4.16 0.00 (0.00%)
After hours: 5:16PM EST
|Bid||4.11 x 4000|
|Ask||4.45 x 1100|
|Day's Range||3.8600 - 4.3500|
|52 Week Range||3.4600 - 8.2770|
|Beta (3Y Monthly)||2.36|
|PE Ratio (TTM)||N/A|
|Earnings Date||Mar 6, 2019 - Mar 11, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||14.43|
CORAL GABLES, FL/ ACCESSWIRE / February 22, 2019 / With the new year only a few months old, the biotech stock market is already whirring with the excitement surrounding companies developing nuanced approaches to creating a wide array of new forms of treatment options for patients in need of care. Naturally, companies in the biotech sector working to address these challenges are garnering significant notoriety among consumers as well as investors. Premier Health Group (PHGRF) (PHGI), Ocular Therapeutix Inc (OCUL), Voyager Therapeutics Inc (VYGR), and Amarin Corporation plc (NASDAQ:AMRN) represent 4 biotech stocks stepping up their game on Friday.
Ocular Therapeutix™, Inc. (OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has entered into a note purchase agreement with an accredited investor to issue $37.5 million aggregate principal amount of 6.00% subordinated convertible notes due 2026 pursuant to Regulation D promulgated under the Securities Act of 1933, as amended (the “Securities Act”). The notes will be senior unsecured subordinated obligations of the Company and will mature on March 1, 2026, unless earlier converted, repurchased or redeemed in accordance with their terms. The notes will be convertible at any time, provided that no conversion results in a holder owning more than 19.99% of the Company’s issued and outstanding common stock.
Ocular Therapeutix™, Inc. (OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the dosing of the first patient in a Phase 1 trial of OTX-TKI (tyrosine kinase inhibitor implant) in patients with wet Age-related Macular Degeneration (AMD). The first patient was dosed at the Sydney Retina Clinic in Sydney, Australia. “We are excited to announce the first patient has been successfully dosed in our Phase 1 program with OTX-TKI, our tyrosine kinase inhibitor implant for the treatment of serious retinal disease,” said Michael Goldstein, M.D., Chief Medical Officer at Ocular Therapeutix.
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NEW YORK, Jan. 22, 2019 -- In new independent research reports released early this morning, Market Source Research released its latest key findings for all current investors,.
Ocular (OCUL) files an sNDA to the FDA for expanding the label of its eye drug, Dextenza, to treat ocular inflammation post ophthalmic surgery.
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks The following biotech stocks hit 52-week highs Jan. 10: Takeda Pharmaceutical Co Ltd (NYSE: TAK*) Veracyte ...
Ocular Therapeutix™, Inc. (OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for DEXTENZA (dexamethasone ophthalmic insert). The sNDA filing seeks to expand the current indication for DEXTENZA to include the treatment of ocular inflammation following ophthalmic surgery. The Company expects that the FDA review will be completed in the second half of 2019.
Purdue Pharma L.P. and Ocular Therapeutix, Inc. (OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies, today announced the initiation of research activities leading to a strategic research collaboration. The goal is to determine compatibility of Purdue’s non-opioid new chemical entities with Ocular’s bioresorbable hydrogel-based technology, ideally leading to the development of new products for the treatment of pain. Ocular Therapeutix will initiate formulation testing, with the goal of bringing it to a stage where efficacy can be assessed.
Ocular Therapeutix™, Inc. (OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has closed a refinancing of its existing debt by entering into a new $25.0 million term loan with MidCap Financial and Silicon Valley Bank. The 5-year term loan facility allows for an expansion of the Company’s prior $18 million credit facility to $25.0 million, all of which was drawn at closing. The restated and amended agreement extends the term of the credit facility until December 21, 2023 and permits the Company to make interest-only payments until January 1, 2021.
We often see insiders buying up shares in companies that perform well over the long term. The flip side of that is that there are more than a few examples Read More...
Ocular Therapeutix™, Inc. (OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has been selected for addition to the Nasdaq Biotechnology Index® (NASDAQ:NBI). Ocular Therapeutix’s addition to the NBI will become effective prior to market open on Monday, December 24, 2018. The Nasdaq Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark.
Ocular Therapeutix™, Inc. (OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the hiring of Chad Brines as Vice President, Sales. Mr. Brines will be responsible for implementing the Company’s commercial strategy and leading the commercial field organization as the Company prepares for the launch of DEXTENZA®. Mr. Brines brings extensive experience building and leading regional and national sales organizations in both the pharmaceutical and medical device industries.
Ocular Therapeutix (OCUL) needs investors to pay close attention to the stock based on moves in the options market lately.
Subhead of release should read: DEXTENZA® (dexamethasone ophthalmic insert) is the First Intracanalicular Insert for Drug Delivery (instead of DEXTENZA® (dexamethasone ophthalmic insert) is the First Intracanalicular Insert Approved by the FDA for Drug Delivery).
Ocular Therapeutix, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix, will present at the 30th Annual Piper Jaffray Healthcare Conference on Wednesday, November 28, 2018 at 3:00 PM ET at the ...
H.C. Wainwright analysts are convinced these three biotech stocks are worth a lot more than their current market values. All have recently been given price targets that suggest they could nearly double your money, or better. Here's why these analysts are willing to stick their necks out and predict huge gains ahead for Catalyst Pharmaceuticals (CPRX), Amarin Corporation (AMRN), and Ocular Therapeutix (OCUL).Catalyst's Upcoming PDUFA Is a Major CatalystAs the PDUFA goal date of November 28, 2018 for Firdapse in Lambert-Eaton Myasthenic Syndrome (LEMS) is approaching, H.C. Wainwright analyst Andrew Fein expects to see a straightforward nod from the FDA. As such, Fein reiterates a Buy rating on CPRX stock with a price target of $6.00, which implies an upside of 108% from current levels.Fein wrote, "We point to several notable efforts in anticipation of an approval that positions the company for a “swift and efficient” launch: (1) the Chief Commercial Officer Daniel Brennan joined the firm in June this year to lead the commercial team. He has previous launch experience (four specialty orphan products) in the rare neurology space at Lundbeck, which we believe he can leverage in Firdapse launch in a similar setting; (2) one of the near-term priorities is to transition LEMS patients in the expanded access program to the commercial product, which we think could constitute the first bolus of patients; and (3) ongoing commercial infrastructure building, including sales force hiring/training, market access, patient service etc., which should ready the company for commercialization in the months ahead."Furthermore, "Given that formal FDA approval will mark the "official" end of the Jacobus debate, we think Catalyst shares may react in an outsized fashion to the announcement of approval. Moreover, we note that given the significant number of companies who have publicly expressed interest in neuro assets, Catalyst may well mark an easy "bolt on" for a number of companies with market caps in the $2-10B range seeking additional commercial assets."Amarin: Is the Recent Pullback a Good Buying Opportunity?Amarin stock has dipped after varying responses from investors who were tuned into data reports from the company's cardio-vascular REDUCE-It presentation. Amarin presented data last weekend at Chicago’s American Heart Association conference to show evidence that its fish-oil capsule called Vascepa improves cardiovascular health for those who suffer from elevated triglyceride levels. The data was also published in the New England Journal of Medicine and some investors interpreted the results negatively, suggesting AMRN is exaggerating the cardiovascular benefits of the pill. The notion comes from a trial that was performed using a mineral oil placebo — and the results between patients taking the placebo and those who took the fish oil were marginal.Regardless of the recent setback, Andrew Fein isn’t skipping a beat. The analyst says the clinical data surpassed his expectations. This spurred Fein to reiterate a Buy rating on AMRN stock, while raising his price target from $31 to $51, which represents nearly 187% from Thursday's closing price. (To watch Fein's track record, click here)The analyst addresses the skepticism around Vascepta that caused the stock to tumble: “With regard to the placebo (mineral oil) controversy, we view it as temporary noise that has been given an oversized weight by the bears. We are not aware of any strong evidence supporting that mineral oil contributed to the worsened outcome on the placebo arm. At most, we believe it mounts to speculation and hypothesis of the potential physiological activity of mineral oil without any clinical validation of such claims. In any case, the possibly minimal biological activity of the placebo arm would not negate the robustness of the results, in our view. We expect the placebo issue to be raised during the FDA review, but do not believe it would negatively impact the regulatory outcome.”Ocular Therapeutix: A J-code for DEXTENZA HighlyOn Monday, EyePoint announced that the Centers for Medicare and Medicaid Services (CMS) had assigned a specific and permanent reimbursement J-code (J1095) through the Healthcare Common Procedure Coding System (HCPCS) for DEXYCU (dexamethasone intraocular suspension) 9%, an injectable steroid administered after ocular surgery to control inflammation.H.C. Wainwright analyst Ram Selvaraju believes that this is an exceptional event, as J-codes are usually issued to drugs used in office-based procedures and not to drugs associated with cataract surgery, which are reimbursed within a package price."The fact that DEXYCU gets a J-code indicates that CMS has changed its stance on steroids used in ocular surgery and is now willing to allow separate reimbursement for novel products in this category, in our view. We believe this is a de-risking event for Ocular Therapeutix’s DEXTENZA (dexamethasone insert) 0.4mg, which has a Prescription Drug User Fee Act (PDUFA) date of December 28, 2018. There has been doubt among investors on how DEXTENZA can be reimbursed after a C-code expires in three years. With a J-code issued to DEXYCU, which is clearly a product that cannot be dissociated from cataract surgery, we believe it is highly likely that DEXTENZA could also secure a J-code after regulatory approval. We continue to believe that DEXTENZA could obtain FDA approval by the end of 2018, and the company may apply for a C-code as well as a J-code with CMS after FDA approval," Selvaraju wrote.In the wake of this update, Selvaraju maintains a Buy rating on OCUL stock, with a price target of $10.00, which implies an upside of 87% from current levels. More recent articles about AMRN: * Tilray (TLRY) Makes Moves to Expand Globally, But the Stock Remains Overvalued * S&P; 500's January Close Produced Rare Setup; Here's Why, and What's Next * What's in Store for Stocks in 2019 * Amarin (AMRN): New Survey Offers Insight Into Vascepa Market Opportunity
Ocular Therapeutix (OCUL) delivered earnings and revenue surprises of -5.56% and 10.67%, respectively, for the quarter ended September 2018. Do the numbers hold clues to what lies ahead for the stock?
The Bedford, Massachusetts-based company said it had a loss of 38 cents per share. The biotechnology company posted revenue of $498,000 in the period. Ocular Therapeutix shares have increased 22 percent ...
Ocular Therapeutix™, Inc. , a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it will report third quarter ended September 30, 2018 financial results on Wednesday, November 7, 2018.
Ocular Therapeutix (OCUL) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Last Friday, Ocular Therapeutix (OCUL) announced that the company had received a warning letter from the FDA. The letter relates to the company’s compliance with data collection and reporting obligations in a post-approval registry study required as a condition for clearance of the premarket approval (PMA) application for ReSure Sealant.In a research note issued to clients today, H.C. Wainwright analyst Ram Selvaraju noted that "the study was agreed upon by the previous management team and has been found to be impractical to implement in its current design. The current management has already been in discussion with the FDA before receiving the letter. We expect the company to work with the FDA to resolve this issue, while ReSure remains on the market."As such, the analyst reiterates his bullish call on OCUL with a Buy rating and $10 price target, which implies an upside of 70% from current levels.Ocular's lead product candidate Dextenza has a Prescription Drug User Fee Act (PDUFA) date of December 28, 2018 for the treatment of ocular pain following ophthalmic surgery. Importantly, Selvaraju points out that "the warning letter has no impact on the ongoing regulatory review process of Dextenza.""As we roll forward the DCF analysis, our estimated market value of the firm has increased from $435M to $456M. Assuming 46.7M shares outstanding at the end of 3Q19, this translates to a per share value of roughly $10," Selvaraju concluded.Overall, when it comes to Wall Street’s bet, the odds are on this biotech player, with TipRanks analytics showcasing OCUL as a Strong Buy. Out of 6 analysts polled in the last 3 months, all 6 are bullish on Ocular stock. With a return potential of nearly 128%, the stock’s consensus target price stands at $13.33. (See OCUL's price targets and analyst ratings on TipRanks) More recent articles about OCUL: * H.C. Wainwright Sees over 80% Upside Potential for These Three Biotech Stocks * Why Analysts See Solid Upside Potential for Ocular Therapeutix (OCUL), Catalyst Pharmaceuticals (CPRX), and AcelRx (ACRX) * JMP Highlights Two Biotech Stocks to Consider Ahead of Upcoming FDA Decisions: Trevena (TRVN), Ocular (OCUL) * Teva Pharmaceutical Industries Ltd (ADR) (TEVA) About to Attract a Lot of Investor Attention with New IP Lawsuit; Ocular Therapeutix Inc (OCUL) Gains a Bull