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 Nov. 30)
- Amicus Therapeutics, Inc. FOLD
- Arcturus Therapeutics Holdings Inc ARCT
- argenx SE – ADR ARGX
- Beam Therapeutics Inc BEAM
- Bioanalytical Systems, Inc. BASI
- BioLife Solutions Inc BLFS
- BioNTech SE – ADR BNTX (reacted to reports of imminent approval for its coronavirus vaccine candidate in the U.K.)
- BioTelemetry Inc BEAT
- Blueprint Medicines Corp BPMC
- BridgeBio Pharma Inc BBIO
- Cardiff Oncology Inc CRDF
- Cellectis SA CLLS
- Cerevel Therapeutics Holdings Inc CERE
- Chimerix Inc CMRX
- China Biologic Products Holdings Inc CBPO
- Crispr Therapeutics AG CRSP
- CureVac BV CVAC (announced third-quarter results and plans to initiate Phase 2b/3 study of its coronavirus vaccine candidate)
- Eidos Therapeutics Inc EIDX
- Fate Therapeutics Inc FATE
- Foghorn Therapeutics Inc. FHTX
- Generation Bio Co GBIO
- Inhibrx Inc INBX
- Inspire Medical Systems Inc INSP
- Intellia Therapeutics Inc NTLA
- Mersana Therapeutics Inc MRSN (announced the appointment of a new chief medical officer)
- Moderna Inc MRNA (announced positive efficacy and safety data from Phase 3 study of coronavirus vaccine candidate and filing for emergency use authorization)
- Myovant Sciences Ltd MYOV
- NeoGenomics, Inc. NEO
- Neuronetics Inc STIM
- Nurix Therapeutics Inc NRIX
- Ocular Therapeutix Inc OCUL
- Oncorus Inc ONCR
- Praxis Precision Medicines Inc PRAX
- Pulmonx Corp LUNG
- Spero Therapeutics Inc SPRO
- Stoke Therapeutics Inc STOK
- Titan Pharmaceuticals, Inc. common stock TTNP
- TRACON Pharmaceuticals Inc TCON
- Trillium Therapeutics Inc TRIL
- Trinity Biotech plc TRIB
- Veracyte Inc VCYT
- Zai Lab Ltd – ADR 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 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% at $5.18 premarket Tuesday.
Pfizer, BioNTech Files Marketing Authorization Application For Coronavirus Vaccine Candidate In Europe
Pfizer Inc. 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% to $39.18 and BioNTech shares were down 0.88% at $123.15.
MacroGenics Strikes Commercialization Partnership For Cancer Drug Ahead of Approval
MacroGenics Inc 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% of Eversana's cumulative service fees, MacroGenics said.
Entera Bio Appoints Biopharma Industry Veteran As CEO
Entera Bio Ltd 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% 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 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% compared to the 26% ORR for Eli Lilly And Co's 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% 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 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 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 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% at $38 premarket Tuesday.
Cogent Biosciences Inc 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% premarket at $8.50.
On The Radar
PDUFA Dates
The FDA will decide on Vanda Pharmaceuticals Inc.'s 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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