The Daily Biotech Pulse: Moderna Invests In Africa, Amgen Announces Neuroscience R&D Collaboration, Decision Day For Chemocentryx, Biophytis To Restate Results

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 Oct. 6)

Enanta Pharmaceuticals, Inc. ENTA
Legend Biotech Corporation LEGN
Opiant Pharmaceuticals, Inc. OPNT

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 6)

4D Molecular Therapeutics, Inc. FDMT
Acutus Medical, Inc. AFIB
Adverum Biotechnologies, Inc. ADVM
Akoya Biosciences, Inc. AKYA
Amgen Inc. AMGN
Angion Biomedica Corp. ANGN
Applied DNA Sciences, Inc. APDN
Applied Genetic Technologies Corporation AGTC
Applied Molecular Transport Inc. AMTI
Aptinyx Inc. APTX
Aravive, Inc. ARAV
Assertio Holdings, Inc. ASRT
Avenue Therapeutics, Inc. ATXI
Aytu Biopharma, Inc. AYTU
Aziyo Biologics, Inc. AZYO
BiondVax Pharmaceuticals Ltd. BVXV
BioSig Technologies, Inc. BSGM
BioVie Inc. BIVI
Black Diamond Therapeutics, Inc. BDTX
Caladrius Biosciences, Inc. CLBS
Calliditas Therapeutics AB (publ) CALT
CASI Pharmaceuticals, Inc. CASI
Catalyst Pharmaceuticals, Inc. CPRX
Cellectis S.A. CLLS
Chemomab Therapeutics Ltd. CMMB
China SXT Pharmaceuticals, Inc. SXTC
CureVac N.V. CVAC
DICE Therapeutics, Inc. DICE
DURECT Corporation DRRX
Eiger BioPharmaceuticals, Inc. EIGR
Ensysce Biosciences, Inc. ENSC
Esperion Therapeutics, Inc. ESPR
Forte Biosciences, Inc. FBRX
Gain Therapeutics, Inc. GANX
Galapagos NV GLPG
Galecto, Inc. GLTO
Gamida Cell Ltd. GMDA
Glaukos Corporation GKOS
Graphite Bio, Inc. GRPH
Harpoon Therapeutics, Inc. HARP
HCW Biologics Inc. HCWB
Heron Therapeutics, Inc. HRTX
Histogen Inc. HSTO
HOOKIPA Pharma Inc. HOOK
Hoth Therapeutics, Inc. HOTH
IMARA Inc. IMRA
Immunic, Inc. IMUX
Immuron Limited IMRN
Incyte Corporation INCY
Indaptus Therapeutics, Inc. INDP
Inhibikase Therapeutics, Inc. IKT
InMed Pharmaceuticals Inc. INM
Kala Pharmaceuticals, Inc. KALA
Kaleido Biosciences, Inc. KLDO
Kiniksa Pharmaceuticals, Ltd. KNSA
Kiromic BioPharma, Inc. KRBP (announced departure of CFO)
Liminal BioSciences Inc. LMNL
Lipocine Inc. LPCN
Lixte Biotechnology Holdings, Inc. LIXT
Longeveron Inc. LGVN
LumiraDx Limited LMDX
MaxCyte, Inc. MXCT
Mesoblast Limited MESO
Minerva Neurosciences, Inc. NERV
Moleculin Biotech, Inc. MBRX
MorphoSys AG MOR
Nautilus Biotechnology, Inc. NAUT
Neovasc Inc. NVCN
NeuroBo Pharmaceuticals, Inc. NRBO
NRx Pharmaceuticals, Inc. NRXP
Nuwellis, Inc. NUWE
Oncorus, Inc. ONCR
Orchard Therapeutics plc ORTX
Oyster Point Pharma, Inc. OYST
Orphazyme A/S ORPH
Pasithea Therapeutics Corp. KTTA
Petros Pharmaceuticals, Inc. PTPI
Pluristem Therapeutics Inc. PSTI
POINT Biopharma Global Inc. PNT
Protara Therapeutics, Inc. TARA
PTC Therapeutics, Inc. PTCT
Rockwell Medical, Inc. RMTI
Roivant Sciences Ltd. ROIV (listed Friday following a SPAC deal)
Sangamo Therapeutics, Inc. SGMO
Solid Biosciences Inc. SLDB
Spectrum Pharmaceuticals, Inc. SPPI
Spruce Biosciences, Inc. SPRB
Stoke Therapeutics, Inc. STOK
Surrozen, Inc. SRZN
Talis Biomedical Corporation TLIS
TCR2 Therapeutics Inc. TCRR
Teligent, Inc. TLGT
Titan Pharmaceuticals, Inc. TTNP
Tiziana Life Sciences PLC TLSA
Trevi Therapeutics, Inc. TRVI
Vertex Pharmaceuticals Incorporated VRTX
Viveve Medical, Inc. VIVE
XBiotech Inc. XBIT

Stocks In Focus

Moderna To Build Vaccine Manufacturing Facility In Africa With Capacity Of 500M Doses/Year

Moderna, Inc. MRNA announced it will build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50 µg dose level.

The company said it anticipates investing up to $500 million in this new facility, which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site. The company expects to begin a process for country and site selection soon.

NeuroMetrix Files For FDA Clearance For Quell Wearable Neuromodulation Device For Treating Fibromyalgia

NeuroMetrix, Inc. NURO said it has submitted a De Novo request to the U.S. Food and Drug Administration for Quell as a prescription treatment for the symptoms of fibromyalgia in adults.

Quell is an advanced, non-invasive, neuromodulation device that is covered by 18 U.S. utility patents. It is the only wearable neuromodulator that is enabled by a proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card.

The stock was up 16.82% at $10.70 in premarket trading.

Denali Presents Positive Early Stage Data For 2 ALS Treatment Candidates

Denali Therapeutics, Inc. DNLI announced positive Phase 1 clinical results and regulatory progress for two investigational small molecule therapeutics in development for the treatment of amyotrophic lateral sclerosis at the 2021 Annual Northeast ALS Meeting.

"DNL343 and SAR443820 are designed to modulate distinct biological pathways implicated in ALS, including the integrated stress response and inflammation, respectively. We are pleased that the data generated preclinically and in Phase 1 studies support clinical investigation of both molecules as potential treatments for individuals with ALS," said Carole Ho, Denali's chief medical officer.

Denali is partnering with Sanofi SNY for the development of SAR443820. The companies plan to launch the Phase 2 HIMALAYA trial in adults with ALS in early 2022.

Amgen Announces Neuroscience R&D Collaboration With Neumora

Amgen announced a strategic collaboration agreement with Neumora Therapeutics, Inc.to advance neuroscience discovery, development and commercialization. The companies will collaborate on programs by applying Neumora's proprietary precision neuroscience platform to insights generated by Amgen's deCODE genetics and human data research capabilities.

Neumora also received a $100 million equity investment from Amgen and acquired exclusive global rights to develop and commercialize Amgen programs targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases.

Amgen shares were up 0.71% at $211.47 in premarket trading.

Brickell Biotech Reports Positive Phase 3 Studies Of Sofpironium Bromide Gell For Excessive Underarm Sweating

Brickell Biotech, Inc. BBI announced positive topline results from the Phase 3 pivotal Cardigan I and Cardigan II studies, which evaluated sofpironium bromide gel, 15% as a once daily topical formulation in patients with primary axillary hyperhidrosis.
The company said it plans to submit a new drug application to the NDA by the middle of 2022.

The shares were rallying 31.15% to 86.85 cents in premarket trading.

Bristol-Myers Squibb's Deucravacitinib Flunks Midstage Ulcerative Colitis Study

Bristol-Myers Squibb Company BMY announced the Phase 2 LATTICE-UC study evaluating deucravacitinib compared to placebo in moderate to severe ulcerative colitis did not meet the primary efficacy endpoint of clinical remission at week 12, nor secondary efficacy endpoints.

The stock was down 1.59% at $58.25.

Biophytis To Restate Financial Statements For Fiscal Years 2019, 2020 To Correct Accounting Treatment Of Convertible Notes

Biophytis SA BPTS announced that its previously issued audited consolidated financial statements for the fiscal years ended Dec. 31, 2019 and 2020 and unaudited consolidated financial statements for the six-month periods ended June 30, 2021 and 2020 will be restated to correct the its accounting treatment of its convertible notes.

The company said it is in the process of evaluating the impact of these corrections on its financial statements for the affected periods, adding that it does not believe the corrections will affect the cash position.

Biophytis also said it expects, as soon as it is reasonably practical, to file restated financial statements on Form 20-F/A for the years ended Dec. 31, 2019 and 2020, and furnish restated financial statements for the half years ended June 30, 2020 and 2021 on Form 6-K.

CytoDyn Appoints New Execs To Assist With Leronlimab BLA Resubmission, Announces Start Of Breast Cancer Study

CytoDyn Inc. CYDY announced the appointments of Christopher Recknor as senior executive VP of Clinical Operations and Nitya Ray as the chief operating officer.

CytoDyn said it is realigning its management structure to optimize the biologic license application resubmission process for leronlimab in HIV and to advance clinical development potential.

Separately, the company announced an investigator-initiated study for treating triple-negative breast cancer with leronlimab in a humanized TNBC xenograft model.

The study is intended to determine the potential synergistic therapeutic efficacy of leronlimab in combination with immune checkpoint blockade to attempt to raise the standard of care for breast cancer patients, CytoDyn said.

Miramatrix Announces Successful Completion Of Bioengineered Liver Transplant Into Large Animal

Miromatrix Medical Inc. MIRO said it has successfully completed the first ever heterotopic implant of its bioengineered liver transplant into a large animal. The transplant was part of a preclinical study in collaboration with researchers at Mayo Clinic, designed to assess the initial transplantation and functionality of a bioengineered liver in an acute liver failure model.

Offerings

Osmotica Pharmaceuticals, plc OSMT announced that it has commenced an underwritten public offering of its ordinary shares and warrants to purchase its ordinary shares.

The stock was plunging 32.35% to $2.07 in premarket trading.

Click here to access Benzinga's FDA Calendar.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on ChemoCentryx, Inc. CCXI's new drug application for avacopan as a treatment for ANCA-associated vasculitis. After a split Adcom verdict, the FDA extended the review period by three months, thereby pushing forward the PDUFA date.

ANCA-associated vasculitis is a systemic disease in which overactivation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This leads to organ damage and failure, mainly the kidney, and is fatal if not treated.

Clinical Readouts/Presentations

Presentations at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

Prelude Therapeutics Incorporated PRLD: data from the dose escalation portion of the Phase 1 trial of PRT543 in unselected solid tumor patient populations; data from the dose escalation portion of the Phase 1 trial of PRT811 in solid tumors and high-grade gliomas

Turning Point Therapeutics, Inc. TPTX: update from the Phase 2 registrational trial of repotrectinib in TKI-pretreated patients with ROS1+ advanced non-small cell lung cancer and with NTRK+ advanced solid tumors (9 a.m.)

Bicycle Therapeutics plc BCYC: data from Phase 1/2 study of BT5528 in patients with advanced malignancies associated with EphA2 expression (12:50 p.m.)

Turning Point & Zai Lab Limited ZLAB: Preliminary interim Phase 1 data of elzovantinib (TPX-0022) in patients with advanced solid tumors harboring genetic alterations in MET (9 a.m.)

Forma Therapeutics Holdings, Inc. FMTX: initial results from the Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer

ORIC Pharmaceuticals, Inc. ORIC: initial results from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with Pfizer, Inc. PFE's Xtandi in patients with metastatic prostate cancer (9 a.m.)

Earnings

IPOs

Theseus Pharmaceuticals, Inc. THRX said it has priced its upsized initial public offering of 10 million shares at $16, which is the upper bound of the estimated price range of $14-$16. The shares of the Cambridge, Massachusetts-based biopharma, which is engaged in the development of targeted cancer therapies, will begin trading on the Nasdaq under the ticker symbol "THRX."

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