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It was a busy week for the biotech sector. While the fourth-quarter earnings season is nearing the end, other pipeline and regulatory updates were in focus.
Recap of the Week’s Most Important Stories:
BLUE Stock Plunges on Update
bluebird bio’s BLUE shares plunged after the company announced that it has entered into a definitive agreement to be acquired by funds managed by global investment firms Carlyle and SK Capital Partners, LP.
Per the terms of the agreement, bluebird stockholders will receive $3.00 per share in cash and a contingent value right per share, entitling the holder to a payment of $6.84 per share in cash. This amount will become payable if bluebird’s current product portfolio achieves $600 million in net sales in any trailing 12-month period prior to or ending on Dec. 31, 2027.
bluebird’s board determined that this transaction is in the best interest of stockholders following a comprehensive review of strategic alternatives.
Updates From GILD
Gilead Sciences, Inc. GILD announced that the European Medicines Agency (“EMA”) has validated the company’s marketing authorization application and EU-Medicines for all applications for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir. Gilead is seeking approval for lenacapavir for the prevention of HIV as pre-exposure prophylaxis (PrEP).
Both these applications are being assessed under an accelerated assessment review timeline as the EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that twice-yearly lenacapavir for HIV prevention is a product of major interest for public health and therapeutic innovation.
The European Commission also granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
The EC’s approval followed the positive opinion of the CHMP of the EMA and is primarily based on results from the pivotal placebo-controlled phase III RESPONSE study.
Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regulatory Update From TRDA
Entrada TRDA announced that the FDA has lifted the clinical hold on ENTR-601-44. TRDA also obtained FDA authorization to initiate ELEVATE-44-102, a phase Ib multiple ascending dose (MAD) clinical study of ENTR-601-44, for the potential treatment of Duchenne muscular dystrophy (DMD) in adult patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping.