The Daily Biotech Pulse: Pfizer-BioNTech Starts Omicron-Specific Vaccine Study, J&J Misses On Topline, Sierra Oncology Reports Positive Data

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

Stocks In Focus

Pfizer, BioNTech Initiates Study Of Omicron-Based Vaccine Candidate

Pfizer, Inc. PFE and BioNTech SE BNTX announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an omicron-based vaccine candidate in healthy adults 18 through 55 years of age. The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine.

Opiant Announces Award of Incremental $2.2M BARDA Funding For Opioid Overdose Drug

Opiant Pharmaceuticals, Inc. OPNT announced a modification to its contract with the BARDA for an additional commitment of up to $2.2 million to support OPNT003, nasal nalmefene, for opioid overdose. The increase in funding is primarily directed toward the costs of Opiant's clinical studies to support its submission of OPNT003 to the Food and Drug Administration.

Click here to access Benzinga's FDA Calendar

89bio Announces Positive Phase 1b/2a Data For NASH Drug

89bio, Inc. ETNB announced positive topline results from an open-label expansion cohort of 20 patients, named Cohort 7, in the Phase 1b/2a proof-of-concept study evaluating pegozafermin for the treatment of non-alcoholic steatohepatitis.

The stock was up 2.08% at $9.80 in premarket trading.

Roche's Application For Expanding Label Of Spinal Muscular Dystrophy Treatment Accepted For Priority Review In U.S.

Roche Holding AG RHHBY said the FDA has granted priority review of a supplemental new drug application for the use of Evrysdi to treat pre-symptomatic babies under two months of age with spinal muscular atrophy.

Sierra Oncology Announces Positive Phase 3 Data For Myelofibrosis Treatment

Sierra Oncology, Inc. SRRA announced positive topline data from the pivotal Phase 3 MOMENTUM study of momelotinib in myelofibrosis patients who are symptomatic and anemic and previously treated with an approved JAK inhibitor. The trial met all of its primary and key secondary endpoints.

The company said it plans to submit a NDA for the treatment to the FDA in the second quarter.

Separately, the company said it has entered into a term loan agreement with Oxford Finance to primarily support the commercial preparation and potential launch of momelotinib.

Capricor Sells U.S. Commercialization Rights For DMD Drug To Nippon Shinyaku For Up to $735M

Capricor Therapeutics, Inc. CAPR said it has entered into a partnership with Japanese pharma company Nippon Shinyaku for the exclusive commercialization and distribution in the U.S. of Capricor's lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy.

Under the terms of the agreement, Capricor will be responsible for the conduct of HOPE-3 as well as the manufacturing of CAP-1002. Capricor will sell commercial product to Nippon Shinyaku and in addition will receive a meaningful, double-digit share of product revenue and additional development and sales-based milestone payments. Capricor will receive an upfront payment of $30 million with potential additional milestone payments of up to $705 million.

Related Link: The Week Ahead In Biotech (Jan. 23-29): Roche, Azurity FDA Decisions, J&J, Vertex Earnings, Samsara Vision IPO And More

Mustang Bio's IND Application For Lentiviral Gene Therapy For Bubble Boy Disease Placed On Hold

Mustang Bio, Inc. MBIO announced that the FDA has issued a hold, pending Chemistry, Manufacturing and Controls clearance, on its investigational new drug application.

Submitted in December, the IND is to initiate a pivotal Phase 2 multicenter study to assess the safety, tolerability and efficacy of MB-207, Mustang's lentiviral gene therapy for the treatment of patients with X-linked severe combined immunodeficiency also known as bubble boy disease, who have been previously treated with a hematopoietic stem cell transplantation and for whom re-treatment is indicated.

Imara Announces FDA Clearance For Starting Phase 2 Study Of Heart Failure Drug

Imara Inc. IMRA said the FDA cleared the IND application for tovinontrine to commence clinical development for the treatment of heart failure with preserved ejection fraction.

The company plans to initiate a Phase 2 trial in the second quarter.

The stock was up 4.45% at $1.64 in premarket trading.

Evotec Ties Up With Boehringer Ingelheim For IPSC-Based Drug For Ophthalmic Disorders

Evotec SE EVO said it has entered a target and drug discovery partnership with Boehringer Ingelheim, focusing on induced pluripotent stem cell-based disease modelling for ophthalmologic disorders. The partnership will leverage on Evotec's human IPSC-based phenotypic screening and panomics platforms and will aim to identify and validate promising targets and approaches for therapeutics interventions.

Amarin Gains On Disclosure Of Fund Stake

Amarin plc AMRN disclosed in the filing with the SEC that Sarissa Capital Management held 24 million shares in the company or a roughly 6.06% stake.

The stock was adding 3.68% to $3.1 in premarket trading.

On The Radar

Earnings

Johnson & Johnson, Inc. JNJ (sales $24.8 billion Vs $22.48 billion a year ago and consensus of $25.29 billion/non-GAAP EPS of $2.13 Vs $1.86 Last Year and $2.12 Consensus; FY22 Guidance calls for $100.3 billion to $101.8 billion in revenues and adjusted EPS of $10.40-$10.60, exceeding Street estimates)

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