Pharmaceutical Industry Roundup: Major Deals, Clinical Setbacks, and Regulatory Updates

In a flurry of activity across the pharmaceutical landscape, several companies have announced significant developments, ranging from strategic partnerships to clinical trial results and regulatory milestones. This week's news highlights the industry's ongoing efforts to reshape portfolios, advance novel therapies, and navigate the complex drug development process.

Sanofi Finalizes Consumer Health Joint Venture

French pharmaceutical giant Sanofi has reached an agreement with private equity firm Clayton, Dubilier & Rice (CD&R) to create a joint venture for its consumer health business, Opella. Under the terms of the deal, CD&R will acquire a 50% stake in Opella, while Bpifrance, the French state-owned investment bank, will take a 2% minority stake. The transaction, which was initially outlined in October, is expected to close in the second quarter of this year.

This strategic move allows Sanofi to free up capital for increased investment in its prescription drug research pipeline, aligning with the company's focus on innovative medicines. The deal represents a significant shift in Sanofi's business structure and highlights the ongoing trend of pharmaceutical companies streamlining their portfolios to concentrate on core therapeutic areas.

Clinical Setbacks and Pipeline Developments

Supernus Faces Disappointment in Depression Study

Supernus Pharmaceuticals reported a setback in its clinical program for treatment-resistant depression. The company's experimental drug, SPN-820, failed to meet its primary endpoint in a mid-stage study. The oral medication, designed to enhance a protein complex involved in brain cell signaling and function, did not demonstrate significant improvement in depressive symptoms compared to placebo after four weeks of treatment.

Despite the disappointing results, Supernus CEO Jack Khattar indicated that the company plans to conduct further analysis of the trial data and discuss the future of the program with development partner Navitor Pharmaceuticals. The news led to a double-digit decline in Supernus shares.

Arcus Retains Rights to Cancer Drug as Gilead Declines Option

In a separate development, Arcus Biosciences announced that it will retain control of its experimental cancer drug, casdatifan, after Gilead Sciences declined to exercise its option to license the compound. Casdatifan, a HIF-2a inhibitor similar to Merck & Co.'s recently approved Welireg, is being developed for clear cell renal cell carcinoma.

The decision comes as part of a 10-year collaboration agreement between Arcus and Gilead signed in 2020. To support the independent development of casdatifan, Arcus has announced a $150 million stock offering.

Regulatory Progress for Novel Therapies

Gilead Advances HIV Prevention Drug

Gilead Sciences received positive news from the U.S. Food and Drug Administration (FDA) regarding its HIV prevention drug, lenacapavir. The FDA has accepted Gilead's approval application for lenacapavir as pre-exposure prophylaxis (PrEP) for HIV, setting a decision deadline of June 19, 2025.

If approved, lenacapavir would become the first twice-yearly option for HIV prevention, potentially offering a significant advancement in PrEP regimens. The drug is already marketed in several countries as a treatment for multi-drug resistant HIV when used in combination with other medicines.

Ultragenyx Nears Potential Approval for Rare Disease Gene Therapy

Ultragenyx Pharmaceutical is approaching a critical regulatory milestone for its gene therapy targeting Sanfilippo syndrome type A, a rare and fatal lysosomal storage disease. The FDA is set to decide on the approval of UX111 by mid-August. The therapy uses an adeno-associated virus to deliver a functional gene capable of producing an enzyme that patients with Sanfilippo syndrome lack.

Originally developed by Abeona Therapeutics, UX111 was transferred to Ultragenyx in a 2022 deal. The company does not anticipate the FDA will convene an advisory committee meeting as part of the review process, potentially streamlining the path to approval for this innovative treatment.