Outlook Therapeutics Inc

Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. Its pipeline includes unmet patient needs, repackaged IV bevacizumab, and anti-VEGF. The company was founded by Pankaj Mohan on January 5, 2010 and is headquartered in Iselin, NJ.

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Outlook Therapeutics progresses well with ONS-5010, eyes global expansion

Outlook Therapeutics is well-positioned for potential approvals in Europe and the US in 2024 and 2025.
Strong financial backing and progress in key studies indicate a positive trajectory.
Challenges include addressing FDA queries and ensuring smart approval processes.
Opportunities lie in leveraging existing infrastructure, pricing discussions, and FDA agreements.

Outlook Therapeutics advances clinical trials and secures EU market entry

Outlook Therapeutics made significant progress with marketing authorization and clinical trial advancements.
Financial stability improved with reduced convertible notes and ample cash reserves.
Challenges lie in managing expenses, addressing analyst inquiries, and preparing for commercial launch.

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Outlook Therapeutics (NASDAQ: OTLK ) stock is taking a beating on Wednesday after getting a rejection letter from the FDA. That letter has to do with its biologics license application (BLA) for ONS-5010.

Why Is Outlook Therapeutics (OTLK) Stock Down 78% Today?

Outlook Therapeutics Inc (NASDAQ:OTLK) stock collapsed, losing some 70% of its value in premarket, after the drug discovery firm's potential treatment for eye disease was rejected by the US Food and Drug Administration. The FDA denied the company's license application for a treatment for wet age-related macular degeneration (AMD), telling the company that its unable to approve the drug in its current form and further clinical evidence would be required.

Outlook Therapeutics collapses as FDA rejects application for eye drug

Outlook Therapeutics said on Wednesday the U.S. Food and Drug Administration declined to approve its experimental eye disease drug, in part due to manufacturing issues observed during pre-approval inspections.

US FDA declines to approve Outlook Therapeutics' eye disease drug

Advanced Micro Devices

Outlook Therapeutics Inc.'s stock OTLK, +10.16% tumbled 71% in premarket trade Wednesday, after the company said the U.S. Food and Drug Administration has issued a Control Response Letter for the company's Biologics License Application for a treatment for wet age-related macular degeneration. The FDA issues a CRL when it's unable to approve a drug in its current form, and is seeking further confirmatory clinical evidence.

Outlook Therapeutics' stock tumbles 71% premarket after FDA rejects treatment for wet AMD

FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence

Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

Outlook Therapeutics (OTLK) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Should You Buy Outlook Therapeutics (OTLK) Ahead of Earnings?

ISELIN, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced recent corporate highlights and financial results for its fiscal third quarter ended June 30, 2023.

Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones

ISELIN, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced that Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2023 on Monday, August 7, 2023 at 1:00 PM ET.

Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2023

OTLK is developing an ophthalmic formulation of bevacizumab. There is a logic behind this, and there's also positive data. However, certain developments stop me from being overly enthusiastic.

Outlook Therapeutics: August PDUFA May Be A Buy With Some Caveats

Outlook, a clinical-stage biotech, is awaiting potential approval for a wet AMD therapy. The therapy has a PDUFA date of Aug. 29 from the FDA.

Why Shares of Outlook Therapeutics Rose Tuesday

From a technical perspective, Oncobiologics, Inc. (OTLK) is looking like an interesting pick, as it just reached a key level of support. OTLK's 50-day simple moving average crossed above its 200-day simple moving average, which is known as a "golden cross" in the trading world.

Should You Buy Oncobiologics, Inc. (OTLK) After Golden Cross?

ISELIN, N.J., May 15, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2023.

Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2023 and Provides Corporate Update

Oncobiologics, born in pursuit of oncology biosimilars, dramatically shifted its outlook, appropriately rechristening itself as Outlook Pharmaceuticals. Outlook has set its sights full bore on treatment of retinal diseases.

Outlook Therapeutics: August PDUFA For Wet AMD Blockbuster

Russ Trenary, President and Chief Executive Officer and Glen Olsheim, Executive Director, Commercial Excellence of Outlook Therapeutics to participate in a live moderated fireside chat on Tuesday, May 2nd at 2:00 PM ET Russ Trenary, President and Chief Executive Officer and Glen Olsheim, Executive Director, Commercial Excellence of Outlook Therapeutics to participate in a live moderated fireside chat on Tuesday, May 2nd at 2:00 PM ET

Outlook Therapeutics® to Present at the H.C. Wainwright BioConnect Investor Conference

ISELIN, N.J., March 13, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it is aware that the Federal Deposit Insurance Corp. has taken control of Silicon Valley Bank (“SVB”).

Outlook Therapeutics® Confirms It Has No Exposure to Silicon Valley Bank

Outlook Therapeutics Inc (NASDAQ:OTLK) announced that it has ended its first quarter of fiscal 2023 with cash and equivalents of $52.3 million as of December 31, 2022, which the company says is expected to provide sufficient capital to support operations past the anticipated US Food & Drug Administration (FDA) approval of ONS-5010 in the third calendar quarter of 2023 and into the fourth calendar quarter of 2023. The biopharmaceutical firm also noted that pre-launch commercial activities are underway as the company advances toward the FDA Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023, for ONS-5010/LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation for the treatment of wet age-related macular degeneration (wet AMD).

Outlook Therapeutics ends 1Q with cash and equivalents of $52.3M; says it has sufficient capital into 4Q 2023

ISELIN, N.J., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2022.

Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2023 and Provides Corporate Update

ISELIN, N.J., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics, will present at the SVB Securities Global Biopharma Conference on Tuesday, February 14, 2023 at 4:20 PM ET.

Outlook Therapeutics® to Present at the SVB Securities Global Biopharma Conference

The stock price of Outlook Therapeutics, Inc. (OTLK) increased by 9.57% in the most recent trading session. This is why.

OTLK Stock: 9.57% Increase Explanation

Outlook Therapeutics Inc (NASDAQ:OTLK) has announced the appointments of Dr Surendra Sharma as senior vice president of medical affairs and Glen Olsheim as executive director of commercial excellence as it grows its leadership team.  The biopharmaceutical company said Sharma has more than 15 years of experience in the pharmaceutical and biotechnology industries leading corporate alliances among research and development (R&D), commercial, marketing and business stakeholders.

Outlook Therapeutics strengthens medical affairs and commercial expertise with new appointments

Dr. Sharma and Mr. Olsheim bring more than 30 years of combined experience in the global pharmaceutical and biotechnology industry from their various roles launching and commercializing ophthalmic products Dr. Sharma and Mr. Olsheim bring more than 30 years of combined experience in the global pharmaceutical and biotechnology industry from their various roles launching and commercializing ophthalmic products

Outlook Therapeutics® Strengthens Medical Affairs and Commercial Expertise with Appointments of Surendra Sharma, MD, Senior Vice President of Medical Affairs and Glen Olsheim, Executive Director of Commercial Excellence

Live video webcast presentation on Tuesday, January 17th at 11:00 AM ET Live video webcast presentation on Tuesday, January 17th at 11:00 AM ET

Outlook Therapeutics® to Present at the Virtual Investor 2023 Companies to Watch Event

Outlook Therapeutics Inc (NASDAQ:OTLK) has announced financial results for its fiscal year ended September 30 and laid out plans for 2023 in an end-of-year letter. “Our fiscal year 2022 laid a solid foundation for what we believe will be a transformational 2023,” CEO Russell Trenary III said.

Outlook Therapeutics plots course for wet AMD drug approval in year-end shareholder letter

ISELIN, N.J., Dec. 29, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced its financial results for its fiscal year ended September 30, 2022, and provided recent corporate highlights.

Outlook Therapeutics® Reports Financial Results for Fiscal Year 2022 and Provides Corporate Update

ISELIN, N.J., Dec. 23, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, announced that it has entered into a Securities Purchase Agreement (“SPA”) with an accredited investor (the “lender”), and pursuant to the SPA, issued the lender an unsecured convertible promissory note (the “Note”) with a face amount of $31,820,000. The closing of the financing is expected to occur on December 28, 2022, subject to satisfaction of closing conditions, including the receipt of at least $25.0 million of equity financing. The proceeds from the Note and a previously announced equity financing, which remains subject to satisfaction of customary closing conditions, are expected to provide funding through the anticipated U.S. Food and Drug Administration approval of ONS-5010 expected in the third calendar quarter of 2023.

News for Outlook Therapeutics Inc Stock (OTLK)