Recap Of Tuesday's Biotech Catalysts - End Of the Day Summary
- The U.S. Food and Drug Administration (FDA) has approved Amphastar’s (NASDAQ: AMPH) New Drug Application (ND") for Epinephrine injection USP, 1 mg/10mL (0.1 mg/mL) Single Dose Pre-Filled Syringe. Epinephrine injection is designated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Amphastar shares traded in a range of $32.11 to $33.05 on a day volume of 299.62 thousand shares, closed regular trading session at $32.52.
- ANI Pharmaceuticals (NASDAQ: ANIP) has received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg, the generic version of the Reference Listed Drug (RLD) Decadron. ANI shares traded in a range of $36.76 to $39.64 on a day volume of 101.71 thousand shares, closed regular trading session at $38.01.
- The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for AstraZeneca (NASDAQ: AZN) and Merck’s (NYSE: MRK) New Drug Application (sNDA) for LYNPARZA in combination with abiraterone and prednisone or prednisolone in the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The FDA has set a target action, date in the fourth quarter of 2022. Merck shares traded in a range of $89.87 to $90.9 on a day volume of 4.05 million shares, closed regular trading session at $90.59.
- Mersana Therapeutics (NASDAQ: MRSN) announced the initiation of patient dosing in its Phase 1 trial of XMT-1660 for the treatment of Breast, Endometrial and Ovarian Cancers. Mersana shares traded in a range of $7.13 to $7.69 on a day volume of 1.02 million shares, closed regular trading session at $7.23. The company shares are currently trading at $7.09, down 1.94 percent in the after-hours trading session.
- HeartBeam (NASDAQ: BEAT) has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its HeartBeam AIMI™ platform technology for use in diagnosing heart attacks. HeartBeam shares traded in a range of $1.41 to $1.63 on a day volume of 331.58 thousand shares, closed regular trading session at $1.45. The company shares are currently trading at $1.5, up 3.45 percent in the after-hours trading session.
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