CHMP gives nod for Sanofi’s Cenrifki for multiple sclerosis
Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.

CHMP gives nod for Sanofi’s Cenrifki for multiple sclerosis
Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.
Grace Therapeutics hits CRL setback with GTx-104 despite positive trial
Grace Therapeutics Inc.’s hopes of becoming the first company in decades to update the standard of care in aneurysmal subarachnoid hemorrhage were delayed after the U.S. FDA issued a complete response letter (CRL) for its GTx-104 NDA, citing manufacturing and nonclinical deficiencies rather than concerns over efficacy or safety.
Neuro deals aplenty: UCB’s $1B+ takeover of Neurona the latest
A flurry of deals focused on the neurological disease space in 2026 suggest large biopharma companies are searching for the next best therapeutics for everything from epilepsy and narcolepsy to post-traumatic stress disorder and hyperphagia.
Edwards raises 2026 guidance on strong TAVR performance
Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings per share of $2.95 to $3.05, compared with earlier guidance of $2.90 to $3.05.
Today's news in brief
BioWorld briefs for April 24, 2026.
Anaptysbio’s spinout First Tracks hits the slopes
Anaptysbio Inc. announced in September of 2025 that it planned to separate its drug development business from the royalties it receives on Jemperli (dostarlimab) from GSK plc and imsidolimab from Vanda Pharmaceuticals Inc. Just seven months later, on April 20, 2026, well ahead of its “year-end 2026” goal, First Tracks Biotherapeutics Inc., the drug development arm of the company, started trading as a standalone company on Nasdaq under the ticker symbol TRAX.
Ribo, Diagens tally 2 Hong Kong biotech, medtech IPOs in Q1 2026
Ribo Life Science Co. Ltd.’s HK$1.8 billion (US$230 million) raise on Jan. 9 was the sole Chinese biotech IPO on the Hong Kong Stock Exchange in the first quarter (Q1) of 2026, despite a growing backlog of more than 70 filings from China life science firms in 2025. Among med-tech companies, Hangzhou Diagens Biotechnology Co. Ltd. debuted with a $101 million Hong Kong IPO March 30, 2026.
Xenon spikes, Theravance sinks after phase III readouts in March
BioWorld tracked 209 clinical trial readouts across phases I through III in March 2026, up from 152 in February and 144 in January. Among late-stage programs, 26 phase III trials reported positive results, two produced mixed results, and three failed to meet key endpoints. By phase, March updates included 62 from phase I, 74 from phase II and 73 phase III.

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Analysis and data insight

China partnerships lead biopharma deal surge in Q1 2026
Deals and M&A
Biopharma deal value reached $79.22 billion in the first quarter (Q1) 2026, marking a strong start to the year and an increase of about 17% from $67.6 billion in Q1 2025 and similar to $78.93 billion in Q4 2025. The total is the highest first-quarter tally in recent years, and the highest quarter...
Cochlear’s 39% stock plunge resets ‘defensive growth’ narrative
Medical technology
Shares in Aussie hearing implant maker Cochlear Ltd. plummeted nearly 39% April 22 after the company slashed fiscal 2026 earnings guidance and warned that weaker-than-expected demand in developed markets was exposing a more cyclical and discretionary side to its business than investors had assumed.
FDA, CMS partner to deliver RAPIDly for innovative devices
Medical technology
The U.S. FDA and CMS are teaming up to give Medicare beneficiaries quicker access to breakthrough medical devices and provide manufacturers with certainty of reimbursement.
CMS to Bridge coverage for obesity drugs as BALANCE teeters
Regulatory
When the U.S. CMS didn’t get takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced late April 21 that it will indefinitely delay the BALANCE model in Medicare but...

Financings

Tortugas launches with $106M for neurology, neuropsychiatric drugs
Newco news
Tortugas Neuroscience Inc. came out of its shell to announce the raising of $106 million between its seed and series A financing rounds. “We like the symbolism of the sea turtle – long-lived, persistent, very determined,” Tortugas CEO Jeff Jonas said of the company’s name.

Medical technology

Forsight’s robot-assisted platform to transform cataract surgery
Ocular
The first fully robot-assisted cataract surgery recently performed using Forsight Robotics Ltd.’s Jasper platform was not only a “transformative” event and a major “milestone” for the company, but also a “huge step forward for the industry,” Joseph Nathan, co-founder, president and chief medical...

Pharma industry faces long haul to get return on investment from AI
Conferences
Artificial intelligence tools are springing up at multiple points along drug discovery and development, but despite the hype, as yet there is minimal return on investment (ROI). “I would say a lot of companies sort of get this big excitement about AI, but then when you look at how much ROI they...
Boston Sci’s CEO ‘disappointed’ as company cuts 2026 guidance
Boston Scientific Corp.'s CEO Mike Mahoney said that the year is turning out to be “more challenging” than the company anticipated, prompting a cut to its organic sales growth guidance to 6.5% to 8%, from 10% to 11%. The company also lowered its adjusted earnings-per-share guidance to $3.34 to...

Newco news

Remedy pushes ‘cell-free’ secretome therapy for IPF into phase I
Clinical
“Single drugs targeting single biological pathways are insufficient for complex diseases,” Remedy Cell Ltd. CEO Ayelet Dilion Mashiah told BioWorld. Remedy is taking a secretome-based approach to treat lung disorders, having moved its lead asset, RC-0315, into a first-in-human clinical trial for...
‘Immune reset’ is ambition of Tr1x’s allogenic Tr1 cell therapy
Clinical
Tr1x Inc. was founded with a simple but ambitious goal: to change how autoimmune and inflammatory diseases are treated, moving away from chronic treatment and toward durable cures. “We are trying to flip the script on regulatory T cells (Tregs),” Tr1x CEO David de Vries told BioWorld. “The goal is...
Realta secures another $40M for its hypoxic ischemic encephalopathy treatment
Financings
Realta Life Sciences Inc. raised an additional $40 million in the final tranche of its series A investment, bringing the total the company has raised to more than $150 million through mission-driven investors and a family-office model.
New China biotech Syneron chases macrocycle frontier
Financings
Syneron Bio is emerging as one of the most heavily backed new entrants in the macrocyclic peptide space, raising more than $250 million in venture funding and securing a multibillion-dollar deal with Astrazeneca plc as it builds a platform spanning several of the most competitive frontiers in drug...
Sidewinder’s bispecific ADC approach draws $137M series B
Financings
Founded amid the booming next-generation antibody-drug conjugate (ADC) space, Sidewinder Therapeutics Inc. has emerged from stealth with an oversubscribed $137 million series B round and plans to advance a lead program into the clinic in 2027.

U.S.

Revolution rocks on with first-line PDAC data at AACR
Clinical
And the positive news continues to flow for Revolution Medicines Inc. On the heels of a successful phase III trial for RAS inhibitor daraxonrasib in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC) – not to mention the firm pricing the largest follow-on offering...

Europe

Netrin-1 inhibitor blocks chemo resistance in pancreatic cancer
Clinical
Netris Pharma SA has delivered positive phase Ib data showing its first-in-class netrin-1 inhibitor NP-137 alleviates resistance to chemotherapy in pancreatic cancer. This could represent an important advance in treating these tumors, which are notoriously resistant to chemotherapy.

Whole genome sequencing unveils blood cancer trajectory
Conferences
A new study tracking the genomic evolution of chronic myeloproliferative neoplasms has shown that progression to myelofibrosis or acute myeloid leukemia is encoded in mutations that occur years before the transformation is clinically evident.
Meta-analysis: Anti-amyloid Alzheimer’s drugs not ‘clinically meaningful’
Neurology/psychiatric
The ongoing controversy over the effectiveness of anti-amyloid drugs is about to get more heated, after a review of clinical trials showed statistically significant results do not read across to clinical benefit for patients with Alzheimer’s disease.

Clinical

Akeso sets durability bar as immuno-oncology 2.0 race heats up
Conferences
Akeso Pharmaceuticals Inc. has raised the bar for next-generation immuno-oncology, reporting more than 23 months median overall survival in pancreatic cancer with its PD-1/CTLA-4 bispecific antibody cadonilimab, as emerging competitors begin to...
Early data position Junshi in next-gen immuno-oncology race
Conferences
Shanghai Junshi Biosciences Co. Ltd reported early clinical signals across its next-generation immuno-oncology pipeline, including response rates of up to 71% in metastatic colorectal cancer and 45.5% in hepatocellular carcinoma, at the American...
Nektar’s rezpeg more than worth its SALT in alopecia phase IIb
Dermatologic
With rezpegaldesleukin (rezpeg) phase IIb data in alopecia areata holding strong over time, backers of Nektar Therapeutics Inc. are hopeful that the biologic can do for the hair loss market what Dupixent (dupilumab, Regeneron Pharmaceuticals...
Lilly’s GLP-1 Foundayo aces MACE in DILI of a phase III
Diabetes
Wall Street met with satisfaction but not surprise Eli Lilly and Co.’s undeniably positive top-line results from the phase III Achieve-4 study testing the efficacy and safety of Foundayo (orforglipron) compared to insulin glargine in adults with...
Synox en route to approval on positive phase III for TGCT
Cancer
Synox Therapeutics Ltd. is preparing to file for FDA approval of emactuzumab in treating tenosynovial giant cell tumor (TGCT), after announcing positive top-line phase III results.
Spyre’s SPY-001 induces better outcomes in ulcerative colitis
Gastrointestinal
Spyre Therapeutics Inc. is off to a good start in its goal to create the best combination therapy for inflammatory bowel disease, a group of chronic, relapsing autoimmune conditions of the digestive tract that encompasses Crohn’s disease and...

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