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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MONMOUTH JUNCTION, N.J., May  26, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has entered into a Stock Purchase Agreement with Syntone Ventures LLC for a private placement of $16.0 million of common stock at a price of $1.00 per share. In addition, Outlook Therapeutics entered into a joint venture agreement with Syntone Technologies Group Co. Ltd. (“Syntone”) to form a PRC joint venture to develop and commercialize  ONS-5010 / LYTENAVA™  (bevacizumab-vikg) in China pursuant to a license agreement to be entered into between Outlook Therapeutics and the joint venture. Outlook Therapeutics will use $0.9 million of the private placement proceeds to fund its initial capital contribution to the PRC joint venture.

Outlook Therapeutics Announces $16.0 Million Private Placement to Advance the Development of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

MONMOUTH JUNCTION, N.J., May  15, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced its corporate highlights and financial results for its fiscal second quarter ended March 31, 2020.

Outlook Therapeutics Reports Financial Results for the Second Quarter of Fiscal Year 2020 and Provides Corporate Update

CRANBURY, N.J., April  21, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc.  (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has bolstered its Board of Directors with the appointments of Prof. Dr. Gerd Auffarth and Mr. Julian Gangolli.

Outlook Therapeutics Bolsters Clinical and Commercial Expertise with Two Key Appointments to Board of Directors

Outlook Therapeutics (OTLK) saw a big move last session, as its shares jumped nearly 8% on the day, amid huge volumes.

Outlook Therapeutics (OTLK) Catches Eye: Stock Jumps 7.6%

CRANBURY, N.J., April  14, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today provided a clinical update on the impact of the COVID-19 pandemic on the status of NORSE 1 and NORSE 2, its ongoing registration clinical trials for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab.

Outlook Therapeutics Provides COVID-19 Impact Update on Ongoing Clinical Trials NORSE 1 and NORSE 2

CRANBURY, N.J., March  05, 2020  (GLOBE NEWSWIRE) --  Outlook Therapeutics, Inc.  (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has received U.S. Food and Drug Administration (FDA) tentative approval of the Tradename for ONS-5010 as LYTENAVA™ (bevacizumab-vikg). The Tradename is conditionally approved by FDA and will be subject to further review at the time of the Company’s planned filing of a new biologics license application (BLA) with the FDA for LYTENAVA™ (bevacizumab-vikg) in 2021. 

Outlook Therapeutics Announces LYTENAVA™ (bevacizumab-vikg), Anticipated Brand Name for ONS-5010, If Approved

CRANBURY, N.J., Feb.  26, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has closed its previously-announced registered direct offering priced at-the-market under Nasdaq rules of 7,598,426 shares of its common stock, at a combined purchase price of $1.016 per share and associated unregistered warrant, for aggregate gross proceeds of approximately $7.72 million. The Company also issued to the investors in the registered direct offering unregistered warrants to purchase up to an aggregate of 3,799,213 shares of its common stock. The warrants have an exercise price of $0.9535 per share of common stock, are exercisable on the date of issuance, and will expire four years following the date of issuance.

Outlook Therapeutics Announces Closing of $10.2 Million Financings Priced At-The-Market

CRANBURY, N.J., Feb.  04, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”),  a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it is scheduled to participate in the BIO CEO & Investor Conference at the New York Marriott Marquis in New York on Feb 10th-11th.

Outlook Therapeutics to Present at the 2020 BIO CEO & Investor Conference

CRANBURY, N.J., Jan.  28, 2020  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has entered into agreements with BioLexis Pte. Ltd. (“BioLexis”), its largest stockholder, and MTTR, LLC (“MTTR”), its development partner for ONS-5010, to better align the interests of all parties with the Company’s common stockholders and support the continued development of ONS-5010.

Outlook Therapeutics Announces Agreements to Streamline Capital Structure and Regain 100% Ownership of Any Future Net Profits for ONS-5010

CRANBURY, N.J., Dec.  26, 2019  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has completed the previously announced warrant restructuring.

Outlook Therapeutics Announces Completion of Warrant Restructuring

CRANBURY, N.J., Dec.  23, 2019  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has taken action to improve the Company’s balance sheet through two separate transactions.

Outlook Therapeutics Announces Warrant Amendment and Restructuring of Senior Secured Notes in Separate Transactions

CRANBURY, N.J., Dec.  03, 2019  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has received agreement from the U.S. Food and Drug Administration (“FDA”) on three Special Protocol Assessments (“SPAs”) for three additional registration clinical trials for its ongoing Phase 3 program for ONS-5010, an investigational ophthalmic formulation of bevacizumab. The agreements reached with the FDA on these SPAs cover the protocols for NORSE 4, a registration clinical trial to treat BRVO, and NORSE 5 and NORSE 6, two registration clinical trials to treat DME. Outlook Therapeutics intends to initiate NORSE 4, 5 and 6 in 2020.

Outlook Therapeutics Receives FDA Agreement for Three Special Protocol Assessments for Additional Planned Clinical Trials of ONS-5010

CRANBURY, N.J., Sept.  11, 2019  (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”) today announced that it is scheduled to participate in the Ladenburg Thalmann 2019 Healthcare Conference being held at the Sofitel New York in New York on September 24th.

Outlook Therapeutics to Present at the 29th Annual  Ladenburg Thalmann 2019 Healthcare Conference

Outlook Therapeutics obtains clearance from FDA to initiate a second phase 3 study using its drug ONS-5010 to treat patients with wet age-related macular degeneration.

Outlook Is The One To Watch After Latest Advancements For Wet-AMD Treatment

Just about every positive catalyst came together at one time for Outlook Therapeutics.

Outlook Therapeutics: A Perfect Storm Of Positive Catalysts Driving Share Price Up

Shares of Outlook Therapeutics Inc. OTLK, +37.25% rocketed on heavy volume in premarket trade Monday, putting them on track to nearly triple in three days, in the wake of the biotechnology company's upbeat update on a drug trial and bullish analyst report.

Outlook Therapeutics stock rockets on heavy volume again, set to triple in 3 days

Shares of Outlook Therapeutics Inc. rocketed 38% in very active morning trade Friday, putting them on track to more than double in two days.

Outlook Therapeutics' stock rockets on heavy volume again, has more than doubled in 2 days

News for Outlook Therapeutics Inc Stock (OTLK)