BioSpace News Archive

KemPharm, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted the Orphan Drug Designation to serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH), for the treatment of idiopathic hypersomnia (IH), a rare neurological sleep disorder.

Twist Bioscience Corporation today reported financial results and business highlights for the fourth quarter and full year fiscal 2022 ended September 30, 2022.

Rain Therapeutics Inc. (NasdaqGS: RAIN), (“Rain”), a late-stage biotechnology company developing precision oncology therapeutics with a lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, today announced that it will be participating in Piper Sandler’s 34th Annual Healthcare Conference.

Belite Bio, Inc (NASDAQ: BLTE) today announced that, following discussions with the FDA, it has finalized the study design for its planned Phase 3 clinical trial to evaluate efficacy and safety of Tinlarebant (a/k/a LBS-008) in patients with geographic atrophy (GA) associated with Dry AMD.

Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) and MEI Pharma, Inc. (NASDAQ: MEIP) today announced topline data from the Phase 2 MIRAGE study evaluating zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta (“PI3Kδ”) inhibitor, in patients with indolent B-cell Non-Hodgkin’s Lymphoma (iB-NHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) in Japan.

Microbot Medical Inc., in a continuation of its efforts to create barriers and expand its global intellectual property portfolio for the LIBERTY® Robotic System, was issued a design patent allowance by the US Patent & Trademark Office, covering the LIBERTY Robotic System’s remote controller unique interface design.

Prasco Laboratories announced today the launch of the Authorized Generic of ZIOPTAN® (tafluprost ophthalmic solution) 0.0015%.

IDEX Corporation (NYSE:IEX) today announced that it has completed its previously-announced acquisition of micro-precision technology manufacturing company Muon B.V. and its subsidiaries (“Muon Group”).

Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”) today announced that recently completed exploratory biomarker analysis has confirmed clinical development plans for REVTx-300 in the treatment of CKD and AKI.

Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) (“Kiora” or the “Company”) announced today it has entered into warrant inducement offer letters to raise $3.12 million in gross proceeds from the exercise of 654,609 Class A warrants issued in the Company’s public offering from July 2022.