The Daily Biotech Pulse: Novartis Prostate Cancer Drug Lands FDA Approval, Ligand Announces SPAC Deal To Spin Off Antibody Business, Lilly's Lung Cancer Therapy Hit With CRL

Zinger Key Points
  • Eli Lilly announced the FDA has issued a complete response letter for the biologics license application for the investigational medicine sintilimab injection, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of people with nonsquamous non-small cell lung cancer.
  • Ascendis Pharma announced its intention to offer, subject to market and other conditions, a $500 million aggregate principal amount of convertible senior notes due 2028 in a private offering to qualified institutional buyers.

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

Stocks In Focus

Novartis Announces FDA Approval Of Prostate Cancer Drug Pluvicto

Novartis AG NVS said the U.S. Food and Drug Administration approved Pluvicto for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer that has spread to other parts of the body. These patients have already been treated with other anti-cancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).

The stock was edging up 0.44% to $85.93 in premarket trading.

Ligand To Spin Off Antibody Discovery Business Through SPAC Deal

Ligand Pharmaceuticals, Inc. LGND announced the signing of a definitive merger agreement with Avista Public Acquisition Corp. II AHPA, a publicly traded special purpose acquisition company, for the spin-off of OmniAb, Inc. its antibody discovery business, immediately followed by a merger with a newly formed subsidiary of APAC.

The combined company will be led by Ligand's president Matt Foehr and will be renamed OmniAb, Inc.

Upon the closing of the transaction, Avista Capital Partners, the sponsor of the SPAC, has agreed to invest up to $115 million in the combined company, and Ligand will contribute $15 million. The combined company will have an initial pre-money equity valuation of $850 million. 

Quest Diagnostics Gets CDC Contract For COVID Surveillance Data

Question Diagnostics Inc. DGX said it has been granted a contract by the CDC to perform testing and provide laboratory data analysis to help identify patterns in SARS-COV-2 seroprevalence on a multistate basis. The goal is to aid the CDC in assessing the proportion of the population that has been infected by or vaccinated against SARS-CoV-2, the virus that causes COVID-19.

Pfizer's RSV Vaccine Candidate For Older Individuals Gets Breakthrough Therapy Designation

Pfizer, Inc. PFE announced that its respiratory syncytial virus vaccine candidate, PF-06928316, received breakthrough therapy designation from the FDA for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.

Related Link: The Week Ahead In Biotech (March 20-26): Focus On Zogenix FDA Decision, Dermatology Conference Presentations & Earnings

FDA Rejects Lilly's Regulatory Application For Co-Developed Lung Cancer Drug 

Eli Lilly and Company LLY announced the FDA has issued a complete response letter for the biologics license application for the investigational medicine sintilimab injection, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of people with nonsquamous non-small cell lung cancer. Sintilimab is being developed by Hong Kong-based Innovent Biologics and Lilly.

Fennec Announces Resubmission For Approval Of Pedmark For Treating Chemo-Induced Hearing Issues In Children

Fennec Pharmaceuticals Inc FENC announced the resubmission of its new drug application to the FDA for Pedmark, a unique formulation of sodium thiosulfate, for the prevention of platinum-induced ototoxicity in pediatric patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.

The investigational therapy was handed down a CRL in November 2021.

The stock was up 4.93% to $6.38 in premarket trading.

BiondVax Announces Licensing Option Agreement For Developing Nanosized Antibodies

BiondVax Pharmaceuticals Ltd. BVXV announced the signing of definitive agreements with the Max Planck Society, the parent organization of the Max Planck Institute for Multidisciplinary Sciences, and the University Medical Center Göttingen, both in Germany, to enter into a strategic collaboration for the development of innovative nanosized antibodies.

BiondVax will have an exclusive option for an exclusive worldwide license at pre-agreed commercial terms for further development and commercialization of each generated NanoAb.

The stock was rallying 20.44% to $1.65 in premarket trading.

Immutep Announces Publication Of Abstract For Lung Cancer Combo Therapy

Australian biotech Immutep Limited IMMP said new interim data from the TACTI-002 Phase 2 Part B study evaluating its eftilagimod alpha, a LAG-3 protein, in combination with Merck & Co., Inc.'s MRK Keytruda in advanced NSCLC patients showed the combination continues to be safe and well tolerated. The combo therapy also showed encouraging signs of antitumor activity in this difficult to treat patient population with limited treatment options.

The company noted that the data has been published in an abstract in advance of ESMO's European Lung Cancer Congress, which is scheduled to be held virtually from March 30 to April 2.

Imago Appoints Biopharma Industry Veteran As Chief Operating & Business Officer

Imago Biosciences, Inc. IMGO announced the appointment of Michael Arenberg to the role of chief operating and business officer. Arenberg is a biopharmaceutical industry veteran and he will also lead strategic operations, investor relations, commercial development and business development, the company announced.

Click here to access Benzinga's FDA calendar.

Offerings

Apellis Pharmaceuticals, Inc. APLS announced that it has commenced an underwritten public offering of $300 million of its common stock. All of the shares are being offered by Apellis.

The stock was slipping 7.28% to $49 in premarket trading.

Ascendis Pharma A/S ASND announced its intention to offer, subject to market and other conditions, a $500 million aggregate principal amount of convertible senior notes due 2028 in a private offering to qualified institutional buyers.

Ascendis Pharma intends to use a portion of the net proceeds to repurchase up to 1 million ADSs and the remaining to fund commercialization and further clinical development of TransCon hGH.

The stock was pulling back by 3.53% to $113 in premarket trading.

On The Radar

Earnings

  • Titan Medical Inc. TMDI (before the market open)
  • HOOKIPA Pharma Inc. HOOK (before the market open)
  • Evelo Biosciences, Inc. EVLO (before the market open)
  • Athira Pharma, Inc. ATHA (after the close)
  • Co-Diagnostics, Inc. CODX (after the close)
  • Eledon Pharmaceuticals, Inc. ELDN (after the close)
  • Panbela Therapeutics, Inc. PBLA (after the close)
  • TFF Pharmaceuticals, Inc. TFFP (after the close)

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

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