Despite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.
After leaving Tessera Therapeutics earlier this month, Michael Severino will take over Sarepta Therapeutics as the biotech awaits two key regulatory decisions in Duchenne muscular dystrophy.
AstraZeneca remains “very much on track” to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said during the company’s Q2 earnings presentation on Monday.
Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
The star of the takeover is Forte Biosciences’ investigational antibody therapy, FB102, which has shown early potential in vitiligo and celiac disease.
Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.
FEATURED STORIES
The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings were called at all, while many have questioned the rationale behind them and other adcomms on deck.
As drug hunting gets more complex, where and how data is generated in partnerships between Big Pharmas and AI biotechs is becoming a headache for dealmakers.
With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape with innovative approaches—and experts say there’s room for all of them.
UPCOMING EVENTS
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Tuesday, July 28, 2026 10–11am EDT·Virtual
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Wednesday, August 26, 2026 11am EDT·Virtual
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Tuesday, September 1, 2026 8am–5:30pm PDT·San Francisco, California
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Wednesday, September 2, 2026 8am–6:10pm PDT·San Francisco, California
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Thursday, September 3, 2026 8am–6:10pm PDT·San Francisco, California
LATEST PODCASTS
In this episode of Denatured, you’ll hear from Ester Sklarsky, principal at Sound Bioventures and João Ribas, partner at Novo Holdings Seed Investments. In this episode, we explore the diverging trajectories of Nordic biotech and what it will take for the region, including Norway and Finland, to compete more cohesively on the global stage.
Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics space; more drama unfolds at FDA as the agency goes back and forth on its policy of publishing complete response letters in real-time; and IPO fever continues.
In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has remained such a difficult therapeutic area to tackle and one of the biggest unmet needs today, and how non-opioid mechanisms to regenerative therapies could reshape the future of treatment.
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SPECIAL EDITIONS
Who is the highest paid CEO in all of pharma? In this special edition, BioSpace examines top paid CEOs and their pay packages.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Opportunities increased by the end of the first quarter, according to BioSpace data.
DEALS
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Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unlikely to trigger a broad wave of Big Pharma deals. -
Top-selling cell therapies from BMS, J&J and Gilead depend on a BioLife product, positioning Repligen to use the takeover to increase its exposure to the modality. -
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026. -
Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics space; more drama unfolds at FDA as the agency goes back and forth on its policy of publishing complete response letters in real-time; and IPO fever continues. -
With PolyPeptide manufacturing peptides such as GLP-1 medicines, Samsung Biologics has identified the deal as a way to tap into fast-growing demand for obesity drug production services.
WEIGHT LOSS
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Acmopatide met the main goal of a Phase 2 study in type 1 diabetes, but Roche is axing the investigational drug to prioritize enicepatide for weight loss, type 2 diabetes and cardiovascular outcomes. Both assets come from the $2.7 billion buy of Carmot Therapeutics. -
With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expected later this year. -
Kalohexis is working on peptide therapies, including one for obesity that could offer an alternative approach to the GLP-1s that currently dominate the weight loss space. -
New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study. -
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
POLICY
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A Congressional advisory panel recommends the U.S. government put supportive policies in place for rare disease drug development, such as a finalized platform designation from the FDA and the allowance of novel trial designs for small patient populations. -
The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversight and quality controls remain essential. -
The agency’s finalized recommendations for clinical testing of psychedelic compounds for mental health could pave the way for companies like Compass Pathways, whose psilocybin-based therapy for treatment-resistant depression could win approval as early as this year. -
Through the proposal, the FDA could clear barriers to distributed manufacturing approaches intended to enhance emergency preparedness and supply chain resilience. -
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
Controlling CEOs, manipulative middle managers and high-performing jerks can damage employees’ trust in employers and motivate them to hit the job market. Kaye/Bassman’s Michael Pietrack discusses the problematic behaviors executives must watch for in the workplace.
Even something as simple as “Tell me about yourself” can trip up biopharma professionals during job interviews. Two recruiting experts discuss what candidates should and shouldn’t say when answering five specific questions.
Rather than getting hung up on what to call DEI in the workplace, leaders should take three specific actions to help their employees embrace and engage with it. Companies and the patients they serve will benefit.
Three experts discuss whether biotech and pharma professionals should try to convince employers to adjust employment offers, mistakes people make during the process and tips for getting it right.
The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
HOTBEDS
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
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Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be required for Summit and China-based partner Akeso—and other transnational tandems—to secure FDA approval? -
Safety will be the key determinant of in vivo CAR T therapies, according to H.C. Wainwright’s Mitchel Kapoor, who noted that convenience and efficacy won’t be enough to impress investors in this space. Eli Lilly, AbbVie, AstraZeneca and more are up for the challenge. -
Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing with a decision expected by Nov. 14. -
Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer assets in late-stage development. -
Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistically significant.
NEUROSCIENCE
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Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021. -
Psychedelics, chiefly Compass Pathways’ COMP360, are unlikely to make an immediate dent in the sales of Johnson & Johnson’s depression drug Spravato, H.C. Wainwright’s Patrick Trucchio told BioSpace. -
New mid-stage data from Biogen’s Ionis-partnered therapy diranersen served to both validate the tau hypothesis in Alzheimer’s disease and raise questions that could soon be elucidated by anti-tau candidates from Denali Therapeutics, Eisai and Eli Lilly. -
Biogen’s new data, presented at the Alzheimer’s Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
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Eli Lilly’s anti-amyloid Alzheimer’s drug is designed to be stopped after patients drop below a certain amyloid level in the brain. However, at the Alzheimer’s Association International Conference on Wednesday, Lilly revealed it is studying the potential of maintenance therapy for patients who need it.
CELL AND GENE THERAPY
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Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm. -
In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demeetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP. -
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year. -
The FDA approved the expansion of Casgevy, which had previously been greenlit for patients 12 and up, into a younger pediatric population under the agency’s Commissioner’s National Priority Voucher program.
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Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA.
