Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.
After two patients who received the investigational CDC7 blocker died, pushing forward with SGR-2921’s development would be “difficult,” according to Schrödinger, whose stock dropped 17.5% before the opening bell on Thursday.
The death was linked to acute kidney injury in a patient who had a single kidney remaining and a “complex medical history,” according to CytomX.
Vedanta is parting ways with 23 employees, or approximately 20% of its headcount, after Phase II data for microbiome therapy VE202 failed to demonstrate significant response rates in patients with ulcerative colitis.
Citing other priorities—such as the upcoming U.S.-Russia summit—four anonymous sources claim that pharma tariffs could still be weeks away, according to Reuters.
In this episode of Denatured, BioSpace’s head of insights Lori Ellis discusses the ‘enormous implications’ of patent policy changes with Aaron Cummings and Anne Li of Brownstein Hyatt Farber Schreck.
Looking for a biopharma job in Texas? Check out the BioSpace list of six companies hiring life sciences professionals like you.
FEATURED STORIES
As the FDA prepares to render a verdict on BMS’ closely watched schizophrenia drug, BioSpace takes a closer look at the late-stage pipeline for this neuropsychiatric disorder.
Summit Therapeutics’ ivonescimab has the potential to challenge Merck’s blockbuster checkpoint inhibitor in non-small cell lung cancer, but experts stress the need for diverse and overall survival data.
The release of early-stage data on three oral weight loss drug candidates hints at which companies have the strongest hand, but the comparisons are rife with confounding variables, leaving analysts unsure about where to place their bets.
Last month, Vertex said sickle cell patients had not yet received infusions of its gene therapy Casgevy. That’s now changed, as the company races with bluebird bio’s Lyfgenia.
ALS
Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform Trial has generated disappointing results for many but also continuing programs from Clene and Prilenia.
The potential of mRNA vaccines was established during the COVID-19 pandemic. Now, a new wave of candidates could soon hit the market for cancer, influenza and more.
FROM BIOSPACE INSIGHTS
In 2025, landmark obesity drug deals, China’s biotech surge, and AI’s deeper integration into pharma operations drove a year of transformation and renewed momentum for life sciences.
UPCOMING EVENTS
LATEST PODCASTS
In this episode presented by Slone Partners, Leslie Loveless, Co-CEO and Managing Partner discusses how hiring and the building of executive teams has responded to the current biotech environment.
Pfizer seals the deal with Metsera for $10 billion after Novo Nordisk bowed out; President Donald Trump welcomes executives from Novo and Eli Lilly to the White House to announce that the companies’ GLP-1 medicines would be sold at a reduced cost; and the FDA grants the second round of priority review vouchers—primarily to already marketed drugs.
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
  1. BioSpace and guests from Halia Therapeutics, Triumvira Immunologics and the Alzheimer’s Drug Discovery Foundation will discuss alternative financing strategies to consider for 2024. Watch now.
  2. The companies have received all required regulatory approvals to complete the deal, the largest for the sector in the past three years and the biggest for the hot antibody-drug conjugate market.
  3. With the acquisition, AstraZeneca will gain access to Icosavax’s investigational combination vaccine IVX-A12, which is being developed for respiratory syncytial virus and human metapneumovirus in older adults.
  4. FDA
    Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.
  5. The deal, announced late Wednesday, will provide AbbVie with access to Cerevel Therapeutics’ pipeline of clinical-stage and preclinical candidates for psychiatric and neurological diseases.
WEIGHT LOSS
  1. Full data from the FLOW study show that Novo Nordisk’s top-selling GLP-1 receptor agonist semaglutide can significantly reduce the risk of death by 20% in diabetes patients with chronic kidney disease.
  2. SixPeaks Bio emerged from stealth Wednesday with up to $110 million, a deal with AstraZeneca and plans to take weight-loss candidates designed to preserve muscle mass toward the clinic.
  3. While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinical development for obesity and type 2 diabetes, according to analytics firm GlobalData.
  4. A Senate health committee report published Wednesday forecasts spending on prescription drugs to hit $1 trillion a year in 2031, unless the prices of GLP-1 medicines such as Novo Nordisk’s Wegovy are cut.
  5. Roche’s $2.7 billion acquisition of Carmot Therapeutics in December 2023 appears to be paying off as its investigational GLP-1/GIP receptor agonist induced strong weight loss in a Phase Ib study.
POLICY
  1. Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea.
  2. As technology continues to evolve, companies should have strategies that incorporate an understand of where they are now, where they want to be, and do they have the talent to get there.
  3. In a high-profile showdown Tuesday with Sen. Bernie Sanders’ Senate health committee, Novo Nordisk CEO Lars Fruergaard Jørgensen will be asked to defend the drugs’ U.S. monthly list prices of $969 and $1,349, respectively.
  4. Regulators, policymakers and others can more effectively battle the disease by creating incentives to make mpox a more attractive investment opportunity.
  5. A lawsuit filed by the Pharmaceutical Research and Manufacturers of America, which claims the Inflation Reduction Act’s Medicare Drug Price Negotiation Program is unconstitutional, now goes back to a lower Texas court.
CAREER HUB
Here are some tips for getting in the door at one of the top international pharmas in the world.
Medical and health service managers work hard to improve the quality and efficiency required to deliver first rate healthcare services.
Understanding which direction to take can be challenging for many professionals, whether they are in an early career stage, or later in their career.
There are several ways to assess if a biotech company has plans in place to diversify their workplace or if they have already achieved this milestone.
Regardless of if your motivation is to increase your salary or find a job that is more interesting to you, preparing for a career change can take a lot of time and energy.
Let’s take a trip through the alphabet to pick up 26 tips to optimize your cover letters.
To help you in your job search, we’ve compiled a list of cover letter do’s and don’ts.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
In the Phase III FIBRONEER-IPF study, Jascayd demonstrated significant lung capacity improvements over placebo.
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
  1. The pharma said Thursday it is stopping a late-stage study of its blockbuster Keytruda plus the anti-TIGIT antibody vibostolimab and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer, following a recommendation from an independent data monitoring committee.
  2. Servier Pharmaceuticals’ vorasidenib on Tuesday secured the FDA’s green light for the treatment of patients with grade 2 gliomas carrying mutations in the IDH gene.
  3. The specialty pharmaceutical company has twice filed for bankruptcy in recent years, driven by opioid-related litigation. Mallinckrodt’s deal with CVC will allow it to pay off more than half of its net debt.
  4. The FDA is looking for stronger overall survival data to back Actinium’s application for Iomab-B, an investigational therapy that will allow acute myeloid leukemia patients to receive bone marrow transplants.
  5. As part of a pipeline realignment, Bristol Myers Squibb is returning the rights to Agenus for its proprietary TIGIT bispecific antibody program and terminating their 2021 license, development and commercialization agreement.
NEUROSCIENCE
  1. Sage Therapeutics announced Wednesday it is scrapping its Parkinson’s disease program after the company’s investigational drug showed no benefit over placebo. Phase II studies of the oral treatment will continue in Huntington’s and Alzheimer’s diseases.
  2. After withdrawing ALS drug Relyvrio from the U.S. and Canadian markets and laying off 70% of its workforce, the Cambridge, Mass.–based biopharma got a much-needed win in Wolfram syndrome.
  3. At this week’s American Academy of Neurology annual meeting, Amylyx provided additional data from its Phase III amyotrophic lateral sclerosis study showing the full extent of Relyvrio’s failure.
  4. Amylyx looks to the future after Relyvrio withdrawal, ADCs continue to attract investment and the drug shortage persists in the U.S.
  5. Already approved in schizophrenia and bipolar depression, Intra-Cellular Therapies reported strong late-stage data Tuesday for its antipsychotic Caplyta in major depressive disorder.
CELL AND GENE THERAPY
  1. The regulator has granted a priority review of the efficacy supplement for Sarepta Therapeutics’ gene therapy Elevidys with a target decision date of June 21, 2024.
  2. Kelonia Therapeutics’ in vivo gene placement system is being tapped to help Astellas Pharma expand its portfolio of in vivo CAR-T cell therapies for cancer.
  3. Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
  4. With last year’s approval of Vertex and CRISPR’s Casgevy, it’s the start of a new era of gene editing. But there are still challenges we must face.
  5. Shares of preclinical genetic medicines company Metagenomi tanked more than 30% on Friday afternoon in a disappointing debut for its initial public offering, bucking the trend of positive IPOs so far this year.