Summit’s decision to conduct an interim analysis of a closely watched trial backfired. Elsewhere, Axsome got a much-needed label expansion and an FDA committee sided against an AstraZeneca breast cancer medicine.
The company is making up for a decline in U.S. vaccine sales with better results elsewhere, continuing a turnaround that’s vaulted its stock price in 2026.
Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.
Seaport Therapeutics and Hemab Therapeutics on Thursday became the latest drugmakers to debut on Wall Street, continuing a stretch of large IPOs this year that collectively raised almost $3.2 billion.
Despite updated study data that suggest Terns’ treatment may be less differentiated, company executives claimed Thursday that it still could be an important step forward in care.
The biotech will use the proceeds to develop inhalable versions of therapies already on the market for the “idiopathic” and “progressive” forms of pulmonary fibrosis.
A Jefferies analyst argued the deal — Teva’s largest in a decade — “makes sense” given the synergies between Emalex and the pharmaceutical giant’s neurology business.
The acquisition is the fifth of a biotech company so far this week and, according to some Wall Street analysts, proves pharma’s interest in new and emerging oral therapies for hereditary angioedema.
Through two pioneering studies, Amgen and AstraZeneca will share study data with FDA scientists as it’s accrued. Elsewhere, Lilly inked a gene editing deal and Pfizer reported success for a multiple myeloma drug.
Settlements delaying the arrival of generic versions of tafamidis will protect billions in Pfizer revenue and have implications for others, including BridgeBio Pharma and Alnylam.
Tavneos’ original developer hid a study analysis and then altered data, the FDA alleged. Elsewhere, Erasca’s RAS drug was met with skepticism and Rocket Pharma sold a voucher.
Backed by Novo Holdings, Regeneron’s venture arm and several others, the biotech believes an oral drug licensed from Galapagos might hold potential treating many immunological diseases.
Young biotechs usually get acquired instead of profitably selling their own medicines. A growing number are proving they can, which could make the sector more broadly appealing to investors, some say.
A therapy that works similarly to AbbVie’s blockbuster Skyrizi appeared more potent in a mid-stage trial and has the potential to be dosed less frequently.
The results could support the first approval in decades for an oral medicine that can treat male pattern baldness, though the therapy will face competition from generics and over-the-counter medications.
Worth up to $2.3 billion overall, the deal hands Lilly a drug designed to address the weaknesses of a class of medicines used to treat myelofibrosis and other diseases.
The findings position Intellia to bring to market the first “in vivo” gene editing medicine, though the therapy’s commercial potential remains the source of intense investor debate.
Tolebrutinib, which the FDA recently turned back due to safety concerns, received a positive recommendation that positions the therapy for its first regulatory approval.
Lilly shares dipped, and Novo’s climbed, as Foundayo’s early trajectory diverged from that of oral Wegovy. Elsewhere, Regeneron inked a drug price deal and two companies announced leadership changes.
Otarmeni, now cleared to treat a rare, inherited kind of hearing loss, is the first gene therapy cleared under the FDA’s “national priority” voucher program and will be offered to eligible patients at no cost.
The 185-acre site will be the company’s largest single investment to date, with a focus on small-volume parenteral products like vials and prefilled syringes.
On a conference call, executives claimed that a closely watched breast cancer pill and portfolio of weight loss medicines could bank more than $9 billion annually.
A string of research setbacks have left the pharmaceutical giant at a crossroads just as a new CEO is set to take over. But positive first-quarter earnings provided the company with a needed boost.
The findings build on data suggesting Revolution’s therapy could upend treatment for a notoriously tough-to-treat tumor and generate billions in sales.
A program that got caught up in HHS’ decision to abandon mRNA research was revived by a public-private coalition and is now beginning a large, late-stage test that could support a future approval.
Merck is making a $1 billion investment in a deal with Google Cloud. Elsewhere, Roche pitched its case for a closely watched multiple sclerosis pill and Arcus and Gilead are ending a yearslong alliance.
Led by former Sage Therapeutics executives Jeff Jonas and Al Robichaud, the company is starting out with a portfolio of neurological medicines in clinical testing.
Welireg’s failure in first-line kidney cancer removes a blockbuster opportunity and could leave an opening for a rival drug from Arcus Biosciences, analysts said.
The company has rallied from an earlier setback in obesity thanks to early progress for a drug targeting “NLRP3,” an inflammasome linked to a variety of health conditions.
Meant to speed research and access to psychedelics for mental health conditions, the order is the latest in a series of developments that, to Wall Street, make psychedelics a more “investable space.”
Republicans largely praised the HHS secretary’s track record during a marathon of House hearings last week, but some raised concerns about proposed budget cuts to the National Institutes of Health.
Patients who'd seen substantial hair regrowth in the first part of Nektar’s trial had a "deepening" treatment response, extending a comeback bid that’s caused shares to skyrocket over the last year.
Worth up to $7 billion, Lilly’s second recent acquisition of a company in the space is centered around a cell therapy that’s currently in early-stage testing for multiple myeloma.
Featured at this year’s meeting on early cancer research were results from an immunotherapy Merck acquired in 2024 and several targeted medicines for lung tumors.
This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.
The acquisition helps diversify UCB’s small molecule-centric arsenal of seizure treatments with a potentially one-off therapy in early testing for a hard-to-treat form of a common epilepsy.
Some 1,390 Foundayo prescriptions were written in two days, according to analysts. Elsewhere, multiple biotechs are using OpenAI’s “GPT-Rosalind” and Janux debuted a “double-masked” T cell engager.
The high-profile obesity drug developer priced the biotech sector’s biggest offering in years and will use the proceeds to support a portfolio of medicines licensed from China’s Hengrui Pharma.
The agency’s decision to hold an advisory committee meeting on the topic comes after HHS Secretary Robert F. Kennedy Jr. told podcaster Joe Rogan he’s a “big fan” of peptides.
Replimune is laying off 63 staffers days after the second FDA rejection of its melanoma drug. Elsewhere, Revolution raised $2 billion and a regulatory filing revealed details on negotiations between Biogen and Apellis.
The Swiss drugmaker, which owns rights to the Duchenne gene therapy outside the U.S., hopes the trial will yield additional approvals in Europe and elsewhere.
The combined company will trade on the Nasdaq under the ticker OBX. It has also secured commitments for a private placement expected to deliver $350 million in gross proceeds.
The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually.
A growing multiple myeloma franchise helped the pharmaceutical giant top Wall Street’s expectations and surpass $15 billion in first-quarter drug sales.
Novo intends to “fully integrate” AI capabilities across its operations. Elsewhere, Regeneron made its first foray into radiopharmaceuticals and a GSK cancer drug showed early promise.
The decision, which has been a flashpoint in an ongoing debate about regulatory flexibility, was made because Replimune failed to address the agency's issues with the drug's study results, the FDA said.
The newly published charter widens the required expertise to become an ACIP member and stresses vaccine safety. Elsewhere, Gilead licensed a Kymera drug and a new RNA-focused startup emerged.
The drug, which Invivyd sees as a potential treatment and “targeted alternative” for the vaccine-hesitant, comes as measles cases in the U.S. are reaching levels not seen in decades.
Backed by Novo Holdings and multiple other prominent investors, the biotech is developing what it’s positioning as superior versions of entrenched — but flawed — medicines for idiopathic pulmonary fibrosis.
After winning the battle for injectable obesity medicines, Lilly hopes Foundayo can help it catch up in the oral market, where Novo has a three-month lead.
Backed by OrbiMed, Novartis’ venture arm and many other investors, the biotech is among those working on newer technology that could broaden the reach of antibody-drug conjugates.
On a conference call with analysts, Gilead walked through how a string of recent deals focused on cancer and autoimmune conditions could help a diversification plan it’s long struggled to execute.
Shah Capital, which has agitated for change at the vaccine maker for years, is calling on fellow shareholders to end what it calls “dogmatic leadership” that’s led to the “destruction” of Novavax’s equity value.
Jeito claimed the new bankroll, which will support 15 to 20 clinical-stage companies, is the largest ever for a “fully independent European fund dedicated to biopharma.”
Novo escalated a GLP-1 pricing war with the launch of its newest obesity medicine. Elsewhere, analysts came to Insmed’s defense and HHS changed the way panelists for a key vaccine committee are selected.
Regulatory filings show that Terns ultimately accepted an offer 15% lower than a previous proposal as four companies vied for rights to the coveted leukemia drug developer.
Gilead’s third acquisition since late February hands it a technology designed to make antibody-drug conjugates less toxic and multiple cancer medicines already in clinical testing.
The findings could help Amgen defend Tepezza’s market-leading position against emerging rivals, though some analysts expressed doubt about its competitive standing.
In its budget request, the agency proposed a way to speed up early drug testing and help smaller biotech firms. Elsewhere, two startups raised megarounds.
The deal hands Neurocrine a “controversial” medicine, Vykat, that achieved $190 million in sales last year but faces persistent questions about its growth trajectory and safety, according to Wall Street analysts.
"Section 232" national security levies won't apply to a wide array of drugs, meaning the "overall threat to the sector should be low," according to one analyst.
Shares of Immunovant, Alto and Oric Pharmaceuticals fell this week on clinical trial updates. Elsewhere, Orca Bio’s cell therapy hit a delay and Korsana entered a reverse merger.
In an interview, Chief Financial Officer Robin Kramer said the combined cash flow from Biogen and Apellis will not only help debt leverage ratios but also free up capacity to do other strategic deals.
Constant leadership changes and erratic decision-making have left the biopharmaceutical industry feeling its chief regulator is as unpredictable as it’s ever been.
Chief Financial Officer Robin Kramer explained how the deal not only provides two marketed products, but a team with nephrology expertise that will be valuable as Biogen prepares to launch felzartamab.
In an R&D collaboration worth as much as $838 million, Merck will lean on Infinimmune to discover immune cell-directed antibodies for multiple targets.
The six companies that have priced initial public offerings so far banked a median of $287.5 million, a figure far surpassing what’s been observed over a similar timeframe in prior years, according to BioPharma Dive data.
