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Viridian may have edge over Amgen in eye drug showdown, analysts argue

The FDA, through a new approval, gave Viridian's drug a label that some on Wall Street believe makes it well-positioned to compete against Tepezza in the thyroid eye disease market.

Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program

The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.

Theravance, after clinical setbacks, agrees to $929M buyout

The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.

To Wall Street, psychedelics biotechs are more teammates than rivals

Some analysts argue that, even for competitors, a big clinical trial win for Definium Therapeutics helps validate the psychedelic field and “bring it even further into the mainstream.”

‘The window’s open’: At BIO, investors take stock of a growing class of biotech IPOs

In interviews as well as a panel at BIO’s annual meeting, investors and life sciences bankers predicted an acceleration in offerings later this year — but only among companies fitting a certain criteria.

How Kardigan spun deal leftovers into a $400M IPO

CEO Tassos Gianakakos said having late-stage assets and a team fortified at MyoKardia really resonated with investors. SpaceX's huge public offering didn't hurt either.

Beeline ups its Series A round for immune drug work

The company, which was built by Bain Capital, has now raised more than $426 million in its quest to advance a portfolio of Bristol Myers drugs.

FDA accepts Replimune filing; Merck KGaA drops $11B on life sciences services

Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicines outlined more RAS-blocking data and a Definium stock offering brought in $800 million.

On second try, Acadia drug gets nod from European regulators

The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.

Ionis, with new FDA nod, hits a ‘commercial inflection point’

Historically seen as a "platform monetization story," according to one analyst, Ionis now has a potential multibillion-dollar medicine in Tryngolza, which secured expanded approval Wednesday.

Remix to go public in reverse merger with once high-flying Passage Bio

The transaction marks the latest turn in the fortunes of Passage Bio, one of the companies started by gene therapy pioneer Jim Wilson.

Antares gets $105M from Novartis for new cancer drugs

Adam Friedman, CEO of the Scorpion Therapeutics spinout, said the deal helps both companies accelerate research "faster than either of us could alone."

Ollin refuels with $330M to back pivotal tests of Vabysmo challenger

One of the year’s largest venture funding rounds comes just after a head-to-head study showed Ollin’s drug — licensed from a China-based developer — had certain advantages over Roche’s eye treatment.

Investors pour $115M into RQ Bio in search of a preventive flu drug

The startup claims to have a “differentiated” antibody that can provide long-lasting protection against a variety of influenza strains.

Sangamo holds a bankruptcy sale; VCs back a China-linked Beam competitor

Eli Lilly and Astellas will be the lead bidders at an auction for Sangamo assets. Elsewhere, an investor syndicate committed $230 million to a gene editing startup and Merck KGaA struck a “build-to-buy” deal.

HHS, responding to China’s rise, moves to fast-track early drug research

A series of newly planned reforms are designed to entice companies to start early trials in the U.S. rather than overseas.

Pfizer drug acquired in Seagen deal disappoints in lung cancer study

The setback dims the outlook for a medicine Pfizer sees as an important contributor going forward, though some analysts are optimistic about the drug’s chances in another trial.

AbbVie to acquire Apogee, staking nearly $11B on long-acting autoimmune drugs

AbbVie’s largest deal in more than half a decade adds a group of immune disease medications — among them a Dupixent competitor — the company believes to have “mega-blockbuster” sales potential.

Sanofi swaps R&D leaders; Merck’s Prometheus deal pays dividends

Houman Ashrafian is leaving Sanofi to pursue a new opportunity. Elsewhere, one of Merck’s prized immune drugs succeeded in a pivotal study and a psychedelics biotech’s shares surged.

Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection

The agency took another step toward clearing a backlog of Makary-era rejections that appeared to contradict earlier agreements with drugmakers.

Bionyra brings in $165M for next-generation immune drugs

The biotech, co-founded by Sofinnova Partners and a former Sanofi immunology R&D head, is testing new biologics against common immune conditions.

Hospitals irate after Eli Lilly follows through on 340B ultimatum

The drugmaker stopped paying 340B discounts to hospitals that didn’t comply with its new paperwork requirements late last week. Hospitals are urging HRSA to step in.

Moderna flu vaccine wins unanimous support from FDA panel

The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.

UniQure to file gene therapy for approval, reflecting major shifts at FDA

The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases. 

Biogen adds more immune drugs in $1B buyout of secretive startup RayThera

The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues.