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Home » Newsletters » BioWorld

BioWorld

May 10, 2019

View Archived Issues

Uber good day for biopharma IPOs; hearts and minds lead the way, investors not immune

Biopharma companies priced four IPOs Thursday, the most for any single day since last June, raising a combined total of $303.9 million. When adding in Trevi Therapeutics Inc.'s $55 million IPO on Tuesday, the week's debuts represent a quarter of all those completed on U.S. exchanges this year, and about 18% of the total money raised. Read More

Opdivo fails second GBM phase III study

DUBLIN – Opdivo (nivolumab) is now approved in 13 distinct cancer indications spread across eight different types of cancer, but glioblastoma multiforme (GBM) is looking unlikely to become an addition to that list, as Bristol-Myers Squibb Co. reported Tuesday that the PD-1 inhibitor failed to demonstrate a survival benefit in the phase III Checkmate-498 study in 550 newly diagnosed GBM patients. Participants had the difficult-to-treat O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated form of the condition. Read More

Debt-laden Takeda sells Xiidra to Novartis in potential $5.3B deal; Tachosil goes to J&J

Novartis AG is buying from Takeda Pharmaceutical Co. Ltd. the dry eye therapy Xiidra (lifitegrast ophthalmic solution) for a $3.4 billion up-front payment, with up to $1.9 billion more if milestones are met, and the Basel, Switzerland-based firm is bringing aboard about 400 employees – mostly based in the U.S. and Canada – associated with the drug, which was approved by the FDA in the summer of 2016. Read More

Chimerix's brincidofovir nothing but a chimera as company halts development due to enrollment

Chimerix Inc. is discontinuing clinical trials for oral and intravenous brincidofovir because it can't attract enough patients for the studies, the company said Thursday. The shutdown means laying off more than half its staff in Durham, N.C. Read More

Investors keeping 'tab' on Atara progress; phase III's enrollment less than brisk

Atara Biotherapeutics Inc.'s backers proved less than happy with the phase III delay for the T-cell immunotherapy tab-cel (tabelecleucel), but the company remained upbeat about prospects with the compound in patients with Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disease (PTLD, or lymphomas that develop after a transplant). Read More

Despite record-breaking year, China-focused VC investors still see challenges

SHANGHAI – Despite a year in which China's venture investors raised a highest-ever $42.8 billion to invest in life sciences companies, deploying a record sum globally, superlatives about the nation's supersized investment activity can wear thin. Inviting a closer look, Chinabio Group founder and CEO Greg Scott enlisted a panel of key VCs to take a closer look at the unfolding dynamics during the second and final day of the Chinabio Partnering Forum. Read More

Drug pricing conversation continues as 'fixes' move through Congress

Even as legislation targeting U.S. drug prices is advancing in Congress, lawmakers continue to try to wrap their heads around the factors that are driving those prices. Read More

Phage therapy treats drug-resistant mycobacterial infection

In a first, researchers were able to use a genetically modified specific lytic phage strain to stop an otherwise generally lethal drug-resistant Mycobacterium abscessus infection in a cystic fibrosis patient after persistent infections, as reported in the May 8, 2019, issue of Nature Medicine. Read More

Earnings

Acelrx Pharmaceuticals Inc., of Redwood City, Calif., which launched Dsuvia, a sublingual 30-mcg tablet version of sufentanil, in February, recorded a net loss of $13.7 million, or 17 cents per basic and diluted share for the first quarter of 2019, compared to $11.6 million, or 23 cents per basic and diluted share, for the first quarter of 2018. The company closed the period with cash, cash equivalents and short-term investments of $90.2 million. Read More

Financings

Zosano Pharma Corp., of Fremont, Calif., said it issued and sold an additional 750,000 shares of common stock, pursuant to the exercise in full of the underwriter's option in connection with Zosano's public offering. A total of 5.75 million shares of common stock have now been sold, resulting in net proceeds of about $18.4 million.  Read More

Regulatory front

The U.S. House Committee on Appropriations has passed a spending bill that would fund the Department of Health and Human Services with $99 billion in fiscal year 2020, which if enacted would constitute an increase of $8.5 billion over the level enacted for fiscal 2019.  Read More

Other news to note

Eisai Co. Ltd. and Allm Inc., both of Tokyo, are collaborating to develop digital health solutions using Allm's ICT systems for medical treatment and care. Terms of the deal weren't disclosed. Read More

Clinical data for May 9, 2019

Read More

Regulatory actions for May 9, 2019

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