The Daily Biotech Pulse: Moderna Seeks FDA Approval For COVID-19 Shot For Children 2-6, Tax Disclosure For Amgen, Fast Track Tags For SQZ Biotech, Timber Pharma Candidates

Zinger Key Points
  • Amgen says that earlier this month the company received a notice of deficiency from the Internal Revenue Service centered on 2013 to 2015. 
  • The agency seeks to increase Amgen's taxable income for the period by an amount that would result in an additional federal tax of approximately $5.1 billion plus interest. 

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

Stocks In Focus

Moderna Seeks FDA Emergency Use Nod For COVID-19 Shot In Kids 2-6

Moderna Inc MRNA submitted a request for FDA emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children 6 months to under 6 years of age. 

The requests are based on a 25 μg two-dose primary series of mRNA-1273.

The EUA submission for children ages 6 months to under 6 years will be complete next week. Moderna is also currently studying booster doses for all pediatric cohorts.

Amgen Hit By Bombshell Tax Disclosure 

Amgen Inc AMGN says that earlier this month the company received a notice of deficiency from the Internal Revenue Service centered on 2013 to 2015. 

The agency seeks to increase Amgen's taxable income for the period by an amount that would result in an additional federal tax of approximately $5.1 billion plus interest. 

In addition, the notice proposes penalties of roughly $2 billion.

The notice is similar to the adjustments Amgen received from the IRS for the 2010 to 2012 period. 

Y-MAbs Therapeutics' CEO Exits, Expects FY22 Danyelza Sales of Up To $50M

Y-mAbs Therapeutics Inc's YMAB CEO and board member Claus Moller has stepped down from his position effective immediately. 

Thomas Gad, the company's founder, chairman and president, has assumed the interim CEO and board member role. 

The company posted preliminary Q1 FY22 Danyelza sales of $10.5 million, with a $45-$50 million full-year revenue guidance.

Cara, Vifor's Kapruvia Scores European Approval

The European Commission has approved Vifor Pharma AG and Cara Therapeutics Inc's CARA Kapruvia (difelikefalin) for pruritus (itchy skin) associated with chronic kidney disease in adult hemodialysis patients. 

The FDA approved the treatment in August 2021.

SQZ Biotech Receives Fast Track Tag For Lead Cancer Cell Therapy

The FDA has granted Fast Track Designation to SQZ Biotechnologies' SQZ lead cell therapy candidate, SQZ-PBMC-HPV, for HPV16+ advanced or metastatic solid tumors.

The cell therapy is being evaluated in a Phase 1/2 clinical trial.

Shares are trading 17% higher at $3.24 during the premarket session.

Click here to access Benzinga's FDA Calendar.

AnaptysBio Posts Topline Data From ANB032 Study In Healthy Volunteers

AnaptysBio Inc ANAB announced topline data from a Phase 1 trial of ANB032, an anti-BTLA agonist antibody. 

Topline data demonstrated favorable safety, tolerability, and rapid and sustained pharmacokinetics and pharmacodynamic profile, supporting the advancement of ANB032 into subsequent patient trials.

ANB032 was generally well-tolerated and no dose-limiting toxicities were observed.

AstraZeneca's Ultomiris Scores FDA Approval For Rare Neuromuscular Disease

The FDA has approved AstraZeneca Plc AZN Ultomiris (ravulizumab-cwvz) for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody-positive.  

The approval was based on positive results from the CHAMPION-MG Phase 3 trial. Ultomiris was superior to placebo on a patient-reported scale that assesses patients' abilities to perform daily activities.

gMG is a rare, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness.

Statera Biopharma, Immune Therapeutics Ink Pact For Low Dose Naltrexone Rights

Statera Biopharma Inc STAB has entered into a non-binding term sheet with Immune Therapeutics Inc IMUN to sell its naltrexone and met-enkephalin rights.

Statera will receive an initial $2-million upfront payment and 5% of the issued and outstanding stock of Immune Therapeutics. 

Additionally, Statera will receive milestone-based payments. Potential indication payments will include asthma, multiple sclerosis, HIV and chemotherapy. This transaction can generate over $400 million in non-dilutive payments to Statera.

Shares are up 62.7% at 34 cents during the premarket session.

Sio Gene Therapies Ditches Two Remaining Programs, Seeks Buyer(s)

Sio Gene Therapies Inc SIOX will terminate its licensing agreement with the University of Massachusetts to develop and commercialize gene therapy product candidates, including AXO-AAV-GM1 and AXO-AAV-GM2, for GM1 gangliosidosis and GM2 gangliosidosis, respectively.

The company announced that it plans to explore and review a range of strategic alternatives in parallel.

The Sio held cash and cash equivalents of approximately $64 million at March 31. 

Shares are down 38.6% at 37 cents during the premarket session.

Opiant Pharma's Nasal Nalmefene Non-Inferior To Nasal Naloxone In Opioid Overdose

Opiant Pharmaceuticals Inc OPNT announced topline results from a pharmacodynamic study for OPNT003, nasal nalmefene for opioid overdose.

OPNT003 met the primary endpoint of non-inferiority to nasal naloxone.

A preliminary analysis of the 50 subjects completing the study found that treatment with OPNT003 produced nearly twice the reversal of respiratory depression than produced by nasal naloxone at 5 minutes. 

Timber Pharma TMB-001 Scores FDA Fast Track Tag For Skin Scaling Disorder

The FDA has granted Fast Track designation to Timber Pharmaceuticals Inc's TMBR TMB-001, topical isotretinoin formulated for X-linked recessive ichthyosis and autosomal recessive congenital ichthyosis lamellar ichthyosis.

Congenital ichthyosis is a group of rare genetic keratinization disorders that lead to dry, thickened and scaling skin. 

Timber expects to launch a pivotal Phase 3 ASCEND trial for TMB-001 within 60 days.

Shares are up 0.72% at 46 cents during the premarket session.

Abbvie, Plexium Collaborate For Protein Degradation Therapies In Neurological Conditions

Plexium Inc and AbbVie Inc ABBV have entered into an exclusive strategic collaboration to develop and commercialize novel Targeted Protein Degradation therapeutics for neurological conditions. 

Plexium will conduct preclinical research activities for the collaboration targets, after which AbbVie has the option to select programs for additional research and development activities. 

Specific deal terms were not disclosed.

On The Radar

Earnings

  • Merck & Co Inc MRK (Before Market Open).
  • CureVac BV CVAC (Before Market Open).
  • Sanofi SA SNY (Before Market Open).
  • NovoCure Limited NVCR (Before Market Open).
  • Eli Lilly And Co LLY (Before Market Open).
  • Alnylam Pharmaceuticals Inc ALNY (Before Market Open).
  • Gilead Sciences Inc GILD (After Market Close).
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