The Daily Biotech Pulse: Assembly Bio Halts HBV Study, Moderna Initiates Submission For COVID-19 Booster Dose, FDA Nod For BeiGene, Tiziana Out-Licenses Foralumab - iShares Biotechnology ETF (NASDAQ:IBB)

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 1)

AbbVie Inc. ABBV (after hitting a 52-week high in morning trading, the stock pulled back on the FDA requiring a heart risk warning on the label of its arthritis drug Rinvaq)
Adagio Therapeutics, Inc. ADGI (IPOed Aug. 6)
Axonics, Inc. AXNX
Bicycle Therapeutics plc BCYC
BioLife Solutions, Inc. BLFS (announced closing of Sexton Biotechnologies acquisition)
Bio-Rad Laboratories, Inc. BIO
Biohaven Pharmaceutical Holding Company Ltd. BHVN
Catalent, Inc. CTLT
Celldex Therapeutics, Inc. CLDX
Cerevel Therapeutics Holdings, Inc. CERE
Crinetics Pharmaceuticals, Inc. CRNX
Cryo-Cell International, Inc. CCEL (announced uplisting to Nasdaq on Tuesday)
DexCom, Inc. DXCM
Dynavax Technologies Corporation DVAX
Enanta Pharmaceuticals, Inc. ENTA
Erasca, Inc. ERAS
Fulcrum Therapeutics, Inc. FULC
Humacyte, Inc. HUMA
Intuitive Surgical, Inc. ISRG
Kezar Life Sciences, Inc. KZR
Merit Medical Systems, Inc. MMSI
MiMedx Group, Inc. MDXG
Nuvalent, Inc. NUVL
OrthoPediatrics Corp. KIDS
PAVmed Inc. PAVM
Pieris Pharmaceuticals, Inc. PIRS
PPD, Inc. PPD
Quest Diagnostics Incorporated DGX
Regeneron Pharmaceuticals, Inc. REGN
Repligen Corporation RGEN
Surmodics, Inc. SRDX
Taiwan Liposome Company, Ltd. TLC
Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 1)

Mesoblast Limited MESO
Silverback Therapeutics, Inc. SBTX

Stocks In Focus

FDA Approves BeiGene's Brukinsa For Rare Blood Cancer

BeiGene, Ltd BGNE said its Brukinsa has received approval from the U.S. Food and Drug Administration in the treatment of adult patients with Waldenström's macroglobulinemia. This is second indication for which Brukinsa has been approved.

The stock was advancing 0.84% to $330 in premarket trading.

Assembly Biosciences Halts Midstage Study Of Hepatitis B Virus Drug Candidate Due To Safety Concerns Over Drug-Induced Liver Toxicity

Assembly Biosciences, Inc. ASMB announced its decision to discontinue development of ABI-H2158 following the observation of elevated ALT levels consistent with drug-induced hepatotoxicity in an ongoing Phase 2 trial.

"Patient safety is always our priority, which is why we have elected to discontinue the development of 2158," said John McHutchison, CEO and president of Assembly Bio.

"We remain focused on expeditiously advancing our additional clinical programs, including the two ongoing Phase 2 triple combination studies, accelerating the clinical development for 3733 and 4334, and progressing additional research programs in our HBV portfolio with complementary mechanisms. And, as always, we will continue evaluating strategic opportunities to build additional value in the company's pipeline," he said.

The stock was seen slipping 21.28% to $3.07 in after-hours trading.

Moderna Initiates COVID-19 Vaccine Booster Dose Review With FDA

Moderna, Inc. MRNA said it has initiated its submission to the FDA for the evaluation of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level. The company expects to submit data to the European Medicines Agency and other regulatory authorities around the world in the coming days.

The stock was adding 1.09% to $394.20 in premarket trading.

Precision Biosciences In-Licenses Tiziana's Antibody Drug For Evaluation As Lymphodepletion Agent In Cancer Drug Study

Precision BioSciences, Inc. DTIL and Tiziana Life Sciences PLC TLSA announced an exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody, as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy.

Under the terms of the agreement, Precision gains an exclusive license to use foralumab as a lymphodepletion agent in conjunction with its allogeneic CAR T therapeutics for the treatment of cancers. Precision will be responsible for the development, commercialization and costs for use of foralumab, and Tiziana will receive upfront payments, certain milestone payments and royalties for foralumab.

Tiziana shares were up 21.21% to $2 in premarket trading and Precision was adding 4.46% to $14.30.

Pfizer Commences Late-Stage Study Of Respiratory Syncytial Virus Vaccine Candidate In Older People

Pfizer, Inc. PFE announced the initiation of RENOIR, a Phase 3 clinical trial evaluating the efficacy, immunogenicity and safety of a single dose of its respiratory syncytial virus bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 years or older.

The stock was moving up 0.56% to $46.30 in premarket trading.

Plus Therapeutics Strikes Manufacturing Partnership For Radiopharmaceutical Pipeline Products

Plus Therapeutics, Inc. PSTV announced that it has entered into an agreement with RadioMedix, Inc. for the commercial production of its radiopharmaceuticals.

"This strategic partnership substantially supports our efforts to have fully compliant 186RNL available by mid-2022 for a potential Phase 2/3 clinical study in adults with recurrent glioblastoma," said Mark Hedrick, CEO of Plus.

The strategic partnership further secures the commercial supply chain for 186RNL and extends to future products under the RNL platform, the company said.

Plus shares were gaining 16.32% to $2.21 in premarket trading.

INmune Announces Positive Biomarker Data From Phase 1 Study Of Alzheimer's Drug

INmune Bio, Inc. INMB said XPro, its selective DN-TNF inhibitor candidate for the treatment of Alzheimer's disease, treatment resistant depression and other neurological diseases where neuroinflammation is implicated, has been found to decrease multiple species of Phospho Tau and improve neuroimaging biomarkers of myelination in patients with AD.

These biomarker data are from the analysis of the company's recently concluded Phase 1 study of XPro in Alzheimer's patients.

The stock was seen jumping 11.81% to $26.69 in premarket trading.

Takeda's Study Evaluating Drug-Chemo Combo Flunks Late-Stage Blood Cancer Study

Takeda Pharmaceutical Company Limited TAK said the Phase 3 PANTHER study did not achieve pre-defined statistical significance for the primary endpoint of event-free survival. The trial evaluated whether the combination of pevonedistat plus Bristol-Myers Squibb Company BMY's chemotherapy drug Vidaza as first-line treatment for patients with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia and low-blast acute myeloid leukemia improved EFS versus Vidaza alone.

An event in the trial is defined as death or transformation to AML in participants with higher-risk MDS or CMML, whichever occurs first, and death in participants with AML.

The stock was declining 0.95% to $16.75 in premarket trading.

Clearside Medical Drops On Insider Selling

Clearside Biomedical, Inc. CLSD disclosed in a filing with the SEC that company insider Bradford Whitmore sold 420,285 shares in the company at prices ranging from $6.8913 to $7.0634.

The stock was moving down 4.47% to $6.41 in after-hours trading.

Quidel To Make At-Home COVID-19 Antigen Test Available In CVS Stores

Quidel Corporation QDEL announced, starting next week, it will make its non-prescription QuickVue at-Home OTC COVID-19 Test available to consumers at more than 7,000 CVS Pharmacy locations across the U.S. and online.

The company received emergency use authorization for the test in early March.

In premarket trading, the stock was up 2.66% at $139.14.

Codex DNA Announces Release Of Full Length Genome Of Delta Variant Of SARS-CoV-2 Virus

Codex DNA, Inc. DNAY announced the release of its first full-length synthetic genome for the highly infectious delta variant of the SARS-CoV-2 virus. The genome was synthesized and constructed using Codex DNA's BioXp 3250 system, its fully automated synthetic biology benchtop workstation for rapid, accurate and reproducible writing of DNA and mRNA.

On The Radar

Earnings

MEI Pharma, Inc. MEIP (after the close)

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