The Daily Biotech Pulse: Q1 Beat From Johnson & Johnson, KalVista Study Placed On Hold, European Label Expansion For GW Pharma's Epidiolex

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 April 15)

• Alexion Pharmaceuticals, Inc. ALXN
• AtriCure, Inc. ATRC
• BioNTech SE BNTX(announced a deal to supply the EU with 100 million doses of COVID-19 vaccine)
• PPD, Inc. PPD
• Vericel Corporation VCEL
• West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 15)

• 4D Molecular Therapeutics, Inc. FDMT
• Adagene Inc. ADAG
• ADMA Biologics, Inc. ADMA
• Akoya Biosciences, Inc. AKYA (went public Friday)
• Ascendis Pharma A/S ASND
• Assembly Biosciences, Inc. ASMB
• Aurinia Pharmaceuticals Inc. AUPH
• AVROBIO, Inc. AVRO
• Checkmate Pharmaceuticals, Inc. CMPI (announced the commencement of Phase 2 head and neck cancer study)
• ChemoCentryx, Inc. CCXI
• Concert Pharmaceuticals, Inc. CNCE
• ContraFect Corporation CFRX
• Decibel Therapeutics, Inc. DBTX
• Edgewise Therapeutics, Inc. EWTX
• Foghorn Therapeutics Inc. FHTX
• Fusion Pharmaceuticals Inc. FUSN
• Haemonetics Corporation HAE (announced termination of plasma collection devices supply contract by CSL)
• Homology Medicines, Inc. FIXX
• Hoth Therapeutics, Inc. HOTH
• IMARA Inc. IMRA
• Inhibikase Therapeutics, Inc. IKT
• InMed Pharmaceuticals Inc. INM
• Ionis Pharmaceuticals, Inc. IONS
• Karyopharm Therapeutics Inc. KPTI (announced publication of health-related quality of life data from the Phase 3 study of selinexor in liposarcoma)
• Kronos Bio, Inc. KRON
• Lixte Biotechnology Holdings, Inc. LIXT
• Lucira Health, Inc. LHDX
• MediciNova, Inc. MNOV
• Metacrine, Inc. MTCR
• Millendo Therapeutics, Inc. MLND
• NeuBase Therapeutics, Inc. NBSE
• NeuroBo Pharmaceuticals, Inc. NRBO
• PainReform Ltd. PRFX
• Pluristem Therapeutics Inc. PSTI
• Repro Med Systems, Inc. KRMD
• Sigilon Therapeutics, Inc SGTX
• Stealth BioTherapeutics Corp MITO
• Syros Pharmaceuticals Inc SYRS
• Vaxcyte Inc PCVX
• VectivBio Holding AG VECT
• Virpax Pharmaceuticals Inc VRPX (announced positive results of an animal study model for MMS019, its antiviral product candidate for respiratory viruses)
• Voyager Therapeutics Inc VYGR
• Vyne Therapeutics Inc VYNE
• Windtree Therapeutics Inc WINT (announced filing for expedited review of patent application for lead drug istaroxime)
• Zymeworks Inc. ZYME (announced departure of chief commercial officer)

Stocks In Focus

Eyrtech Requests Pre-BLA Meeting With FDA For Lead Candidate In Hypersensitive Blood Cancer Patients

French biopharma ERYTECH Pharma ERYP announced the initiation of the process of seeking marketing approval from the Food and Drug Administration for its lead product candidate eryaspase.

The drug is aimed at patients with acute lymphoblastic leukemia who developed hypersensitivity reactions to PEG-asparaginase based on the positive results of the NOPHO-sponsored Phase 2 clinical trial.

Following the review of a comprehensive data package submitted by Erytech, the FDA invited the company to request a pre-biologic license application meeting to discuss the potential for the clinical trial to support marketing approval in the U.S. Subject to the feedback received in that meeting, the company plans to submit a BLA in the second half of 2021.

Allakos Appoints Former Aimmune Executive As CFO

Allakos Inc. ALLK announced the appointment of Baird Radford as its chief financial officer.

"Baird brings broad experience and a track record of success at commercial-stage companies as we position Allakos for growth and potential commercialization of our first product candidate," said Robert Alexander, CEO of Allakos.

Incyte, Morphosys Commence Late-Stage Study Of Antibody Combo Treatment For B-Cell Non-Hodgkin's Lymphoma

MorphoSys AG MOR and Incyte Corporation INCY announced the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with Bristol-Myers Squibb Company's BMY Revlimid and rituximab in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.

Tafasitamab is a monoclonal antibody candidate MorphoSys licensed from Xencor, Inc. XNCR.

Amgen Granted Breakthrough Designation For Stomach Cancer Drug

Amgen AMGN said the FDA granted breakthrough therapy designation for investigational bemarituzumab.

The drug is a first-line treatment for patients with fibroblast growth factor receptor 2b overexpressing and human epidermal growth factor receptor 2-negative, metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6, based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.

KalVista Announces FDA Clinical Hold On Midstage Study Of Hereditary Angioedema Treatment

KalVista Pharmaceuticals, Inc. KALV said the FDA has placed a clinical hold on the proposed Phase 2 clinical trial of KVD824, an oral product candidate being developed for prophylactic treatment of hereditary angioedema.

The FDA letter did not seek additional studies or new data as a precondition for initiating a Phase 2 study, but has requested further information and analysis related to certain preclinical studies of KVD824, according to KalVista.

The regulatory agency also proposed refinements to the intended KVD824 Phase 2 study protocol.

Related Link: The Week Ahead In Biotech: Johnson & Johnson, Biogen Earnings, Neurology Conference And IPOs

Lilly, Incyte Hair Loss Drug Aces Second Phase 3 Study

Eli Lilly and Company LLY and Incyte announced results from a second Phase 3 trial evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata.

The data is consistent with findings from the first Phase 3 clinical trial, top-lined earlier this year.

In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at week 36 compared to patients treated with placebo.

Alopecia areata is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. There are no FDA-approved therapies for the disease. 

GW Pharma's Epidiolex Gets Label Expansion In Europe

GW Pharmaceuticals plc GWPH announced that the European Commission has approved the Type II variation application for Epidyolex as an adjunctive treatment of seizures associated with tuberous sclerosis complex for patients two years of age and older.

This approval, which represents the third indication for the company's cannabidiol drug in Europe, paves the way for the expanded launch of the medicine across Europe.

180 LifeSciences Gets Nasdaq Letter For Non-Filing Of 2020 Financial Report

180 Life Sciences Corp. ATNF said it that it received an expected letter from the Nasdaq stating that the company is not in compliance with the exchange's listing standards, as it has yet to file its annual report on Form 10-K for the year ended December 2020.

The company said the letter has no immediate effect on the listing or trading of its stock on the Nasdaq.

The stock was down 8.76% premarket at $7.60. 

Offerings

Zai Lab Limited ZLAB said it has commenced an underwritten public offering of $750 million in American depositary shares, with each representing one ordinary share of the company. All shares will be offered by Zai Lab.

Investors have an option to receive ordinary shares of the company in this offering only, and such an option will not be available to purchasers of the additional shares.

The stock lost 5.68% to $154.99 in after-hours trading.

On The Radar

Clinical Readouts

Syndax Pharmaceuticals, Inc. SNDX will host a conference call and live webcast at 8 a.m. on Tuesday to provide updated data from the Phase 1 dose escalation portion of the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with relapsed or refractory acute leukemias.

Earnings

• Johnson & Johnson's JNJ (Q1 sales $22.32B vs. $21.98B consensus estimate; adjusted EPS $2.59 vs. $2.34 consensus; tightened 2021 guidance)
• Abbott Laboratories ABT (before the market open)
• Intuitive Surgical, Inc. ISRG (after the close)
• Edwards Lifesciences Corporation EW (after the close)

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