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 Dec. 14)
- Acceleron Pharma Inc XLRN (announced orphan drug designation for sotatercept in pulmonary arterial hypertension)
- Adaptive Biotechnologies Corp ADPT
- Affimed NV AFMD
- Alexion Pharmaceuticals, Inc. ALXN - announced a deal to be bought by AstraZeneca plc AZN for $39 billion
- Agios Pharmaceuticals Inc AGIO
- Alkermes Plc ALKS
- Amicus Therapeutics, Inc. FOLD
- Apellis Pharmaceuticals Inc APLS
- argenx SE – ADR ARGX
- Arrowhead Pharmaceuticals Inc ARWR
- Arvinas Inc ARVN (announced positive results for early stage breast cancer studies)
- Ascendis Pharma A/S ASND
- Athira Pharma Inc ATHA
- Beam Therapeutics Inc BEAM
- Bioanalytical Systems, Inc. BASI
- BioCardia Inc BCDA
- BioCryst Pharmaceuticals, Inc. BCRX
- BioLife Solutions Inc BLFS
- BioLineRx ADR Representing 15 Ord Shs BLRX
- Blueprint Medicines Corp BPMC
- BridgeBio Pharma Inc BBIO
- CareDx Inc CDNA
- Castle Biosciences Inc CSTL
- Cellectis SA CLLS
- Cerevel Therapeutics Holdings Inc CERE
- Corcept Therapeutics Incorporated CORT
- Curis, Inc. CRIS
- Denali Therapeutics Inc DNLI
- Editas Medicine Inc EDIT
- Eidos Therapeutics Inc EIDX -reacted to reports of a rival bid from GlaxoSmithKline plc GSK
- Evelo Biosciences Inc EVLO
- Fate Therapeutics Inc FATE
- Foghorn Therapeutics Inc. FHTX
- Frequency Therapeutics Inc FREQ
- Globus Medical Inc GMED
- ImmunoGen, Inc. IMGN
- Inhibrx Inc INBX
- Insmed Incorporated INSM
- Intellia Therapeutics Inc NTLA
- InVitae Corp NVTA
- Iovance Biotherapeutics Inc IOVA (announced the appointment of Jean-Marc Bellemin as CFO)
- Kymera Therapeutics Inc KYMR
- MannKind Corporation MNKD
- Mirati Therapeutics Inc MRTX
- Natera Inc NTRA
- NeoGenomics, Inc. NEO
- Neuronetics Inc STIM
- NGM Biopharmaceuticals Inc NGM
- Novocure Ltd NVCR
- Ocular Therapeutix Inc OCUL
- Otonomy Inc OTIC
- Pacific Biosciences of California Inc PACB
- PRA Health Sciences Inc PRAH
- Praxis Precision Medicines Inc PRAX
- Precigen Inc PGEN
- Prelude Therapeutics Inc PRLD
- Provention Bio Inc PRVB
- PTC Therapeutics, Inc. PTCT
- Pulse Biosciences Inc PLSE
- Sarepta Therapeutics Inc SRPT (announced management changes)
- Spero Therapeutics Inc SPRO
- Stoke Therapeutics Inc STOK
- Surface Oncology Inc SURF
- Tarsus Pharmaceuticals Inc TARS
- Tcr2 Therapeutics Inc TCRR (reacted to data from Phase 1/2 study of TC-210 in mesothelin-expressing solid tumors)
- TG Therapeutics Inc common stock TGTX
- Travere Therapeutics Inc TVTX
- Turning Point Therapeutics Inc TPTX
- Ultragenyx Pharmaceutical Inc RARE
- United Therapeutics Corporation UTHR
- Veru Inc VERU (announced positive midstage breast cancer study)
- Xencor Inc XNCR
- XOMA Corp XOMA
- ‘X T L Biopharmaceuticals Ltd XTLB
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Dec. 14)
- Avita Therapeutics Inc RCEL
- InMed Pharmaceuticals Inc INM
- Nanobiotix S.A. NBTX
Stocks In Focus
Mediwound Announces Distribution Agreement For Severe Burn Treatment In UAE
Mediwound Ltd MDWD announced the signing of a distribution agreement with UAE's Ghassan Aboud Group, giving the latter an exclusive right to market and distribute NexoBrid in UAE for the treatment of severe burns.
Commercialization of NexoBrid in the UAE will commence upon securing regulatory approval, which is expected within a year, the company said.
The stock was up 7.69% at $3.92 premarket Tuesday.
Kezar Life Sciences, Legend Biotech, MediciNova to Join Nasdaq Biotech Index
Kezar Life Sciences Inc KZR, Legend Biotech Corp LEGN and MediciNova, Inc. MNOV announced separately that their shares will be added to the Nasdaq Biotech Index prior to the open of the market on Dec. 21.
Kezar shares were up 13.92% premarket at $6.30, while Legend Biotech rose 2.47% to $30.74.
Ziopharm Announces Departure of CFO
ZIOPHARM Oncology Inc. ZIOP announced that CFO Satyavrat Shukla will step down from the role effective Dec. 31 to pursue another opportunity. The company said it has initiated a search for a new CFO
In after-hours trading, the stock declined 0.97% to $3.06.
Related Link: The Week Ahead In Biotech: 2 IPOs Plus FDA Decisions On Moderna's COVID Vaccine And Drugs From Amgen, MacroGenics
Opiant Gets Additional BARDA Funding For Development of Opioid Overdose Drug
Opiant Pharmaceuticals Inc OPNT said the BARDA has announced an additional commitment of up to $3.5 million to advance the clinical development of OPNT003, nasal nalmefene, for opioid overdose. The contract modification increases the total potential value of the BARDA contract to $8.1 million, Opiant said.
The company said it remains on track to file an NDA for the investigational asset by the end of 2021.
The stock jumped 22.26% to $10.16 premarket.
Mesoblast Reports Mixed Results For Late-Stage Study Of Stem Cell Therapy In Advanced Chronic Heart Failure
Mesoblast limited MESO announced mixed top-line results from the DREAM-HF Phase 3 study of its allogeneic cell therapy rexlemestrocel-L in 537 patients with advanced chronic heart failure.
Over a mean 30 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial treatment with rexlemestrocel-L on top of maximal therapies had 60% reduction in incidence of heart attacks or strokes and 60% reduction in death from cardiac causes when treated at an earlier stage in the progressive disease process, the company said.
Yet there was no reduction in recurrent non-fatal decompensated heart failure events, which was the trial's primary endpoint, the company said.
The stock was down 14.15% premarket at $14.50.
Neovasc Found In Violation of Nasdaq Listing Standards
Neovasc Inc NVCN said it has received written notification from the Nasdaq that the company is not in compliance with the minimum bid price requirement set forth in Nasdaq Rules for continued listing on the Nasdaq. The company has been given until June 14, 2021 to regain compliance.
Burning Rock In-Licenses OncoCyte's Lung Cancer Test In China
Burning Rock Biotech Ltd BNR announced a licensing agreement with OncoCyte Corp OCX to bring the latter's DetermaRx, a risk stratification test for early stage lung cancer patients, to China.
In premarket trading Tuesday, Burning Rock shares were slipping 0.41% to $24.55, while OncoCyte was advancing 19.34% to $2.53.
Offerings
Ocular Therapeutix Inc OCUL said it has commenced an underwritten public offering of $75 million of its common stock. All of the shares in the offering are to be sold by the company.
The stock was down 3.67% at $21.50 premarket Tuesday.
Mirum Pharmaceuticals Inc MIRM priced its previously announced underwritten public offering of 3.75 million shares of its common stock at $20 per share for raising gross proceeds of $75 million.
The stock fell 15.75% to $20.22 in premarket trading.
Castle Biosciences Inc CSTL said it has commenced a proposed underwritten public offering of $125 million of its common stock.
In after-hours trading, the stock moved down 1.08% to $61.25.
Cellectis announced the launch, subject to market conditions, of an underwritten public offering of $100 million of its ADSs, each representing one ordinary share of Cellectis.
The stock was down 8.81% premarket at $28.46.
BioCardia said it has entered into definitive agreements with investors for the sale of 1.89 million shares of its common stock at a purchase price of $4.75 per share in a registered direct offering priced at-the-market. The offering is expected to close Dec. 16.
In premarket trading Tuesday, BioCardia shares were retreating 4.46% to $4.28.
On The Radar
Adcom Review
FDA's Cardiovascular and Renal Drugs Advisory Committee is scheduled to discuss Novartis AG's NVS supplemental new drug application for Entresto (sacubitril and valsartan) tablets, for the proposed indication of heart failure with preserved ejection fraction.
Clinical Readouts
Gossamer Bio Inc GOSS will release initial results from the ongoing two-week Phase 1b clinical trial of GB002, its inhaled PDGFR inhibitor, for the treatment of pulmonary arterial hypertension. The release is scheduled for 11 a.m.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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