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The Daily Biotech Pulse: FDA Panel Backs Shionogi's Antibiotic, Hepion Surges On Data Publication, Innate Pharma IPO

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The Daily Biotech Pulse: FDA Panel Backs Shionogi's Antibiotic, Hepion Surges On Data Publication, Innate Pharma IPO

The following is a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Oct. 16.)

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  • Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN): announced a deal to be acquired by Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN). 
  • China Biologic Products Holdings Inc (NASDAQ: CBPO)
  • Celgene Corporation (NASDAQ: CELG)
  • Kodiak Sciences Inc (NASDAQ: KOD)
  • The Medicines Company (NASDAQ: MDCO)
  • Reata Pharmaceuticals Inc (NASDAQ: RETA)

Down In The Dumps

(Biotech stocks that hit 52-week lows on Oct. 16.)

  • Aevi Genomic Medicine Inc (NASDAQ: GNMX)
  • BioSpecifics Technologies Corp. (NASDAQ: BSTC)
  • Cleveland BioLabs, Inc. (NASDAQ: CBLI)
  • Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)
  • Fulcrum Therapeutics Inc (NASDAQ: FULC)
  • Hoth Therapeutics Inc (NASDAQ: HOTH)
  • Kaleido Biosciences Inc (NASDAQ: KLDO)
  • Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)
  • Mirum Pharmaceuticals Inc (NASDAQ: MIRM)
  • Precision BioSciences Inc (NASDAQ: DTIL)
  • Rexahn Pharmaceuticals, Inc. (NASDAQ: REXN)
  • Titan Medical Inc. (NASDAQ: TMDI): suspended timeline of surgical robot. 
  • Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP): priced $9-million common stock offering. 
  • Trinity Biotech plc (NASDAQ: TRIB): reacted to Q3 results. 

See also: The Week Ahead In Biotech: FDA Decisions, Johnson & Johnson Among Big Pharma Earnings

Stocks In Focus

FDA Panel Recommends Approval Of Shionogi's Antibiotic

SHIONOGI & CO L/ADR (OTC: SGIOY) said the FDA's Antimicrobial Drugs Advisory Committee voted 14-2 to recommend approval of its investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections, including pyelonephritis, in patients with limited or no alternative treatment options.

The PDUFA date for the NDA has been fixed for Nov. 14. If approved, the investigational asset will be marketed under the brand name Fetroja.

Hepion Announces Publication Of Data Supporting CRV431 In Liver Diseases

Hepion Pharmaceuticals Inc (NASDAQ: HEPA), which was previously known as ContraVir, announced the publication of a research article, "A Pan-Cyclophilin Inhibitor, CRV431, Decreases Fibrosis and Tumor Development in Chronic Liver Disease Models," in the peer-reviewed Journal of Pharmacology and Experimental Therapeutics.

The company said the study presented findings on CRV431 that highlighted its potential as a drug candidate for chronic liver diseases.

The stock rallied 86% to $4.65 in after-hours trading.

Mesoblast Strikes Agreement With Lonza For aGVHD Cell Therapy

Mesoblast limited (NASDAQ: MESO) announced an agreement with LONZA GRP AG/ADR (OTC: LZAGY) under which the latter will commercially manufacture the former's lead allogenic cell therapy candidate remestemcel-L for pediatric steroid-refractory acute graft versus host disease, or aGVHD.

Mesoblast said this agreement will facilitate inventory build ahead of the planned U.S. launch of the therapy and commercial supply. The company expects to complete the filing of the rolling BLA to the FDA by the end of the year. If the application is approved, the company expects the U.S. launch to occur next year.

The stock added 3.29% to $6.27 in after-hours trading.

On The Radar

Earnings

Intuitive Surgical, Inc. (NASDAQ: ISRG) (after the close)

IPOs

French biotech Innate Pharma, which develops antibody therapies for cancer, priced its IPO of 12.5 million shares. The offering, comprising a 8.047-million ADS offering and a concurrent private placement of 4.45 million ordinary shares in Europe and countries outside of the U.S., is expected to raise gross proceeds of $68.8 million. The shares will be listed on the Nasdaq under the ticker symbol "IPHA."

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