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Benzinga

Technology

Vandana Singh

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

Nasdaq EC GSK BARDA Cancer FDA Pfizer Vaccine Valneva

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 Therapeutics Inc (NASDAQ:MRSN) announced a global collaboration that provides GSK plc (NYSE:GSK) an exclusive option to co-develop and commercialize XMT-2056.

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.

Under the terms of the agreement, Clearside will receive an initial payment of $32.5 million. At the same time, an additional $12.5 million will be deposited in an escrow account to be released to Clearside upon attainment of a pre-specified sales milestone for XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use.

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 Biomedical Advanced Research and Development Authority (BARDA) has awarded an additional approximately $2.1 million to Opiant Pharmaceuticals Inc (NASDAQ:OPNT) to support OPNT003, nasal nalmefene, for opioid overdose.

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

CorMedix Inc (NASDAQ:CRMD) received a second Complete Response Letter (CRL) from the FDA for DefenCath, developed as a catheter lock solution to reduce catheter-related bloodstream infections.

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

Pfizer Inc (NYSE:PFE) and Valneva SE (NASDAQ:VALN) have initiated a Phase 3 study for Lyme disease vaccine candidate VLA15.

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

Zealand Pharma A/S (NASDAQ:ZEAL) has notified its intention to remove its American Depositary Shares from listing on NASDAQ voluntarily.

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

Moderna Inc (NASDAQ:MRNA) amended its agreement with the European Commission (EC) to convert contractually agreed doses of Moderna's COVID-19 vaccine to its omicron-containing bivalent vaccines for supply in 2022, pending regulatory approval.

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

AstraZeneca Plc (NASDAQ:AZN) reported initial results from the TROPION-Lung02 phase 1b trial showing that datopotamab deruxtecan (Dato-DXd) combo therapies demonstrated promising clinical activity and a tolerable safety profile in non-small cell lung cancer (NSCLC) without actionable genomic alterations.

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

BeiGene Ltd's (NASDAQ:BGNE) global Phase 3 RATIONALE 301 trial with tislelizumab met its primary endpoint of non-inferior Overall Survival (OS) versus sorafenib as a first-line treatment for unresectable hepatocellular carcinoma (HCC).

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.

Karuna Therapeutics Inc (NASDAQ:KRTX) commenced an underwritten public offering of $600 million, and underwriters can purchase an additional $90 million.

CinCor Pharma Inc (NASDAQ:CINC) has launched an underwritten public offering of 6 million shares.