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Recap Of Thursday's Biotech Catalysts – End Of the Day Summary

The European Commission (EC) has approved AstraZeneca AZN and Merck’s 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 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 TherapeuticsATXS

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 TherapeuticsRAIN

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 BiotechnologyPDSB

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 BiotherapeuticsARQT

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 BiosciencesPLSE

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 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.

NovavaxNVAX

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’ 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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