It was a busy week for the biotech sector, with quite a few important regulatory and pipeline updates. Among these, Amgen’s AMGN impending acquisition of Horizon Therapeutics HZNP remains in the spotlight.

Recap of the Week’s Most Important Stories:

COVID Vaccine Updates by Moderna:  Moderna MRNA announced encouraging data on its updated COVID-19 vaccine, mRNA-1273.815. The updated vaccine generated an 8.7-fold increase in neutralizing antibodies against the BA.2.86 variant, also known as Pirola. This variant is a highly mutated strain of COVID-19 with more than 30 mutations compared to prior Omicron strains and is being vigilantly monitored by public health authorities. The Centers for Disease Control has indicated that the highly mutated BA.2.86 variant may be more capable of causing infection in people who previously had COVID-19 or were vaccinated with prior vaccines. The vaccine also proved effective against the EG.5 and FL.1.5.1 variants.

A regulatory filing is currently under the agency’s review seeking authorization for mRNA-1273.815. A final FDA decision is expected in the coming weeks for the vaccine’s launch for the upcoming fall season. The vaccine is also currently under review in Europe. Moderna earlier stated that it built an ample supply for mRNA-1273.815 and is ready to ship the doses in the upcoming fall vaccination season, provided the FDA authorizes the vaccine.

Moderna currently carries a Zacks Rank #3 (Hold).

Amgen, Horizon Resolve Lawsuit: Amgen and Horizon Therapeutics plc announced that they have resolved the pending Federal Trade Commission administrative lawsuit. This clears Amgen’s path to acquire Horizon for $28 billion. As a result of the consent order agreement, Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order in the U.S. District Court for the Northern District of Illinois, and the firms will quickly seek the final approvals required under Irish law to close the acquisition. Shares of both companies were up on the news.

Amgen will not be bundling any of its products with Horizon Therapeutics’ two essential products — Tepezza (approved for treating thyroid eye disease) and Krystexxa (approved for treating chronic refractory gout). Both companies expect to close the acquisition in early fourth-quarter 2023.

Alnylam’s Study Data: Alnylam Pharmaceuticals, Inc. ALNY announced positive results from the phase II KARDIA-1 study on zilebesiran for the treatment of hypertension in patients at high cardiovascular risk. The candidate is an investigational RNAi therapeutic targeting liver-expressed angiotensinogen. Zilebesiran met the primary endpoint, demonstrating greater than 15 mmHg reduction of systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) at three months of treatment compared to placebo at both 300 mg and 600 mg doses. Alnylam also reported meeting key secondary endpoints in the study, including a significant change in 24-hour mean SBP as measured by ABPM at month six, as well as a significant change in office SBP at month three and month six for all zilebesiran arms compared to placebo.

Alnylam further stated that the candidate demonstrated an encouraging safety and tolerability profile.  Alnylam is developing zilebesiran in partnership with Roche. Alnylam also reported that the phase II KARDIA-2 study completed enrollment in June 2023, expecting top-line results in early 2024.

Biohaven’s Study Update: Biohaven BHVN announced preliminary analyses and positive biomarker data from its exploratory phase I electroencephalogram (EEG) biomarker study. The phase I EEG study was designed to evaluate qualitative changes from baseline in EEG spectral power after administration of single doses of BHV-7000 (10, 25, or 50 mg) to healthy volunteers. Biohaven is developing BHV-7000 for the treatment of epilepsy and mood disorders. The analysis confirms central nervous system activity of BHV-7000 at projected therapeutic concentrations, dose-dependent and time-dependent changes in EEG spectral power. It is consistent with EEG effects observed with other antiseizure medications approved for treating epilepsy.

BHV-7000 is well tolerated in phase I single ascending dose and multiple ascending dose studies to date. Biohaven has also completed the development of an extended-release formulation of BHV-7000 to allow once-daily dosing to be studied in future clinical programs. With target engagement now confirmed in the biomarker EEG study, favorable safety profile demonstrated in phase I studies and development of a once-daily formulation of BHV-7000, Biohaven plans to initiate its phase III program in focal epilepsy before the end of 2023.

Performance

The Nasdaq Biotechnology Index has lost 1.15% in the past four trading sessions. Among the biotech giants, Moderna has lost 4.17% during the period. Over the past six months, shares of Moderna have plunged 23.18%.

What’s Next in Biotech?

Stay tuned for more pipeline updates.
Alnylam Pharmaceuticals, Inc. (ALNY): Free Stock Analysis Report

Amgen Inc. (AMGN): Free Stock Analysis Report

Moderna, Inc. (MRNA): Free Stock Analysis Report

Horizon Therapeutics Public Limited Company (HZNP): Free Stock Analysis Report

Biohaven Ltd. (BHVN): Free Stock Analysis Report

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