The Daily Biotech Pulse: Novartis Funding For Gene Therapy Research, Priority Review For Amgen Cancer Drug, Pfizer-BioNTech Vaccine Supply Deal

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Feb. 16)

• 10X Genomics Inc (TXG)
• 9 Meters Biopharma Inc NMTR
• Angion Biomedica Corp ANGN
• Applied Genetic Technologies Corp AGTC
• Applied Molecular Transport Inc. AMTI
• Aslan Pharmaceuticals Ltd ASLN
• Avanos Medical Inc AVNS
• Beigene Ltd BGNE
• BIO-TECHNE Corp TECH
• Bioanalytical Systems, Inc. BASI
• BioNano Genomics Inc BNGO
• Catalent Inc CTLT
• Cerecor Inc CERC
• China Biologic Products Holdings Inc CBPO
• China SXT Pharmaceuticals Inc SXTC
• Clearpoint Neuro Inc CLPT
• Cleveland BioLabs, Inc. CBLI
• DarioHealth Corp DRIO
• DermTech Inc DMTK
• Diffusion Pharmaceuticals Inc DFFN (reported positive Phase 1b results for trans sodium crocetinate in hospitalized COVID-19 patients with confirmed hypoxemia)
• G1 Therapeutics Inc GTHX
• Genetron Holdings Ltd – ADR GTH
• GenMark Diagnostics, Inc GNMK
• Globus Medical Inc GMED
• Horizon Therapeutics PLC HZNP
• Immunic Inc IMUX
• Inari Medical Inc NARI
• Inspire Medical Systems Inc INSP
• Intra-Cellular Therapies Inc ITCI
• Krystal Biotech Inc KRYS
• Medtronic PLC MDT
• Nantkwest Inc NK
• NeoGenomics, Inc. NEO
• Oncternal Therapeutics Inc ONCT
• Oramed Pharmaceuticals, Inc. ORMP
• PAVmed Inc PAVM (said the first U.S. patient recently underwent successful carpal tunnel release using its CarpX minimally invasive carpal tunnel device)
• PPD Inc PPD
• Protagonist Therapeutics Inc PTGX
• Seelos Therapeutics Inc SEEL
• Seneca Biopharma Inc SNCA
• Sesen Bio Inc SESN (announced FDA acceptance for priority review, its BLA for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer)
• Syneos Health Inc SYNH
• Varian Medical Systems, Inc. VAR

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Feb. 16)

• Bioventus BVS
• bluebird bio Inc BLUE ( announced temporary stalling of sickle cell disease gene therapy studies due to serious adverse events in the form of blood cancer)
• Decibel Therapeutics Inc DBTX (IPOed Friday)
• Evaxion Biotech A/S – ADR EVAX
• Galapagos ADR Representing Ord Shs GLPG
• Talis Biomedical Corp TLIS (IPOed Friday)

Stocks In Focus

Novartis Gets Gates Foundation Funding For Sickle Cell Disease Gene Therapy Study

Novartis AG NVS announced a grant agreement with the Bill & Melinda Gates Foundation with respect to funding support for the discovery and development of a single-administration, in vivo gene therapy to cure sickle cell disease, an inherited genetic blood disorder.

The Gates Foundation has agreed to provide funding support for a research team within NIBR wholly dedicated to developing an approach to delivering this potential treatment. Novartis will provide in-kind support and access to its suite of technologies and resources.

Separately, Novartis said the FDA has approved an expanded indication for Entresto to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.

The labeling also states that benefits are most clearly evident in patients with left ventricular ejection fraction below normal.

Exact Sciences To Buy Genomic Testing Lab, Reports a Wider-than-expected Loss For Q4

EXACT Sciences Corporation EXAS said it has entered into an agreement to acquire Ashion Analytics from The Translational Genomics Research Institute, an affiliate of City of Hope.

Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities for customers focused on precision cancer treatments. The team at Ashion will help accelerate the development of Exact Sciences' precision oncology portfolio, including minimal residual disease and other sequencing-based tests.

Exact Sciences also said it entered a 10-year collaboration, bringing in the expertise of TGen and City of Hope, to develop differentiated MRD testing capabilities.

Separately, Exact Sciences reported fourth-quarter revenues of $466.3 million, up from $295.58 million a year ago. The company reversed to a net loss of $2.79 per share from a profit of 54 cents per share, markedly wider than the 22 cents per share loss expected by analysts.

The stock slipped 4.39% to $147.50 in after-hours trading.

Amgen Regulatory Application For KRAS G12-C Mutated Lung Cancer Drug Granted Priority Review

Amgen, Inc. AMGN said the FDA has granted priority review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, following at least one prior systemic therapy.

Based on the priority review designation, the PDUFA date for the application is Aug. 16, the company said.

Amgen had submitted the application in mid-December.

AstraZeneca, Merck to Commence Early Primary Analysis of Late-stage Breast Cancer Drug Data Following IDMC Recommendations

AstraZeneca plc AZN and Merck & Co., Inc. MRK said the Phase 3 OlympiA trial for Lynparza will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee.

The committee concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival versus placebo in the adjuvant treatment of germline BRCA-mutated, high-risk HER2-negative early-stage breast cancer following definitive local treatment and neoadjuvant or adjuvant chemotherapy.

In premarket trading, AstraZeneca shares were rising 0.16% to $50.97 and Merck was advancing 0.74% to $74.80.

Roche's COVID-19 Antigen Test Approved In Canada

Roche Holdings AG RHHBY said its SARS-CoV-2 Rapid Antigen Test has received approval under Health Canada's Interim Order. This can help healthcare professionals identify a SARS-CoV-2 infection with results typically ready in 15 minutes.

Pfizer/BioNTech Strikes Deal to Supply Additional 200M Doses of Coronavirus Vaccine to Europe

Pfizer Inc. PFE and BioNTech SE – ADR BNTX announced an agreement with the European Commission to supply an additional 200 million doses of Comirnaty, their COVID-19 vaccine, to the 27 EU member states. The EC has the option to request supply of an additional 100 million doses.

The additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in the second quarter.

Separately, Pfizer announced the commencement of registration-enabling Phase 2 MagnetisMM-3 study of elranatamab, an investigational B-cell maturation antigen CD3-targeted bispecific antibody, in patients with relapsed/refractory multiple myeloma.

Mereo, Prothena, Adaptimmune Gain On Fund Stake Disclosure

Mereo BioPharma Group ADR MREO shares rallied after 13G filings revealed stake holdings by institutions. Baker Bros. Advisors held 39.632 million shares in the biopharma, amounting to a 11.4% stake, Boxer Capital held 10.309 million shares, Vivo Capital had 1.999 million shares or a 1.822% stake and Citadel Advisors held 30.907 million shares, amounting to a 8.9% stake.

In after-hours trading, the stock rallied 13.79% to $3.96.

Prothena Corporation PLC PRTA gained ground after filings revealed that First Light Asset Management beneficially owned 2.92 million shares of the company, giving it a 7.34% stake and that Great Point Partners owned 977,647 shares in the company or a 2.45% stake.

The stock was up 7.83% to $24.80 in after-hours trading.

Adaptimmune Therapeutics PLC – ADR ADAP said in filings that Matrix Capital Management beneficially owned 233.85 million shares or a 25.18% stake in the company and Baker Bros. owned 58.985 million shares or a 6.4% stake. Additionally, Capital World Investors beneficially owned 48.016 shares or a 5.2% stake.

The stock rose 7.83% to $7.30 in after-hours trading.

Offerings

Citius Pharmaceuticals Inc CTXR said it has entered into definitive agreements with certain healthcare-focused and institutional investors for the purchase of an aggregate of 50.831 million shares of its common stock and accompanying warrants to purchase up to an aggregate of 25.415 million shares of its common stock, at a purchase price of $1.505 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules.

The aggregate gross proceeds to the company from the offering are expected to be approximately $76.5 million.

The stock jumped 15.98% to $1.96 in after-hours trading.

Aikido Pharma Inc AIKI said due to demand, the underwriter has agreed to increase the size of the previously announced bought out deal to 46.875 million shares of common stock of the company at a price to the public of $1.60 per share, for raising gross proceeds of $75 million.

In after-hours trading, the stock was up 8.45% to $1.95.

AEterna Zentaris Inc. AEZS announced an increase to the size of a bought out deal to 20.51 million common shares of Aeterna, at a price to the public of $1.45 per share. The closing of the offering is expected to occur on or about Feb. 19.

The stock pulled back 9.39% to $1.64 in after-hours trading.

Y-mAbs Therapeutics, Inc YMAB announced the commencement of a registered underwritten public offering of up to $100 million in shares of its common stock. All shares in the offering are expected to be offered by the company.

The stock fell 2.21% to $45.10 in after-hours trading.

ESSA Pharma Inc EPIX announced that it has commenced an underwritten public offering of up to $100 million worth of its common shares. The company said it intends to use the net proceeds for pre-clinical and clinical activities, chemistry, manufacturing and controls, R&D, as well as working capital and general corporate purposes. All common shares to be sold in the Offering will be offered by ESSA.

In after-hours trading, the stock was up 0.80% to $25.11.

On The Radar

Earnings

Royalty Pharma plc (RPRX) (before the market open)
Ironwood Pharmaceuticals, Inc. I(RWD) (before the market open)
Blueprint Medicines Corp (BPMC) (before the market open)
10X Genomics Inc (TXG) (after the close)
Invitae Corp (NVTA) (after the close)
Globus Medical Inc (GMED) (after the close)
Shockwave Medical Inc (SWAV) (after the close)
Veracyte Inc (VCYT) (after the close)
Viking Therapeutics Inc (VKTX) (after the close)

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