The Daily Biotech Pulse: Revance's DAXI Regulatory Decision, Reata Slips On FDA Feedback, Liquidia Setback

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 Nov. 24)

• AbbVie Inc ABBV
• Affimed NV AFMD
• Apellis Pharmaceuticals Inc APLS
• Atea Pharmaceuticals, Inc. AVIR
• C4 Therapeutics Inc CCCC
• Cardiff Oncology Inc CRDF
• Celldex Therapeutics, Inc. CLDX
• Cellectis SA CLLS
• Eidos Therapeutics Inc EIDX
• Frequency Therapeutics Inc FREQ
• Generation Bio Co GBIO
• Inspire Medical Systems Inc INSP
• Kronos Bio Inc KRON
• Merit Medical Systems, Inc. MMSI
• NeoGenomics, Inc. NEO
• NGM Biopharmaceuticals Inc NGM
• Nurix Therapeutics Inc NRIX
• Ocular Therapeutix Inc OCUL
• Pulmonx Corp LUNG
• Relay Therapeutics Inc RLAY
• Sotera Health Co SHC (began trading on Nasdaq Friday following its IPO)
• Trinity Biotech plc TRIB
• Veracyte Inc VCYT
• Zai Lab Ltd – ADR ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Nov. 24)

• Advaxis, Inc. ADXS ( announced a public offering of common stock and warrants)
• Immunome Inc IMNM
• InMed Pharmaceuticals Inc INM
• Kiromic Biopharma Inc KRBP
• Maravai Lifesciences Holdings Inc MRVI debuted on Wall Street Friday)
• Qualigen Therapeutics Inc QLGN

Stocks In Focus

Liquidia's Hypertension Drug Fails to Win FDA Nod

Liquidia Corp LQDA said the FDA has issued a complete response letter for its NDA for LIQ861 inhalation powder for the treatment of pulmonary arterial hypertension.

The CRL identified the need for additional information and clarification on chemistry, manufacturing and controls data pertaining to the drug product and device biocompatibility, the company said. The FDA did not seek any further clinical studies or additional studies related to toxicology or clinical pharmacology.

The FDA also reconfirmed the need to conduct on-site pre-approval inspections of two of Liquidia's U.S. manufacturing facilities before the application can be approved.

Liquidia said it believes it can address the items raised in the CRL without delaying the otherwise projected launch timing of LIQ861 in the second half of 2022, subject to FDA approval.

In premarket trading Wednesday, Liquidia shares were up 3.23% to $3.20.

Reata Says FDA Does Not See Additional Neuromuscular Disorder Drug Study Results Strengthening Pivotal Study Data

Reata Pharmaceuticals Inc RETA said following FDA's internal review of baseline-controlled study results for omaveloxolone for the treatment of patients with Friedreich's ataxia, a rare inherited neuromuscular disorder, the agency concluded the results do not strengthen the results of Part 2 of the MOXIe study.

The FDA has suggested some additional exploratory analyses using patients randomized to placebo during the MOXIe Part 2 study, but stated that the potential for these analyses to strengthen the study results was questionable due to the small number of patients available for analysis.

Reata said it plans to submit these analyses and request a meeting with the FDA to discuss the development program. The company also said it is exploring the next steps, including whether to conduct a second pivotal study in patients with FA.

The stock fell 8.79% to $150 in after-hours trading.

Altimmune Submits Application For Commencing Phase 1 Study of Intranasal COVID-19 Vaccine

Altimmune Inc ALT said it has submitted an investigational new drug application to the FDA to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The company said it is on track to begin the Phase 1 study in December.

The stock was adding 4.86% to $9.70 in premarket trading.

Karyopharm Announces Clearance of Phase 3 Study of Xpovio In Endometrial Cancer Following Futility Analysis

Karyopharm Therapeutics Inc KPTI said following a pre-specified interim futility analysis for the ongoing Phase 3 SIENDO study, the Data and Safety Monitoring Board has recommended that the study should continue, as previously planned, without the need for adding additional patients to the trial or amending the study protocol.

The study is evaluating the efficacy and safety for front-line maintenance therapy with Xpovio in patients with advanced or recurrent endometrial cancer.

Earnings

Renalytix AI PLC RNLX reported a loss of 10 cents per share for the first quarter of fiscal year 2021 compared to a loss of 3 cents per share a year ago.

On The Radar

PDUFA Dates

The FDA is set to rule on Revance Therapeutics Inc's RVNC regulatory application for Daxi in the treatment of moderate to severe glabellar, or frown, lines.