Posts tagged Phase 3 trial
Paradigm starts Profound Medical at buy

Paradigm Capital launched coverage of Profound Medical (TSXV:PRN; OTCQX:PRFMF) with a “buy” rating and price target of $2.25. The stock closed at 95 cents on Sept. 27.

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Leerink ups Dova to OP, price target to $32

Leerink upgraded for Dova Pharmaceuticals (NASDAQ:DOVA) to “outperform” from “market perform” and raised its price target to $32 from $24 after competitor, Shionogi, announced results from a Phase 3 trial. Shares of Dova closed at $22.45 on Sept. 25.

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Stifel ups Esperion price target to $45

Stifel raised its price target for Esperion Therapeutics (NASDAQ:ESPR) to $45 from $30. The stock closed at $29.33 on March 2.

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Stifel downgrades Argos to hold

Stifel downgraded Argos Therapeutics (NASDAQ:ARGS) to “hold” from “buy” and slashed its price target to $1.40 from $10 after an independent data monitoring committee (IDMC) recommended discontinuation of the ADAPT Phase 3 trial of AGS-003 in metastatic renal cell carcinoma (RCC) patients.

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Richard Glickman adds CEO title at Aurinia

Richard Glickman, founder and chairman of Aurinia Pharmaceuticals (NASDAQ:AUPH; TSX:AUP), was named to the added post of CEO. The board also accepted the resignation of Charles Rowland as CEO and an executive member of the board, effective immediately.

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Maxim downgrades Galena to hold

Maxim Group downgraded Galena Biopharma (NASDAQ:GALE) to “hold” from “buy” and removed its price target after the departure of Galena CEO, Dr. Mark Schwartz. The stock was quoted at $1.11 at midday Feb. 2.

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Roth starts Inotek Pharma at buy

Roth Capital Partners initiated coverage of Inotek Pharmaceuticals (NASDAQ:ITEK) with a “buy” rating and $10 price target. The stock closed at $6.40 on Nov. 30.

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Stifel ups Aerie Pharma price target to $50

Stifel raised it price target for Aerie Pharmaceuticals (NASDAQ:AERI) to $50 from $40 after the company’s Roclatan eye drop hit all its endpoints with clinically meaningful results in a Phase 3 trial. The stock closed at $21.13 on Wednesday.

Analyst Annabel Samimy writes that the 90-day primary efficacy readout of the MERCURY-1 trial demonstrated statistically significant lowering of intraocular pressure (IOP) of Roclatan over its Rhopressa and latanoprost components.

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Vital Therapies updates Phase 3 trial

In a corporate update, Vital Therapies (NASDAQ:VTL) reported that 14 subjects have been enrolled at sites in the U.S. and EU in VTL-308, the company's Phase 3 trial, designed to evaluate the ELAD System in subjects with severe acute alcoholic hepatitis.  

There are now 24 sites open for enrollment in the U.S and EU. The company expects to announce topline results in mid-2018.

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Vital Therapies names Faheem Hasnain as a director

Vital Therapies (NASDAQ:VTL) appointed Faheem Hasnain to the board, effective immediately.

Mr. Hasnain served as president, CEO and as a director of Receptos from November 2010 to August 2015, when it was purchased by Celgene for $7.8-billion. He is currently chairman of Tocagen and Sente.

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Maxim cuts Galena Biopharma price target to $1

Maxim Group lowered its price target for Galena Biopharma (NASDAQ:GALE) to $1 from $2, citing a shift in the company’s pipeline focus. The stock closed at 46 cents on Tuesday.

At the end of June, an Independent Data Monitoring Committee stopped a Phase 3 trial of Galena’s NeuVax in early-stage breast cancer for futility.

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Oramed names Dr. Roy Eldor as CMD

Oramed Pharmaceuticals (NASDAQ:ORMP) appointed Dr. Roy Eldor to the newly created post of chief medical director.

“We are very pleased to welcome Dr. Eldor on board at this pivotal time for Oramed as we head towards a Phase 3 trial for our oral insulin capsule, ORMD-0801,” CEO, Nadav Kidron, said in a statement.

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Stifel starts Concert Pharma at buy

Stifel launched coverage of Concert Pharmaceuticals (NASDAQ:CNCE) with a “buy” rating and 12-month target price of $23. The stock closed at $11.20 on Friday.

“Our bullish thesis centers on two key pipeline assets: AVP-786 in Phase 3 trials for Alzheimer’s agitation and CTP-543 in Phase 1 studies for alopecia areata,” writes analyst Adam Walsh.

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Ocular Therapeutix second Phase 3 trial unsuccessful

Ocular Therapeutix’s (NASDAQ:OCUL) results from its second Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA, a bioresorbable intracanalicular depot, for the treatment of ocular itching associated with chronic allergic conjunctivitis failed to achieve statistical significance.

The single primary endpoint of the trial was the difference in the mean scores in ocular itching between the treatment group and the placebo comparator group at three time points seven days following insertion of the depots and was not achieved.

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Vital enrolls first subject in Phase 3 ELAD trial

Vital Therapies (NASDAQ:VTL) has enrolled the first subject in its Phase 3 trial designated, VTL-308, to evaluate the ELAD System in subjects with severe acute alcoholic hepatitis. ELAD is an extracorporeal human allogeneic cellular liver therapy.

The trial is intended to enroll a minimum of 150 subjects, who will be randomized one-to-one to either ELAD therapy plus standard-of-care, or standard-of-care alone. The company expects to enroll subjects among roughly 40 sites in the U.S. and EU. There are now ten sites open for enrollment in VTL-308.

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Can-Fite submits Phase 3 RA trial protocol to EMA

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has submitted to the European Medicines Agency (EMA) a protocol design for a Phase 3 trial and registration plan for its lead compound, CF101, in the treatment of rheumatoid arthritis. The company previously had a pre-submission meeting with the EMA.

The global trial is expected to begin in either the second or third quarter of 2016. It will investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis treated with conventional disease modifying drugs.

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Dipexium reaches 75% enrolment in Phase 3 trials

Dipexium Pharmaceuticals’ (NASDAQ:DPRX) OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials have reached the 75% enrollment milestone in total, with each study having enrolled nearly the same number of patients.

OneStep-1 and OneStep-2 are identical Phase 3 trials, with 180 patients per clinical trial. They are being conducted under a SPA with the FDA for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers.

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Rodman starts EyeGate Pharma at buy

Rodman & Renshaw has launched coverage of EyeGate Pharmaceuticals (NASDAQ:EYEG) with a “buy’ rating and a 12-month price target of $10. The stock closed at $1.70 on Friday.

"In our view, the company’s EGP-437 combination product is differentiated from eye drops and intraocular injections in that it is non-invasive and solves patient non-compliance and safety issues that currently plague conventional ophthalmic drug delivery methods,” writes analyst Yi Chen.

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EyeGate starts confirmatory Phase 3 trial in AU

EyeGate Pharmaceuticals (NASDAQ:EYEG) has enrolled the first patient in a confirmatory Phase 3 clinical trial of its EGP-437 combination lead product in patients with non-infectious anterior uveitis, an inflammation of the anterior chamber of the eye.

“Enrolling the first patient in our second Phase 3 trial for anterior uveitis marks an important milestone for the company as we move another step closer to bringing our EGP-437 combination product to the market,” Stephen From, president and CEO of EyeGate, said in a statement.

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