RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the FDA approved approved Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults. Shares closed up 6% to $7.35.

FibroGen, Inc. (NASDAQ: FGEN) shares closed down 8% to $37.01 following a short report published by Plainview, LLC titled “The Next Biotech Blow-Up”. The authors noted that they believe a presentation of key major adverse cardiac events (MACE) data of its lead drug, roxadustat at the ASN meeting on November 8, will be negative.

Agile Therapeutics, Inc. (Nasdaq: AGRX) shares added a further 32% to $1.78 following last week’s positive vote from an FDA Advisory Committee meeting which delivered a 14 to 1 vote supporting approval of the New Drug Application (NDA) for its contraceptive patch, Twirla.

AVEO Oncology (NASDAQ: AVEO) shares closed down 37% to $0.57 following an update regarding its pipeline candidate tivozanib for the treatment of refractory renal cell carcinoma (RCC). The FDA recommended that the company not submit an NDA at this time due to concerns regarding overall survival data from its TIVO-3 Phase 3 trial. The company will now file a NDA in 1Q 2020 but will withdraw the filing if overall survival data to be released in June 2020 yields a hazard ratio above 1.00.

Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that the HALO-301 Phase 3 trial of PEGPH20 as a first-line therapy for treatment of patients with pancreatic cancer failed to reach the primary endpoint of overall survival. Shares recovered from losses early in the session to close flat on the day at $15.44.

Merus N.V. (Nasdaq: MRUS) announced after hours a proposed underwritten public offering of up to $60m of its common shares. Shares are trading down 3% after hours to $14.40 after closing the normal trading session down 7%.

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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:

Bellicum Pharmaceuticals, Inc. (BLCM): $1.28; +20%.

Celldex Therapeutics, Inc. (CLDX): $2.80; +17%.

Oncolytics Biotech Inc. (ONCY): $1.33; +16%.

Ovid Therapeutics Inc. (OVID): $2.83; +15%.

BioNTech SE (BNTX): $18.97; +15%.

DECLINERS:

Omeros Corporation (OMER): $13.60; -16%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $3.03; -16%.

Seneca Biopharma, Inc. (SNCA): $1.22; -13%.

Rexahn Pharmaceuticals, Inc. (REXN): $1.84; -12%.

Forty Seven, Inc. (FTSV): $6.90; -9%.

Pipeline updates below: