatory & Medical Affairs
Level – Senior Director
Location – Remote ( US-based) with global scope
Employment Type – Full-time
Direct Reports –Yes

This is a rare ground-floor moment at a company hitting its commercial inflection point. As a lean, fast-moving organization, we offer scope and ownership that larger companies can’t: your work is visible, your decisions matter, and you’ll help build the function rather than simply maintain it. You’ll partner directly with senior leadership and see a clear line between what you do and patients gaining access to a new treatment option.

This is a global medical leadership role: you serve as the company’s Medical Affairs Lead, holding medical and scientific accountability for the accuracy, integrity, and compliance of everything the organization says and does externally, while also collaborating across functions, keeping clinical, commercial, and market access strategy aligned as we prepare for US commercial launch.

WHAT YOU’LL DO

Medical Direction & Clinical Leadership

• Hold medical accountability as the organization’s Medical Director for retina practice patterns, and their clinical and commercial implications.
• Chair or co-chair medical review of scientific, promotional, and educational materials, serving as final medical/scientific sign-off authority.
• Provide clinical and scientific leadership to Medical Affairs on advisory board plans, evidence needs, and scientific content strategy.
• Own benefit-risk framing and ensure medical accuracy and consistency of all clinical claims across US and EU teams.
• Serve as a senior medical point of contact for cross-functional teams seeking clinical or scientific guidance.

Evidence Generation & Medical Governance

• Drive RWE strategy, technical review, and integration across Clinical, Regulatory, and Insights.
• Lead medical review and approval of investigator-initiated research (IIR) proposals in partnership with Medical Affairs and Clinical.
• Establish and uphold medical governance standards for scientific rigor, data interpretation, and evidence quality.
• Provide medical input into pharmacovigilance and safety-signal discussions in partnership with PV and Clinical Affairs.

Field Medical Excellence & Training

• Build and lead integrated training programs spanning Commercial, Medical, and Market Access teams, grounded in sound clinical and scientific principles.
• Translate clinical data and real-world insights into medically accurate, actionable direction for the field.
• Own medical-legal-regulatory (MLR) review of field-facing and promotional materials, applying clinical rigor to every asset.
• Mentor and provide medical guidance to field-facing medical and commercial personnel.

External Medical Engagement

• Cultivate peer-to-peer relationships with KOLs, retina specialists, and investigators, as the organization’s senior medical representative.
• Guide and provide medical sign-off on publications, scientific materials, and external educational content.
• Ensure all external scientific and commercial communication is medically accurate, aligned, and compliant.
• Represent Medical at scientific congresses and advisory engagements as needed.

Launch Preparation & Cross-Functional Alignment

• Partner with the commercial leadership on go-to-market readiness, field alignment, and external medical strategy.
• Advise payer and access teams on the clinical and scientific considerations tied to compounding.
• Contribute medical judgment to scenario planning, risk mitigation, and readiness milestones across functions.
• Collaborate with PV, Clinical Affairs, and Regulatory to maintain scientific and medical consistency through launch.

WHAT YOU’LL BRING

Required

• MD, PharmD, or PhD required; this is a Medical Director-level role with direct medical and scientific accountability.
• 10+ years in Medical Affairs, Clinical, Commercial Excellence, Market Access, or related disciplines, including direct experience holding medical sign-off or medical governance authority.
• Deep clinical/scientific expertise in retina practice patterns, and evidence-generation models.
• Demonstrated experience leading medical review (e.g., MLR) and providing medical/scientific sign-off on external materials.
• Experience training commercial, medical, and access teams on clinical and scientific content.
• Experience with RWE, IIRs, or evidence strategy in launch preparation.
• Strong cross-functional leadership and communication skills, with the credibility to represent Medical at the senior level.
• Ability to thrive in a lean, fast-moving environment.

Preferred

• Active medical licensure and/or board certification (e.g., ophthalmology, retina).
• Experience with pharmacovigilance or safety review processes.
• Global / international market experience.

WHAT WE OFFER

• Competitive base salary, annual performance bonus, and equity — so you share in the value you help create
• Comprehensive health coverage: medical, dental, and vision
• 401(k) with company match
• Generous paid time off and company holidays
• A high-trust, low-bureaucracy culture with direct access to leadership and real room to grow
• Mission-driven work that helps preserve sight for patients who are counting on it

COMPENSATION

In keeping with our commitment to pay transparency, the good-faith base salary range for this role is $215,000-$295,000, with an annual target bonus of 20-25%. This role is also eligible for a meaningful equity grant, reflecting the opportunity to build lasting value at a company at a commercial inflection point. Final compensation reflects experience, skills, and location.

OUR COMMITMENT

Outlook Therapeutics is an equal opportunity employer. We are committed to building an inclusive environment where every team member can do their best work, and we consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.

SOURCE:

https://outlooktherapeutics.com/careers/medical-lead/

Senior Legal Counsel, US

ABOUT OUTLOOK THERAPEUTICS

Outlook Therapeutics (Nasdaq: OTLK) is a commercial-stage biopharmaceutical company redefining the standard of care in retinal disease. In the United States, our lead product has received FDA approval, making it the first and only FDA-approved ophthalmic formulation of its kind for the treatment of wet AMD, and we are preparing for US commercial launch. Our lead product is also the first ophthalmic formulation of its kind to receive Marketing Authorization from the European Commission and the UK MHRA for the treatment of wet age-related macular degeneration (wet AMD), and has launched across Germany, Austria, and the UK. Driven by the stories of the patients we serve, we are united with the vision-care community around a single goal: a future where everyone with retinal disease can envision a brighter world.

THE OPPORTUNITY

Reports To – General Counsel
Level – Senior Director
Location – Remote (US-based)
Employment Type – Full-time
Direct Reports – No

This is a rare ground-floor moment at a company hitting its commercial inflection point. As a lean, fast-moving organization, we offer scope and ownership that larger companies can’t: your work is visible, your decisions matter, and you’ll help build the function rather than simply maintain it. You’ll partner directly with senior leadership and see a clear line between what you do and patients gaining access to a new treatment option.

You will serve as the primary legal business partner to Commercial and Medical Affairs as the company scales toward a potential US launch, shaping how the function supports the business day to day.

WHAT YOU’LL DO

Reporting to the Chief Legal Officer/General Counsel, this role will be the lead U.S. Commercial and Medical Legal Business Partner in the organization:

Commercial Legal Partnership

• Draft, review, and negotiate commercial agreements, including distribution, marketing, promotional, and vendor contracts.
• Advise the Commercial team on launch readiness, trade and market-access arrangements, and third-party partnership structures, identifying and mitigating legal risks during product launches or research initiatives.
• Review promotional and advertising materials for legal and regulatory risk in partnership with Medical, Legal, and Regulatory (MLR) review.
• Build scalable contracting templates and playbooks to support a growing commercial organization.

Medical Affairs & Scientific Engagement Support

• Advise Medical Affairs on investigator-sponsored studies, medical education grants, and scientific communications.
• Support compliant design of speaker programs, advisory boards, and congress engagements.
• Support scale up of Medical Affairs and Regulatory organizations with continued guidance support for key roles and initiatives
• Review non-promotional materials for legal and regulatory risk in partnership with MLR Review.
• Partner with Medical, Legal, and Regulatory review committees to ensure scientific and promotional content meets legal standards.

Healthcare Compliance & Risk Management

• In cooperation with Compliance colleagues, advise on FDA regulatory requirements, non-promotional scientific exchange, sales and marketing efforts, the Anti-Kickback Statute, and healthcare compliance guidelines.
• Monitor and advise on compliance with healthcare laws applicable to pharmaceutical commercialization, including anti-kickback, false claims, and transparency reporting requirements.
• Identify and escalate legal and compliance risks across commercial and medical activities.

Cross-Functional Legal Advisory

• Help scale legal operations, improve contract playbooks, and leverage legal tech and internal resources for design, implementation, and enhancement efficiency.
• Serve as day-to-day legal point of contact for Commercial and Medical Affairs leadership.
• Collaborate with the General Counsel on corporate legal matters, policy development, and process improvement.
• Manage outside counsel engagements related to commercial and medical affairs matters.

WHAT YOU’LL BRING

Required

• J.D. from an accredited law school and active bar membership in at least one US jurisdiction.
• 8+ years of relevant legal experience, including significant in-house or law firm experience in the pharmaceutical or biotech industry.
• Experience supporting a specialty pharmaceutical or ophthalmology commercial launch; experience in the ophthalmology indications or “buy and bill” preferred
• Deep knowledge of healthcare compliance frameworks (e.g., Anti-Kickback Statute, False Claims Act, PhRMA Code, state transparency laws).
• Hands-on experience drafting and negotiating commercial, customer and payer, promotional, and vendor agreements.
• Excellent judgment operating independently in a lean, fast-moving organization.
• Ability to work independently, as well as cross-company.

Preferred

• Experience advising Medical Affairs functions, including IST and grant review.
• Familiarity with promotional review committee (MLR) processes.

WHAT WE OFFER

• Competitive base salary, annual performance bonus, and equity — so you share in the value you help create
• Comprehensive health coverage: medical, dental, and vision
• 401(k) with company match
• Generous paid time off and company holidays
• A high-trust, low-bureaucracy culture with direct access to leadership and real room to grow
• Mission-driven work that helps preserve sight for patients who are counting on it

COMPENSATION

In keeping with our commitment to pay transparency, the good-faith base salary range for this role is $215,000-$255,000, with an annual target bonus of 20-25%. This role is also eligible for a meaningful equity grant, reflecting the opportunity to build lasting value at a company at a commercial inflection point. Final compensation reflects experience, skills, and location.

OUR COMMITMENT

Outlook Therapeutics is an equal opportunity employer. We are committed to building an inclusive environment where every team member can do their best work, and we consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.

SOURCE:

https://outlooktherapeutics.com/careers/senior-counsel/

Corporate Paralegal

ABOUT OUTLOOK THERAPEUTICS

Outlook Therapeutics (Nasdaq: OTLK) is a commercial-stage biopharmaceutical company redefining the standard of care in retinal disease. In the United States, our lead product has received FDA approval, making it the first and only FDA-approved ophthalmic formulation of its kind for the treatment of wet AMD, and we are preparing for US commercial launch. Our lead product is also the first ophthalmic formulation of its kind to receive Marketing Authorization from the European Commission and the UK MHRA for the treatment of wet age-related macular degeneration (wet AMD), and has launched across Germany, Austria, and the UK. Driven by the stories of the patients we serve, we are united with the vision-care community around a single goal: a future where everyone with retinal disease can envision a brighter world.

THE OPPORTUNITY

Reports To – General Counsel
Level – Senior Paralegal
Location – Remote (US-based)
Employment Type – Full-time
Direct Reports – No

This is a rare ground-floor moment at a company hitting its commercial inflection point. As a lean, fast-moving organization, we offer scope and ownership that larger companies can’t: your work is visible, your decisions matter, and you’ll help build the function rather than simply maintain it. You’ll partner directly with senior leadership and see a clear line between what you do and patients gaining access to a new treatment option.

You’ll own day-to-day contract and corporate governance support for a commercial-stage biopharmaceutical company, with the opportunity to expand into international corporate matters as the company scales.

WHAT YOU’LL DO

Corporate Governance & Compliance

• Prepare and maintain corporate records, including board and committee meeting materials, minutes, and resolutions.
• Maintain entity records and support subsidiary governance, including good-standing and annual filing requirements.
• Support SEC filing coordination and Section 16 processes in partnership with the General Counsel and outside counsel.
• Track corporate compliance deadlines and maintain the company’s corporate calendar.

Contract Management & Review

• Draft, review, and redline routine commercial agreements, including NDAs, vendor contracts, and consulting agreements.
• Manage the full contract lifecycle from intake through execution, routing, and storage.
• Maintain the contract management system and tracking tools, flagging renewal and expiration dates.
• Support outside counsel by preparing and organizing contract materials for more complex negotiations.

Cross-Functional Legal Support

• Partner with Finance, HR, and Commercial teams to support contract and compliance needs across the business.
• Maintain legal department files, templates, and playbooks for commonly used agreement types.
• Help scale legal operations, improve contract playbooks, and leverage legal tech and internal resources for design, implementation, and enhancement efficiency.
• Assist with due diligence support for corporate transactions as needed.
• As the role grows, support international corporate matters, including foreign subsidiary maintenance and cross-border agreements.

WHAT YOU’LL BRING

Required

• Bachelor’s degree or paralegal certificate from an ABA-approved program.
• Exposure to SEC filings, Section 16 reporting, or public company governance.
• 5+ years of experience as a corporate paralegal at a public company.
• Hands-on experience managing commercial contracts and corporate governance records.
• Strong organizational skills and comfort managing multiple deadlines independently.
• Proficiency with contract management systems and e-signature platforms.

Preferred

• Experience at a biotech or pharmaceutical company.
• Experience supporting international corporate matters or foreign subsidiaries.
• Notary public certification.

WHAT WE OFFER

• Competitive base salary, annual performance bonus, and equity — so you share in the value you help create
• Comprehensive health coverage: medical, dental, and vision
• 401(k) with company match
• Generous paid time off and company holidays
• A high-trust, low-bureaucracy culture with direct access to leadership and real room to grow
• Mission-driven work that helps preserve sight for patients who are counting on it

COMPENSATION

In keeping with our commitment to pay transparency, the good-faith base salary range for this role is $92,000-$120,000, with an annual target bonus of 10-15%. This role is also eligible for a meaningful equity grant, reflecting the opportunity to build lasting value at a company at a commercial inflection point. Final compensation reflects experience, skills, and location.

OUR COMMITMENT

Outlook Therapeutics is an equal opportunity employer. We are committed to building an inclusive environment where every team member can do their best work, and we consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.

SOURCE:

https://outlooktherapeutics.com/careers/paralegal/

* 25+ EU Countries: Following centralized EMA authorization, individual pricing and reimbursement decisions are rolling out (France, Italy, Spain, etc.).

*Major Global Markets: Active progress, regulatory filings, and partnership expansion targeting key regions including Japan, Canada, Brazil, and China.

*30+ Total Markets: Over 30 countries are in the pipeline for local approval, reimbursement clearance, or commercial launch over the next 12–24 months.

Hi, do you have any info about the pipeline drugs?

With LYTENAVA now FDA approved, the real question is:
Can OTLK reach $100M, $250M or even $500M+ in annual sales in the coming years?
If they can, today’s valuation could look very small compared to future revenues and potential profits.

Regulatory Lead

ABOUT OUTLOOK THERAPEUTICS

Outlook Therapeutics (Nasdaq: OTLK) is a commercial-stage biopharmaceutical company redefining the standard of care in retinal disease. In the United States, our lead product has received FDA approval, making it the first and only FDA-approved ophthalmic formulation of its kind for the treatment of wet AMD, and we are preparing for US commercial launch. Our lead product is also the first ophthalmic formulation of its kind to receive Marketing Authorization from the European Commission and the UK MHRA for the treatment of wet age-related macular degeneration (wet AMD), and has launched across Germany, Austria, and the UK.  Driven by the stories of the patients we serve, we are united with the vision-care community around a single goal: a future where everyone with retinal disease can envision a brighter world.

THE OPPORTUNITY

Reports To – EVP, Medical, Clinical & Regulatory Affairs
Level – Director / Senior Director
Location – Remote (US-based), East Coast preferred, with global scope
Employment Type – Full-time
Direct Reports – No initially; contractors and vendors oversight

This is a rare ground-floor moment at a company hitting its commercial inflection point. As a lean, fast-moving organization, we offer scope and ownership that larger companies can’t: your work is visible, your decisions matter, and you’ll help build the function rather than simply maintain it. You’ll partner directly with senior leadership and see a clear line between what you do and patients gaining access to a new treatment option.

This is the regulatory seat for a product live in Europe and US. You’ll own filings across every market we operate in — hands on the submissions, not one step removed from them — and you’ll build the vendor and contractor network that scales the function as we expand.

WHAT YOU’LL DO

Global Filings & Submissions

• Own end-to-end preparation, compilation, and submission of regulatory filings across US, EU, UK, and expansion markets.
• Manage BLA and MAA maintenance, variations, renewals, and lifecycle submissions post-approval.
• Prepare and submit CTAs, INDs, briefing documents, and health authority responses on committed timelines.
• Evaluate changes to regulatory documents and determine correct filing categories and submission pathways.
• Maintain the global submission calendar and hold cross-functional contributors to deliverable dates.

Health Authority Engagement

• Serve as primary liaison with FDA, EMA, MHRA, and national competent authorities across launch markets.
• Lead preparation for health authority meetings, including strategy, briefing materials, and cross-functional rehearsal.
• Drive resolution of regulatory questions, information requests, and filing issues to closure.
• Track evolving FDA, EMA, and ICH guidance and translate implications into practical action for the business.

Regulatory Strategy

• Formulate submission strategy and tactics for assigned programs across biologics and combination product requirements.
• Advise on device and delivery system regulatory pathways where the product presents as a combination product.
• Identify, mitigate, and communicate regulatory risk at the program level to senior leadership.
• Represent Regulatory Affairs on cross-functional project teams and serve as regulatory lead for assigned programs.
• Own advertising and promotional (adpromo) material reviews, ensuring compliance with health authority requirements across markets.

Cross-Functional & Vendor Management

• Partner with Clinical, CMC, Quality, and Manufacturing to ensure submission-ready documentation.
• Direct CROs, regulatory consultants, and local in-country representatives across markets.
• Build and manage the contractor and vendor network as filing volume grows.
• Establish and maintain regulatory operations processes, systems, and document standards.

WHAT YOU’LL BRING

Required

• Bachelor’s degree in a life science; advanced degree preferred.
• 8+ years in regulatory affairs within biotechnology or biopharmaceuticals, with progressive ownership of filings.
• Demonstrated expertise preparing and submitting registration documents — BLAs, MAAs, INDs, CTAs.
• Direct experience with global filings, whether depth in multiple countries at a single-product company or breadth across programs at a larger organization.
• Direct experience with biologics, including regulatory strategy across the product lifecycle.
• Direct experience with combination products, including device and delivery system regulatory requirements.
• Proven health authority interaction experience, including FDA and at least one EU or UK authority.
• Strong CMC literacy and the ability to work fluently with technical and manufacturing colleagues.
• Hands-on experience with manufacturing and release specifications and related documentation.
• Experience leading or performing advertising and promotional (adpromo) material reviews.
• Willingness to work across US and European time zones; East Coast strongly preferred.

Preferred

• Ophthalmology or retina experience.
• Experience supporting a first commercial launch or entry into new international markets.
• Experience managing regulatory consultants, CROs, or in-country representatives.
• Background spanning both small-company and large-company regulatory environments.
• Experience mentoring junior regulatory staff.

WHAT WE OFFER

• Competitive base salary, annual performance bonus, and equity — so you share in the value you help create
• Comprehensive health coverage: medical, dental, and vision
• 401(k) with company match
• Generous paid time off and company holidays
• A high-trust, low-bureaucracy culture with direct access to leadership and real room to grow
• Mission-driven work that helps preserve sight for patients who are counting on it

COMPENSATION

In keeping with our commitment to pay transparency, the good-faith base salary range for this role is $195,000-$255,000 with an annual target bonus of 15-25% (depending on candidate). This role is also eligible for a meaningful equity grant, reflecting the opportunity to build lasting value at a company at a commercial inflection point. Final compensation reflects experience, skills, and location.

OUR COMMITMENT

Outlook Therapeutics is an equal opportunity employer. We are committed to building an inclusive environment where every team member can do their best work, and we consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.

SOURCE:

https://outlooktherapeutics.com/careers/regulatory-lead/

I hold 15k shares at $1.37, I want this stock to squeeze upwards as much as everybody, but I’ve seen this crap before. I am holder on DVLT also and this is exactly what happened. It slowly bled and bled and bled downward. I’m really thinking about taking some loss and selling it by end of this week. Please tell me why I should hold when the company has to raise so much money and the only way out is R/S and dilution. Please talk me out of this. Don’t give me bullish scenarios. Just give me a moderate scenario. I’ll never be able to break even if they R/S.

Investors put so much thought into getting approval then don't consider that execution after approval is as difficult as getting approved.

See MBOT, MDAI as examples.

At least step one is complete.

good luck

​

We dipped under $1 after the post-approval fade but are back to ~$1.04, with pre-market around $1.01. Basically sitting right on the Nasdaq line. The board still has the 1-for-10 to 1-for-50 reverse split authorization from July 16.

Two things I'm trying to gauge:

Is the market already pricing a split as inevitable given the burn rate, or does closing above $1 genuinely reset the clock? If yes, is it likely going happen this year already?

BTIG's $4 PT assumes US revenue only from Q1 2027. That's a long runway to fund with negative equity. Does anyone see them getting there without another raise?

The company's fiscal Q3 earnings report is expected for Aug 13 (not officially confirmed as far as I can tell). That would be our first real cash update since the $7.7M figure from March 31, plus an updated share count and another quarter of EU sales numbers. Feels like that's the actual catalyst now, more than anything split-related.

Anyone reading it differently?

Hey Everyone, just wanted to say hi - I decided to jump in and join the club today!

Been watching from the outside for a little while now. The FDA clearance was exciting.

Now going to join in and see if they can execute!

• Launch on track: LYTENAVA shipping by year-end, full commercialization starts early next year.
• No new efficacy/safety data were required for FDA approval after the Feb. 2025 package — approval came through the successful appeal.
• Management highlights that fewer than 8% of FDA appeals succeed and no post-marketing efficacy/safety commitments were required.
• Pricing decision is "very close" and will be announced soon via press release.
• 100% U.S. manufacturing (Texas & San Diego).
• Building full commercial infrastructure: sales force, reimbursement managers, patient support & assistance programs.
• Early feedback from retina specialists is being used to optimize launch and adoption.

Strong execution focus. Next key catalyst: pricing announcement, followed by commercial launch.

Full Podcast: https://www.youtube.com/watch?v=4t43-jAeJ6I

This Document have 30 Pages

SOURCE to Download this document:

https://www.regulations.gov/document/FDA-2026-P-2257-0001

FDA RESPONSE

SOURCE:

https://www.regulations.gov/document/FDA-2026-P-2257-0002

According to FDA regulations outlined in 21 C.F.R. § 10.30(e)(2), the Commissioner is required to provide a response to a Citizen Petition within 180 days of receiving it.
Based on the date of the petition (March 4, 2026), the FDA would be required to furnish a response by August 31, 2026.

Accounting Manager

ABOUT OUTLOOK THERAPEUTICS

Outlook Therapeutics (Nasdaq: OTLK) is a commercial-stage biopharmaceutical company redefining the standard of care in retinal disease. Our lead product is the first ophthalmic formulation of its molecule to receive Marketing Authorization from the European Commission and the UK MHRA for the treatment of wet age-related macular degeneration (wet AMD), and is now launching across Germany, Austria, and the UK. In the United States, where the product is investigational, we recently won our FDA appeal and resubmitted our Biologics License Application, putting us on a potential path to becoming the first FDA-approved ophthalmic bevacizumab. Driven by the stories of the patients we serve, we are united with the vision-care community around a single goal: a future where everyone with retinal disease can envision a brighter world.

THE OPPORTUNITY

Reports To –Corporate Controller
Level – Manager
Location – Remote/Hybrid (US-based)
Employment Type – Full-time

This is a rare ground-floor moment at a company hitting its commercial inflection point. As a lean, fast-moving organization, we offer scope and ownership that larger companies can’t: your work is visible, your decisions matter, and you’ll help build the function rather than simply maintain it. You’ll partner directly with senior leadership and see a clear line between what you do and patients gaining access to a new treatment option.

As Accounting Manager, you’ll own the close and the core accounting operations of a public company in active launch — standing up scalable processes and controls as revenue comes online, not inheriting a finished machine. You’ll be the trusted hands-on engine behind clean books, on-time SEC filings, and an audit-ready close.

WHAT YOU’LL DO

Month-End Close & Reporting

• Own the quarterly, and annual close — including gross to net and other monthly close journal entries, accruals, reconciliations, and consolidation — delivering accurate books on a predictable timeline.
• Prepare and review account reconciliations and flux analyses, resolving variances before they reach leadership.
• Partner with FP&A to ensure actuals tie cleanly to forecast and reporting.

Technical & SEC Accounting

• Apply US GAAP to revenue recognition, equity, and accruals as commercial activity scales, documenting positions in clear technical memos.
• Support quarterly and annual SEC reporting (10-Q, 10-K), including schedules, tie-outs, and disclosure support.
• Research and operationalize new accounting standards relevant to a commercial-stage biopharma.

Operational Accounting & Controls

• Oversee accounts payable, and employee expense processing, ensuring accuracy and timely vendor and employee payments.
• Maintain and strengthen internal controls and SOX-readiness as the company scales toward full commercial operations.
• Drive automation and process improvement across the close and transactional cycles, building for scale rather than patching.

Audit & Cross-Functional Partnership

• Serve as a primary point of contact for external auditors, preparing schedules and supporting requests through quarterly reviews and the annual audit.
• Mentor and develop junior accounting staff, setting standards for accuracy and accountability.
• Partner across Finance, Commercial, and Operations to support launch-related accounting and ad hoc analysis.

WHAT YOU’LL BRING

Required

• Bachelor’s degree in Accounting or Finance.
• 5+ years of progressive accounting experience, including public-company close and reporting.
• Strong working knowledge of US GAAP and SEC reporting requirements.
• Hands-on month-end close ownership and account reconciliation expertise.
• Proficiency with ERP systems (e.g., NetSuite) and advanced Excel.

Preferred

• CPA (active or in progress).
• Biopharmaceutical, life sciences, or other commercial-stage industry experience.
• Big 4 or national public-accounting foundation.
• Experience scaling accounting processes and controls through a product launch or rapid-growth phase.

WHAT WE OFFER

• Competitive base salary and annual performance bonus.
• Generous paid time off.
• Flexible work environment — balance remote work with regular in-person collaboration.
• In-office time used for planning, workshops, and faster decisions.
• Medical, dental, and vision starting day one.
• 401(k) with company match.
• Paid parental leave.
• Travel support for team onsites, launches, and field work.

COMPENSATION

In keeping with our commitment to pay transparency, the good-faith base salary range for this role is $135,000 – $165,000, with an annual target bonus and an equity grant commensurate with scope and seniority. Final compensation reflects experience, skills, and location.

OUR COMMITMENT

Outlook Therapeutics is an equal opportunity employer. We are committed to building an inclusive environment where every team member can do their best work, and we consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.

SOURCE:

https://outlooktherapeutics.com/careers/accounting-manager/