Pre-Open Stock Movers 10/18: (ADMP) (OYST) (INFI) Higher; (RVNC) (OMER) (MNKD) Lower (more...)

October 18, 2021 9:23 AM EDT

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Pre-Open Stock Movers:

Revance Therapeutics, Inc. (Nasdaq: RVNC) 34.4% LOWER; announced that the United States (U.S.) Food and Drug Administration (FDA) has issued a Complete Response Letter, or CRL, regarding the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, for the treatment of moderate to severe glabellar (frown) lines.

Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) 23.9% HIGHER; announced that the U.S. Food and Drug Administration (FDA) has approved Adamis ZIMHI (naloxone HCL Injection, USP) 5 mg/0.5 mL product. ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose.

Omeros Corporation (Nasdaq: OMER) 21.1% LOWER; today announced that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

MannKind Corporation (Nasdaq: MNKD) 14.5% LOWER; learned that the U.S. Food and Drug Administration (FDA) issued a complete response to United Therapeutics Corporation regarding the New Drug Application (NDA) for Tyvaso DPI™ for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA declined to approve the NDA at this time, noting only one deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil drug substance, the active ingredient of Tyvaso DPI. The complete response did not pertain to MannKind, and no issues were cited by the FDA as it relates to MannKind’s facility in Connecticut for manufacturing, testing and packaging of finished Tyvaso DPI, including its associated device.

Oyster Point Pharma, Inc. (Nasdaq: OYST) 11.2% HIGHER; announced that the U.S. Food and Drug Administration (FDA) has approved TYRVAYA (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray is the first and only nasal spray approved for the treatment of dry eye disease. TYRVAYA Nasal Spray is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases.

Zillow Group (NASDAQ: ZG) (NASDAQ: Z) 8% LOWER; has reportedly stopped buying U.S. homes until the end of the year.

Infinity Pharmaceutical (NASDAQ: INFI) 5.7% HIGHER; H.C. Wainwright initiates coverage with a Buy rating and a price target of $9.00.

Upstart Holdings Inc (NASDAQ: UPST) 5.6% LOWER; BofA Securities downgraded from Buy to Underperform with a price target of $300.00.

NetApp (NASDAQ: NTAP) 3.6% LOWER; Goldman Sachs downgraded from Neutral to Sell with a price target of $81.00 (from $85.00).

Occidental Petroleum (NYSE: OXY) 2.9% HIGHER; Truist Securities upgraded from Hold to Buy with a price target of $50.00 (from $35.00).

Walt Disney (NYSE: DIS) 2.3% LOWER; Barclays downgraded from Overweight to Equalweight with a price target of $175.00 (from $210.00).



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