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The Daily Biotech Pulse: Roche Scraps Alzheimer's Disease Trials, Amgen Issues Weak Guidance

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks hitting 52-week highs on Jan. 29)

  • BioDelivery Sciences International, Inc. (NASDAQ: BDSI)
  • Loxo Oncology Inc (NASDAQ: LOXO)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Jan. 29)

  • Pulmatrix Inc (NASDAQ: PULM) (announced pricing of common stock offering)
  • Tricida Inc (NASDAQ: TCDA)

Stock In Focus Roche To Discontinue Two Late-stage Studies Of Alzheimer's Disease Drug

Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) said it plans to discontinue its late-stage studies dubbed CREAD 1 and 2 that evaluate its crenezumab in early Alzheimer's disease.. Crenezumab is Roche's anti-beta-amyloid molecule, which is being tested for early sporadic Alzheimer's disease in collaboration with partner AC Immune SA (NASDAQ: ACIU)
The decision to discontinue was based on the results of an interim analysis assessing the safety and efficacy by the Independent Data Monitoring Committee, which felt the candidate was unlikely to meet the primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes.

However, Roche said it remains committed to the ongoing clinical studies in Alzheimer's disease, including GRADUATE Phase III trials with gantenerumab and the TAURIEL Phase II anti-tau trial.

View more earnings on IBB

See Also: After Axsome's Triple-Digit Gains, Is There Room For Further Upside?

FDA Okays Inspire Medical's New Respiratory Pattern Monitor

Inspire Medical Systems Inc (NYSE: INSP) said the FDA has approved its new sensing lead, which monitors a patient's respiratory pattern. The company said it plans to introduce the new sensing lead to its U.S. medical centre customers in March.


Amgen, Inc. (NASDAQ: AMGN) reported adjusted earnings of $3.42 per share for its Q4 compared to $2.89 per share a year-ago. Revenues climbed 7 percent to $6.2 billion. The results exceeded estimates. However, the company's FY19 guidance trailed expectations. The stock fell 2.36 percent to $187.57.

Illumina, Inc. (NASDAQ: ILMN) reported Q4 adjusted EPS of $1.32, down 8 percent year-over-year, and revenues of $867 million, up 11 percent. The EPS trailed the consensus estimate of $1.36 per share but the revenues were higher than the consensus. The company guided FY19 revenues growth to 13-14 percent and non-GAAP EPS to $6.50-$6.60. Analysts, on average, estimate revenue growth of 14.40 and non-GAAP EPS of $6.46. The stock shed 2.54 percent to $278.

Novartis AG (NYSE: NVS) reported Q4 core operating profit that slightly trailed estimates, while revenues were in line. The company also said it expects to see mid-single-digit sales growth from its core businesses in 2019.

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