Phase 2 Trial

Clene Inc (NASDAQ: CLNN) presented new data from the RESCUE-ALS Phase 2 study of CNM-Au8, a catalytically active gold nanocrystal suspension for amyotrophic lateral sclerosis (ALS). Data were shared at the 4th Annual ALS ONE Research Symposium. New data presented included analyses...

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) claimed its second early-stage win after announcing positive results in a small study of VX-147 on a genetically defined form of chronic kidney disease. The 16-patient, Phase 2 trial focused on patients with focal segmental...

Mereo BioPharma Group plc (NASDAQ: MREO) reported interim data from ACTIVATE Phase 1b/2 study of its anti-TIGIT antibody, etigilimab, in combination with Bristol Myers Squibb Co (NYSE: BMY) Opdivo (nivolumab) in select recurrent advanced/metastatic solid tumors. As of the...

The FDA authorized an investigator-initiated Phase 2 trial evaluating Cybin Inc's (NYSE: CYBN) psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing COVID-related distress. The trial will be conducted at the University of Washington. It...

Olema Pharmaceuticals Inc (NASDAQ: OLMA) had been preparing to present the first clinical data from its lead program in development for metastatic breast cancer at a conference next week. But its poster supposedly leaked online on Monday.  In response, Olema issued a statement...

MEI Pharma Inc (NASDAQ: MEIP) and Kyowa Kirin Co Ltd have announced data from the pivotal Phase 2 TIDAL study of zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies. Data demonstrated a 70.3% objective...

The independent data monitoring committee (DMC) has recommended First Wave BioPharma Inc (NASDAQ: FWBI) to continue enrollment in Part 2 of the RESERVOIR Phase 2 trial evaluating FW-COV for COVID-19-related gastrointestinal (GI) infections.  FW-COV is a proprietary, oral tablet...

The FDA has cleared Adagene Inc's (NASDAQ: ADAG) Investigational New Drug (IND) application to proceed with a Phase 1b/2 trial of ADG116, in combination with Merck & Co Inc (NYSE: MRK) Keytruda (pembrolizumab).  The global trial (ADG116-P001 / KEYNOTE-C97)...

Sigilon Therapeutics Inc (NASDAQ: SGTX) reported that fibrosed spheres were observed during a retrieval procedure in a patient in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A. The SIG-001 trial had been placed on FDA clinical hold following a serious...

Israel Institute for Biological Research (IIBR) has posted scientific results from an initial sample of Phase 2 vaccinated patients to assess the BriLife vaccine against the COVID-19 Delta variant. Blood (Sera) from an initial sample of 11 trial participants demonstrated effective...

The FDA has placed a clinical hold on Selecta Biosciences Inc's (NASDAQ: SELB) Phase 1/2 trial of SEL-302 (which consists of MMA-101 plus ImmTOR) for methylmalonic acidemia (MMA). MMA is a disorder in which the body cannot break down certain proteins and fats, resulting in...

Pfizer Inc (NYSE: PFE) has provided an update on the Phase 2b study of vupanorsen, investigational antisense therapy for cardiovascular (CV) risk reduction and severe hypertriglyceridemia. In the dose-ranging study in subjects with elevated non-HDL-C and triglycerides (TG), the study met...

Gilead Sciences Inc (NASDAQ: GILD) and Merck & Co Inc (NYSE: MRK) have temporarily paused enrollment in the Phase 2 study evaluating the combination regimen of islatravir and lenacapavir in HIV infection. The temporary pause has been implemented out of an abundance of...

The FDA has signed off Tonix Pharmaceuticals Holding Corp's (NASDAQ: TNXP) Investigational New Drug (IND) Application to initiate Phase 2 study of TNX-1900 for migraine.  TNX-1900 is intranasal potentiated oxytocin designed for the prevention of migraine headaches in...

Imara Inc (NASDAQ: IMRA) has announced a change to the primary endpoint for the Ardent Phase 2 trial of tovinontrine (IMR-687) in sickle cell disease. Imara is a biopharmaceutical company focused on therapeutics for rare inherited genetic disorders of hemoglobin. The change follows...