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The Daily Biotech Pulse: FDA Panel Backs Amgen's Hypertension Drug, Adamis Allergy Drug Launched In US

Shanthi Rexaline

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 Jan. 16)

  • Avenue Therapeutics Inc (NASDAQ: ATXI)
  • BioDelivery Sciences International, Inc. (NASDAQ: BDSI)
  • ResMed Inc. (NYSE: RMD)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Jan. 16)

  • Amneal Pharmaceuticals Inc (NYSE: AMRX)
  • Aptinyx Inc (NASDAQ: APTX)(reported a mid-stage trial that evaluated NYX-2925, its treatment candidate for patients with painful diabetic peripheral neuropathy, did not meet the primary endpoint)
  • Bio-Path Holdings Inc (NASDAQ: BPTH)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND) (short seller Citron Research said there is likely to be 80-percent downside in the stock from the current levels)
  • Neuronetics Inc (NASDAQ: STIM)

Stock In Focus Mirati Prices Common Stock Offering

Mirati Therapeutics Inc (NASDAQ: MRTX) said it has priced its underwritten public offering of 1.61 million shares at $62 per share compared to $62.47 at which they closed Wednesday. The company expects to generate gross proceeds of about $100 million from the offering,

The stock slipped 1.54 percent to $61.51 in after-hours trading.

J&J Unit Receives Complete Response Letter For sNDA For Hypertension Drug

Johnson & Johnson (NYSE: JNJ) unit Janssen's Actelion Pharma said it has received complete response letter for its sNDA for Opsumit to treat adults with inoperable chronic thromboembolic pulmonary hypertension, or CTEPH. The company said the FDA required additional data to evaluate the use of Opsumit for CTEPH.

Opsumit is approved in the U.S. for treating pulmonary arterial hypertension.

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

Adamis' Allergy Drug Launched In U.S. By Partner Sandoz

Adamis Pharmaceuticals Corp (NASDAQ: ADMP) said its commercial partner Novartis AG (NYSE: NVS)'s Sandoz unit has launched its Symjepi, chemically epinephrine, 0.3mg injection in the U.S. for the emergency treatment of allergic reactions, including anaphylaxis.

Sandoz is launching the drug as an affordable single-dose, pre-filled syringe alternative to auto-injectors.

Adamis said it is working with Sandoz to prepare for the U.S. launch of Sympjepi 0.15mg to treat patients, who weigh between 33 and 65 pounds.

Adamis shares rose 11.03 percent to $2.92 in after-hours trading.

FDA Panel Votes In Favor of Approving Amgen's Osteoporosis Drug

Amgen, Inc. (NASDAQ: AMGN) and UCB said FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 18-1 in favor of approval of their Evenity for the treatment of post-menopausal women with osteoporosis at high risk of fracture. The committee emphasized the need for post-marketing follow up.

The Adcom's decision follows review of safety and efficacy data from the pivotal Phase 3 studies.

FDA Accepts Roche's sBLA for Tecentriq

Roche Holdings AG Basel ADR (OTC: RHHBY) said the FDA has accepted its sBLA for its cancer drug Tecentriq in combination with Abraxane and carboplatin for first-line treatment of metastatic non-squamous non-small cell lung cancer, who do not have EGFR or ALK genomic tumor aberrations. The PDUFA date is set for Sep. 2, 2019.

Amicus Shares Rally After Citi Upgrades Stock

Citigroup analyst Mohit Bansal upgraded shares of Amicus Therapeutics, Inc. (NASDAQ: FOLD) to Buy, citing $1 billion peak sales potential of its Fabry disease therapy Galafold.

The stock rose 3.54 percent to $12.59 in after-hours trading.

On The Radar Adcom Meeting

The Endocrinologic and Metabolic Drugs Advisory Committee will discuss the NDA for sotagliflozin oral tablet, codeveloped by Sanofi SA (NASDAQ: SNY) and Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX). The candidate is being evaluated as an adjunct to insulin therapy to improve glycemic control in adults with Type 1 diabetes mellitus.

Clinical Trial Results

Five Prime Therapeutics Inc (NASDAQ: FPRX) and Zai Lab Ltd (NASDAQ: ZLAB) are due to present Phase 1 data for their gastric and gastro-esophageal junction cancer treatment candidate FPA144 along with chemotherapy.

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