Posts tagged placebo
IntelGenx seeks Health Canada approval for montelukast VersaFilm trial

IntelGenx (OTCQX:IGXT; TSXV:IGX) submitted a clinical trial application to Health Canada for approval to initiate a Phase 2a proof-of-concept study with montelukast in mild-to-moderate Alzheimer's disease (AD). 

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Aurinia’s voclosporin meets 48-week remission endpoints

Aurinia Pharmaceuticals’ (NASDAQ:AUPH; TSX:AUP) Phase 2b AURA-LV study of voclosporin in lupus nephritis (LN) met its complete and partial remission (CR/PR) endpoints at 48 weeks.

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BTIG starts Intra-Cellular Therapies at buy

BTIG launched coverage of Cellular Therapies (NASDAQ:ITCI) with a “buy” rating and $44 price target, saying there is considerable promise for the company’s antipsychotic, ITI-007, in multiple indications. The stock closed at $15.05 on Dec. 21.

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BTIG starts CoLucid Pharma at buy

BTIG initiated coverage of CoLucid Pharmaceuticals (NASDAQ:CLCD) with a “buy” rating and $58 price target, calling the company’s Lasmiditan drug candidate a game changer in acute migraine. The stock closed at $36.16 on Dec 21.

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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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Aurinia to begin Phase 3 voclosporin trial in Q2

After an end-of-Phase 2 meeting with the FDA, Aurinia Pharmaceuticals (NASDAQ:AUPH) plans to begin a single Phase 3 clinical trial for voclosporin in the treatment of lupus nephritis (LN).

Aurinia believes the Phase 3 trial, whose design is consistent with the ongoing AURA study, will support a NDA submission.

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HCW starts Proteon Therapeutics at buy

H.C. Wainwright has initiated coverage of Proteon Therapeutics (NASDAQ:PRTO) with a ‘buy” rating and $18 price target. The stock closed at $8.75 on Wednesday.

Proteon is developing a novel therapy to help prolong vascular access patency for dialysis patients. The company’s lead product, vonapanitase, is a recombinant human elastase used during vascular surgery.

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Leerink reiterates rating on Aurinia following trial results

Leerink reiterated its “outperform” rating on Aurinia Pharmaceuticals (NASDAQ:AUPH; TSX:AUP) after the reported top-line results with voclosporin in a Phase 2b clinical study in patients with active lupus nephritis.

Analyst Joseph Schwartz writes that the study met its primary endpoint of complete remission and improvements in partial remission versus placebo. While efficacy was higher among patients receiving the low-dose, the high-dose cohort also achieved meaningful improvements in partial remission.

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HCW cuts Seres Therapeutics price target to $15

H.C. Wainwright lowered its price target for Seres Therapeutics (NASDAQ:MCRB) to $15 from $50 after disappointing Phase 2 results in patients with recurrent C. difficile infection (CDI). The stock was quoted at $9.83, down $1.11, or 10% at in afternoon trading on Monday.

Last week, Seres announced the Phase 2 SER-109 ECOSPOR trial in 89 patients with recurrent CDI failed to meet its primary endpoint of reducing the relative risk of CDI recurrence at up to eight weeks.

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Fibrocell Phase 2 vocal scaring trial fails

A Phase 2 clinical trial of Fibrocell Science’s (NASDAQ:FCSC) azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia failed to meet its primary endpoints.

Fibrocell intends to focus its efforts on the development of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa and its earlier-stage programs.

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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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Oramed posts positive oral insulin Phase 2b results

Oramed Pharmaceuticals (NASDAQ:ORMP) has reported positive top-line results from its Phase 2b study, designed to evaluate the safety and efficacy of its oral insulin capsule, ORMD-0801, in patients with Type 2 diabetes.

The study’s primary objective, which is a significant reduction of weighted mean nighttime glucose, was successfully achieved.

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Ocular Therapeutix to initiate Phase 3 program with OTX-TP

Ocular Therapeutix (NASDAQ:OCUL) has completed an end-of-Phase 2 review with the FDA for its sustained release travoprost product candidate, OTX-TP, for the treatment of glaucoma and ocular hypertension and intends to initiate the first of two Phase 3 clinical trials during the third quarter of 2016.

The FDA has stated that it agrees with the overall Phase 3 clinical development program proposed by Ocular in its briefing package submitted to the FDA.

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