The Daily Biotech Pulse: DBV's Positive FDA Feedback, Pfizer's Cancer Drug Gets Label Expansion, Applied DNA COVID Testing Volume Surges

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 Jan. 14)

10X Genomics Inc TXG
4D Molecular Therapeutics Inc FDMT
Adaptive Biotechnologies Corp ADPT
Aligos Therapeutics Inc ALGS
Apyx Medical Corp APYX (reacted to its preliminary fourth-quarter results)
Arcus Biosciences Inc RCUS
Arvinas Inc ARVN
Atea Pharmaceuticals Inc AVIR
Axonics Modulation Technologies Inc AXNX
Beigene Ltd BGNE
BIO-TECHNE Corp TECH
Bioatla Inc BCAB
Biodesix Inc BDSX
BioNano Genomics Inc BNGO
C4 Therapeutics Inc CCCC
CareDx Inc CDNA
CASI Pharmaceuticals Inc CASI
Celsius Holdings, Inc. CELH
Clearside Biomedical Inc CLSD
Corcept Therapeutics Incorporated CORT
Crispr Therapeutics AG CRSP
Curis, Inc. CRIS
Dyne Therapeutics Inc DYN
Edap Tms SA EDAP
ESSA Pharma Inc EPIX (announced positive 24-month interim results from the study comparing outcomes from high intensity focused ultrasound versus radical prostatectomy in prostate cancer patients)
Evogene Ltd EVGN
Fate Therapeutics Inc FATE
Fulgent Genetics Inc FLGT
Genetron Holdings Ltd – ADR GTH
Genmab 10 Sponsored ADR Ord Shs GMAB
Halozyme Therapeutics, Inc. HALO
INmune Bio Inc INMB
Inspire Medical Systems Inc INSP
Insulet Corporation PODD
Intra-Cellular Therapies Inc ITCI
Iovance Biotherapeutics Inc NIOVA
Jazz Pharmaceuticals PLC JAZZ
Johnson & Johnson JNJ
Kaleido Biosciences Inc KLDO (announced positive interim results for mild to moderate COVID study)
Kodiak Sciences Inc KOD
LeMaitre Vascular Inc LMAT
Lexicon Pharmaceuticals, Inc. LXRX(announced positive regulatory feedback for heart failure drug)
Mediwound Ltd MDWD
Nantkwest Inc NK (announced positive interim data for pancreatic cancer study)
Natera Inc NTRA
Neuronetics Inc STIM
Novocure Ltd NVCR
Organogenesis Holdings Inc ORGO (reacted to its preliminary fourth-quarter results)
Orphazyme A S ADR NORPH
Pacira Biosciences Inc PCRX
PRA Health Sciences Inc PRAH
Renalytix AI PLC RNLX
Repligen Corporation RGEN
SAGE Therapeutics Inc SAGE
Silverback Therapeutics Inc SBTX
Shockwave Medical Inc SWAV
Stoke Therapeutics Inc STOK
Surface Oncology Inc SURF
Syneos Health Inc SYNH
Taysha Gene Therapies Inc TSHA
Travere Therapeutics Inc TVTX
Turning Point Therapeutics Inc TPTX
Twist Bioscience Corp TWST
Vericel Corp VCEL
Vistagen Therapeutics Inc VTGN
Zai Lab Ltd – ADR ZLAB
Zimmer Biomet Holdings Inc ZBH

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 14)

Viveve Medical Inc VIVE (priced $24 million worth of common stock offering)

Stocks In Focus

DBV Says FDA Feedback On Peanut Allergy Patch Application Provides Well-defined Regulatory Path Forward

DBV Technologies DBVT announced the receipt of regulatory feedback from the FDA for the questions raised in the Type A meeting request made by the company with respect to the complete response letter received for its Viaskin Peanut, which is being evaluated for peanut allergy in children, ages 4-11 years.

The feedback received from the FDA regarding DBV's proposed potential resolutions to FDA's concerns regarding the impact of patch adhesion and the need for patch modifications, provides a well-defined regulatory path forward, the company said.

In order to confirm the consistency of efficacy data between the existing and modified patches, FDA has requested an assessment comparing the uptake of allergen between the patches in peanut allergic children ages 4-11. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population.

The stock jumped 55.61% to $5.82 in after-hours trading.

Teva Launches Generic Version of Contraceptive In The U.S.

Teva Pharmaceutical Industries Ltd TEVA announced the availability of a generic version of NuvaRing 0.120 mg/0.015 mg per day, in the U.S. Teva's AB-rated and bioequivalent etonogestrel and ethinyl estradiol vaginal ring, is an estrogen/progestin combination hormonal contraceptive indicated for use by women to prevent pregnancy.

Applied DNA Says Daily Volume of COVID-19 Testing Increases 158% Month-over-month In January

Applied DNA Sciences Inc APDN said its safeCircle pooled surveillance testing service, launched in the fourth quarter ended Sept. 2020, has seen a 158% increase in the daily average number of tests performed to date in January 2021 compared to December 2020.

The company said it is increasing production of its Linea COVID-19 assay kit and sample collection kits to meet expected demand from existing customers, from its safeCircle service and due to heightened interest in the assay kit following a recent FDA alert that identified the assay as an EUA-approved molecular diagnostic test that can potentially identify certain SARS-CoV-2 mutations.

The stock was up 6.62% to $9.50 in premarket trading Friday.

Pfizer's Cancer Drug Gets Label Expansion to Treat Blood Cancer In Children and Young Adults

Pfizer Inc. PFE said the FDA approved the supplemental New Drug Application for Xalkori for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is ALK-positive. ALCL is a rare form of non-Hodgkin lymphoma and accounts for approximately 30% of cases of NHL in young people, and about 90% of ALCL cases in young people are ALK-positive, the company said.

AstraZeneca Gets Label Expansion For a Less Frequent, Fixed-Dose Schedule of Its Lung Cancer Drug In Europe and U.K.

AstraZeneca plc AZN said its Imfinzi has been approved in the European Union and the U.K. for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer in adults whose tumors express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.

DermTech Announces Positive Findings Regarding Its Skin Cancer Diagnostic Genomic Test

DermTech Inc DMTK announced publication of the results of a large registry study finding that the evaluation of genomic atypia using its pigmented lesion assay may be a superior approach to guide treatment decisions and manage pigmented lesions, when compared to visual assessment of pigmented lesions.

The study showed that lesions biopsied based on genomic atypia criteria identified by the PLA were associated with a nearly five-fold enrichment of melanoma in the patient specimens compared to those biopsied based solely on visual assessment criteria.

In premarket trading Friday, the stock was moving up 3.35% to $41.

Kadmon, Anaptys Bio Rally On Disclosure of Hedge Fund Stakes

Kadmon Holdings Inc KDMN reacted to a SEC filing that showed hedge fund Point72 Asset Management held a 5.3% stake in the company.

The stock was up 5.08% to $4.97 in after-hours trading.

AnaptysBio Inc ANAB rallied in reaction to a filing that showed biotech-focused hedge fund EcoR1 Capital owned 13.9% stake in the biopharma.

In after-hours trading, the stock gained 11.16% to $28.49.

Offerings

Lantern Pharma Inc. LTRN priced its public offering of 4.286 million shares of its common stock at $14 per share, for gross proceeds of $60 million. All of the shares of common stock are being offered by Lantern Pharma.

The stock was down 1.79% to $14.25 in premarket trading Friday.

On The Radar

Clinical Readouts

ASCO Gastrointestinal Cancer Symposium Presentations

Arcus Biosciences: Preliminary dose-escalation data from ARC-8 Phase 1/1b study evaluating AB680 in combination with zimberelimab and gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer

Agios Pharmaceuticals Inc AGIO: mature overall survival data from the Phase 3 ClarIDHy study of Tibsovo in patients with previously treated IDH1-mutant cholangiocarcinoma

Incyte Corporation (NASDAQ: INCY: preliminary safety and efficacy data from a Phase 1/2 trial evaluating the arginase inhibitor INCB001158 plus chemotherapy in patients with advanced biliary tract cancers (The asset has been out-licensed from Calithera Biosciences Inc (NASDAQ: CALA))

AVEO Pharmaceuticals, Inc. AVEO: Results from AstraZeneca's Imfinzi in patients with first-line metastatic hepatocellular carcinoma

Zymeworks Inc ZYME: results from the Phase 1 study of zanidatamab in HER2-expressing gastroesophageal adenocarcinoma and post presentation of results from the phase 2b study of zanidatamab monotherapy in subjects with advanced or metastatic HER2-amplified biliary tract cancers

Five Prime Therapeutics Inc FPRX & Zai Lab: late-breaker, oral presentation of detailed results from the Phase 2 FIGHT trial evaluating bemarituzumab plus mFOLFOX6 chemotherapy in patients with FGFR2b+, non HER2+ advanced gastric and gastroesophageal junction cancer

Merus NV MRUS: Data from Phase 1 dose escalation study of MCLA-158 in metastatic colorectal cancer

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