Biotech Daily: Regulatory Setback For CorMedix, Mersana & GSK In Cancer Pact, BARDA Funding For Opioid Overdose Hopeful

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

Stocks In Focus

Mersana, GSK Ink $1.36B Biobuck Deal For Cancer-Focused Therapy

Mersana will receive an upfront option purchase fee of $100 million. Mersana is also eligible to receive up to $1.36 billion in the form of an option exercise payment and development, regulatory and commercial milestone payments if GSK exercises its option.

Mersana has retained options to profit-share and to co-promote in the U.S. 

Clearside Biomedical Secures Non-Dilutive fUNDING fROM HealthCare Royalty Partners

Clearside Biomedical Inc (NASDAQ:CLSD) has entered into a Royalty Interest Purchase and Sale Agreement with HealthCare Royalty Partners.

The terms of the agreement also provide for an additional milestone payment of $20 million to Clearside upon attainment of a second pre-specified 2024 sales milestone for XIPERE.

Opiant Pharma Secures Additional BARDA Funding For Opioid Overdose Treatment

The increase in funding is primarily directed toward preparing and filing a marketing application for OPNT003 to the FDA.

CorMedix Slapped With Second FDA Rejection For DefenCath

The letter states that DefenCath cannot be approved until deficiencies related to the contract manufacturing organization and the supplier of the active pharmaceutical ingredient heparin during inspections are resolved to the satisfaction of the FDA. 

Shares are down 54.1% at $3.45 during the premarket session.

Pfizer, Valneva Kickstart Late-Stage Study For Lyme Disease Vaccine

The randomized, placebo-controlled, Phase 3 VALOR study will enroll approximately 6,000 participants 5 years and older. 

Pending successful completion of the Phase 3 study, Pfizer could submit marketing applications to the FDA and European Medicines Agency in 2025.

Pfizer will make a $25 million milestone payment to Valneva upon initiating the Phase 3 study.

Zealand To Cease Trading On US Stock Exchange

The company's ordinary shares will continue to be listed on Nasdaq Copenhagen, which is the primary source of liquidity and trading flexibility for Zealand shares.

The decision is part of Zealand's refocused strategy to prioritize R&D and streamline corporate operations.

Moderna, Europe Amend COVID-19 Pact For Supply Of Omicron-Targeted Vaccine

In addition, the EC has agreed to purchase an additional 15 million doses of Omicron-containing vaccine booster candidates.

Under the amendment, contractually scheduled doses in July and August of Moderna's COVID-19 vaccine will be deferred to later in 2022.

Moderna is advancing two bivalent candidates. Both bivalent candidates contain 25 µg of the currently authorized booster (mRNA-1273) and 25 µg of an Omicron-specific subvariant.

AstraZeneca's Dato-DXd-Based Combo Therapies Show Promising Activity In Lung Cancer Patients

The interim analysis demonstrated an overall response rate in the overall population of 37% in patients receiving datopotamab deruxtecan plus Merck & Co Inc's Keytruda (pembrolizumab) (doublet therapy).

The data showed an ORR of 41% in patients receiving datopotamab deruxtecan plus pembrolizumab and platinum chemotherapy (triplet therapy). 

Beigene's Liver Cancer Candidate At Par With Bayer's Drug

The safety profile for tislelizumab was consistent with previous studies, and no new safety signals were reported. 

HCC (a form of liver cancer) is the sixth most common cancer worldwide.

Offering

Aytu BioPharma Inc (NASDAQ:AYTU) launched an underwritten public offering. Details are yet to be determined.

On The Radar

Earnings

Dare Bioscience Inc (NASDAQ:DARE): Before the market open.

Intra-Cellular Therapies Inc (NASDAQ:ITCI): Before the market open.

Rubius Therapeutics Inc (NASDAQ:RUBY): Before the market open.

Syros Pharmaceuticals Inc (NASDAQ:SYRS): Before the market open.

Beam Therapeutics Inc (NASDAQ:BEAM): Before the market open.

Verve Therapeutics Inc (NASDAQ:VERV): Before the market open.

Axsome Therapeutics Inc (NASDAQ:AXSM): Before the market open.

Ionis Pharmaceuticals Inc (NASDAQ:IONS): Before the market open.

Eagle Pharmaceuticals Inc (NASDAQ:EGRX): Before the market open.

Vir Biotechnology Inc (NASDAQ:VIR): After market close.

Inovio Pharmaceuticals Inc (NASDAQ:INO): After market close.

Exelixis Inc (NASDAQ:EXEL): After market close.

Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT): After market close.

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