The Daily Biotech Pulse: Iterum's Regulatory Setback, Decision Day For Provention Bio, Cidara & Outset Medical Announce CFO Departures

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 July 1)

• Alexion Pharmaceuticals, Inc. ALXN
• Beam Therapeutics Inc. BEAM ( announced a R&D collaboration with Apellis Pharmaceuticals, Inc. APLS
• Bio-Techne Corporation TECH
• Century Therapeutics, Inc. IPSC
• Globus Medical, Inc. GMED
• Intuitive Surgical, Inc. ISRG
• Lantheus Holdings, Inc. LNTH
• Legend Biotech Corporation LEGN
• Molecular Partners AG MOLN
• Protagonist Therapeutics, Inc. PTGX
• ResMed Inc. RMD
• VistaGen Therapeutics, Inc. VTGN
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 1)

• Aerovate Therapeutics, Inc. AVTE (IPOed Wednesday)
• Angion Biomedica Corp. ANGN
• CVRx, Inc. CVRX (IPOed Wednesday)
• Edgewise Therapeutics, Inc. EWTX
• Miromatrix Medical Inc. MIRO (IPOed June 24)
• Pharvaris N.V. PHVS
• Tempest Therapeutics, Inc. TPST
• Theravance Biopharma, Inc. TBPH

Stocks In Focus

Iterum Faces Probable Delay In Sulopenem Approval as FDA Identifies Deficiencies In Application

Iterum Therapeutics plc ITRM received a letter from the FDA, stating that, as part of their ongoing review of its new drug application for sulopenem etzadroxil/probenecid, the agency has identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time. The NDA has a PDUFA goal date of July 25.

The company noted that no further details with respect to deficiencies were disclosed by the FDA. The letter further states that the notification does not reflect a final decision on the information under review.

The stock was down 31% at $1.58 in premarket trading.

LabCorp Launches Companion Diagnostic Test For Amgen's Lung Cancer Treatment

Laboratory Corporation of America Holdings LH announced the availability of therascreen KRAS PCR mutation analysis, a companion diagnostic to identify patients with non-small cell lung cancer, who are eligible for treatment with Amgen, Inc.'s AMGN Lumakras.

Outset Medical's CFO to Resign; MedTech Preannounces Above-consensus Q2 Revenue Guidance

Outset Medical, Inc. OM announced that Rebecca Chambers will step down from her position as chief financial officer to pursue other opportunities, effective July 16. The company named Nabeel Ahmed, current VP, Finance, as interim chief financial officer.

The company also preannounced second-quarter revenues of $24.5 million to $25 million, ahead of the $23.26 million consensus estimate.

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

Cidara Announces Resignation of CFO

Cidara Therapeutics, Inc. CDTX announced that James Levine has resigned from his position as chief financial officer, effective July 9, to pursue other opportunities. Levine will continue to serve as a consultant to the company for at least six months and will provide transitional support to a successor CFO.

Krystal Biotech Reports Positive Data from Phase 1/2 Study of Drug to Treatment Skin Disorder

Krystal Biotech, Inc. KRYS announced updated results from the Phase 1/2 clinical trial evaluating topical administration of KB105 in patients with autosomal recessive congenital ichthyosis associated with mutations in the TGM1 gene, showing repeat doses of KB105 continued to be well tolerated with no adverse events and with no evidence of immune response, systemically or at the sites of application.

Phenotypic improvement, based on the IGA scale, was observed at each KB105 dosing site at varying time points throughout the 30-day dosing period, with the maximum effect observed in the treatment areas that received the highest KB105 dose, the company added.

"The totality of the data from our Phase 1/2 trial is encouraging, showing that topical application of KB105 to exfoliated skin results in detectable and correctly localized and functionally active TGM-1 enzyme," said Suma Krishnan, chief operating officer of Krystal Biotech.

The company said it is currently determining the optimal dosing regimen and endpoints to take forward into the next Phase 2 cohort, which will include pediatric patients, in 2022.

Merck Withdraws Regulatory Application For Keytruda In Third Line Setting In Stomach Cancer

Merck & Co., Inc. MRK said it plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.

The decision followed the April 29 Oncologic Drugs Advisory Committee evaluation of this third-line gastric cancer indication for Keytruda as a monotherapy because it failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a Phase 3 study.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Provention Bio, Inc.'s PRVB biologic license application for teplizumab as a treatment option for type 1 diabetes mellitus.

Offerings

BioSig Technologies, Inc. BSGM said it has commenced an underwritten public offering of its common stock. The company intends to use the net proceeds from the offering for the continuation of full commercialization activities related to the Pure EP System, including additional support for organizational development, the continuation of R&D activities for new products, and general corporate purposes and other capital expenditures.

In premarket trading, the stock was losing 8.05% to $4.

IPO

Ensysce Biosciences, Inc. will begin trading its common stock under the ticker symbol "ENSC" on the Nasdaq and warrants under the ticker symbol "ENSCW" on the OTC Market.

The company had closed its merger with Leisure Acquisition Corp. on June 30, which was approved by LACQ's shareholders on June 28.