Pfizer, BioNTech File Marketing Application In Europe, NuCana Jumps On Data, Amarin Takes On Hikma In Patent Lawsuit

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



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Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Nov. 30)

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Amicus Therapeutics, Inc. (NASDAQ: FOLD) Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) argenx SE – ADR (NASDAQ: ARGX) Beam Therapeutics Inc (NASDAQ: BEAM) Bioanalytical Systems, Inc. (NASDAQ: BASI) BioLife Solutions Inc (NASDAQ: BLFS) BioNTech SE – ADR (NASDAQ: BNTX) (reacted to reports of imminent approval for its coronavirus vaccine candidate in the U.K.) BioTelemetry Inc (NASDAQ: BEAT) Blueprint Medicines Corp (NASDAQ: BPMC) BridgeBio Pharma Inc (NASDAQ: BBIO) Cardiff Oncology Inc (NASDAQ: CRDF) Cellectis SA (NASDAQ: CLLS) Cerevel Therapeutics Holdings Inc (NASDAQ: CERE) Chimerix Inc (NASDAQ: CMRX) China Biologic Products Holdings Inc (NASDAQ: CBPO) Crispr Therapeutics AG (NASDAQ: CRSP) CureVac BV (NASDAQ: CVAC) (announced third-quarter results and plans to initiate Phase 2b/3 study of its coronavirus vaccine candidate) Eidos Therapeutics Inc (NASDAQ: EIDX) Fate Therapeutics Inc (NASDAQ: FATE) Foghorn Therapeutics Inc. (NASDAQ: FHTX) Generation Bio Co (NASDAQ: GBIO) Inhibrx Inc (NASDAQ: INBX) Inspire Medical Systems Inc (NYSE: INSP) Intellia Therapeutics Inc (NASDAQ: NTLA) Mersana Therapeutics Inc (NASDAQ: MRSN) (announced the appointment of a new chief medical officer) Moderna Inc (NASDAQ: MRNA) (announced positive efficacy and safety data from Phase 3 study of coronavirus vaccine candidate and filing for emergency use authorization) Myovant Sciences Ltd (NYSE: MYOV) NeoGenomics, Inc. (NASDAQ: NEO) Neuronetics Inc (NASDAQ: STIM) Nurix Therapeutics Inc (NASDAQ: NRIX) Ocular Therapeutix Inc (NASDAQ: OCUL) Oncorus Inc (NASDAQ: ONCR) Praxis Precision Medicines Inc (NASDAQ: PRAX) Pulmonx Corp (NASDAQ: LUNG) Spero Therapeutics Inc (NASDAQ: SPRO) Stoke Therapeutics Inc (NASDAQ: STOK) Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP) TRACON Pharmaceuticals Inc (NASDAQ: TCON) Trillium Therapeutics Inc (NASDAQ: TRIL) Trinity Biotech plc (NASDAQ: TRIB) Veracyte Inc (NASDAQ: VCYT) Zai Lab Ltd – ADR (NASDAQ: ZLAB)

None of the NYSE or Nasdaq-listed biopharma stocks and medical device manufacturers hit fresh 52-week highs Nov. 30.

Stocks In Focus

Amarin Accuses Hikma Of Infringing Vascepa Patents

Amarin Corporation plc (NASDAQ: AMRN) said it has filed a patent infringement lawsuit against Hikma Pharma and Hikma’s U.S. affiliate, alleging Hikma has infringed on certain patents related to its Vascepa by selling and importing icosapent ethyl capsules in or into the U.S.

The lawsuit was filed in the U.S. District Court in Delaware.

“The Amarin complaint details its position that Hikma has knowingly and willfully introduced its generic product in a manner that infringes Amarin’s patent rights and has exceeded the scope of permitted Hikma activity,” Amarin said.

Amarin shares were up 4.44{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} at $5.18 premarket Tuesday. 

Pfizer, BioNTech Files Marketing Authorization Application For Coronavirus Vaccine Candidate In Europe

Pfizer Inc. (NYSE: PFE) and its partner BioNTech announced the submission Monday of a formal application for Conditional Marketing Authorization to the European Medicines Agency for BNT162b2, the companies’ investigational vaccine against SARS-CoV-2.

The companies said the submission completes the rolling review process initiated on Oct. 6.

In premarket trading Tuesday, Pfizer shares were rising 2.27{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} to $39.18 and BioNTech shares were down 0.88{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} at $123.15. 

MacroGenics Strikes Commercialization Partnership For Cancer Drug Ahead of Approval

MacroGenics Inc (NASDAQ: MGNX) said it has partnered with Eversana, a commercial services company to the global life sciences industry, to commercialize margetuximab in the U.S. if it is approved.

Maegetuximab has a PDUFA action date of Dec. 16, by which time the FDA will decide whether to approve the monoclonal antibody for the treatment of breast cancer.

Under the agreement, Eversana stands to receive a co-exclusive right to conduct approved commercialization activities for which it will be compensated with the right to earn future revenue share payments that are capped at 125{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} of Eversana’s cumulative service fees, MacroGenics said.

Entera Bio Appoints Biopharma Industry Veteran As CEO

Entera Bio Ltd (NASDAQ: ENTX) said its board has appointed Spiros Jamas to the role of CEO and as a member of the board effective Jan. 4, 2021. Jamas will succeed Dr. Roger Garceau, who has been serving as interim CEO since August. 

“Spiros Jamas is a biotech entrepreneur with over 30 years of senior management experience in the biopharmaceutical industry,” Entera Bio said.

The stock was up 1.62{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} to $1.25 in after-hours trading.

Related Link: The Week Ahead In Biotech: Hematology Conference Gets Underway, Vanda And BioCryst Await FDA Decisions

NuCana’s Chemo Combo Found More Effective Than Standard-Of-Care In Early Stage Study

NuCana PLC (NASDAQ: NCNA) announced publication in the online edition of The Oncologist final results of the Phase 1b study of Acelarin plus cisplatin for patients with advanced biliary tract cancer, confirming a high objective response rate and favorable safety profile.

The ORR for the Acelarin plus cisplatin was 44{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} compared to the 26{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} ORR for Eli Lilly And Co’s (NYSE: LLY) gemcitabine plus cisplatin.

“We are very encouraged by the final efficacy and safety data from ABC-08”, said Hugh Griffith, NuCana’s CEO.

“We are committed to developing Acelarin plus cisplatin as the first approved front-line treatment for patients with advanced biliary tract cancer.”

The stock gained 12.06{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} to $5.11 in after-hours trading.

Galapagos Reports Positive Proof-Of-Concept Topline Data For Idiopathic Pulmonary Fibrosis Drug

Galapagos ADR Representing Ord Shs (NASDAQ: GLPG) announced positive topline results for its investigational GPR84 antagonist GLPG1205 in a proof-of-concept Phase 2 trial in idiopathic pulmonary fibrosis patients.

The company said it plans to advance the investigational asset into a dose-finding Phase 2b study.

Boston Scientific To Divest BTG Specialty Pharma Business For $800M In Cash

Boston Scientific Corporation (NYSE: BSX) said it has entered into a definitive agreement with SERB, a European specialty pharmaceutical group, to sell its BTG Specialty Pharmaceuticals business for $800 million in cash.

SERB, backed by private equity firm Charterhouse Capital Partners, owns a diversified portfolio of prescription medicines focused on rare and life-threatening diseases, Boston Scientific said.

The transaction is expected to close in the first half of 2021, subject to customary regulatory approvals and other closing conditions.

Offerings

Intellia Therapeutics Inc (NASDAQ: NTLA) said it has commenced an underwritten public offering of $150 million of shares of its common stock. All of the shares in the proposed offering are to be sold by Intellia.

The stock slid 3.23{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} at $38 premarket Tuesday. 

Cogent Biosciences Inc (NASDAQ: COGT) said it has commenced an underwritten public offering of $60 million in shares of its common stock. All the shares are being sold by the company.

The stock was down 13.35{ceedb287d77e8cde5bf2878339831566d6a2b6f7559fed38ec8bb489262cb257} premarket at $8.50.

On The Radar

PDUFA Dates

The FDA will decide on Vanda Pharmaceuticals Inc.’s (NASDAQ: VNDA) sNDA for Hetlioz capsules and its NDA for the liquid formulation of Hetlioz for the treatment of adults and children, respectively, with Smith-Magenis Syndrome.

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

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