Biotechnology Archives - MicroSmallCap

FDA Approves Bayer’s Nubeqa for Wider Use in Prostate Cancer Subtype.

In combination with docetaxel, the U.S. Food and Drug Administration (FDA) has approved Bayer’s Nubeqa for the treatment of hormone-sensitive metastatic prostate cancer (mHSPC).Nubeqa (darolutamide) was previously approved for the treatment of non-metastatic castration-resistant prostate ... [Read]

FDA provides a positive pre-IND response to Alzamend Neuro for AL001.

Jul 19 Peter Olaoluwapo

Alzamend Neuro, Inc. (Nasdaq:ALZN) is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”), and post-traumatic stress disorder (“PTSD”), announced today ... [Read]

Amryt to Pursue Formal Dispute Resolution for Oleogel-S10 NDA

Amryt to Pursue Formal Dispute Resolution for Oleogel-S10 (Filsuvez®) NDA

Jun 24 Peter Olaoluwapo

Amryt (Nasdaq: AMYT), a multinational, commercial-stage biopharmaceutical company with a focus on acquiring, developing, and commercializing novel treatments for rare diseases, today announced its intention to submit a Formal Dispute Resolution Request (FDRR) for its ... [Read]

Eton Pharmaceuticals Sells Hospital Supplies to Dr. Reddy’s for up to $50M

Jun 24 Peter Olaoluwapo

Eton Pharmaceuticals, Inc. (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today declared that it had agreed to sell its hospital goods to Dr. Reddy’s Laboratories SA, a ... [Read]

Evaxion Biotech Broadens EVX-03 DNA Vaccine Project Into Non-Small Cell Lung Cancer.

Jun 23 Peter Olaoluwapo

Evaxion Biotech A/S (NASDAQ: EVAX) a clinical-stage biotechnology company focused on the creation of AI-driven immunotherapies, announced today that it has chosen EVX-03 as the product candidate within its DNA technology platform to target a ... [Read]

Optimi Health Requests for Authorization to Manufacture MDMA, Other Synthetic Psychedelics

Jun 22 Peter Olaoluwapo

Optimi Health Corp, a native Canadian business that creates natural, scalable, and affordable mushroom formulations for transformational human experiences, has made a health request to Canada for an amendment to the Controlled Substances Dealer’s Licence. ... [Read]

Akouos Presents Nonclinical Data Supporting the Planned Clinical Development of AK-OTOF and Strategies for Regulated Gene Expression in the Inner Ear at the American Society of Gene and Cell Therapy 25th Annual Meeting

May 19

– Nonclinical data demonstrate that a single intracochlear administration of an AAVAnc80 vector led to durable restoration of auditory function and was well tolerated, supporting planned clinical development of AK-OTOF for the treatment of OTOF ... [Read]

Inmagene Receives FDA IND Clearance for a Third Generation BTK Inhibitor Targeting Immunological Diseases

May 15

PR Newswire SAN DIEGO and SHANGHAI , May 15, 2022 /PRNewswire/ — Inmagene Biopharmaceuticals (“Inmagene”) announces that today the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug ... [Read]

Aileron Therapeutics Announces Late-Breaking Oral Presentation of Non-Clinical Data Demonstrating ALRN-6924 Protected Human Hair Follicles and Their Stem Cells from Chemotherapy-Induced Damage at Upcoming Society for Investigative Dermatology 2022 Annual Meeting

May 10

Taxanes, such as paclitaxel and docetaxel, cause severe and often permanent chemotherapy-induced hair loss (alopecia) New non-clinical data demonstrate proof of principle that ALRN-6924 can temporarily arrest the cell cycle in human scalp hair follicles ... [Read]

Codexis to Present Data Highlighting Three Gene Therapy Programs at the ASGCT 25th Annual Meeting

May 2

REDWOOD CITY, Calif., May 02, 2022 (GLOBE NEWSWIRE) — Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company enabling the promise of synthetic biology, today announced two poster presentations highlighting three of the Company’s gene ... [Read]