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 Sept. 29)
- Acceleron Pharma Inc. XLRN
- Eagle Pharmaceuticals, Inc. EGRX
- Innoviva, Inc. INVA
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Sept. 29)
- 4D pharma plc LBPS
- ADMA Biologics, Inc. ADMA
- Akoya Biosciences, Inc. NASDAQ
- Alzamend Neuro, Inc. ALZN
- Applied Genetic Technologies Corporation AGTC
- Aziyo Biologics, Inc. AZYO
- Aptose Biosciences Inc. APTO
- Athenex, Inc. ATNX
- Athersys, Inc. ATHX
- Avenue Therapeutics, Inc. ATXI
- Axcella Health Inc. AXLA
- Aytu Biopharma, Inc. AYTU
- BioVie Inc. BIVI
- Burning Rock Biotech Limited BNR
- Checkmate Pharmaceuticals, Inc. CMPI
- Chemomab Therapeutics Ltd. CMMB
- Clarus Therapeutics Holdings, Inc. CRXT
- Cue Health Inc. HLTH (IPOed Friday)
- Dermata Therapeutics, Inc. DRMA
- Design Therapeutics, Inc. DSGN
- Eiger BioPharmaceuticals, Inc. EIGR
- Eledon Pharmaceuticals, Inc. ELDN
- Emergent BioSolutions Inc. EBS
- First Wave BioPharma, Inc. FWBI
- Forte Biosciences, Inc. FBRX
- Galapagos NV GLPG
- Gamida Cell Ltd. GMDA
- GBS Inc. GBS
- Graybug Vision, Inc. GRAY
- Harpoon Therapeutics, Inc. HARP
- HOOKIPA Pharma Inc. HOOK
- IMARA Inc. IMRA
- Immuron Limited IMRN
- InMed Pharmaceuticals Inc. INM
- Inozyme Pharma, Inc. INZY
- Ionis Pharmaceuticals, Inc. IONS
- Jasper Therapeutics, Inc. JSPR
- Kiniksa Pharmaceuticals, Ltd. KNSA
- Kintara Therapeutics, Inc. KTRA (announced fiscal year 2021 results)
- MaxCyte, Inc. MXCT
- Nautilus Biotechnology, Inc. NAUT
- Orchard Therapeutics plc ORTX
- Passage Bio, Inc. PASG
- Pliant Therapeutics, Inc. PLRX
- Pluristem Therapeutics Inc. PSTI
- Poseida Therapeutics, Inc. PSTX
- RenovoRx, Inc. RNXT
- Silverback Therapeutics, Inc. SBTX
- Singular Genomics Systems, Inc. OMIC
- TCR2 Therapeutics Inc. TCRR
- Titan Pharmaceuticals, Inc. TTNP
- Tiziana Life Sciences PLC TLSA
- Voyager Therapeutics, Inc. VYGR
- XBiotech Inc. XBIT
- Zynex, Inc. ZYXI
Stocks In Focus
Merck Confirms Deal To Buy Acceleron For $11.5B
Merck & Co., Inc. MRK and Acceleron announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Acceleron for $180 per share in cash for an approximate total equity value of $11.5 billion.
The transaction is expected to close in the fourth quarter of 2021.
The deal has been the subject of speculatation since the start of the week.
Merck shares were edging up 0.43% at $75.41 and Acceleron, which has been running up since the speculation began doing the rounds, was up 1.89% at $178.67.
Regeneron Reports Positive Data For COVID-19 Antibody Cocktail In Hospitalized COVID-19 Patients
Regeneron Pharmaceuticals, Inc. RGEN announced that a trial assessing investigational REGEN-COV (casirivimab and imdevimab) in patients hospitalized with COVID-19 met its primary endpoint. The results showed that REGEN-COV significantly reduced viral load in patients hospitalized with COVID-19 who entered the trial without having mounted their own antibody response and required low-flow or no supplemental oxygen.
REGEN-COV is an investigational medicine authorized by the Food and Drug Administration under an emergency use authorization to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings. In the U.S., it is not currently authorized in patients who are hospitalized due to COVID-19 infection.
The company is co-developing REGN-COV with Roche Holding AG RHHBY.
Separately, Regeneron announced the New England Journal of Medicine published positive detailed results from a Phase 3 trial that assessed the ability of REGEN-COV to treat COVID-19 in infected high-risk non-hospitalized patients (outpatients). The trial met its primary and all secondary endpoints and showed treatment with REGEN-COV significantly reduced the risk of hospitalization or death, with a safety profile consistent with previously reported data.
In premarket trading, Regeneron shares were up 2.2% at $620.50.
MannKind Announces $102.25M Non-Dilutive Financing From Sale-Leaseback Deal
MannKind Corporation MNKD announced that it has entered into a sale-leaseback transaction with an affiliate of Creative Manufacturing Properties, which will generate $102.25 million in gross proceeds upon closing.
The real property sale includes 263,900 square feet of manufacturing space at 1 Casper Street in Danbury, but does not include MannKind's research and development facility. Upon closing of the agreement, MannKind will enter into a 20-year lease agreement with the purchaser, with multiple renewal options available.
The stock was up 1.79% at $4.56 in premarket trading.
Vir Biotech Announces Strong Orders For Co-Developed COVID-19 Antibody Treatment; CMO Buys Shares In Biopharma
Vir Biotechnology, Inc. VIR said in a filing with the SEC, to date, binding agreements have been received for the sale of more than 420,000 doses of sotrovimab worldwide, including a portion of those procured by the U.S. government. In addition, more than 220,000 doses have been reserved through other agreements.
Sotrovimab is an investigational monoclonal antibody treatment for COVID-19 developed in partnership with GlaxoSmithKline plc GSK.
In a separate filing, the company said its chief medical officer Phillip Pang purchased 5,000 shares of the company for 85.5 cents each.
The stock was adding 7.74% to $46.50 in premarket trading.
Centogene Announces Publication Of Findings On Structural Birth Defects Drawn From Its Rare Diseases Bio/Databank
Centogene N.V. CNTG announced publication in the New England Journal of Medicine results from a global genetic study, including findings of a potential treatment of structural birth defects caused by specific gene alterations.
The collaborative research study utilized data derived from the company's rare disease-centric Bio/Databank. The analysis revealed that genetic variations affecting a central Wnt regulator – WLS – causes syndromic structural birth defects.
The Wnt signalling pathway regulates cellular development, particularly at the embryonic stage. The researchers were able to administer a pharmacologic Wnt agonist that partially restored erroneous embryonic development in preclinical studies.
In premarket trading, the stock was up 3.87% at $11.01.
Lilly's Diabetes Drug Scores Over Novo Nordisk's In Reducing Liver Fat, Abdominal Adipose Tissue
Eli Lilly and Company LLY said its Tirzepatide led to greater improvements in liver fat content and abdominal adipose tissue compared to titrated insulin degludec in adults with type 2 diabetes in an MRI sub-study of its phase 3 SURPASS-3 clinical trial.
Insulin degludec is an ultralong-acting basal insulin analogue that was developed Novo Nordisk A/S NVO under the brand name Tresiba.
The results were presented today at the 57th European Association for the Study of Diabetes Annual Meeting in an EASD-sponsored symposium.
Takeda In-Licenses Huntington's Disease Treatment Candidate
Takeda Pharmaceutical Company Limited TAK and JCR Pharmaceuticals Co., Ltd. announced a geographically-focused exclusive collaboration and license agreement to commercialize JR-141, an investigational treatment of Hunter syndrome, aka, mucopolysaccharidosis type II.
Under the terms of the agreement, Takeda will exclusively commercialize JR-141 outside of the U.S., including Canada, Europe, and other regions. JCR will receive an upfront payment for such ex-U.S. license, and is eligible to receive additional development and commercial milestones as well as tiered royalties on potential sales.
Takeda receives an option under a separate option agreement, which allows Takeda to acquire an exclusive license to commercialize JR-141 in the U.S. upon completion of the Phase 3 program.
AIM ImmunoTech Strikes Clinical Trial Agreement For Midstage Study of Ampligen For Prophylactic Use Against Respiratory Viruses
AIM ImmunoTech Inc. AIM and hVIVO signed a clinical trial agreement for a Phase 2a human challenge trial to test the company's drug Ampligen as a potential intranasal prophylactic using a human rhinovirus and influenza A virus.
This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc. The AIM-sponsored study is expected to start in the fourth quarter.
Trevena Reports Positive Results For Proof-Of-Concept Study Of COVID-19 Treatment
Trevena, Inc. TRVN announced data from 30 patients enrolled in the proof-of-concept study of TRV027 IN hospitalized COVID-19, which showed that the investigational asset was well-tolerated and provided initial evidence of its potential to improve biomarker and clinical endpoints associated with COVID-19 disease severity and progression.
The stock was rising 4% to $1.27 in premarket trading.
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On The Radar
Altimmune, Inc. ALT will host a Key Opinion Leader call on its 12-week Phase 1 clinical trial of pemvidutide (formerly known as ALT-801) in overweight and obese subjects at 9 a.m.
European Association of Dermatology And Venereology 30th Anniversary Congress Presentations
RAPT Therapeutics, Inc. RAPT: clinical safety and efficacy data from the RPT193 Phase 1b monotherapy trial in patients with moderate-to-severe atopic dermatitis (9:15 a.m. to 9:30 a.m.)
Arcutis Biotherapeutics, Inc. ARQT: new data from the DERMIS-1 and DERMIS-2 Phase 3 pivotal trial of Roflumilast Cream 0.3% in plaque psoriasis
AbbVie Inc. ABBV: new long-term efficacy and safety data for risankizumab in adults with psoriatic arthritis treated up to 52 weeks and new analysis of data from the head-to-head trial evaluating safety and efficacy of Rinvoq (upadacitinib) versus dupilumab in specific body regions of patients with moderate to severe atopic dermatitis
11th Annual International Conference for Frailty & Sarcopenia Presentations
Biophytis SA BPTS: full results from the SARA-INT Phase 2 trial of Sarconeos in sarcopenia (9 a.m. to 9:30 a.m.)
International Symposium on Retinal Degeneration Presentations
Lineage Cell Therapeutics, Inc. LCTX: updated interim results from a Phase 1/2a study of lead product candidate OpRegen, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration
North American Cystic Fibrosis Conference Presentations
Calithera Biosciences, Inc. CALA: interim data from the Phase 1b study of CB-280 in cystic fibrosis
ID Week Presentations
AstraZeneca PLC AZN: data from the Phase 3 PROVENT study of efficacy and safety of AZD7442 (Tixagevimab/Cilgavimab) for pre-exposure prophylaxis of COVID-19 in adults (6:15 pm to 6:30 pm)
AngioDynamics, Inc. ANGO
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