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

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

Down In The Dumps

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

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

Stocks In Focus

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

Roche Holdings AG Basel ADR 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 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 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 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. 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.

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

Xenon Pharmaceuticals Inc 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 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 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. ISRG