The Daily Biotech Pulse: Pfizer Reports Solid Q3 Earnings, Regulatory Setback For Legend, Lilly to Supply Additional COVID-19 Antibody Cocktails To US

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

Stocks In Focus

SAB Spikes On Analyst Action

SAB Biotherapeutics, Inc. SABS shares are rallying Tuesday after Baird initiated coverage of the shares with an Outperform rating. SAB, a clinical-stage biopharmaceutical company with a novel immunotherapy platform, debuted on Wall Street last week through a SPAC deal.

Filings with the SEC also revealed that SAB's co-founder Christine Hamilton and Eddie Sullivan, president and CEO of the company, owned 24.58% and 13.12%, respectively, of shares in the company.

In premarket trading, the stock was spiking 25.74% to $10.60.

Lumira COVID-19 Antigen Test's Authorization Expanded To Screening Of Asymptomatic Individuals

LumiraDx LMDX announced the intended use for its Food and Drug Administration emergency use authorization for its SARS-CoV-2 antigen test has been expanded to include screening of asymptomatic individuals.

This claim builds on its existing claim that covers use of the test in individuals suspected of COVID-19 by their health care provider within 12 days of symptom onset.

Legend Biotech's Out-Licensed Blood Cancer Drug Review Period Extended By 3 Months

Legend Biotech Corporation LEGN announced that the FDA extended the PDUFA target date for ciltacabtagene autoleucel (cilta-cel) to Feb. 28, 2022. Cilta-cel is a BCMA-directed CAR-T therapy being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma.

The biologics license application was submitted by Legend Biotech's collaboration partner Johnson & Johnson JNJ's Janssen unit. The FDA notified Janssen Thursday of the extension of the PDUFA date to allow sufficient time to review information recently submitted pertaining to an updated analytical method following an FDA information request. No additional clinical data have been requested.

Legend shares were down 8.92% to $48 in premarket trading.

Lilly Strikes Deal With US Government To Supply Incremental Doses of COVID-19 Antibody Cocktail

Eli Lilly and Company LLY announced an additional purchase by the U.S. government for bamlanivimab with etesevimab for administration together. This neutralizing antibody therapy is authorized for emergency use for the treatment of mild to moderate COVID-19 or for post-exposure prophylaxis of COVID-19 in certain individuals.

As part of the agreement, Lilly will supply 614,000 doses of bamlanivimab with etesevimab no later than Jan. 31, 2022 for a total of $1.29 billion. A minimum of 400,000 doses will be supplied no later than Dec. 31, 2021.

Related Link: The Week Ahead In Biotech (Oct. 31-Nov. 6): Earnings Pick Up Pace, Eton Awaits Seizure Drug Approval, Kidney Conference, More IPOs In The Pipeline

Moderna Announces R&D Collaboration For Gene Editing Therapeutics

Moderna, Inc. MRNA AND Metagenomi, a genetic medicines company with a portfolio of next-generation gene editing tools, announced that the two companies have entered into a strategic R&D collaboration focused on advancing new gene editing systems for in vivo human therapeutic applications.

The collaboration will utilize Metagenomi's novel gene editing tools and leverage Moderna's mRNA platform, as well as lipid nanoparticle delivery technologies, with the goal of developing curative therapies for patients with serious genetic diseases.

Management Changes

Aadi Bioscience, Inc. AADI announced the appointment of Scott Giacobello to the role of chief financial officer and treasurer, effective Nov. 28, 2021. Most recently, Giacobello was the CFO of GW Pharmaceuticals plc until its $7.2-billion acquisition by Jazz Pharmaceuticals plc JAZZ.

Context Therapeutics Inc. (CNTX announced the appointment of Jennifer Minai-Azary as CFO, and the prior appointment, in April, of Alex Levit as chief legal officer.

Earnings

Neurocrine Biosciences, Inc. NBIX reported third-quarter revenues of $296 million, up from $258.5 million a year-ago. On a non-GAAP basis, the company reversed to a profit of 64 cents from a loss of 18 cents, exceeding the 60-cent per share consensus estimate.

The stock was retreating 6.8% to $99 in premarket trading.

Pfizer Inc. PFE said its third-quarter revenues jumped 130% operationally to $24.1 billion. Excluding Comirnaty sales, revenues were up 7% to $11. Billion. Adjusted earnings per share came in at $1.34. The company raised its full-year guidance.

The stock was seen adding 3.46% to $45.15 in premarket trading.

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On The Radar

Earnings

• Sage Therapeutics, Inc. SAGE (before the market open)
• Myriad Genetics, Inc. MYGN (before the market open)
• Incyte Corporation INCY (before the market open)
• Integra LifeSciences Holdings Corporation IART (before the market open)
• Esperion Therapeutics, Inc. ESPR (before the market open)
• Catalent, Inc. CTLT (before the market open)
• Bio-Techne Corporation TECH (before the market open)
• Avanos Medical, Inc. AVNS (before the market open)
• Pulmonx Corporation LUNG (after the close)
• Amgen Inc. AMGN (after the close)
• Deciphera Pharmaceuticals, Inc. DCPH (after the close)
• Exelixis, Inc. EXEL (after the close)
• Exact Sciences Corporation EXAS (after the close)
• Halozyme Therapeutics, Inc. HALO (after the close)
• Inspire Medical Systems, Inc. INSP (after the close)
• Pacific Biosciences of California, Inc. PACB (after the close)
• MacroGenics, Inc. MGNX (after the close)
• REGENXBIO Inc. RGNX (after the close)
• Ultragenyx Pharmaceutical Inc. RARE (after the close)
• Vertex Pharmaceuticals Incorporated VRTX (after the close)

Related Link: Moderna To Supply Additional COVID-19 Vaccine Doses To COVAX Alliance