Phase Ib data show Hernexeos can elicit a confirmed objective response rate of 44% in patients with HER2-mutated NSCLC who had previously been treated with a directed antibody-drug conjugate.
The autoimmune and inflammatory disease–focused company canceled plans to go public earlier this year as the IPO window slammed shut.
These 27 markets, comprising countries across Asia, Europe and South America, together contributed some 12% of Lundbeck’s earnings in 2024.
Jefferies analysts expect a regulatory filing for rocatinlimab later this year, with a product launch in 2026.
Cullinan Therapeutics and Taiho Oncology’s zipalertinib elicited promising response rates in two mid-stage studies of non-small cell lung cancer patients with typical and uncommon EGFR mutations.
CDC
Former CDC director Susan Monarez and former chief medical officer Debra Houry will appear in front of the Senate HELP Committee on Sept. 17.
Novo Nordisk also lowered its full-year profit growth guidance in connection with the restructuring effort. The pharma now anticipates operating profit to grow from 4% to 10%, down from its prior projection of 10% to 16%.
FEATURED STORIES
Large pharmaceutical companies were out in force at this week’s 2024 Cell & Gene Meeting on the Mesa, as they look to expand their presence in the industry.
Eli Lilly CEO David Ricks is confident his company and peer Novo Nordisk are years ahead in the weight loss space, as biotechs press on with compelling data.
Big Pharma can’t seem to get enough radiopharmaceutical biotechs. With Lilly, Sanofi and BMS chasing Novartis into the complex space, all eyes are on these specialty biotechs.
Tim Hunt, CEO of the Alliance for Regenerative Medicine, said Monday at the 2024 Cell & Gene Meeting on the Mesa that investments reached $10.9 billion in the first half of this year—outpacing 2019’s $9.8 billion total—but far below the pandemic peak.
After several high-profile failures, including BMS’ $1.5B breakup with Agenus, anti-TIGIT therapies are generating cautious optimism.
After psychological side effects doomed the first generation of cannabinoid receptor 1–targeting drugs for weight loss, Novo Nordisk, Corbus Pharmaceuticals and Skye Bioscience are betting that a new mechanism of action will improve the safety profile.
FROM BIOSPACE INSIGHTS
Biotech’s slump may finally be over in 2026. In interviews with BioSpace, Zymeworks’ CEO Ken Galbraith and Zai Lab’s President and COO Josh Smiley explain what’s fueling the comeback.
UPCOMING EVENTS
LATEST PODCASTS
In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO of Zymeworks and Josh Smiley, president and COO of Zai Lab, about how renewed confidence is driving biotech entering 2026.
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.
In this episode of Denatured presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, Mayo Clinic; Marilyn Geller, the Celiac Disease Foundation; and Dr. Paul Lizzul, AnaptysBio, about the challenges and opportunities facing celiac disease treatment.
Job Trends
4D Molecular Therapeutics, a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, reported full year 2023 financial results and provided operational highlights.
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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. Ahead of a Senate health committee hearing next week with Novo Nordisk CEO Lars Jørgensen, Sen. Bernie Sanders claims he has secured assurances from generics developers that they will charge a significantly lower monthly price than the $969 Americans currently pay for the Danish drugmaker’s diabetes blockbuster.
  2. If Johnson & Johnson refuses to scrap its proposed changes to the 340B drug pricing for hospitals, it risks the termination of participation in the program and monetary fines, the Health Resources and Services Administration warned.
  3. It’s time for Congress to step up and fund America’s supply chain independence from Chinese companies by bolstering our domestic manufacturing capabilities.
  4. Healthcare players are pointing fingers amid regulatory crackdowns on pharmacy benefit managers, but proposed reforms wouldn’t address a dearth of competition in the larger market.
  5. A recent study estimated that Wegovy’s label expansion beyond obesity could push Medicare spending to $145 billion annually, but analysts remain dubious of the estimate.
CAREER HUB
Here are the top pharmaceuticals interview questions for you. They can help you clear any interview with ease. So let’s take a look at the questions now.
Transferable skills are skills you’ve used in any sector of your life and career that are transferable and applicable to what you what you want to do next.
In the meantime, here are a few things you can do to fill your resume while you’re in between jobs.
Our recent article describing six prominent careers in the biopharma industry was well-received by both college students and current biopharma professionals. As the first installment in a six-part series, we present an in depth review of a rewarding career as a genetic counselor.
A well-written thank you letter after interview can help you make an impact on the interviewers. It can increase your chance of getting hired so learn how to write one.
The more you funnel the universe of employers into a laser-focused, precise, narrow segment of those who would love to hire you, the more successful you’ll be.
Background checks, especially at the executive level, have become routine in the recruitment process.
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
The highest dose of Eli Lilly’s eloralintide led to 20.1% weight loss after 48 weeks in a Phase II trial, exceeding analyst expectations and highlighting a “potentially best in class profile,” according to BMO Capital Markets.
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 Biden administration on Thursday touted discounts of up to 79%, but many of these first 10 drugs are already sold well below list price.
  2. The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday.
  3. The Connecticut-based biotech, which emerged from stealth last year, has secured $202 million to date as it looks to move two assets targeting prostate and breast cancer into the clinic.
  4. Gilead Sciences’ liver disease portfolio delivered surprisingly robust performance in the second quarter, jumping 17% as the company awaits next week’s potential FDA approval of seladelpar in primary biliary cholangitis.
  5. Citius Pharmaceuticals’ Lymphir is a reformulated version of denileukin diftitox—an FDA-approved cancer therapy—and the only treatment for cutaneous T cell lymphoma that targets the IL-2 receptor located on malignant T cells and Tregs.
NEUROSCIENCE
  1. Ketabon is working to develop a medication that harnesses ketamine’s antidepressant effects without the safety issues that currently prohibit its at-home use.
  2. Biogen on Wednesday exceeded analyst profit estimates for the first quarter of 2024 as the biotech’s cost-cutting measures took hold and sales of its Alzheimer’s disease therapy Leqembi started to pick up.
  3. An undisclosed once-daily oral dose of Neurocrine Biosciences’ Takeda-partnered investigational drug significantly reduced symptom severity in adults with major depressive disorder.
  4. As the Phase III amyotrophic lateral sclerosis pipeline thins out, the ALS community is placing its hopes on earlier-stage trials sponsored by Denali Therapeutics, PTC Therapeutics and more.
  5. As AbbVie and NeuroDerm race toward potential U.S. approvals later this year, the companies presented strong data at last week’s American Academy of Neurology 2024 annual meeting for their respective continuous subcutaneous levodopa infusions.
CELL AND GENE THERAPY
  1. BioNTech will pay $50 million in cash and purchase $200 million of Autolus Therapeutics’ shares to progress the companies’ respective CAR-T candidates to commercialization.
  2. On Thursday, Kyverna Therapeutics is debuting on the Nasdaq with an upsized initial public offering which the biotech will use to support its pipeline of anti-CD19 CAR T therapy candidates.
  3. Under the FDA’s compassionate use program, an eyedrop formulation of Krystal Biotech’s Vyjuvek restored the vision of a teenager with the rare genetic disease dystrophic epidermolysis bullosa.
  4. Metagenomi could potentially raise over $100 million if the underwriters exercise their option to purchase additional shares in full, assuming an initial public offering price of $16 per share.
  5. Topline results from a mid-stage study show that 4D Molecular Therapeutics’ investigational gene therapy cut annual rates of Eylea injections by 85% and 89% for the low and high doses, respectively.