The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
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.
Biotech investors, executives and analysts worry that blanket bans on deals with Chinese companies could curb domestic entrepreneurs’ ambitions in the sector.
Blair Jackson says the next 12 months may be the most important in Alkermes’ history, as the brain drugmaker races to join an “orexin” market that analysts see as a multibillion-dollar opportunity.
The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.
Adam Friedman, CEO of the Scorpion Therapeutics spinout, said the deal helps both companies accelerate research "faster than either of us could alone."
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.
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.”
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.
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.
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.
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.
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.
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.
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.
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.
A search is underway for a successor to Dave Denton, who took a job outside the pharmaceutical industry. Elsewhere, a new kind of Duchenne gene therapy got venture backing and a GSK deal paid dividends.
Including the heart drug developer’s offering, four biotechs in 2026 have raised at least $400 million in IPO proceeds — the most in a single year since 2021, according to BioPharma Dive data.
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.
The potentially $4 billion collaboration is the latest example of drugmakers working to broaden the use of T cell engagers, which, so far, have had limited success outside of certain blood cancers.
Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention.
Express Scripts and the PBM lobby are following in CVS Caremark’s footsteps in filing complaints challenging the FAIR Rx Act, which was passed earlier this year despite vehement opposition from PBMs.
Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year.
Still, the results leave somewhat unclear how different the company’s drug is than marketed hypertrophic cardiomyopathy medicines from Bristol Myers Squibb and Cytokinetics.
Neumora’s stumble is the latest setback for a once-promising class of brain drugs. Elsewhere, a cell therapy manufacturing specialist took steps toward an IPO and J&J made its latest U.S investment.
Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.
In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
The developer of a leading PD-1/VEGF cancer drug cited “market conditions” for the cancellation. Its shares have struggled to break out following data milestones.
A strategic review determined that the development environment had "notably changed," leading Sensorion to end work on its gene therapy for OTOF-related hearing loss.
The data showed that del-brax, an “antisense oligonucleotide conjugate” being tested against a muscle-wasting disease, met its primary endpoint in a Phase 1/2 study.
New data suggest Imaavy could be an effective treatment for autoimmune anemia. Elsewhere, Enliven detailed data for a Merck leukemia rival and MBX hyperparathyroidism drug hit its goal.
The startup is developing a medicine that works differently than available treatments for thyroid eye disease and could benefit people with a related condition, too.
The largest-ever new stock sale for a venture-backed biotech company extends a streak of large IPOs in 2026 that’s now resulted in 12 drug startups securing more than $4.1 billion combined.
Newly published data convinced AstraZeneca to conduct a sprawling late-stage program for its GLP-1 pill. Elsewhere, Bausch + Lomb will lay off 119 employees and Cartesian boosted its ‘in vivo’ cell therapy capabilities.
Trodelvy's latest setback carries implications for a newly important Merck drug, while the success of a once-weekly HIV tablet could boost Gilead's main business.
The British drugmaker's third acquisition this year gives it two experimental lung cancer drugs under FDA review that it hopes will support a franchise.
Co-founded by longtime Alnylam CEO John Maraganore, City has brought a clotting disorder drug into early human testing. An experimental therapy for Stargardt disease could soon follow.
Potentially worth up to $2.3 billion, the collaboration is a bet that drugs able to eliminate the “BTK” enzyme will prove superior to existing medicines that block its activity.
A combination involving Tango’s experimental therapy appeared to boost response rates in a small clinical trial well beyond what would be expected, sparking a share surge.
Acquiring Vega Therapeutics, an offshoot of "hub-and-spoke" biotech Star Therapeutics, would give Incyte a medicine that’s in late-stage testing and designed to control bleeding.
A possible alternative to “anti-CGRP” medications, the drug didn’t meet some analysts’ expectations in mid-stage testing but still convinced Lundbeck to pursue further development.
The Supreme Court ruled that a knockoff version of Amarin’s Vascepa didn’t infringe on patents — a decision with far-reaching implications for the availability of generics.
Shares for ADC Therapeutics fell more than 50% after a Phase 3 trial observed a death rate that at least one analyst believes “may be difficult to accept for physicians, patients and regulators.”
Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off generic competitors.
Ona Therapeutics, a Barcelona-based drugmaker, is developing next-generation drugs it says could help patients with advanced forms of breast and colorectal cancers.
Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
A proposal to add biotechnology to the COINS Act follows two big deals involving Pfizer and Bristol Myers, and comes amid U.S. fears that China’s drugmaking progress may threaten national security.
The anti-aging biotech has secured one of the year’s biggest venture fundings to bring its first drug into testing. Elsewhere, Lilly nabbed a “GLP-2” obesity drug and Praxis shares tumbled.
Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.
Select hospitals have refused to share data to prove they’re not double-dipping drug discounts, Lilly said. Hospitals, which have until Monday to comply, are urging the government to intervene.
Fulcrum’s setback is the latest in a series of stumbles for the developers of sickle cell medicines, among them Pfizer, Novartis and Intellia Therapeutics.
A handful of cancer cases reported among treatment recipients overshadowed efficacy results analysts described as “best-in-disease” and sent shares down more than 30%.
At the year’s biggest cancer meeting, a high-stakes clash between two popular drug classes erupted, and scientists made headway against a once-insurmountable foe.
It's the second attempt for the rare disease company, which initially announced plans to merge with Candid Therapeutics before the immune drug developer was bought by UCB.
The French drugmaker has agreed to acquire an experimental tablet from Edgewise Therapeutics that some bullish analysts say could eventually hit peak sales of over $2 billion.
Ivonescimab reduced the risk of death by one-third compared to chemotherapy in a China-based study that’s seen as an important barometer for a class of cancer immunotherapies known as "PD-1/VEGF inhibitors."
Study results accrued so far are giving Merck greater conviction that the therapy, licensed from a China-based biotech, was worth placing into a sprawling Phase 3 program.
Called mezigdomide, the drug is one of two protein-degrading medicines Bristol Myers hopes to soon position as successors to its lucrative Revlimid franchise.
A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.
David Chang will leave his post after an eight-year run at the cell therapy maker. Elsewhere, a next-generation blood disease drug stumbled and an acquisition yielded an FDA approval for AbbVie.
As leadership changes create more instability at the FDA, here’s what one former agency official thinks it will take to keep speedier drug approvals on track.
The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.
Formerly known as Verge Genomics, the new Verge Labs will help pharma and biotech partners match potential brain drugs to patients who best benefit from them.
The review extension comes weeks after an advisory panel found the evidence supporting the drug, camizestrant, inconclusive in what would be a new kind of treatment setting.
Founded by former MyoKardia executives, the startup has in mid- to late-stage testing three medicines licensed from the likes of Sanofi, Ionis and Bristol Myers Squibb.
As Lilly completes the pivotal program for its “triple-G” drug, Phase 1 data from Kailera partner Hengrui suggest their offering might spur greater weight loss.
The company made the announcement after a new round of research results bolstered the case for the experimental medicine, which may ultimately compete against Dupixent and Ebglyss.
Worth close to $4 billion combined, the acquisitions of Curevo, LimmaTech and Vaccine Co. signal plans by Lilly to build an infectious disease portfolio.
The Japanese pharma is aiming for $1.3 billion in yearly savings between now and 2030. Elsewhere, Datroway gained a new clearance in breast cancer and the FDA approved a drug for hepatitis D.
