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The Daily Biotech Pulse: Novartis Earnings, Hepion's NASH Candidate Beats Rival Drugs, Annovis Bio To Debut

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The Daily Biotech Pulse: Novartis Earnings, Hepion's NASH Candidate Beats Rival Drugs, Annovis Bio To Debut

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. 28)

  • 10X Genomics Inc (NASDAQ: TXG)
  • Acceleron Pharma Inc (NASDAQ: XLRN) (announced positive Phase 2 results for its pulmonary hypertension drug)
  • Agile Therapeutics Inc (NASDAQ: AGRX)
  • AtriCure Inc. (NASDAQ: ATRC)
  • Avenue Therapeutics Inc (NASDAQ: ATXI)
  • Catalent Inc (NYSE: CTLT)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Insulet Corporation (NASDAQ: PODD)
  • Johnson & Johnson (NYSE: JNJ)
  • NeoGenomics, Inc. (NASDAQ: NEO)
  • Nevro Corp (NYSE: NVRO)
  • Profound Medical Corp (NASDAQ: PROF)
  • Quest Diagnostics Inc (NYSE: DGX)
  • Rapt Therapeutics Inc (NASDAQ: RAPT)
  • Satsuma Pharmaceuticals Inc (NASDAQ: STSA)
  • SI-Bone Inc (NASDAQ: SIBN)
  • TFF Pharmaceuticals Inc (NASDAQ: TFFP)
  • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB)(H.C. Wainwright reiterated a Buy rating on shares)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Jan. 28)

  • Correvio Pharma Corp (NASDAQ: CORV)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Galectin Therapeutics Inc. (NASDAQ: GALT)
  • Heat Biologics Inc (NASDAQ: HTBX)
  • Neuronetics Inc (NASDAQ: STIM)
  • REDHILL BIOPHAR/S ADR (NASDAQ: RDHL)
  • Salarius Pharmaceuticals Inc (NASDAQ: SLRX)
  • X4 Pharmaceuticals Inc (NASDAQ: XFOR)
  • VIVUS, Inc. (NASDAQ: VVUS)

Stocks In Focus

Novartis Q4 Sales, Core Income Rise, Guides to Sales, Earnings Growth

Novartis AG (NYSE: NVS) said its fourth-quarter sales rose 8% to $12.403 million, up 8% year-over-year. However, net income fell 7% to $1.13 billion, dragged by higher taxes. Core net income, however climbed 11% to $2.99 billion.

The company guided full-year 2020 net sales to increase in the mid-to-high single digits in constant currency and core operating income to growth in the high-single to low double digits in constant currency. The guidance excluded Alcon and Sandoz U.S. oral solids and dermatology business from both 2019 and 2020 and assumed no Gilenya and Sandostatin LAR generics entering in 2020 in the U.S.

BioPharmX to Reverse Merge Into Timber Pharma

Biopharmx Corp (NYSE: BPMX) announced a definitive reverse merger agreement with Timber Pharma, a privately-held biopharma focused on the development of treatments for orphan dermatologic diseases. Upon completion of the merger, BioPharmX will change its name to Timber Pharma.

Timber has committed to secure at least $20 million in financing to support operations of the combined company and will also provide $2.25 million in bridge loan to BioPharmX in exchange for a 30-month warrant to purchase 2.3 million in BioPharmX shares.

BioPharmX shares were down 10.05% to 70 cents in after-hours trading.

Hepion's NASH Drug Found More Effective Than Rivals'

Hepion Pharmaceuticals Inc (NASDAQ: HEPA) announced positive finding from an expanded study of its non-alcoholic steatohepatitis, or NASH, drug candidate CRV 431 with human precision cut liver slices.

The company noted that CRV431 prevented experimentally induced liver fibrosis to a greater extent than other four leading NASH candidates Intercept Pharmaceuticals Inc's (NASDAQ: ICPT) obeticholic acid, GENFIT S A/ADR (NASDAQ: GNFT)'s elafibranor, Madrigal Pharmaceuticals Inc (NASDAQ: MDGL)'s resmetirom and Galmed Pharmaceuticals Ltd's (NASDAQ: GLMD) Aramchol.

Hepion shares rallied 37.75% to $6.86 in after-hours trading.

Amphastar's Epinephrine Injection Handed Down a Minor CRL By The FDA

Amphastar Pharmaceuticals Inc (NASDAQ: AMPH) said the FDA issued a minor complete response letter, or CRL, for its NDA for Epinephrine injection, USP 30mg/30mL multiple dose.

The company said it responded to the minor CRL Jan. 27, and expects a decision from the FDA within three months.

The stock declined 3.40% to $19.05 in after-hours trading.

Teva Gets FDA Nod For Autoinjector Device For Migraine Drug

Teva Pharmaceutical Industries Ltd (NYSE: TEVA) said the FDA approved an autoinjector device for its migraine treatment Ajovy injection.

"AJOVY is the only FDA-approved anti-CGRP that offers the flexibility of quarterly (675 mg) or monthly (225 mg) dosing options, and we are pleased that patients and their healthcare providers will be able to decide if an autoinjector is the right administration option for their needs," said Brendan O' Grady, executive VP, North America, Commercial.

Th stock added 0.69% to $10.28 in after-hours trading.

Exelixis' Partner Takeda Files Regulatory Submission For Liver Cancer Drug In Japan

Exelixis, Inc. (NASDAQ: EXEL) said Takeda Pharmaceutical Co Ltd (NYSE: TAK), its partner responsible for the development and commercialization of Cabometyx in Japan, has made regulatory submission for the drug in Japan for the treatment of patients with unresectable hepatocellular carcinoma that had progressed after prior systemic therapy.

Takeda is liable to pay $10 million in milestone payment to Exelixis due to the materialization of this regulatory milestone.

Akcea Reports Positive Results for Mid-stage Study of Drug to Treat Cardiovascular & Metabolic Diseases

Akcea Therapeutics Inc (NASDAQ: AKCA, a majority-owned affiliate of Ionis Pharmaceuticals Inc (NASDAQ: IONS), announced positive topline results from the Phase 2 study of AKCEA-ANGPTL3-LRx, an investigational antisense oligonucleotide therapy, in patients with hypertriglyceridemia, type 2 diabetes and non-alcoholic fatty liver disease.

Akcea shares were up 0.74% to $18.99 in pre-market trading, while Ionis stock slipped 3.37% to $57.89.

Offerings

Cerus Corporation (NASDAQ: CERS) commenced a registered underwritten public offering of $50 million worth of its common stock. All shares are to be offered by the company.

The stock slipped 3.68% to $3.99 in after-hours trading.

Denali Therapeutics Inc (NASDAQ: DNLI) priced its previously-announced public offering of 7.83 million shares of its common stock at $23 per share. The company expects to receive gross proceeds of about $180 million from the offering. The offering is subject to close on or about Jan. 31, 2020.

The stock declined 2.05% to $24.33 in after-hours trading.

Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) commenced an underwritten public offering of $250 million worth of its common shares. All shares are to be sold by the company.

The stock moved down 9.64% to $51 in after-hours trading.

Earnings

Illumina, Inc. (NASDAQ: ILMN) (after the market close)
Varian Medical Systems, Inc. (NYSE: VAR) (after the market close)
Hologic, Inc. (NASDAQ: HOLX) (after the market close)

IPO

Annovis Bio, a clinical-stage drug platform addressing neurodegenerative disease such as Alzheimer's and Parkinson's said it has priced its initial public offering, or IPO, of 2 million shares at $6 per share for raising gross proceeds of $12 million. The shares will commence trading on the NYSE American Exchange Wednesday under the ticker symbol ANVS.

Posted-In: Biotech M&A News Offerings FDA IPOs Top Stories Pre-Market Outlook

 

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