The Daily Biotech Pulse: Molecular Partners Plunges On Double Bad News, Pfizer/BioNTech Seek Nod For COVID-19 Shot In Kids, Pfizer Invests In Zentalis

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

Stocks In Focus

Pfizer, BioNTech Seeks Emergency Use Nod For COVID-19 Vaccine For Kids 5-11 Years

Pfizer Inc PFE and BioNTech SE BNTX have submitted an FDA Emergency Use Authorization (EUA) application for a 10-µg booster dose of COVID-19 Vaccine for children 5 through 11 years of age.

The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose approximately six months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-µg two-dose primary series.

Molecular Partners, Novartis Notes EUA For COVID-19 Therapy May Need Additional Data

Molecular Partners AG MOLN and its partner Novartis AG NVS expect that FDA may require additional clinical data for the Emergency Use Application (EUA) for ensovibep, a DARPin antiviral therapeutic candidate to treat COVID-19.

Novartis AG NVS is engaging with the FDA to align on a potential Phase 3 study design that could provide the additional data the agency is seeking for the EUA or full regulatory approval.

Molecular Partners Regains Rights To Early-Stage Cancer Asset From Amgen

Molecular Partners AG's MOLN collaborating partner Amgen Inc AMGN for MP0310 (AMG 506) will return the global rights of MP0310 to Molecular Partners following a strategic pipeline review. 

After completing the ongoing Phase 1 study, Amgen will look to initiate discussions with potential collaborators.

MOLN shares are down 37.9% at $8.62 in the premarket session.

Click here to access Benzinga's FDA Calendar

Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer 

The FDA has granted Breakthrough Therapy Designation (BTD) to Daiichi Sankyo DSKYF and AstraZeneca Plc's AZN Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.

The designation covers patients who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of adjuvant chemotherapy. 

Achieve Life Sciences Aces Smoking Cessation Study With Cytisinicline

Achieve Life Sciences Inc ACHV has announced positive topline results from the Phase 3 ORCA-2 trial of 3mg cytisinicline for six weeks or 12 weeks compared to a placebo in 810 adult smokers. 

The six- and 12-week cytisinicline treatments demonstrated significantly better quit rates than placebo, with odds ratios of 8.0 and 6.3, respectively.

Shares are up 8.7% at $7.50 in the premarket session.

Novartis - BeiGene's Tislelizumab Aces Late-Stage Esophageal Cancer Trial

Novartis AG NVS and its partner BeiGene Ltd BGNE have announced topline results from an interim analysis of the Phase 3 RATIONALE 306 study of tislelizumab plus chemotherapy in esophageal squamous cell carcinoma (ESCC).

Data showed that tislelizumab plus chemotherapy significantly improved overall survival compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent, or metastatic ESCC, regardless of PD-L1 expression. 

Pfizer - Biohaven's Migraine Med Scores European Approval

The European Commission has approved Pfizer Inc PFE and Biohaven Pharmaceutical Holding Company Ltd's BHVN VYDURA (rimegepant) for both acute and prophylactic treatment of migraine. 

The marketing authorization application by the Medicines & Healthcare products Regulatory Agency is underway, and approval is expected shortly.

Related Link: The Week Ahead In Biotech Bristol-Myers Squibb, Supernus, Hutchmed, Axsome, Coherus FDA Decisions, Big Pharma Earnings, IPOs.

Zentalis Secures $25M Equity Funding From Pfizer

Pfizer Inc PFE has agreed to invest $25 million in Zentalis Pharmaceuticals Inc ZNTL via the purchase of 953,834 shares at $26.21 per share.

With prioritization of the clinical development of ZN-c3 and ZN-d5, budget reallocation, and Pfizer's investment, the company extends its current cash runway into the first quarter of 2024.

Shares are up 7.51% at $23.48 during the premarket session.

Caladrius Biosciences to Merge With Cend Therapeutics

In an all-stock transaction, privately-held Cend Therapeutics Inc will merge with Caladrius Biosciences Inc CLBS.

Following closing, the combined company will be renamed Lisata Therapeutics Inc and trade on the Nasdaq under the ticker symbol LSTA. The merger is currently expected to close in the third quarter of 2022.

BioCryst's Candidate For Ultra Rare Disorder Receives European PRIME Designation

The European Medicines Agency has granted access to the Priority Medicines (PRIME) scheme for BioCryst Pharmaceuticals Inc BCRX BCX9250 for fibrodysplasia ossificans progressiva (FOP).

FOP is an ultra-rare, severely disabling genetic disorder characterized by the irregular formation of bone outside the normal skeleton.

Shares are trading 5.16% higher at $9.99 in the premarket session.

Allogene's First TurboCAR T Cell Therapy Receives FDA Orphan Drug Tag

The FDA has granted Orphan Drug status to Allogene Therapeutics Inc's ALLO ALLO-605 targeting BCMA to treat multiple myeloma.

ALLO-605 is the Company's first TurboCAR product candidate based on a programmable cytokine signaling designed to control T cell exhaustion and improve T cell function & potency.

Shares are up 6.15% at $8.98 in the premarket session.

Offerings

Deciphera Pharmaceuticals Inc DCPH has priced an underwritten public offering of 5.25 million shares at $10.00 per share, for gross proceeds of $150 million.

On The Radar

Earnings

GlaxoSmithKline Plc GSK (Before Market Open).

Solid Biosciences Inc SLDB (Before Market Open).

Alkermes Plc ALKS (Before Market Open).

Repligen Corporation RGEN (Before Market Open).

Amgen Inc AMGN (After Market Close).

BioMarin Pharmaceutical Inc BMRN (After Market Close).

Geovax Labs Inc GOVX (After Market Close).

Oragenics Inc OGEN (After Market Close).

Molina Healthcare Inc MOH (After Market Close).

Viking Therapeutics Inc VKTX (After Market Close).

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