The Daily Biotech Pulse: J&J Files For Booster Dose Authorization, Gemini Restructures, Strata Skin CFO Departs, Kaleido Reports Positive Readout - 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 Oct. 4)

Avadel Pharmaceuticals plc AVDL
Celldex Therapeutics, Inc. CLDX
Cytokinetics, Incorporated CYTK
Eagle Pharmaceuticals, Inc. EGRX
Horizon Therapeutics Public Limited Company HZNP
Legend Biotech Corporation LEGN
Merck & Co, Inc. MRK
Opiant Pharmaceuticals, Inc. OPNT
Legend Biotech Corporation LEGN
Xenon Pharmaceuticals Inc. XENE (announced positive midstage trial results for XEN1101 in focal seizure)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 4)

Acutus Medical, Inc. AFIB
Aditxt, Inc. ADTX
Applied Genetic Technologies Corporation AGTC
Aravive, Inc. ARAV
Atai Life Sciences N.V. ATAI
Athenex, Inc. ATNX
Avenue Therapeutics, Inc. ATXI
AVROBIO, Inc. AVRO
Aziyo Biologics, Inc. AZYO
BiondVax Pharmaceuticals Ltd. BVXV
BioSig Technologies, Inc. BSGM
BioVie Inc. BIVI
Black Diamond Therapeutics, Inc. BDTX
Burning Rock Biotech Limited BNR
Cardiovascular Systems, Inc. CSII
Centessa Pharmaceuticals Limited CNTA
Checkmate Pharmaceuticals, Inc. CMPI
Chemomab Therapeutics Ltd. CMMB
China SXT Pharmaceuticals, Inc. SXTC
Clarus Therapeutics Holdings, Inc. CRXT
Cue Health Inc. HLTH (IPOed Sept. 24)
CureVac N.V. CVAC
Eiger BioPharmaceuticals, Inc. EIGR
Eledon Pharmaceuticals, Inc. ELDN
Ensysce Biosciences, Inc. ENSC
Exscientia Limited EXAI (IPOed Friday)
FibroGen, Inc. FGEN
First Wave BioPharma, Inc. FWBI
Galapagos NV GLPG
Galecto, Inc. GLTO
Gamida Cell Ltd. GMDA
Glaukos Corporation GKOS
Harpoon Therapeutics, Inc. HARP
HCW Biologics Inc. HCWB
Histogen Inc. HSTO
IMARA Inc. IMRA
Immunic, Inc. IMUX
Incyte Corporation INCY
InMed Pharmaceuticals Inc. INM
Jazz Pharmaceuticals plc JAZZ
Kala Pharmaceuticals, Inc. KALA
Kiniksa Pharmaceuticals, Ltd. KNSA
Kintara Therapeutics, Inc. KTRA
Lantern Pharma Inc. LTRN
Liminal BioSciences Inc. LMNL
Lixte Biotechnology Holdings, Inc. LIXT
Minerva Neurosciences, Inc. NERV
Nanobiotix S.A. NBTX
Nautilus Biotechnology, Inc. NAUT
NeuroBo Pharmaceuticals, Inc. NRBO
Omeros Corporation OMER
Onconova Therapeutics, Inc. ONTX
Orchard Therapeutics plc ORTX
Oyster Point Pharma, Inc. OYST
Poseida Therapeutics, Inc. PSTX
Puma Biotechnology, Inc. PBYI
RenovoRx, Inc. RNXT
Rockwell Medical, Inc. RMTI
Roivant Sciences Ltd. ROIV (listed Friday following a SPAC deal)
Silverback Therapeutics, Inc. SBTX
Spectrum Pharmaceuticals, Inc. SPPI
Talis Biomedical Corporation TLIS
TCR2 Therapeutics Inc. TCRR
Titan Pharmaceuticals, Inc. TTNP
Tiziana Life Sciences PLC TLSA
Trevi Therapeutics, Inc. TRVI
Tyra Biosciences, Inc. TYRA (IPOed Sept. 15)
Unity Biotechnology, Inc. UBX
VectivBio Holding AG VECT
Verona Pharma plc VRNA
Vertex Pharmaceuticals Incorporated VRTX
VYNE Therapeutics Inc. VYNE
Wave Life Sciences Ltd. WVE
XBiotech Inc. XBIT
Zynex, Inc. ZYXI

Stocks In Focus

Nabriva Announces Publication of Positive Non-Clinical Study Results For Xenleta As Treatment Option For Inflammation

Nabriva Therapeutics plcNBRV announced publication in the peer-reviewed journal PLOS ONE of data showing potent anti-inflammatory properties in the drug Xenleta.

In the nonclinical study of inflammatory lung disease, Xenleta potently inhibited inflammation caused by the migration of neutrophils in the lungs of mice. It also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone and greater than that of azithromycin, a macrolide antibiotic commonly utilized for its anti-inflammatory properties.

Galapagos Announces Positive Results From Late-Stage Studies Of Filgotinib In Ulcerative Colitis

Galapagos announced positive results of two post-hoc analyses from the SELECTION and SELECTION LTE Phase studies, which are part of the investigational clinical program for filgotinib, for the treatment of patients with moderately to severely active ulcerative colitis.

These analyses showed clinical benefits of continued dosing with filgotinib 200mg in patients who did not respond at week 10. Separately, health-related quality of life benefits of filgotinib 200mg treatment versus placebo in patients with UC were shown. The data will be presented at the UEGW virtual 2021 congress, the company said.

Orphazyme To Hold Type A Meeting With FDA In Mid-October To Discuss Arimoclomol Regulatory Application

Orphazyme A/S ORPH announced a timeline for the regulatory review process for its arimoclomol as a treatment option for Niemann-Pick disease Type C.

The review process under the centralized procedure in Europe is underway and following dialogue with the Rapporteurs and the anticipated timeline to respond to the Day 180 List of outstanding issues, the company now anticipates a CHMP opinion in the first quarter of 2022 compared to the previous estimate of the fourth quarter of 2021.

In the U.S, Orphazyme requested and has been granted a post-action Type A meeting with the U.S. Food and Drug Administration that's scheduled for mid-October. At this meeting, the company said it plans to engage in a collaborative dialogue with the FDA to better understand its decision in the complete response letter issued in June 2021, as well as to discuss proposals to address key topics raised in the letter.

The company expects to communicate an update to the market once it has received and assessed formal minutes from the FDA Type A meeting.

Orphazyme also announced that it now expects to end 2021 with a cash position of no less than 80 million Danish Krone ($12.48 million) compared to prior guidance of approximately 50 million Danish Krone, with the improvement stemming from the ongoing restructuring plan.

The stock was up 1.25% at $4.06 in premarket trading.

Johnson & Johnson Submits FDA Application For COVID-19 Booster Shot

Johnson & Johnson JNJ announced it has submitted data to the FDA to support use of a booster shot of its COVID-19 vaccine in individuals 18 years of age and older.

The submission includes recent results from the Phase 3 EMSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94% protection against symptomatic COVID-19 in the U.S. and 100% protection against severe/critical COVID-19 at least 14 days post-booster vaccination.

The stock was adding 0.61% at $160.19 in premarket trading.

AstraZeneca Files For Emergency Use Authorization For Long-Acting Antibody Combo For Prophylactic Treatment Of Symptomatic COVID-19

AstraZeneca plc AZN said it has submitted a request to the FDA for an emergency use authorization for AZD7442, its long-acting antibody combination for prophylaxis of symptomatic COVID-19.

If granted, AZD7442 would be the first LAAB to receive an authorization for COVID-19 prevention, the company said. It is the first LAAB with Phase 3 data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo, AstraZeneca said.

Kaleido Announces Positive Data For Microbiome Metabolic Therapy For Ulcerative Colitis

Kaleido Biosciences, Inc. KLDO announced positive topline data from the non-IND/CTA clinical study evaluating KB295, a microbiome metabolic therapy, in mild-to-moderate ulcerative colitis.

The primary objective of safety and tolerability was achieved, as KB295 was well tolerated and no safety concerns were observed.

In the study, subjects receiving KB295 experienced a reduction in three biomarkers — fecal calprotectin, fecal lactoferrin and FimH — that are known to be associated with UC disease activity.

The stock was moving up 6.36% to $6.19 in premarket trading.

Click here for accessing Benzinga's FDA Calendar.

Gemini Announces Restructuring To Focus On Development Of Geographic Atrophy Candidate

Gemini Therapeutics, Inc. GMTX announced a corporate restructuring, including several executive officer transitions, to prioritize assets and focus on initiating and executing GEM103's resource-intensive pivotal trial in geographic atrophy.

As part of the restructuring, Gemini's research and non-clinical programs will be ceased, including activities associated with gene therapy programs and translational research. The company will accordingly reduce employee headcount by 20% compared to planned 2021 year-end headcount, including the elimination or transition of certain leadership positions.

T2 Biosystems Gets Incremental $6.4M Funding As BARDA Exercises Contract Option 2A

T2 Biosystems, Inc. TTOO announced that the BARDA has exercised contract option 2A providing an additional $6.4 million of funding for the multiple year cost share contract between BARDA and T2. Following the company's successful completion of the base period and option one, the additional funding will be used to further advance the development of the four of its products.

The stock was up 3.24% at 92 cents in premarket trading.

STRATA Skin Sciences CFO Departs, Names Insider Christopher Lesovitz as Next CFO

STRATA Skin Sciences, Inc. SSKN announced that Christopher Lesovitz, its current controller, has been named chief financial officer. He succeeds Matthew Hill, who has decided to leave effective Oct. 15 to pursue a new opportunity. Lesovitz will assume the role of CFO effective Oct. 16.

Offerings

Close on heels of reporting a positive clinical readout, Xenon Pharma said it has commenced an underwritten public offering of $250 million of its common shares pursuant to its existing shelf registration statement.

The stock was up 2.86% at $32.40 in premarket trading.

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