The Daily Biotech Pulse: Pfizer/BioNTech Ink New COVID-19 Vaccine Supply Pact, Sanofi Hit By FDA Clinical Hold, Angion Biomedica Halts Second Kidney Disease Trial

Zinger Key Points
  • Sanofi paused enrollment in Phase 3 tolebrutinib trials in the U.S.
  • Angion believes discontinuation of the JUNIPER study is in the best interest of patients

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

Stocks In Focus

US Government Calls For Additional Doses Of Pfizer/BioNTech COVID-19 Vaccine

Pfizer Inc PFE and BioNTech SE BNTX have announced a new vaccine supply agreement with the U.S. government.

The U.S. government will receive 105 million doses (30 µg, 10 µg, and 3 µg) for $3.2 billion. It may include adult omicron-adapted COVID-19 vaccines, subject to FDA authorization. 

The U.S. government can purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.

FDA Institutes Partial Hold On Sanofi's Tolebrutinib Studies 

The FDA has placed Sanofi SA's SNY Phase 3 studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold. 

The FDA action was based on a limited number of drug-induced liver injury cases identified with tolebrutinib exposure in Phase 3 studies. 

Shares are slipping 3.53% at $50.81 during the premarket session.

Within Three Months, Angion Biomedica Pulls The Plug On Second Kidney Disease Trial

Angion Biomedica Corp ANGN has discontinued the JUNIPER Phase 2 trial of ANG-3070, an oral tyrosine kinase inhibitor, in primary proteinuric kidney diseases.

A reassessment was conducted following a potential safety signal of an unexpected and substantial decline in kidney function in a patient in the trial's drug treatment arm.

Shares closed 18.7% lower at $1.39 during after-hours trading.

Lexicon Pharma Aces Midstage Diabetic Neuropathy Study

Lexicon Pharmaceuticals Inc LXRX announced topline results of the RELIEF-DPN-1 Phase 2 proof-of-concept study of LX9211 in painful diabetic neuropathy.

LX9211 achieved the study's primary endpoint, demonstrating a statistically significant reduction in average daily pain score at week six compared to placebo in the low dose arm, with results that plateaued in the high dose arm.

Separation from placebo was seen by week 1 in both dose arms. 

Shares are down 1.79% at $2.20 during the premarket session.

AstraZeneca Says Imfinzi/Chemo Combo Shows Promising Action In Late-Stage Lung Cancer Study

AstraZeneca Plc AZN announced high-level results from a planned interim analysis of the AEGEAN Phase 3 trial of Imfinzi (durvalumab) combined with neoadjuvant chemotherapy in patients with resectable non-small cell lung cancer.

The data showed that Imfinzi plus neoadjuvant chemo before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete response compared to neoadjuvant chemotherapy alone.

Novartis's Tislelizumab Extended Overall Survival In Late-Stage Esophageal Cancer Study

Novartis AG NVS announced results from the Phase 3 RATIONALE 306 trial of tislelizumab plus chemotherapy in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.

The data showed that the tislelizumab/chemo combo significantly improved overall survival (OS) as a first-line treatment, regardless of PD-L1 status versus chemotherapy.

Tislelizumab combo demonstrated a median OS of 17.2 months versus 10.6 months in patients receiving chemotherapy plus placebo and reduced the risk of death by 34%.

MediciNova Extends BARDA Contract For MN-166

MediciNova Inc MNOV modified its contract with the Biomedical Advanced Research and Development Authority (BARDA) to repurpose MN-166 (ibudilast) as a potential medical countermeasure against chlorine gas-induced lung damage. 

The contract was amended to extend the period of performance until March 2023.

Adagene Announces Share Buyback

Adagene Inc ADAG authorized a share repurchase program of up to $10 million.

The company expects to utilize its existing funds to fund repurchases made under this program.

Adagene ended 2021 with a cash balance of $174.4 million.

Shares are up 15.5% at $2.42 during the premarket session.

Corcept Therapeutics Launches Late-Stage Ovarian Cancer Trial

Corcept Therapeutics Incorporated CORT initiated the ROSELLA Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer.

ROSELLA has a planned enrollment of 360 women.

The primary endpoint will be progression-free survival, with overall survival as a key secondary endpoint. 

Novartis Resumes Production, Delivery Of Radioligand Therapy Medicines

Novartis AG NVS said that in early June, the company restarted radioligand therapy (RLT) production at its sites in Ivrea, Italy and Millburn, New Jersey.

It also resumed delivering doses to patients in a phased approach, ahead of the expected six-week time frame. 

The company has remediated the issues that led to a temporary, voluntary suspension of production in May.

Avadel Outlines Strategy To Accerlate FDA Approval Of FT218

Avadel Pharmaceuticals plc AVDL is pursuing strategies to accelerate the final FDA approval of FT218 for excessive daytime sleepiness or cataplexy in adults with narcolepsy.

The company is optimizing its cost structure to fund strategic priorities and extend its cash runway. It expects to cut quarterly operating expenses to $12-$14 million.

Avadel is continuing key activities to accelerate the launch timing of FT218.

Aura Biosciences Bladder Cancer Candidate Fast-Tracked In US

The FDA has granted Fast Track designation to Aura Biosciences Inc's AURA belzupacap sarotalocan (AU-011), Aura's first VDC product candidate, for non-muscle invasive bladder cancer.

Aura's planned Phase 1 trial will evaluate the safety and early proof of mechanism. The company expects to initiate the trial in 2H of 2022, with initial Phase 1 data expected in 2023.

Offerings

Verrica Pharmaceuticals Inc VRCA priced its underwritten public offering of 12 million shares at $2.10 per share, with gross proceeds of approximately $25.2 million.

Seres Therapeutics Inc MCRB has announced a registered direct offering of 31.7 million shares at $3.15 per share, resulting in gross proceeds of approximately $100 million.

On The Radar

Stock Split

Exicure Inc XCUR: Reverse stock split of 30:1.

Posted In: COVID-19 CoronavirusCOVID-19 VaccineBiotechLarge CapNewsPenny StocksHealth CareFinancingOfferingsContractsSmall CapFDAStock SplitMoversTrading IdeasGeneral

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