The Daily Biotech Pulse: Kodiak Sinks On Adverse Study Outcome, Marinus Flags Delay In Clinical Trial, Mainz Biomed Gains On Positive Regulatory Development

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

Stocks In Focus

Kodiak's Wet AMD Treatment KSI-301 Did Not Meet Primary Endpoint In Phase 2b/3 Study

Kodiak Sciences Inc. KOD announced negative top-line results from its Phase 2b/3 clinical trial evaluating the KSI-301 in treatment-naïve subjects with neovascular age-related macular degeneration. The study did not meet the primary efficacy endpoint of showing non-inferior visual acuity gains for subjects dosed on extended regimens compared to aflibercept given every eight weeks.

The stock was sinking 70.86% to $14.67 in premarket trading.

Akebia's Announces Expanded Agreement With Vifor Regarding Marketing Of Its Kidney Disease Drug

Akebia Therapeutics, Inc. AKBA and Vifor Pharma AG GNHAF announced that the companies have amended and restated the terms of their license agreement. Under the amended agreement Akebia granted Vifor an exclusive license to sell vadadustat, its investigational oral therapeutic for the treatment of anemia due to chronic kidney disease, to Fresenius Medical Care North America, subject to vadadustat's approval by the U.S. Food and Drug Administration.

Vadadustat has been assigned a PDUFA action date of March 29, 2022.

Previous agreements between the companies granted Vifor an exclusive license to sell vadadustat to Fresenius Kidney Care Group for use solely within its dialysis facilities and certain other third-party dialysis facilities in the U.S. The new agreement further expands this license to also include additional independent dialysis organizations.

In consideration for the extension of Vifor's customer group, Vifor Pharma agreed to an additional equity purchase of $20 million. Further, Vifor will contribute $40 million for use as working capital.

Akebia shares were adding 1.02% to $1.99 in premarket trading.

Click here to access Benzinga's FDA Calendar

Marinus Announces Delay In Ganaxolone Trials In Status Epilepticus Due to Omicron Impact And Clinical Supply Interruption

Marinus Pharmaceuticals, Inc. MRNS said due to the impact of the COVID-19 omicron variant on hospital resources and an unexpected interruption of clinical supply material associated with IV ganaxolone, the RAISE, Phase 3 trial for the treatment of status epilepticus, is now expected to be completed in the second half of 2023.

As a result of these impacts, Marinus said it is revising its target for announcing top line data from the RAISE trial to the second half of 2023. Timing for the Phase 2 RESET trial of adjuvant use of ganaxolone in established status epilepticus and the Phase 3 RAISE II trial are both expected to incur a six-month initiation delay.

The stock was slipping 9.84% to $10.08 in premarket trading.

Mainz Biomed Announces FDA Acceptance Of Pre-submission Filing For Colorectal Cancer Detection Test

Mainz Biomed N.V. MYNZ announced its pre-submission filed with the FDA for ColoAlert has been accepted for review. By accepting the pre-submission for review, the FDA will provide feedback to the company on its proposed pivotal U.S. clinical trial design for ColoAlert, its detection test for colorectal cancer.

The FDA feedback is expected in the second quarter and will offer Mainz the opportunity to gain preliminary insight and guidance on the potential technical parameters and endpoints of the study, which is on track to commence in 2023.

The stock was gaining 12.34% to $15.20 in premarket trading.

Moderna Announces Commercialization Agreement For Spikevax In Latin America

Moderna, Inc. MRNA announced a distribution service agreement with Adium Pharma, a private Latin American pharma company, to support the commercialization of the Moderna COVID-19 vaccine, Spikevax across Latin America. The agreement covers 18 countries in Latin America, including Brazil, Mexico, Colombia, and Argentina.

Earnings

Bausch Health Companies Inc. BHC said its fourth-quarter revenues slipped 1% to $2.2 billion. On a GAAP basis, the company reversed from a loss of 43 cents per share to a profit of 19 cents per share. For 2022, the company expects 2022 revenues of $8.4 billion to $8.60 billion and adjusted EBITDA of $3.45 billion to $3.60 billion.

The stock was adding 2.75% to $24.26 in premarket trading.

Offerings

Ocugen, Inc. OCGN priced its underwritten public offering of approximately 15.97 million shares of its common stock for gross proceeds of approximately $53.5 million. The offering is expected to close on or about February 25.

In premarket trading, the stock was slipping 16.68% to $3.44.

Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates

On The Radar

Earnings

Avanos Medical, Inc. AVNS (before the market open)
NeoGenomics, Inc. NEO (before the market open)
Arena Pharmaceuticals, Inc. ARNA (after the market close)
Fulgent Genetics, Inc. FLGT (after the market close)
Global Blood Therapeutics, Inc. GBT (after the market close)
BioMarin Pharmaceutical Inc. BMRN (after the market close)
Guardant Health, Inc. GH (after the market close)
Inari Medical, Inc. NARI (after the market close)
Insulet Corporation PODD (after the market close)
iRhythm Technologies, Inc. IRTC (after the market close)
Maravai LifeSciences Holdings, Inc. MRVI (after the market close)
NuVasive, Inc. NUVA (after the market close)
Nevro Corp. NVRO (after the market close)