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The Daily Biotech Pulse: Roche Reports Positive SMA Data Readout, Vir Biotech To Work On Virus Treatment

Shanthi Rexaline

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week highs on Jan. 22)

  • 10X Genomics Inc (NASDAQ: TXG)
  • Abbott Laboratories (NYSE: ABT)(reported strong fourth-quarter results and issued in-line guidance)
  • Apellis Pharmaceuticals Inc (NASDAQ: APLS)
  • Applied Genetic Technologies Corp (NASDAQ: AGTC)
  • AtriCure Inc. (NASDAQ: ATRC)
  • BIO-TECHNE Corp (NASDAQ: TECH)
  • Bristol-Myers Squibb Co (NYSE: BMY)
  • Cardiovascular Systems Inc (NASDAQ: CSII)
  • Dr.Reddy's Laboratories Ltd (NYSE: RDY)
  • Eli Lilly And Co (NYSE: LLY)
  • Fortress Biotech (NASDAQ: FBIO)
  • Horizon Therapeutics PLC (NASDAQ: HZNP)( received FDA nod for its thyroid eye disease drug)
  • Insulet Corporation (NASDAQ: PODD)
  • Medtronic PLC (NYSE: MDT)
  • Masimo Corporation (NASDAQ: MASI)
  • Medpace Holdings Inc (NASDAQ: MEDP)
  • Nevro Corp (NYSE: NVRO)
  • Novocure Ltd (NASDAQ: NVCR)(announced coverage in Israel for its Optune in combination with temozolomide for the treatment of newly-diagnosed glioblastoma)
  • Prevail Therapeutics Inc (NASDAQ: PRVL)
  • Repligen Corporation (NASDAQ: RGEN)
  • ResMed Inc. (NYSE: RMD)
  • Selecta Biosciences Inc (NASDAQ: SELB)
  • SI-Bone Inc (NASDAQ: SIBN)
  • Soligenix, Inc. Common Stock (NASDAQ: SNGX)
  • Syneos Health Inc (NASDAQ: SYNH)
  • Varian Medical Systems, Inc. (NYSE: VAR)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
  • Veru Inc (NASDAQ: VERU)
  • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)
  • Zoetis Inc (NYSE: ZTS)
  • Zymeworks Inc (NYSE: ZYME)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Jan. 23)

  • Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
  • Evolus Inc (NASDAQ: EOLS)
  • Second Sight Medical Products Inc (NASDAQ: EYES)
  • Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)
  • Therapix Biosciences Ltd – ADR (NASDAQ: TRPX)

Stocks In Focus Roche's Spinal Muscular Atrophy Drug Aces Pivotal Trial In Pediatric Population

Roche Holdings AG Basel ADR (OTC: RHHBY) said the pivotal Part 2 of the FIREFISH study that evaluated its risdiplam in infants aged 1-7 months with Type 1 spinal muscular atrophy produced positive results.

The primary endpoint of the proportion of infants sitting without support for at least five second at 12-months of treatment, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition, has been met, the company said.

Vir Biotech Working On Coronavirus Treatment

Vir Biotechnology Inc (NASDAQ: VIR), which IPOed in October, said it's working to rapidly determine whether its previously identified anti-coronavirus monoclonal antibodies bind and neutralize 2019-n CoV, also known as Wuhan coronavirus.

The company also said its scientists are planning to apply whole genome CRISPR-based screening capabilities to identify the host receptor that allows Wuhan coronavirus infection, which will allow additional approaches to address the coronavirus scare.

The stock rose 8.83% to $18 in after-hours trading.

Biohaven's Verdiperstat Given Go Ahead for Potential Registrational Trial In ALS

Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) said the FDA has notified its collaborators at the Sean M. Healey & AMG Center for Amyotrophic Lateral Sclerosis, or ALS, at Massachusetts General Hospital that they may proceed with the clinical investigation of Biohaven's myeloperoxidase inhibitor verdiperstat in ALS.

The stock added 2.25% to $58.58 in after-hours trading.

Offerings

Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) announced a definitive agreement with Armistice Capital, a healthcare-focused institutional investor, for a private placement of shares and accompanying warrants as well pre-funded warrants and accompanying warrants. The private placement is expected to raise gross proceeds of $10 million. The company also announced a registered direct offering of common stock and pre-funded warrants that would mobilize around $7.5 million in gross proceeds.

The stock fell 24.22% to $2.91 in after-hours trading.

ImmunoGen, Inc. (NASDAQ: IMGN) priced its previously announced underwritten public offering of 21.33 million shares at $4.25 per share. All the shares are being offered by the company. The company expects to raise $90.6 million in gross proceeds from the offering.

View more earnings on IBB

The stock slipped 2.78% to $4.55 in after-hours trading.

Xenon Pharmaceuticals Inc (NASDAQ: XENE) priced its previously announced underwritten public offering of 3.75 million shares at $16 per share, with the gross proceeds from the offering estimated to be about $60 million.

The stock shed 3.45% to $16.25 in after-hours trading.

Zymeworks priced its previously announced underwritten public offering of 4.93 million shares at $46.50 per share. The pre-funded warrants offered to some shareholders to purchase up to 1.075 million shares were priced at $46.4999 per pre-funded warrant. The company expects to raise gross proceeds of $279 million from the offering.

The stock moved down 1.85% to $48.88 in after-hours trading.

Misonix Inc (NASDAQ: MSON) commenced an underwritten public offering of its common stock. The company intends to use the net proceeds for general corporate purposes.

The stock dipped 2.94% to $19.50 in after-hours trading.

PDUFA Dates

The FDA is scheduled to rule on Epizyme Inc's (NASDAQ: EPZM) tazemetostat, an experimental drug to treat metastatic or locally advanced, unresectable epithelioid sarcoma. FDA's Oncologic Drugs Advisory Committee, which met Dec. 18 to discuss the NDA for tazemetostat,unanimously recommended approval of the drug.

Clinical Readouts

Applied Genetic Technologies is scheduled to release interim Phase 1/2 data for its AAV gene therapy for the treatment of achromatopsia.

Earnings

Intuitive Surgical, Inc. (NASDAQ: ISRG)

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