The Daily Biotech Pulse: Alnylam's Oxluma Snags Early FDA Approval, DBV Chief Scientific Officer To Depart, Decision Day For Liquidia

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. 23)

AbbVie Inc ABBV
Affimed NV AFMD
ALX Oncology Holdings Inc ALXO
Apellis Pharmaceuticals Inc APLS
Atara Biotherapeutics Inc ATRA
Beam Therapeutics Inc BEAM
Cardiff Oncology Inc CRDF
CareDx Inc CDNA
Celldex Therapeutics, Inc. CLDX
Cerevel Therapeutics Holdings Inc CERE
Clearpoint Neuro Inc CLPT
Corcept Therapeutics Incorporated CORT
CTI BioPharma Corp CTIC
Eidos Therapeutics Inc EIDX
Fate Therapeutics Inc FATE
Frequency Therapeutics Inc FREQ
Galecto, Inc. GLTO (appointed health care veteran Jayson Dallas to its board)
Inspire Medical Systems Inc INSP
Keros Therapeutics Inc KROS
Kronos Bio Inc KRON
LeMaitre Vascular Inc LMAT
Marinus Pharmaceuticals Inc MRNS
Morphic Holding Inc MORF
NeoGenomics, Inc. NEO
Neuronetics Inc STIM
NGM Biopharmaceuticals Inc NGM
Nurix Therapeutics Inc NRIX
Ocular Therapeutix Inc OCUL
Olema Pharmaceuticals Inc OLMA (debuted on Wall Street Thursday)
Organogenesis Holdings Inc ORGO
Pacira Biosciences Inc PCRX
PLx Pharma Inc PLXP
PTC Therapeutics, Inc. PTCT
Shockwave Medical Inc SWAV
Sotera Health Co SHC (began trading on Nasdaq Friday following its IPO)
Spero Therapeutics Inc SPRO
Syndax Pharmaceuticals Inc SNDX
TRACON Pharmaceuticals Inc TCON (announced publication of data on its cancer treatment candidate TRC102)
Trinity Biotech plc TRIB
Twist Bioscience Corp TWST (reacted to fourth-quarter results)
Veracyte Inc VCYT

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Nov. 23)

HTG Molecular Diagnostics HTGM (began trading on a reverse split-adjusted basis)
Kiromic Biopharma Inc KRBP
Maravai Lifesciences Holdings Inc MRVI (debuted on Wall Street Friday)
Polarityte Inc PTE

Stocks In Focus

DBV Announces Departure Of Chief Scientific Officer

DBV Technologies ADR Representing 0.5 Ord Shs DBVT announced that Dr. Hugh Sampson is stepping down from his role as chief scientific officer effective Dec. 1 to return to his research program at the Jaffe Food Allergy Institute at Mount Sinai.

Sampson will take on a new role as scientific adviser to the CEO and chairman of DBV's Scientific Advisory Board, the company said.

The stock was down 10.99% at $2.43 in premarket trading Tuesday.

Novartis Details Sales, Pipeline, Margins At Investor Meeting

Novartis AG NVS said at its annual investor event that key growth drivers now contribute to 48% of innovative medicines sales. The company sees upcoming launches as fueling future sales expansion.

Novartis said it is committed to driving consistent margin expansion, with margins at Innovative Medicines expected to reach the high 30s in the mid-term.

The company also said its pipeline, including 116 assets in Phase 1 or 2 studies; 49 in Phase 3 studies or undergoing registration; and more than 65 new molecular entities will fuel growth in the mid-to long-term, with about 90% potential first-in-class/first-in-indication medicines and about 80% of targets in areas of high unmet patient need.

The company also said it has initiated a stock buyback of up to $2.5 billion.

The stock was up 0.27% to $87.55 in premarket trading Tuesday.

ObsEva Submits App For Menstrual Bleeding Drug In Europe

Obseva SA OBSV said it has submitted to the European Medicines Agency a Marketing Authorization for linzagolix 100mg and linzagolix 200mg, to be used for the management of heavy menstrual bleeding associated with uterine fibroids.

The company said it expects to submit an NDA to the FDA in the first half of 2021.

In premarket trading Tuesday, ObsEva shares were rallying 6.8% to $2.04.

MediciNova Starts Intranasal COVID-19 Vaccine Manufacturing

MediciNova, Inc. MNOV said Master Virus Seed Stock production of its novel intranasal SARS-CoV-2 vaccine for COVID-19 has been initiated at Millipore Sigma BioReliance Services, a group company of Germany's Merck KGaA MKGAF, using BC-PIV technology.

"By infecting MVSS to the packaging cells, BC-PIV/S is produced, which is then recovered and purified to produce the BC-PIV SARS-CoV-2 vaccine for clinical studies," the company said.

FDA OKs Alnylan's Oxluma For Primary Hyperoxaluria Type 1

The FDA approved Alnylam Pharmaceuticals, Inc.'s ALNY Oxlumo as the first treatment for primary hyperoxaluria type 1, a rare genetic disorder.

The NDA had a PDUFA action date of Dec. 3.

PH1 is the most common and severe type of primary hyperoxalurias, a disorder caused by the excess production of oxalate, and affects an estimated one to three individuals per million in North America and Europe. It accounts for approximately 80% of PH cases.

Last week, the company said the European drug regulator approved Oxluma for the same indication.

Neuronetics Gets FDA Clearance For TouchStar Treatment

Neuronetics said the FDA granted clearance for its TouchStar treatment, a 3-minute intermittent theta burst protocol with its NeuroStar Advanced Therapy System, administered with patented Contact Sensing technology.

The stock gained 4.29% to $8.27 premarket.

Bristol-Myers Squibb's Opdivo Approved For Gastroesophageal Cancer

Bristol-Myers Squibb Co BMY said the European Commission has approved Opdivo for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.

The stock was moving up 0.78% to $62.40 in premarket trading.

KemPharm Issues Pipeline Update

Providing an update to its prodrug development pipeline, KemPharm Inc KMPH said it expects to file an investigational new drug application for KP879, an agonist replacement therapy for the treatment of stimulant use disorder, before the end of 2020. The company also introduced a new prodrug candidate, KP1077, as a potential treatment for idiopathic hypersomnia.

Earnings

Enanta Pharmaceuticals Inc's ENTA third-quarter revenue fell from $51.31 million to $23.63 million year-over-year. The company reversed from a profit of 44 cents per share to a loss of $1.46 per share. Analysts had estimated a narrower loss of 95 cents per share.

The stock fell 4.85% to $41.55 in after-hours trading.

Arrowhead Pharmaceuticals Inc ARWR unexpectedly reversed to a loss in its fourth quarter.

In after-hours trading, the stock was down 3.24% to $65.99.

Offerings

Advaxis, Inc. ADXS said it intends to offer shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering.

In after-hours trading, the stock fell 18.64% to 32 cents.

On The Radar

PDUFA Dates

Liquidia Technologies Inc LQDA awaits an FDA decision on its NDA for LIQ861, an investigational, inhaled dry powder formulation of Treprostinil for the treatment of pulmonary arterial hypertension.