The Daily Biotech Pulse: Mesoblast Releases Mixed Data, MediWound Jumps On Distribution Deal, Kezar Life Sciences Rallies On Index Inclusion, Opiant Gets BARA Funding

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.

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.

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