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Home » Newsletters » BioWorld

BioWorld

Dec. 5, 2019

View Archived Issues
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Key for aducanumab success: higher dose, longer exposure

SAN DIEGO  – Following up on its October announcement that it would file for FDA approval of beta-amyloid-targeting aducanumab, Biogen Inc. presented the final dataset for the phase III Emerge and Engage studies at the 12th Clinical Trials on Alzheimer’s Disease Meeting. Read More

FDA issues CRL for Enzyvant's congenital athymia therapy

An FDA review of Enzyvant Inc.'s RVT-802, a tissue-based therapy for children born without a thymus, has drawn a complete response letter (CRL) from the agency over concerns about chemistry, manufacturing and controls, scuttling hopes it would become the first FDA-designated regenerative medicine advanced therapy (RMAT) to win approval from the agency. Read More
Stock surge

Borealis keys to palace: Aurinia’s Aurora phase III bid with voclosporin lights up LN

In the summer of 2016, when Victoria, British Columbia-based Aurinia Pharmaceuticals Inc. offered phase IIb results with its calcineurin inhibitor voclosporin in lupus nephritis (LN), Wall Street ignored the otherwise-positive results and zeroed in on the trial’s death rate: 13 casualties across three arms of the 265-subject Aura-LV study.  Read More

Scaling the Mountain: Sage study marks a primary endpoint miss

Despite some encouraging top-line data from Sage Therapeutics Inc.’s phase III Mountain study of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD), the company, the market and analysts were taken aback at the trial’s failure to hit its primary endpoint.  Read More

Worth the wait, Acadia’s Nuplazid looks good in dementia-related psychosis

SAN DIEGO – Three months ago, Acadia Pharmaceuticals Inc. said Nuplazid (pimavanserin), its serotonin inverse agonist and antagonist that preferentially targets the 5-HT2A receptor, met the primary endpoint during an interim look at the phase III Harmony study in patients with dementia-related psychosis (DRP). Read More

Cancer-focused Black Diamond raises $85M series C

Tumor-agnostic therapy developer Black Diamond Therapeutics Inc. has completed an oversubscribed series C financing of $85 million. The Cambridge, Mass.-based company said proceeds will help it advance candidates targeting oncogenic driver mutations of the ErbB kinases in EGFR and HER2, starting with a combined phase I/II trial of its most advanced candidate next year. Read More

Rapt licenses FLX-475 to Hanmi in deal worth up to $118M

HONG KONG – Rapt Therapeutics Inc., of San Francisco, and Seoul, South Korea-based Hanmi Pharmaceutical Co. Ltd. entered a license agreement for Rapt’s FLX-475 in Asia. FLX-475 is an oral, small-molecule CCR4 antagonist for cancer treatment.  Read More

4Teen4 closes $8M A round to test first-in-class cardiogenic shock drug

DUBLIN – 4Teen4 Pharmaceuticals GmbH raised €6.9 million (US$7.7 million) in a series A round to take procizumab, a first-in-class inhibitor of circulating dipeptidyl-peptidase 3 (cDPP3), into clinical trials for patients with cardiogenic shock. Read More

Akoya Biosciences rakes in $50M to back CODEX, Phenoptics platforms

Menlo Park, Calif.-based Akoya Biosciences Inc. has scooped up $50 million in financing, with an eye toward growing via the expansion of commercial and operational resources and continuing product development activities around its platforms for spatial biology. Read More

Financings for Dec. 5, 2019

Biopharmas raising money in public or private financings. Read More

In the clinic for Dec. 5, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Other news to note for Dec. 5, 2019

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief. Read More

Regulatory actions for Dec. 5, 2019

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

Regulatory front for Dec. 5, 2019

The latest global regulatory news, changes and updates affecting biopharma. Read More

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