The European Commission (EC) has approved AstraZeneca (NASDAQ:AZN) and Merck’s (NYSE:MRK) LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm). This regulatory approval was supported by the results from the Phase 3 OlympiA trial. Merck shares traded in a range of $86.64 to $87.89 on a day volume of 7.99 million shares, closed regular trading session at $86.82.
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Qorvo’s (NASDAQ: QRVO) Qorvo Omnia SARS-CoV-2 Antigen Test in Point-of-Care (POC) settings. Merck shares traded in a range of $86.64 to $87.89 on a day volume of 7.99 million shares, closed regular trading session at $86.82.
Astria Therapeutics (NASDAQ: ATXS) announced initiation of a Phase 1a clinical trial of STAR-0215 in healthy subjects. The Phase 1a is a single ascending dose (SAD) trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of STAR-0215 in approximately 24 subjects. Astria shares traded in a range of $4.22 to $4.58 on a day volume of 73.02 thousand shares, closed regular trading session at $4.54. The company shares are currently trading at $4.41, down 2.86 percent in the after-hours trading session.
Rain Therapeutics (NASDAQ: RAIN) has completed patient enrolment in its Phase 3 MANTRA trial of its lead asset, milademetan for well-differentiated / dedifferentiated (WD/DD) liposarcoma (LPS). The company expects topline data readout from the Phase 3 clinical trial in the first half of 2023. Rain Therapeutics shares traded in a range of $6.39 to $7.1 on a day volume of 29.37 thousand shares, closed regular trading session at $7.1.
PDS Biotechnology (NASDAQ: PDSB) announced that the independent Data Monitoring Committee (DMC) met for its scheduled review of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab) for the potential treatment of recurrent or metastatic HPV16-positive head and neck cancer. The DMC recommended continuing the trial with no modifications. PDS Biotechnology shares traded in a range of $4.65 to $5.24 on a day volume of 421.97 thousand shares, closed regular trading session at $5.14.
Arcutis Biotherapeutics (NASDAQ: ARQT) has completed patient enrolment in its INTEGUMENT-1 pivotal Phase 3 trial of roflumilast cream 0.15% in adults and children with Atopic dermatitis (AD). Based on the outcome of the trial results, the company is planning to submit a supplemental New Drug Application (sNDA) for roflumilast cream 2023. Arcutis shares traded in a range of $22.3 to $24.64 on a day volume of 1.91 milion shares, closed regular trading session at $24.61. The company shares are currently trading at $23.73, down 3.58 percent in the after-hours trading session.
Pulse Biosciences (NASDAQ: PLSE) has received (FDA) 510(k) clearance of expanded energy settings for use with the family of CellFX System treatments tips in dermatology. Pulse Biosciences shares traded in a range of $1.57 to $1.78 on a day volume of 209.31 thousand shares, closed regular trading session at $1.63. The company shares are currently trading at $1.51, down 7.36 percent in the after-hours trading session.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Vaxcyte’s (NASDAQ: PCVX) lead asset VAX-24, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in adults ages 18 and older. Vaxcyte shares traded in a range of $24.29 to $25.72 on a day volume of 531.23 thousand shares, closed regular trading session at $25.62. The company shares are currently trading at $25.13, down 1.91 percent in the after-hours trading session.
Novavax (NASDAQ: NVAX) has initiated its Phase 2b/3 Hummingbird global clinical trial evaluating the safety, effectiveness (immunogenicity), and efficacy of two doses of the Novavax COVID-19 vaccine (NVX-CoV2373) in younger children aged six months through 11 years. Novavax shares traded in a range of $60.01 to $63.24 on a day volume of 3.32 milion shares, closed regular trading session at $61.93.
The U.S. Food and Drug Administration (FDA) has announced clearance to Marker Therapeutics’ (NASDAQ: MRKR) Investigational New Drug (IND) application for MT-601 for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma. Marker shares traded in a range of $0.32 to $0.35 on a day volume of 182.9 thousand shares, closed regular trading session at $0.33. The company shares are currently trading at $0.80, up 144 percent in the after-hours trading session.
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