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

Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates

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