The Daily Biotech Pulse: Lilly Reorganizes Business Units In Neuroscience Focus, Helius Medical Spikes On Breakthrough Designation, Ra Medical Sells Dermatology Business

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 Aug. 16)

• Bio-Rad Laboratories, Inc. BIO
• Crinetics Pharmaceuticals, Inc. CRNX
• Gilead Sciences, Inc. GILD
• GlaxoSmithKline plc GSK
• Johnson & Johnson JNJ
• Laboratory Corporation of America Holdings LH
• Monte Rosa Therapeutics, Inc. GLUE
• NanoVibronix, Inc. NAOV (announced intention to enter over-the-counter pain relief market with its PainShield Relief)
• Novo Nordisk A/S NVO
• Pfizer, Inc. PFE (submitted initial data for authorization for COVID-19 booster shot and FDA approval for its vaccine for tick-borne encephalitis)
• Quest Diagnostics Incorporated DGX
• ResMed Inc. RMD (launched AirSense 11, a device designed to treat sleep apnea)
• West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 16)

• 23andMe Holding Co. ME
• 4D pharma plc LBPS
• Absci Corporation ABSI
• ABVC BioPharma, Inc. ABVC
• ACADIA Pharmaceuticals Inc. ACAD
• Accelerate Diagnostics, Inc. AXDX
• Achieve Life Sciences, Inc. ACHV
• Acurx Pharmaceuticals, Inc. ACXP
• Adaptive Biotechnologies Corporation ADPT
• Adverum Biotechnologies, Inc. ADVM
• Agile Therapeutics, Inc. AGRX
• Akoya Biosciences, Inc. AKYA
• Angion Biomedica Corp. ANGN
• Applied Genetic Technologies Corporation AGTC
• Aptinyx Inc. APTX
• Aptose Biosciences Inc. APTO
• Aravive, Inc. ARAV
• Ardelyx, Inc. ARDX
• Arena Pharmaceuticals, Inc. ARNA
• Aridis Pharmaceuticals, Inc. ARDS
• Assertio Holdings, Inc. ASRT
• Atai Life Sciences N.V. ATAI
• Athenex, Inc. ATNX
• Athira Pharma, Inc. ATHA
• Avenue Therapeutics, Inc. ATXI
• AVITA Medical, Inc. RCEL
• AVROBIO, Inc. AVRO
• Axsome Therapeutics, Inc. AXSM
• Aytu Biopharma, Inc. AYTU
• Baudax Bio, Inc. BXRX
• Bellerophon Therapeutics, Inc. BLPH
• Biodesix, Inc. BDSX
• Biomea Fusion, Inc. BMEA
• BiondVax Pharmaceuticals Ltd. BVXV
• Caladrius Biosciences, Inc. CLBS
• Cellectis S.A. CLLS
• Celularity Inc. CELU
• Checkmate Pharmaceuticals, Inc. CMPI
• Chemomab Therapeutics Ltd. CMMB
• CNS Pharmaceuticals, Inc. CNSP
• ContraFect Corporation CFRX
• Corvus Pharmaceuticals, Inc. CRVS
• Deciphera Pharmaceuticals, Inc. DCPH
• Dermata Therapeutics, Inc. DRMA
• Diffusion Pharmaceuticals Inc. DFFN
• DURECT Corporation DRRX
• Edgewise Therapeutics, Inc. EWTX
• Eloxx Pharmaceuticals, Inc. ELOX
• Ensysce Biosciences, Inc. ENSC
• Enveric Biosciences, Inc. ENVB
• Epizyme, Inc. EPZM
• Eton Pharmaceuticals, Inc. ETON
• Evofem Biosciences, Inc. EVFM
• EyeGate Pharmaceuticals, Inc. EYEG
• FibroGen, Inc. FGEN
• Flexion Therapeutics, Inc. FLXN
• Freeline Therapeutics Holdings plc FRLN
• Gain Therapeutics, Inc. GANX
• Galecto, Inc. GLTO
• Gemini Therapeutics, Inc. GMTX
• Genocea Biosciences, Inc. GNCA
• Genprex, Inc. GNPX
• GlycoMimetics, Inc. GLYC
• Harpoon Therapeutics, Inc. HARP
• Heron Therapeutics, Inc. HRTX
• HOOKIPA Pharma Inc. HOOK (
• Hoth Therapeutics, Inc. HOTH
• IMARA Inc. IMRA
• Immunocore Holdings plc IMCR
• IN8bio, Inc. INAB
• Indaptus Therapeutics, Inc. INDP
• InflaRx N.V. IFRX
• Inhibikase Therapeutics, Inc. IKT
• Insmed Incorporated INSM
• Invitae Corporation NVTA
• Itamar Medical Ltd. ITMR
• Karyopharm Therapeutics Inc. KPTI
• Keros Therapeutics, Inc. KROS
• Kiniksa Pharmaceuticals, Ltd. KNSA
• Kinnate Biopharma Inc. KNTE
• Kura Oncology, Inc. KURA
• Liminal BioSciences Inc. LMNL
• Lixte Biotechnology Holdings, Inc. LIXT
• Longeveron Inc. LGVN
• Madrigal Pharmaceuticals, Inc. MDGL
• Medicenna Therapeutics Corp. MDNA
• MediciNova, Inc. MNOV
• Moleculin Biotech, Inc. MBRX
• MorphoSys AG MOR
• Nabriva Therapeutics plc NBRV
• Nektar Therapeutics NKTR
• Nevro Corp. NVRO
• Ocean Bio-Chem, Inc. OBCI
• Oncorus, Inc. ONCR
• Orchard Therapeutics plc ORTX
• Otonomy, Inc. OTIC
• Palisade Bio, Inc. PALI
• Panbela Therapeutics, Inc. PBLA
• Passage Bio, Inc. PASG
• Phathom Pharmaceuticals, Inc. PHAT
• Phio Pharmaceuticals Corp. PHIO
• Praxis Precision Medicines, Inc. PRAX
• Protara Therapeutics, Inc. TARA
• Pulmatrix, Inc. PULM
• Rhythm Pharmaceuticals, Inc. RYTM
• Rockwell Medical, Inc. RMTI
• Scopus BioPharma Inc. SCPS
• Seres Therapeutics, Inc. MCRB
• Singular Genomics Systems, Inc. OMIC
• Soleno Therapeutics, Inc. SLNO
• Sonnet BioTherapeutics Holdings, Inc. SONN
• Spruce Biosciences, Inc. SPRB
• Stoke Therapeutics, Inc. STOK
• Strongbridge Biopharma plc SBBP
• Syros Pharmaceuticals, Inc. SYRS
• T2 Biosystems, Inc. TTOO
• Taysha Gene Therapies, Inc. TSHA
• Teligent, Inc. TLGT
• TherapeuticsMD, Inc. TXMD
• Titan Pharmaceuticals, Inc. TTNP
• Tiziana Life Sciences PLC TLSA
• TransCode Therapeutics, Inc. RNAZ
• Treace Medical Concepts, Inc. TMCI
• VectivBio Holding AG VECT
• Viveve Medical, Inc. VIVE
• VYNE Therapeutics Inc. VYNE
• ZIOPHARM Oncology, Inc. ZIOP
• ZIVO Bioscience, Inc. ZIVO

Stocks In Focus

Lilly's Bio-Medicines To Splinter Into Neuroscience, Immunology Business Units

Eli Lilly and Company LLY announced executive leadership changes and the creation of neuroscience and immunology business units to increase its focus on introducing breakthrough new medicines to millions of people with unmet needs.

Effective Sept. 5, Lilly Bio-Medicines will split into two business units, namely Lilly Neuroscience and Lilly Immunology. Anne White, currently SVP and president of Lilly Oncology, will lead Lilly Neuroscience as SVP and president. White will be responsible for Lilly's launched products and a Phase 3 portfolio in pain and neurodegeneration, including the potential launch of donanemab for the treatment of Alzheimer's disease.

Jacob Van Naarden, currently CEO of Loxo Oncology at Lilly, has been promoted to SVP and CEO of Loxo Oncology at Lilly and presiden of, Lilly Oncology and will be unifying these organizations. Patrik Jonsson will lead Lilly's launched products and Phase 3 portfolio of medicines in dermatology, gastroenterology and rheumatology as president of Lilly Immunology.

The shares were up 0.8% at $272.09 in premarket trading.

Corvus' Chinese Partner To Initiate Clinical Trial Of Lymphoma Treatment

Corvus Pharmaceuticals, Inc. CRVS announced that an investigational new drug application submitted by its partner in China, Angel Pharma for the initiation of a Phase 1/1b clinical trial of Corvus' CPI-818 for the treatment of relapsed/refractory T cell lymphomas has been accepted by the Center for Drug Evaluation of the China National Medical Products Administration.

Angel Pharma plans to initiate the trial before the end of 2021 and will be responsible for all expenses related to executing the trial in China.

Corvus shares were up 5.83% at $2 in premarket trading.

Incyte Out-Licenses Greater China Rights To Cancer Drug For Up To $117.5M

Incyte Corporation INCY announced a collaboration and license agreement with InnoCare for the development and commercialization of tafasitamab, a monoclonal antibody, in Greater China.

Under the terms of the agreement, InnoCare will pay Incyte $35 million upfront,and Incyte is eligible to receive up to an additional $82.5 million in potential development, regulatory and commercial milestones, as well as tiered royalties.

In turn, InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.

Pfizer Prices $1B Worth In Notes Issued To Fund COVID-19 Vaccine Program

Pfizer, Inc. PFE announced the pricing of a sustainability bond of $1 billion in aggregate principal amount of 1.75% senior notes due 2031.

The closing of the offering is expected to occur on Aug. 18. Pfizer intends to use the net proceeds to finance or refinance, in whole or in part, R&D expenses related to COVID-19 vaccine, capital expenditures in connection with the manufacture and distribution of COVID-19 vaccines and other projects of Pfizer or any of its subsidiaries that have environmental and/or social benefits.

Ra Medical Sells Dermatology Business To STRATA Skin

Ra Medical Systems, Inc. RMED announced the sale of its Pharos dermatology business to STRATA Skin Sciences, Inc. SSKN for $3.7 million in cash. The Pharos excimer laser is FDA-cleared for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.

Separately, Ra Medical reported second-quarter results, showing a modest increase in revenues and a narrower loss.

In premarket trading, Ra Medical shares were slipping 7.36% to $2.77, while STRATA Skin shares were advancing 7.47% to $1.44.

Related Link: The Week Ahead In Biotech: Fate Therapeutics Data Readout, RenovoRx IPO In Focus Amid Tapering Earnings News Flo

Bristol-Myers Squibb Regulatory Applications For Opdivo Combo Therapies Accepted For Review In Europe For Esophageal Cancer

Bristol-Myers Squibb Company BMY announced the European Medicines Agency has validated its Type II variation marketing authorization applications for both Opdivo in combination with Yervoy and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Validation of these applications confirm that the submissions are complete and begins the EMA's centralized review process.

Helius Medical's PoNS Device Gets Breakthrough Designation For Gait, Balance Deficits Following Stroke

Helius Medical Technologies, Inc. HSDT announced it has received breakthrough designation from the Food and Drug Administration for its PoNS device with the proposed indication for use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over.

The stock was jumping 23.68% to $17.76 in premarket trading.

Gritstone Bio Gets CEPI Funding For COVID-19 Vaccine Study

Gritstone bio, Inc. GRTS announced that it has entered into a funding agreement of up to $20.6 million with the CEPI to advance the development of Gritstone's CORAL Phase 1 COVID-19 vaccine program with an initial focus in South Africa.

The stock was rising 2.63% to $8.21 in premarket trading.

Geron Expedites Timeline For Topline Data Readout From IMerge Phase 3 Trial

Geron Corporation GERN said 91% of the planned enrollment in IMerge Phase 3 evaluating imetelstat in lower risk myelodysplastic syndrome has been achieved. The company expects the trial to be fully enrolled in the fourth quarter of 2021.

In addition, the expected timing for top-line results in IMerge Phase 3 has been accelerated by three months to the first quarter of 2023, Geron said.

OncoSec Sets Up Leadership Committee To Oversee Development Of Lead Asset, Announces Departure Of Interim CEO

OncoSec Medical Incorporated ONCS announced the establishment of a leadership committee consisting of three board members — Margaret Dalesandro, Herbert Kim Lyerly and Yuhang Zhao — to lead all development efforts, with a focus on the lead asset Tavo.

The company also said, effective immediately, OncoSec's interim CEO Brian Leuthner will be leaving the company. The search for a permanent CEO has been actively underway since late June.

Click here to access Benzinga's FDA Calendar

Tiziana Announces Publication Of Positive Data For COVID-19 Antibody Treatment, To Begin Phase 2 Proof-Of-Concept Study

Tiziana announced publication of a peer-reviewed article on data from the clinical study of its intranasally administered monoclonal antibody Foralumab in the treatment of mild-to-moderate COVID-19 patients in Brazil.

The treatment was well-tolerated and produced significant reduction in lung inflammation as assessed by computerized tomography scanning, and this anti-inflammatory effect of treatment was strongly supported by a reduction in serum levels of pro-inflammatory biomarkers Interleukin-6, IL-18 and C-reactive protein, the company said.

Tiziana said it will shortly initiate a Phase 2 proof-of-concept study in Brazil to evaluate safety, tolerability and efficacy of intranasal Foralumab in a larger number of hospitalized patients with COVID-19.

The stock was up 7.1% at $1.80 in premarket trading.

Lumos Gains On Insider Buying

Lumos Pharma, Inc. LUMO said in a filing with the SEC that Kevin Lalande, a director, through the Sante Health Venture II fund, bought 93,000 shares in the company.

In premarket trading, the stock was adding 3.26% to $8.23.

Earnings

Biocept, Inc. BIOC said its second-quarter revenues climbed from $917,000 in 2020 to $12 million in 2021, thanks primarily to RT-PCR COVID-19 testing. The net loss per share narrowed from 51 cents to 14 cents.

The stock was down 7.39% at $3.51 in after-hours trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates