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Editor's Note: Fierce Biotech will not publish on Monday in observance of the July Fourth holiday, but we’ll be back in your inbox on Tuesday, July 6.

Today's Rundown

Featured Story

GSK, under pressure to perform, pens $2.2B deal with Alector focused on neuro R&D, Alzheimer's

GlaxoSmithKline is penning an upfront and biobucks combo deal worth up to $2.2 billion with Fierce 15 winner Alector in neurodegenerative diseases.

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Top Stories

Acumen surges in first day of trading as it rides coattails of Biogen's Aduhelm approval, Lilly Alzheimer's developments

Acumen Pharmaceuticals soared in its first day of trading on the Nasdaq as the company raised $160 million to bankroll its Alzheimer's candidate following Biogen's Aduhelm approval and Eli Lilly's plans to move toward an accelerated approval for its own drug for the disease.

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Lundbeck sells off flopped Alzheimer's drug as Aduhelm approval ups interest

Lundbeck has offloaded the rights to an Alzheimer’s disease drug candidate that failed three phase 3 clinical trials in 2016 and 2017. China’s Denovo Biopharma has picked up the global rights to the 5-HT6 receptor antagonist in a deal that gives Lundbeck the option to reacquire the asset down the line.

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Sponsored: The Far-Reaching Value of Deeply Understanding the Patient Journey

An experiential learning program where Alexion employees “walk in the shoes” of patients to deepen understanding of the rare disease journey and develop impactful solutions. Learn more about LEAP.

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Arrowhead slams brakes on early-stage cystic fibrosis study after rat study triggers lung inflammation concerns

Arrowhead Pharmaceuticals is pausing a phase 1/2 study for an RNAi therapeutic after rats in a preclinical study showed unexpected lung inflammation. The Pasadena, California-based biopharmaceutical company is developing ARO-ENaC to treat patients with cystic fibrosis. The therapy aims to reduce production in the lungs' airways of a protein associated with airway dehydration and reducing the transport of mucus in patients with the disease.

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Roche vet leaves Nordic Nanovector 3 months after joining as CEO

Peter Braun is leaving Nordic Nanovector three months after joining the company as CEO. Nordic Nanovector attributed Braun’s departure to “personal reasons” and named its chief financial officer to the top job on an interim basis.

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FDA finds faults in Iterum antibiotic filing with decision date looming

Five months after hopping into the fast lane, Iterum’s oral antibiotic is hitting a roadblock. The FDA has stopped discussing labeling and postmarketing requirements thanks to “deficiencies” found in the drug’s application. The news came in a letter from the agency that did not detail what those deficiencies were, the company said in a statement on Thursday afternoon.

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Caribou eyes $100M IPO as it aims off-the-shelf CAR-Ts at the clinic

Another day, another $100 million. In a move that’s starting to look like a rite of passage in biotech, Caribou Biosciences filed on Thursday to raise $100 million in its Wall Street debut. The proceeds will propel three off-the-shelf CAR-T therapies into and through the clinic and boost Caribou’s work in natural killer (NK) cell therapies.

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Fierce15 winner Rallybio establishes proof-of-concept in phase 1/2 study for rare fetal bleeding disorder

2018 Fierce15 winner Rallybio has established proof-of-concept for an antibody treatment aiming to prevent a rare disease that causes a mother’s immune system to attack her fetus or newborn child’s platelets. Rallybio is conducting a phase 1/2 study of RLYB211 to prevent Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), which can cause uncontrollable bleeding in fetuses and newborns.

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Eschewing an IPO (for now), Sirnaomics nabs a rare series E worth $105M for next-gen RNA work

It’s a case of déjà vu (and no IPO) for the U.S.-China RNAi biotech Sirnaomics as it grabs a $105 million funding round, just under a year after grabbing the same amount in a D round.

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Parexel snapped up, again, as Goldman Sachs, EQT spend $8.5B on the CRO

The rumors were true: Whispers grew this year that Parexel, owned for the past four years by Pamplona Capital, was seeking a sale or an IPO. Today, the whispers stopped as the CRO loudly declared it is being bought out for $8.5 billion.

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Astronauts perform first CRISPR gene-editing studies in space

Aboard the International Space Station, astronauts used CRISPR to help zero in on how cells repair DNA that may be damaged by cosmic radiation.

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Regeneron pinpoints gene variants that protect against obesity, launches search for new drugs

A team at Regeneron Genetics Center has discovered mutations in the gene GPR75 that protect against obesity. They showed in a new study that when they fed a high-fat diet to mice that were engineered to lack either one or two copies of the gene, the animals didn't gain nearly as much weight as normal mice did. Now, Regeneron is searching for drugs to target the gene.

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Chutes & Ladders—AstraZeneca internally promotes Galbraith to helm cancer R&D

After 11 years working on cancer therapies at AstraZeneca, Susan Galbraith, Ph.D., has been named the Big Pharma's successor to the late José Baselga, who led cancer R&D. Former Sanofi research head Carlos Garcia-Echeverria, Ph.D., joins EQRx to lead drug discovery and creation for the in-licensed-focused biotech. And Moderna taps an Ogilvy executive as its first chief brand officer.

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Fierce Pharma Asia—Fujifilm, WuXi STA plan major expansions; Hanmi's GLP-1 posts heart data; BeiGene plots $3B China IPO

Fujifilm and WuXi STA are expanding their CDMO capacities in the U.S. Hanmi's GLP-1 diabetes drug, once partnered with Sanofi, showed it could reduce the risks of heart and kidney diseases. BeiGene has won clearance to stage a $3 billion IPO on China's Nasdaq-like STAR market. And more.

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Resources

Whitepaper: Strategies for mitigating supply chain risk in clinical trials

Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget.

Whitepaper: Evaluating current manufacturing platforms for recombinant AAV production

Choose the right AAV platform for your viral vector-based therapy

E-Book: Digital Therapeutics 101

E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic.

Whitepaper: To De-Risk Your Next Trial, Seek Outside Expertise

Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions.

Report: Cell & Gene Therapy in 2040: Seizing the moment to propel the industry forward

What does the future of Cell & Gene Therapy look like?

Whitepaper: How to Launch a Successful BYOD Strategy in Any Phase

For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink.

eBook: Improving Diversity and Inclusion in Clinical Trials

Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them.

Whitepaper: Closed Cell Processing System Benefits for Cell & Gene Therapy

Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process.

Guide: Your Guide to Overcome Inconsistent Clinical Data Standards

Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Content Hub: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

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