It was a busy week for the biotech sector, with regulatory and pipeline updates. Sage Therapeutics SAGE was in focus after it rejected Biogen's BIIB acquisition proposal.
Recap of the Week’s Most Important Stories:
SAGE Stock Up on Rejecting BIIB’s Proposal
Sage Therapeutics stock gained after it announced that its board of directors has rejected the unsolicited, non-binding proposal offer from biotech giant Biogen to acquire the remaining shares of SAGE.
Per Sage Therapeutics, the BIIB offer significantly undervalues the company and is not in the best interest of shareholders. Biogen currently owns a 10.2% stake in SAGE, per a SEC filing by the company.
Earlier this month, Biogen made an acquisition offer to buy the remaining shares of SAGE that it does not already own for $7.22 per share. The offer price represented a premium of 30% on Sage Therapeutics’ closing price of $5.55 on Jan. 10.
SAGE’s board of directors has now started exploring strategic alternatives and evaluating other options to maximize its shareholders’ value. Sage Therapeutics and Biogen have a collaboration deal for the commercialization of Zurzuvae, which was approved for treating postpartum depression in August 2023. The drug was commercially launched in December 2023 and has witnessed an encouraging uptake so far.
Sage Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cytokinetics Stock Up on Pipeline Update
Cytokinetics CYTK announced that it has begun enrolling patients in its mid-stage study of CK-4021586 (CK-586), a cardiac myosin inhibitor, for treating heart failure patients. The intended patient population includes those with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥60%. The stock gained following the news.
The primary goal of the phase II AMBER-HFpEF study is to evaluate the safety and tolerability profile of CK-586 compared to placebo in HFpEF patients. As secondary objectives, the study will also assess the effect of CK-586 on LVEF and NT-proBNP, and determine the candidate’s pharmacokinetics and pharmacokinetic/pharmacodynamic relationship. Other exploratory endpoints of the study include evaluating the effect of CK-586 on patient function, and symptoms and measures of cardiac function.
Cytokinetics plans to enroll approximately 60 HFpEF patients in the phase II AMBER-HFpEF study who will receive CK-586 or placebo in three dose escalation cohorts.
AKRO Stock Surges on Study Data
Akero Therapeutics AKRO announced initial positive top-line 96-week data from a mid-stage study of its lead product candidate, efruxifermin (EFX), in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH). AKRO’s shares soared on the positive data.
The phase IIb SYMMETRY study evaluated two doses of EFX (28mg and 50mg) compared with placebo in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to MASH.
Per the data readout, in patients with both baseline and week 96 biopsies, 39% of those receiving 50mg EFX experienced cirrhosis reversal without MASH worsening compared to 15% in the placebo group.
In the Intent-to-Treat analysis, which considered missing week 96 biopsies as treatment failures, 29% of the 50mg EFX group achieved cirrhosis reversal without MASH worsening compared to about 12% in the placebo group.
The SYMMETRY study highlights the advantages of extended EFX treatment for patients with compensated cirrhosis, as evidenced by more than a twofold increase in effect size in the 50mg group, rising from 10% at week 36 to 24% at week 96.
Akero further reported that among patients in the SYMMETRY study who were not on GLP-1 therapy at baseline (n=97) with week 96 biopsies, 45% receiving 50mg EFX experienced cirrhosis reversal without MASH worsening compared to 17% in the placebo group. This suggested that the observed cirrhosis reversal was independent of GLP-1 therapy.
Updates From BIIB
Biogen announced that the FDA has approved a monthly maintenance dosing version of Leqembi, its intravenously (IV) administered Alzheimer's disease (AD) drug.
Post the FDA approval, patients have the option to transition to a monthly maintenance dosing regimen of Leqembi after completing an 18-month course of biweekly infusions of the drug. Alternatively, patients can continue with the biweekly dosing regimen.
Last week, the FDA and EMA have accepted Biogen’s regulatory filings seeking label expansion for a higher dose of its blockbuster spinal muscular atrophy (SMA) drug Spinraza.
This new proposed dosing regimen simplifies administration by offering two initial 50 mg doses spaced 14 days apart, followed by a 28 mg maintenance dose every four months. This approach reduces the dosing frequency compared to the current regimen, which requires four loading doses of 12mg administered at an interval of 14 days, followed by a 12 mg maintenance dose every four months.
Biogen’s regulatory filings are supported by data from the phase II/III DEVOTE study, which achieved its primary endpoint of statistically significant improvement in motor function in infants with SMA treated with a higher dose of Spinraza.
Performance
The Nasdaq Biotechnology Index has gained 2.05% in the past five trading sessions and MRNA’s shares have gained 25.22%. In the past six months, shares of MRNA have plunged 63.22%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA, NTLA Down on Updates, SAGE Up on Biogen’s Offer & Other Updates)
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What's Next in Biotech?
Stay tuned for more pipeline updates.
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