Biotech

Merck pays startup Orna $150M as ‘circular RNA’ attracts industry interest

The pharmaceutical company has formed an alliance with Orna and invested $100 million in its Series B round, hoping the young biotech’s approach could lead to multiple new vaccines and drugs. 

By Ben Fidler • Aug. 16, 2022

Amid market turbulence, a Flagship startup pushes off an IPO with a new fundraise

Senda Biosciences decided to raise a $123 million Series C round rather than test public markets with an initial offering, its top executive said.

By Gwendolyn Wu • Aug. 16, 2022

Explore the Trendline➔

Cell therapy

Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.

By BioPharma Dive staff

‘Treg’ cell therapy: bringing CAR-T to autoimmune disease

At least seven companies, including five richly funded startups, are developing cell-based treatments for inflammatory conditions, making it one of biotech’s most competitive fields. 

By Ben Fidler • Aug. 16, 2022

Despite failed trial, Brainstorm asks FDA to approve ALS drug

The move comes less than a month after the agency agreed to review Biogen’s tofersen — another ALS drug with a questionable record in clinical testing.

By Jacob Bell • Aug. 15, 2022

UK approves Moderna’s two-pronged COVID-19 booster

Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus. 

By Jonathan Gardner • Aug. 15, 2022

Seagen loses arbitration case to Daiichi Sankyo over cancer drug technology

An arbitrator ruled against Seagen in a dispute over technology used in Enhertu and other Daiichi Sankyo drugs, stopping an attempt by Seagen to collect lucrative royalties.

By Ben Fidler • Aug. 12, 2022

Shifting focus, ProQR to seek partners for stalled eye drugs

The company will wind down five trials involving two drug candidates and lay off more staff, prioritizing instead its RNA-editing technology.

By Delilah Alvarado • Aug. 11, 2022

Samantha Truex on biotech hiring, competing for funding and Upstream’s next steps

The CEO recently led Upstream through a $200 million financing that will support development of an inflammatory disease drug. “We have what investors probably want at this time,” she told BioPharma Dive.

By Ned Pagliarulo • Aug. 9, 2022

Karuna shares soar on schizophrenia drug results

The company plans to ask regulators to approve its KarXT therapy based on the results, which one analyst called “as good as one could hope for.”

By Jacob Bell • Aug. 8, 2022

Acadia turned back by FDA on second attempt to get psychosis drug approved

The agency issued Acadia a complete response letter for pimavanserin, for which the company had sought to win an expanded clearance in Alzheimer’s disease psychosis.

By Ned Pagliarulo • Aug. 5, 2022

ElevateBio, Boston Children’s launch startup to test new approach to ‘off-the-shelf’ cell therapy

Spun out of a Boston Children’s research lab, the biotech is the first to emerge from a partnership ElevateBio and the hospital struck to create new cell and gene therapy companies.

By Delilah Alvarado • Aug. 4, 2022

Gilead, following cell therapy approval, impresses Wall Street with fast sales

Together, the biotech’s two CAR-T therapies earned $368 million between April and June, a substantial jump over last year and above what analysts forecast.

By Jacob Bell • Aug. 3, 2022

Alnylam drug succeeds in key heart disease study, boosting company

The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.

By Ben Fidler • Aug. 3, 2022

IDRx, a new biotech startup, raises $122M to develop better cancer drug combinations

Founded by entrepreneur Alexis Borisy, the company comes equipped with two experimental medicines it licensed from Merck KGaA and Blueprint Medicines.

By Ned Pagliarulo • Aug. 2, 2022

Strand CEO on founder-led biotech, venture capital and the market’s retreat

Jake Becraft, founder and current chief of mRNA startup Strand Therapeutics, argues biotech would be healthier if more scientists and researchers lead the companies they start.

By Ned Pagliarulo • Aug. 2, 2022

How Belite Bio, a small, under-the-radar drugmaker, emerged as one of biotech’s best performing IPOs

Belite's shares have risen nearly 500% from their IPO price at a time when many other newly public biotech companies are struggling to hold their value.

By Delilah Alvarado • Updated Aug. 2, 2022

Nuvation to cut workforce by 35% as it scraps lead drug program

The company, which is led by former Medivation executives and focuses on cancer research, said the shake-up is in response to an “internal risk-benefit analysis” that raised doubts about its most advanced program.

By Jacob Bell • Aug. 1, 2022

Concert to seek approval for hair loss drug after second study success

The biotech plans to file an application with the FDA in the first half of next year for clearance in alopecia areata, potentially positioning it to compete with Eli Lilly and Pfizer for market share.

By Ned Pagliarulo • Aug. 1, 2022

Sarepta to ask FDA for accelerated approval of Duchenne gene therapy

After discussions with the FDA, the biotech aims to submit an application this fall — sooner than expected and ahead of a Phase 3 study that’s now ongoing.

By Jonathan Gardner • July 29, 2022

Alnylam reveals longer wait for anticipated drug trial results

Important data from the APOLLO study of the biotech's drug Onpattro are due before the end of August, Alnylam said Thursday.

By Ned Pagliarulo • July 28, 2022

Novartis-linked startup launches with technology designed to remove ‘destroy’ tags on helpful proteins

Vicinitas and its protein-stabilizing research have attracted $65 million from a group of investors that includes a16z, Deerfield and GV.

By Jacob Bell • July 28, 2022

Versant partners with AbCellera to arm startups with better antibodies

The companies pitch their collaboration as a way to give young drugmakers backed by Versant a head start. “Our business is advanced by great ideas coming into the funnel,” said AbCellera’s CEO. 

By Ned Pagliarulo • July 27, 2022

BridgeBio advances drug for dwarfism after study data

The highest tested dose of BridgeBio’s drug helped the bones of children with achondroplasia grow faster, leading the company to expand study enrollment.

By Ned Pagliarulo • July 26, 2022

Seagen, Astellas claim positive results in study key to cancer drug's success

The mid-stage trial tested the companies’ drug Padcev with Merck’s Keytruda in first-line bladder cancer. The data are reportedly a factor in Merck’s talks with Seagen over a potential buyout.

By Ned Pagliarulo • July 26, 2022

FDA, in another test of its flexibility, agrees to review Biogen's closely watched ALS drug

Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.

By Jacob Bell • July 26, 2022