The Daily Biotech Pulse: Exelixis Liver Cancer Drug On Track For European Approval, Medtronic Goes Shopping, Opiant Snags BARDA Funding

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 Sept. 20.)

  • Abbott Laboratories ABT
  • Acceleron Pharma Inc XLRN
  • Amgen, Inc. AMGN
  • AtriCure Inc. ATRC
  • Baxter International Inc BAX
  • Cara Therapeutics Inc CARA
  • ELANCO ANIMAL HEALTH INC ELAN (After pricing its IPO at $24 per share, the shares of the company opened at a premium of about 34 percent over the IPO price and closed with a gain of 50 percent.)
  • Emergent Biosolutions Inc EBS
  • GW Pharmaceuticals PLC- ADR GWPH
  • Medtronic PLC MDT
  • Minerva Neurosciences Inc NERV
  • Pfizer Inc. PFE
  • Nightstar Therapeutics PLC NITE
  • Seattle Genetics, Inc. SGEN

Down In The Dumps

(Biotech stocks that hit 52-week lows Sept. 20.)

  • Eidos Therapeutics Inc EIDX
  • Titan Pharmaceuticals, Inc. TTNP

Stocks In Focus

Exelixis Receives Positive Opinion For European Cabometyx Approval

Exelixis, Inc. EXEL and partner Ispen announced that the European Union's Committee for Medicinal Products for Human Use has provided a positive opinion for their Cabometyx tablets as monotherapy for treating hepatocellular carcinoma in adults who have been previously treated with sorafenib.

The EMA will now review the opinion and decide on the approvability of the candidate.

Exelixis is eligible to receive a milestone payment of $40 million for the approval of the second-line treatment of HCC.

Medtronic to Buy Mazor Robotics For $1.64B

Medtronic announced a deal to buy Mazor Robotics Ltd – ADR MZOR for $58.59 per ADS, or $29.25 per ordinary share, in cash for a total value of $1.64 billion, or $1.34 billion, net of Medtronic's existing stake in Mazor and cash acquired.

Mazor shares rallied 9 percent to $57.50 in after-hours trading Thursday, while Medtronic slipped 0.48 percent to $97.01.

See also: New Class of Migraine Drug Creates Four-Way Pharma Development Race

Opiant Clinches BARDA Funding Deal For Opioid Overdose Drug

Opiant Pharmaceuticals Inc OPNT said it has entered into a multiyear contract with the Biomedical Advanced Research and Development Authority for potential funding of up to a maximum of $4.6 million to accelerate development of Opiant's lead candidate OPTN003, a long-acting opioid antagonist in development for opioid overdose.

The stock climbed 7.14 percent to $24 in after-hours trading Thursday.

European Medicines Agency Committee Gives Positive Opinion On Two Merck HIV Cocktails

Merck & Co., Inc. MRK said the EMA's CHMP has adopted a positive opinion, recommending granting marketing authorization for two of its HIV medicines: Delstrigo, a once-daily fixed-dose combo tablet of doravirine, lamivudine and tenofovir disoproxil fumarate, and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor to be administered with other antiretroviral medicines.

The stock rose 0.52 percent to $71.15 in after-hours trading Thursday.

Shire Notches Japanese Approval For Edema Drug

Shire PLC SHPG said it has received Japanese approval for its Firazyr for treating hereditary angioedema attacks. The company said the approval was supported by data from dedicated study of HAE patients in Japan.

Offerings

Fate Therapeutics Inc FATE priced its underwritten public offering of 9.259 million shares at $13.50 per share, for an aggregate offering of about $125 million. The offering is expected to close on or about Sept. 25.

The stock fell 0.93 percent to $13.90 in after-hours trading Thursday.

Crispr Therapeutics AG CRSP announced it has priced its underwritten public offering of 4.21 million shares at $47.50 per share, a discount to Thursday's closing price of $48.99.

The stock shed 1.22 percent to $48.39 in after-hours trading Thursday.

Titan Pharma priced its underwritten public offering, with the offering expected to generate gross proceeds of $9.5 million.

The stock slipped 2 percent to 49 cents in after-hours trading Thursday.

On The Radar

IPO

Y-MABS Therapeutics, a developer of antibody-based therapeutic products for treating cancer, priced its upsized initial public offering of 6 million shares at $16, the upper end of the estimated price range of $14-$16. The shares will be listed on the Nasdaq under the ticker symbol YMAB.

Related Link: The Week Ahead In Biotech (Sept. 16-22): Conferences, PDUFA Dates, Clinical Trial Results And IPOs

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