- The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ:ELDN) Investigational New Drug (IND) application to evaluate Tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Eledon shares traded in a range of $2.89 to $3.16 on a day volume of 31.27 thousand shares, closed regular trading session at $3.03.
- The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Beam Therapeutics’ (NASDAQ:BEAM) Investigational New Drug (IND) application for the candidate BEAM-201 in the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL). Beam Therapeutics shares traded in a range of $56.78 to $62.15 on a day volume of 1.58 million shares, closed regular trading session at $58.84.
- ALX Oncology Holdings (NASDAQ:ALXO) receives Fast Track designation from the U.S. Food and Drug Administration (FDA) for its lead asset Evorpacept in combination with KEYTRUDA (pembrolizumab) for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma (HNSCC). ALX Oncology shares traded in a range of $9.31 to $10.02 on a day volume of 250.32 thousand shares, closed regular trading session at $9.42. The company shares are currently trading at $9.61, up 2.02 percent in the after-hours trading session.
- The United States Food and Drug Administration (FDA) has accepted Krystal Biotech’s (NASDAQ:KRYS) Investigational New Drug (IND) application to evaluate KB407 in a clinical trial for cystic fibrosis (CF). Krystal shares traded in a range of $69.33 to $73.7 on a day volume of 150.98 thousand shares, closed regular trading session at $69.77. The company shares are currently trading at $66.29, down 4.99 percent in the after-hours trading session.
- The U.S. Food and Drug Administration (FDA) has accepted for filing the Gamida Cell’s (NASDAQ:GMDA) Biologics License Application (BLA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant. The regulatory agency has granted Priority Review for the BLA and has set a target action date of January 30, 2023. Gamida shares traded in a range of $1.57 to $1.79 on a day volume of 881.6 thousand shares, closed regular trading session at $1.61. The company shares are currently trading at $1.66, up 3.11 percent in the after-hours trading session.
- SCYNEXIS (NASDAQ: SCYX) announced that the U.S. Food and Drug Administration (FDA) has accepted its submission of a supplemental New Drug Application (sNDA) to expand the label of BREXAFEMME (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC). The regulatory agency has granted Priority Review for the submission and assigned the target decision date as November 30, 2022. SCYNEXIS shares traded in a range of $2.29 to $2.44 on a day volume of 82.29 thousand shares, closed regular trading session at $2.42.
- Agenus (NASDAQ:AGEN) has dosed the first patient in the Phase 1 clinical study of AGEN1571 in advanced solid tumors. The Phase 1 dose-escalation and expansion study will evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571. Agenus shares traded in a range of $2.46 to $2.62 on a day volume of 3.44 million shares, closed regular trading session at $2.48.
- Aerie Pharmaceuticals (NASDAQ:AERI) has initiated patient dosing in the Phase 3 registrational COMET-3 study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye disease (DED). Aerie shares traded in a range of $6.35 to $6.94 on a day volume of 425.77 thousand shares, closed regular trading session at $6.37. The company shares are currently trading at $6.06, down 4.87 percent in the after-hours trading session.
- The U.S. Food and Drug Administration (FDA) has announced clearance to Cellectis' (NASDAQ:CLLS) Investigational New Drug (IND) application to initiate a Phase 1/2a clinical trial of UCART20x22 for patients with relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL). Cellectis shares traded in a range of $2.74 to $3.28 on a day volume of 353.42 thousand shares, closed regular trading session at $3.00. The company shares are currently trading at $3.08, up 2.67 percent in the after-hours trading session.
- Concert Pharmaceuticals (NASDAQ:CNCE) announced positive topline results from its second Phase 3 clinical trial, THRIVE-AA2, evaluating its oral investigational medicine CTP-543 in adult patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete scalp hair loss. THRIVE-AA2 Study Met Primary and SecondaryEndpoints.Concert shares traded in a range of $5.66 to $6.24 on a day volume of 2.07 million shares, closed regular trading session at $5.89. The company shares are currently trading at $6.13, up 4.07 percent in the after-hours trading session.
- Otonomy (NASDAQ:OTIC) announced that the OTO-313 Phase 2 trial in tinnitus demonstrated no clinically meaningful benefit versus placebo for primary and secondary endpoints across all timepoints. The company to discontinue development of OTO-313 and implement other measures to extend its cash runway. Otonomy shares traded in a range of $0.29 to $0.43 on a day volume of 28.42 million shares, closed regular trading session at $0.29.
- CymaBay Therapeutics (NASDAQ:CBAY) announced the completion of enrollment for RESPONSE, a global Phase 3 study evaluating seladelpar for patients with Primary Biliary Cholangitis (PBC) that targeted enrollment of 180 patients recruited in over 20 countries, have not achieved the recommended treatment goal or who cannot tolerate UDCA. CymaBay shares traded in a range of $3.07 to $3.34 on a day volume of 631.91 thousand shares, closed regular trading session at $3.21. The company shares are currently trading at $3.31, up 3.12 percent in the after-hours trading session.
