The Daily Biotech Pulse: Eisai, Biogen Pursue Approval Of Second Alzheimer's Treatment; Sanofi Changes mRNA Strategy; GSK Subsidiary To Develop Long-Acting HIV Preventive - 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. 27)

Acceleron Pharma Inc. XLRN - moved on rumors of a $11-billion buyout deal with Merck MRK
Apyx Medical Corporation APYX
Cardiol Therapeutics Inc. CRDL
Cytokinetics, Incorporated CYTK
Dynavax Technologies Corporation DVAX
Eagle Pharmaceuticals, Inc. EGRX
Gossamer Bio, Inc. GOSS
Innoviva, Inc. INVA
IVERIC bio, Inc. ISEE
Oramed Pharmaceuticals Inc. ORMP

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 27)

4D pharma plc LBPS
Accelerate Diagnostics, Inc. AXDX
Acutus Medical, Inc. AFIB
Aridis Pharmaceuticals, Inc. ARDS
BioVie Inc. BIVI
Centessa Pharmaceuticals Limited CNTA
Clarus Therapeutics Holdings, Inc. CRXT (went public through a SPAC deal and began trading on the Nasdaq on Sept. 10)
Emergent BioSolutions Inc. EBS
First Wave BioPharma, Inc. FWBI
Galecto, Inc. GLTO
Global Blood Therapeutics, Inc. GBT
Incyte Corporation INCY - announced an in-licensing agreement for Syndax Pharmaceuticals, Inc. SNDX's axatilimab, an anti-CSF-1R monoclonal antibody
Nautilus Biotechnology, Inc. NAUT
Passage Bio, Inc. PASG
Pluristem Therapeutics Inc. PSTI
Scopus BioPharma Inc. SCPS
Silverback Therapeutics, Inc. SBTX
Singular Genomics Systems, Inc. OMIC
Talis Biomedical Corporation TLIS
Vertex Pharmaceuticals Incorporated VRTX
Zynex, Inc. ZYXI

Stocks In Focus

Eisai Initiates Rolling Submission Of Regulatory Application For Accelerated Approval Of Partnered Early Alzheimer's Antibody Treatment Candidate

Eisai Co., Ltd. ESALY and Biogen Inc. BIIB announced that Eisai has initiated a rolling submission to the Food and Drug Administration of a biologics license application for lecanemab, Eisai's investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer's disease.

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology.

Biogen shares were edging down 0.22% to $286 in premarket trading.

Sanofi Declines To Pursue Study Of mRNA Vaccine Candidate For COVID-19

Sanofi SNY announced positive interim results from a Phase 1/2 study of its mRNA-based COVID-19 vaccine candidate, confirming the potential of recently acquired Translate Bio's messenger RNA and lipid nanoparticle platform.

The initial data from Phase 1/2 showed neutralizing antibody seroconversion in 91% to 100% of study participants two weeks after a second injection across the three dosages tested.

No safety concern has been observed and the tolerability profile is comparable to that of other unmodified mRNA COVID-19 vaccines.

Sanofi is not pursuing development of the vaccine candidate against COVID-19 but said it is taking the mRNA platform to the next level in development, including moving to modified mRNA, and against other diseases, including flu.

Sanofi shares were down 0.25% at $48 in premarket trading.

Paratek Awarded Incremental $19M BARDA Funding For Development of Nuzyra In Pulmonary Anthrax

Paratek Pharmaceuticals, Inc. PRTK announced that the BARDA has awarded an option under the company's Project BioShield contract.

This option provides additional funding to continue the development of Nuzyra to support a supplemental new drug application to the FDA for post-exposure prophylaxis and treatment of pulmonary anthrax. The additional studies supported by this option increase the value of the BARDA contract by approximately $19 million.

Pfizer Begins Clinical Study Of mRNA Vaccine For Flu

Pfizer, Inc. PFE said the first participants have been dosed in a Phase 1 clinical trial to evaluate the safety, tolerability and immunogenicity of a single dose quadrivalent mRNA vaccine against influenza in healthy adults.

Pfizer's mRNA influenza vaccine program is the first in a planned wave of programs leveraging mRNA technology for influenza. Beyond influenza, the company plans to explore mRNA in other respiratory viruses, including medically appropriate vaccine combinations that could provide protection against more than one respiratory virus, as well as expand to develop mRNA technology in oncology and genetic diseases.

The stock was down 0.83% at $43.21 in premarket trading.

ViiV In-Licenses HIV Asset With Potential For Ultra Long-Acting Regimens

ViiV Healthcare, majority owned by GlaxoSmithKline plc GSK, with Pfizer and Shionogi as shareholders, announced an exclusive collaboration and license agreement with Shionogi & Co., Ltd. SGIOF for S-365598, a third-generation investigational integrase strand transfer inhibitor with potential for use in ultra-long-acting HIV regimens, with dosing intervals of three months or longer.

Under the terms of the agreement, ViiV Healthcare will make an upfront payment of 20 million pounds to Shionogi, a 15-million-pound payment for the achievement of a clinical development milestone and royalties on net sales.

Separately, ViiV said the FDA has accepted and granted Priority Review for a NDA for investigational, injectable cabotegravir long-acting for pre-exposure prophylaxis, or PrEP.

If approved, cabotegravir would be the first, long-acting therapy for the prevention of HIV for individuals at risk of sexually acquired HIV-1 infection who have a negative HIV-1 test prior to initiation. The FDA has set a target approval date of Jan. 24, 2022.

Pfizer, BioNTech Submit Phase 2/3 Data To FDA For COVID-19 Vaccine In Children

Pfizer and BioNTech SE BNTX announced the submission of data to the FDA from the Phase 2/3 trial of a COVID-19 vaccine in children ages 5 to less than 12 years of age.

A formal submission to request emergency use authorization of the companies' COVID-19 vaccine in children is expected to follow in the coming weeks. Submissions to the European Medicines Agency and other regulatory authorities are also planned.

Regeneron's Application For Libtayo In Cervical Cancer Accepted For Priority Review

Regeneron Pharmaceuticals, Inc. REGN said the FDA has accepted for priority review the supplemental biologics license application for PD-1 inhibitor Libtayo to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.

The target action date for the FDA decision is Jan. 30, 2022. The sBLA is also being reviewed under the FDA's Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada and Switzerland.

Additional global regulatory submissions are planned, including in the European Union, by the end of 2021.

The stock was down 2.89% at $601.20 in premarket trading.

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Sonoma Announces OTC Consumer Launch of 3 Products Based On Microcyn Tech

Sonoma Pharmaceuticals, Inc. SNOA announced the over-the-counter consumer launch of Regenacyn advanced scar gel and Ocucyn eyelid & eyelash cleanser on Amazon, Inc. AMZN and MucoClyns on Amazon sites in Europe.

All three products are based on Sonoma's patented Microcyn technology and are immediately available for customer orders.

The stock was jumping 57.01% to $8.40 in premarket trading.

Altimmune Reports Mixed Phase 1 Data For ALT-801

Altimmune, Inc. ALT announced mixed results from a 12-week, Phase 1 trial of pemvidutide, formerly known as ALT-801, an investigational glucagon-like peptide-1 (GLP-1)/glucagon dual receptor agonist.

At 12 weeks, subjects receiving pemvidutide achieved mean weight losses of 4.9%, 10.3%, and 9.0% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, with the placebo group experiencing a mean weight loss of 1.6%. At the lower doses, the weight loss wasn't statistically significant relative to the placebo.

Weight loss occurred rapidly and consistently over 12 weeks. Side effects were mild to moderate, with no serious or severe treatment-emergent adverse events.

The stock was down 14.42% at $13 in premarket trading.

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