The Daily Biotech Pulse: Quidel Slides On Negative Pre-Announcement, Roche Gets Positive EMA Committee Recommendation, 3 IPOs

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 22)

• AtriCure, Inc. ATRC
• Axonics, Inc. AXNX
• BioNTech SE BNTX
• Bio-Techne Corporation TECH
• Boston Scientific Corporation BSX
• Edwards Lifesciences Corporation EW
• Galectin Therapeutics Inc. GALT
• Globus Medical, Inc. GMED
• Integra LifeSciences Holdings Corporation IART
• Lantheus Holdings, Inc. LNTH
• IRadimed Corporation IRMD
• MacroGenics, Inc. MGNX
• Medpace Holdings, Inc. MEDP
• Medtronic plc MDT
• Merit Medical Systems, Inc. MMSI
• Ortho Clinical Diagnostics Holdings plc OCDX
• PLx Pharma Inc. PLXP
• PRA Health Sciences, Inc. PRAH (announced expansion of its pharmacosvigilance solutions to COVID-19 vaccines and treatments)
• Prometheus Biosciences, Inc. RXDX
• ShockWave Medical, Inc. SWAV (reacted to insider selling)
• SI-BONE, Inc. SIBN
• Syneos Health, Inc. SYNH
• United Therapeutics Corporation UTHR
• West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 22)

• Biomerica, Inc. BMRA
• Design Therapeutics, Inc. DSGN
• Instil Bio, Inc. TIL
• Longboard Pharmaceuticals, Inc. LBPH
• NeuBase Therapeutics, Inc. NBSE (priced its $40 million common stock offering at a discount)
• Soligenix, Inc. SNGX

Stocks In Focus

Quidel Pre-announces Below-consensus Q1 Revenues Due to Lower Flu and Respiratory Product Revenues

Quidel Corporation QDEL announced preliminary first-quarter revenues of $374 million to $376 million, up an estimated 114% from the year-ago period. The guidance, however, trailed the $465.7 million consensus estimate.

The softness, according to the company, stemmed from lower sales of influenza and other respiratory disease products due to a lack of a respiratory season.

Separately, Quidel said it has completed a distribution and fulfillment agreement McKesson Corporation MCK expedites consumer access to its non-prescription QuickVue At-Home OTC COVID-19 Test.

In after-market trading, the stock slipped 15.03% to $103.85.

Roche Announces FDA Approval For Companion Diagnostic Test For Endometrial Cancer

Roche Holding AG RHHBY announced the U.S. Food and Drug Administration approved its VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients.

Testing can identify patients eligible for treatment with Jemperli, an anti-PD1 immunotherapy from GlaxoSmithKline plc GSK that was approved by the FDA on 22 April 2021, the company said.

Separately, Roche said the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, CHMP, has recommended the approval of Enspryng as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody seropositive neuromyelitis optica spectrum disorder, as a monotherapy or in combination with immunosuppressive therapy.

Illumina, Krators to Co-develop Companion Diagnostic For Hematologic Indications

Illumina, Inc. ILMN and Kartos Therapeutics, Inc. announced a new partnership to co-develop a TP53 companion diagnostic based on the content of Illumina's comprehensive genomic profiling assay, TruSight Oncology 500. This companion diagnostic for multiple hematologic indications will be the first to use TSO 500 with peripheral whole blood as a diagnostic sample type.

The initial focus of the collaboration, according to the company, will be the co-development of multiple CDx claims in blood cancers for Kartos' KRT-232, a potent and selective oral MDM2 inhibitor that activates p53 to drive tumor cell death in TP53 wild-type cancers.

Verona Announces Safety Data From Pilot Study of COVID-19 Treatment

Verona Pharma plc VRNA announced data from a pilot study of a pressurized metered-dose inhaler formulation of ensifentrine, showing ensifentrine was safe and well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19.

The trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with ensifentrine treatment added on to standard of care was observed in the trial. One patient death was reported in the ensifentrine treatment group.

"Overall, the patients in this study recovered exceptionally well, as the mortality rate in the study was much lower than aggregate data from the hospital would have suggested over the same time period," said Mike Wells, principal investigator of the study.

Gilead Files For Japanese Regulatory Approval of Filgotinib For The Additional Indication of Ulcerative Colitis

Gilead Sciences, Inc. GILD and Eisai Co., Ltd. ESALY announced that Gilead submitted an application to Japan's Pharmaceuticals and Medical Devices Agency for the approval of filgotinib for an additional indication to treat patients with moderately to severely active ulcerative colitis.

Filgotinib was approved in Japan in September 2020 for the treatment of rheumatoid arthritis.

Eisai, Merck Submit File For Label Expansion For Combo Cancer Therapy In Uterine Body Cancer In Japan

Eisai and Merck & Co., Inc. MRK announced the submission of an application in Japan for the additional indication of Eisai's Lenvima, in combination with Merck's Keytruda as a treatment for patients with advanced uterine body cancer.

Calliditas' Lead Drug Gets Accelerated Assessment Procedure By EMA Committee In Kidney Inflammation Disease

Calliditas Therapeutics AB CALT said its lead product candidate Nefecon, an oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy, has been granted accelerated assessment procedure by the EMA's CHMP.

If approved, Nefecon could be available to patients in Europe in H1 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying.

Progenity Shares Higher On Momentum

Progenity, Inc. PROG shares are surging in premarket trading Friday. The spike comes despite a lack of any company-specific announcement. Recently, there has been a series of insider buying of the company's stock.

The stock was jumping 63.25% to $4.93 in premarket trading Friday.

Genfit Names Thomas Baetz as CFO

Genfit SA GNFT anounced that Thomas Baetz has been appointed as chief financial officer. Baetz joins the Executive Committee, along with Stefanie Magner, chief compliance officer.

Offerings

EDAP TMS S.A. EDAP said it has priced its 4.15 million ADS offering at $6.75 per ADS, for raising $28 million. The closing of the offering is expected to occur on April 27, subject to customary closing conditions.

The stock slipped 12.31% to $7.41 in after-hours trading.

On The Radar

Clinical Readouts

Arena Pharmaceuticals, Inc. ARNA announced that data from the Phase 2b ADVISE trial evaluating the safety and efficacy of etrasimod in participants with moderate-to-severe atopic dermatitis will be presented during a late-breaking session at the American Academy of Dermatology Virtual Meeting Experience.

The presentation will be released online at 10 am, Friday, with a live Q&A session with presenter to be held Saturday.

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

IPOs

Treace Medical Concepts, Inc., a commercial-stage orthopaedic medical device company that focuses on the surgical treatment of Hallux Valgus, priced its upsized initial public offering of an aggregate of 11.25 million shares of its common stock at $17 per share.

Of the total shares offered, 6.25 million shares are being sold by Treace and 5 million by certain selling stockholders. The gross proceeds from the offering to Treace are expected to be approximately $106.3 million. Treace clarified that it will not receive any proceeds from the sale of shares by the selling stockholders

The shares are expected to begin trading on the Nasdaq under the ticker symbol TMCI.

Impel NeuroPharma, Inc., a late-stage pharma focused on therapies for patients suffering from diseases with high unmet medical needs, priced its IPO of 5.333 million shares at $15 per share, for raising gross proceeds of $80 million. All of the shares are being offered by Impel. The shares are expected to begin trading on the Nasdaq under the symbol IMPL.

Rain Therapeutics Inc., a clinical-stage company developing precision oncology therapeutics, priced its IPO of 7.353 million shares of common stock at $17 per share. The gross proceeds to Rain from the offering, are expected to be approximately $125 million. All of the shares are being offered by Rain. The shares are expected to begin trading on the Nasdaq under the ticker symbol RAIN.