Drug approvals and other regulatory news are in focus in the biotech sector. Updates on booster doses of COVID-19 vaccines are also in the spotlight with the approaching winter season, which is likely to see a spike in the infection rate.

Recap of the Week’s Most Important Stories:

Bristol Myers Up on Drug Approval:  Shares of Bristol Myers (BMY Quick QuoteBMY - Free Report) surged after it obtained FDA approval for its experimental candidate deucravacitinib under the brand name Sotyktu. The drug is approved to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The psoriasis market has potential and investors were impressed with the regulatory nod for the drug.  The FDA approval is based on results from the phase III POETYK PSO-1 and POETYK PSO-2 studies, demonstrating superior efficacy of once-daily Sotyktu over placebo and twice-daily Otezla (apremilast) in 1,684 patients, aged 18 years and above, with moderate-to-severe plaque psoriasis.

Sotyktu demonstrated superior efficacy over placebo and Otezla at both 16 and 24 weeks that lasted through 52 weeks.  Sotyktu is also under regulatory review of the European Medical Association and other health authorities worldwide. The approval of potential new drugs will add an incremental revenue stream to boost growth in the coming quarters.

Bristol Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Regeneron Gains on Study Data: Shares of Regeneron Pharmaceuticals, Inc. (REGN Quick QuoteREGN - Free Report) gained after it announced that the two studies evaluating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) were successful. Please note that aflibercept injection 2mg is approved under the brand name Eylea for treating patients with wAMD, macular edema following retinal vein occlusion (RVO), DME, and diabetic retinopathy (DR). Eylea is Regeneron’s lead drug. The company is evaluating a higher dose of aflibercept with less frequent injections in the targeted population.

Data from the PHOTON trial in DME and the PULSAR trial in wAMD showed that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the 8-week dosing regimen of Eylea. These trials further showed that around 90% of patients with DME and almost 80% of patients with wAMD were able to continue a 16-week dosing regimen while maintaining the safety profile.

Amylyx Rises on Regulatory Update:  Shares of Amylyx Pharmaceuticals (AMLX Quick QuoteAMLX - Free Report) rallied significantly after an FDA Advisory Committee recommended the approval of its new drug application (NDA) for AMX0035, an oral medicine to treat amyotrophic lateral sclerosis (ALS). The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) voted 7:2, with the majority favoring the drug’s approval for ALS. A final decision from the FDA is expected by Sep 29, 2022. The positive recommendation increases the likelihood of an FDA nod.  This favorable decision from the PCNSDAC is based on data from the phase II CENTAUR study, which evaluated the drug for ALS compared with placebo in ALS patients.  The study achieved its primary efficacy endpoint, as participants administered AMX0035, demonstrated a significant slowdown of ALS progression and a functional decline.

Novavax Vaccine Update: Novavax (NVAX Quick QuoteNVAX - Free Report) announced that the European Commission (EC) expanded its conditional marketing authorization (CMA) for Nuvaxovid (NVX-CoV2373), its protein-based COVID-19 vaccine, to allow its use as a booster dose in adults aged 18 years and older in the European Union (EU). Novavax can now cater to a broader population regardless of whether they completed a primary vaccine regimen using Nuvaxovid or any other authorized vaccine. The authorization follows a positive review by the Committee for Medicinal Products for Human Use (CHMP), which recommended the vaccine’s use as a booster earlier this month. The decision by the EC and CHMP was based on multiple mid-stage studies conducted by Novavax separately in Australia, South Africa and the U.K., evaluating a booster dose of NVX-CoV2373.

Akero Surges on NASH Study Data:  Shares of clinical-stage company Akero Therapeutics, Inc (AKRO Quick QuoteAKRO - Free Report) skyrocketed after its topline data was released from the phase IIb HARMONY study, currently evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3). The study met its primary endpoint for both the 50 mg and 28 mg EFX dose groups, with 41% and 39% of EFX-treated patients, respectively, experiencing at least a one-stage improvement in liver fibrosis with no worsening of NASH by week 24 compared with 20% for the placebo arm. The study also met a key secondary goal with 76% and 47% of patients treated with 50mg and 28mg, respectively, achieving NASH resolution without worsening of fibrosis compared with 15% for placebo.

Akero is also conducting the SYMMETRY study, a phase IIb program in biopsy-confirmed NASH patients with compensated cirrhosis (F4). AKRO expects to report results from the SYMMETRY study in the second half of 2023.

Performance

The Nasdaq Biotechnology Index has gained 3.02% in the past five trading sessions. Among the biotech giants, Regeneron has gained 22.20% during the period. Over the past six months, shares of Vertex have rallied 16.13%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD’s Updates, FMTX Up on NVO Deal, SPRO Surges & More)

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What's Next in Biotech?

Stay tuned for other updates.