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The Daily Biotech Pulse: FDA Nod For Roche, Bristol-Myers Hikes Dividend, 2 Biotechs To Debut

The Daily Biotech Pulse: FDA Nod For Roche, Bristol-Myers Hikes Dividend, 2 Biotechs To Debut

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Dec. 6)

  • Gritstone Oncology Inc (NASDAQ: GRTS)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 6)

  • Achaogen Inc (NASDAQ: AKAO)
  • Ardelyx Inc (NASDAQ: ARDX)
  • Assertio Therapeutics Inc (NASDAQ: ASRT)
  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL)
  • AzurRx BioPharma Inc (NASDAQ: AZRX)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • Conatus Pharmaceuticals Inc (NASDAQ: CNAT)(reacted to disappointing Phase 2b trial for its Emriscan that is being evaluated for liver disease)
  • Curis, Inc. (NASDAQ: CRIS)
  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)
  • Edge Therapeutics Inc (NASDAQ: EDGE)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Epizyme Inc (NASDAQ: EPZM)
  • Evogene Ltd (NASDAQ: EVGN)
  • Eyegate Pharmaceuticals Inc (NASDAQ: EYEG)
  • GlycoMimetics Inc (NASDAQ: GLYC)
  • Insys Therapeutics Inc (NASDAQ: INSY)
  • Intra-Cellular Therapies Inc (NASDAQ: ITCI)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Leap Therapeutics Inc (NASDAQ: LPTX)
  • Melinta Therapeutics Inc (NASDAQ: MLNT)
  • Mustang Bio Inc (NASDAQ: MBIO)
  • Nantkwest Inc (NASDAQ: NK)
  • Neuralstem, Inc. (NASDAQ: CUR)
  • Neurotrope Inc (NASDAQ: NTRP)
  • Novan Inc (NASDAQ: NOVN)
  • Novus Therapeutics Inc (NASDAQ: NVUS)
  • OHR Pharmaceutical Inc (NASDAQ: OHRP)
  • Oncomed Pharmaceuticals Inc (NASDAQ: OMED)(announced a reverse merger with U.K.'s Mereo BioPharma)
  • Ophthotech Corp (NASDAQ: OPHT)
  • Precision Therapeutics Inc (NASDAQ: AIPT)
  • Savara Inc (NASDAQ: SVRA)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Sonoma Pharmaceuticals Inc (NASDAQ: SNOA)
  • Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS)
  • Tenax Therapeutics Inc (NASDAQ: TENX)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)
  • Verrica Pharmaceuticals Inc (NASDAQ: VRCA)
  • Voyager Therapeutics Inc (NASDAQ: VYGR)

Related Link: Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates

Stocks In Focus

Roche Gets FDA Approval For Expanded Use of its Lung Cancer Drug

Roche Holdings AG Basel ADR (OTC: RHHBY) announced FDA approval for its Tecentriq in combination with Avastin, paclitaxel and carboplatin for treating people with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberations compared to Avastin plus chemotherapy.

The FDA has earlier extended the review period by three months before deciding on the sBLA.

Bristol-Myers Raises Dividend

Bristol-Myers Squibb Co (NYSE: BMY) announced a 2.5 percent increase to its quarterly dividend, beginning in the first quarter of 2019.


Global Blood Therapeutics Inc (NASDAQ: GBT) announced an agreement to sell $150 million worth of shares in a registered underwritten public offering. The company said it would use the net proceeds for preparing for the commercial launch of voxelotor, if approved by the FDA, for future clinical trials and for working capital and general corporate purposes.

The stock fell 4.01 percent to $44.80 in after-hours trading.

Inspire Medical Systems Inc (NYSE: INSP) said it has priced its previously announced public offering of 2.5 million shares at $40 per share, a discount to Thursday's closing price of $41.07. About 1.5 million shares earmarked for the offering will be sold by the company and the remaining 1 million by certain selling shareholders.

Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) priced its underwritten public offering of 17.39 million shares of its common stock at $11.50 per share for total aggregate gross proceeds to Momenta of approximately $200 million.

Orthopediatrics Corp (NASDAQ: KIDS) said it has commenced an underwritten public offering of 1.5 million shares of its common stock.

On The Radar


Moderna, which develops therapies based on its modified mRNA platform, priced its upsized initial public offering, or IPO, of 26.28 million at $23, the midpoint of the estimated price range of $22-$24. The shares will be listed on the Nasdaq under the ticker symbol MRNA.

Synthorx, which develops immunotherapies for solid tumors and autoimmune disorders, priced its IPO of 11.91 million shares, upsized from the initially revealed offer size of 9.1 million shares, at $11 per share, at the midpoint of the estimated range of $10 and $12. The shares will be listed on the Nasdaq under the ticker symbol THOR.


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