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Home » Newsletters » BioWorld

BioWorld

Jan. 25, 2019

View Archived Issues

Gossamer uses novel path to file for $230M IPO on Nasdaq despite shutdown

Leveraging a little-used Securities Act rule made freshly relevant by the ongoing U.S. government shutdown, Gossamer Bio Inc. has set terms for a $230 million IPO. The San Diego-based company, which is developing therapies primarily for immunology and inflammation, has set terms for an offering of 14.4 million shares for $16 each. Barring a reevaluation of its approach should the SEC restore normal operations, the filing will become effective Feb. 12, with Gossamer listing on Nasdaq under the symbol GOSS. Read More

U.K.'s 20-year plan aims to address market failure in antimicrobial space

LONDON – The U.K. government has set out plans to address the market failure in antibiotics, saying it will test a new model "to de-link the payments made to companies from the volume of antibiotics sold." Read More

What you know can HER2: Breast paradigm changes, Street mulls Nerlynx odds

In December, when Puma Biotechnology Inc. disclosed data with the breast cancer drug Nerlynx (neratinib), a kinase inhibitor that irreversibly binds to EGFR, HER2 and HER4, questions that were already on the burner bubbled harder regarding the drug's future, especially given the shifting treatment setup in HER2-positive disease. Read More

AI gains traction as biopharma innovation app, but beware the turdly trap

As the 37th Annual J.P. Morgan (JPM) Healthcare Conference was drawing to a close, a research team led by investigators from the NIH and Global Good generated considerable buzz with the disclosure of a computer algorithm that can analyze digital images of a woman's cervix and accurately identify precancerous changes that require medical attention. Researchers said the artificial intelligence (AI) approach, dubbed automated visual evaluation, offered the potential to transform cervical cancer screening, particularly in low-resource settings. Read More

Ironwood, Cyclerion take steps toward split, move neuro sGC stimulator into clinic

Ironwood Pharmaceuticals Inc. initiated a phase I study in healthy volunteers with IW-6463, its oral central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator, aimed at the treatment of serious and orphan CNS disorders, potentially including vascular dementia and Alzheimer's disease (AD). Data from the study are expected in the second half of the year, positioning IW-6463 to follow several ongoing programs into midstage development, but not by Ironwood. Instead, the sGC stimulator portfolio is set to transition to spinout Cyclerion Therapeutics Inc., with separation of the companies on track to complete in the first half of the year. Read More

Tara's heart-on-a-chip platform creates functional, differentiated tissue from any cells: study

New York-based Tara Biosystems Inc. has staked its claim to offering a functional representation of the human heart that is the closest, most accurate one that is currently marketed. To help back that up, its technology, the Biowire II platform, has been assessed for the first time by researchers in a peer-reviewed journal. Read More

Napajen solving oligonucleotide delivery challenge, advancing GVHD drug with $12.4M series C

HONG KONG – With a focus on precision drug delivery, Napajen Pharma Inc. has developed a platform technology that enables stable and selective delivery of oligonucleotide compounds to immune cells, with sights set on treating immune-related conditions, such as autoimmune diseases and cancer, as well as developing transplants and vaccines. Read More

Regulatory front

U.S. President Donald Trump, Health and Human Services Secretary Alex Azar and other administration officials met with patients and doctors Wednesday to discuss fair and honest pricing in health care. Besides listening to patient experiences about surprise health care costs and unaffordable drugs, diagnostics and other medical services, the administration used the roundtable as a showcase for steps it has and is taking to reduce health care prices.  Read More

Other news to note

Seelos Therapeutics Inc., of New York, said it completed its merger with Apricus Biosciences Inc., of San Diego, with the combined company – to be known as Seelos Therapeutics – focusing on development and commercialization of CNS therapeutics. Seelos began trading Thursday on Nasdaq under the ticker SEEL. Read More

Financings

Bio-Path Holdings Inc., of Houston, said it closed a registered direct offering priced at the market, generating gross proceeds of approximately $1.7 million from the sale of 648,233 shares at $2.65 each. Additionally, in a concurrent private placement, the company issued to the investors unregistered warrants to purchase up to 324,117 shares of common stock with an exercise price of $2.65 per share. It intends to use the net proceeds from the offerings for working capital and general corporate purposes. Read More

Clinical data for Jan. 24, 2019

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Regulatory actions for Jan. 24, 2019

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