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  • Intercept Pharma soars after nabbing 'breakthrough' title for blockbuster NASH contender

    Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation (BTD) for obeticholic acid (OCA), a closely watched therapy in the pipeline for a blockbuster NASH indication. The biotech says the BTD win was based on data from a pair of midstage studies of OCA, which persuaded some analysts to tap it as a major new therapy in the clinic for a rapidly growing population of patients suffering from liver disease. While no guarantee of success, the agency has been handing out BTDs as a hall pass for companies looking for quick access and feedback from the agency. In this case, the company says a breakthrough designation should help grease the tracks for the late-stage program. Read more >>

Spark nails a $161M IPO to fund its 'breakthrough' gene therapy

Spark Therapeutics, at work on one-time treatments for rare diseases, pulled off a $161 million IPO, pricing above its range and keeping biotech's Wall Street hot streak rolling.

Obama wants $215M to kick off 'precision medicine' project

President Barack Obama is asking Congress for $215 million to sequence the genomes of 1 million Americans and help develop a new generation of medicines, part of a sweeping plan to accelerate biomedical R&D.

Astellas bets on Immunomic's allergy vaccine in a $75M deal

Astellas Pharma is teaming up with biotech Immunomic Therapeutics on a vaccine that could relieve a common allergy that affects millions in its native Japan.

Pfizer bails on a $70M rare disease deal with Repligen

Pfizer is walking away from a $70 million collaboration with Waltham, MA's Repligen, handing back some early-stage treatments for the rare spinal muscular atrophy.

Tracon raises $36M in a downsized IPO

Cancer drug developer Tracon Pharmaceuticals pulled in $36 million in an IPO, pricing well below its expected range as it works to get its top drug into late-stage trials.

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