Biotech Investor News - November 2024

As the biotech sector continues to evolve at a rapid pace, November brings a wealth of insights and developments that highlight the industry’s resilience, innovation, and challenges. From successful IPOs and groundbreaking drug approvals to significant M&A activity and the integration of artificial intelligence, this month’s newsletter provides a comprehensive overview of the key events shaping the biotech landscape.

Initial Public Offerings (IPOs) and Investments

Upstream Bio, a Boston-based biotech company specializing in inflammatory diseases and respiratory disorders, held a successful IPO on October 9th, 2024. The company's shares soared upon going public, demonstrating strong investor confidence.

Purespring Therapeutics, focused on gene therapies for kidney diseases, secured £80 million in Series B funding on October 9th, 2024. This investment will advance their research, including a Phase 1/2 trial for IgA nephropathy.

F2G, dedicated to novel antifungal therapies, raised $100 million in funding during September 2024. This significant investment highlights growing interest in antifungal treatments.

Deals and Acquisitions

Sanofi is in discussions to sell a controlling 50% stake in Opella, its consumer healthcare division, to private equity firm Clayton Dubilier & Rice (CD&R). The potential deal, valued at over $16 billion, was announced on October 10th, 2024. Sanofi’s rare disease drug, Enjaymo, acquired through a 2018 buyout of Bioverativ, is also slated to be transferred to Recordati as part of a deal announced on October 4th, 2024.

Lundbeck has agreed to acquire Longboard Pharmaceuticals as of October 14th, 2024. This acquisition provides Lundbeck access to bexicaserin, a promising 5-HT2C receptor agonist for treating seizures in rare developmental epileptic encephalopathies.

Drug Approvals and Trials

Pfizer received FDA approval for Hympavzi (marstacimab-hncq) on October 11th, 2024, for routine prophylaxis to reduce bleeding episodes in hemophilia A or B patients aged 12 and older. This marks a significant milestone in hemophilia treatment.

Roche achieved FDA clearance for its breast cancer drug, Itovebi, on October 10th, 2024, strengthening its presence in the oncology market.

Scholar Rock announced positive Phase 3 results for its SMA therapy on October 7th, 2024, potentially establishing a new standard treatment for spinal muscular atrophy and exploring applications for preserving muscle mass in obesity.

Stealth BioTherapeutics gained an FDA advisory committee’s recommendation for elamipretide on October 14th, 2024, paving the way for potential approval of its lead product.

Industry Trends and Challenges

Mergers and Acquisitions: In 2024, acquisitions of private biotech companies have outpaced those of public companies, reflecting a shift in the M&A landscape that investors should monitor closely.

Compounding Pharmacies: Debate continues over compounding pharmacies producing Eli Lilly’s tirzepatide for diabetes and obesity. The FDA’s initial opposition has softened following industry pushback.

Hurricane Helene: The hurricane’s impact on a Baxter manufacturing facility led to shortages of essential medicines, highlighting vulnerabilities in pharmaceutical supply chains.

Regulatory Backlogs: The FDA’s backlog of overseas drug manufacturer inspections is causing approval delays, underscoring the importance of streamlined regulatory processes.

Policy Setbacks: California’s proposed PBM reform bill, SB 966, failed to pass due to opposition from large employers favoring a single national standard. This setback illustrates the complexities of state versus federal healthcare regulation.

Artificial Intelligence (AI) in Healthcare

Eli Lilly appointed Thomas Fuchs as its first Chief AI Officer on October 7th, 2024, highlighting the company’s commitment to leveraging AI in drug discovery, clinical trials, and manufacturing.

Novo Nordisk is exploring the potential of its GLP-1 drug Wegovy to improve heart health in non-obese populations using AI. Preliminary findings suggest this weight-loss drug could also serve as a preventive treatment for heart attack and stroke, expanding its market potential.

Lilly’s AI Collaboration: Eli Lilly partnered with Insitro, an AI specialist, to develop innovative metabolic medicines. This collaboration exemplifies how AI is accelerating drug discovery and addressing unmet medical needs.

November has showcased the biotech industry’s unwavering commitment to addressing critical healthcare needs, driven by innovation and strategic investments. While challenges such as regulatory backlogs and supply chain vulnerabilities persist, the sector’s adaptability and forward-thinking approaches—especially in harnessing AI—paint a promising picture for the future. Stay informed and poised to capitalize on these transformative trends.

Yasir Hassan

The Biotech Investor