The Daily Biotech Pulse: Ocugen Faces Regulatory Setback, vTv CEO Quits, Biogen-Eisai Make Headway With Second Alzheimer's Antibody Treatment In Japan

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

Stocks In Focus

Merck's Keytruda Evaluated In Combination With Microbiome Therapeutic In Biliary Tract Cancer

South Korea's Genome and Company, a developer of microbiome anti-cancer drug, said it has entered into a first clinical trial collaboration and supply agreement with Merck & Company, Inc. MRK.

Under the agreement, the Korean company will conduct a Phase 2 clinical trial to evaluate the safety and efficacy of its immuno-oncology microbiome therapeutic, GEN-001, in combination with Merck's Keytruda in patients with biliary tract cancer. Genome and Company will be the sponsor of the clinical trial and Merck will supply Keytruda.

vTv Announces Resignation Of CEO, Appoints Board Member Rich Nelson As Acting CEO

vTv Therapeutics, Inc. (VTVT) announced the appointment of Rich Nelson as acting chief executive officer. Nelson joined the vTv board in 2020 and is credited with more than 25 years of business and legal experience in mergers & acquisitions and corporate development.

This follows an announcement by the incumbent Deepa Prasad's that she intends to resign.

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Eisai-Biogen Initiates Regulatory Submission For Approval For Second Alzheimer's Antibody Treatment In Japan

Eisai Company Limited ESALY and Biogen, Inc. BIIB announced that the Japanese biopharma has initiated a regulatory submission to Japan's Pharmaceuticals and Medical Devices Agency for the investigational anti-amyloid beta protofibril antibody lecanemab.

In September, the companies initiated a rolling submission of the regulatory application for lecanemab to the U.S. Food And Drug Administration.

FDA Refuses To Grant Authorization For Ocugen's COVID-19 Vaccine In Pediatric Population

Ocugen, Inc. OCGN announced that the FDA, at this time, has declined to issue an emergency use authorization for its Covaxin for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age.

Ocugen said it intends to continue working with FDA to evaluate the regulatory pathway for the pediatric use of Covaxin.

The shares were slumping 27.36% to $2.39 in premarket trading.

Earnings

Chembio Diagnostics, Inc. CEMI reported fourth-quarter revenue of $20.6 million, more than doubling from a year ago. The net loss per share, however, widened from 35 cents to 47 cents. This was wider than the consensus estimate for a loss of 20 cents per share.

In premarket trading, the stock was down 9.98% at 82.99 cents.

Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates

Offerings

Eyenovia, Inc. EYEN announced that the company has entered into a securities purchase agreement with Armistice Capital Master Fund, a healthcare investor, for offering 3 million shares of its common stock pre-funded warrants to purchase up to 1.87 million shares of its common stock, and common warrants to purchase up to 4.87 million shares.

The gross proceeds to Eyenovia are expected to be about $15 million.