Biotech Catalysts - EOD Summary

The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics’ (NASDAQ: AXSM) lead asset AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. Axsome shares traded in a range of $50.5 to $61...

The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ: KRYS) Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB). The regulatory agency has granted  Priority...

The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s (NASDAQ: BLUE) lead asset ZYNTEGLO (betibeglogene autotemcel) to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. Bluebird...

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...

Gritstone bio (NASDAQ: GRTS) announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published today in Nature Medicine. The initial results from the study are expected during second half...

Pfizer (NYSE: PFE) announced positive top-line results from its pivotal U.S. Phase 3 study in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD). The study met two co-primary objectives, associated with...

The U.S. Food and Drug Administration (FDA) has accepted the Menarini Group and Radius Health’s (NASDAQ: RDUS), New Drug Application (NDA) for elacestrant for patients with ER+/HER2- advanced or metastatic breast cancer. The agency has granted Priority Review designation and assigned a...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ: RLMD) lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD). Relmada shares traded in a range of $26.02 to $27.96 on a day volume of 173.79...

Kodiak Sciences Inc. (NASDAQ: KOD) announced positive topline results its BEACON Phase 3 study of tarcocimab tedromer (KSI-301; tarcocimab) in patients with macular edema due to retinal vein occlusion. Kodiak shares traded in a range of $10.02 to $11.79 on a day volume of 4.05 million shares,...

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...

The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ: MDWD) recently re-submitted Biologics License Application (BLA) for its lead asset NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns....

Avalo Therapeutics (NASDAQ: AVTX) has dosed the first patient in the pivotal LADDER trial to assess the efficacy and safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II) ER). Avalo shares traded in a range of $3.5 to $3.91 on a day volume of 33.54 thousand shares,...

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 $...

The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ (NASDAQ: ARQT) New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in patients 12 years of age or older. The company expects commercial launch of the...

European Commission (EC) has approved AbbVie’s (NYSE: ABBV) lead asset RINVOQ (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis. AbbVie shares traded in a range of $150.33 to...