The Daily Biotech Pulse: Amylyx Announces Negative Adcom Vote, Clovis Jumps On Ovarian Cancer Data, Masimo Warns Of Q1 Shortfall

Zinger Key Points
  • CytoDyn Inc. said the FDA has placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the U.S.
  • Hong Kong-listed Biopharma Everest Medicines said it has submitted a NDA to the Department of Health, the Hong Kong Special Administrative Region, China for Gilead Sciences' Trodelvy for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer in adult patients who have received two or more prior systemic therapies, with at least one of them being for metastatic disease.

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Amylyx Says FDA Committee Casts Negative Vote On ALS Drug

Amylyx Pharmaceuticals, Inc. AMLX said Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee, which reviewed its new drug application for AMX0035 for the treatment of amyotrophic lateral sclerosis, voted that the results from the Phase 2 study did not support the effectiveness of the treatment in ALS patients.

Although the FDA considers the recommendations of its advisory committees, the recommendations by the panel are non-binding. The AMX0035 NDA has a PDUFA action date of June 29.

Separately, the company reported full-year results showing lower revenues and a wider loss.

CytoDyn Announces Imposition Of Partial Hold On HIV Program, Full Clinical Hold On COVID Study

CytoDyn Inc. CYDY said the FDA has placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the U.S. The company also said it elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV biologic license resubmission.

Gilead's Partner Submits Regulatory Application For Trodelvy In Advanced Breast Cancer In Hong Kong

Hong Kong-listed Biopharma Everest Medicines said it has submitted a NDA to the Department of Health, the Hong Kong Special Administrative Region, China for Gilead Sciences, Inc.'s GILD Trodelvy for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer in adult patients who have received two or more prior systemic therapies, with at least one of them being for metastatic disease.

Related Link: The Week Ahead In Biotech (March 27-April 2): Lipocine, Akebia, Merck Await FDA Verdicts, Adcom Test For Amylyx, BioNTech Earnings And More

Clovis Announces Positive Phase 3 Data For Rubraca In Ovarian Cancer

Clovis Oncology, Inc. CLVS announced positive top-line data from the monotherapy arm of the Phase 3 ATHENA trial demonstrating that Rubraca as a maintenance treatment successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival compared with placebo.

Based on these results, the company said it plans to submit a supplemental NDA to the U.S. FDA during the second quarter of 2022 followed by a Type II Variation to the EMA during the third quarter of 2022 for a first-line maintenance treatment indication for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy.
The stock was jumping 54% to $2.54 in premarket trading.

Novavax Files For Expanding Authorization Of COVID-19 Vaccine To Treat Adolescents In Europe

Novavax, Inc. NVAX said it has submitted a request to expand the conditional marketing authorization of Nuvaxovid COVID-19 vaccine in the European Union for adolescents age 12-17. 

The stock was moving up 1.81% to $76.10 in premarket trading.

Masimo Warns Of Q1 Revenue Shortfall Due to Supply Chain Issues

Masimo Corporation MASI said it expects product revenue for the first quarter of 2022 to fall in the range of $285 million-$315 million. Shortages of critical components in combination with other supply chain issues, including freight carrier delays, have led to lower-than-expected sales in the first quarter, according to the company. 

The stock was slipping 8.82% to $141.70 in premarket trading.

Mainz Biomed Receives Positive Feedback On Design For Potential Pivotal Study Of Colorectal Cancer Detection Test

Mainz Biomed N.V. MYNZ said it has received supportive feedback from the U.S. FDA on its pre-submission package profiling the potential pivotal clinical trial design for ColoAlert, its easy-to-use detection test for colorectal cancer. The company also announced the formal commencement of its reimbursement process for ColoAlert by scheduling an initial meeting with the Centers for Medicare and Medicaid Services in April 2022.

The stock was gaining 7.3% to $16.17 in premarket trading.

Jaguar Health Announces Crofelemer Distribution, Commercialization Deal For Select Middle East Countries

Jaguar, Heath, Inc. JAGX said it has entered an agreement with Quadri Pharmaceuticals that grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for specified human indications of crofelemer in Bahrain, Kuwait, Qatar, Saudi Arabia, the United Arab Emirates and Oman following regulatory approval to market Crofelemer in these countries for the specified indications.

The stock was rallying 16% to 62 cents in premarket trading.

Click here to access Benzinga's FDA calendar.

Earnings

EDAP TMS SA EDAP reported lower fourth-quarter revenues but its earnings per share exceeded expectations.

The stock was adding 9.72% to $7.90 in premarket trading.

Acutus Medical, Inc. AFIB reported a year-over-year increase in fourth-quarter revenues but the loss per share was wider than expected. The company also issued below-consensus revenue guidance for the first quarter.

The stock was retreating 9.84% to $1.74 in premarket trading.

Clarus Therapeutics Holding Inc. CRXT reported higher revenues and a narrower-than-expected loss for the fourth quarter.

In premarket trading, the stock was plunging 20% to $1.66.

On The Radar

Earnings

  • Taysha Gene Therapies, Inc. TSHA (before the market open)
  • PDS Biotechnology Corporation PDSB (before the market open)
  • Affimed N.V. AFMD (before the market open)
  • Adamis Pharmaceuticals Corporation ADMP) (after the close)
  • INVO Bioscience, Inc. INVO) (after the close)
  • Calithera Biosciences, Inc. CALA (after the close)
  • Inhibikase Therapeutics, Inc. IKT (after the close)
  • Spero Therapeutics, Inc. SPRO (after the close)
  • Biocept, Inc. BIOC

Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures

Posted In: BiotechEarningsNewsPenny StocksGuidanceSmall CapFDAGeneral

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