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 June 23)
- ACADIA Pharmaceuticals Inc. ACAD
- Acceleron Pharma Inc XLRN
- ADC Therapeutics SA ADCT
- Adverum Biotechnologies Inc ADVM
- Aeglea Bio Therapeutics Inc AGLE
- Alnylam Pharmaceuticals, Inc. ALNY
- Amicus Therapeutics, Inc. FOLD
- Ascendis Pharma A/S ASND
- Avidity Biosciences Inc RNA (went public June 12)
- BioXcel Therapeutics Inc BTAI
- Burning Rock Biotech Ltd BNR (went public June 12)
- Corcept Therapeutics Incorporated CORT
- Crispr Therapeutics AG CRSP (moved on analyst action)
- Dr.Reddy's Laboratories Ltd RDY
- Dyadic International, Inc. DYAI
- Editas Medicine Inc EDIT
- GENMAB A/S/S ADR GMAB
- Halozyme Therapeutics, Inc. HALO )
- Hologic, Inc. HOLX
- Horizon Therapeutics PLC HZNP
- Immunomedics, Inc. IMMU
- Immunovant Inc IMVT
- Incyte Corporation INCY
- Innoviva Inc INVA
- Inovio Pharmaceuticals Inc INO (announced DoD funding for coronavirus vaccine delivery device)
- Inspire Medical Systems Inc INSP
- Intellia Therapeutics Inc NTLA
- ITAMAR MED LTD/S ADR ITMR
- Keros Therapeutics Inc KROS
- KITOV PHARMA LT/S ADR KTOV (announced a $35-million registered direct offering)
- Legend Biotech Corp LEGN (went public June 5)
- Liquidia Technologies Inc LQDA
- MacroGenics Inc MGNX
- MannKind Corporation MNKD
- MEI Pharma Inc MEIP
- Meridian Bioscience, Inc. VIVO
- Mersana Therapeutics Inc MRSN
- Momenta Pharmaceuticals, Inc. MNTA
- Myovant Sciences Ltd MYOV (announced positive results for a combo treatment involving its relugolix in endometriosis-related pain)
- Neoleukin Therapeutics Inc NLTX
- Neurocrine Biosciences, Inc. NBIX
- Novavax, Inc. NVAX
- Novo Nordisk A/S NVO
- Passage Bio Inc PASG
- Pliant Therapeutics Inc PLRX
- ResMed Inc. RMD
- Sanofi SA SNY - announced an accelerated timeline for its co-developed COVID-19 vaccine and an expanded partnership with Translate Bio Inc TBIO for RNA vaccine research
- Sarepta Therapeutics Inc SRPT
- Satsuma Pharmaceuticals Inc STSA
- Seattle Genetics, Inc. SGEN
- Spero Therapeutics Inc SPRO
- Translate Bio (moved on expanded pact with Sanofi)
- Trevena Inc TRVN
- Twist Bioscience Corp TWST
- Ultragenyx Pharmaceutical Inc RARE
- Vertex Pharmaceuticals Incorporated VRTX
- Y-mAbs Therapeutics, Inc YMAB
- Zai Lab Ltd ZLAB
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows June 23)
- Evofem Biosciences Inc EVFM
- Genetron Holdings Ltd – ADR GTH (went public Friday)
- Lyra Therapeutics Inc LYRA
Stocks In Focus
MediciNova Announces Receipt of Intent To Grant European Patent For Lipid-Lowering Drug
MediciNova, Inc. MNOV said it has received a notice of intention to grant from the European Patent Office for a pending patent application that covers MN-001 and MN-002 for the treatment of hypertriglyceridemia, hypercholesterolemia and hyperlipoproteinemia.
The patent pertains to a method of reducing a triglyceride blood level, a method of reducing total cholesterol blood level and a method of reducing a low-density lipoprotein blood level using MN-001 or MN-002
The patent is expected to expire no earlier than 2034 from the date of issuance.
"As we already have granted patents for similar indications in the U.S., Japan, and China, we believe this additional patent in Europe could substantially increase the potential value of MN-001," MediciNova CEO Yuichi Iwaki said in a statement.
The stock added 14.68% to $6.25 in after-hours trading.
GW Pharma's Epidyolex Moves To Low Level Of Control In UK
GW Pharmaceuticals PLC- ADR GWPH said the the U.K. Home Office has reclassified Epidyolex as a Schedule 5 drug, with the change taking effect immediately in all four constituent nations of the U.K.
"The decision to move EPIDYOLEX to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole – reducing costs and ensuring the medicine can be dispensed more easily," Chris Tovey, GW Pharma's chief operating officer, said in a statement.
See also: The Week Ahead In Biotech: Karyopharm, Zogenix, Heron, Chiasma On The Radar Ahead Of FDA Decisions
Tela Bio Expects Revenue Decline In June Quarter, Plans Offering
TELA Bio Inc TELA said in a 8-K filing with the SEC that it expects revenue of between $2.1 million and $2.3 million for the quarter ended June 15, reflecting the adverse impact of decreased procedure volumes as a result of the deferral of elective procedures and corresponding reduced sales of units of OviTex products in the wake of the COVID-19 pandemic.
The company expects a net loss of $5.5 million to $5.7 million.
Analysts on average estimate a loss of 59 cents per share on revenue of $1.86 million.
Separately, the company said it has commenced a proposed underwritten public offering of 3 million shares of its common stock. All the shares are being offered by the company.
In after-hours trading, the stock fell 6.06% to $20.
Regeneron Loses Antibody Patent Case Against Kymab
U.K.-based biopharma Kymab said the Supreme Court of the U.K. has held that all of the claims of two patents owned by Regeneron Pharmaceuticals Inc REGN that were asserted against Kymab are invalid.
The patents in question cover genetically modified mice containing chimeric human-mouse antibody genes and the human antibodies made using such mice.
The Court's decision upholds a February 2016 decision of the High Court to revoke the claims and reverses the Appeal Court's determination that they were valid, Kymab said.
FDA Lifts Partial Clinical Hold On Innate Pharma's Blood Cancer Study
Innate Pharma SA IPHA said the FDA has lifted the partial clinical hold placed on the lacutamab TELLOMAK Phase 2 clinical trial.
The trial is to evaluate the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas.
The decision follows a quality assessment of a new Good Manufacturing Practice-certified batch that has been successfully manufactured for the lacutamab clinical development program.
In the wake of the decision, the company said it is taking the operational measures to re-activate U.S. clinical trial sites.
Imara's IMR-687 Receives Orphan Drug Designation For Beta-Thalassemia
Imara Inc IMRA said the FDA has granted Orphan Drug Designation for IMR-687 for the treatment of patients with beta-thalassemia. The agency had previously granted Orphan Drug Designation for IMR-687 for the treatment of patients with sickle cell disease.
Offerings
Editas said it has priced its underwritten offering of 6 million shares of its common stock at $31.25 per share for gross proceeds of about $187.5 million. The offering is expected to close on or about June 26.
The stock slipped 5.68% to $32.39 in after-hours trading.
Soleno Therapeutics Inc SLNO said it intends to offer and sell shares of its common stock in an underwritten public offering.
The stock was down 5.5% premarket Wednesday.
On The Radar
Clinical Readouts, Presentations
- Insmed Incorporated INSM is due to present at the American Thoracic Society 2020 Virtual: Clinical Trials Session, Phase 2 WILLOW study evaluating the efficacy, safety, and pharmacokinetics of INS1007 administered once daily in adults with non-cystic fibrosis bronchiectasis.
Related Link: Evoke Gets FDA Nod For Gimoti, A Nasally-Administered Gastroparesis Drug
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