Docoh
Loading...

Thu. 7 Oct 2021, 8:23am ETBenzinga
In: Biotech, News, Penny Stocks, Offerings, Small Cap, FDA

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. (NASDAQ:ENTA)
  • Legend Biotech Corporation (NASDAQ:LEGN)
  • Opiant Pharmaceuticals, Inc. (NASDAQ:OPNT)

Down In The Dumps

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

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

Stocks In Focus

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

Moderna, Inc. (NASDAQ: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. (NASDAQ: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. (NASDAQ: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 (NASDAQ: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.

Related Link: The Week Ahead In Biotech (Oct. 3-9): ChemoCentryx FDA Decision, Conference Presentations, IPOs And More

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

Brickell Biotech, Inc. (NASDAQ: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 (NYSE: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 (NASDAQ: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. (OTC: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. (NASDAQ: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 (NASDAQ: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. (NASDAQ: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 (NASDAQ: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. (NASDAQ: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 (NASDAQ: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 (NASDAQ: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. (NASDAQ:FMTX): initial results from the Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer

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

Earnings

IPOs

Theseus Pharmaceuticals, Inc. (NASDAQ: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."

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