Posts tagged 505(b)(2) pathway
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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HCW starts Strongbridge Biopharma at buy

H.C. Wainwright has initiated coverage of Strongbridge Biopharma (NASDAQ:SBBP) with a “buy” rating and $15 price target. The stock closed at $5.23 on Tuesday.

“Within the span of two years, Strongbridge has made material progress to strengthen its rare endocrine portfolio and had strategically planted its footing in a Cushing’s syndrome asset with comparatively low clinical and regulatory risk,” writes analyst Andrew Fein.

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Titan Pharma receives FDA feedback on Parkinson’s implant

The FDA has provided written feedback to Titan Pharmaceuticals (NASDAQ:TTNP) on the initial development plan for its proprietary ropinirole hydrochloride implant for Parkinson’s disease.

Based on the FDA’s feedback on the development plan submitted in December 2015, Titan is proceeding with the required non-clinical studies to support a potential IND submission in the fourth quarter of 2016, followed by an initial pharmacokinetic and proof-of-concept clinical study. Titan is pursuing a 505(b)(2) registration pathway for the implant.

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