FDA documents hint at ‘uphill battle’ for broad approval of Sage’s depression drug

The newly posted documents show the agency had concerns about the side effects experienced by people with clinical depression who took Sage’s drug, Zurzuvae.

By Jacob Bell • Sept. 1, 2023

Sage, reeling from depression drug decision, to lay off 40% of workforce

Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.

By Kristin Jensen • Aug. 31, 2023

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

Intarcia, a former biotech unicorn, gets new life with startup deal

I2o Therapeutics, now led by former Intarcia head Kurt Graves, licensed the diabetes treatment Intarcia has spent more than a decade developing.

By Gwendolyn Wu • Aug. 30, 2023

Novo, continuing deal streak, buys another obesity drug startup

The acquisition of Embark Biotech, which Novo helped found, gives the company another prospect to add to its arsenal of weight-loss medicines.

By Jonathan Gardner • Aug. 30, 2023

FibroGen’s Duchenne drug fails second trial in latest study setback

The failure marks another Phase 3 miss for the drug, pamrevlumab, and follows a restructuring and CEO switch for the struggling biotech.

By Delilah Alvarado • Aug. 30, 2023

Epigenic joins wave of startups raising cash to edit the epigenome

The China-based company is one of at least four young biotechs in a competitive race to use CRISPR tools to alter gene expression without changing DNA.

By Kristin Jensen • Aug. 30, 2023

Apellis to lay off 25% of staff, trim research in major restructuring

The job cuts will affect about 225 employees, making it one of the largest single rounds of layoffs within the biotech sector this year.

By Ben Fidler • Aug. 29, 2023

Superluminal draws RA Capital, Nvidia as investors in GPCR drug hunt

GPCRs, a ubiquitous family of proteins that are prime drug targets, have drawn the interest of companies like Structure Therapeutics, Septerna and now Superluminal Medicines.

By Gwendolyn Wu • Aug. 28, 2023

Bayer reports positive early data for Parkinson’s cell therapy

The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression. 

By Jacob Bell • Aug. 28, 2023

Artificial intelligence: The prime mover in drug discovery

With its ability to process vast amounts of data and identify patterns, AI can significantly reduce the time and cost involved in developing new drugs.

Aug. 28, 2023

Neumora, a richly funded brain drug developer, readies for an IPO

Neumora’s filing, along with that of radiopharmaceutical startup RayzeBio last week, could be an important test of the biotech IPO market.

By Gwendolyn Wu • Aug. 25, 2023

Radiopharmaceutical drugmaker RayzeBio signals plans to go public

Biotech's IPO drought has endured into late August, but a small group of drugmakers are now in line ahead of a fall that analysts predict could be busier.

By Gwendolyn Wu • Aug. 25, 2023

Agenus to lay off 25% of staff, trim pipeline in cancer drug push

The job cuts are meant to preserve enough cash so the nearly three-decade-old company can potentially pursue its first drug approval next year.

By Delilah Alvarado • Aug. 23, 2023

J&J-backed startup raises another $150M for brain drug development

The funding for Rapport Therapeutics saw participation from a series of so-called crossover investors, many of which have pulled back from biotech startups in recent years. 

By Jacob Bell • Aug. 23, 2023

Apellis finds faulty needles in probe of rare eye drug side effects

The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.

By Kristin Jensen • Aug. 23, 2023

‘Project NextGen’ to spend $1.4B in search for better COVID drugs, vaccines

The funds going to Regeneron, clinical trial partners and other developers are the first major investments under a federal program announced in May.

By Ben Fidler • Aug. 22, 2023

Fulcrum rejoins sickle cell drug race as FDA lifts study hold

The biotech, which aims to develop an alternative to existing medicines and emerging gene-based treatments, will focus further testing on sicker patients.

By Ben Fidler • Aug. 22, 2023

Foundery, a new biotech venture firm, sets out to speed early immune drug research

Billing itself as both a scientific and investment partner, Foundery aims to provide drug development support to researchers working on new immunotherapies.

By Gwendolyn Wu • Aug. 22, 2023

Genesis raises $200 million for AI drug discovery research

The Series B round brings the total funding for Genesis, a California startup backed by Andreessen Horowitz and Nvidia’s VC arm, to over $280 million.

By Delilah Alvarado • Aug. 21, 2023

FDA expands use of Neurocrine drug to Huntington’s patients

Analysts expect the approval of Ingrezza in Huntington’s patients with a movement disorder known as chorea to intensify a commercial battle between Neurocrine and Teva.

By Jacob Bell • Aug. 21, 2023

Appeals court rules to limit abortion pill access

Federal judges said recent changes by the FDA to loosen prescribing rules for mifepristone should be rolled back. Biotech leaders have warned the case could undermine the agency’s authority.

By Delilah Alvarado • Updated Aug. 17, 2023

FDA won’t hold advisory meeting for Bluebird’s sickle cell gene therapy

The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review. 

By Kristin Jensen • Aug. 16, 2023

In a year with few biotech IPOs, ‘crossover’ financings are hard to find

Investors known for funding the final private financing round before a biotech company goes public have pulled back as the IPO window remains shut.

By Gwendolyn Wu • Updated Aug. 16, 2023

Gilead allies with targeted drug startup Tentarix in latest research bet

San Diego-based Tentarix will receive $66 million in cash and equity from Gilead, which holds an option to acquire up to three of the company’s subsidiaries.

By Ned Pagliarulo • Aug. 15, 2023

Radiopharmaceuticals for cancer: Making radiation precise

More than a dozen startups have joined a few publicly traded biotechs and larger pharmaceutical firms in what’s become one of the most competitive areas in drug research.

By Ben Fidler • Aug. 15, 2023