Biotech Archives - Page 715 of 795

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Immunovant Announces Two New Development Programs For Batoclimab

September 7, 6:31 AM

Plan to initiate a Pivotal Phase 2b trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the second half of 20221 with initial results from open-label period 1 expected in the first half of

IMVT

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BioVie Announces Topline Results From Investigator-Sponsored Exploratory Biomarker And Imaging Trial Of NE3107 For Treatment Of Alzheimer’s Disease; Says ‘Vast majority of patients saw significant improvements in the Global Rating of Change’

By Bill Haddad

September 7, 6:03 AM

Vast majority of patients saw significant improvements in the Global Rating of Change (overall impression of patient's daily abilities) with NE3107 treatment (p<0.0001 to p<0.05). NE3107 is

BIVI

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Equillium Buys Inflammatory Bowel Disease Player In All-Stock Deal

By Vandana Singh

September 7, 5:58 AM

Equillium Inc (NASDAQ:EQ) has agreed to acquire Metacrine Inc (NASDAQ:MTCR) in an all-stock transaction. The transaction is anticipated to add $33 million…

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Rhythm Secures European Commission Marketing Authorization For Genetic Disease Candidate

By Ragothaman Srinivasan

September 6, 5:11 PM

The European Commission (EC) has expanded the marketing authorization for Rhythm’s (NASDAQ: RYTM) lead drug product IMCIVREE (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age an

RYTM

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Vaxcyte Completes Enrolment In Mid-Stage Pneumococcal Disease Study, Sees Top-line Data In H1 2013

By Ragothaman Srinivasan

September 6, 4:49 PM

Vaxcyte (NASDAQ: PCVX) has completed patient enrollment in the Phase 2 study evaluating VAX-24 in healthy adults 65 years of age and older. VAX-24 is its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

PCVX

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Eledon Shares Climb After Securing FDA Nod For Mid-Stage Kidney Disease Study

By Ragothaman Srinivasan

September 6, 4:27 PM

Eledon Pharmaceuticals (NASDAQ: ELDN) received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to evaluate tegoprubart for the treatment of IgA Nephropathy (IgAN).

ELDN

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This Analyst Sees Recovery For PolyPid Despite Failed Phase 3 Readout

By Vandana Singh

September 6, 3:25 PM

Raymond James downgraded PolyPid Ltd (NASDAQ:PYPD) from Strong Buy to Outperform post SHIELD I Phase 3 results that, despite consistency and evidence of…

PYPD

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Athira Outlines Possible Comeback For Alzheimer’s Candidate

By Vandana Singh

September 6, 3:22 PM

Athira Pharma Inc (NASDAQ:ATHA) announced an update to its plans for the ongoing LIFT-AD trial of fosgonimeton (ATH-1017) for mild-to-moderate Alzheimer’s…

ATHA

2 minute read

FDA Again Highlights Lacking Data From Amylyx’s Amyotrophic Lateral Sclerosis Candidate

By Vandana Singh

September 6, 3:12 PM

The FDA released briefing documents for Amylyx Pharmaceuticals Inc’s (NASDAQ:AMLX) experimental amyotrophic lateral sclerosis drug, as a second adcomm is scheduled…

AMLX