The Daily Biotech Pulse: Merck Rallies On Antiviral Pill Data, Gilead Files For Yescarta Label Expansion, Exscientia IPO

Here's a roundup of top developments in the biotech space over the last 24 hours.

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Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 30)

• Biohaven Pharmaceutical Holding Company Ltd. BHVN
• Cytokinetics, Incorporated CYTK
• Eagle Pharmaceuticals, Inc. EGRX
• Leap Therapeutics, Inc. LPTX
• Legend Biotech Corporation LEGN

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 30)

• 4D pharma plc LBPS
• ADMA Biologics, Inc. ADMA
• Agile Therapeutics, Inc. AGRX
• Alzamend Neuro, Inc. ALZN
• Applied Genetic Technologies Corporation AGTC
• Applied Molecular Transport Inc. AMTI
• Aptose Biosciences Inc. APTO
• Aridis Pharmaceuticals, Inc. ARDS
• Athersys, Inc. ATHX
• BioVie Inc. BIVI
• Black Diamond Therapeutics, Inc. BDTX
• Centessa Pharmaceuticals Limited CNTA
• Chemomab Therapeutics Ltd. CMMB
• Clarus Therapeutics Holdings, Inc. CRXT
• CNS Pharmaceuticals, Inc. CNSP
• Cue Health Inc. HLTH (IPOed Sept. 24)
• Cullinan Oncology, Inc. CGEM
• Eiger BioPharmaceuticals, Inc. EIGR
• Eledon Pharmaceuticals, Inc. ELDN
• Emergent BioSolutions Inc. EBS
• First Wave BioPharma, Inc. FWBI
• Forte Biosciences, Inc. FBRX
• Galapagos NV GLPG
• Global Blood Therapeutics, Inc. GBT
• Graybug Vision, Inc. GRAY
• Harpoon Therapeutics, Inc. HARP
• HOOKIPA Pharma Inc. HOOK
• Humanigen, Inc. HGEN
• IMARA Inc. IMRA
• Inozyme Pharma, Inc. INZY
• Ionis Pharmaceuticals, Inc. IONS
• Jasper Therapeutics, Inc. JSPR
• Kala Pharmaceuticals, Inc. KALA
• LumiraDx Limited LMDX
• MorphoSys AG MOR
• Nanobiotix S.A. NBTX
• Nautilus Biotechnology, Inc. NAUT
• NextCure, Inc. NXTC
• Orchard Therapeutics plc ORTX
• Pliant Therapeutics, Inc. PLRX
• RedHill Biopharma Ltd. RDHL
• RenovoRx, Inc. RNXT
• Silverback Therapeutics, Inc. SBTX
• Spruce Biosciences, Inc. SPRB
• TCR2 Therapeutics Inc. TCRR
• Titan Pharmaceuticals, Inc. TTNP
• Tiziana Life Sciences PLC TLSA
• Voyager Therapeutics, Inc. VYGR
• VYNE Therapeutics Inc. VYNE
• Zynex, Inc. ZYXI

Stocks In Focus

BioNTech Commences Mid-stage Study of mRNA Vaccine Against Colorectal Cancer

BioNTech SE BNTX announced that the first colorectal cancer patient has been treated with its individualized mRNA cancer vaccine BNT122 in a Phase 2 clinical trial.

The trial has been initiated in the U.S., Germany, Spain and Belgium. It's planned to enroll about 200 patients to evaluate the efficacy OF BNT122 compared to watchful waiting after surgery and chemotherapy, the current standard of care for these high-risk patients.

The stock was down 2.84% at $265.23 in premarket trading.

Merck Announces Positive Phase 3 Results For Oral Antiviral Therapy In Non-hospitalized Mild-to-moderate COVID-19 Patients

Merck & Co., Inc. MRK and Ridgeback Biotherapeutics announced that molnupiravir, an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19.

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%. About 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization compared with 14.1% of placebo-treated patients.

Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.

At the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, recruitment into the study is being stopped early due to these positive results. Merck said it plans to submit an application for emergency use authorization to the FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.

Merck shares were 4.91% higher at $78.79 in premarket trading.

Related Link: Aduhelm's 'Blockbuster Potential' Is Underappreciated, Says Biogen Analyst

Gilead Files Regulatory Application For Approval of Yescarta Cell Therapy In Advanced B-cell Lymphoma Second-line Setting
Gilead Sciences, Inc. GILD announced that it has submitted a supplemental biologics license application to the Food and Drug Administration for Yescarta (axicabtagene ciloleucel) to expand its current indication to include the treatment of adults with relapsed or refractory large B-cell lymphoma in the second-line setting.

Bristol-Myers Squibb Says European Regulator Accepts For Review 2 Of its Regulatory Applications

Bristol-Myers Squibb Company BMY announced that the European Medicines Agency has validated its marketing authorization application for mavacamten, an investigational treatment of patients with obstructive hypertrophic cardiomyopathy.

Separately, the company said the EMA has also validated its MAA for the LAG-3-blocking antibody relatlimab and Opdivo fixed-dose combination for first-line treatment of adult and pediatric patients with advanced melanoma.

Haemonetics' Vascade Device Receives FDA Indication For Same-day Discharge Following Atrial Fibrillation Ablation

Haemonetics Corporation HAE announced that the Vascade MVP venous vascular closure system received FDA indication for same-day discharge following atrial fibrillation ablation.

The same-day discharge labeling was granted following the conclusion of the first two registries in the AMBULATE same-day discharge clinical study series, which evaluated the safety and efficacy of using Vascade MVP to facilitate same-day discharge of AF ablation patients.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Gilead's sBLA for Tecartus, a CAR T-cell therapy that is being evaluated in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Clinical Readouts/Presentations

European Association for the Study of Diabetes 57th Annual Meeting Presentations

Precigen, Inc. PGEN: Additional data from the AG019 Phase 1b/2a clinical trial in Type 1 diabetes (6 am)

American Society for Bone and Mineral Research Annual Meeting Presentations

Entera Bio Ltd. ENTX: interim 3-month analysis from Phase 2 study of oral PTH in postmenopausal women with low bone mass (8pm)

International Symposium on Retinal Degeneration Presentations

Adverum Biotechnologies, Inc. ADVM: new clinical data on ADVM-022 intravitreal injection gene therapy from the Phase 1 OPTIC trial in wet age-related macular degeneration (4 pm)

REGENXBIO Inc. RGNX & Clearside Biomedical, Inc. CLSD: interim results at six months of follow-up for patients in Cohort 1 of the Phase 2 AAVIATE trial of RGX-314 in patients with wet age-related macular degeneration

ID Week Presentations

AstraZeneca PLC AZN & Vaccitech plc VACC: asymptomatic Infection and duration of viral shedding in symptomatic breakthrough infections in a Phase 3 study of AZD1222

IPOs

Exscientia plc EXAI, an AI-driven pharmatech company, priced its upsized initial public offering of 13.85 million ADSs, representing 13.85 million ordinary shares at an initial public offering price of $22 per ADS, for total gross proceeds of approximately $304.7 million. All ADSs sold in the offering were offered by Exscientia. The ADSs are expected to begin trading on the Nasdaq under the ticker symbol "EXAI."