AMGN

Amgen Inc.

223.4800
USD
0.20%
223.4800
USD
0.20%
166.3000 244.9900
52 weeks
52 weeks

Mkt Cap 136.31B

Shares Out 609.94M

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​Alexion ALXN buyout chatter +8%; Clearside CLSD set to receive Complete Response Letter -38%

Price and Volume Movers

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) shares closed up 8% to $123.49 following a report from Spanish news outlet, Intereconomia, that Amgen (NASDAQ: AMGN) is considering an acquisition of the company for $200 per share.

Retrophin, Inc. (NASDAQ: RTRX) shares closed down 22% to $13.56 following news its Phase 3 FORT trial evaluating fosmetpantotenate compared to placebo in patients with pantothenate kinase-associated neurodegeneration (PKAN) did not meet its primary endpoint and did not demonstrate a difference between treatment groups. The trial also did not meet its secondary endpoint.

Clearside Biomedical, Inc. (Nasdaq:CLSD) announced that it expects to receive a Complete Response Letter from the FDA for its New Drug Application (NDA) for Xipere (triamcinolone acetonide suprachoroidal injectable suspension). The PDUFA date is October 19, 2019. Clearside noted that following a meeting with the FDA, the agency has requested stability data for its new manufacturing process, which it plans to provide with its resubmitted NDA in 1Q 2020. Shares slid to close down 38% to $0.78.

Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) announced top-line data from their comparative clinical trial evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin's lymphoma. The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for ABP 798 compared to Rituxan, showing clinical equivalence.

AstraZeneca (NYSE: AZN) announced that it will purchase an FDA Priority Review Voucher (PRV) for $95m from a subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi). A PRV entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target review time.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

Progenics Pharmaceuticals, Inc. (PGNX): $4.50; +17%.

Aclaris Therapeutics, Inc. (ACRS): $1.09; +14%.

NGM Biopharmaceuticals, Inc. (NGM): $17.51; +11%.

Atreca, Inc. (BCEL): $22.06; +10%.

DURECT Corporation (DRRX): $1.53; +10%.

DECLINERS:

ASLAN Pharmaceuticals Limited (ASLN): $2.07; -16%.

Principia Biopharma Inc. (PRNB): $35.09; -12%.

Adaptimmune Therapeutics plc (ADAP): $1.44; -9%.

Molecular Templates, Inc. (MTEM): $4.78; -9%.

Outlook Therapeutics, Inc. (OTLK): $1.67; -9%.

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