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BIO-Europe, November 3–5, 2025, in Vienna, Austria, is the life science partnering event you can’t afford to miss! 🌍 Partnering is now OPEN, giving you exclusive access to schedule meetings with top innovators, decision-makers, and industry leaders shaping the future of biopharma.

With registration surging, the biggest names in the industry will be there, ready to collaborate and create impactful partnerships. Don’t wait—register now to secure your priority meetings before schedules fill up!

👉 Register now, complete your profile, and start partnering—all while saving up to €600 with early bird pricing ending October 17!

SNIPPETS

What’s happening in biotech today?

🏃‍♂️Antisense win: Ionis Pharmaceuticals announced that its experimental antisense therapy zilganersen achieved a statistically significant improvement in mobility for patients with Alexander disease in a phase 1-3 trial, marking the first time a treatment has shown disease-modifying effects for this rare neurological disorder. After 61 weeks, treated patients walked an average of 33.3% faster than baseline, with the primary endpoint narrowly reaching significance. Most adverse events were mild or moderate, with more serious ones occurring in the placebo group. Ionis plans to file for FDA approval in early 2026 and explore an expanded access program, building on existing orphan drug designations.

 📈IPO incoming: MapLight Therapeutics has filed for an initial public offering to support the development of its lead drug, ML-007C-MA, aimed at treating schizophrenia and Alzheimer’s disease psychosis. The drug targets muscarinic receptors to modulate acetylcholine release, positioning it as a potential competitor to Bristol Myers Squibb’s recently approved Cobenfy. MapLight claims its candidate could offer more convenient dosing and fewer side effects than Cobenfy, which requires multi-day titration and frequent dosing. Phase 2 trials are underway, with results expected in 2026 and 2027. Backed by $511 million in venture funding, MapLight is also developing treatments for autism, Parkinson’s disease, and hyperactivity-related conditions.

🌊SERD surge: Roche has announced positive phase 3 results for its oral selective estrogen receptor degrader (SERD) giredestrant in the evERA trial, marking a rebound after earlier clinical setbacks. The trial, involving patients with ER-positive, HER2-negative advanced breast cancer previously treated with CDK 4/6 inhibitors and endocrine therapy, showed that giredestrant combined with everolimus improved progression-free survival over standard care in both the overall and ESR1-mutated populations, meeting its co-primary endpoints. Overall survival data are still maturing. This result positions Roche to potentially re-enter the competitive SERD space, with additional pivotal trial readouts expected in 2026 that could broaden giredestrant’s market reach.

💸$60M reloaded: Avenzo Therapeutics has raised an additional $60 million in a financing round led by OrbiMed and SR One, bringing its total funding to $446 million since its formation in 2022 by former Turning Point executives. Focused on building a best-in-class oncology pipeline through strategic partnerships, Avenzo has in-licensed four drug candidates from three Chinese biotechs. These include two kinase inhibitors from Allorion Therapeutics (AVZO-021 and AVZO-023), a bispecific EGFR/HER3 ADC from Duality Bio (AVZO-1418), and a Nectin4/TROP2 bispecific ADC from VelaVigo (AVZO-103). The new funds will support development across these assets, all of which are in early-stage or preclinical testing.

💰Gilead jolt: Ensoma has secured $53 million in new financing, including backing from Gilead Sciences, to advance its in vivo hematopoietic stem cell (HSC) engineering platform. The funds will primarily support a Phase I/II clinical trial of its lead candidate, EN-374, for X-linked chronic granulomatous disease (X-CGD), a rare genetic disorder caused by CYBB mutations. EN-374 uses virus-like particles to engineer HSCs to express the CYBB transgene in neutrophils, potentially offering a durable, one-time treatment. The financing will also help expand Ensoma's platform to immuno-oncology and sickle cell disease. Existing and new investors include 5AM Ventures, RTW, the Gates Foundation, and others.

SPEED READ

More news

• Starpharma has signed a collaboration and license agreement with Genentech to develop dendrimer-drug conjugates for cancer therapies, securing $5.5M upfront and up to $564M in milestones.

• BlueRock Therapeutics has begun a phase 3 trial of its stem cell-derived therapy bemdaneprocel for Parkinson’s, aiming to restore dopaminergic function and improve patient outcomes.

• The FDA has delayed its decision on Sanofi’s multiple sclerosis drug tolebrutinib to December 28 due to newly submitted data requiring extended review of its NDA.

• Bristol Myers Squibb plans to charge U.S.-level pricing for its schizophrenia drug Cobenfy in the U.K., challenging NICE's cost-effectiveness standards amid global pricing pressures.

• The Trump administration plans to warn against Tylenol use in early pregnancy due to a proposed autism link and promote leucovorin as a potential, yet unproven, treatment.

• The FDA has rejected Lundbeck and Otsuka’s bid to expand Rexulti’s use to PTSD, citing insufficient efficacy data despite three Phase 3 trials supporting the application.

• With FDA approval of subcutaneous induction dosing for ulcerative colitis, J&J’s Tremfya becomes the first IL-23 inhibitor offering both IV and injection options across inflammatory bowel disease care.

• Ipsen has received Japanese approval for Bylvay to treat pruritus in PFIC, a rare liver disorder causing severe itching and developmental issues due to bile acid buildup.

• Ipsen has also secured UK approval for Cabometyx to treat advanced pancreatic and extra-pancreatic neuroendocrine tumors in adults who progressed after prior non-SSA therapies.

• The FDA has granted Priority Review to Chiesi’s idebenone for LHON, a rare genetic cause of sudden vision loss, with a decision expected by February 28, 2026.

TOUR OPERATOR

Upcoming events

• 🇦🇪 Dubai, 23-25 September 2025 – ArabLab

• 🇨🇭 Basel, 30 September-2 October 2025 – Festival of Biologics

• 🇨🇭Basel, 8-9 October 2025 - 25th Annual Biotech in Europe Forum

• 🇳🇱 Amsterdam, 11-14 October 2025 - ENCP Congress

• 🇩🇪 Berlin, 17-21 October 2025 - ESMO Congress

• 🇳🇱 Amsterdam, 27-30 October 2025 - World Orphan Drug Congress

• 🇩🇪 Frankfurt, 28-30 October 2025 - CPHI

• 🇦🇹 Vienna, 3-5 November 2025 - BIO-Europe 2025

• 🇺🇸 Boston, 13-14 November, 2025 - Pharma Partnering Summit

• 🇦🇪 Dubai, 17-18 November, 2025 - World Biotechnology and Bioengineering Congress

• 🇫🇷 Paris, 24-25 November, 2025 - 2nd International Congress on Virology, Emerging Diseases and Vaccines

• 🇧🇪 Brussels, 4-5 December, 2025 - BIOVERSE Europe 2025